What changed in this filing

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Item 1. Business

2024-03-01 compared with 2023-03-16 · 136 added, 114 removed, 489 unchanged (34% of the section changed)

We are a medical technology company focused on the development and manufacturing of glucose monitoring products designed to transform lives in the global diabetes community with differentiated, long-term implantable glucose management technology.

Our implantable CGM (“Eversense”), including 90-day Eversense, Eversense XL and Eversense E3 continuous glucose monitoring (“CGM”) system versions are designed to continually and accurately measure glucose levels in people with diabetes via an under-the-skin sensor, a removable and rechargeable smart transmitter, and a convenient app for real-time diabetes monitoring and management for a period of up to six months in the case of Eversense XL and Eversense E3, as compared to seven to 14 days for non-implantable CGM systems.

Our implantable CGM (“Eversense”), including the Eversense E3 continuous glucose monitoring (“CGM”) system version is designed to continually and accurately measure glucose levels in people with diabetes via an under-the-skin sensor, a removable and rechargeable smart transmitter, and a convenient app for real-time diabetes monitoring and management for a period of up to six months as compared to seven to 14 days for non-implantable CGM systems.

We affixed the CE mark to the original 90-day Eversense CGM system in June 2016, which marked the first certification for the product to be sold within the European Economic Area (being the European Union plus Norway, Iceland, and Liechtenstein) (“EEA”).

Subsequently, we affixed the CE mark to the extended life Eversense XL CGM system in September 2017 to be sold in select markets in Europe and the Middle East.

In June 2022, we affixed the CE mark to the extended life Eversense E3 CGM system and Ascensia began commercialization in select markets in Europe during the third quarter of 2022.

In June 2022, we affixed the CE mark to the Eversense E3 CGM system and Ascensia began commercialization in select markets in Europe during the third quarter of 2022.

In June 2018, the U.S.

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With this approval and the availability of a new app in December 2019, the Eversense system can now be used as a therapeutic CGM in the United States to replace fingerstick blood glucose measurement to make treatment decisions, including insulin dosing.

In February 2022, the 180-day extended life Eversense E3 CGM system was approved by the FDA and Ascensia Diabetes Care Holdings AG (“Ascensia”) began commercializing Eversense E3 in the United States in the second quarter of 2022.

In February 2022, the 180-day extended life Eversense E3 CGM system was approved by the FDA and Ascensia began commercializing Eversense E3 in the United States in the second quarter of 2022.

In February 2020, we announced that the FDA approved a subgroup of PROMISE trial participants to continue for a total of 365 days to gather feasibility data on the safety and accuracy of a 365-day sensor.

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Information gathered from this sub-set and additional development efforts provided us the confidence to start the Pivotal study for the Eversense 365-day System.

The ENHANCE pivotal study for the Eversense 365-day system completed enrollment in the third quarter of 2022 and we expect to have data in the second half of 2023.

The ENHANCE pivotal study for the Eversense 365-day system has completed enrollment, the last patient of the adult cohort completed the study and we completed analysis of the data.

Based on this analysis we determined to advance to the next generation sensor platform as the underlying technology used in the 365-day and future products.

We expect that this data will support an FDA submission to be made in the coming weeks for a new product with a target 365-day duration and once per week calibration.

We are in the early commercialization stages of the Eversense brand and are focused on driving awareness of our CGM system amongst people with diabetes and their healthcare providers.

During 2020, we initiated a new commercialization strategy and collaboration to bring our product to market.

As described in detail below, in August 2020, we entered into a collaboration and commercialization agreement (“Commercialization Agreement”), with Ascensia pursuant to which we granted Ascensia the exclusive right to distribute our 90-day Eversense CGM system and

our 180-day Eversense E3 CGM system worldwide, with certain initial exceptions.

As described in detail below, in August

2020, we entered into a collaboration and commercialization agreement (“Commercialization Agreement”), with Ascensia pursuant to which we granted Ascensia the exclusive right to distribute our 90-day Eversense CGM system and our 180-day Eversense E3 CGM system worldwide, with certain initial exceptions.

While Ascensia is responsible for sales, marketing, market access, patient and provider onboarding and first level customer support, we remain responsible for product development and manufacturing, including regulatory submissions, approvals, conformity assessment and requests for CE Certificates of Conformity and registrations and second level customer support.

2022 and Significant Recent Developments

Significant Recent Developments

Global Commercialization of Eversense E3 CGM System

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In June 2022, we affixed the CE mark to the extended life Eversense E3 CGM system, and Ascensia began commercialization in all EEA markets during the third and fourth quarters of 2022.

In October 2023, Ascensia and the Company announced a new direct to consumer U.S.

marketing campaign launched on television in select markets, in addition to social and digital media platforms.

‘The CGM for Real Life’ campaign expanded market awareness of the Eversense E3 system's unique benefits among people with diabetes and healthcare professionals.

‘The CGM for Real Life’ campaign aims to highlight the reality of the diabetes experience, through everyday complexities, successes, and challenges that people with diabetes face.

The campaign demonstrates how Eversense E3 provides a differentiated CGM option, with unparalleled flexibility and long-term use that allows it to seamlessly integrate into real life.

The continued success of the commercial launch of the Eversense E3 product globally will continue to depend on several factors such as:

(1) growing the installed base of users, (2) increasing patient awareness of Eversense above current levels in order to expand the population of Eversense users, through driving sales and marketing efforts on the Eversense E3 system, (3) increasing awareness and adoption of Eversense by healthcare providers, including high volume CGM prescribers, through expanded targeted marketing efforts, (4) educating patients and prescribers regarding the six-month product and its benefits relative to legacy products, (5) continuing to grow the base of the authorized inserters through geographically targeted efforts so that potential users locating a qualified inserter of Eversense is not an impediment to adoption, (6) timely establishing and maintaining favorable payor coverage for the product, including transitioning commercial payors from 90-day coverage to six month coverage, (7) more effective tender participation outside the U.S.

