Category Archives: Insulin Delivery

Lilly’s Tempo Smart Button Receives 510(k) Clearance; EASD 2022 Key Press Releases (Sept 21)

On the third day of EASD 2022, three key press releases were observed from Zealand, Carmot Therapeutics, and Abbott. Separately, Lilly’s Tempo Smart Button received FDA 510(k) clearance on September 16, 2022 (view FDA website), although Lilly has not issued a press release. Below FENIX provides insights and context for the respective 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.

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Insulet Omnipod 5 Receives CE Mark; Novo Nordisk and Octagon Therapeutics Collaboration for Inflammatory Disease Targets; Diamyd Presents Updated 12-month Results from Ph2 GADinLADA Trial; EASD 2022 Key Press Releases (Sept 20)

On the second day of EASD 2022, three key press releases were observed from Insulet, Novo Nordisk, and Diamyd. Below FENIX provides insights and context for the respective 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.

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Purchase Blast$599.00

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Biocorp’s SoloSmart receives CE Mark; EASD 2022 Key Press Releases (Sept 19)

On the first day of EASD 2022, Biocorp announced it received CE Mark for SoloSmart, an accessory medical device for Sanofi’s SoloStar/DoubleStar pens that records dose information (e.g., dose amount, time, and date). According to the press release, Biocorp will provide more details regarding the SoloSmart launch during its CY Q3 ’22 earnings call scheduled for September 29th. Below, FENIX provides brief thoughts on the new SoloSmart device as well as potential implications for Novo Nordisk, Lilly, and other insulin pen manufacturers.

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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Purchase Blast$599.00

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

Ypsomed Launches Remote Bolus Feature; Lannett Completes Bs-glargine Pivotal Trial; Madrigal Initiates MAESTRO-NASH Outcomes Study for Resmetirom

Three cardiometabolic-related news items have been observed: Ypsomed announced the launch of a smartphone bolus delivery feature for its mylife YpsoPump using the mylife App; Lannett announced it completed subject dosing in its Ph1 bs-glargine pivotal trial (view CT.gov record); and Madrigal announced the initiation of a Ph3 MAESTRO-NASH Outcomes study evaluating the effect of QD oral 80mg resmetirom compared to placebo in patients with compensated NASH cirrhosis (view CT.gov record). Below, FENIX provides context and insight on 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.

Medtronic CY Q2 ‘22 Earnings Updates; Glytec Collaborates with CPS for Glycemic Management Technology

Two cardiometabolic-related news items have been observed: Medtronic (press release; slides) released their CY Q2 ‘22 (FY Q1 ‘23) earnings, including updates to the ongoing FDA warning letter situation; and Glytec announced a partnership with CPS to offer glycemic management technology to HCPs (press release). Below, FENIX provides context and insight on 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.

Novo Announces Positive Ph2 Cagrisema Results; Insulet’s Omnipod 5 Receives Expanded FDA Clearance; Digbi Health Enrolled in Novo’s Accelerator Program; New Lyumjev Trial for Inreda’s Bi-hormonal AID System; Amarin Discontinues Vazkepa in Germany

A series of cardiometabolic updates have been observed: Novo announced positive topline results from its Ph2 study of cagrisema in T2DM; Insulet announced Omnipod 5 received expanded FDA clearance in patients down to 2 years of age; Digbi Health has enrolled in Novo’s Global Prevention Accelerator program; an Inreda-sponsored study has been observed evaluating Lyumjev in its bi-hormonal closed loop system (FAST 1; view CT.gov record); and Amarin announced it is discontinuing Vazkepa in Germany. Below, FENIX provides context and insight on 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.

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Purchase Blast$599.00

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

Sean Saint Takes Over as Beta Bionics CEO

Beta Bionics announced it has appointed Sean Saint (view LinkedIn; pictured below) as the company’s new CEO and board member. Saint will be replacing Martha Goldberg Aronson (view LinkedIn) who will remain on the Beta Bionics Board of Directors after serving as the interim CEO since February 2022. Prior to Beta Bionics, Saint founded and led Companion Medical, which was acquired by Medtronic in August 2020 (previous FENIX insight). More recently, in April 2022, Saint co-founded a new diabetes insulin delivery company called Luna Diabetes in collaboration with other diabetes device veterans including Jon Brilliant (view LinkedIn), John Sjolund (view LinkedIn), and Jasper Benke (view LinkedIn; previous FENIX insight). Below, FENIX provides brief thoughts on Saint’s appointment as Beta Bionics’s new CEO and what it means for the company’s future as it prepares for the launch of its insulin-only iLet bionic pancreas (previous FENIX insight).

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.

Abbott Expands CGM Manufacturing Capacity; Dario and Embecta Q2 ‘22 Earnings Updates

Three cardiometabolic-related news items have been observed: Abbott reportedly plans to invest $450M to expand CGM manufacturing (view article); and Dario (press release) and Embecta (press release; slides) hosted their respective Q2 ‘22 earnings calls. Below, FENIX provides highlights and insights for the respective new 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.

Xeris, Zealand, and MannKind Q2 ’22 Earnings Updates

Three cardiometabolic-related news items have been observed: Xeris Biopharma (press release), Zealand (press release; slides), and MannKind (press release; slides) hosted their Q2 ’22 earnings calls. Below, FENIX provides highlights and insights for the respective new 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.

Insulet, Provention Bio, Bayer, and Regeneron Q2 ‘22 Earnings Updates; Abbott Partners with WeightWatchers

A series of cardiometabolic-related news items have been observed: Insulet (press release), Provention Bio (press release), Bayer (press release; slides), and Regeneron (press release; slides) hosted their respective earnings calls; and Abbott announced a partnership with WeightWatchers for Libre CGM data integration. Below, FENIX provides highlights and insights for the respective new 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.