What changed in this filing

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Item 1. Business

2024-03-28 compared with 2023-03-09 · 765 added, 134 removed, 612 unchanged (59% of the section changed)

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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.

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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 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 the have published 38 real world data studies with total of 10 generated in 2022, and several more already planned for 2023.

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.

Recent Developments

Integration of Dexcom CGM Data

We collaborated with Dexcom to integrate the data from its market-leading Continuous Glucose Monitoring (“CGMs)” technology, which uses a small, wearable sensor to continuously measure and send glucose levels to a receiver or smart device to enable better real-time decision making for people living with diabetes, into our multi-chronic condition platform.

This partnership, signed in early 2023, enables the integration of data from Dexcom CGMs directly into our metabolic solution, making it easy for people using the wearable device to benefit from our highly personalized support.

Our 2022 agreement with Sanofi continues to evolve after the first year of our agreement across all three pillars of the agreement.

First, our co-promotion efforts are yielding a healthy pipeline of health plans and Pharmacy Benefit Managers (“PBMs”), and we have several opportunities in or close to contracting.

Second, our product development has yielded several new features currently in beta testing with our consumer membership.

We expect that these features will be released more broadly to the market in the spring of 2023.

Third and finally, we are preparing our first two research studies with Sanofi with the release of data expected in the summer of 2023.

Director and Officers

In January 2023, we announced that we executed a Termination of Employment and Separation with Dror Bacher, our prior Chief Operating Officer, pursuant to which Mr.

Bacher’s position as Chief Operating Officer was terminated with immediate effect.

We have retained Mr.

Bacher as a member of our advisory board.

In February 2023, on the recommendation of the Nominating Committee of the Board of Directors, we expanded the Board by one seat and appointed Jon Kaplan as a member of the Board.

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.

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

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

Two years post-shift from our business-to-consumer into a B2B2C business model, we believe that the financial impacts are validating our growth and DTaaS theses.

Our pro-forma gross profit for the quarter ended December 31, 2022, excluding acquisition related amortizations, has improved to 50% of revenues in 2022 compared to 39% of revenues in 2021.

In 2022, our commercial revenue exceeded our consumer revenue.

Competitive Strengths

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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 in a study in mid-2023.

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

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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

Users’ interactions with devices, smartphones, coaches, providers, and third-party solutions must be personalized along these axes to ensure optimal engagement, retention, and outcomes.

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.

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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.

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.

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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.

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.

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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 in 2023 to enhance our opportunities with a one-to-many approach.

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.

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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.

Clinical Studies

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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

● Reduction of 14% Blood Glucose average was observed in T2D within 12 months

● The study presented a reduction of 14% Blood Glucose average was observed in T2D within 12 months

● 76% of the population showed 24% improvement in Blood glucose average within 12 months

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The study assessed the average blood glucose readings along a year of usage.

The average of glucose readings was calculated per user in periods of 30 days intervals from 30-60 to 330-360 days and compared to the first 30 days as the starting point baseline of analysis.

The average glucose readings was calculated per user in periods of 30 days intervals from 30-60 to 330-360 days and compared to the first 30 days as the starting point baseline of analysis.

Overall of 238 highly engaged T2D users (more than one daily measurement in average) whose average blood glucose level was above 180mg/dL in the first 30 days of measurements (225±45 mg/dL) showed continuous reduction in glucose level average vs.

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7.14% ± 0.98%).

An additional study evaluated on the potential improvement in glycemic variability in Type 2 diabetes over six months in patients monitoring with Dario Digital Diabetes Management System.

An additional study evaluated the potential improvement in glycemic variability in Type 2 diabetes over six months in patients monitoring with Dario Digital Diabetes Management System.

Dario presented the study results at the Advance Technologies and Treatment for Diabetes (ATTD) conference in February 2019 in Berlin.

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Decrease in Glycemic Variability for T2D over Six Months in Patients Monitoring with Dario Digital Diabetes Management System

● Reduction of 14%-18% in measurements variability was observed in T2D within 6 months

● The study demonstrated a reduction of 14%-18% in measurements variability was observed in T2D within 6 months

● Hypo events (<70 mg/dL) remained <1 event on average

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

A population of T2D high-risk patients (blood glucose measurements average (GM avg ) >180 mg/dL) measuring more than 20 times in the first

30 days (analysis baseline) was evaluated on days 60-90 (3 months) and 150-180 days (6 months).

A population of T2D high-risk patients (blood glucose measurements average (GM avg ) >180 mg/dL) measuring more than 20 times in the first 30 days (analysis baseline) was evaluated on days 60-90 (3 months) and 150-180 days (6 months).

Standard deviation (SD) and GM avg were calculated and compared to the baseline.

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A 39% increase in the in-range (80-130 mg/dL;

<180mg/dL post-meal) measurements was observed in a subgroup of 101 patients who started with

average blood glucose levels of over 140mg/dL.

<180mg/dL post-meal) measurements was observed in a subgroup of 101 patients who started with average blood glucose levels of over 140mg/dL.

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 February 2020, we presented an additional clinical study at the Advanced Technologies & Treatments for Diabetes (“ATTD”) conference in Madrid, Spain.

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

Insulin dependent of users with type 1 or type 2 diabetes population was evaluated for two year of continuous system use.

Insulin dependent of users with type 1 or type 2 diabetes population was evaluated for two years of continuous system use.

Average numbers of level 1 hypoglycemia (<70mg/dL) and level 2 hypoglycemia (<54 mg/dL) events were calculated monthly and compared to baseline (first month).

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34.92%) on average.

Post-meal readings ratio of <180 mg/dL per entire post-meal measurements increased by 5% (73.75% vs.

70.42%) on average over a year.

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

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diabetes and hypertension.

The study presented Hypertension and Diabetes clinical outcomes.

Hypertension:

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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.

● Blood pressure:

● Blood pressure outcomes:

o Normal levels increased from 6% to 12% and percentage of users with hypertension stage 2 decreased from 53% to 45%

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Diastolic 89.9 ±11 vs.83.7 ±8.7)

● Blood Glucose:

● Blood Glucose outcomes:

o A group of 345 users measured with Dario their blood glucose in addition to blood pressure, 89% are type 2 and pre-diabetes - average age is 60.4.

o For the group of 345 users a reduction of 33% (5.4% vs.8.0%) in high readings ratio (>250 mg/dL) and 67% (0.3%vs.0.9%) in severe events ratio (>400 mg/dL) was observed following six months on average.

A subset of 114 users with diabetes in higher risk started with BG average >160 mg/dL improved their average blood glucose by 14% (207±47 vs.177±50 mg/dL) following six months.

A subset of 114 users with diabetes in higher risk started with BG average >160 mg/dL improved their average blood glucose by 14% (207±47 vs.177±50 mg/dL) following six months compared to baseline.

In November 2020, we presented additional clinical study data at the Virtual Diabetes Technology Society (DTS) meeting.

The Effect of a Digital Therapeutic Platform on Glycemic Control in Adults above Age 65 with Type 2 Diabetes.

This study showed reduction of 13% blood glucose average in age group ≥65 (N=298) at six months by 13% 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.

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:

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However, in the sub-group of 173 users, basal insulin usage and fasting glucose levels remained stable following three months.

In May 2021, a prospective pilot study was published in “Journal of Diabetes Science and Technology” the article:

In May 2021, a prospective pilot study was published in a peer reviewed journal “Journal of Diabetes Science and Technology”:

“Digital Therapeutics for Type 2 Diabetes:

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The study suggests that a diabetes digital platform with real-time feedback and access to coaching improved diabetes outcome measures such as HbA1c with a reduction in GV.

Importantly, we provide clinical validation for digital self-monitoring to deliver personalized care for patients with T2DM.

Importantly, we provide clinical validation for digital self-monitoring to deliver personalized care for patients with type 2 diabetes mellitus (“T2DM”).

Future research should replicate our findings using a larger sample.

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● Weekly engagement with CDCES predicted reduction of participants’ GV during the following week

In June 2021, two studies were presented in ADA:

In June 2021, two studies were presented in 81 th ADA:

Impact of Digital Intervention Tools on Engagement and Glycemic Outcomes

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P-value <0.03)

In February 2022, another article was published in “ Journal of Medical Internet research (JMIR)”

In February 2022, another manuscript was published in “ Journal of Medical Internet research (JMIR)”

“Blood Pressure Monitoring as a Digital Health Tool for Improving Diabetes Clinical Outcomes:

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The subgroup of 108 users that started at high-risk blood glucose levels (average blood glucose >180 mg/dL) reduced their weight by 4.9%, average blood glucose by 16.1% and high readings ratio by 38% over 12 months (p<0.05).

In June 2022, three retrospective data analysis studies were presented in ADA:

In June 2022, three retrospective data analysis studies were presented in 82 th ADA:

Persons with high-risk diabetes, depression and stress using a Digital health platform experience improvement in glycemic management

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A retrospective data analysis on the Dario TM database of users who activated the mobile app during 2019-2021 and who self-reported stress and depression in the app questionnaire.

Participants who took at least 5 measurements

during their 1 st and 12 th months with Dario and who started with an average blood glucose >180 mg/dL were termed “high-risk”.

Participants who took at least 5 measurements during their 1 st and 12 th months with Dario and who started with an average blood glucose >180 mg/dL were termed “high-risk”.

A statistical analysis (T-test) was used to evaluate the differences in average blood glucose and high blood glucose (>180 mg/dL) readings ratio over a year.

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The study demonstrates an improvement in multiple chronic conditions (diabetes and hypertension) for people using one digital platform.

A retrospective data evaluation was performed on the Dario data base.

A retrospective data evaluation was performed on the Dario database.

A population of active users who started with hypertension stage 1 (Systolic ≥130 mmHg or Diastolic ≥ 80mmHg) as their baseline since 2019 was identified.

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No difference between the groups was found at 12th month(P=0.751).

In August 2022 were presented a retrospective data analysis study in the ADCES.

In August 2022, we presented a retrospective data analysis study in the ADCES.

Digital therapeutic platforms improve blood glucose management across rural/nonrural groups.

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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).

On 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” (IASP) large conference.

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

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Also, the training duration predicted the following week’s posture quality (B=0.0004, p<0.001) and in turn posture quality predicted the following week’s pain.

In December 2022, a first manuscript was published in a peer-reviewed journal on retrospective data analysis on UpRight posture biofeedback platform.