(1) growing the installed base of users, (2) increasing patient awareness of Eversense above current levels in order to expand the population of Eversense users, through driving sales and marketing efforts on the Eversense E3 system, (3) increasing awareness and adoption of Eversense by healthcare providers, including high volume CGM prescribers, through expanded targeted marketing efforts, (4) educating patients and prescribers regarding the six-month and future generation products and its benefits relative to legacy products, (5) continuing to grow the base of the authorized inserters through geographically targeted efforts so that potential users locating a qualified inserter of Eversense is not an impediment to adoption, (6) timely establishing and maintaining favorable payor coverage for the product, including transitioning commercial payors from six month to one year coverage, (7) more effective tender participation outside the U.S.

and (8) Ascensia’s continued organizational development of its sales and marketing capabilities relative to CGM.

In February 2024, we announced that Medicare coverage was expanded for Eversense E3 to include all people with diabetes using insulin and non-insulin users who have a history of problematic hypoglycemia providing access to millions of Medicare patients.

The first Medicare administrative contractor (“MAC)” expansion became effective on February 25, 2024 with the remaining MAC’s expected to become effective in the near future.

In November 2022, we announced a collaboration with the Nurse Practitioner Group (“NPG”) designed to expand U.S.

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Under the agreement between Senseonics and NPG, NPG providers will be certified to perform Eversense procedures in the specified geographies and will offer its services for patients who have been prescribed Eversense.

Senseonics will initially assist NPG as they set up their Eversense procedure capabilities in select geographic areas.

During 2023, we expanded the inserter network by setting up Eversense procedure capabilities in additional select geographic areas.

Diabetes is a chronic, life-threatening disease for which there is no known cure.

The disease is caused by the body's inability to produce or effectively utilize the hormone insulin, which prevents the body from adequately regulating blood glucose levels.

The disease is caused by the body's inability to produce or effectively utilize the hormone insulin, which prevents the body from adequately

regulating blood glucose levels.

If diabetes is not managed properly, it can lead to serious health conditions and complications, including heart disease, limb amputations, loss of kidney function, blindness, seizures, coma and even death.

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In November 2022, the Centers for Medicare and Medicaid Services (“CMS”) released its Calendar Year 2023 Medicare Physician Fee Schedule Proposed Rule that updates the payment amounts for the three CPT© Category III codes to account for the longer 6-month sensor.

During 2022, we have been working with payors to transition their policies to Eversense E3 and have confirmed immediate coverage policy transition from select payors.

The Calendar Year 2024 Medicare Physician Fee Schedule continues to include the three CPT© Category III codes.

We are headquartered in Germantown, Maryland.

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Ascensia sells our products directly to strategic fulfillment partners, who provide our Eversense CGM systems to healthcare providers and patients through a prescribed request and invoice insurance payors for reimbursement.

Sales of the Eversense E3 CGM system and future models are widely dependent on the ability of patients to obtain coverage and adequate reimbursement from third-party payors or government agencies.

Sales of the Eversense E3 CGM system and future models are widely dependent on the ability of patients to obtain coverage and adequate reimbursement from third-party

payors or government agencies.

Ascensia is leveraging and targeting regions where we have coverage decisions for patient device use and provider insertion and removal procedure payment.

As a result of the COVID-19 pandemic, in the first quarter of 2020, we temporarily suspended commercial sales and marketing of the Eversense CGM System in the United States to new patients to solely focus our resources on supporting existing users.

In connection with these actions, on March 26, 2020, we reduced our direct sales organization that consists of sales representatives, clinical trainers, customer care, and other specialists to educate, train, and support the patient and healthcare provider in their diabetes management with CGM systems.

In the third quarter of 2020, we announced the formation of a strategic partnership with Ascensia, pursuant to which Ascensia became the exclusive worldwide distribution partner for Senseonics CGM systems, including the 90-day Eversense®, Eversense® XL and future generations products, now including Eversense® E3.

In the fourth quarter of 2020, Ascensia initiated U.S.

marketing and sales activities and full transition of commercial activities took place in the second quarter of 2021 and included full marketing, market access, sales, healthcare provider training and frontline patient and provider support responsibilities.

Addressing reimbursement and access barriers has been a top priority for us and during 2022, we reached over 250 million covered lives in the U.S.

through positive insurance payor coverage decisions.

In efforts to address these priorities, Ascensia, in consultation with us, initiated a broad patient assistance program to provide financial assistance for patients adopting Eversense E3.

Addressing reimbursement and access barriers has been a top priority for us and during 2023, we reached approximately 300 million covered lives in the U.S.

through positive insurance payor coverage decisions including UnitedHealthcare, the largest healthcare insurance company in the U.S.

In efforts to address these priorities, Ascensia, in consultation with us, initiated the Patient Assistance and Simple Savings (PASS) program to provide financial assistance for patients adopting Eversense E3.

Additionally, as discussed above, we announced a collaboration with NPG designed to expand U.S.

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Collaboration and Commercialization Agreement with Ascensia Diabetes Care Holdings AG

On August 9, 2020, we entered into a Commercialization Agreement with Ascensia Diabetes Care Holdings AG pursuant to which we have granted Ascensia the exclusive right to distribute the Company’s 90-day Eversense CGM system and our Eversense 180-day (XL) CGM system worldwide for use in people with diabetes, with the following initial exceptions:

(1) until January 31, 2021, the territory did not include countries covered by our then existing distribution agreement with Roche Diagnostics International AG and Roche Diabetes Care GmbH, which are the Europe, Middle East and Asia, excluding Scandinavia and Israel, and 17 additional countries, including Brazil, Russia, India and China, as well as select markets in the Asia Pacific and Latin American regions;

On August 9, 2020, we entered into a Commercialization Agreement with Ascensia pursuant to which we have granted Ascensia the exclusive right to distribute the Company’s 90-day Eversense CGM system and our Eversense 180-day (XL) CGM system worldwide for use in people with diabetes, with the following initial exceptions:

(1) until January 31, 2021, the territory did not include countries covered by our then existing distribution agreement with Roche Diagnostics International AG and Roche Diabetes Care GmbH (collectively “Roche”), which are the Europe, Middle East and Asia, excluding Scandinavia and Israel, and 17 additional countries, including Brazil, Russia, India and China, as well as select markets in the Asia Pacific and Latin American regions;

(2) until September 13, 2021, the territory did not include countries covered by our current distribution agreement with Rubin Medical, which are Sweden, Norway and Denmark;

and (3) until May 31, 2022, the territory does not include Israel.

and (3) until May 31, 2022, the territory did not include Israel.

