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Item 1. Business

2025-03-10 compared with 2024-03-28 · 604 added, 365 removed, 1012 unchanged (49% of the section changed)

Dario is revolutionizing how people with chronic conditions manage their health through the innovation of a new category of digital health:

Digital Therapeutics as a Service (“DTaaS”).

We believe that our innovative approach to digital therapeutics disrupts the traditional provider-centered system of healthcare delivery by offering user-centric care that is continuous, customized supportive of better overall health.

Our solutions combine the power of technologies and behavior science to make better health accessible, affordable, and easy for all by solving for what people need, when and where they want it, with hyper-personalized care that is always connected – to services, devices, and people – and delivered continuously.

Our solutions are proven to drive savings for health plans and employers by improving the health of their populations.

Twill, a company which we recently acquired, is a global, digital-first solution with a mission to improve the mental and physical health of people everywhere.

Through Twill, we provide personalized and connected care that accelerates access to mental health and well-being through highly engaging evidence-based programs, supportive communities, human-led coaching and therapy.

Twill’s solution is used by enterprises, health plans, pharmaceutical companies, and individuals around the world, and is available globally in 10 languages, covering more than 18 million lives.

During the last few years, our strategy has been to evolve from point solution to a comprehensive multi condition platform.

We have pursed this strategy since 2021, resulting in various acquisitions and the recent acquisition of Twill.

We believe that digital health is undergoing a massive transformation, as innovators evolve from offering point solutions to more integrated approaches.

We believe that we are uniquely poised to answer that call and usher in the next generation of digital health.

Twill Acquisition

With the integration of Twill, we believe that we can achieve multiple advantages as well as synergies in multiple fronts:

Product offering

Commercial channels

Improved clients and member experience and economics

Improved financial profile with accelerated path to profitability.

Product Offering

With Twill, we believe we have created the most comprehensive and engaging digital health platform to provide best-in-class support for mental well-being, maternal health, and the costliest chronic conditions.

We believe that this unified approach will meet people where they are on their health journey and accelerate access to personalized support and connected care.

With the combination of Twill, we also plan to tap into navigation technology “Twill Care” that helps take over the top of the funnel and help employers and health plans to enroll more members into the platform.

With a unified platform, we believe that our platform addresses multiple health needs in a seamless user experience and represents a significant step forward to unlock the value of digital health for our members, clients, and partners.

In addition, following the acquisition of Twill, we now have a combined wealth of data and insights across individual care journeys to guide strategy across a wide range of health needs.

As a result, we believe that our unified set of solutions, delivering best-in-class outcomes, are now ready to optimize and scale for greater impact.

Commercial Channels

Following the acquisition of Dario and Twill, we are sharing the exact same channels for product offering delivery:

● Health Plans

In our experience over the last few years, we believe that payers would like to utilize one integrated solution.

We now have synergies with Twill where we can offer such an integrated solution.

In addition, our acquisition of Twill creates immediate scale, with four of the five top health plans, multiple Fortune 100 employers, and several major pharmaceutical companies as customers.

Improved client and member experience and economics

Following the acquisition of Twill, we believe we will see a significant improvement in higher revenue per every dollar invested into sales and marketing.

We expect improvement in all metrics:

more eligible lives to support, improved enrollment rate, higher engagement, and also higher revenue per user on average from total lives.

It all starts with the ability to deliver a streamlined and holistic member journey.

With industry-leading activation rates, Twill’s immediate access to mental health and well-being support significantly expands our reach across populations.

We are then able to keep members engaged through a variety of health and condition areas to meet their dynamic needs.

We use billions of consumer data insights to drive 80% retention after one year.

Addressing each person’s well-being is the key to delivering lasting behavior change.

We are aiming to reach more people by providing them with an approachable entry point to care and a more holistic solution to whole body health.

The acquisition of Twill allows us to do more in one place, incorporating some of the most common and interconnected health conditions, to drive more value for both members and customers.

Not only does the combination of our complementary solutions address the market need for more integrated solutions but the combination of two digitally led companies enables us to continue innovating without the usual requirements for deep investment to deliver the ultimate value for our stakeholders’ better outcomes at lower cost to accelerate profitability.

Improved financial profile

We believe that the synergies following our acquisition of Twill are also on the organization and operations levels, as both companies are technology companies operating in the health care industry and focusing on the consumer to achieve clinical performance.

Given the synergies above we anticipate improvement in the combined entity financial profile including the potential for 30% annualized cost synergies within two years, a potential increase in revenues on a pro forma basis, an increase in margins and an accelerated path to profitability in 2025 through revenue scale, increased gross margins and cost synergies.

We began as a direct-to-consumer digital therapeutics company, solving first for the problem of how to engage users and support behavior change to improve clinical outcomes in diabetes.

Beginning in 2020, Dario enacted a strategic shift to transform the business model by deploying a business-to-business-to-consumer (“B2B2C”) approach, leveraging the strengths of our consumer solution platform to enable commercial growth opportunities in traditional health business channels by selling to health plans and employers.

At the same time, we expanded from a single-condition platform to a multi-condition platform, creating a robust suite of solutions to address the five most commonly co-occurring, behaviorally driven, and expensive chronic conditions, which are also representative of some of the most sought-after digital health solutions:

diabetes, hypertension, pre-diabetes/weight management, musculoskeletal and behavioral health.

After building weight loss and hypertension management into the legacy diabetes platform, we made three acquisitions in order to expand into musculoskeletal (“MSK”) and behavioral health (“BH”).

In that regard, we acquired Upright Technologies Ltd.

(“Upright”), PsyInnovations Inc.

(“PsyInnovations”) and Physimax Technology assets to expand into the fields of MSK and BH.

Our approach to integrating all solutions into one digital therapeutics platform follows the “best-of-suite” offering design principal which provides the user one place to monitor all identified chronic conditions and to deliver a seamless user experience for commonly co-occurring chronic conditions.

These two shifts led to the rapid expansion of our B2B2C business over the last two years and positioned the company for success in commercial markets.

We continue to achieve key benchmarks as we rapidly scale our B2B2C model, including more than 100 total signed contracts as of today and the shift in our commercial pipeline where more than 50% of the contracts signed in the second half of 2022 are for multi-chronic solutions.

We believe we have a unique and defensible position in the market thanks to our unique solution origin in consumer markets.

In that regard, we have worked with various health care plans, including Aetna, to provide our platform to their members.

In January 2024, we launched the Aetna platform with several customers, and we have continued to add customers that are planned for launches through the second quarter of 2024.

We have already seen a strong start to the 2024 employer sales cycle with larger opportunities compared to 2023.

We anticipate additional health plan customers in 2024 directly and through our partners that cover more than 87 million members.

We continue to generate a significant number of clinical publications.

In that regard, we have published 47 real world data studies with total of 10 generated in 2022, 10 generated in 2023, and several more planned for 2024.

Business Overview

We are a leading global digital health company with a mission to power the behavior changes that drive better health.

We are committed to transforming healthcare by delivering a comprehensive and highly engaging whole-person health platform, which enables us to create a future where healthy change is effortless and accessible to all.

At the core of our mission and vision is engagement.

We believe that most existing digital health solutions in the market fail to deliver improved health outcomes because users are not engaged due to a lack relevance, personalization, consumerization, and longitudinal data and information.

We, and our acquired companies, first commercialized our digital behavioral health products in the direct-to-consumer (“D2C”) marketplace, and we continue to use the D2C marketplace as a sandbox and laboratory to innovation.

These consumers pay for these digital health products out of their own pockets and are therefore the most value driven among all healthcare consumers.

These consumers demanded that we deliver highly engaging user experiences that deliver strong clinical health outcomes for which consumers will pay.

The bottom line is that if users are not engaged in digital solutions over a long period of time, they cannot change their behavior and they cannot get healthier – we first deliver engagement followed by sustained behavior change that then leads to measurable health outcomes and improvement.

We believe that our D2C marketplace roots and continued focus delivers better user experiences, longer sustained engagement, stronger clinical outcomes, at the most affordable prices, that then delivers the highest return on investment (“ROI”) in the industry.

Our whole-person health model includes the following five elements:

Physical Health:

Focuses on the prevention, and treatment of physical ailments;

primarily cardiometabolic and musculoskeletal conditions.

Mental Health:

Addresses emotional and psychological well-being, including stress management, as well as clinical anxiety, and depression across all levels of severity.

Social and Environmental Factors:

Considers influences like socioeconomic status, community resources, housing, and education.

Individualized Care:

Tailored user journey and care plans that respect personal goals, cultural values, and life circumstances.

Integration of Clinical Services:

Combines different healthcare providers and systems to deliver seamless care for both physical and mental health needs.

We have created our whole-person healthcare solution through both organic development and acquisitions of leading companies across several therapeutic areas.

As a digital health consolidation leader, we have acquired companies that have spent over a decade and nearly $525 million, in combination with our own investment, to develop and deliver the most engaging whole-person health platform in the market to empower individuals to achieve their optimal health through data-driven, precision artificial intelligence (“AI”) personalized care solutions that integrate the management of physical and mental health needs.

Leveraging advanced analytics, data-driven AI precision and personalization, a deep understanding of consumer behavior, user-centric technology, and a holistic approach, we provide tailored interventions that meet the unique needs of each user to deliver the health industry’s highest levels of user activation and sustained engagement.

Our digital self-care solutions ensure optimal levels of clinical outcomes with the highest levels of clinical efficacy by empowering users to overcome the psychological, social, and physical barriers to effective and sustainable behavior change.

With our whole-person digital health platform, we address a broad range of health needs, including chronic condition management (e.g., diabetes, hypertension, obesity, and musculoskeletal issues), behavioral health (e.g., stress, anxiety, and depression), and preventive care.

By integrating digital therapeutics and well-being solutions with real-time data monitoring and access to professional care teams, we ensure an AI driven adaptive and continuous care experience that combines digital self-care, with virtual coaching, and virtual clinical care.

As of 2024, our eligible user base spans millions of individuals worldwide, supported by partnerships with employers, health plans, pharmaceutical companies, and providers aiming to deliver instant access to the highest quality and most effective self-care and virtual human care that delivers the optimal level of clinical utilization to ensure the best value and outcomes to our users and customers.

We serve four primary market segments that drive our business model.

Our historic roots, as well as those of our largest acquisition, Twill, Inc.

(“Twill”), began in the D2C market, which has forced us to create what we consider the industry’s most engaging and effective self-care whole-person digital health solutions;

and we continue to operate in the D2C market in the U.S.

by providing our chronic condition management and patient engagement solutions across many different health conditions.

In addition, we use the D2C market as an innovation laboratory to develop and test new features and benefits to ensure that these innovations meet our high engagement and outcomes standards before deploying them in the business-to-business (“B2B”) market.

From our D2C origins, Dario and Twill expanded into similar B2B market segments over the past seven years such that these market segments now represent three-fourths of our current revenues.

These B2B market segments include medium-to-large employers, national and regional health plans, and global pharmaceutical companies.

Our medium-to-large employer market segment is focused on employers with over 1,000 employees and currently includes three of the five largest global technology companies and one of the two largest employers in the United States.

In total, we had 53 employer customers in 2024.

We seek to provide solutions to their employees that address the primary areas of health condition focus on by employers for meaningful costs savings that can deliver high and sustainable returns on investment, which can exceed 5:1.

In this market segment, we go to market through a direct sales force, consultants, brokers, and channel partners that sell our solutions to their health plan and employer customers.

Our health plan customers include five of the nation’s largest organizations where we provide our solutions to their members both nationally and regionally.

We have particularly specialized in providing its behavioral health offering to Medicare and Medicaid members, where we have established itself as the most engaging and effective solutions among these demographics.

We are now leveraging this Medicare and Medicaid behavioral health specialty to expand access to its other chronic condition solutions to these populations.

We go to market primarily through our own sales force and partners with large national health plans and other channel partners.

In 2018, Twill began to expand its offering to pharmaceutical companies, and in 2022 we entered into our first pharmaceutical company partnership.

We now deliver these combined capabilities on our engagement platform to the pharmaceutical industry to provide three value propositions:

1) Top of the Funnel education and awareness to help companies find new patients for their treatments, 2) Mental and physical health support to improve medication adherence, persistence, and compliance, 3) Patient journey data analytics to better understand and target patients to get the right therapy to the right patient at the right time.

We have provided our engagement platform services to a dozen global pharmaceutical companies across nearly as many medical conditions.

We have a dedicated team with many years of experience selling into the pharmaceutical industry.

How We Generate Revenue

All of our customers have an interest in value-based health outcomes and care and have begun to work with us to align various types of outcomes with innovative revenue models.

We differentiate ourselves versus our competitors by being willing to enter into risk-based agreements with performance guarantees that align the financial incentives with the employer, health plan, employee, plan member, and we deliver the best health outcomes at the most affordable price, thereby delivering the highest ROI.

Across all market segments, we follow a digital health engagement platform subscription revenue model that is priced upon either a per user population basis (“PMPM”) or a per engaged user basis (“PEMPM”), and in some cases a customer may employee both pricing options together.

These revenue models can also include milestone-based payments, as well as performance guarantees.

Our digital health platform subscription model applies across our various product and therapeutic areas of focus.

We have the following product offerings with the engagement platform subscription revenue models:

Dario Connect (Well-being) – Our free D2C user engagement offering activates users, educates them, and encourages them to take the next best action on their patient journey.

It is a digital front door to all other Dario products, as well as to our customer’s other digital offerings.

For pharmaceutical companies, Dario Connect is used to create engaged communities around specific health conditions to increase awareness and education so that they will seek access to the most effective medication prescriptions.

Previous claims-based analysis of script conversion completed by third parties demonstrated a 10:1 ROI for pharmaceutical companies who subscribed to this service.

For pharmaceutical companies, their subscription fees are a function of the therapeutic area, the complexity of the patient journey, number of patients targeted, and platform configuration required to meet the needs of these patients.

Among employers, this offering is used to increase access to our product benefits among non-employee dependents, and the payment for this service is included in the subscription for the primary product purchased for the various conditions addressed.

For health plans, it provides support to patients across a broad array of medical conditions.

Dario Mind (Mental Health) – Our behavioral health offering decreases the symptoms of stress, anxiety, and depression by 25-30% in 8 weeks or less when used as directed.

Many users will continue to use the product for many months and even years, with sustained engagement rates of close to 60% at 2 months, 40% at 12 months, and 30% at three years.

Most of our customers see mental health condition prevalence among their employees at 20%.

This is a digital first offering for empowered digital self-care that is then augmented with virtual coaching, and/or virtual clinical care from therapists and/or prescribers to address the needs of users across all levels of clinical severity.

Customers can pay for digital self-care and virtual coaching on either a PMPM or PEMPM basis.

When adding clinical care services, these can be paid for on a fee-for-service (“FFS”) basis, PMPM, or PEMPM basis, and is only offered through our B2B sales channel.

We find prevalence of mental health conditions to be around 20% among employer and health plan populations, and more than 50% among some pharmaceutical company therapeutic areas of focus.

