Category Archives: Glucose Monitoring

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.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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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.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

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.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

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.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

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.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

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.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

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.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Livongo Q4 ’19 Earnings Update

Livongo hosted its Q4 and FY 2019 earnings call and provided updates to its business. Unsurprisingly, the vast majority of the call focused on the user and revenue growth outlook for the Livongo platform. Below, FENIX provides highlights and insights from the call.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

FDA Approves Senseonics Extension Study for 365-Day CGM

Senseonics announced FDA approved an extension phase of the PROMISE clinical trial to allow for a subset of patients to continue the trial for a total of 365 days with a single Eversense implantable CGM sensor. Below, FENIX provides thoughts on how the move from a 90-day sensor to 180- and 365-day sensors may be the catalyst that Senseonics needs to turn around its business.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

New Nemaura H2H CGM Study; Welldoc partners with Redox to integrate BlueStar with EHRs

A series of diabetes-related news has been observed including an announcement that Nemaura plans to initiate a H2H study comparing its sugarBEAT CGM with a “highly successful major incumbent CGM sensor” (press release) as well as Welldoc’s new strategic partnership with Redox Inc., to integrate BlueStar with EHRs (press release). Below, FENIX provides additional highlights and insights on Nemaura’s H2H study, especially in the context of the comparative CGM used in the study.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.