Pursuant to the Commercialization Agreement, in the United States, Ascensia began providing sales support for the 90-day Eversense product on October 1, 2020 and Ascensia ramped up sales activities and assumed commercial responsibilities for 90-day Eversense product during the second quarter of 2021.

The distribution rights under the Roche agreement expired January 31, 2021 after Roche provided certain transition and wind-down services.

In February 2022, the extended life Eversense E3 CGM system was approved by the FDA and Ascensia began commercializing Eversense E3 in the United States during the second quarter of 2022.

Ascensia will receive a portion of net revenue at specified tiered percentages ranging from the mid-teens to the mid-forty’s based on levels of global net revenues.

Ascensia receives a portion of net revenue at specified tiered percentages ranging from the mid-teens to the mid-forty’s based on levels of global net revenues.

Ascensia is obligated to achieve specified minimum annual revenue targets and meet specified levels of sales and marketing spend.

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We have agreed to establish a joint alliance committee and joint marketing committee, each with equal representation from each party, in order to collaborate.

Prior Distribution Agreement with Roche Diabetes Care

On May 24, 2016, we entered into an exclusive distribution agreement with Roche Diagnostics International AG and Roche Diabetes Care GmbH (collectively, “Roche”).

Pursuant to the agreement, as amended, we granted Roche the exclusive right to market, sell and distribute Eversense in the EMEA, excluding Scandinavia and Israel.

In addition, Roche had exclusive distribution rights in 17 additional countries, including Brazil, Russia, India and China, as well as select markets in the Asia Pacific and Latin American regions.

On December 12, 2019, we amended the distribution agreement to lower minimum volumes for 2020 and increase pricing for the remaining period of the contract.

On November 20, 2020, we amended the distribution agreement and entered into a settlement agreement to facilitate transition to Ascensia as Roche sales concluded on January 31, 2021, including final purchases and transition support activities, and Roche’s obligation to purchase certain quantities of products at certain prices under the distribution agreement have now terminated.

The distribution rights under the agreement expired January 31, 2021 after to Roche provided certain transition and wind-down services.

Clinical Development and Regulatory Pathway

We affixed the CE mark to the Eversense XL CGM system in the EEA in September 2017.

The Eversense XL CGM system has historically been sold commercially in our overseas markets.

Our Promise U.S.

pivotal trial was completed during 2020.

Our Promise pivotal trial in the U.S.

was completed during 2020.

We received a Premarket Approval (“PMA”) supplement, from the FDA for the Eversense E3 system in February 2022 and Ascensia began commercializing Eversense E3 in the United States during the second quarter of 2022.

We affixed the CE mark to Eversense E3 in the EEA in June 2022 and Ascensia began commercializing Eversense in all oversea markets by the end of 2022.

We are also continuing to conduct a number of post-approval and feasibility studies.

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Subjects with a history of unexplained severe hypoglycemia, defined as hypoglycemia resulting in loss of consciousness or seizure, or diabetic ketoacidosis, in the six months prior to the trial were excluded from participation in the clinical trial.

After screening, sensor(s) were inserted and accuracy measurements were taken at multiple visits during the first 30 days and then every 30 days to 180 days post-insertion or until sensor failure, if earlier than 180 days post-insertion.

After screening, sensor(s) were inserted and accuracy measurements were taken at multiple visits during the first 30 days and then every 30 days to 180 days post-insertion or

until sensor failure, if earlier than 180 days post-insertion.

In the trial, we observed performance matching that of the 90-day Eversense system available in the United States, with MARD of 8.5%-9.6%.

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Over 165 subjects were inserted with Eversense systems in four centers across the United States.

We completed enrollment of the 365-day sensor configuration in September 2022 and expect our last patient to complete their 365-day visit during the third quarter of 2023.

Data gathered in this trial will also be used to submit for the integrated continuous glucose monitoring (“iCGM”) designation in 2023.

We also submitted and received approval for an investigational device exemption (“IDE”) for an extension of the trial to allow for pediatric patients and we plan to begin enrollment of pediatrics in the second quarter of 2023.

In mid-2023, the data gathered in this trial was used to submit an application to the FDA for the integrated continuous glucose monitoring (“iCGM”) designation.

The iCGM designation will enable our ability to integrate with insulin delivery devices like pens and pumps to create systems that would use Eversense for autonomous control and we expect approval in the first half of 2024.

In 2022, we submitted and received approval for an investigational device exemption (“IDE”) for an extension of the trial to allow for pediatric patients and we began enrolling patients in the first half of 2023.

The ENHANCE pivotal study for the Eversense 365-day system has been fully enrolled, the last patient of the adult cohort completed the study and we completed analysis of the data.

Based on this analysis we determined to advance the next generation sensor platform as the underlying technology used in the 365-day and future products.

We expect that this data will support an FDA submission to be made in the coming weeks for a new product with a target 365-day duration and once per week calibration.

Our Technology

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The sensor consists of an optical system, known as a micro-fluorometer, encased in a rigid, translucent polymer capsule, which is 3.3 mm in diameter and 15 mm in length.

The capsule is coated with a glucose-indicating hydrogel that

is bound to the surface of the capsule through polymerization.

The capsule is coated with a glucose-indicating hydrogel that is bound to the surface of the capsule through polymerization.

This hydrogel is energized, or excited, by a light-emitting diode (“LED”), contained in the optical system of the sensor, causing the hydrogel to fluoresce, or glow.

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iOS mobile devices, including iPhones, iPads and Apple Watches, and Android mobile devices.

The mobile app receives information from the transmitter via BLE and displays that information discreetly to the user.

The mobile app receives information from the transmitter via

BLE and displays that information discreetly to the user.

This user-friendly, intuitive app provides real-time glucose readings, alerts, trends, and graphs.

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We expect these product development initiatives to include system modifications and next generation enhancements that we believe will further increase the convenience and appeal of our products to the diabetes community.

We are focusing our future development efforts on enhancing current product offerings by reducing the once or twice daily calibrations towards a once per week calibration.

Our next generation sensor under pivotal testing now is designed to extend the sensor duration even longer at up to 365 days.

We are focusing our future development efforts on enhancing current product offerings by reducing calibrations towards a once per week calibration.

Our next generation sensor which recently completed pivotal testing is designed to extend the sensor duration even longer at up to 365 days.