Dario Health (Diabetes) – Combining our proprietary glucometer as well as our Dario Health digital self-care application and virtual coaching, Dario Health for diabetes delivers the highest level of A1c reduction among the leading digital health

companies focused on diabetes, of between 1.4 and 2.3 points, depending on the patients’ initial baseline.

This is offered through both our D2C and B2B sales channels.

In the B2B sales channel, we see prevalence of this condition between 8-10% for most employers and health plans.

Studies completed with a top 20 pharmaceutical company using claims data suggested total medical cost savings for patients using this solution reaching $5,000 per year.

Customers can pay for digital self-care and virtual coaching on either a PMPM or PEMPM basis.

Dario Health (Hypertension) – We include our own proprietary blood pressure cuff with our Digital Health self-care application and virtual coaching.

Clinical research has demonstrated that more than two-thirds of users with Hypertension stage 1 levels experience a 13mmHg reduction in systolic blood pressure when used as directed.

As hypertension is one of the most prevalent conditions among adults in the United States, we find that among health plans and employers this solution is useful to 35% or more of their employees and members.

This is offered through both our D2C and B2B sales channels.

Customers can pay for digital self-care and virtual coaching on either a PMPM or PEMPM basis.

Dario Health (Weight management and GLP-1) – 30.7% of the U.S.

population is overweight with about 42.4% being obese, meaning they have a body-mass index (“BMI”) of 30 or greater, creating the greatest level of prevalence among all of our product offerings.

The recent introduction of GLP-1 medication has also increased the interest in this solution.

We believe that we have demonstrated that our digital self-care solution, with our proprietary weight scale, Dario Health app and virtual coaching, delivers the industry’s highest level of digital self-care weight loss, at 10%, over 12 months.

By educating users and helping them change their diet, exercise, and sleep behaviors, users can keep the weight off.

We have modified our core offering to complement GLP-1 onboarding and offboarding, as well as GLP-1 prescription services.

We offer this through B2B sales channels.

Customers can pay for digital self-care and virtual coaching on either a PMPM or PEMPM basis.

In 2024, we provided our GLP-1 offering to 20% of our employer customers, and we expect this to increase due to the strong demand for GLP-1s among patients and employers.

Dario Move (MSK) – Pain is one of the primary reasons for employees missing work and it is one of the key drivers of healthcare costs.

Dario Move focuses on improving posture to alleviate pain with its proprietary medical device used with its Dario Move application and virtual coaching.

We find that prevalence among employers is nearly 25%.

This solution is only sold on a B2B and D2C basis, and is generally combined with our other offerings, and can be paid for on either a PMPM or PEMPM basis.

Bundled Full-suite or Partial-suite – While any one of our solutions can be subscribed to individually, increasingly employers and health plans are seeking vendors who are no longer point solution providers but who can consolidate multiple condition offerings into a single offering with one simple price.

To accommodate these market demands, we now increasingly provides subscriptions for its full-suite or partial-suite on a PMPM or PEMPM basis, where additional clinical network services can be added on either a FFS basis or added to the PMPM or PEMPM subscription pricing.

As one of the only whole-person digital health companies with a full suite of cardiometabolic, behavioral health, and musculoskeletal solutions, we believe that we have a competitive advantage with our bundled offering.

Why We Have Confidence in Our Digital Offerings

We have developed a comprehensive body of research, encompassing over 90 studies, that have demonstrated the transformative potential of our digital health solutions in advancing clinical care.

We believe that these findings emphasize the platform’s ability to deliver long-term sustainable outcomes, including durable results over three years, while showcasing scalability with outcomes for more than 100,000 members.

We have established ourselves as a pioneer in the digital health sector, being the first to analyze multi-condition impacts by exploring relationships such as blood glucose and blood pressure, as well as blood glucose and weight monitoring.

This work spans diverse clinical domains, including diabetes, hypertension, weight loss, pain, depression, and anxiety.

Among diabetes users, significant improvements were recorded, i.e.

those with a baseline HbA1c greater than 9, with a 2.3-point reduction in HbA1c compared to a 1.8-point reduction among non-Dario users.

Additionally, our members achieved substantial cost savings of $5,077 per person annually, driven by reductions in all-cause healthcare resource utilization (“HCRU”) and office visit costs.

These outcomes are underpinned by the demonstrated effectiveness of behavioral engagement, which serves as a critical driver of improved clinical results.

Collectively, these achievements position us as a leader in digital health, delivering enhanced care and meaningful economic value.

The following provides a summary of many of our clinical research findings that support our claims to improving user clinical, health, and economic outcomes.

• 28% reduction in depression and anxiety symptoms

• 2.0 reduction in A1c

• 10% reduction in weight

• 10% reduction in blood pressure

• 10% improvement in medication adherence

• 50% reduction in pain

• $2,323 annual medical cost savings from behavioral interventions

• $5,077 annual medical cost savings from cardiometabolic interventions

Competitive Strengths

Our competitive advantage has emerged from our founding roots as a D2C company, that required us to develop the most engaging self-care digital behavioral programs and medical devices.

Over more than a decade and over $500 million investment in technology, we have completed over 90 studies on the various whole-person health offerings to demonstrate their first-in-class clinical and health outcomes that results for a combination of high levels of sustained user engagement and highly effective clinically validated behavior change.

We expanded from our initial diabetes focus to now include hypertension, obesity, weight management, musculoskeletal pain, stress, anxiety, and depression, that are all offered from the same digital health platform and can be bundled together or sold individually.

By collecting billions of data points across all these health conditions over a decade, we have developed and commercialized it AI driven personalization that magnifies all of our competitive advantages to deliver more valuable results for users and customers.

Claim-based analysis of our users has shown that we generate the highest ROI for its customers, whether they be employers, health plans, or pharmaceutical companies.

D2C Roots Ensured Highest Levels of Engagement

Unlike most of our competitors, we have always operated in the D2C market, and we continue to operate in both the D2C market as well as the B2B market, where the former drives rapid innovation cycles that require accelerated deployment of new features that can then be provided to our B2B customers.

This ensures that our whole-person health platform continues to be highly intuitive and engaging so that it drives high user satisfaction and sustained engagement, ensuring better adherence to care plans that deliver the highest levels of quality outcomes and the industry’s leading ROI.

Across all our offerings, we have had over 5 million users with billions of datapoints that have enabled the company to A/B test thousands of product features and functions and measure which deliver the highest levels of engagement.

Clinical Validation of The Highest Levels of Health Outcomes

Over more than a decade, we have completed over 90 randomized controlled trials (“RCTs”), real-world evidence studies (“RWE”), observational studies, interventional studies, and insurance-claims-based analysis.

These have demonstrated our ability to generate best-in-class clinical and economic outcomes.

Such studies provide the supporting evidence and confidence for us to provide at-risk offerings, performance guarantees, and value-based care.

Integrated Whole-Person Digital Health Platform

During the past five years, employers, health plans, healthcare providers, and pharmaceutical companies have expressed “point solution fatigue,” and have begun to prune the number of point solutions vendors and instead consolidate their digital health offering with vendors that provide a whole-person portfolio that covers all the major health conditions that drive their healthcare spending.

Our whole-person digital health platform addresses these primary therapeutic areas of focus among employers, health plans, health systems, and pharmaceutical companies.

These include all areas of cardiometabolic health (e.g., diabetes, hypertension, overweight/obesity), behavioral health (e.g., stress, anxiety, and depression), and musculoskeletal pain.

In addition, we are partnering with clinical healthcare provides to provide virtual clinical care to its digital health offerings and virtual coaching.

By integrating all these onto its whole-person digital health platform, it enables a hyper personalized, seamless, and individualized experience across all relevant health needs that ensure high levels of user engagement to deliver robust clinical outcomes that exceed those of nearly all competitors across all medical conditions.

AI and Data-Driven Personalization

Our proprietary AI and machine learning algorithms deliver highly personalized health insights and interventions, ensuring relevance and efficacy for each user.

These were developed initially based upon our D2C experience with millions of users who pay out-of-pocket for our digital self-care solutions.

By leveraging billions of data points with our D2C offering, we optimize our user recruitment, activation, and engagement algorithms for first-in-class engagement.

Dario applies its AI, developed in the D2C market, to its B2B businesses to optimize the B2B businesses to enable Dario to outperform competitors in each market segment in engaging users and delivering valuable outcomes.

The Industries Highest ROIs

We have done claims-based analysis of our various offerings with its customers to measure the medical and economic outcomes that results from using its whole-person digital health offerings.

These studies support our claims for providing the digital health industry’s strongest ROIs by decreasing medical costs, increasing medication adherence, and activating and engagement users in the healthcare system more effectively than alternatives.

In addition, our offerings deliver impressive improvements in worker productivity by decreasing absenteeism, presenteeism, and healthy engagement in work.

The key to these costs savings is that we collaborate with employers, payers, pharmaceutical companies, and providers to deliver comprehensive care solutions and improve accessibility.

Across all these market segments, we power behavior change by providing digital first self-care, complemented with virtual coaching care, and then the optimal level of clinical care delivered through our clinical provider partners to accelerate access to care and improved whole-person health outcomes, at the lowest possible cost.

Our Growth Strategies

We have four core growth strategies that leverage all aspects of our whole-person digital health platform.

After the acquisition of Twill in 2024 and integrating its commercial offerings and technological platform with ours, we are now prepared in 2025 to execute our growth strategies to both drive top line growth and to do so with greater operating efficiency that we believe will enable profitable growth.

Dario Health Comprehensive Cardiometabolic Health

Our core offering is our Dario Health cardiometabolic suite that provides FDA cleared devices and a digital behavioral health experience that enables users to decrease the symptoms of hypertension, diabetes, and obesity.

Our primary market for this offering are medium-to-large sized employers that are seeking to control their chronic disease healthcare spending.

We also work with large regional health plans to provide this offering to their members and self-insured employer customers.

We provide virtual coaching to all of these users and provides access to virtual clinical services to these users as well.

We find that among employees for most employers, the prevalence of diabetes is about 10%, while hypertension is 35%, and obesity and being overweight is between 35-75%.

Dario Connect is offered with Dario Health as a free digital experience that engages users across many different medical conditions.

Users of Dario Connect participate in digital communities to learn more about their health condition, treatment options, learn from healthcare experts, including clinicians, and explore ways that they can improve their overall health.

Dario Connect acts as a gateway and digital front door to get access to all of our whole-person digital offerings, as well as to get access to our customer products and services.

Among employer customers, Dario Connect is how non-employee dependent learn about health care benefits they have access to and can access those benefits.

Users can also get access to our virtual clinic partners and services through Dario Connect.

Dario Connect is also the product that we configure for pharmaceutical companies to provide Top of Funnel awareness campaigns to help them find new patients.

Dario Mind Comprehensive Behavior Health

We have expanded our Dario Mind offering to include not only the industry leading self-care digital mental health application to decrease the symptoms of stress, anxiety, and depression, but also to provide access to virtual coaching, and virtual clinical services including virtual therapy and virtual clinical consultations, prescribing, and medication management.

We are the only provider in the market with a comprehensive whole-person digital health offering supported by RCTs that demonstrate the clinical efficacy of its digital cognitive behavioral therapy (“CBT”) and mindfulness interventions.

This offering has been deployed globally in 10 different languages among some of the world’s largest employers and health plans.

We find that among most of our employer clients, over 20% will have a meaningful mental health challenge that require some level of treatment and support that Dario Mind can provide.

In addition, we have several large pharmaceutical companies that provide Dario Mind to patients to address their comorbid stress, anxiety, and depression associated with their underlying medical condition.

By addressing these symptoms, and providing imbedded psychoeducation about their condition, we have seen medication adherence rates increase by 10-20% over 6–12-month periods.

Bundled Full Suite Offering for Body and Mind

We offer the most comprehensive whole-person digital health offering in the market and can offer it as a bundled full-suite offering to employers and health plans where these customers can pay for the full bundle under any one of several revenue models such as PMPM, PEMPM, and milestone value-based.

This full suite bundle includes Dario Mind, Dario Health, Dario Connect, and Dario Move.

When pricing the full bundle, we price this based upon expected prevalence, engagement, outcomes for each component of the full bundle.

By so doing, we believe that we can achieve meaningful economies of scale related cost savings that it can pass on to our customers and thereby deliver industry leading ROIs.

GLP-1 Opportunities with Employers and Pharmaceutical Companies

According to the Center for Disease Control (the “CDC”), 42.4% of Americans meet the BMI level of 30 for an obesity diagnosis.

In the past few years, pharmaceutical companies like Eli Lilly and Novo Nordisk have launched expensive, blockbuster GLP-1 drugs for patient who have been diagnosed as obese that have demonstrated the ability to decrease BMI by 10-20%.

Due to the success of these drugs in decreasing BMI, there are now nearly 100 drugs in the pipeline among these two pharmaceutical companies and their competitors that address many of the side effects that these drugs have with regards to tolerability, fatigue, and muscle loss.

Research indicates that 26.2% of patients discontinue GLP-1s at 3 months, with an additional 30.8 doing so at 6 mots, and 36.5% at 12 months;

with only 25% remaining on the medication after two years.

Once a patient discontinues use of the GLP-1, the typical patient regained two-thirds of their weight within one year.

For this reason, employers are eager to have their employees engaged in an effective digital behavioral health program while they are on a GLP-1 that will in crease their weight loss while on the medication and keep the weight off after discontinuation by helping the patient develop new, sustainable healthy habits.

Presently, 20% of our employer customers now subscribe to its GLP-1 offering, and we see this as an important growth engine in the future.

We have also found interest among pharmaceutical companies in providing our GLP-1 solution so support patients on their medication in developing healthy habits to improve outcomes.

Dario Flywheel Integrates All These Growth Strategies

Our strategy is to integrate all these growth strategies into a united whole through its flywheel as diagramed below, which shows how its B2B and D2C strategies feed one another to create greater value as follows:

More B2B Clients :

By getting more B2B customers it increases the number of users on the platform, which increases the data collected and used, increases the value to third-party and inhouse virtual clinical care networks, increases cross

condition and cross client monetization, such as from behavior health to cardiometabolic health, which increases the average revenue per user, and then increases the D2C users and value.

User come from both our B2B and D2C market strategies, which drives our data driven innovation, and our value to virtual human care services.

More Value Per User :

Data and associated AI, machine learning and analytics is what drives improved personalized user experience, which drives better outcomes, increased trust, more clients, and more users.

In addition, our whole-person health model creates more value per user by providing access to different kinds of care and access to virtual clinical care.

Better Health Outcomes :

As the users increase, the clients increase, the data increases with greater personalization, and expanded access to virtual human care, users achieve better health outcomes, that increase trust among both customers and users, which then increases the data, cross condition referrals.

Sales and Marketing

We employ a multi-channel sales and marketing approach designed to effectively reach diverse stakeholders.

Employer Sales

We employ a hybrid approach to the employer market due to its size and complexity.

This means that it works with brokers and consultants as well as employing a direct sales force.

Most medium-to-large employers go through a two-to-three-year request for proposal (“RFP”) cycle where they evaluate digital health vendors to select new ones based upon the value of their offering.

Our value proposition with employers is to engage their employees at the highest levels, with effective, evidenced-based behavioral interventions that deliver meaningful clinical outcomes, and show compelling evidence of ROI at twice the industry average.