Finaly, posture quality mediated the effect of weekly training duration on the pain levels in two weeks.

In December 2022, the first manuscript was published in a peer-reviewed journal “ Frontiers in Physiology ” on retrospective data analysis on UpRight posture biofeedback platform.

The two-stage therapeutic effect of posture biofeedback training on back pain and the associated mechanism:

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Finally, perceived posture quality mediated the effect of weekly training duration on the pain levels in 2 weeks ( p <.0001).

In January 2023, a manuscript was published in a peer-reviewed journal “ MDPI-Applied sciences ” on retrospective data analysis glycemic management across Racial/Ethic groups:

Glycemic Management by a Digital Therapeutic Platform across Racial/Ethnic Groups:

A Retrospective Cohort Study

Our findings demonstrate improvement in blood glucose levels in high-risk racial/ethnic minority populations with T2DM, showing that in this group of users who are motivated to use a digital device there appears to be no difference in the outcomes between racial/ethnic groups.

The retrospective real-world analysis followed a group of 1,000 people with Type 2 diabetes who used the Dario digital therapeutic platform over 12 months.

Participants included in the study had a blood glucose average > 180 mg/dL (hyperglycemia, high-risk) in their first month.

The differences between/within the groups’ average blood glucose level (Avg.bg) and glycemic variability were evaluated.

Furthermore, three general linear models were constructed to predict the Avg.bg by the number of blood glucose measurements (Bgm) in Model 1 (with the moderator White persons ( " WP " )/people from racial and ethnic minority groups ( " REM " )) and by the frequency of measurements by months (F.m) within REM and WP in Model 2 and Model 3, respectively.

The Avg.bg was significantly reduced in each group over a year with no differences between REM/WP users.

Blood glucose measurements in Model 1 and frequency of measurements by months in Model 2 and Model 3 predicted the Avg.bg.

Findings indicate a positive association between digital engagement and glycemia, with no differences between REM and WP participants.

In February 2023, a manuscript was published in a peer-reviewed journal “ PAIN reports ” on an analytical framework of retrospective data for personalized pain management using piecewise mixed-effects model trees:

Personalizing digital pain management with adapted machine learning approach

This analytical framework offers an opportunity for investigating the personalized efficacy of digital therapeutics for pain management, taking into account users' characteristics and boosting interpretability and can benefit from including more users' characteristics.

We demonstrated the implementation of the model with posture biofeedback training data of 3610 users collected during 8 weeks.

The users reported their pain levels and posture quality.

We developed personalized models for nonlinear time-related fluctuations of pain levels, posture quality, and weekly training duration using age, gender, and body mass index as potential moderating factors.

Pain levels and posture quality demonstrated strong improvement during the first 3 weeks of the training, followed by a sustained pattern.

The age of the users moderated the time fluctuations in pain levels, whereas age and gender interactively moderated the trajectories in the posture quality.

Train duration increased during the first 3 weeks only for older users, whereas all the users decreased the training duration during the next 5 weeks.

In February 2023, we presented two additional clinical studies at the ATTD conference in Berlin, Germany:

Decrease in Hypoglycemia Events over Year in Older adults with Diabetes Monitoring with Digital Diabetes Management System

Older adults using a digital diabetes management platform have the potential to promote behavioral change and prevent hypoglycemia, demonstrating better glycemic outcome.

A retrospective data analysis was performed on the Dario database.

A cohort of users aged 67 or older with Type 1 or Type 2 diabetes and using Dario over a year was evaluated.

Average numbers of Hypoglycemia Level 1 (<70mg/dL) and Level 2 (<54 mg/dL) events as defined by the ADA were observed monthly and compared to baseline (first month).

In the cohort of 28 44 users, hypoglycemia level 1 events were reduced by 31% and 35% from baseline (0.54, 0.51 vs.

0.78) on average within 6 months and sustained over a year (p<0.05).

Hypoglycemia level 2 events were reduced by 53% (0.08, 0.08 vs.

0.17) on average within 6 months and sustained over a year (<0.05).

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.

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

Impact of Digital Coaching on Diabetes

Self-management and Glycemic Outcomes for People with Type 2 Diabetes

Self-monitoring blood glucose and digital engagement have a mediating role in the effect of digital coaching on blood glucose levels.

Coaching interactions have the potential to lead to behavioral change, which can positively impact the trajectory of a low-engaged user.

By constantly learning from the user's data, the digital therapeutic platform can continually improve and adapt to the user's individual needs, leading to better outcomes.

The study demonstrated that our platform is digital first where the human coaching intervention is provided to the right user at the right time and with the right intervention.

Retrospective data analysis was performed on a sample size of 712 users with type 2 diabetes with baseline average >180 mg/dL measured blood glucose over 12 months on the platform.

534 did not use a coaching service and 178 users interacted with a coach over a year.

Monthly Average blood glucose level significantly reduced in both groups w and w/o coach interaction over a year (18% vs.

Blood glucose measurements and digital engagement activities mediated the effect of coaching on average blood glucose levels.

For individuals who are less inclined to measure their blood glucose, coaching can help establish regular monitoring habits and to understand the importance of monitoring their levels.

In June 2023, we presented three clinical studies at the 83 th ADA conference:

Blood Glucose Reduction and Long-term Sustainability in High-risk Patients with Type 2 Diabetes Over Three Years Using a Digital Platform

The study showed that digital diabetes monitoring has the potential to enhance users’ awareness and affect and sustain glycemic control improvements over 3 years.

Moreover, it is highly expected that engagement to app features in a chronic condition management may help users with type 2 diabetes consistently taking care of their lifestyle behaviors to maintain better clinical outcomes.

A retrospective data analysis was performed on users with T2D in high-risk (baseline BG avg>169 mg/dL in month1;

equivalent to A1C 7.5) who activated between 2017-2020 and measured their BG using Dario platform over three consecutive years (at months 1,6,12,24 and 36).

The outcomes assessed were average blood glucose (BG avg) and high BG readings ratio (>180 mg/dL).

Digital engagement was assessed by additional parameters including measurement type (fasting/premeal/post meal/bedtime), carbohydrate intake, meal type and physical activity alongside glucose measurement.

A group of 1,239 users significantly reduced their BG avg consistently over three years by 15.6% (179±55 vs.

212±42) (p<0.05) and high readings ratio by 39% (p<0.05).

A subset of users who completed at least one engagement type following months 12, 24, and 36 (N=433) demonstrated significantly greater reductions versus the complementary group (N=806):

BG avg by 18.8% (172±51 vs.

212±45) and high readings ratio by 45% (p<0.05).

Digital Platform Users Managing Three Chronic Conditions Diabetes, Hypertension and Overweight Experience Better Outcomes than those Who Manage One Condition Following Six Months

Monitoring several conditions on an integrated platform may have the potential to offer a greater means for a person with diabetes to effectively manage glycemia, engage with the treatment and improve outcomes.

This study can illuminate the relative contribution of multi chronic conditions management driving behavioral change to successful diabetes outcomes.

A retrospective data analysis was performed on users who were active during 2019-2022 and measured blood glucose (BG) using Dario platform for at least six months.

The test group included users who measured blood pressure (BP) and weight within 6 months from their first BG measurement;

a matched control group of users who measured BG only in the first six months was generated.

BG levels were assessed by average BG (BG avg) and BGMS engagement was assessed by counting BG measurements per month.

High-risk users were defined as those with baseline BG avg>180mg/dL in Month 1.

A total number of 17,108 users were included in the study:

a test group of 2154 users measured BG, BP and Weight in the first six months on the platform and a control group of 14,954 users measured BG only in the first six months on the platform.

The test group (N=2,154) demonstrated significantly greater (1.7-fold) engagement evaluated by higher number of BG measurements, than the control group (N=14,954) in Month 1 and Month 6 (p<0.01).

A subgroup of the test group, 343 users at high-risk who measured 3 conditions BG, BP and weight was evaluated.

A matched control group of 1,579 high-risk users was generated.

The high-risk test group (N=343) demonstrated significantly greater reduction in BG avg versus the control subgroup (N=1579) measured BG only, after 6 months (17% vs.11%) (p<0.01).

Moreover, the ratio of population that reduced their BG avg to lower than 180 mg/dL after 6 months (equivalent to A1C 8.0;

HEDIS measure) was significantly higher in the test subgroup versus control subgroup in high-risk (by 30%;

Impact of a Digital Health Educational Feature on Engagement and Glycemic Outcomes

The present study demonstrates that by providing improved knowledge, increased motivation, and personalized learning digital health educational features can help users feel more empowered to manage their diabetes effectively.

A retrospective data evaluation study was performed on Dario TM members with type 2 (T2D) and prediabetes who experienced the educational feature.

Engagement (blood glucose measurements and logging carbs to Dario mobile app) and glycemic outcomes were assessed three months pre-post experiencing the feature.

Glycemic outcomes were assessed by average blood glucose (mg/dL) and glycemic variability (SD).

A group of 994 people with type 2 and prediabetes who were active in the mobile app and measured their blood glucose three months before using the new feature and in the following three months after, was evaluated.

The average number of blood glucose measurements increased by 34% (p<0.05) following the introduction of the new learning feature.

A subgroup of 303 users with type 2 and prediabetes that reported depression in the app as a co-existing condition increased carbs logging event by 39%.

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.

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.

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.

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

Linear mixed effects models investigated changes in engagement and clinical outcomes.

A population of 119,482 platform users was included, Age:

High-risk subgroup included 31,562 users with first month (baseline) average BG>180 mg/dL.

Total users’ engagement increased significantly by 29% (14.3 to 18.5) over two years (p<0.001).

High readings ratio (>180mg/dL) in high-risk subgroup decreased significantly by 38% (38.8% vs.

63.1%) over two years (p<0.001).

The monthly average BG of the high-risk subgroup was reduced significantly by 16% (218.1mg/dL to 183.4mg/dL) over two years (p<0.001).

A negative interaction effect was found with monthly engagements and the monthly average BG, as users with increased engagements (+1 SD) demonstrated stronger reductions in monthly average BG.

In September 2023, a manuscript was published in a peer-reviewed journal “ Journal of Medical Internet research (JMIR) Diabetes” on the contribution of specific digital engagement tools to mental health conditions – Depression and Anxiety.

Specifying the Efficacy of Digital Therapeutic Tools for Depression and Anxiety:

Retrospective, 2-Cohort, Real-World Analysis

This study demonstrated general improvement followed by a period of stability of depression and anxiety symptoms associated with cognitive behavioral therapy–based digital intervention.