We expect the next generation sensor to support our goal of extending the market for long-term implantable CGM to include Type 2 patients not on intensive insulin therapy.

We are also developing our “Gemini” product variation to allow for a 2-in-1 glucose monitoring system combining the functionality of CGM and Flash Glucose Monitoring, in an implantable sensor that may be utilized with a smart transmitter to get continuous glucose readings and alerts, or be utilized through a swipe over the sensor with a smart phone to get on-demand glucose reading without a smart transmitter.

We are also developing our “Freedom” product variation which would include an implantable battery and Bluetooth eliminating the on-body component.

We are also developing our “Gemini” product variation to allow for a 2-in-1 glucose monitoring system combining the functionality of CGM and Flash Glucose Monitoring, in an implantable sensor with battery that may be utilized with a smart transmitter to get continuous glucose readings and alerts, or be utilized through a swipe over the sensor with a smart phone to get on-demand glucose reading without a smart transmitter.

We are also developing our “Freedom” product variation which would include Bluetooth in the sensor eliminating the on-body component.

We are seeking to ensure that we meet the growing and unique needs of people with diabetes utilizing our core and proprietary sensor technology.

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We are in the early commercialization stages of Eversense and are focused on driving awareness and adoption of our CGM system amongst intensively managed patients and their healthcare providers with our commercial partner Ascensia.

We are party to a commercialization agreement with Ascensia, pursuant to which we have granted Ascensia the exclusive right to distribute our 90-day Eversense CGM system and our six-month Eversense CGM system worldwide for use in people with diabetes, with certain exceptions.

We are party to a commercialization agreement with Ascensia, pursuant to which we have granted Ascensia the exclusive right to distribute our prior 90-day Eversense CGM system and our current six-month Eversense CGM system worldwide for use in people with diabetes, with certain exceptions.

Pursuant to the Commercialization Agreement, in the United States, Ascensia began providing sales support for the 90-day Eversense system on October 1, 2020 and Ascensia ramped up sales activities and assumed commercial responsibilities for the 90-day Eversense system during the second quarter of 2021.

In February 2022, the extended life Eversense E3 CGM system was approved by the FDA and Ascensia began commercializing Eversense E3 in the United States in the second quarter of 2022.

In anticipation of the launch, we and Ascensia have been designing the go-to-market strategy for the U.S.

six-month product.

As a result of our strategic partnership, Ascensia is responsible for sales, marketing, market access, patient and provider onboarding and level one customer support.

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The CES network offers an alternative for healthcare providers who want to prescribe Eversense for their patients but prefer to refer the procedure to a specialist.

In 2022, we announced a collaboration with NPG designed to expand U.S.

patient access to the Eversense E3 System by providing additional convenient in-office and at-home sensor insertion options utilizing NPG’s broad network in over 30 states.

Under the agreement between Senseonics and NPG, NPG providers will be certified to perform Eversense

procedures in the specified geographies and will offer its services for patients who have been prescribed Eversense.

We will continue to expand the inserter network by setting up Eversense procedure capabilities in additional select geographic areas.

As people with diabetes often consult with their healthcare providers about treatment options, we believe that educating healthcare providers regarding the benefits of Eversense compared to SMBG and other currently available CGM systems is an important step in promoting its use in people with diabetes.

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We intend to continue educating healthcare providers and people with diabetes on the advantages of Eversense compared to SMBG and other currently available CGM systems.

In October 2023, Ascensia and the Company announced a new direct to consumer U.S.

marketing campaign launched on television in select markets, in addition to social and digital media platforms.

‘The CGM for Real Life’ campaign expanded market awareness of the Eversense E3 system's unique benefits among people with diabetes and healthcare professionals.

‘The CGM for Real Life’ campaign aims to highlight the reality of the diabetes experience, through everyday complexities, successes, and challenges that people with diabetes face.

The campaign demonstrates how Eversense E3 provides a differentiated CGM option, with unparalleled flexibility and long-term use that allows it to seamlessly integrate into real life.

Reimbursement

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commercial third-party payor community in efforts to establish coverage for Eversense.

To date, approximately 250 million people in the United States may have coverage and access to the Eversense E3 product via commercial or government (i.e., Medicare) payors.

To date, approximately 300 million people in the United States may have coverage and access to the Eversense E3 product via commercial (for example, UnitedHealthcare) or government (for example, Medicare) payors.

Some commercial payors have denied coverage deeming Eversense as an “experimental and investigational” technology electing to wait for further clinical evidence, more safety data, or time in market.

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Additionally, in 2019 we published several sets of real-world data, which show Eversense provides the same clinical benefits as other CGM systems and has a favorable safety profile.

However, until payment for the Eversense sensor placement becomes consistent, some patients will be required to bear the financial cost for the placement of the

sensor by their healthcare provider.

However, until payment for the Eversense sensor placement becomes consistent, some patients will be required to bear the financial cost for the placement of the sensor by their healthcare provider.

As a result, some patients and their healthcare provider may choose not to use Eversense on a widespread basis.

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This can be a long process with varying results in each case but is a prudent step to challenge payor positions of non-coverage given the strong evidence that supports CGM and Eversense.

Further, coverage policies and third-party payor reimbursement rates may change at any time.

Therefore, even if favorable coverage and reimbursement status is attained, less favorable coverage policies and reimbursement rates may be implemented in the future.

Coverage Outside the United States

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Coverage systems in international markets vary significantly by country and, within some countries, by region.

Coverage approvals must be obtained on a country-by-country, region-by-region or, in some instances, a case-by case basis.

Coverage approvals

must be obtained on a country-by-country, region-by-region or, in some instances, a case-by case basis.

The responsibility for securing this coverage resides with our third-party distributors in the respective markets.

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This ISO 13485:2016 certification includes design control requirements.

As a medical device manufacturer, the facilities of our sterilization and other critical suppliers are subject to periodic inspection by the FDA and corresponding state and foreign regulatory agencies and Notified Bodies.

We believe that our quality systems and those of our suppliers are robust and achieve high product quality.

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We compete with well-capitalized companies, some of which are publicly traded, that manufacture CGM systems including Dexcom, Medtronic and Abbott.

Each of these companies has received FDA approval and CE Certificates of Conformity to market their respective CGM systems across the United States and EEA.