We can contract directly with an employer or enable the employer to leverage their existing health plan benefits to pay for our services.

Health Plan Integration

We partner with payers to integrate our solutions into their benefit plan offerings.

We can also provide our services on either a direct basis or through its claims-based billing.

Health plans are a channel to employers as well as a channel to Medicare Advantage members.

We have our own direct-to-health plan sales force but will also leverage consultants and brokers where appropriate.

Marketing is focused on industry conferences, and highly targeted outreach.

Pharmaceutical Sales and Marketing

Many pharmaceutical companies work with consultants to identify how they can leverage digital health to complement and provide companion digital health services to support patients on their medications or to find new patients for their medications.

We will often work with these consultants to design solutions with its engagement platform for their pharmaceutical clients.

In addition, our pharma sales team will reach out to executives at pharmaceutical companies in the targeted areas we have identified to market and sell subscriptions to its engagement platform to these companies.

Its primary areas of focus are oncology, rare disease, cardiometabolic health, dermatology, and mental health.

Dario AI Creating a Hyper-personalized Digital Health Future

We are successfully integrating AI to enhance patient care, streamline operations, and drive continuous innovation on its whole-person digital health platform.

Our mission has been to empower individuals with personalized, data-driven health solutions while continuously improving clinical outcomes and healthcare efficiency.

AI has been instrumental in harnessing the power of data to deliver precise, proactive, and personalized care.

We employ curated generative AI models trained on our decade of user journey data on millions of users and large content library to derive proprietary insights not otherwise attainable from publicly available data to drive significant competitive advantages in engagement, clinical and financial outcomes.

We apply these insights to the Dario experience to create a sustainable competitive advantage.

Data and AI as a Strategic Asset

We, along with Twill (formerly a standalone entity before being acquired by us), has built an extensive repository of health data over a cumulative 25 years.

This wealth of information serves as a critical asset, fueling AI-driven insights that enhance decision-making, predict health risks, and optimize patient engagement.

Our proprietary datasets span multiple health conditions, providing a unique foundation for developing advanced AI models tailored to real-world patient needs.

25 Years of Cumulative Experience, With Billions of Proprietary Data Points

Our AI capabilities are built upon a rich foundation of proprietary data and research, including:

• Large available member datasets :

Billions of data points from providing its products to over 5 million users over a cumulative 25 years.

• Multi-condition focus :

Addressing multiple therapeutic areas Cardiometabolic (diabetes, hypertension, weight management), Behavioral Health (stress, anxiety, depression), and musculoskeletal pain with over 75 million physical and behavioral health measurements collected through our medical devices and tens of billions of data points through its applications.

• Uniquely matched datasets :

Enriched with metadata such as biomedical and behavioral, as well as location, nutrition, and other timely and relevant health information for deeper insights.

• Extensive AI research :

Over 7 years of AI advancements, including the development of large language models, conversational AI chatbot, and advanced machine learning and deep learning algorithms, delivering over 15 million behavioral health interventions and 25 million digital behavioral health virtual coaching interactions.

• Direct access to claims data :

Utilized on an anonymized basis in-house to train proprietary models for optimized care delivery and outcomes.

• Open architecture :

Enabling integration with client-provided care modalities, seamlessly connecting them to Dario’s digital care pathways.

Our AI strategy has three primary pillars:

Operational Efficiency and Simplification :

Optimizing workflows, reducing administrative burdens, and enhancing operational efficiency to drive better healthcare outcomes.

Whole-Person Patient Care :

Expanding our product offerings to provide the most comprehensive and personalized care experience for every individual from digital self-care to virtual clinical care.

Curated generative AI :

Leveraging a cumulative 25 years of proprietary data collection and content creation to develop a unique generative AI model tailored to personalized care in a highly regulated healthcare environment.

Recent advancements in AI model training, particularly in reducing hardware costs, serve as a significant accelerator for Dario’s curated generative AI.

These developments enable us to scale and refine our AI models more efficiently, further enhancing predictive accuracy and real-time personalization.

Operational Efficiency and Simplification

Our AI has been instrumental in improving operational efficiency across multiple functions, enhancing productivity, automating routine tasks, and optimizing decision-making processes.

Specific applications include:

• High-Quality Content Creation :

AI-driven tools assist in generating engaging, evidence-based health content, improving efficiency and consistency.

• Culturally Adapted Content Translation :

Custom trained generative AI models based on our vast content library in more than 10 languages enable automatic translation of new content that maintains a consistent tone of voice and cultural sensitivities across all languages.

• Software Development :

AI accelerates software development by optimizing code generation, debugging, and deployment processes.

• Member Services :

Deploy AI-powered automation to optimize member engagement, enhance customer support, improve response times and member satisfaction.

• Product Management :

Enables data-driven product decisions, enhancing usability and personalization.

• Human Resources (HR) :

Improve recruitment, employee engagement, and workforce planning, streamlining HR processes.

Optimize financial operations, forecasting, and risk management, reducing manual efforts and improving accuracy.

• Internal Knowledge Retrieval :

Retrieval-Augmented Generation (“RAG”) used to facilitate seamless access to organizational knowledge, enabling employees to quickly find relevant data, policies, and historical insights for improved decision-making and efficiency.

Our AI development and adoption is enabling us to reduce operating expenses.

Looking ahead, we expect ongoing AI advancements to drive an additional efficiency gains in the next few years, further reducing costs and improving user experience, customer service, innovation, and value.

Curated Generative AI

We are pioneering a proprietary generative AI model today, which delivers highly personalized care solutions in a tightly regulated healthcare environment.

Our advancements in AI model training reduce hardware dependency and costs and further accelerate the scalability and performance of curated generative AI.

RAG represents a key component of this model that enhances generative AI by integrating real-time, domain-specific proprietary data retrieval, which represents a proprietary advantage.

• Context-Aware Generative AI – Our RAG engine enhances AI-generated content by incorporating the latest medical insights, ensuring accuracy and relevance.

• Unique and Certified Data - Unlike generic GenAI models relying on publicly available internet data, our generative AI is built upon a unique, healthcare-intelligent, and certified dataset.

• Healthcare-Specific Intelligence – Our generative AI integrates domain-specific knowledge, ensuring high accuracy and contextual relevance for patient care applications.

• Regulatory Compliance – We designed our RAG to adhere to strict healthcare regulations.

As such, we supports safe, ethical, and privacy-compliant AI-driven health solutions.

• Commitment to Ethical AI - We prioritize fairness, transparency, and ethical AI development in all our models.

• Regulatory Adherence - Our AI systems comply with healthcare regulations, including Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and the EU General Data Protection Regulation (“GDPR”), ensuring data security and patient privacy.

• Bias Mitigation - Continuous refinement of AI models help minimize bias, improving accuracy and equitable healthcare delivery.

• Patient Trust - AI systems are built with patient trust in mind, ensuring that AI-driven insights enhance rather than replace clinical decision-making.

Whole-Person Patient Care

Our AI-powered solutions enhance patient engagement, provide predictive analytics, and deliver personalized treatment plans.

AI applications in patient care include:

• Personalized Digital Therapeutics :

AI-powered algorithms tailor interventions based on individual health data, improving adherence and engagement.

• Predictive Analytics for Chronic Disease Management :

Our predictive model for blood glucose levels demonstrates over 90% accuracy, which can support efforts to guide user behaviors to engage in timely interventions and proactive treatment in cases where early warning signs can ameliorate health deterioration.

• Automated Coaching and Behavioral Insights :

AI-driven behavioral coaching adapts to users in real-time, enhancing self-management and lifestyle modifications.

• Clinical Decision Support :

AI enhances provider decision-making by surfacing actionable insights based upon algorithms that are based upon vast data sources that enhance clinical judgments.

• Recommendation Engine Optimization :

AI-driven recommendation systems refine patient treatment strategies, enhance engagement and improve health outcomes.

On Dario’s AI Roadmap

In 2025, we plan to widen and deepen its utilization of AI in the following four areas:

• GLP-1 optimization :

Utilize AI-powered models to predict members’ level of adherence to GLP-1 prescription prior to prescribing and their level of success in maintaining outcomes post GLP-1 off-boarding.

This capability will allow Dario to intelligently prioritize prescriptions over other weight loss and behavior change programs.

• Advancing RAG -powered Generative AI:

Refining AI-driven personalized healthcare by integrating real-time monitoring, improving predictive accuracy, and adapting models to personalized treatment plans.

Leveraging reinforcement learning enables continuous AI improvements based on patient feedback and outcomes.

• Operational Efficiency and Simplification :

We have several productivity initiatives in multiple areas such as Product Management, Member Services, and Human Resources.

We operate in a highly competitive digital health market, characterized by rapid innovation and evolving consumer expectations.

During the past five years, employers and health plans have expressed “point-solution fatigue” and have begun to decrease the number of their point-solution digital health vendors, and to consolidate their digital health vendors among those that provide multiple, integrated offerings.

This has driven substantial industry consolidation and has enabled us to differentiate itself as a consolidation leader among competitors as it provides a whole-person health care solutions covering six different medical conditions.

We see two primary dimensions emerging:

economies of scale and economies of scope.

The first dimension is an increased focus on ROI driving by economies of scale.

Recent surveys of employer’s priorities indicates that they want digital health solutions that have much lower costs that can be broadly deployed among their populations and deliver much higher ROIs than they have accepted in the past.

A 2:1 ROI is no longer adequate to meet the needs of employers and health plans.

For this reason, we have leveraged our AI investments, superior user engagement, highly effective user behavior change, and access to virtual digital care and services to deliver the highest ROIs in the industry that generally exceed 5:1.

The second dimension is driven by economies of scope that increases simplicity by decreasing the number of digital health vendor that deliver an increasingly broad scope of digital health offerings.

This simplifies contracting, reporting, value creation, access to users, and the creation of value for users, employers, and health plans.

With these two emerging value creation dimensions that are driving competitive advantage, we see the following companies as its primary competitors:

Broad-based Digital Health Platforms

Companies such as Teladoc Health, Inc.

and MDLive, an Evernorth company, offer a full array of integrated virtual care solutions for primary care, chronic and behavioral health.

While these companies have both scale and scope, they have not yet developed an operating model that deliver their services profitably at scale.

Cardiometabolic Health Platforms

There are other more narrowly focused companies such as Omada Health, Inc., Vida Health, Inc., Virta Health Corp, and Welldoc, Inc.

that focus on the B2B market.

And other D2C oriented companies such as Ro, Inc., Hims & Hers, Inc., Weight Watchers International, Inc., and Noom, Inc., that compete with us in the cardiometabolic and GLP-1 space.

Most of these companies lack the whole-personal digital health scope that we offer, and still deliver ROIs that are half of what customers expect and demand.

Behavioral Health Providers

Specialized mental health platforms like Spring Care, Inc., Lyra Health, Inc., Headspace, Inc., BetterHelp, Inc.

(a division of Teladoc), Calm.com, Inc., and Talkspace, Inc., compete in the B2B behavioral health marketplace.

All these companies focus narrowly on behavioral health with no plans to expand their scope to include additional chronic disease conditions.

Wearable Technology Firm

While we integrate with many wearable technology firm’s devices from companies such as Fitbit, Garmin, and Apple, these companies also provide some D2C offerings that could be considered as competitors to our D2C products.

However, these companies do not truly compete in the B2B employer, health plan, and pharmaceutical marketplace with

competitive comprehensive behavioral and cardiometabolic offerings.

As such, we do not see these companies are true competitors.

Traditional Healthcare Systems and Health Plans

While many health systems may have their own home-grown solutions for many of the conditions that we address, few really provide a commercially competitive offering beyond their own network.

The same is generally true for most health plans, which primarily focus on vendors like us to provide chronic and behavioral health solutions to their members.

Given this competitive landscape, we differentiate ourself through our integrated whole-person health approach, AI and data-driven personalization, and commitment to user-centric design to deliver industry leading levels of sustained user engagement.

Our focus on measurable outcomes and strong partnerships positions us as a leader in the digital health market that can deliver the economies of scale and scope that delivers the highest ROI and easiest delivery of its individual or bundled solutions.

Recent Developments

Dario Published Research

In November 2023, we announced new research presented at the Diabetes Technology Society 2023 Meeting on November 7, 2023.

The new research demonstrated the value of associating physical activity tracking alongside blood

sugar tracking for people living with diabetes and pre-diabetes.

The new study examined the blood glucose and walking data of 989 Dario users to understand the impact of integrating clinical and behavioral data in a single digital app-based experience.

The results demonstrated significantly reduced blood glucose levels in the first four months of using Dario and increased step levels in the same timeframe maintained for 12 months.

In addition, the results demonstrated clinically significant reductions in blood glucose levels in users who tracked at least 400 steps per day.

In November 2023, we announced two new analyses recently presented by Sanofi U.S.

demonstrating two mediators associated with improved clinical and economic in Dario users.

Presentations by Sanofi U.S.

at the Diabetes Technology Society (DTS) annual conference examined real-world data from matched Dario users and non-users with type 2 diabetes to determine the association of medication adherence from Dario's digital health solution with blood glucose control.

Dario users saw an overall clinically significant reduction in HbA1c and an associated 10.6% improvement in medication adherence.

The new research helps explain the results of a previously reported study on reductions in HbA1c, because medication adherence is one behavioral component of self-care needed to achieve improved clinical outcomes.

In addition, Sanofi also presented research at ISPOR Europe 2023 of a new analysis showing more frequently engaged Dario users were associated with 10% reduction in all-cause healthcare resource use over 100 days and were 15% less likely to incur related charges.

Engagement was defined by activities meaningful to diabetes management, such as taking a blood glucose reading;

inputting an insulin dose;

recording physical activity or tagging a meal.

This new analysis provides additional information from previously reported study results demonstrating Dario's ability to contribute to a reduction in all-cause healthcare utilization by 9% including inpatient hospitalizations by 23% compared to non-users at 12 months.

In the first quarter of 2024, we launched the Aetna behavioral platform with approximately a dozen customers, whereby we began to generate revenue from that collaboration, and we expect Aetna to continue to add employers to the platform.

A separate self-help program contracted with Aetna last year launched on the platform at the end of the first quarter and is also expected to grow throughout 2024.

Employer Contracts

In November 2023, we announced a new contract to provide its cardiometabolic solution to an employer beginning in January 2024.

The employer, a national financial and business services company, selected Dario to improve the cardiometabolic health of its population with an integrated solution for diabetes, pre-diabetes, weight management and hypertension along with tailored support for employees taking a GLP-1, or anti-obesity, medications.

In December 2023, we announced today a new contract to provide cardiometabolic and GLP-1 solutions to a national employer beginning in January 2024.

The employer, a national logistics company, selected Dario to deliver integrated support for employees living with diabetes, pre-diabetes, weight management and hypertension, while also providing a tailored experience for employees taking a GLP-1 medication.

In January 2024, we announced today a new contract to provide its cardiometabolic solution to a regional union, expected to begin in the first quarter of 2024.

The Union, representing food industry workers, selected Dario to deliver integrated support for employees living with diabetes, pre-diabetes and weight management needs along with special support for those taking a GLP-1, or anti-obesity medication.