Interestingly, engagement with a coaching session but not a breathing exercise was associated with a reduction in depression symptoms.

Moreover, breathing exercise but not engagement with a coaching session was associated with a reduction of anxiety symptoms.

These findings emphasize the importance of using a personalized approach to behavioral health during digital health interventions.

Depression and general anxiety symptoms were evaluated in real-world data cohorts using the digital health platform for digital intervention and monitoring change.

This retrospective real-world analysis of users on a mobile platform–based treatment followed two cohorts of people:

(1) users who started with moderate levels of depression and completed at least 2 depression assessments (n=519) and (2) users who started with moderate levels of anxiety and completed at least 2 anxiety assessments (n=474).

Levels of depression (Patient Health Questionnaire-9) and anxiety (Generalized Anxiety Disorder-7) were tracked throughout the first 16 weeks.

A piecewise mixed-effects model was applied to model the trajectories of the Patient Health Questionnaire-9 and the Generalized Anxiety Disorder-7 mean scores in 2 segments (1-6 weeks and 7-16 weeks).

Finally, simple slope analysis was used for the interpretation of the interactions probing the moderators:

coaching sessions and breathing exercises in both depression and anxiety cohorts.

Analysis revealed a significant decrease in depression symptoms ( β =–.37, 95% CI –0.46 to 0.28;

P ≤.001) during the period of weeks 1-6 of app use, which was maintained during the period of 7-16 weeks.

Coach interaction significantly moderated the reduction in depression symptoms during the period of weeks 1-6 ( β =–.03, 95% CI –0.05 to –0.001;

A significant decrease in anxiety symptoms ( β =–.41, 95% CI –0.50 to –0.33;

P ≤.001) was revealed during the period of 1-6 weeks, which was maintained during the period of 7-16 weeks.

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).

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.

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

By integrating the information that counts steps people with diabetes can access a single platform that helps them feel supported in their daily diabetes care and lifestyle management.

In this retrospective real-world study, a cohort of 989 platform users with Type 2 diabetes and pre-diabetes, who regularly tracked their blood glucose levels for 12 months using the Dario digital platform was evaluated.

The association between blood glucose levels and the number of steps was examined over time.

A piecewise linear mixed effects model was applied to test the trajectories over time of monthly average blood glucose and monthly average number of steps a day in two time periods defined by previous research 3 as well as to test non-linear association between them.

The sample included 437 (44%) women, 546 (55%) men and 6 (0.6%) others.

The average age was 62.5 (SD ±12.7) and the average BMI was 32.5 (SD ±6.9).

The baseline average BG was 142.5 mg/dL (SD ±37.7).

808 (82%) users have type 2 diabetes and 181 (18%) have pre-diabetes.

Analysis revealed that during the first 4 months there is a positive trend of monthly average steps ( B =.02, P <.001) while there is a negative trend of blood glucose levels ( B = -2.00, P <.001) in the same time frame.

Significant improvement in monthly average blood glucose was observed in users with at least 400 steps a day (B= -2.26, P <.001), while for those with less than 400 steps a day there was no significant change.

Certain clinical studies were published by Sanofi on our data in 2023.

The first poster was published at ISPOR May 2023.

Comparison of All-Cause Healthcare Resource Utilization Rates between Patients with Type 2 Diabetes Who Use a Digital Diabetes Solution Versus Non-Users:

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.

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.

Baseline was 12 months before index date (first DDS registration [users] or first medical encounter in the quarter with medical claims [non-users]);

follow-up was 12 months.

User and non-user cohorts were matched 1:3 using exact and propensity score matching.

Analysis included patients with access to care 12 months pre- and post-index date.

Primary endpoint was all-cause HCRU (inpatient hospitalizations + ER visits) rates during follow-up.

Data were analyzed using a generalized linear model with negative binomial distribution.

Of 9779 patients, DDS users (n=2445) and non-users (n=7334) were matched;

mean±SD age was 58.2±10.6 and 58.3±12.5 years, respectively.

At 12 months, mean (95% CI) all-cause HCRU rate (inpatient hospitalization + ER visits) was 0.475 (0.438–0.516) and 0.524 (0.500–0.549) events/year for users and non-users, respectively.

Users had 9.3% lower HCRU rate compared with non-users (incidence rate ratio [IRR], 0.907 [0.826–0.996];

Mean all-cause inpatient hospitalization rate was 0.166 (0.147–0.186) and 0.216 (0.203–0.230) events/year for users and non-users, respectively.

Users had 23.5% lower inpatient hospitalization incident rate versus non-users (IRR, 0.765 [0.671–0.873];

ER visit rates were similar in both cohorts (IRR, 1.01 [0.907–1.125];

Three studies were presented by Sanofi at the 83 th ADA conference:

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.

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

follow-up period was 6 months.

DDS user and nonuser cohorts were matched 1:3 using exact and propensity score matching.

Primary endpoint was change in HbA1c from BL to 6 months, with subgroup analyses of patients (pts) with BL HbA1c >7.5%, >8%, >9%, and ≥1% drop from BL.

Difference-in-difference results are reported using least squares (LS) means from linear models.

The study included 568 DDS users and 1699 nonusers.

For all 2267 pts, mean ± SD age was 57.5±11.3 years and HbA1c was 9.14±1.83% at BL.

At 6 months, LS mean difference between groups was −0.23% (mean HbA1c change vs BL:

users, −1.02% [95% CI, −1.15, −0.89];

nonusers, −0.79% [−0.87, −0.71];

HbA1c drop ≥1% from BL to 6 months was achieved by 47% of users vs 37% nonusers (difference:

Subgroup analysis at all BL HbA1c showed users achieved more significant HbA1c reductions vs nonusers ( P <0.05).

For pts with BL HbA1c >9%, the healthcare effectiveness data and information set performance measure, mean difference between groups was -0.47% (users, -2.25% [-2.50, -1.99];

nonusers, -1.78% [-1.92, -1.63];

Use of Digital Diabetes Solution Is Associated with Improved Glycemic Control without Increased Risk of Severe Hypoglycemia in Adults with Type 2 Diabetes Mellitus in the United States—Retrospective Cohort Study

In this retrospective study, a larger proportion of adults with uncontrolled T2DM (BL HbA1c ≥8%) achieved HbA1c <8% after using DDS vs nonusers, with no increased risk of severe hypoglycemia (SH).

This retrospective cohort analysis included adults with T2DM who used DDS (users) and nonusers from 1JAN2017 to 31OCT2021.

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

nonusers, first claim date in the quarter);

follow up was 6 months.

DDS users and nonusers were sequentially matched 1:3 using exact and propensity score matching.

Secondary endpoints included SH (event requiring medical intervention) rates for all patients (pts) and for pts with BL HbA1c ≥8% who achieved predefined target HbA1c <8%.

SH incidence in users vs nonusers was examined.

Overall cohort included 568 DDS users and 1699 nonusers:

mean age, 57.5±11.3 years;

mean BL HbA1c, 9.14±1.83%;

oral antidiabetic drugs, 51%;

BL SH was rare (users, 7/568;

nonusers, 12/1699).

There were 387 users and 1089 nonusers with BL HbA1c ≥8% (mean BL HbA1c, 10.0±1.7%).

In this subgroup, HbA1c <8% was achieved by 9% more DDS users (174/387 [45%]) vs nonusers (393/1089 [36%]) at 6 months;

At 6 months, overall SH rate was 38.8 (users) vs 10.6 (nonusers) events/1,000 pts per year (incidence rate ratio, 0.9;

No observed increase in SH risk was associated with DDS in this population.

SH was rare in pts who achieved HbA1c <8% (users, 1/174;

nonusers, 3/393).

Effect of a Digital Diabetes Solution on All-Cause Health Care Resource Utilization Charges for Patients with Type 2 Diabetes—A Retrospective Cohort Study

In this retrospective cohort study, pts with T2DM who utilized DDS incurred significantly lower all-cause HCRU and OV charges vs nonusers.

This retrospective cohort study (pt selection window:

1JAN2017 - 31APR2021) included adults (≥18 years) with T2DM receiving antidiabetic medication(s) with ≥1 inpatient or ≥2 outpatient visits ≥30 days apart during the baseline (BL) period.

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

nonusers, 1st claim date in the quarter);

follow up was 1 year.

User and nonuser cohorts were matched 1:3 using exact and propensity score matching.

Study assessed HCRU rates and charges.

A 2-part gamma distribution model was used to determine 1) likelihood (odds ratio, OR) of users vs nonusers to incur charges, then 2) total charges per patient per year (PPPY) including all-cause HCRU and office visit (OV) charges.

Of 9779 pts, 2445 DDS users and 7334 nonusers were matched;

mean age, 58.2±10.6 and 58.3±12.5 years, respectively.

At 1 year, users were 9% less likely to incur all-cause HCRU charges vs nonusers (OR, 0.91;

All-cause HCRU charges were 26% lower for users vs nonusers ( P <0.0001;

$12552 [adjusted] PPPY savings).

Users were more likely to incur all-cause OV charges vs nonusers ( P =0.04).

However, users had 19% lower all-cause OV charges vs nonusers ( P <0.0001;

$1790 [adjusted] PPPY savings).

The percentages of pts who incurred T2DM related HCRU charges were low (users, 3.1%;

nonusers, 3.0%).

Three posters were published at AMCP-Nexus, in October 2023:

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.

DDS offers improved quality outcomes based on HEDIS A1c criteria.

Cohorts of 568 DDS users and 1,699 nonusers were compared.

Inclusion criteria were as follows:

adults with a diagnosis of T2DM, receiving at least 1 diabetes medication, A1c greater than or equal to 7.0%, and not using a continuous glucose monitor between January 1, 2017, and October 31, 2021.

The primary endpoint was a change in A1c from baseline (BL) during a 180-day follow-up period, with subgroup analyses of people with BL A1c greater than 7.5%, greater than 8%, and greater than 9%.

Exploratory analyses were conducted to evaluate whether DDS use could facilitate a lowering of BL A1c from greater than or equal to 8% to less than 8% and from greater than 9% to less than 9% in adults with T2DM.

Secondary endpoints included severe hypoglycemia (event requiring medical intervention) rates for all included DDS users and nonusers and for those with BL A1c greater than or equal to 8% who achieved a predefined target A1c of less than 8%.