Each of these companies has received FDA approval, CE Certificates of Conformity and CE Marked their products, permitting them to market their respective CGM systems across the United States and EEA.

Dexcom’s CGM system was the first CGM system to be approved by the FDA for marketing as a non-adjunctive device, and Abbott’s Freestyle Libre was also approved for non-adjunctive use.

Both Dexcom (G6 and G7) and Abbott (Freestyle Libre) systems have factory calibration, and do not require user calibration.

Both Dexcom (G6 and G7) and Abbott (Freestyle Libre 2 and 3) systems have factory calibration, and do not require user calibration.

Dexcom has also received the first FDA iCGM indication allowing its Dexcom G6 and G7 to be interoperable with other diabetes tech devices such as insulin pumps.

As the industry evolves, we anticipate encountering increasing competition from companies that integrate CGM with insulin pumps.

Abbott also received an iCGM indication for their

Freestyle Libre 2 product and we expect all other CGM companies besides Dexcom to pursue an iCGM indication including Medtronic.

Abbott also received an iCGM indication for their Freestyle Libre 2 and 3 products and we expect all other CGM companies besides Dexcom to pursue an iCGM indication including Medtronic.

In addition to CGM providers, we also compete with providers of SMBG systems.

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and Ascensia.

We may also compete with companies who are developing real-time intermittent sensing devices, low cost transcutaneous CGM systems, fully implantable CGM devices and non-invasive CGM system to measure a user's glucose level.

glucose level.

There are also a number of academic and other institutions involved in various phases of our industry's technology development.

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The medical device industry in general, and the glucose testing sector of this industry in particular, are characterized by the existence of a large number of patents and frequent litigation based on assertions of patent infringement.

We are aware of numerous patents issued to third parties that may relate to the technology used in our

business, including the design and manufacture of CGM sensors and CGM systems, as well as methods for continuous glucose monitoring.

We are aware of numerous patents issued to third parties that may relate to the technology used in our business, including the design and manufacture of CGM sensors and CGM systems, as well as methods for continuous glucose monitoring.

Each of these patents contains multiple claims, any one of which may be independently asserted against us.

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In the United States, the Federal Food, Drug and Cosmetic Act (“FDCA”), and the implementing regulations of the FDA govern product design and development, preclinical and clinical testing, premarket clearance or approval, product manufacturing, import and export, product labeling, product storage, recalls and field safety corrective actions, advertising and promotion, product sales and distribution, and post-market clinical surveillance.

Our business is subject to federal, state, local, and foreign regulations and standards, such as ISO 13485, ISO 14971, FDA's Quality System

Regulation (“QSR”) contained in 21 CFR Part 820, Directive 90/385/EEC concerning active implantable medical devices and, Regulation 2017/745 on Medical Devices, as amended.

Our business is subject to federal, state, local, and foreign regulations and standards, such as ISO 13485, ISO 14971, FDA's Quality System Regulation (“QSR”) contained in 21 CFR Part 820, Directive 90/385/EEC concerning active implantable medical devices and, Regulation 2017/745 on Medical Devices, as amended.

Regulation by the FDA

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The Eversense System is a Class III device and subject to pre-market approval (“PMA”) application under section 515 of the FDCA in order to obtain a marketing approval.

A PMA application must be supported by valid scientific evidence that typically includes extensive technical, preclinical, clinical, manufacturing and labeling data, to demonstrate to the FDA's satisfaction the safety and efficacy of the device.

A PMA application must be supported by valid scientific evidence that typically includes extensive technical, preclinical, clinical, manufacturing and

labeling data, to demonstrate to the FDA's satisfaction the safety and efficacy of the device.

A PMA application also must include a complete description of the device and its components, a detailed description of the methods, facilities and controls used to manufacture the device, and proposed labeling.

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There is a trend towards harmonization of quality system standards among the European Union, United States, Canada and various other industrialized countries.

On 26 May 2021, Regulation (EU) 2017/745 on Medical Devices, or the Medical Device Regulation, entered into application, repealing and replacing both Directive 93/42/EEC concerning medical devices, or MDD, and Directive

90/385/EEC concerning active implantable medical devices, or AIMD.

On May 26, 2021, Regulation (EU) 2017/745 on Medical Devices, or the Medical Device Regulation, entered into application, repealing and replacing both Directive 93/42/EEC concerning medical devices, or MDD, and Directive 90/385/EEC concerning active implantable medical devices, or AIMD.

The Medical Device Regulation and its associated guidance documents and harmonized standards govern, among other things, device design and development, preclinical and clinical or performance testing, premarket conformity assessment, registration and listing, manufacturing, labeling, storage, claims, sales and distribution, export and import and post-market surveillance, vigilance, and market surveillance.

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To demonstrate compliance with the GSPRs provided in the Medical Device Regulation and obtain the right to affix the CE mark, medical devices manufacturers must undergo a conformity assessment procedure, which varies according to the type of medical device and its classification.

Apart from low risk medical devices (Class I with no measuring function and which are not sterile), in relation to which the manufacturer may issue an EC Declaration of Conformity based on a self-assessment of the conformity of its products with the GSPRs, a conformity assessment procedure requires the intervention of a Notified Body, which is an organization designated by a Competent Authority of an EEA country to conduct conformity assessments.

Apart from low risk medical devices (Class I with no measuring function and which are not sterile),

in relation to which the manufacturer may issue an EC Declaration of Conformity based on a self-assessment of the conformity of its products with the GSPRs, a conformity assessment procedure requires the intervention of a Notified Body, which is an organization designated by a Competent Authority of an EEA country to conduct conformity assessments.

Depending on the relevant conformity assessment procedure, the Notified Body audits and examines the technical documentation and the quality system for the manufacture, design and final inspection of the medical devices.

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The Medical Device Regulation provides a transitional provision.

Accordingly, CE Certificates of Conformity issued by Notified Bodies in accordance with the MDD or the AIMD, prior to 25 May 2017 will remain valid until the expiration of the CE Certificate of Conformity, except for EC verification CE Certificates of Conformity issued in accordance with Annex IV to the MDD and Annex 4 to the AIMD which shall become void at the latest on 27 May 2022.

In addition, CE Certificates of Conformity issued by Notified Bodies in accordance with the MDD or the AIMD, from 25 May 2017 will remain valid until the expiration of the CE Certificate of Conformity and at the latest on 27 May 2024.