The Union joins a growing set of public and labor clients using Dario's solution to provide highly personalized chronic condition management solutions to their members.

Market Landscape

The traditional healthcare industry is siloed and service-centric, and it is difficult for people to access care and support, while the healthcare experience itself remains cumbersome and disconnected.

The future of health care is being shaped by digital health technologies that are rapidly becoming more important as access to traditional health care for the management of whole health becomes more difficult.

As a direct-to-consumer pioneer, we presciently identified shifting healthcare consumer behaviors early and designed solutions with the intent of enabling users with easy-to-use technologies that support adoption and engagement.

Our members demanded ease of access and personalization, generally absent in health care but a standard in other consumer service experiences, and our unique approach significantly exceeds those expectations with excellent ratings from our members.

Commercial digital health solutions currently perform poorly in this area, which leads to low engagement and weak outcomes.

As we expand our commercial business, we believe our consumer-centric solutions position us as a leader in digital health through a best-of-suite platform proven to deliver the experience people are demanding.

This enables our service-oriented business model by delivering the engagement our clients demand and yields a stable form of revenue through an Annual Recurring Revenue (“ARR”) model.

Longer term, as the market for digital health solutions faces economic pressures, we believe our consumer origins arm has several natural advantages that will help propel our growth and cement our leadership position.

First, we amassed a trove of billions of data points from our consumer engagement and dozens of clinical publications including multiyear studies with approximately 50,000 participants.

Second, we built what we believe is the best-in-market clinical platform built with a focus on the overlapping chronic health needs present in our user base.

This shift from a single condition platform to a multi-condition platform enables our best-of-suite approach.

Competitive Strengths

We believe that we are proving the value of our solutions as enterprise business sales continue to grow.

With more than 100 signed contracts to date, we have solid evidence on the key differentiators that lead to new business opportunities:

a consumer-friendly approach that drives engagement;

deep integration capabilities;

and best-in-class clinical outcomes.

Consumer Friendly Approach

Most digital health solutions are built to address the needs of a business and then sold directly to the business, bypassing the difficult step of achieving consumer buy-in with respect to the product.

Our experience as a direct-to-consumer company now leverages those insights to drive B2B2C commercial growth by working with health plans, employers, and provider groups and providing them with a solution that their end users are more likely to utilize.

Our current and potential customers recognize that consumer engagement insights are critical to success, and they are prioritizing solutions with more of a consumer-focused experience.

We believe that impaired user engagement in competitor solutions could also drive enterprise customers to switch to us.

Deep Integration Capabilities

Our platform was designed with a flexible, open-framework that yields multi-faceted benefits for our members and partners including their clinical health and user experience.

Our experience is a best of suite platform that leverages four points of integration to drive a connected, dynamic and adaptive user journey:

● User data is being captured and integrated across the experience, driving a personalized member experience across applications.

● User interface, including mobile applications, have been integrated to support a unified member experience.

● Clinical integration informs recommendations across conditions.

● This is all supported by a fully integrated coaching experience which provides one coach who supports the member across their entire journey.

The native integration of data across our solutions, providing a single view of a member data across all conditions and interactions, fuels our consumer-centric approach to engagement and leads to a more seamless user experience.

Our ability to allow integrations at the platform-level, easily allowing for the ingestion and exportation of data, also positions us as uniquely able to support the more connected healthcare experience that members and our partners increasingly demand.

The recent integration of Dexcom CGM data into our platform is one example of the utility of our open-platform, positioning us as an attractive choice for clients and partners interested in building towards the future state of digital health.

Clinical Outcomes

We believe that we lead the digital therapeutic market in published outcomes with 38 studies across our suite of solutions, including the first clinical research demonstrating the positive impact of managing multiple chronic conditions with one digital health solution.

Our ability to use large, real-world, longitudinal data-sets gives us a natural advantage in the scope and type of studies that can be conducted compared to competitors.

This capability enables one of the unique elements of our partnership with Sanofi, allowing our data to be consumed by a third party for independent analysis and eventual publication.

Our Product Offering

Our user-centric software platform integrates digital therapeutics, coaching, professional human support and medical devices to drive superior clinical and financial outcomes.

Our best-of-suite suite of offerings is modular, allowing for enterprise clients to purchase one or more of our chronic condition management solutions, while enjoying the same best-in-class experience supported by our behavior change journey engine so our partners can be confident in achieving sustainable outcomes and value.

Our suite of digital offerings includes:

Dario Metabolic (“Dario Evolve”)

Our metabolic solutions are designed to address some of the most commonly co-occurring metabolic health needs - diabetes, pre-diabetes, hypertension, and weight management - through a combination of software, our smartphone-connected tools, interaction with live coaches, and real-time data analysis to help inform and educate users of the relationship between their behaviors and their health outcomes to drive changes that last.

Dario Musculoskeletal (“Dario Move”)

Our unique approach addresses the most common MSK conditions, including chronic pain, by dealing with the cause and empowers users to create behavioral change.

Dario Move’s digital physical therapy programs and posture training help people improve strength and mobility by using a combination of software, wearable biofeedback sensors, and coaching to drive sustainable improvements in musculoskeletal health.

The inclusion of posture training in the solution supports ongoing engagement in support of prevention and maintenance outside of an exercise therapy program.

Dario Behavioral Health (“Dario Elevate”)

Our behavioral health solution optimizes access to evidence-based care by using an AI-driven screener to triage users and connect them to the most appropriate support across a wide range of mental health needs, including our integrated digital tools and coaching, giving users a seamless path to proven mental health support.

Dario Full Suite (“Dario One”)

Our full suite of chronic condition management solutions offers the maximum benefit for our partners with a completely seamless and holistic approach to managing chronic conditions.

In addition to a better unified member experience, our partners deploying Dario One enjoy several benefits from purchasing the entire suite of solutions:

better overall health as evidenced by recent research published by us;

the convenience and ease of a single vendor to manage;

less strain on internal resources spread across several chronic condition management programs;

and a more affordable program launches due to lower costs of implementation.

Dario’s Solution Main Components

Users vary significantly in their interests and preferences, and unique user preferences also vary over time with respect to the optimal timing, tone, content, channel, frequency, and interventions required to produce sustained behavior change.

Users’ interactions with devices, smartphones, coaches, providers, and third-party solutions must be personalized

along these axes to ensure optimal engagement, retention, and outcomes.

Furthermore, to engage and sustain user interest and participation, and drive outcomes, platforms must be dynamically responsive.

Due to a lack of responsiveness to these types of variances, most digital health platforms that achieve high initial engagement often fail to retain users over time.

Key to our ability to accommodate user behavioral changes is our mature AI-driven user journey engine.

While several in-market solutions now integrate health signals across a range of categories to apply limited, nominal personalization, primarily in the form of nudges, our solution is informed by years of user experience data from over 142,000 users that joined our chronic-condition platform, enabling us to continually personalize and adapt user journeys themselves (and not just messages) over time.

Our journey engine drives our multichannel targeted outreach and enrollment campaigns, informs specific recommendations around a range of categories such as diet, physical activity, self-care, coaching interventions, and provider engagement, and evolves in real time in response to the data exhaust from a user’s interaction with the care ecosystem.

Our journey engine combines complex behavioral science insights with data from hundreds of thousands of users over several years to recommend AI-driven initial and updated care journeys in response to a user’s engagement with the platform.

Most digital health solutions consist primarily of tracking, content, and nudges.

These are often perceived by users as non-rewarding work, and often do not feel relevant to their concerns, particularly as they evolve over time.

We believe that current in-market solutions trivialize within person changes over time and do not appropriately respond to the dynamically evolving interests of users.

This results in reduced engagement and impaired outcomes.

Our journey engine adapts user journeys to drive engagement, retention, and clinical outcomes by optimizing timing, tone, channel, content, frequency and intervention to deliver dynamically personalized user journeys that are more likely to result in the behavior changes needed to drive improved outcomes across a range of conditions.

As we partner with solutions in additional conditions or categories, we engage new populations and generate fresh insights, enhancing the engagement and efficacy of these partnered solutions to deliver additional value to our users.

The engine is designed for integration and scale;

as we add populations and conditions for which behaviors are primary drivers of outcomes, our engine becomes more adept at customizing a user’s evolving preferences and needs.

Software Applications

Our chronic condition management solutions are designed as three separate software applications to provide the best possible user experience across metabolic, MSK and behavioral health needs.

Each application is integrated with Dario’s single digital therapeutics platform and behavior change journey engine to ensure the same hyper-personalized experience across each person’s unique health needs and preferences to keep them on track with healthy changes over time.

Dario Evolve helps users change their behaviors and help better manage their diabetes, blood pressure and weight.

Using real-time data and analysis, the app helps users track their progress and offers real-time feedback and customized content to support each individual’s needs and goals.

Integration with the Dario journey engine ensure that each user receives holistic support and a highly personalized experience that keeps them on track for long-lasting results.

Dario Move helps users improve strength and mobility to help address chronic pain and improve overall musculoskeletal health.

After completing an online assessment, each user receives a personalized, evidence-based exercise program that can be adjusted throughout their journey based on sensor data or self-reported feedback to a coach or in the app.

Dario Move guides members through their tailored program with educational content to support long-term outcomes.

Dario Elevate

Dario’s Elevate helps people get the help they need to address common mental health needs.

Starting with a responsive, AI-driven screener, elevate triages users to understand the need and recommend the most appropriate support

to help them feel better.

Our integrated, evidence-based digital tools and coaching help people learn proven techniques to better manage their emotional health.

Live Coaching

Live coaching is available as part of the Dario experience to give members a human point of contact for support and motivation, and also provide a level of accountability that is proven to help improve engagement and outcomes.

As an integrated component of our suite of solutions, our professionally trained and certified health coaches serve as a personal support for each member throughout their journey across all solutions and are able to connect members with clinical experts when members need additional support.

Our clinical coaches include Certified Diabetes Educators (“CDCES”), Registered Nurses, Pharmacists and Mental Health Clinicians who are able to assist members throughout their journey.

Dario User Devices

Our product offerings include integrated devices to capture relevant clinical and biofeedback data to support continuous, real-time monitoring of member health.

Our native devices include:

● All-in-one smart glucose meter

● Bluetooth connected blood pressure cuff

● Digital Scale

● Biofeedback sensor device

Our Commercial Channels

We are focusing the go-forward business strategy around three key market opportunities:

direct sales to employers and payers and partnerships with the ability to multiply our growth opportunities.

We believe that our scalable business model selling digital therapeutics as a service through multi-year contracting relationships establishes a pipeline of ARR and has the potential to improve our gross margins over time.

Our software solutions are sold across a range of channels to create multiple growth engines and support rapid adoption across all segments of the market.

Our integrated product suite is designed to address a common and growing sentiment from enterprise customers expressing frustration with the large number of condition-specific solutions, lack of transparency, lackluster results and poor member experiences.

Our integrated solution aligns with these key buyer pain points and is proven to deliver value to strategic partners through our differentiated approach in the market.

Finally, our consumer-centric legacy remains a key component of our commercial strategy, bolstering our ongoing solution development by serving as an innovation laboratory for new services and product enhancements.

Health Plans :

Although health plans represent the longest and most complex purchasing cycle across our client base, these contracts often represent sizeable opportunities as they typically offer much larger potential member populations.

We currently have three live contracts with health plans, two are regional payers and one is a large national plan, with several additional plans in negotiation and contracting at present day.

Our most robust growth in 2022 came from the employer market, a key buyer to help demonstrate our ability to deliver results.

Today, we have approximately 120 employer populations actively on our platform, and growth of our employer pipeline continues to grow and mature.

Partnerships:

Strategic partnerships play a key role in helping to expand our reach across markets quickly and efficiently.

Our consumer-centric platform, the rate at which we have evolved our product, added and integrated solutions and provided product improvements and ability to easily share data and support a multitude of integrations makes Dario an attractive choice of partner for many in the market.

One such significant partnership agreement is our collaboration with Sanofi, a global leader in health care, a relationship that resulted after an extensive search determined we are uniquely capable of providing the robust data and analytics required by Sanofi.

The multi-year, $30 million-dollar agreement, is

helping to accelerate commercial adoption of our full suite of digital therapeutics through the promotion of our solutions in Sanofi’s sales channels and the collaborative development of new products.

We also entered into partner agreements with several large employer benefits platforms such as Virgin Health Pulse in 2021, helping expand our reach within the employer market.

In addition to our partnership with Sanofi, Dario is actively pursuing distribution partnerships in both the payer and employer verticals.

In 2022, we partnered with Solera to establish a payer channel through their large network of plans.

We also entered into partnership agreements with several large platforms such as Virgin Health Pulse, Alliant Insurance Services, and Vitality Group , helping expand our reach within the employer market.

Dario is actively pursuing new partnerships in both markets to enhance our opportunities with a one-to-many approach.

Our ability to engage members and improve health begins with our consumer-centric approach, and this audience remains key to our commercialization at the enterprise client level.

Our direct-to-consumer channel continues to attract members to our platform and provides a neutral audience to test innovative product ideas, something traditional B2B companies are unable to do given limitations on commercial membership.

These insights inform both our AI-driven behavior change journey engine, helping continuously improve engagement and retention, and inform product design to ensure our solutions remain at the forefront of consumer expectations.

On February 28, 2022, we entered into an exclusive preferred partner, co-promotion, development and license agreement (the “Agreement”) with Sanofi for a term of five (5) years.

Pursuant to the Agreement, we and Sanofi will co-promote certain of our products and services, including devices and accessories, and to develop new products and services based on insights derived from our data relating to the use of those devices and services.

In addition, we granted Sanofi a license to access and use certain of our data, and Sanofi granted us a license under certain intellectual property of Sanofi for purpose of developing and promoting certain products and services for Sanofi in the United States.

Pursuant to the Agreement, in consideration of the preferred co-promotion and development rights granted by us, Sanofi agreed to pay us an aggregate amount of up to $30 million over the initial term of the Agreement, consisting of (i) an upfront payment, (ii) annual compensation for development costs per annual development plans to be agreed upon annually and (iii) certain contingent milestone payments upon meeting certain net sales and enrollment rate milestones at any time during the term of the Agreement.

The Agreement also provides for us to make certain revenue sharing payments to Sanofi in a percentile beginning in the low double digits to low twentieth percentile of specified revenues upon qualifying sales through Sanofi introductions achieving a minimum revenue amount, and provided that the qualifying sales through Sanofi introductions remain above a specified percentage of total sales after year 3 of the agreement.

Revenue sharing in the thirtieth percentile will apply with respect to new solutions or services developed under the agreement.

The Agreement has a term of five (5) years and may be renewed for a subsequent five (5) year term upon the mutual agreement of the parties.

The Agreement may be terminated (i) by either party for a material breach, force majeure or insolvency;

(ii) by us if net sales requirements are not reached;

(iii) by either party for convenience, upon sixty days’ prior notice, beginning in the third year of the Agreement;

or (iv) by Sanofi if we fail to complete a development plan within nine (9) months of the Effective Date, or upon our change of control.

In July 2023, we entered into an amended and restated strategic agreement with Sanofi, an innovative global healthcare company.

