Tag Archives: Senseonics

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.

Medtronic CY Q4 ’19 (FY Q3 ’20); Cigna Reimburses Eversense Implantable CGM; Diasome HDV-Lispro Ph2 Topline Data

Yesterday, a series of diabetes-related news were observed including Medtronic’s CY Q4 ’19 (FY Q3 ’20) earnings call, Senseonics’s positive coverage decision from Cigna for the Eversense implantable CGM, and Diasome’s topline data from its Ph2 OPTI-1 study. Below, FENIX provides highlights and insights from the respective news items.

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 Integrates with Companion Medical; Nemaura Medical CY Q4 ’19 Earnings Update

Senseonics announced a new partnership with Companion Medical to integrate Eversense implantable CGM data into the Companion Medical InPen platform. Additionally, Nemaura Medical issued a press release for its FY Q3 ’19 (CY Q4 ’19) earnings. Below, FENIX provides thoughts on the partnership including why it makes sense for both Senseonics and Companion Medical.

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.

Novo/UVA Partnership; Roche Decreases Eversense CGM Commitment; Lilly Insulin Pricing Open Letter

A series of diabetes-related news has been observed including a new partnership between Novo Nordisk and UVA, Roche amended its agreement with Senseonics to reduce the minimum CGM volume obligation, and Lilly publishes an open letter on insulin pricing. Below, FENIX provides highlights and insights for the respective news items.

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 Launches Non-Adjunctive Claim; Dexcom Data Transmission Issue; Onduo RWE Published

A series of diabetes-related news has been observed including Senseonics’s launch of its Eversense implantable CGM non-adjunctive claim, an issue with Dexcom’s CGM follow app, and new Onduo real-world evidence. Below, FENIX provides highlights and insights from the respective news.

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 Q3 ’19 Earnings Update

Senseonics hosted its Q3 ’19 earnings call (press release) and provided updates to its Eversense implantable CGM commercial and pipeline activities. Separately, Senseonics also announced Medicare has finalized a payment rate for Eversense through Medicare Part B. 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.

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.

Omnipod Approved to use Novo’s Fiasp; Senseonics Now Covered on Humana

Insulet announced it has received 510(k) clearance to use Novo’s Fiasp in Insulet’s Omnipod patch pump. Recall, earlier this week, Novo announced it received FDA approval for Fiasp pump compatibility in adult patients requiring insulin therapy. Additionally, Senseonics announced that Humana will now be providing coverage for the Eversense implantable CGM system and insertion procedure (effective October 22, 2019). Below, FENIX provides brief thoughts and potential market implications for each news item.

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 Completes Enrollment for 180-Day CGM Trial

Senseonics announced it has completed enrollment for its trial evaluating the 180-day configuration of its Eversense implantable CGM. Recall, Senseonics’s partner, Roche, is already commercializing the 180-day system (Eversense XL) in Europe. Below, FENIX provides thoughts on how the move from a 90 to 180-day sensor may impact Eversense uptake in the US.

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.

MannKind and Senseonics Q2 ’19 Earnings Updates

MannKind and Senseonics hosted their Q2 ’19 earnings calls and provided updates to their respective diabetes businesses. Below, FENIX provides highlights and insights from the calls.

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.