Medical devices with such valid CE Certificates of Conformity issued under the MDD or the AIMD may continue to be placed on the market for the remaining validity of the CE Certificate of Conformity or until May 27, 2024 at the latest, provided that (1) the devices continue to comply with the requirements of the MDD or AIMD, (2) there are no significant changes in the design or intended purpose and (3) from 26 May 2021, compliance with the EU Medical Device Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices is ensured in place of the corresponding requirements in the MDD or AIMD.

Accordingly, CE Certificates of Conformity issued by Notified Bodies in accordance with the MDD or the AIMD from May 25, 2017, and which remained valid on May 26, 2021 and have not since been withdrawn will, with certain exceptions, remain valid until December 31, 2027 for Class III and Class IIb implantable medical devices and until December 31, 2028 for other Class IIb, Class IIa and Class I devices with a measuring function or which are sterile.

Class I medical devices, for which the conformity assessment procedure in accordance with the MDD or the AIMD did not require the involvement of a Notified Body but will require the involvement of a Notified Body in accordance with the Medical Device Regulation and for which an EU Declaration of Conformity was issued in accordance with the MDD or the AIMD prior to May 26, 2021, can continue to be placed on the EEA market until December 31, 2028.

Manufacturers of medical devices may only benefit from the above extended transitional provisions deadlines if the following conditions are fulfilled:

(i) the devices continue to comply with the requirements of the MDD or AIMD, (ii) there are no significant changes in the design and intended purpose, (iii) the devices do not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health, (iv) the manufacturer implements a quality management system by May 26, 2024 which complies with the requirements of the Medical Devices Regulation, (v) by May 26, 2024 an application is lodged with a Notified Body for conduct of the conformity assessment of the devices covered by the CE Certificate of Conformity, or the devices intended to substitute for such devices, in accordance with the Medical Device Regulation and a related written agreement is signed with the Notified Body by September 26, 2024, and (vi) from May 26, 2021, compliance with the Medical Device Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices is ensured in place of the corresponding requirements in the MDD or AIMD.

In addition, CE Certificates of Conformity issued by Notified Bodies in accordance with the MDD or the AIMD from May 25, 2017, which were valid on May 26, 2021 and have not been withdrawn since but which expired before March 20, 2023, will only continue to be valid in accordance with the extended transitional deadlines above if either (i) the manufacturer signed a written agreement with a Notified Body for the conformity assessment of the device covered by the expired CE Certificate of Conformity, or the device intended to substitute that device, in accordance with the Medical Device Regulation before the date of expiry of the CE Certificate of Conformity, or (ii) a competent authority of an EU Member State has granted a derogation from the application conformity assessment procedure in accordance with Article 59(1) or Article 97(1) of the Medical Device Regulation.

Class III custom-made implantable medical devices may be placed on the market until May 26, 2026 without a CE Certificate of Conformity issued by Notified Body, provided that (i) by May 26, 2024, an application is lodged with a Notified Body for the conformity assessment of the devices, in accordance with the Medical Device Regulation and a related written agreement is signed with the Notified Body by September 26, 2024.

The advertising and promotion of medical devices in the EU is subject to the national laws of the individual EU Member States that implemented the MDD, the AIMD and that apply the Medical Device Regulation, Directive 2006/114/EC concerning misleading and comparative advertising, and Directive 2005/29/EC on unfair commercial practices, as well as other national legislation of individual EU Member States governing the advertising and promotion of medical devices.

EU Member States’ national legislation may also restrict or impose limitations on our ability to advertise our products directly to the general public.

In addition, voluntary EU and national industry Codes of Conduct provide guidelines on the advertising and promotion of our products to the general public and may impose limitations on our promotional activities with healthcare professionals.

Accordingly, CE Certificates of Conformity issued by Notified Bodies in accordance with the MDD or the AIMD from May 25, 2017, and which remained valid on May 26, 2021 and have not since been withdrawn will, with certain exceptions, remain valid until December 31, 2027 for Class III and Class IIb implantable medical devices and until 31 December 2028 for other Class IIb, Class IIa and Class I devices with a measuring function or which are sterile.

Manufacturers of medical devices may only benefit from the above extended transitional provisions deadlines if the following conditions are fulfilled:

EU Member States’ national legislation may also restrict or impose limitations on our ability to advertise our products directly to the general public.

In addition, voluntary EU and national industry Codes of Conduct

provide guidelines on the advertising and promotion of our products to the general public and may impose limitations on our promotional activities with healthcare professionals.

Other Regulatory Requirements

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Also, the FDA requires us to conduct Post Approval Studies (post-market surveillance studies) and establish and maintain a system for tracking our products through the chain of distribution to the patient level.

The FDA and applicable regulatory agencies enforce regulatory requirements by conducting periodic, unannounced inspections and market surveillance.

The FDA and applicable regulatory authorities enforce regulatory requirements by conducting periodic, unannounced inspections and market surveillance.

Inspections may include the manufacturing facilities of our subcontractors.

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If the FDA believes that any of our contract manufacturers or regulated suppliers are not in compliance with these requirements, it can shut down such manufacturing operations, require recall of our products, refuse to approve new marketing applications, institute legal proceedings to detain or seize products, enjoin future violations or assess civil and criminal penalties against us or our officers or other employees.

Health Insurance Portability and Accountability Act of 1996 and Similar Foreign and State Laws and Regulations Affecting the Transmission, Security and Privacy of Health Information

Health Insurance Portability and Accountability Act of 1996 and Other Foreign and State Laws and Regulations Affecting the Transmission, Security and Privacy of Personal Information

We may also be subject to data privacy and security regulation by both the federal government and the states in which we conduct our business.

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The GDPR includes more stringent operational requirements for data processors and data controllers and creates additional rights for data subjects.

Additionally, California enacted legislation, effective January 1, 2020, that has been dubbed the first “GDPR-like” law in the United States.

Known as the California Consumer Privacy Act, or CCPA, it creates new individual privacy rights for consumers (as that word is broadly defined in the law) and places increased privacy and security obligations on entities handling personal data of consumers or households.

The CCPA requires covered companies to provide new disclosures to California consumers, provide such consumers new ways to opt-out of certain sales of personal information, and allows for new causes of action for data breaches.

