Tag Archives: WaveForm

Menarini Launches GlucoMen CGM in Europe

Menarini announced its GlucoMen Day CGM is now broadly available in Europe through Menarini’s affiliates and partners (in territories not directly covered by Menarini). Recall, in April 2019, WaveForm (formerly AgaMatrix) partnered with Menarini to market the CGM in ex-US geographies (previous FENIX insight). WaveForm received CE Mark for the CGM in November 2019 (previous FENIX insight). Below, FENIX provides thoughts on the market potential for GlucoMen in the context of its key differentiators (e.g. needle-less insertion sensor insertion).

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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Libre 2 US Approval Was Worth the Wait for Abbott, but Not Its Pump Partners

Abbott announced FDA approval of the Libre 2 iCGM in patients 4 years of age and older; however, the initial approval comes without closed-loop compatibility. According to FDA’s 510(k) database, Libre 2 was approved on Friday, June 12, but FDA typically doesn’t update the database until Monday. Recall, Libre 2 approval had been delayed for undisclosed reasons, but FENIX recently anticipated a near-term US approval with the closure of Bigfoot’s Series C (previous FENIX insight). Below, FENIX provides thoughts on the Libre 2 approval, a comparative analysis with the Dexcom G6, and potential implications to other CGM manufacturers including Medtronic, Senseonics, Lifescan, Waveform, and Nemaura.

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.

Josh Riff Leaves Onduo; Thoughts on AgaMatrix+Bayer for China, and Confusion on Cascade CGM Wear Time in Europe

Two diabetes-related news items have been observed: Onduo announced the departure of CEO Josh Riff and AgaMatrix Holdings announced a corporate name change to “WaveForm Diabetes,” the appointment of a new Executive Chairman and CEO, Rick Valencia, and a partnership in China with Bayer for its CGM distribution. Below, FENIX provides thoughts on the leadership appointments in Onduo and WaveForm, as well as insight into the somewhat ironic partnership between WaveForm and Bayer, and some observed confusion on 15-day vs. 14-day wear time from Menarini’s product materials.

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.

WaveForm CGM Receives CE Mark; Senseonics Sensor Recall

WaveForm, a subsidiary of AgaMatrix, announced it received CE Mark for its Cascade CGM system. Importantly, WaveForm also provided insight into its plans for US commercialization. Additionally, Senseonics recently initiated a voluntary recall on some of its Eversense implantable CGMs. Below, FENIX provides thoughts on the new CGM market entrant and the potential commercial outlook.

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.