Overall, DDS user and nonuser cohorts were well matched , including by payer type (70% commercial and 18% Medicare for both groups).

Among 387 DDS users with BL A1c greater than or equal to 8%, 174 (45%) had A1c less than 8% during follow-up, compared with 393 (36%) of 1,089 nonusers (P=0.0021).

In a subgroup analysis of people with BL A1c greater than 9%, among 237 DDS users, 86 (36%) had follow-up A1c greater than 9%, compared with 347 (49%) of 713 nonusers (P=0.0009).

There was no increase in rates of severe hypoglycemia comparing groups (P>0.4).

Association between more frequent engagement with the Dario Diabetes Solution, a digital health technology, and a reduction in HbA1c in adults with type 2 diabetes mellitus

Higher DDS engagement was associated with a significantly greater reduction in A1c in adults with T2DM.

The highest engagement was in the first 2 months of follow-up and correlated with the greatest reductions in HbA1c.

Engagement decreased over time during follow-up.

Further research is needed to assess additional interventions that may sustain engagement over time.

This analysis included DDS users receiving at least 1 diabetes medication, with A1c ≥7.0%, and not using a continuous glucose monitor between January 1, 2017, and October 31, 2021.

Baseline (BL) was 1 year before the index date (first registration for DDS), with follow-up of 180 days from the index date.

Engagement activities were collected via the DDS app.

Engagement activity was measured in active days (ie, number of days when a user performed any engagement activity).

Ten DDS engagement activities were evaluated, including measuring BG, tagging (timing of BG measurement or meal type), food logging, and sharing logbook.

Associations between overall DDS engagement and change in A1c were analyzed over 180 days using a linear regression method, and associations were evaluated at 60- day intervals over those 180 days.

Individual components of engagement were also analyzed.

568 DDS users were included.

At BL, their mean age was 57.3 years (SD ±11.3) and mean A1c was 9.14±1.78%.

Median engagement activity was 65 active days of 180.

Each day with any DDS engagement activity was associated with a 0.01% change in A1c (P<0.0001).

Users in the most engaged quartile had 5× greater reduction in A1c than the least engaged quartile.

Individual engagement activities with significant associations with reduced A1c were BG measurement, tagging (meal type), and inputting insulin dose.

A retrospective cohort study comparing health care resource utilization, length of stay and 30-day readmissions in users and non-users of a digital diabetes health intervention for patients with type 2 diabetes mellitus.

In this real-world analysis, all-cause HCRU, inpatient, and 30-day readmission rates were significantly lower among DDS users vs nonusers (9%, 23%, and 36%, respectively), and LOS was significantly shorter (1.6 days).

In this retrospective cohort study, adults (aged >18 years) receiving therapy for type 2 diabetes who used DDS from January 1, 2017, to April 30, 2021, were identified;

index date was defined as the date of first DDS registration.

Anonymized DDS user data were linked to patient-level claims data within the Symphony Health Integrated Dataverse.

The DDS cohort was matched 1:3 using exact and propensity score matching to a nonuser cohort from the Symphony Health Integrated Dataverse with medical claims for type 2 diabetes mellitus during the study period.

For nonusers, the index date was the first medical claim date in the matched quarter.

All patients were required to have 12 months’ post-index follow-up and to have at least 2 outpatient claims (>30 days apart) or at least 1 inpatient claim within this period.

This analysis compared all-cause HCRU rates (inpatient + emergency department), LOS, and 30- day readmission rates in DDS users and nonusers.

Negative binomial generalized linear models adjusting for baseline rates were used to generate incidence rates (per personyear) and incidence rate ratios (IRRs) and corresponding 95% Cis for all-cause HCRU and 30-day readmission rates.

LOS was compared between groups using a two-sample t-test.

DDS users (n=2,445) and nonusers (n=7,334) were well matched (mean+SD age:

58.2+10.6 vs 58.3+12.5 years;

sex, 53.3% female for both).

At follow-up, the all-cause HCRU rate was 0.47 (95% CI= 0.44-0.52) in DDS users and 0.52 (95% CI= 0.50-0.55) in nonusers (IRR=0.91;

95% CI=0.83-1.00;

The mean all-cause inpatient event rate was 0.17 (95% CI= 0.15-0.19) in DDS users and 0.22 (95% CI= 0.20-0.23) in nonusers (IRR= 0.77;

95% CI= 0.67-0.87;

there was no significant difference in emergency department visits.

DDS users with an inpatient event (users, n=327;

nonusers, n=1,196) had a shorter LOS (7.2 vs 8.8 days;

P=0.017) and lower 30-day readmission rate (IRR= 0.64;

95% CI= 0.45-0.92;

P=0.014) vs nonusers.

Additional poster was presented at ISPOR EU, in November 2023.

The Impact of Patient Engagement with a Digital Diabetes Solution on All-Cause Healthcare Resource Utilization Rates and Charges

Overall engagement with DDS was associated with a reduction in all-cause HCRU and lower likelihood of incurring HCRU-related charges.

Patient-level claims data for adult DDS users (>18 years;

registered 01-Jan-2017 to 30-Apr-2021) receiving therapy for T2DM were retrieved from Symphony Health Integrated Dataverse.

All patients had >2 outpatient (>30 days apart) or >1 inpatient visit within 12 months prior to index (date of first DDS registration).

This analysis reports all-cause HCRU (inpatient + emergency room visits) and odds of incurring HCRU-related charges >$0 based on user engagement with any of 10 DDS activity metrics (‘components’ of activity metrics:

measuring BG, measuring blood pressure, measuring weight, tagging [BG timing and meal type], food logging, inputting insulin dose, recording physical activity, sharing logbooks, reading articles, coach interaction).

Overall engagement was defined as number of days any component was used within 12 months post-index.

All-cause HCRU rates and charges per 100 days of engagement were adjusted for baseline values with a negative binomial generalized linear model and logistic model, respectively;

incidence rate ratios (IRR) for HCRU and odds ratios (OR) for charges >$0 were derived.

We identified 2445 DDS users (mean+SD age, 58.2+10.6 years;

53.3% female).

Overall engagement (use of any DDS component) was associated with a 10% reduction in all-cause HCRU (IRR:

Overall DDS engagement was associated with 15% decreased odds of incurring all-cause HCRU-related charges >$0 (OR:

Another poster was presented at Diabetes Technology Society at Nov 2023, the abstract will be published in JDST early 2024.

The title is:

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

Government Regulation

2 unchanged sentences

United States Regulation Generally

In the United States, devices are subject to varying levels of regulatory control, the most comprehensive of which requires that a clinical evaluation is conducted before a device receives clearance for commercial distribution.

Under Section 201(h) of the Food, Drug, and Cosmetic Act, a medical device is an article, which, among other things, is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease, in man or other animals.

In the United States, medical devices are subject to extensive regulatory control at the federal level by the FDA under the Federal Food, Drug, and Cosmetic Act (“FDCA”) and its implementing regulations.

Under Section 201(h) of the FDCA, a medical device is an article, which does not achieve its intended purpose through chemical action or metabolism in or on the body and, among other things, is intended (i) for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease, in man or other animals or (ii) to affect the structure or any function of the body of man or other animals.

The Dario Blood Glucose Monitoring System is classified as a medical device and subject to regulation by numerous agencies and legislative bodies, including the FDA and its foreign counterparts.

FDA regulations govern product design and development, pre-clinical and clinical testing, manufacturing, labeling, storage, pre-market clearance or approval, advertising and promotion, and sales and distribution.

Specifically, the FDA classifies medical devices into one of three classes.

Class I devices are relatively simple and can be manufactured and distributed with general controls.

Class II devices are somewhat more complex and require greater scrutiny.

Class III devices are new and frequently help sustain life.

Unless an exemption applies, each medical device commercially distributed in the United States will require a 510(k) clearance, 510(k)+ “de-novo” clearance, or pre-market approval (or PMA) from the FDA.

510(k) Clearance Process.

FDA regulations govern, among other things, device design and development, nonclinical and clinical testing, manufacturing, packaging, labeling, storage, pre-market clearance or approval, establishment registration and device listing, advertising and promotion, sales and distribution, recalls and field actions, servicing and post-market surveillance.

A number of U.S.

states also impose licensing and compliance regimes on companies that manufacture or distribute prescription devices into or within the state.

The FDA classifies medical devices into one of three classes.

Classification of a device is important because the class to which a device is assigned determines, among other things, the necessity and type of FDA review required prior to marketing the device.

Unless an exemption applies, each medical device commercially distributed in the United States will require a clearance through the pre-market notification (or 510(k)) process, De Novo classification, or pre-market approval (“PMA”) from the FDA.

Class I devices are those for which reasonable assurance of safety and effectiveness can be maintained through adherence to general controls, which include compliance with the applicable portions of the FDA’s Quality System Regulation (“QSR”), as well as regulations requiring facility registration and product listing, reporting of adverse medical events, and appropriate, truthful and non-misleading labeling, advertising, and promotional materials.

The Class I designation also applies to devices for which there is insufficient information to determine that general controls are sufficient to provide reasonable assurance of the safety and effectiveness of the device or to establish special controls to provide such assurance, but that are not life-supporting or life-sustaining or for a use which is of substantial importance in preventing impairment of human health, and that do not present a potential, unreasonable risk of illness or injury.

Class II devices those for which general controls alone are insufficient to provide reasonable assurance of safety and effectiveness and there is sufficient information to establish “special controls.” These special controls can include performance standards, post-market surveillance requirements, patient registries and FDA guidance documents describing device-specific special controls.

While most Class I devices are exempt from the pre-market notification requirement, most Class II devices require a pre-market notification prior to commercialization in the United States;

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

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.

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.

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.

Premarket notifications are subject to user fees, unless a specific exemption applies.

After a device receives 510(k) clearance, any modification that could significantly affect its safety or effectiveness, or that would constitute a major change in its intended use, requires a new 510(k) clearance or could even require a premarket application approval.

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De Novo Classification .

If the FDA denies 510(k) clearance of a device because it is novel and an adequate predicate device does not exist, the “de novo classification” procedure can be invoked based upon a reasonable assurance that the device is safe and effective for its intended use.

This procedure approximates the level of scrutiny in the 510(k)

process but may add several months to the clearance process.

If the FDA grants the request, the device is permitted to enter commercial distribution in the same manner as if 510(k) clearance had been granted.

Premarket Application Approval Process .