As currently written, the CCPA could impact our business activities and is an example of the type of activity in an evolving regulatory environment related to personal data and protected health information that could continue to affect our operations.

Fraud and Abuse Laws

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Transparency laws regarding payments or other items of value provided to healthcare providers and teaching hospitals may also impact our business practices.

The federal Physician Payment Sunshine Act requires most medical device manufacturers to report annually to CMS financial arrangements, payments, or other transfers of value made by that entity to physicians (defined to include doctors, dentists, optometrists, podiatrists, and chiropractors), other healthcare professionals (such as physician assistants and nurse practitioners), and teaching hospitals.

The payment information is made publicly available in a searchable format on a CMS website.

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Similar laws have been enacted or are under consideration in many states and foreign jurisdictions.

Outside the United States, interactions between medical device companies and health care professionals are also governed by strict laws, such as national anti-bribery laws of European countries, national sunshine rules, regulations, industry self-regulation codes of conduct and physicians’ codes of professional conduct.

Healthcare and Regulatory Reform

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In August 2011, President Obama signed into law the Budget Control Act of 2011, which, among other things, included aggregate reductions to Medicare payments to providers of up to 2% per fiscal year, starting in 2013 and, due to subsequent legislative amendments, will remain in effect until 2032 unless additional congressional action is taken.

Under current legislation, the actual reduction in Medicare payments will vary from 1% in 2022 to up to 4% in the final fiscal year of this sequester.

Additionally, in January 2013, President Obama signed into law the American Taxpayer Relief Act of 2012, which, among other things, reduced Medicare payments to several providers and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.

In addition, regulatory requirements governing medical devices may evolve.

On January 6, 2023, the European Commission adopted a proposal to amend the transitional provisions of the Medical Device Regulation.

The proposal is intended to prevent medical device shortages on the EEA market.

The proposed amendments introduce an extension to the transitional periods established in the Medical Device Regulation to provide medical device manufacturers with more time to bring their devices into conformity with the requirements of the Medical Device Regulation.

The length of the proposed extension is contingent on the risk classification of devices.

As a result, the current timeframes established in the transitional provisions of the Medical Device Regulation may be subject to upcoming amendments.

It is uncertain whether and how future legislation could affect prospects for our product candidates or what actions federal, state, or private payors for healthcare treatment and services may take in response to any such healthcare reform proposals or legislation.

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The TCA primarily focuses on ensuring free trade between the European Union and the UK in relation to goods.

The TCA does not, however, specifically address medical devices.

Among the changes that will now occur are that Great Britain (England, Scotland and Wales) will be treated as a "third country," a country that is not a member of the European Union and whose citizens do not enjoy the European Union right to free movement.

Northern Ireland will continue to follow many aspects of the European Union regulatory rules, particularly in relation to trade in goods.

Northern Ireland will continue to follow many aspects of the European Union regulatory rules, particularly in relation to trade in goods, including the Medical Device Regulation.

On May 26, 2021, the Medical Device Regulation entered into application in the EU.

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In the UK, medical devices are governed by the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) which retains a regulatory framework similar to the framework set out by the MDD.

As a result, there will be some regulatory divergence in the UK from the EU.

In light of the fact that the CE marking process is set out in EU law, which no longer applies in the UK, the UK has devised a new route to market culminating in a UK Conformity Assessed ("UKCA") mark to replace the CE Mark for placing medical devices on the market in Great Britain.

Northern Ireland will, however, continue to be covered by the regulations governing CE Marks (a CE Mark or a CE Mark and UKNI Mark will be required to place products on the Northern Ireland market).

CE Marks will continue to be recognized in Great Britain for medical devices until June 30, 2024, however all medical devices must be registered with the MHRA, in order to be placed on the Great Britain market.

The EU legal framework, including the Medical Device Regulation, remains applicable in Northern Ireland (any products placed on the market in the NI must be compliant with EU law).

From July 1, 2024, transitional arrangements will apply for CE and UKCA marked devices placed on the Great Britain market.

The UK Medicines and Healthcare products Regulatory Agency also plans on introducing new legislation governing medical devices with an aim to bring the new regulations into force by July 2024.

In light of the fact that the CE Marking process is set out in EU law, which no longer applies in the UK, the UK has devised a new route to market culminating in a UKCA Mark to replace the CE Mark.

Northern Ireland will, however, continue to be covered by the regulations governing CE Marks.

The UK Government has established transitional provision to recognize the acceptance of CE marked medical devices on the Great Britain market.

Accordingly, Class III and Class IIb implantable medical devices which have been CE marked in accordance with the MDD or AIMD and for which a CE Certificate of Conformity has been delivered by a Notified Body in accordance with the MDD or AIMD, can be placed on the Great Britain market until the sooner of the expiry of the related CE Certificate of Conformity or June 30, 2028.

However, in light of the extended transitional provisions of the Medical Device Regulation, related CE Certificates of Conformity will expire, at the latest, on December 31, 2027.

Other Class IIb, Class IIa and Class I devices with a measuring function which have been CE marked in accordance with the MDD or AIMD and for which a CE Certificate of Conformity has been delivered by a Notified Body in accordance with the MDD or AIMD, can be placed on the Great Britain market until the sooner of the expiry of the related CE Certificate of Conformity or June 30, 2028.

Medical devices which have been CE marked in accordance with the Medical Device Regulation may be placed on the Great Britain market until June 30, 2030.

The UK government plans on introducing new legislation governing medical devices with an aim for core aspects of the future regime for medical devices to apply from July 1, 2025.

New legislation is also anticipated to bring into force strengthened post-market surveillance requirements ahead of the wider future regulatory regime.

These post-market surveillance requirements are expected to apply from mid-2024.

Foreign Corrupt Practices Act

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We consider our relationship with our employees to be good.

Employee engagement is always important to us, and improving our employee engagement with a remote, in-person and hybrid workforce was a strategic imperative for us in 2022.

Employee engagement is always important to us, and improving our employee engagement with a remote, in-person and hybrid workforce remained a strategic imperative for us in 2023.

Throughout the year, we committed to employ initiatives and communications to build close connections between our employees and the company mission, vision, and values.

Our values define the behaviors of our current employees, and the new hires that we welcomed to our organization during 2022.