In this amendment, the parties adjusted certain pre agreed economic parameters, to better align the common interests of the parties in light of the developments in the digital health market after the first year of partnership, including revenue share adjustments that align with both parties' strategic goals.

The changes apply to certain customers in exchange for additional promotional activities to be performed by Sanofi.

The parties also agreed to allow the acceleration of certain development milestones agreed upon in the initial agreement.

This multi-year, $30 million agreement, which is subject to certain contingencies, will help accelerate commercial adoption of our full suite of digital therapeutics and drive the expansion of digital health solutions on our platform.

We and Sanofi will collaborate on promoting our multi-condition digital therapeutics solution, significantly increasing our sales reach in the health plan market and selectively in the employer channel.

In addition, the agreement calls for us and Sanofi to develop new or

enhanced solutions leveraging our platform, and for the parties to generate robust evidence to support future commercialization in the health plan channel.

In April 2024, we announced four new contracts to provide integrated chronic condition management solutions for two employers beginning in the second quarter of 2024.

In November 2024, we announced the signing of four contracts with self-insured employers that are expected to go live in the first quarter of 2025.

The contracts span across the full suite of our platform, with no one opting for a single condition, showing evidence of the value of a multi-condition offering.

Presentation of New Studies

In March 2024, we announced two new clinical studies presented at the International Conference on Advanced Technologies and Treatments for Diabetes (ATTD) 2024, demonstrating a 6.38% reduction in weight for members with a baseline BMI of 30 and above and an overall reduction in blood glucose levels, with average blood glucose levels remaining below 140 mg/dL for one year.

In April 2024, we announced two new studies published in the leading peer-reviewed journal for digital health and medicine, Journal of Internet Medicine (JMIR), including a Randomized Controlled Trial (RCT) demonstrating the impact of a digital stress reduction program for teens.

In April 2024, we announced new research published in the leading peer-reviewed journal for digital health and medicine, JMIR, demonstrating a clinically significant reduction in blood glucose levels for members using Dario to manage weight alongside diabetes.

GLP-1 Updates

In June 2024, we announced a new contract with a national employer to provide its cardiometabolic solution with integrated support for GLP-1s to employees beginning in the third quarter of 2024.

In June 2024, we presented two studies presented at the 84th Annual American Diabetes Association (ADA) Scientific Sessions in Orlando.

The first study provides an analysis of member data for those tracking a GLP-1 medication

in Dario's cardiometabolic solution.

A retrospective analysis was conducted using data from members using Dario to manage Type 2 diabetes or prediabetes and taking either Metformin, a standard medication prescribed for diabetes, or a GLP-1.

Both member groups were tracked for 12 months as they engaged with our digital chronic condition solution to measure blood glucose levels and track lifestyle activities such as diet and exercise.

Members also utilized our Medication Cabinet feature to log Metformin or GLP-1 dataset reminders and report adherence.

The data showed significant improvement in adopting healthy behaviors over a 12-month period across both groups as shown by increased tracking of healthy lifestyle behaviors as shown by logged meals and physical activity beginning in the first three months and sustained through the 12-month period.

Additional research presented by us at the ADA conference examined Dario's ability to help members realize the goal of diabetes remission for people living with Type 2 diabetes.

The ADA considers remission to be achieve when an individual with Type 2 diabetes sustains normal blood glucose levels of less than 6.5% HbA1c for three months without the aid of a diabetic medication.1 This retrospective study analyzed the data of 7,240 individuals with Type 2 diabetes using our platform to help manage their condition without the help of insulin for at least six months.

The results demonstrated a significant impact:

● 31% of our members experienced blood glucose levels reflecting the goal of diabetes remission with average blood glucose readings of less than 140 mg/dL (A1c 6.5%) during a three-month period;

● 70% of our members achieved a blood glucose level of less than 140 mg/dL in their last month of usage maintained it for three-month period, indicating behavior change and improved long-term glycemic control;

● Lifestyle activities as shown by logged meals and physical activity moderated the reduction in average blood glucose levels and high readings ratio.

New Research Reveals How Physical Activity Mediates the Impact of Depression on Blood Glucose Levels in Individuals with Diabetes or Prediabetes

In September 2024, we announced the publication of a new study in the peer-reviewed journal Frontiers in Endocrinology.

The study demonstrates the effectiveness of our cardiometabolic solution for members living with diabetes or prediabetes and depression.

Integration of Twill Behavioral Health Capabilities into Cardiometabolic Health Solution

In September 2024, we announced the integration of condition-specific communities and peer groups with personalized navigation capabilities into our cardiometabolic solution to improve outcomes-based engagement, marking a significant milestone in the integration of the Dario-Twill product offering.

Twill by Dario to Offer a Benefit for AARP Members

In October 2024, we announced a new AARP member benefit that provides members with proven digital behavioral health and well-being solutions from Twill by Dario.

The new benefit is expected to launch in January of 2025 for AARP members.

Integration of Twill Capabilities Across Full Multi-Condition Platform

In October 2024, we announced the full integration of Twill's advanced behavioral health and navigation capabilities into our platform.

The integration completed our effort to create one of the most comprehensive and effective end-to-end digital health solutions in the market.

By unifying data across mental and physical health, we offer a more personalized and effective approach to care.

New Regional Health Plan, Expanding Reach in Medicaid Population

In October 2024, we announced a new contract with a regional health plan in the Medicaid space, which has launched with the full suite of cardiometabolic solutions.

Starting with an initial pilot program, we will work closely with the health plan to bring its proven solutions to the plan's population, which includes nearly 10,000 Medicaid members.

Pharma Collaborations with Global Pharma Leader to Enhance User Engagement

In November 2024, we announced a new collaboration with a pharma company that will utilize Dario Connect (formerly Twill Care) among their patient populations to further their direct-to-consumer efforts using our refined engagement and navigation technologies.

In an effort to strengthen and expand connections across patient populations that are candidates for a new drug to treat psoriasis, a top pharmaceutical company chose us to pilot a cutting-edge initiative aimed to help onboard patients that will engage with the drug via the platform.

This collaboration is designed to collect critical insights on patient outcomes and drug effectiveness, with Dario Connect's innovative community-building capabilities playing a key role in enhancing patient engagement.

GLP-1 Solution with Prescribing Capabilities through Collaboration with MediOrbis LLC, Targeting Employers and Direct-to-Consumer Markets

In January 2025, we announced a collaboration with MediOrbis, a multi-specialty digital health provider, to add prescribing capabilities to our GLP-1 behavior change solution for a comprehensive medical weight loss program.

This strategic addition creates a fully integrated solution for employers covering weight-loss medications and supports direct-to-consumer offerings, expanding our addressable market in one of the fastest-growing segments of digital health.

On November 26, 2024, we were notified of the termination of the Amended and Restated Exclusive Preferred Partner, Co-Promotion, Development and License Agreement with Sanofi U.S.

Services Inc.

(“Sanofi”), dated July 10, 2023, which was originally executed on February 28, 2022.

On December 4, 2024, we transitioned our relationship with Sanofi and entered into a services agreement.

Pursuant to the services agreement, we will configure our Twill Care platform for Sanofi and transition the relationship to a recuring revenue model.

In March 2025, we announced a strategic collaboration with Path CCM, Inc.

d/b/a Rula Health ("Rula”), a leading provider of high-quality behavioral health services, to expand access to mental health support for employers and their workforce nationwide.

Through this strategic collaboration, we will have exposure to Rula’s extensive network of over 15,000 providers.

By leveraging Rula’s high-quality provider network with extensive coverage, we will offer an “easy button” solution for employers looking to implement behavioral health support seamlessly within their existing benefits structure.

Clinical Studies

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Our studies below demonstrate the clinical value of our legacy digital therapeutic devices and the ability of our solutions to deliver sustainable outcomes over time.

Dario reported an Average Reduction in Estimated HbA1C of 1.4% for High-Risk type 2 Diabetes Users.

We presented at the 77 th ADA session a study that was titled “Reducing A1C Levels in Individuals with High-Risk Diabetes Using the Mobile Glucose Meter Technology.” In the study we reported an average reduction in estimated HbA1C of 1.4% for high-risk type 2 Diabetes users.

At the ADA 2018 session, Dario presented three real-world-data analysis studies, as detailed below.

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A retrospective data evaluation study was performed on the Dario TM cloud database.

A population of active Type 2 Diabetic (T2D) users that continuously measured their blood glucose using Dario TM BGMS during the full year of 2017 was evaluated.

A population of active T2D users that continuously measured their blood glucose using Dario TM BGMS during the full year of 2017 was evaluated.

The study assessed the ratio of high (180-400 mg/dL) and hyperglycemic (>400mg/dL) blood glucose readings during full year of 2017 as recorded in the database.

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For 225 T2D active users the ratio of high events (180-400 mg/dL) was reduced gradually in 19.6% (from 23.4% to 18.8% of the entire measurements) from baseline compared to the 12 th month of the year.

Moreover, the

ratio of severe hyperglycemia events (>400 mg/dL) was decreased in 57.8% (from 0.90% to 0.38% of the entire measurements) at the same period.

Moreover, the ratio of severe hyperglycemia events (>400 mg/dL) was decreased in 57.8% (from 0.90% to 0.38% of the entire measurements) at the same period.

Continuous Reduction of Blood Glucose Average during One Year of Glucose Monitoring Using Dario Digital Monitoring System in a High-Risk Population

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219.5±38.5) while patient’s hypoglycemic event (<70mg/dL) was in average, less than one (<1) during this period.

Subgroup analyses (355 patients) revealed substantial GV improvement among non-Insulin T2D patients.

Subgroup analyses (355 patients) revealed substantial

GV improvement among non-Insulin T2D patients.

The GV was reduced by 14% and 18% from baseline through 3 and 6 months, respectively (SD of 52.8, 50.7 vs.61.7).

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A retrospective data evaluation study was performed on the Dario TM cloud database.

A population of active Type 2 Diabetic (T2D) users (>15 measurements per month on average) was evaluated.

A population of active T2D users (>15 measurements per month on average) was evaluated.

The study assessed the ratio of in-range blood glucose readings (70-140 mg/dL) as a function of App engagement level for 6 months as recorded in the database compared to first 30 days as a starting point of analysis.

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In November 2019, another analysis was presented in Diabetes Technology conference “The Effect of Digital Intervention on Glycemic Control in Users with Diabetes” looking on total in-range measurements ratio 70-180 mg/dL showing increase of 19% following 3 months on the Dario Engage platform.

In In February 2020, we presented an additional clinical study at the ATTD conference in Madrid, Spain.

In February 2020, we presented an additional clinical study at the ATTD conference in Madrid, Spain.

The presented data shows the Dario digital therapeutics platform successfully assists insulin dependent patients with diabetes in reducing hypoglycemic events.

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34.92%) on average.

In August 2020, we presented an additional clinical study at the Virtual Association of Diabetes Care & Education Specialists (ADCES) conference.

In August 2020, we presented an additional clinical study at the Virtual Association of Diabetes Care and Education Specialists (ADCES) conference.

The presented observational study data demonstrated better glycemic and blood pressure control.

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First month measuring on Dario platform was used as study baseline.

Clinical outcomes examined were blood pressure values, percentage of blood pressure categories, average blood glucose (BGavg) and high blood glucose readings (>250 mg/dL, >400 mg/dL) ratios.

Clinical outcomes examined were blood pressure values, percentage of blood pressure categories, BGavg and high blood glucose readings (>250 mg/dL, >400 mg/dL) ratios.

A group of 345 active users started at baseline with Hypertension stage 1, 2 or hypertensive crisis levels and measured following 3 months was evaluated.

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This study showed reduction of 13% blood glucose average in age group ≥65 (N=298) at six months sustained for 12 months, and reduction of 38.1% in high readings ratio (>250 mg/dL) in the ≥65 age group at six months and by 41.5% at 12 months.

In Feb 2021 we published in the first time in a peer-reviewed journal “ Journal of Medical Internet research (JMIR) Diabetes”, the article:

In February 2021 we published in the first time in a peer-reviewed journal “ Journal of Medical Internet research (JMIR) Diabetes”, the article:

“Role of Digital Engagement in Diabetes Care Beyond Measurement:

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In this study (ClinicalTrials.gov:

NCT04057248), 12 participants with baseline HbA1c >8.5% were provided with Dario digital therapeutic platform (connected blood glucose meter, test strips, mobile app and access to live CDCES).

NCT04057248), 12 participants with baseline HbA1c >8.5% were provided with Dario digital therapeutic platform (connected blood glucose meter, test strips, mobile app and access to live certified diabetes care and education specialist (“CDCES”)).

At both study enrollment and completion, participants completed blood testing and a satisfaction report.

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Clinical outcomes and self reported data before and after intervention were compared.

● Significant reduction in lab values such as HbA1C (2 points), Fasting Blood Glucose (18%) and Body Mass Index (BMI) (10%)

● Significant reduction in lab values such as HbA1C (2 points), Fasting Blood Glucose (18%) and BMI (10%)

● Statistically significant improvement in glucose variability (21%)

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Our findings also underscore the need and provide a basis for a comprehensive approach to understanding the mechanism of BP regulation associated with BG.

In this retrospective, real-world case-control study, we extracted the data of 269 people with type 2 diabetes (T2D) who tracked their BG levels using the Dario digital platform for a chronic condition.

In this retrospective, real-world case-control study, we extracted the data of 269 people with T2D who tracked their BG levels using the Dario digital platform for a chronic condition.

We analyzed the digital data of the users who, in addition to BG, monitored their BP using the same app (BP-monitoring [BPM] group, n=137) 6 months before and after starting their BP monitoring.

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Both groups showed similarly stable BG time trajectories (B=0.98, t =1.16, P =.25) before starting the use of the BP-monitoring system.

In addition, the BPM group showed a significant reduction in systolic ( t =–6.42, P <.001) and diastolic ( t =–4.80, P <.001) BP during the first 6 months of BP monitoring.

In addition, the BPM group showed a significant reduction in systolic ( t =–6.42, P <.001) and diastolic ( t =–

4.80, P <.001) BP during the first 6 months of BP monitoring.

Finally, BG levels were positively associated with systolic (B=0.24, t =2.77, P =.001) and diastolic (B=0.30, t =2.41, P =.02) BP.

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● No significant difference between Rural/Nonrural groups was found at first, 6 th and 12 th months periods (Kruskal-Wallis, P=0.235/0.163/0.142 respectively).

In August 2022, we published in the first-time two retrospective data analysis on behavioral health outcomes, Depression and Anxiety in the American Psychology Association (APA).

In August 2022, we published in the first-time two retrospective data analysis on behavioral health outcomes, Depression and Anxiety in the American Psychology Association (the “APA”).

Effectiveness of a Digital Behavioral Health Solution for Depression Symptoms

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Additionally, out of 100 users who started at a moderate anxiety level, 84 (84%) improved or maintained their level (P<0.001), and out of 126 users started at a severe anxiety level, 69 (55%) reduced their level to moderate or minimal-mild (P<0.001).

In September 2022, a retrospective data analysis study was published in “International Association for the Study of Pain” (IASP) large conference.

In September 2022, a retrospective data analysis study was published in “International Association for the Study of Pain” large conference.