After approval of a premarket application, a new premarket application or premarket application supplement is required in the event of a modification to the device, its labeling or its manufacturing process.

The premarket application approval pathway is much more costly, lengthy and uncertain.

It generally takes from one to three years or longer.

This device regulatory pathway allows a manufacturer whose novel device is automatically classified into Class III to request that the FDA classify such device as Class I or Class II based on evidence that the device in fact presents low or moderate risk, instead of following the typical Class III device pathway requiring the submission and approval of a PMA application.

If the manufacturer seeks reclassification into Class II, the classification request must include a draft proposal for special controls that are necessary to provide a reasonable assurance of the safety and effectiveness of the medical device.

The FDA typically issues a decision within 150 days of receipt on a De Novo classification request but, as with 510(k) submissions, may stop the review clock for up to 180 days to request that the applicant respond to the agency’s requests for additional information.

If FDA grants the De Novo request, the device may be legally marketed in the United States.

However, the FDA may reject the classification request if the agency identifies a suitable legally marketed predicate device that provides a reasonable basis for review of substantial equivalence or determines that the device is not low to moderate risk or that general controls would be inadequate to control the risks and adequate special controls cannot be developed.

De Novo classification requests are subject to user fees, unless a specific exemption applies.

Premarket Approval (PMA) .

The PMA process is more demanding than the 510(k) and De Novo classification processes.

For a PMA, the manufacturer must demonstrate through extensive data, including data from nonclinical studies and one or more clinical trials, that the device is safe and effective for its proposed indication.

The PMA application must also contain a full description of the device and its components, a full description of the methods, facilities and controls used for manufacturing, and proposed labeling.

Following receipt of a PMA submission, the FDA determines whether the application is sufficiently complete to permit a substantive review.

If the FDA accepts the application for review, it has 180 days under the FDCA to complete its review and determine whether the proposed device can be approved for commercialization, although in practice, PMA reviews often take significantly longer, and it can take up to several years for the FDA to issue a final decision.

Before approving a PMA, the FDA generally also performs an on-site inspection of manufacturing facilities for the product to ensure compliance with the QSR.

The FDA may refer any PMA submission, including applications for novel device candidates or device candidates that present difficult questions of safety or efficacy, to an advisory committee for review.

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.

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.

When and if those conditions have been met to the satisfaction of the FDA, the agency will issue a PMA approval order, subject to the conditions of approval and the limitations established in the approval order.

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.

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.

After approval of a premarket application, a new PMA application or PMA supplement may be required in the event of a modification to the labeling, manufacturing process, specifications, materials or design of the device.

PMA supplements often require submission of the same type of information as an initial PMA application, except that the supplements are limited to information needed to support any changes from the device covered by the approved PMA application and may or may not require as extensive clinical data or the convening of an advisory committee.

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

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.

However, the 21st Century Cures Act, which became law in December 2016, expressly excluded from the FDCA’s device definition some software functions, such as software to support healthcare facility administration, general wellness software, electronic health records and certain clinical decision support software.

In September 2019, the FDA published a revised guidance, General Wellness:

Policy for Low Risk Devices , describing its approach to general wellness products, including software, which states that the agency does not intend to examine the compliance of low risk general wellness products, as long as they are intended to (i) maintain or encourage general health or healthy activity and do not make any claims relating to specific diseases or conditions, or (ii) encourage a healthy lifestyle to help reduce the risk or impact of or help the user live well with certain chronic diseases or conditions where there is an established connection between a healthy lifestyle and the disease or condition.

In addition, the FDA has published the Policy for Device Software Functions and Mobile Medical Applications guidance, which describes the agency’s approach to regulating software device functions, and in particular, the types of software that are the focus regulatory enforcement, under enforcement discretion, or not considered medical devices.

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.

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:

Quality management systems—Requirements for regulatory purposes (ISO 13485:2016), which will become effective on February 2, 2026.

The harmonization process is not expected to have a significant impact on the quality system compliance operations of device manufacturers because most requirements described in the QSR correspond to requirements set forth in ISO 13485:2016.

However, device manufacturers will likely need to revise certain quality system procedures to ensure compliance with the harmonized regulations and any failure to make such revisions or adapt to the harmonized regulations, once they become effective, may result in observations of noncompliance during facility inspections by the FDA or comparable regulatory authorities.

European and Non-European Regulation Generally

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.

The commercialization of medical devices in Europe is regulated by the European Union.

The European Union presently requires that all medical products bore the CE mark, an international symbol of adherence to quality assurance standards and demonstrated clinical effectiveness.

Compliance with the Medical Device Directive (MDD) or the Active Implantable Medical Device Directive (AIMD) or the In Vitro Diagnostic Medical Device Directive (IVDD) as audited by a notified body and certified by a recognized European Competent Authority, permits the manufacturer to affix the CE mark on its products.

In September 2013, we obtained ISO 13485 certification for our quality management system and CE Mark certification to market Dario, and in May 2015 Dario was cleared to fulfill the criteria according to EN ISO 15197:2013 The granting of the CE Mark allows Dario to be marketed and sold in 32 countries across Europe as well as in certain other countries worldwide.

For example, the European Union (EU) has adopted specific directives and subsequently regulations regulating the design, manufacture, clinical investigations, labeling, conformity assessment, post-market surveillance and vigilance reporting for medical devices.

The EU rules described below are generally applicable in the European Economic Area (EEA).

Other countries, such as Switzerland, have entered into Mutual Recognition Agreements and allow the marketing of medical devices that meet EU requirements.

The EU presently requires that all medical products be certified to meet the EU’s safety and performance requirements for such products and bear a CE mark, an international symbol of adherence to quality assurance standards and demonstrated clinical effectiveness.

Prior to May 26, 2021, all medical devices placed on the EU market had to meet the relevant essential requirements laid down in Council Directive 93/42/EEC, or the Medical Device Directive (MDD), and if applicable, the Council Directive 90/385/EEC, or the Active Implantable Medical Device Directive (AIMD), or for in vitro diagnostic devices, Council Directive 98/79/EC, or the In Vitro Diagnostic Directive (IVDD).

Active Implantable Medical Devices (AIMD) are defined as medical devices that rely on a source of electrical energy or any source of power other than that generated by the body, which are totally or partially introduced, either surgically or medically, into the human body and intended to remain after the procedure.

On May 26, 2021, the Medical Devices Regulation, EU 2017/745, (MDR) became effective, repealing and replacing the MDD and the AIMDD.

The MDR is directly applicable in all EU member states.

The MDR changed several aspects of the regulatory framework for medical device marketing in Europe in order to increase regulatory oversight of all medical devices marketed in the EU (which, in turn, increased the costs, time and requirements to place innovative or high-risk medical devices on the European market).

The MDR among other things (i) strengthens the rules on placing devices on the market and reinforces post-market surveillance;

(ii) establishes explicit provisions on a manufacturer’s responsibilities for the follow-up of the quality, performance and safety;

(iii) improves the traceability of medical devices through a unique identification number;

and (iv) sets up a central database to provide patients, healthcare professionals and the public with comprehensive information on products available in the EU.

An overarching requirement under the MDR is that any device must be designed and manufactured in such a way that it will not compromise the clinical condition or safety of patients, or the safety and health of users and others.

In addition, the device must meet the performance specifications intended by the manufacturer and be designed, manufactured and packaged in a suitable manner.

To that effect, the European Commission has adopted various standards applicable to medical devices.

These include standards governing common requirements, such as sterilization and safety of medical electrical equipment and product standards for certain types of medical devices.

There are also harmonized standards relating to design and manufacture.

While not mandatory, compliance with harmonized standards is a way for manufacturers to demonstrate that products comply with relevant EU legislation.

To demonstrate compliance with the General Safety and Performance Requirements (GSPRs) set forth in the MDR, medical device manufacturers must undergo a conformity assessment procedure, which varies according to the type of medical device and its classification.

Conformity assessment procedures require an assessment of the technical documentation, including the device description, the design stages, the manufacturing process, available clinical evidence, literature data for the product, and post-market experience in respect of similar products already marketed.

Except for low-risk medical devices (Class I non-sterile, non-measuring devices), where the manufacturer can self-declare the conformity of its products with the GSPRs (except for any parts which relate to sterility or metrology), a conformity assessment procedure requires the intervention of a Notified Body.

Notified Bodies are independent organizations designated by EU member states to assess the conformity of devices before being placed on the market.

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.

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.

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

Devices lawfully placed on the market pursuant to the MDD and the AIMDD prior to May 26, 2021 could initially continue to be made available on the market or put into service until May 26, 2025.

Nevertheless, the European Parliament recently adopted legislation to extend this transitional period to give manufacturers more time to switch from the previously applicable provisions to the new certification requirements for medical devices as laid down by the MDR.

For high risk, class III and class IIb implantable devices the transitional period is extended until December 31, 2027.

For medium and low risk, class IIb devices and class IIa, Im, Is and Ir devices the transition period is extended until December 31, 2028.

In May 2022, the IVDD was replaced by the In Vitro Diagnostic Device Regulation, EU 2017/746, (IVDR) and given a 5-year transition period until its full implementation on May 26, 2022.

Unlike the IVDD, the IVDR has binding legal force throughout every EU member state.

The major goal of the IVDR was to standardize diagnostic procedures within the EU, increase reliability of diagnostic analysis and enhance patient safety.

Under the IVDR, IVDs are subject to additional legal regulatory requirements.

Among other things, the IVDR introduces a new risk-based classification system and requirements for conformity assessments.

Under the IVDR and subsequent amendments, IVDs already certified by a Notified Body under the IVDD may remain on the market until May 26, 2025, and IVDs certified without the involvement of a Notified Body may be placed on, or remain in, the market for up to three additional years (until May 26, 2028) depending on the classification of the IVD.

The manufacturers of such devices remaining on the market must comply with specific requirements in the IVDR, but ultimately, such products, as with all new IVDs, will have to undergo the IVDR’s conformity assessment procedures.

In addition, the IVDR imposes additional requirements relating to post-market surveillance and submission of post-market performance follow-up reports.

The granting of the CE Mark allows Dario to be marketed and sold in 32 countries across Europe as well as in certain other countries worldwide.

On November 21, 2014, MDSS, our European Authorized Representative, completed the registration of the Dario Blood Glucose Monitoring System with the German Authority as required by Article 10 of Directive 98/79/EC on in vitro diagnostic medical devices.

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To the extent that we seek to market our product in other non-CE Mark countries in the future, we will be required to comply with the applicable regulatory requirements in each such country.

