Category Archives: Glucose Monitoring

CGM: Thoughts on Lifescan/Sanvita CGM Trial Impact from COVID-19

With the ongoing COVID-19 pandemic, a number of clinical trials have been impacted across the industry. Lifescan/Sanvita Medical’s CGM pilot study, in particular, is ongoing but it remains unclear if or how COVID-19 will impact the overall development of the novel CGM. Recall, in May 2019, Lifescan announced it entered into an exclusive agreement with Sanvita Medical to distribute the Sanvita CGM. Below, FENIX provides thoughts on the impact of COVID-19 on Lifescan/Sanvita’s CGM trial, the possibility of FDA favoritism for Libre 2 from Abbott’s COVID-19 testing wins, as well as the potential impact on Dexcom’s CGM business.

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Senseonics Suspends US Commercial Sales to New Patients

In a recent 8K SEC filing, Senseonics disclosed that it will no longer ship Eversense implantable CGMs to new customers in the US; however, the company intends to maintain supply for existing customers. The news comes just days after Senseonics announced plans to explore strategic options for the company, including a potential sale. Below, FENIX provides additional thoughts on Senseonics’s current position.

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DarioHealth Partners with Vitality Group

DarioHealth announced a partnership with Vitality Group to integrate Dario digital therapeutics for chronic conditions into Vitality’s wellness solution platform. According to Dario, the partnership is intended to accelerate penetration into the self-insured employer US market. Below, FENIX provides insight into the Dario/Vitality partnership as well as potential implications to Livongo and Onduo.

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Senseonics Exploring Strategic Alternatives

Senseonics announced today that the company is exploring strategic alternatives, including a potential sale. Below, FENIX provides a summary of the press release and a favors/disfavors analysis regarding a possible acquisition as the company searches for new financing sources.

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Nemaura to Use Wellness Category for US CGM Launch

Nemaura announced plans to launch its non-invasive sugarBEAT CGM in the US under the wellness category following feedback from the FDA (press release). Below, FENIX provides insight on this new foray for CGM in the US, especially in the context of how other marketed CGMs use a non-adjunctive claim to dose insulin for diabetes management.

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DarioHealth Q4 ’19 Earnings Update

DarioHealth hosted its Q4 ’19 earnings call (press release) and provided brief updates to its commercial developments and strategic collaborations. Of note, management indicated that they currently have ~46k active users, including the users from the membership program and those with device usage. Below, FENIX provides additional highlights and insights from the call.

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Senseonics Q4 ’19 Earnings Update

Senseonics hosted its Q4 ’19 earnings call (press release) and provided updates to its Eversense implantable CGM commercial and pipeline activities. Of note, the iCGM designation filing for the 90-day Eversense CGM is now anticipated in Q2 ’20. Below, FENIX provides highlights and insights from the call.

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Lilly to Join New Part D Senior Savings Model for Affordable Insulins; Welldoc Partners With Dexcom

Yesterday, FENIX observed a series of diabetes-related news including an announcement that Welldoc partnered with Dexcom to integrate G6 into the BlueStar platform (press release) as well as Lilly plans to participate in the new Part D Senior Savings Model for affordable insulins (press release). Below, FENIX provides brief thoughts on these announcements.

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Nemaura enters into multiple non-binding agreements for sugarBEAT; Mylan wins over Sanofi in Lantus patent litigation

A series of diabetes-related news has been observed including an announcement that Nemaura has entered into multiple non-binding agreements for its sugarBEAT CGM (press release) as well as the US District Court ruling favorably for Mylan/Biocon’s bs-glargine over Sanofi’s Lantus (press release). Below, FENIX provides brief thoughts on these announcements in the context of the recent news from Nemaura and the potential launch of Mylan/Biocon’s bs-glargine.

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Nemaura Launches sugarBEAT CGM App on Google Play

Nemaura Medical announced it has launched an updated sugarBEAT app on Google Play (download here) ahead of the BEAT diabetes subscription-based service UK launch in April 2020. Recall, Nemaura recently disclosed plans to conduct a H2H trial comparing its non-invasive CGM to a “highly successful major incumbent CGM sensor.” Below, FENIX provides brief thoughts on the new app in the context of Nemaura’s overall non-invasive CGM ecosystem.

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