Pain level reduction mediated by perceived posture quality and training duration in patients using digital therapeutic biofeedback technology

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Piecewise mixed models were used for modeling the two-stage trajectory of pain levels, perceived posture quality, and weekly training duration following an 8-week biofeedback training.

Also, the mediation effect of perceived posture quality on the analgesic effect of training duration was tested using Monte Carlo simulations based on lagged effect mixed models.

Also, the mediation effect of perceived posture quality on the analgeic effect of training duration was tested using Monte Carlo simulations based on lagged effect mixed models.

The analysis revealed significant pain level reduction of 50% ( p <.0001) and posture quality improvement ( p <.0001) during the first 4 weeks of the training, maintaining similar pain levels and perceived posture quality during the next 4 weeks.

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The ratio of hypoglycemia readings per total measurements significantly reduced as well.

Subgroup analyses (1353 patients) of Dario users aged 67 or older with Type 1 or Type 2 using Insulin revealed a substantial reduction of severe hypoglycemia Level 2 of 42% (0.11 vs.

Subgroup analyses (1353 patients) of Dario users aged 67

or older with Type 1 or Type 2 using Insulin revealed a substantial reduction of severe hypoglycemia Level 2 of 42% (0.11 vs.

0.19) (p<0.05) and significant reduction in hypoglycemia events ratio as well over a year.

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In a subgroup of 234 high-risk users (baseline >180 mg/dL) the average blood glucose and glucose variability were significantly reduced by 13% and 11% on average, respectively (p<0.05).

In August 2023, we presented an additional clinical study on the benefits of engagement with a digital therapeutic for better clinical outcomes at the Association of Diabetes Care & Education Specialists (ADCES) conference.

In August 2023, we presented an additional clinical study on the benefits of engagement with a digital therapeutic for better clinical outcomes at the ADCES conference.

Users managing Diabetes with Large-scale Digital Therapeutics Platform Experience a Change in Blood Glucose and Engagement Over Two Years.

T he present study demonstrates the benefits of engagement with a digital therapeutic platform for diabetes management in high-risk patients, demonstrating an improvement in glycemic outcomes and sustainment for a significant period.

The present study demonstrates the benefits of engagement with a digital therapeutic platform for diabetes management in high-risk patients, demonstrating an improvement in glycemic outcomes and sustainment for a significant period.

A retrospective real-world data study was performed on the Dario database.

The current sample is based on active users since 2019 with at least two months measurements for two years.

Engagement was assessed by blood glucose (BG) and weight measurements.

Engagement was assessed by BG and weight measurements.

Clinical outcomes assessed were average BG and high readings (>180mg/dL) ratios.

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Breathing exercises significantly moderated the reduction in anxiety symptoms during the period of 1-6 weeks ( β =–.07, 95% CI –0.14 to –0.01;

In November 2023, we presented additional clinical study data at the virtual Diabetes Technology Society (DTS) meeting that investigated the association between monthly aggregated blood glucose measurements and walking activity (number of steps).

In November 2023, we presented additional clinical study data at the virtual DTS meeting that investigated the association between monthly aggregated blood glucose measurements and walking activity (number of steps).

Non-linear Association between Blood Glucose Levels and Walking in an Integrated Digital Health Platform for Diabetes Management

T his study sheds light on the importance of walking in diabetes management.

This study sheds light on the importance of walking in diabetes management.

Our findings highlight the potential of digital health platforms in promoting physical activity using a diabetes tracking app to improve clinical outcomes.

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A 12-Month Retrospective Cohort Study

I n this retrospective cohort study, utilizing Dario Diabetes Solution (DDS) demonstrated a significantly greater reduction in all-cause HCRU and inpatient hospitalization rates during 12-month follow-up compared with non-users receiving usual care.

In this retrospective cohort study, utilizing Dario Diabetes Solution (DDS) demonstrated a significantly greater reduction in all-cause HCRU and inpatient hospitalization rates during 12-month follow-up compared with non-users receiving usual care.

This retrospective cohort study (January 2017–April 2021) included adults (≥18 years) with T2DM receiving anti-diabetic medication(s) with ≥1 inpatient or ≥2 outpatient visits ≥30 days apart during baseline period.

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Impact of Digital Diabetes Solution on Glycemic Control in Adults with Type 2 Diabetes Mellitus in the United States—A Retrospective Cohort Study

T he study showed adults with uncontrolled T2DM using Dario Diabetes Solution (DDS) had better outcomes at 6 months, with more significant HbA1c reductions than matched nonusers across various BL HbA1c levels, showing incremental improvements to usual care.

This retrospective cohort study included adults with type 2 diabetes mellitus (T2DM) with a baseline (BL) HbA1c ≥7% who used DDS (users) or received usual care (nonusers) between January 1, 2017, to October 31, 2021.

The study showed adults with uncontrolled T2DM using DDS had better outcomes at 6 months, with more significant HbA1c reductions than matched nonusers across various BL HbA1c levels, showing incremental improvements to usual care.

This retrospective cohort study included adults with T2DM with a baseline (BL) HbA1c ≥7% who used DDS (users) or received usual care (nonusers) between January 1, 2017, to October 31, 2021.

BL period was 1 year before index date (first DDS registration [users] or first claim date in the quarter [nonusers]);

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BL period was 1 year before index date (users, first DDS registration;

nonusers, first claim date in the quarter);

nonusers, first claim

date in the quarter);

follow up was 6 months.

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The impact of a digital health technology on healthcare quality measures and clinical outcomes in adults with type 2 diabetes mellitus

In this retrospective study, in adults with T2DM, a greater proportion of Dario Diabetes Solution (DDS) users with BL A1c greater than or equal to 8% achieved A1c less than 8% and a smaller proportion with BL A1c greater than 9% remained greater than 9%, compared with a matched cohort of nonusers, without increasing the risk of severe hypoglycemia.

In this retrospective study, in adults with T2DM, a greater proportion of DDS users with BL A1c greater than or equal to 8% achieved A1c less than 8% and a smaller proportion with BL A1c greater than 9% remained greater than 9%, compared with a matched cohort of nonusers, without increasing the risk of severe hypoglycemia.

DDS offers improved quality outcomes based on HEDIS A1c criteria.

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“Impact of a Digital Diabetes Solution on Medication Adherence in Adults in the United States with Type 2 Diabetes Mellitus”.

In March 2024, we presented two clinical studies at the ATTD conference in Florence, Italy:

Impact of a digital health intervention on awareness of vaccination against influenza among adults with diabetes

leveraging digital health technology to deliver knowledge and information can enhance influenza vaccination rates in diabetes population to reduce public health.

A real-world implementation study of a 6-month digital diabetes intervention was performed in U.S Dario users with diabetes.

A group of 64,952 users were randomly sorted to:

real-world group (RW) received messages designed in the digital platform;

A RCT group received messages as designed in previous published RCT;

Control group (C) received no intervention.

Difference in self-reported vaccination rates and flu risk awareness levels were tested.

A total of 8431 users (13% response rate) with diabetes typ1 or type 2 reported vaccination status.

No compensation was offered during digital intervention.

After a 6-month intervention, a numerical increase was observed in the real-world group (N=3068) versus the RCT (N=3505) and the Control group (N=1858) (71.9% vs.

71% and 70.5%, respectively) (p=0.521).

Awareness to the risk in getting Flu in diabetes and the impact of the content materials were significantly higher (p<0.005) in the real-world group vs RCT (1.2-fold) and Control (1.35-fold).

Impact of digital therapeutic platform on blood glucose and weight levels in prediabetes population

This study demonstrates the potential of digital platforms to improve self-management and clinical outcomes among users with prediabetes, thus assisting in lowering the risk of developing type 2 diabetes.

A retrospective data analysis was performed on the prediabetes population using the platform in 2020-2023, with at least 2-months measuring BG or weight.

Monthly Avg.BG, weight and digital activities were analyzed versus baseline (month 1).

A linear mixed model tree was applied testing potential moderators.

A group of 6853 users with prediabetes who managed their BG on the platform was included (Age 55.4±13;

53% females).

In the subgroup with baseline ≥154 mg/dL (A1c 7.0) (N=819) a significant reduction of 15% in AvgBG was observed after 6 months and maintained along the year (198.9 to 168.2 mg/dL, p<0.001).

In a subgroup with baseline ≥140 mg/dL (A1c 6.5) (N=1282) 66% have improved AvgBG and 40% reduced AvgBG <140mg/dL (p<0.001).

A significant reduction of 6.3% in weight was observed in users with baseline BMI≥30 (N=1186, p<0.001).

Meal tagging activity moderated the trajectory of weight improvement, monthly average >5 meal taggings had a statistically significant and stronger reduction in the average weight (-0.11, p<0.001) compared to ≤5 monthly average meal tagging (-0.08, p<0.001).

In February 2024 we published in a peer-reviewed journal “Journal of Medical Internet research (JMIR)”, the article:

The Impact of Digital Self-Monitoring of Weight on Improving Diabetes Clinical Outcomes:

Quasi-Randomized Study

This study highlights the substantial benefits of self-monitoring of weight in managing BG levels in patients with diabetes, facilitated by a digital health platform, and advocates for the integration of digital self-monitoring tools in chronic disease management.

We also provide initial evidence of testing the underlying mechanisms associated with BG management, underscoring the potential role of patient empowerment.

In this retrospective, real-world quasi-randomized study, 50% of the individuals who regularly used the weight monitoring (“WM”) feature were propensity score matched with 50% of the users who did not use the weight monitoring feature based on demographic and clinical characteristics.

All the patients were diagnosed with T2D and tracked their BG levels.

We analyzed monthly aggregated data 6 months before and after starting their weight monitoring.

A piecewise mixed model was used for analyzing the time trajectories of BG and weight as well as exploring the disaggregation effect of between- and within-patient lagged effects of weight on BG.

The WM group exhibited a significant reduction in BG levels post intervention (P<.001), whereas the non-monitoring group showed no significant changes (P=.59), and both groups showed no differences in BG pattern before the intervention (P=.59).

Furthermore, the WM group achieved a meaningful decrease in BMI (P<.001).

Finally, both within-patient (P<.001) and between-patient (P=.008) weight variability was positively associated with BG levels.

However, 1-month lagged back BMI was not associated with BG levels (P=.36).

Three studies were presented at the 84th ADA conference in June 2024:

Digital platform users taking GLP-1 and managing Diabetes adapt lifestyle behavior change over twelve months

The study showed how lifestyle monitoring components in a metabolic digital disease management solution have the potential to drive behavior change and enhance clinical care among users taking GLP-1 medications.

These lifestyle changes may be important in driving outcomes in users taking GLP-1 medications.

This study followed behavior change in users utilizing a new “medication cabinet” feature for medication logging and were identified as existing GLP-1 users, versus non-GLP-1 users.

The purpose of the study was to investigate monthly activities over twelve months of using a digital platform in GLP-1 users versus non-GLP-1 Metformin users.

A retrospective data analysis was performed on early users of “medication cabinet” with T2D and prediabetes who measured their blood glucose (BG) at months 1,3,6,9,12.

The GLP-1 group included users who reported taking GLP-1 and non-GLP-1 group reported taking metformin.

A piecewise mixed effects model was applied to follow monthly average BG and lifestyle digital activities (logging meal/reference, carbohydrate intake and calories burned).

A cohort of 107 users was evaluated:

GLP-1 (N=35) and non GLP-1 users (N=72).

The groups were statistically equivalent in baseline average BG (150 vs.

152 mg/dL) and monthly average BG measurements (31.3 vs 30.5).

GLP-1 users showed significant reduction in BG at months 1-5 (p=0.02) maintained throughout the year.

GLP-1 and non-GLP-1 users both demonstrated a statistically significant increase in lifestyle activities during their first three months (p<0.001, p=0.02 respectively) maintained for a year.

Moreover, mixed-effects model revealed a statistically significant increase in monthly average weight measurements over the year among GLP-1 users (p<0.001).

Deep sleep interaction with blood glucose levels in people using an integrated digital health platform for diabetes management

A digital health platform that aims to help users adjust deep sleep and manage blood glucose levels can be a powerful tool in promoting overall health and well-being.

Sleep quality assessment connected with blood glucose monitoring on one single platform may provide actionable insights and help users understand the impact of sleep on their metabolic health.

A retrospective data analysis included people with T2D and prediabetes who used iPhone and integrated data into Dario digital health platform during Dec 2022-Dec 2023.

Weekly aggregations of average BG and time of deep sleep were calculated.

A mixed model analysis was used to determine whether the weekly avg BG can be predicted by weekly avg duration of deep sleep over time.

A cohort of 417 users with type 2 and prediabetes was evaluated (Age 60.4±12.3;

female 50.3%).

A significant difference between weekly avg BG levels in different durations of weekly avg deep sleep was demonstrated by the model (B=-.00, CI 95% -0.00- -0.00, p=.029).

Moreover, simple slope analysis showed that users with increased weekly avg deep sleep duration have significantly stronger reductions in avg BG (B=-.26, CI 95% -0.50- -0.03, p=.03) compared to users with low weekly avg deep sleep duration (B=-.13, CI 95% -0.37- 0.12, p=.31).

Sustained reduction in blood glucose levels reflecting diabetes remission in people with type 2 diabetes using a digital health platform

This study exhibits the potential role of digital health technology to change individuals' behaviors during management of T2D and support patients to achieve remission.

A retrospective data analysis was performed on users with T2D who have reported not using insulin and were active on Dario platform >6 months during 2018-2024, measured their BG in the first month and >3 measurements in the last month.

Monthly Avg.BG and percentage of high readings (>180 mg/dL) versus baseline (first month) were evaluated Paired sample t-test was used for testing differences in AvgBG.

A linear mixed-effects model was applied to evaluate the changes in AvgBG and high-readings percentage over time.

Finally, a simple slope analysis was used for the interpretation of the interaction of AvgBG and high-readings percentage with lifestyle activities.

A group of 7240 users was evaluated (Age 53.8 (SD ±24.6);

41% females).

A ratio of 44% (3169/7240) reduced their last monthly AvgBG to <140 mg/dL (equivalent to estimated A1c of 6.5).

A sustained AvgBG of <140 mg/dL for at least three consecutive months was observed in 70% (2223/3169) of the users reflecting diabetes remission.

The AvgBG was reduced by 15% vs.

baseline (P<.001) in this group.

In addition, users at high-risk with a baseline AvgBG ≥183 mg/dL demonstrated significant reductions in AvgBG and high-readings percentage in their last month moderated by the number of monthly lifestyle activities (logging carbs, meals and physical activities) as revealed by the model (B=-.00, P=.02 and B=-.00, P=.002 respectively).

In August 2024 we published in a peer-reviewed journal “Frontiers in Endocrinology” the article:

Walking away from depression:

the mediating role of walking activity in depression impacting blood glucose levels of people with diabetes or prediabetes

This study shows how regular walking may reduce the negative impact of depression on BG levels in people with T2D.

Our findings advocate for the integration of walking activity into treatment protocols as a cost-effective, accessible intervention strategy to improve glycemic management and depressive symptoms in this population.

A cohort of 989 users with T2D and prediabetes, who regularly tracked their steps levels and BG levels for 12 months using the Dario digital health platform was evaluated.