Such regulatory requirements vary by country and may be tedious.

Such regulatory requirements vary by country, and complying with such regulations may require substantial time and effort.

As a result, no assurance can be given that we will be able to satisfy the regulatory requirements to sell our products in any such country.

Clinical Studies

Even when a clinical study has an approved Investigational Device Exemption (IDE) from the FDA under significant risk (SR) determination, has been approved by an Institutional Review Board (IRB) under non-significant risk (NSR) determination and/or has been approved by local or regional Ethics Committee, the study is subject to factors beyond a manufacturer’s control, including, but not limited to the fact that the institutional review board at a given clinical site might not approve the study, might decline to renew approval which is required annually, or might suspend or terminate the study before the study has been completed.

If we fail to comply with applicable foreign regulatory requirements, we may be subject to, among other things, fines, suspension of clinical trials, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions, and criminal prosecution.

Clinical Trials

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.

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.

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.

The IDE will automatically become effective 30 days after receipt by the FDA, unless the FDA expressly approves or denies the application in writing or notifies the sponsor that the investigation is on hold and may not begin until the sponsor provides supplemental information about the investigation that satisfies the agency’s concerns.

If the FDA determines that there are deficiencies or other concerns with an IDE that require modification of the trial, the FDA may permit a clinical trial to proceed under a conditional approval or the sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin.

In addition, the trial must be approved by, and conducted under the oversight of, an institutional review board, or IRB, for each clinical site.

If the device presents a non-significant risk to the patient according to criteria established by FDA as part of the IDE regulations, a sponsor may begin the clinical trial after obtaining approval for the trial by one or more IRBs without separate authorization from the FDA, but must still comply with abbreviated IDE requirements, such as monitoring the investigation, ensuring that the investigators obtain informed consent, and labeling and record-keeping requirements.

As part of its clinical trial oversight responsibilities, an IRB must review and approve, among other things, the trial protocol and informed consent information to be provided to clinical trial subjects.

An IRB must operate in compliance with FDA regulations.

Information about certain clinical studies, including details of the protocol and eventually trial results, also must be submitted within specific timeframes to the National Institutes of Health (NIH), for public dissemination on the ClinicalTrials.gov data registry.

Information related to the product, patient population, phase of investigation, trial sites and investigators and other aspects of the clinical trial is made public as part of the registration of the clinical trial.

Sponsors are also obligated to disclose the results of their clinical studies after completion.

Disclosure of the results of these studies can be delayed in some cases for up to two years after the date of completion of the trial.

Failure to timely register a covered clinical study or to submit study results as provided for in the law can give rise to civil monetary penalties and also prevent the non-compliant party from receiving future grant funds from the federal government.

Department of Health and Human Services’ Final Rule and NIH’s corresponding policy on ClinicalTrials.gov registration and reporting requirements became effective in 2017, and the government has brought enforcement actions against non-compliant clinical trial sponsors.

Progress reports detailing the results of the clinical studies must be submitted at least annually to the FDA and more frequently if unanticipated serious adverse events, or SAEs, occur.

The FDA or the sponsor may suspend or terminate a clinical trial at any time on various grounds, including a finding that the research subjects or patients are being exposed to an unacceptable health risk.

Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the clinical protocol, GCP, or other IRB requirements or if the investigational product has been associated with unexpected serious harm to patients.

In the Consolidated Appropriations Act for 2023, Congress amended the FDCA to require the sponsor of any pivotal clinical trial that will be used to demonstrate the safety and effectiveness of a medical device marketing authorization submission to develop a diversity action plan for such trial, and if submission of an IDE application is required, to submit such diversity action plan to the FDA.

The action plan must include the sponsor’s diversity goals for enrollment, as well as a rationale for the goals and a description of how the sponsor will meet them.

The FDA may grant a waiver for some or all of the requirements for a diversity action plan.

It is unknown at this time how the diversity action plan may affect device pivotal clinical trial planning and timing or what specific information FDA will expect in such plans, but if FDA objects to a sponsor’s diversity action plan and requires the sponsor to amend the plan or take other actions, it may delay trial initiation.

There is no assurance that a clinical study at any given site will progress as anticipated;

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Exported devices are subject to the regulatory requirements of each country to which the device is exported, as well as certain FDA export requirements.

Mobile Medical Applications Guidance

On September 23, 2013, the FDA issued final guidance for developers of mobile medical applications, or apps, which are software programs that run on mobile communication devices and perform the same functions as traditional medical devices.

The guidance outlines the FDA’s tailored approach to mobile apps.

The FDA plans to exercise enforcement discretion (meaning it will not enforce requirements under the Federal Food, Drug & Cosmetic Act) for the majority of mobile apps as they pose minimal risk to consumers.

The FDA plans to focus its regulatory oversight on a subset of mobile medical apps that present a greater risk to patients if they do not work as intended.

The FDA is focusing its oversight on mobile medical apps that:

● are intended to be used as an accessory to a regulated medical device – for example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smart mobile device or a mobile tablet;

● transform a mobile platform into a regulated medical device – for example, an application that turns a smart mobile device into an electrocardiography (ECG) machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.

Ongoing Regulation by FDA

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● establishment registration and device listing;

● quality system regulation, which requires manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation, and other quality assurance procedures during all phases of the product life-cycle;

● QSR requirements, which require manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation, and other quality assurance procedures during all phases of the product life-cycle;

● labeling regulations and FDA prohibitions against the promotion of products for uncleared, unapproved or “off-label” uses, and other requirements related to promotional activities;

● medical device reporting regulations, which require that manufacturers report to the FDA if their device may have caused or contributed to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if the malfunction were to recur;

● corrections and removals reporting regulations, which require that manufacturers report to the FDA field corrections and product recalls or removals if undertaken to reduce a risk to health posed by the device or to remedy a violation of the Federal Food, Drug and Cosmetic Act that may present a risk to health;

● corrections, removal and recall reporting regulations, which require that manufacturers report to the FDA field corrections and product recalls or removals if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health;

● the FDA’s recall authority, whereby the agency can order device manufacturers to recall from the market a product that is in violation of governing laws and regulations;

● post-market surveillance regulations, which apply when necessary to protect the public health or to provide additional safety and effectiveness data for the device.

The medical device reporting requirements also extend to healthcare facilities that use medical devices in providing care to patients, or “device user facilities,” which include hospitals, ambulatory surgical facilities, nursing homes, outpatient diagnostic facilities, or outpatient treatment facilities, but not physician offices.

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.

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

fines, injunctions, civil or criminal penalties, recall or seizure of our current or future products, operating restrictions, partial suspension or total shutdown of production, refusing our request for 510(k) clearance or PMA approval of new products, rescinding previously granted 510(k) clearances or withdrawing previously granted PMA approvals.

warning letters, fines, injunctions, civil or criminal penalties, recall or seizure of our current or future products, operating restrictions, partial suspension or total shutdown of production, refusing our request for 510(k) clearance or PMA approval of new products, rescinding previously granted 510(k) clearances or withdrawing previously granted PMA approvals.

We may be subject to announced and unannounced inspections by the FDA, and these inspections may include the manufacturing facilities of our subcontractors.

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International sales of medical devices are subject to foreign government regulations, which may vary substantially from country to country.

In order to maintain the right to affix the CE Mark to sell medical devices in the European Union, an annual surveillance audit in the company premises and, if needed, at major subcontractors’ premises needs to be carried out by the notified body.

Additionally, European Directives dictate the following requirements:

● Vigilance system, which requires the manufacturer to immediately notify the relevant Competent Authority when a company product has been involved in an incident that led to a death;

led to a serious injury or serious deterioration in the state of health of a patient, user or another person;

or might have led to death, serious injury or serious deterioration in health;

● Post-market surveillance including a documented procedure to review experience gained from devices on the market and to implement any necessary corrective action, commensurate with nature and risks involved with the product.

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

fines, injunctions, civil or criminal penalties, recall or seizure of our current or future products, operating restrictions, partial suspension or total shutdown of production, refusing our request for renewing clearance and/or registration of our products or granting clearance/registration for new products.

In order to maintain the right to affix the CE Mark to sell medical devices in the European Union, periodic surveillance audits of the company premises and, if needed, at major subcontractors’ premises must to be carried out by a Notified Body.

In addition, all manufacturers placing medical devices into the market in the EU must comply with the EU medical device vigilance system.

Under this system, serious incidents must be reported to the relevant authorities of the EU member states, and manufacturers are required to take Field Safety Corrective Actions, (FSCAs), to reduce a risk of death or serious deterioration in the state of health associated with the use of a medical device that is already placed on the market.

A serious incident is defined as any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect that directly or indirectly led, might have led or might lead to death, temporary or permanent serious deterioration of health state, or a serious public health threat.

An FSCA can include the withdrawal of the device from the market, or a recall thereof.

FSCAs must be communicated by the manufacturer or its legal representative to the users of the device through Field Safety Notices.

The advertising and promotion of medical devices is subject to some general principles set forth by EU directives.

Directive 2006/114/EC concerning misleading and comparative advertising and Directive 2005/29/EC on unfair commercial practices.

While the aforementioned directives are not specific to the advertising of medical devices, the provisions of national law transposing them must also be complied with and contain general rules, for example requiring that advertisements are evidenced, balanced and not misleading.

Specific requirements are defined at national level.

EU member states laws related to the advertising and promotion of medical devices, which vary between jurisdictions, may limit or restrict the advertising and promotion of products to the general public and may impose limitations on promotional activities with healthcare professionals.

Many EU member states have adopted specific anti-gift statutes that further limit commercial practices for medical devices, in particular vis-à-vis healthcare professionals and organizations.

Additionally, there has been a recent trend of increased regulation of payments and transfers of value provided to healthcare professionals or entities.

In addition, many EU member states have adopted national “Sunshine Acts” which impose reporting and transparency requirements (often on an annual basis), similar to the requirements in the United States, on medical device manufacturers.

Certain countries also mandate implementation of commercial compliance programs.

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

fines, injunctions, civil or criminal penalties, recall or seizure of our current or future products, operating restrictions, partial suspension or total shutdown of production, refusing our request for renewing marketing authorization of our products or for granting marketing authorization for new products.

Federal Trade Commission Regulatory Oversight

Our advertising for our products in the United States is subject to federal truth-in-advertising laws enforced by the Federal Trade Commission (FTC), as well as comparable state consumer protection laws.