Our values define the behaviors of our existing employees, and the new hires that we welcomed to our organization during 2023:

● Customer Inspired emphasizes how we put the customer first while we use our talents, passion, empathy, and hard work to build technology solutions for the unmet needs of our customers.

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● Get It Done represents working with a sense of urgency to go above and beyond to get the job done right through quality, compliance, and timeliness.

We invested in a new human resource software which collects weekly employee feedback on work experience, culture, communications, interaction with their managers and other topics enabling us to react and address real time feedback.

We utilize a human resource software which collects weekly employee feedback on work experience, culture, communications, interaction with their managers and other topics enabling us to react and address real time feedback.

This software also provides opportunities for peer-to-peer recognition and valuable insights for managers to better lead their teams.

We continue to conduct company calls twice a month to update all employees on progress towards our company objectives, initiatives, what is happening in various departments and to celebrate employee achievements and company milestones.

We launched quarterly Employee Engagement Events to recognize the value of our employees and their contributions.

We also conduct company calls twice per month to update all employees on progress towards our company objectives, initiatives, what is happening in various departments and to celebrate employee achievements and company milestones.

We also conduct quarterly employee engagement events to recognize the value of our employees and their contributions.

Employee Health & Wellbeing

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We operate in modern, efficient, and safe facilities, and have minimal accident and injury rates.

In 2022, we launched a new platform to improve

harassment training efforts and obtained 100% compliance.

We invested in a new wellness program “A Healthier You”, which focused on three pillars:

In 2022, we launched a platform to improve harassment training efforts and in 2023 added Diversity, Equity, and Inclusion training for all employees to this effort.

We continued the momentum with our wellness program “A Healthier You”, which focuses on three pillars:

financial, physical, and workplace wellness.

Each pillar is supported by specific tools and resources to educate and reinforce the importance of wellness.

This program included a stipend to further support healthy behaviors and to demonstrate our commitment to employee well-being.

This program includes a stipend to further support healthy behaviors and to demonstrate our commitment to employee well-being.

To further demonstrate our focus on employee wellness, in 2023, we sponsored our first Senseonics Wellness Fair, which included speakers, workshops, and vendors to support our workplace wellness.

Organizational Development

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As part of our performance management process, all levels of employees are formally required to meet with their managers at least quarterly to receive feedback on their established objectives, identify opportunities for skill development, discuss opportunities to support their career goals, and reflect on how their behaviors demonstrate our corporate values.

We continued to meet with the executive team spending significant time for strategic, operational, and organizational planning.

Many of these meetings were focused on organizational development including reviewing new demographic data to better understand our employee profiles and address their specific needs.

We re-launched our leadership pathways, with an emphasis on the technical leadership path aligning with our corporate focus of designing, developing, and manufacturing glucose monitoring products.

The executive team partnered with our consultants to complete 360-degree feedback and developed a plan to address the identified strengths and opportunities.

We encourage professional certification and continuing education by reimbursement for professional certification classes, testing, maintenance, and tuition reimbursement of up to $5,250 annually.

We continue to deliver training and engage in development conversations with our managers and directors.

The executive team meets routinely to discuss key initiatives for strategic, operational, and organizational planning.

Many of these meetings were focused on organizational development including reviewing demographic data and employment engagement data to better understand our employee profiles and address their specific needs.

We celebrated our revised technical leadership pathway with a formal awards program to recognize and reward our 2023 patent inventors.

We continue to encourage professional certification and continuing education by reimbursement for professional certification classes, testing, maintenance, and tuition reimbursement of up to $5,250 annually.

We deliver training and engage in development conversations with our managers and directors regularly to reinforce best practices and ensure effective performance management.

Diversity, Equity, and Inclusion

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We aspire to create a diverse and inclusive culture that reflects the diversity of the customers we serve and fosters an environment where all employees feel welcomed, respected, and valued.

In 2022, we began a focused diversity, equity, and inclusion, or DEI journey by reviewing demographic data for a baseline and our Sr.

Leaders participated in a customized DEI development program.

At the end of 2022, our employee base was comprised of 40% female and 60% male.

In 2022, we began a focused diversity, equity, and inclusion, or DEI journey by reviewing demographic data for a baseline and our senior management participated in a customized DEI development program.

In 2023, we trained all employees on the basics of Diversity, Equity, and Inclusion.

Total Rewards

We provide competitive compensation and benefits to attract and retain the best people.

We engage nationally recognized compensation and benefits consulting firms to evaluate our total rewards programs and to provide benchmarking against our peers within the industry.

We engage nationally recognized compensation and benefits consulting firms to evaluate our total rewards programs and to provide

benchmarking against our peers within the industry.

We provide our employees with market competitive pay and bonuses.

In 2021, we implemented a year-end market adjustment review process to ensure we maintain our competitive pay and pay equity between active employees and new hires and to align to the highly competitive labor market.

As a result of this review process, we made market adjustments to many of our employees during the beginning of 2022 and mid-year with efforts to stay on track with the everchanging labor market.

As a result of this review process, we evaluate any market adjustments required to stay on track with the everchanging labor market and align with individual employee performance.

Annual increases and incentive compensation are based on merit and documented through our performance management process as part of our annual review procedures.

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in Nevada on June 26, 2014.

On December 7, 2015, pursuant to the Merger Agreement and the transactions contemplated thereby, or the Acquisition, we acquired Senseonics, Incorporated, a medical technology company focused on the design, development and commercialization of glucose monitoring systems to improve the lives of people with diabetes by enhancing their ability to manage their disease with relative ease and accuracy.

In 2015, we acquired Senseonics, Incorporated, a medical technology company focused on the design, development and commercialization of glucose monitoring systems to improve the lives of people with diabetes by enhancing their ability to manage their disease with relative ease and accuracy.

From its inception in 1996 until 2010, Senseonics, Incorporated devoted substantially all of its resources to researching various sensor technologies and platforms.

Beginning in 2010, the company narrowed its focus to designing, developing and refining a commercially viable glucose monitoring system.

In connection with the Acquisition, we reincorporated in Delaware and changed our name to Senseonics Holdings, Inc.

In connection with the acquisition of Senseonics, Incorporated, we reincorporated in Delaware and changed our name to Senseonics Holdings, Inc.

Upon the closing of the acquisition, Senseonics, Incorporated merged with a wholly owned subsidiary of ours formed solely for that purpose and became our wholly owned subsidiary.

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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