The mediating role of the monthly average number of steps on the relationship between the self-reported depression status and lagged monthly average BG was assessed.

Additionally, the association between monthly walking activity and monthly average BG was tested using a piecewise linear mixed effects model

Users with self-reported depression demonstrated increased BG levels compared to users without depression (B=8.00, P=.01).

The association between depression and monthly average number of steps was significant (B=-.27, P<.005) and monthly average number of steps significantly predicted the following months’ average BG (B=-.81, P=.001), adjusting for depression.

The monthly average number of steps significantly mediated the effect of self-reported depression on the following month’s average BG (M=.22, P<.005).

Further sensitivity analysis demonstrated model robustness over various periods.

Finally, non-linear dynamics of walking activity over time was validated using unseen data showing a decrease in monthly average BG for users with over an average of 400 steps per day (B=-1.87, P<.01).

In March 2024 two studies were published in the behavioral health field.

An RCT study was published on Happify for Teens (Twill) we published in a peer-reviewed journal “Journal of Medical Internet research (JMIR)”, the article:

Effects of a Digital Mental Health Intervention on Perceived Stress and Rumination in Adolescents Aged 13 to 17 Years:

Randomized Controlled Trial.

Happify for Teens was effective at reducing perceived stress, rumination, and loneliness among adolescents over 12 weeks when compared to a waitlist control group.

Our data reveal the potential benefits of DMHIs for adolescents, which may present a more scalable, destigmatized, and cost-effective alternative to school-based programs.

This was a 12-week, 2-arm decentralized randomized controlled trial of adolescents aged 13 to 17 years who presented with elevated levels of perceived stress and brooding.

Participants were randomly assigned to engage with a self-guided DMHI (Happify for Teens) or to a waitlist control.

Participants assigned to the intervention group were given access to the program for 12 weeks.

Happify for Teens consists of various evidence-based activities drawn from therapeutic modalities such as cognitive behavioral therapy, positive psychology, and mindfulness, which are then organized into several programs targeting specific areas of concern (eg, Stress Buster 101).

Participants in the waitlist control received access to this product for 12 weeks upon completing the study.

Participants in both groups completed measures of perceived stress, brooding, optimism, sleep disturbance, and loneliness at baseline, 4 weeks, 8 weeks, and 12 weeks.

Changes in outcomes between the intervention and waitlist control groups were assessed using repeated-measures multilevel models.

Of the 303 participants included in data analyses, 132 were assigned to the intervention and 171 to the waitlist.

There were significantly greater improvements in the intervention condition for perceived stress (intervention:

95% CI –1.82 to –1.19;

P<.001 and control:

95% CI –0.44 to 0.26;

P=.61), brooding (intervention:

95% CI –1.00 to –0.68;

P<.001 and control:

95% CI –0.47 to –0.12;

P=.001), and loneliness (intervention:

95% CI –1.2 to –0.73;

P<.001 and control:

–0.64 to –0.12;

P=.005) over the 12-week study period.

Changes in optimism and sleep disturbance were not significantly different across groups (Ps≥.096).

A retrospective data analysis study published in a peer-reviewed journal “JMIR Formative Research” in the article:

Association of Digital Engagement with Relaxation Tools and Stress Level Reduction:

Retrospective Cohort Study

This study sheds light on the association between stress level reduction and specific components of engagement in a digital health app, breathing exercises, and cognitive behavioral therapy–based video sessions.

Our findings provide a basis for further investigation of current and moderating factors that contribute to the personalization of digital intervention.

In addition, results may aid in developing a more comprehensive understanding of how digital intervention tools work for mental health and for whom they are most effective.

Stress levels were evaluated in a real-world data cohort using a behavioral health app for digital intervention and monitoring change.

This retrospective real-world analysis of users on a mobile platform–based treatment followed users (N=490) who started with moderate and above levels of stress and completed at least 2 stress assessments.

The levels of stress were tracked throughout the first 10 weeks.

A piecewise mixed effects model was applied to model the trajectories of weekly stress mean scores in 2-time segments (1-6 weeks and 6-10 weeks).

Next, a simple slope analysis was used for

interpreting interactions probing the moderators:

breathing exercises and video sessions.

Piecewise mixed-effects models were also used to model the trajectories of specific perceived stress item rates in the stress questionnaire in the 2 segments (1-6 weeks and 6-10 weeks) and whether they are moderated by the relaxation engagements.

Simple slope analysis was also used here for the interpretation of the interactions.

Analysis revealed a significant decrease in stress symptoms (β=–.25;

95% CI –0.32 to –0.17;

P<.001) during the period of 1-6 weeks of app use that was maintained during the period of 6-10 weeks.

Breathing exercises significantly moderated the reduction in stress symptoms during the period of 1-6 weeks (β=–.07;

95% CI –0.13 to –0.01;

P=.03), while engagement in digital video sessions did not moderate stress scores.

Engagement in digital video sessions, as well as breathing exercises, significantly moderated the reduction in perceived sense of burden and lack of productivity during weeks 1-6 and remained stable during weeks 6-10 on both items.

Government Regulation

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however, the FDA has the authority to exempt Class II devices from the pre-market notification requirement under certain circumstances.

devices that are not substantially equivalent to other lawfully marketed devices and for which safety and effectiveness cannot be assured solely by the general controls and special controls.

Class III devices are intended to be life sustaining or life supporting, devices that are implantable, devices that present a potential unreasonable risk of harm or are of substantial importance in preventing impairment of health, and devices that are not substantially equivalent to other lawfully marketed devices and for which safety and effectiveness cannot be assured solely by the general controls and special controls.

Pre-market Notification (510(k)) Clearance Process.

Manufacturers of most Class II devices must submit premarket notifications to the FDA under Section 510(k) of the FDCA (21 U.S.C.

§ 360(k)) in order to obtain the necessary authorization to market or commercially distribute such devices.

§ 360(k)) to obtain the necessary authorization to market or commercially distribute such devices.

To obtain 510(k) clearance, manufacturers must submit to the FDA adequate information demonstrating that the proposed device is “substantially equivalent” to a “predicate device” that is already on the market.

A predicate device is a legally marketed device that is not subject to PMA, meaning, (i) a device that was legally marketed prior to May 28, 1976, or pre amendments device, and for which a PMA is not required, (ii) a device that has been reclassified from Class III to Class II or I, or (iii) a device that was found substantially equivalent through the 510(k) process.

The FDA typically issues a decision within 90 days of receipt of a 510(k) submission but may stop the review clock for up to 180 days to request that the applicant respond to the agency’s requests for additional information about the proposed device.

The FDA typically issues a decision within 90 days of receipt of a 510(k)

submission but may stop the review clock for up to 180 days to request that the applicant respond to the agency’s requests for additional information about the proposed device.

If the FDA agrees that the device is substantially equivalent to the predicate device identified by the applicant in a premarket notification submission, the agency will grant 510(k) clearance for the new device, permitting the applicant to commercialize the device.

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Typically, an advisory committee is a panel of independent experts, including clinicians and other scientific experts, that reviews, evaluates and provides a recommendation as to whether the application should be approved and, if so, under what conditions.

The FDA is not bound

by the recommendation of an advisory committee, but it considers such recommendations when making final decisions on approval.

The FDA is not bound by the recommendation of an advisory committee, but it considers such recommendations when making final decisions on approval.

If the FDA’s evaluation of the PMA application and inspection of the manufacturing facility is favorable, the FDA may issue an approval order authorizing commercial marketing of the device, or an “approvable letter,” which usually contains a number of conditions that must be met in order to secure final approval of the PMA.

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If the FDA’s evaluation of a PMA application or manufacturing facility is not favorable, the FDA will deny approval of the PMA or issue a “not approvable letter.” The FDA may also determine that additional studies are necessary, in which case the PMA approval may be delayed for several months or years while such additional studies are conducted, and data is submitted in an amendment to the PMA.

The PMA process can be expensive, uncertain and lengthy, and each PMA submission is subject to a substantial user fee unless a specific exemption applies.

The PMA process can be expensive, uncertain and lengthy, and each PMA submission is subject to a substantial user fee

unless a specific exemption applies.

PMA approval may also be granted with post-approval requirements such as the need for additional patient follow-up or requirements to conduct additional clinical trials.

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The PMA pathway is much more costly, lengthy and uncertain.

Breakthrough Devices.

The Breakthrough Devices Program is a voluntary program intended to expedite the review, development, assessment and review of certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human diseases or conditions for which no approved or cleared treatment exists or that offer significant advantages over existing approved or cleared alternatives.

Submissions for devices designated as Breakthrough Devices will receive priority review, meaning that the review of the submission is placed at the top of the appropriate review queue and receives additional review resources, as needed and available.

Although Breakthrough Device designation or access to any other expedited program may expedite the development or clearance/authorization/approval process, it does not change the standards for clearance/authorization/approval.

Designation for any expedited review procedure does not ensure that we will ultimately obtain regulatory clearance or approval for such a product.

Our acquisition of Twill added a PDT that received a Breakthrough Device Designation.

In general, software that is intended for a medical purpose, whether it is included with a hardware device or is standalone software, is considered a medical device and subject to the same regulatory pathways described above, as long as it meets the definition of a “device” in Section 201(h) of the FDCA.

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Our Smart Diabetes Management Solution software and wireless blood pressure monitor software are considered medical devices under the FDCA and such software products have received the required marketing authorizations and are listed with FDA.

We believe that our other current software products either are not intended for a medical purpose or meet the applicable criteria to be considered low risk general wellness products.

We believe that our other current software products either are not intended for a medical purpose or meet the applicable criteria to be considered low risk products the FDA may exercise enforcement discretion, choosing not to enforce certain regulatory requirements.

Unlike regulatory exemptions from the 510(k) pre-market notification process, which still require compliance with general controls like registration and quality management systems, enforcement discretion means the FDA does not intend to enforce these controls for qualifying low-risk devices.

The FDA issued a Final Rule on February 2, 2024, describing amendments to harmonize the QSR with the 2016 edition of the International Organization for Standardization publication Medical Devices:

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Sales of medical devices outside the United States are subject to foreign regulatory requirements that vary widely from country to country.

These laws and regulations range from simple product registration requirements in some countries

to complex clearance and production controls in others.

These laws and regulations range from simple product registration requirements in some countries to complex clearance and production controls in others.

As a result, the processes and time periods required to obtain foreign marketing clearance may be longer or shorter than those necessary to obtain FDA clearance.

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A Notified Body typically audits and examines a product’s technical dossiers and the manufacturer’s quality management system (which must, in particular, comply with ISO 13485).

If satisfied that the AIMD or other medical device conforms to the relevant GSPRs, the Notified Body issues a certificate of conformity, which the manufacturer uses as a basis for its own declaration of conformity.

If satisfied that the AIMD or other medical device conforms to the relevant GSPRs, the Notified Body issues a certificate of conformity, which the manufacturer uses as a basis for its own declaration

of conformity.

The manufacturer may then apply the CE-Mark to the device, allowing the device to be legally marketed throughout the EU.

Notified Body certificates of conformity are valid for a fixed duration (which shall not exceed five years).

Throughout the term of the certificate, the manufacturer will be subject to periodic surveillance audits to verify continued

compliance with the applicable requirements.

Throughout the term of the certificate, the manufacturer will be subject to periodic surveillance audits to verify continued compliance with the applicable requirements.

In particular, there will be a new audit by the Notified Body before it renews the relevant certificate(s).

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Clinical trials are almost always required to support PMA applications and are sometimes required to support 510(k) and De Novo classification submissions.

All clinical investigations of devices to determine safety and effectiveness must be conducted in accordance with the FDA’s good clinical practice (GCP), regulations, including the investigational device exemption (IDE) regulations that govern investigational device labeling, prohibit promotion of investigational devices, and specify recordkeeping, reporting and monitoring responsibilities of trial sponsors and investigators.

devices, and specify recordkeeping, reporting and monitoring responsibilities of trial sponsors and investigators.

If the device presents a “significant risk,” as defined by the FDA, the agency requires the device sponsor to submit an IDE application to the FDA, which must become effective prior to commencing human clinical studies.

or otherwise preventing impairment of human health, or otherwise presents a potential for serious risk to a patient.

A significant risk device is one that presents a potential for serious risk to the health, safety or welfare of a patient and either is implanted, used in supporting or sustaining human life, substantially important in diagnosing, curing, mitigating or treating disease or otherwise preventing impairment of human health, or otherwise presents a potential for serious risk to a patient.

An IDE application must be supported by appropriate data, such as animal and laboratory test results, showing that the device has a safety profile appropriate for human testing and that the trial protocol is scientifically sound.

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the interim results of a study may not be satisfactory leading the sponsor or others to terminate the study, there may be an insufficient number of patients who qualify for the study or who agree to participate in the study or the investigator at the site may have priorities other than the study.

Also, there can be no assurance that the clinical study will provide sufficient evidence to assure regulatory authorities that the product is safe, effective and performs as intended as a prerequisite for granting market clearance.

Also, there can be no assurance that the clinical study will provide sufficient evidence to assure

regulatory authorities that the product is safe, effective and performs as intended as a prerequisite for granting market clearance.

See “Clinical Trials” above for clinical trials performed to date.

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A device user facility must report any device-related death to both the FDA and the device manufacturer, or any device-related serious injury to the manufacturer (or, if the manufacturer is unknown, to the FDA) within 10 days of the event.

Device user facilities are not required to report device malfunctions that would likely cause or contribute to death or serious injury if the malfunction were to recur but may voluntarily report such malfunctions through MedWatch, the FDA’s Safety Information and Adverse Event Reporting Program.

Device user facilities are not required to report device malfunctions that would likely cause or contribute to death or serious injury if the malfunction

were to recur but may voluntarily report such malfunctions through MedWatch, the FDA’s Safety Information and Adverse Event Reporting Program.

Failure to comply with applicable regulatory requirements can result in enforcement action by the FDA, which may include any of the following sanctions:

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A person or entity does not need to have actual knowledge of the AKS or specific intent to violate it to have committed a violation.

In addition, the government may assert that a claim including items or services resulting from a violation of the AKS constitutes a false or fraudulent claim for purposes of the FCA or federal civil money penalties statute;

● the federal civil and criminal false claims laws and civil monetary penalty laws, including the federal False Claims Act (FCA), which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, false or fraudulent claims for payment to, or approval by Medicare, Medicaid, or other federal healthcare programs, knowingly making, using or causing to be made or used a false record or statement material to a false or fraudulent claim or an obligation to pay or transmit money to the federal government, or knowingly concealing or knowingly and improperly avoiding or decreasing or concealing an obligation to pay money to the federal government.

In addition, the government may assert that a claim including items or services resulting from a violation of the AKS constitutes a false or fraudulent claim for purposes of the federal False Claims Act (“FCA”) or federal civil money penalties statute;

● The federal civil and criminal false claims laws and civil monetary penalty laws, including the federal FCA, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, false or fraudulent claims for payment to, or approval by Medicare, Medicaid, or other federal healthcare programs, knowingly making, using or causing to be made or used a false record or statement material to a false or fraudulent claim or an obligation to pay or transmit money to the federal government, or knowingly concealing or knowingly and improperly avoiding or decreasing or concealing an obligation to pay money to the federal government.