Under the Federal Trade Commission Act, or FTC Act, the FTC is empowered, among other things, to (a) prevent unfair methods of competition and unfair or deceptive acts or practices in or affecting commerce;

(b) seek monetary redress and other relief for conduct injurious to consumers;

and (c) gather and compile information and conduct investigations relating to the organization, business, practices, and management of entities engaged in commerce.

The FTC has very broad enforcement authority, and failure to abide by the substantive requirements of the FTC Act and other consumer protection laws can result in administrative or judicial penalties, including civil penalties, injunctions affecting the manner in which we would be able to market services or products in the future, or criminal prosecution.

Federal Communications Commission Regulation

The Dario Blood Glucose Monitoring System includes a wireless radio frequency transmitter and receiver and, therefore, is subject to equipment authorization requirements in the United States.

The Federal Communications Commission (FCC) requires advance clearance of all radio frequency devices before they can be imported into, sold or marketed in the United States.

These clearances ensure that the proposed products comply with FCC radio frequency emission and power level standards and will not cause interference.

State Licensure Requirements

Several states require that Durable Medical Equipment (“DME”) providers be licensed in order to sell products to patients in that state.

states require that Durable Medical Equipment (“DME”) providers be licensed in order to sell products to patients in that state.

Certain of these states require that DME providers maintain an in-state location.

Some states also require a device manufacturer or distributor to obtain a license in order to distribute prescription medical devices to customers in such states.

If these rules are determined to be applicable to us and if we were found to be noncompliant, we could lose our licensure in that state, which could prohibit us from selling our current or future products to patients in that state.

Federal Anti-Kickback and Self-Referral Laws

The Federal Anti-Kickback Statute prohibits the knowing and willful offer, payment, solicitation or receipt of any form of remuneration in return for, or to induce the:

● referral of a person;

● furnishing or arranging for the furnishing of items or services reimbursable under Medicare, Medicaid or other governmental programs;

● purchase, lease, or order of, or the arrangement or recommendation of the purchasing, leasing, or ordering of any item or service reimbursable under Medicare, Medicaid or other governmental programs.

To the extent we are required to comply with these regulations, it is possible that regulatory authorities could allege that we have not complied, which could subject us to sanction.

Noncompliance with the federal anti-kickback legislation can result in exclusion from Medicare, Medicaid or other governmental programs, restrictions on our ability to operate in certain jurisdictions, as well as civil and criminal penalties, any of which could have an adverse effect on our business and results of operations.

Federal law also includes a provision commonly known as the “Stark Law,” which prohibits a physician from referring Medicare or Medicaid patients to an entity providing “designated health services,” including a company that furnishes durable medical equipment, in which the physician has an ownership or investment interest or with which the physician has entered into a compensation arrangement.

Violation of the Stark Law could result in denial of payment, disgorgement of reimbursements received under a noncompliant arrangement, civil penalties, and exclusion from Medicare, Medicaid or other governmental programs.

Federal False Claims Act

The Federal False Claims Act provides, in part, that the federal government may bring a lawsuit against any person whom it believes has knowingly presented, or caused to be presented, a false or fraudulent request for payment from the federal government, or who has made a false statement or used a false record to get a claim approved.

In addition, amendments in 1986 to the Federal False Claims Act have made it easier for private parties to bring “qui tam” whistleblower lawsuits against companies.

Penalties include fines ranging from $5,500 to $11,000 for each false claim, plus three times the number of damages that the federal government sustained because of the act of that person.

Civil Monetary Penalties Law

The Federal Civil Monetary Penalties Law prohibits the offering or transferring of remuneration to a Medicare or Medicaid beneficiary that the person knows or should know likely to influence the beneficiary’s selection of a particular supplier of Medicare or Medicaid payable items or services.

Noncompliance can result in civil money penalties of up to $10,000 for each wrongful act, assessment of three times the amount claimed for each item or service and exclusion from the Federal healthcare programs.

State Fraud and Abuse Provisions

Many states have also adopted some form of anti-kickback and anti-referral laws and false claims acts.

A determination of liability under such laws could result in fines and penalties and restrictions on our ability to operate in these jurisdictions.

Administrative Simplification of the Health Insurance Portability and Accountability Act of 1996

The Health Insurance Portability and Accountability Act of 1996, or HIPAA, mandated the adoption of standards for the exchange of electronic health information in an effort to encourage overall administrative simplification and enhance the effectiveness and efficiency of the healthcare industry.

Ensuring the privacy and security of patient information is one of the key factors driving the legislation.

Healthcare Laws and Regulations

We must comply with various U.S.

federal and state laws, rules and regulations pertaining to healthcare fraud and abuse, including anti-kickback laws and physician self-referral laws, rules and regulations.

Violations of the fraud and abuse laws are punishable by criminal and civil sanctions, including, in some instances, exclusion from participation in federal and state healthcare programs, including Medicare and Medicaid.

These laws include the following:

● the federal Anti-Kickback Statute (AKS) prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving or paying remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made, in whole or in part, under a federal health care program such as Medicare and Medicaid.

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.

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.

The FCA also permits a private individual acting as a “whistleblower” to bring actions on behalf of the federal government alleging violations of the FCA and to share in any monetary recovery;

● 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;

● 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;

● 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.

Certain states also have adopted marketing and/or transparency laws relevant to device manufacturers, some of which are broader in scope in comparison to applicable federal laws.

Some state laws require medical device companies to comply with the relevant industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government in addition to requiring device manufacturers to report information related to payments to physicians and other healthcare providers or marketing expenditures.

In addition, state and foreign laws also govern the privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.

Violation of any of the federal and state healthcare laws may result in penalties, including without limitation, civil, criminal and/or administrative penalties, damages, fines, disgorgement, exclusion from participation in government programs, such as Medicare and Medicaid, injunctions, private “qui tam” actions brought by individual whistleblowers in the name of the government, or refusal to enter into government contracts, contractual damages, reputational harm, administrative burdens, diminished profits and future earnings, and the curtailment or restructuring of operations.

Our actual or perceived failure to comply with healthcare and data privacy laws could result in liability or reputational harm and could harm our business.

Ensuring compliance with such laws could also impair our efforts to maintain and expand our customer base and thereby decrease our future revenues.

and European Data Security and Data Privacy Laws

HIPAA’s administrative simplification provisions established comprehensive U.S.

federal standards for the privacy and security of health information.

In 2009, Congress enacted Subtitle D of the HITECH provisions of the American Recovery and Reinvestment Act of 2009, which expanded and strengthened HIPAA, created new targets for enforcement, imposed new penalties for noncompliance and established new breach notification requirements.

HIPAA applies to health plans, healthcare clearing houses, and healthcare providers that conduct certain healthcare transactions electronically, which are referred to collectively as Covered Entities, as well as individuals or entities that perform services for Covered Entities involving the use, or disclosure of, individually identifiable health information or protected health information (PHI) under HIPAA.

Such service providers are called "Business Associates." Under HIPAA, as amended by the HITECH Act, HHS has issued regulations to protect the privacy and security of PHI used or disclosed by Covered Entities and Business Associates.

HIPAA also regulates and standardizes the codes, formats and identifiers used in certain

healthcare transactions and standardization of identifiers for health plans and providers, for example insurance billing.

Any non-compliance with HIPAA and HITECH and related penalties, could adversely impact our business.

The HIPAA security standards require the adoption of administrative, physical, and technical safeguards and the adoption of written security policies and procedures to maintain the security of protected health information.

The HIPAA privacy regulations address the privacy of PHI by limiting the use and release of such information.

They also set forth certain rights that an individual has with respect to his or her PHI maintained by a covered entity, including the right to access or amend certain records containing PHI, request an accounting of disclosures of PHI or to request restrictions on the use or disclosure of PHI.

The HIPAA breach notification regulations impose certain reporting requirements on Covered Entities and their Business Associates in the event of a breach of PHI.

Significant civil and criminal fines and other penalties may be imposed for violating HIPAA directly, and in connection with acts or omissions of any agents, including a downstream Business associate, as determined according to the federal common law of agency.

Civil penalties are adjusted for inflation on an annual basis and can exceed one million dollars per year for failure to comply with a HIPAA requirement.

A single breach incident can violate multiple requirements.

Additionally, a person who knowingly obtains or discloses PHI in violation of HIPAA may face a criminal penalties (including fines and imprisonment), which increase if the wrongful conduct involves false pretenses or the intent to sell, transfer or use PHI for commercial advantage, personal gain or malicious harm.

Covered Entities are also subject to enforcement by state Attorneys General who were given authority to enforce HIPAA.

Additionally, while HIPAA does not create a private right of action allowing individuals to file suit against us in civil court for violations of HIPAA, its standards have been used as the basis for duty of care cases in state civil suits such as those for negligence or recklessness in the misuse or breach of PHI.

Even when HIPAA does not apply, according to the FTC, failing to take appropriate steps to keep consumers’ personal information secure constitutes unfair acts or practices in or affecting commerce in violation of Section 5(a) of the Federal Trade Commission Act.

The FTC expects a company’s data security measures to be reasonable and appropriate in light of the sensitivity and volume of consumer information it holds, the size and complexity of its business, and the cost of available tools to improve security and reduce vulnerabilities.

Individually identifiable health information is considered sensitive data that merits stronger safeguards.

The FTC and states' Attorneys General have also brought enforcement actions and prosecuted some data breach cases as unfair and/or deceptive acts or practices under the FTC Act and comparable state laws.

The HIPAA privacy and security regulations establish a uniform federal "floor" and do not preempt state laws that are more stringent or provide individuals with greater rights with respect to the privacy or security of, and access to, their records containing PHI.

These laws overlap with HIPAA and may differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.

Failure to comply with these laws, where applicable, can result in the imposition of significant civil and/or criminal penalties and private litigation.

The State of California, for example, has implemented comprehensive laws and regulations.

The California Confidentiality of Medical Information Act (CMIA), imposes restrictive requirements regulating the use and disclosure of health information and other personally identifiable information.

The California Consumer Privacy Act of 2018 (the CCPA) went into effect January 1, 2020.

The CCPA, among other things, creates new data privacy obligations for covered companies and provides new privacy rights to California residents, including the right to opt out of certain disclosures of their information.

It also creates individual privacy rights for California consumers and increases the privacy and security obligations of entities handling certain personal information.

The CCPA provides for civil penalties for violations, as well as a private right of action for data breaches which has led to an increase data breach litigation.