Manufacturers can be held liable under the FCA even when they do not submit claims directly to government payers if they are deemed to “cause” the submission of false or fraudulent claims.

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● The Civil Monetary Penalties Law , which prohibits, among other things, the offering or giving of remuneration, which includes, without limitation, any transfer of items or services for free or for less than fair market value (with limited exceptions), to a Medicare or Medicaid beneficiary that the person knows or should know is likely to influence the beneficiary’s selection of a particular supplier of items or services reimbursable by a federal or state governmental program;

● the Health Insurance Portability and Accountability Act of 1996 (HIPAA) imposes criminal and civil liability for executing a scheme to defraud any health care benefit program or making false statements relating to health care matters;

● The HIPAA imposes criminal and civil liability for executing a scheme to defraud any health care benefit program or making false statements relating to health care matters;

● HIPAA, as amended by the Health Information Technology for Economic and Clinical Health (“HITECH”) Act, and its implementing regulations, also imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;

● The federal transparency requirements under the Physician Payments Sunshine Act require manufacturers of FDA-approved drugs, devices, biologics and medical supplies covered by Medicare or Medicaid to report, on an annual basis, to the CMS information related to payments and other transfers of value to physicians, certain advanced non-physician healthcare practitioners, and teaching hospitals or to entities or individuals at the request of, or designated on behalf of, such physicians, non-physician healthcare practitioners, and teaching hospitals as well as certain ownership and investment interests held by physicians and their immediate family members;

● The federal transparency requirements under the Physician Payments Sunshine Act require manufacturers of FDA-approved drugs, devices, biologics and medical supplies covered by Medicare or Medicaid to report, on an annual basis, to the Center for Medicare and Medicaid Services (“CMS”) information related to payments and other transfers of value to physicians, certain advanced non-physician healthcare practitioners, and teaching hospitals or to entities or individuals at the request of, or designated on behalf of, such physicians, non-physician healthcare practitioners, and teaching hospitals as well as certain ownership and investment interests held by physicians and their immediate family members;

● Analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by nongovernmental third-party payors, including private insurers.

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The CPRA imposes additional data protection obligations on covered businesses, including additional consumer rights processes, limitations on data uses, new audit requirements for higher risk data, and opt outs for certain uses of sensitive data and expands the application of the CCPA to all human resources personal information of California-based employees.

It also created a new regulatory entity, the California Privacy Protection Agency data protection agency, which is authorized to issue substantive regulations under the CPRA and is expected to result in increased privacy and information security

security enforcement.

Other states have implemented similar laws protecting identifiable health and personal information, and most such laws differ from each other in significant ways and may not be preempted by HIPAA, thus complicating compliance efforts.

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In the European Union, increasingly stringent data protection and privacy rules that have and will continue to have substantial impact on the use of personal and patient data across the healthcare industry became stronger in May 2018.

The EU General Data Protection Regulation (GDPR) applies across the European Union and includes, among other things, a requirement for prompt notice of data breaches to data subjects and supervisory authorities in certain circumstances and significant fines for non-compliance.

The GDPR applies across the European Union and includes, among other things, a requirement for prompt notice of data breaches to data subjects and supervisory authorities in certain circumstances and significant fines for non-compliance.

The GDPR fine framework can be up to 20 million euros, or up to 4% of our total global turnover of the preceding fiscal year, whichever is higher.

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On May 8, 2011, certain of our founders filed a Patent Cooperation Treaty (“PCT”) Application No.

PCT/IL2011/000369, titled “Fluids Testing Apparatus and Methods of Use.” This PCT claimed priority from two

preceding U.S.

PCT/IL2011/000369, titled “Fluids Testing Apparatus and Methods of Use.” This PCT claimed priority from two preceding U.S.

provisional applications filed by our founders, with the earliest priority date being May 9, 2010.

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and an adaptor that connects the glucose meter to a smart-phone to receive power supply and data display, storage, and analysis.

A PCT search report and written opinion on patentability that we received from World Intellectual Property Organization (known as WIPO) that included only two “Y” citations and one additional non-relevant reference.

A PCT search report and written opinion on patentability that we received from World Intellectual Property Organization (“WIPO”) that included only two “Y” citations and one additional non-relevant reference.

Corresponding national applications of our PCT were filed in the U.S., Europe, Japan, China, Australia and Israel.

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We have also filed several families of trademark applications covering the “Dario” name (wordmark), the Dario name and logo (logo), the Dario logo alone (logo), the DARIO-LITE wordmark, the LABSTYLE INNOVATIONS wordmark, the DARIOHEALTH wordmark, and the DARIOHEALTH logo.

In particular, the “Dario” wordmark is registered as a trademark in Australia, Canada, China, Costa Rica, United States, Israel, Hong Kong, South Africa, Japan, Costa Rica, Europe, Israel, Korea, Mexico, New Zealand, Panama and Russia.

In particular, the “Dario” wordmark is registered as a trademark in Australia, Canada, China, Costa Rica, United States, Israel, Hong Kong, South Africa, Japan,

Costa Rica, Europe, Israel, Korea, Mexico, New Zealand, Panama and Russia.

The “DARIOHEALTH” wordmark is registered as a trademark in the United States, Canada, China and India.

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US 11,727,217 B2 titled “SYSTEMS AND METHODS FOR DYNAMIC USER INTERACTION FOR IMPROVING MENTAL HEALTH”.

commence an interactive session with a user, receive input data from the user during the interactive session, analyze the received input data and output a response to the user to continue the interactive session with the user.

The abstract contained in the patent award describes this patent as “A computing system for interacting with a user comprises a processor and a memory storing executable software which, when executed by the processor, causes the processor to commence an interactive session with a user, receive input data from the user during the interactive session, analyze the received input data and output a response to the user to continue the interactive session with the user.

The processor, prior to outputting the response, identifies one or more topics from the received input data, ascertains a tone of the received input data, generates a mirroring prompt based on the ascertained tone of the received input data, and output to the user the generated mirroring prompt.

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Patent Applications

On October 25, 2021, patent application 17/510,341 was filed in the United States Patent office.

Titled “ DYNAMIC INTERACTION SYSTEM AND METHOD”, the abstract for this application describes as “A method and system are provided for dynamic user interaction.

The method includes assessing input data, received from a user, that is used to determine a psychological state of the user.

The method further includes determining a current psychological state of the user, using an application stored in non-transitory storage media, based on the input data, and determining possible courses of action for the user based on the determined current psychological state of the user.

The method additionally includes presenting the current psychological state and the possible courses of action to the user through a physical interface.”.

On December 8, 2021, patent application 17/546,020 was filed in the United States Patent office.

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Overall, processes carried out by the system establish and maintain a patient social content system that utilizes tracking data received from one or more sensors.”.

On August 1, 2022, patent application 17/878,901 was filed in the United States Patent office.

Titled “ APPARATUS FOR COMPUTER GENERATED DIALOGUE AND TASK-SPECIFIC NESTED FILE ARCHITECTURE THEREOF”, the abstract for this application describes as “The present disclosure relates to digital devices adapted to increase the efficacy of a computerimplemented migraine treatment plan.

In some embodiments, an apparatus generates an interactive session comprising a plurality of tracks and sets a need set according to a baseline level.

The need set may comprise a selection of one or more tracks, wherein the selection is a function of the baseline level and/or a variable level.

The interactive session may utilize a threetiered architecture interactive dialogue module comprising a master file, a plurality of skeleton files, and a plurality of skin sets, wherein each of the plurality of skin sets is nested within one of the plurality of skeleton files and the plurality of skeleton files are nested within the master file.

Accordingly, the tracks, the activities, and the tasks, may each utilize the master file, the skeleton files, and the skin sets, respectively.”.

Associated applications have been filed in the WIPO (Application No.PCT/US 2022/046487 and EPO (Application No.

On October 12 , 2022, patent application 17/878,901 was filed in the United States Patent office.

Titled “ MODIFIABLE PHARMACEUTICAL PROTOCOL FOR MIGRAINE TREATMENT AND ASSESSMENT OF DRUG EFFICACY THEREOF”, the abstract for this application describes as “The present disclosure relates to a treatment protocol for treatment of migraine comprising an abortive drug adapted to bind with a plurality of calcitonin gene-related peptides (CGRP) receptors.

The abortive drug may be adapted to mitigate vasodilation in a user.

The treatment protocol may comprise evaluating medication-relevant information from a user input to determine positive and/or negative effects of the abortive drug regimen.

The treatment protocol may include a preventative drug regimen and a corresponding preventative drug.

The treatment protocol may be configured to evaluate the efficacy of the abortive and/or preventive drug regimens based on the determined positive and/or negative effects.

In a further embodiment, the drug protocol may be configured to generate suggested alterations to either regimen based on the efficacy evaluation.”

On October 12 , 2022, patent application 17/964,871 was filed in the United States Patent office.

Titled “ PHARMACEUTICAL ADMINISTRATION TRACKING AND TREATMENT COMPLIANCE SYSTEM’, the abstract for this application describes as “The present disclosure relates to a medication tracking and compliance system.

In an embodiment, the system receives an initial drug regimen comprising one or more drugs configured to inhibit a calcitonin superfamily of peptides.

The system, via a client device, may receive user input and extract the medication-relevant information from said user input.

In a further embodiment, the medication-relevant information may be analyzed in view of drug-specific information to evaluate potential positive and/or negative effects.

The system may generate an activity within the interactive session, where the activity may be replaced with a succeeding activity based on the activity content efficacy and activity type efficacy of the previously generated activity.”

On October 12 , 2022, patent application 17/964,874 was filed in the United States Patent office.

Titled “ DISTRIBUTED NETWORK FOR MODIFIABLE INTERACTIVE SESSIONS AND ADHERENCE ENHANCEMENT THEREOF”, the abstract for this application describes as “The present disclosure relates to a system of networked devices configured to increase the efficacy of a migraine treatment plan and adherence to said treatment plan.

The system may comprise a client device and a server, wherein the client device is adapted to generate an interactive session including one or more tracks.

In a further embodiment, the client device receives user input and alters the track based on an instant instruction.

The instant instruction may be generated by the server based on at least the received input data and the need set.

Thus, the server may transmit the instant instruction to the client device, enabling the client device to alter the track such as to improve at least one need from the need set.”

On April 19, 2023 , patent application 18/136,787 was filed in the United States Patent office.

Titled “ SYSTEMS AND METHODS FOR MANAGING DYNAMIC USER INTERACTIONS WITH ONLINE SERVICES FOR ENHANCING MENTAL HEALTH OF USERS”, the abstract for this application describes as “A system for conducting dialogues with users of an online service recommending N activities comprises a processor to generate a first file including M portions for conducting the dialogues.

The processor generates N second files for the N activities, respectively.

The processor includes in each of the N second files references to a plurality of the M portions of the first file.

The processor generates a plurality of third files, each corresponding to a task for performing one of the N activities.

The processor conducts a dialogue with one of the users about one of the N activities using one of the N second files corresponding to

the one of the N activities, a plurality of the M portions of the first file referenced by the one of the N second files, and one of the third files corresponding to a task for performing the one of the N activities.

On August 15, 2023, patent application 18/234,319, a Continuation of application No.

17/671,251, filed on Feb.

14, 2022, now Pat.

11,727,217, was filed in the United States Patent office.

Titled “SYSTEM S AND METH ODS FOR DYNAMIC USER INTERACTION FOR IMPROVING MENTAL HEALTH”, the abstract for this application describes as “ A computing system for interacting with a user comprises a processor and a memory storing executable software which, when executed by the processor, causes the processor to commence an interactive session with a user, receive input data from the user during the interactive session, analyze the received input data and output a response to the user to continue the interactive session with the user.

The processor outputs the mirroring prompt to the user during the interactive session to cause an increase in a level of engagement of the user with the interactive session.”

Associated applications have been filed in EP (Application No.

Granted Trademarks

Registration No.

Regitrsation Date

Registration Date

Therapeutic Media

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Madrid Protocol

1712124 (BR,UK)

Madrid Protocol

1738488 (AU,UK)

In recent years, a number of digitally supported solutions have emerged to manage diabetes and other chronic conditions.

Competitors are developing new technologies rapidly and, in some cases, are also expanding to manage other chronic conditions.

In this crowded field, our success is predicated on our flexibility to adapt to evolving customer requirements in digital health and superior execution in engagement, retention and clinical outcomes in a manner that delivers clear return on investment in required time-horizons and in complex, highly regulated business environments.

We expect new entrants in the field and the emergence of novel technologies, as well as competition from larger technology platform players such as Amazon, Apple and Google.

Dario’s competitors vary by intervention (devices, applications, coaching and analytics), by channel (health plan, pharma, provider, employer) and by condition (including, for example, diabetes, MSK, HTN, behavioral health and others).

Certain of our competitors offer this integrated approach in varying degrees, including, among others, Hinge Health, Inc., Livongo Health Inc.

(acquired by Teladoc Health Inc.), Omada Health, Inc., Vida Health, Inc.

and Virta Health Corp.

We believe that our competitors are comparatively disadvantaged along several axes:

● Our competitors offer point solutions for a single condition (which model is unattractive to enterprise customers needing to manage multiple vendor relationships and who recognize that conditions frequently overlap in the same individual);

● Our competitors fail to share member-level data or granular reporting with partners, which prevents these partners from leveraging their own assets to support care;

● Competitor applications have limited or minimal levels of personalization, where communications (or “nudge”) from the application may be somewhat personalized, but actual user experiences are heavily templated, and not personalized or dynamic;

● Competitor applications are supported only by short term outcome data, as compared to our studies which cover a 2-year period and offer 8 years of direct-to-consumer data;

● Failure of any one of our competitors to successfully engage and retain a substantial portion of the base population, as few have the direct-to-consumer experience or data required, resulting in frustrated customers who cannot realize promised cost savings;

● Customers of our competitors suffer an inadequate user experience, as evidenced by few app store reviews and low scores in Apple, Google and Amazon stores;

● Our competitors offer medical device-oriented approaches with delayed product update cadences, rather than our more agile, software-driven approaches that push out new products every few weeks;

● Our competitors have slowed their improvements in the area of clinical metrics (including, for example, blood pressure, HbA1c, and pain), which decreases the solution’s return on investment;

● Our competitors often utilize cumbersome form factors and alternative connected devices, which are not easily portable or that otherwise require significant user effort for connectivity.

By contrast, our diabetes solution, for example, utilizes lancets, strips and a dongle held in a lipstick-sized device that physically connects to a user’s phone and doesn’t require independent charging.

As another example, our MSK device is small and easily attaches to body parts for convenient and easy use;

● Our competitors’ applications experience limited interoperability and connectivity, such that they are unable to integrate with third party devices, electronic health records or partnered solutions;

● Our competitors have higher costs;

our solutions are priced 30-50% lower than current comparable in-market solutions.

As of March 22, 2024, and following the acquisition of Twill Inc., we had 276 full-time employees and 18 part-time employees.

As of March 3, 2025, we had 196 full-time employees and 6 part-time employees.

We have employment agreements with our four executive officers.

1 unchanged sentence

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business