Although the law includes limited exceptions, including for PHI maintained by a covered entity or business associate under HIPAA and medical information maintained by healthcare providers under the CMIA, it may regulate or impact our processing of personal information depending on the context.

Further, the California Privacy Rights Act (CPRA) went into effect January 1, 2023, amending the CCPA.

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

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.

In dealing with health information for the development of our technology or for commercial purposes, we will be indirectly affected by HIPAA and state-imposed health information privacy and security laws because these laws regulate the ability of our customers and research collaborators to share health information with us.

Additionally, we must identify and comply with all applicable state laws for the protection of personal information with respect to employee information or other personal information that we collect.

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 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.

The GDPR sets out a number of requirements that must be complied with when handling the personal data of such European Union-based data subjects including:

providing expanded disclosures about how their personal data will be used;

higher standards for organizations to demonstrate that they have obtained valid consent or have another legal basis in place to justify their data processing activities;

the obligation to appoint data protection officers in certain circumstances;

new rights for individuals to be “forgotten” and rights to data portability, as well as enhanced current rights (e.g.

access requests);

the principal of accountability and demonstrating compliance through policies, procedures, training and audit;

and the new mandatory data breach regime.

In particular, medical or health data, genetic data and biometric data where the latter is used to uniquely identify an individual are all classified as “special category” data under the GDPR and are afforded greater protection and require additional compliance measures.

Noncompliance could result in the imposition of fines, penalties, data lockup or orders to stop noncompliant activities.

We could also be subject to evolving European Union laws on data export, for transfers of data outside the European Union to themselves, group companies or third parties.

The GDPR only permits exports of data outside the European Union to jurisdictions that ensure an adequate level of data protection.

The United States has not been deemed to offer an adequate level of protection, so in order for us to transfer personal data from the EU to the United States, we must identify a legal basis for data transfer (e.g., the European Union Commission approved Standard Contractual Clauses).

On July 16, 2020, the Court of Justice of the European Union or the CJEU, issued a landmark opinion in the case Maximilian Schrems vs.

Facebook (Case C-311/18), called Schrems II.

This decision (a) called into question commonly relied upon data transfer mechanisms as between the European Union member states and the United States (such as the Standard Contractual Clauses) and (b) invalidateds the EU-U.S.

Privacy Shield on which many companies had relied as an acceptable mechanism for transferring such data from the EU to the United States.

However, on July 10, 2023, the European Commission adopted an adequacy decision for a new mechanism for transferring data from the EU to the United States – the EU-U.S.

Data Privacy Framework, which provides EU individuals with several new rights, including the right to obtain access to their data, or obtain correction or deletion of incorrect or unlawfully handled data.

The adequacy decision followed the signing of an executive order introducing new binding safeguards to address the points raised in the Schrems II decision by the CJEU.

The European Commission will continually review developments in the United States along with its adequacy decision.

Adequacy decisions can be adapted or even withdrawn in the event of developments affecting the level of protection in the applicable jurisdiction.

Future actions of EU data protection authorities are difficult to predict.

Some customers or other service providers may respond to these evolving laws and regulations by asking us to make certain privacy or data-related contractual commitments that we are unable or unwilling to make.

This could lead to the loss of current or prospective customers or other business relationships.

Intellectual Property

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An additional corresponding patent was granted in Israel in April 2016.

In February 2016 we were granted U.S.

9,257,038, which is a further Continuation application connected to the U.S.

8,797,180, this new patent enhanced the way the Dario Blood Glucose Monitoring System communicates with the end user’s smartphone devices.

In November 11, 2017, U.S.

On November 11, 2017, U.S.

9,832,301 titled “Systems and methods for adjusting power levels on a monitoring device” was granted.

10 unchanged sentences

Design Applications have been filed and granted covering the glucose meter, the cartridge, and connection dongle.

At least some of these applications were granted and registered in the United States, as well as Brazil, Canada, China, Europe, and Hong Kong.

At least some of these applications were granted and registered in the United States, as well as, Canada, Europe, and Hong Kong.

Trademark applications

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 the Australia, Canada, China, Costa Rica, United States, Israel, China, Canada, Hong Kong, South Africa, Japan, Costa Rica, Europe, Israel, Japan, Korea, Mexico, New Zealand, Panama, Russia, South Africa, and the USA.

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.

Upright also added the following trademarks to our list:

UPRIGHT, UPRIGHT GO – registered in the US, AU and EM, and UPRIGHT DASHBOARD, UPRIGHT DESKTOP, UPRIGHT GO 2, UPRIGHT PRO, UPRIGHT POSTURE IS WITHING REACH – registered in the US.

UPRIGHT, UPRIGHT GO – registered in the US, AU and EM, and UPRIGHT DASHBOARD, UPRIGHT DESKTOP, UPRIGHT GO 2, UPRIGHT POSTURE IS WITHING REACH – registered in the U.S.

Utility Models

We have been granted Utility Models for our core invention in Japan and Germany.

We have been granted Utility Models for our core invention in Japan.

Other intangible assets

2 unchanged sentences

The accumulation of this type of know-how and related algorithms are protected as trade secrets using specialized confidentiality protocols.

Twill Intellectual Property

Granted Patents

On October 27, 2020, the United States Patent Office issued Patent No.

US 10,813,584 B2 titled “ ASSESSING ADHERENCE FIDELITY TO BEHAVIORAL INTERVENTIONS USING INTERACTIVITY AND NATURAL LANGUAGE PROCESSING”.

The abstract contained in the patent award describes this patent as “A computer system apparatus and a method carried out by such apparatus for interacting with a user via a behavior intervention designed to cause an increase in emotional well-being of the user.

The behavior intervention has a plurality of conditions to be satisfied.

The process includes receiving input data from the user during the behavior intervention, performing, on at least a portion of the received input data having text, semantic analysis to identify terms that satisfy the plurality of conditions and assessing, based on an amount of completeness of satisfying the plurality of conditions, a level of adherence to the behavior intervention.

When one or more of the plurality of conditions are determined not as satisfied, the process includes generating a prompt designed to elicit, from the user, a response specific to satisfying the missing conditions.”

There are also pending associated patent applications filed in the European Patent Office (Application 18835438.5), Canada (Application 3070229), and Hong Kong (Application 620200109481).

On February 7, 2023, the United States Patent Office issued Patent No.

US 11,575,737 B2 titled “DYNAMIC INTERACTIVE NETWORK SYSTEM FOR PROVIDING ONLINE SERVICE AND SOCIAL COMMUNITY FOR ENGAGING, LEARNING, AND TRAINING SKILLS FOR MENTAL HEALTH”.

The abstract contained in the patent award describes this patent as “A dynamic interactive network system provides an online service and social community for engaging, learning, and training skills for happiness.

The system includes a processor and memory storing instructions which when executed by the processor configure the processor to provide the online service.

The instructions further configure the processor to provide tracks including activities, provide an initial happiness level and a track to a user based on a self-assessment completed by the user upon signing up, monitor progress of the user based on self-assessments periodically completed by the user, modify the track based on the self-assessments, suggest followers to the user from the users whose profiles match the profile of the user in terms of demographics, psychographics, and rating of the users on the online service, and generate a happiness graph for the user that correlates the activities and the followers with their impact on happiness level of the user.”

On February 20, 2024, the United States Patent Office issued Patent No.

US 11,909,811 B2 titled “ DYNAMIC INTERACTIVE NETWORK SYSTEM FOR PROVIDING ONLINE SERVICE AND SOCIAL COMMUNITY FOR ENGAGING, LEARNING, AND TRAINING SKILLS FOR MENTAL HEALTH”.

This patent is a continuation of Patent No.

11,575,737 with additional claims.

On August 10, 2023, the United States Patent Office issued Patent No.

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

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.

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”.

On October 10, 2023, the United States Patent Office issued Patent No.

US 11,779,270 B2 titled “SYSTEMS AND METHODS FOR TRAINING ARTIFICIALLY-INTELLIGENT CLASSIFIER”.

The abstract contained in the patent award describes the patent as “A computing system/method for enabling a user to improve, via training, a system designed to increase the emotional and/or physical well-being of persons or designed for other purposes.

The system/method includes retrieving a user response from a dialogue database, the user response having already labeled thereto an assigned class having a highest confidence score, the confidence score indicating degree of confidence that context of the retrieved user response is of the assigned class, displaying, the assigned class, along with other classes each having a respective lower confidence score, and receiving an indication of validity of the assigned class.

The system/method further includes retrieving of a pair of sequential user response and follow-up prompt from the database, displaying user-selectable ratings, each rating designating a respectively different quality to the follow-up prompt, receiving selection of a rating and a related comment, and associating the selection and the comment to the follow-up prompt.”

There are also pending associated patent applications filed in the European Patent Office (Application 19847959.4), Canada (Application 3109113).

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.

Titled “ CUSTOMIZABLE THERAPY SYSTEM AND PROCESS”, the abstract for this application describes as “The present invention is directed to a computing system and a process carried out by such system for providing a therapy session personalized to the circumstances of the user.

The therapy session includes an audio component that is automatically generated by an algorithm that makes a voice seem to be that of an actual person.

In a similar way, a video component to the therapy session may also be presented.”

On January 26, 2022, patent application 17/585,003 was filed in the United States Patent office.

Titled “ SENSOR TRACKING BASED PATIENT SOCIAL CONTENT SYSTEM”, the abstract for this application describes as “A computing system that includes a server, the system functions as a patient social content system (PSCS) which, among other functions, provides content to a patient/user.

A device with a network connection to the computing system permits the patient to provide information to the computing system.

In addition, one or more sensors are configured to detect changes in various physical parameters relevant to the patient.

Electrical signals from the sensors are conveyed to the computing system so that the computing system is aware of changes in physical parameters of the patient.

Based on the changed physical parameters of the patient, the computing system provides different content to the user that is relevant to the changes.

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

Therapeutic Media

Circular Design (Talk Bubble Design)

HAPPIFY HEALTH

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.

21 unchanged sentences

our solutions are priced 30-50% lower than current comparable in-market solutions.

As of February 28, 2023, we had 241 full-time employees and 11 part-time employees.

We have employment agreements with our five executive officers.

As of March 22, 2024, and following the acquisition of Twill Inc., we had 276 full-time employees and 18 part-time employees.

We have employment agreements with our four executive officers.

See “Management – Employment Agreements.”

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