Category Archives: Insulin Delivery

Insulet Q2 ’19 Earnings Update

Insulet hosted its Q2 ’19 earnings call and provided updates to its commercial and pipeline activities including the Omnipod Horizon hybrid closed-loop development. Below are 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.

Forxiga DECLARE EU Approval, BTD For Provention Bio’s Teplizumab (PRV-031), And MannKind/One Drop Collaboration

Today, three key news items were observed including the Forxiga DECLARE EU approval, Breakthrough Therapy Designation to Provention Bio’s Teplizumab (PRV-031) and a MannKind/ One Drop collaboration. Below, FENIX provides context and analysis for 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.

Tandem Q2 ’19 Earnings Update

Tandem Diabetes Care hosted its Q2 ’19 earnings call and provided updates to its t:slim pump business. Additionally, Tandem announced that all software updates through YE 2020 will be provided free to users with in-warranty pumps. 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.

Medtronic Files CGM for Non-Adjunctive Claim

Medtronic announced it has filed a PMA with FDA seeking a non-adjunctive (insulin dosing) claim for the Guardian Sensor 3 as part of the 670G platform. The timing is consistent with Medtronic’s CGM roadmap from its 2019 ADA investor presentation. Below, FENIX provides thoughts on the filing including the curious observation that Medtronic chose to file as part of the SAP system and not the standalone Guardian Connect CGM.

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.

Connected Care: Sanofi/Biocorp Exclusive Data Partnership

Today, Biocorp and Sanofi announced they have entered into exclusive negotiations for integrating Biocorp’s connected cap device into the Sanofi connected care platform. Below, FENIX provides read-through on what the Biocorp-Sanofi deal may signal.

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.

Beta Bionics Raises $63M in Series B2 Financing

Beta Bionics announced the closing of a $63M Series B2 financing round 6 months after an additional $63M Series B round. According to the press release, the funds will be used to complete final product development, Ph3 clinical trials, regulatory submissions, and the commercial launch of the iLet system. Below, FENIX provides additional thoughts on Beta Bionics and the iLet system.

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 Files for IPO

Livongo has filed for its IPO under the proposed ticker “LVGO”; however, the number of shares and price has not yet been decided. Recall, on March 7, 2019, it was reported by WSJ that Livongo was preparing for a 2019 IPO with a valuation >$1B. Below, FENIX provides a brief overview of key information from the S-1 filing as well as insight into the Livongo IPO including thoughts on how Livongo is under increasing pressure to drive adoption.

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.

Adocia’s Pramlintide + Insulin Combo (ADO09) Ph1b Trial Posted on CT.gov

Consistent with Adocia’s ADA 2019 press release, a clinicaltrials.gov record has recently been observed for the company’s pramlintide + insulin (ADO09) Ph1b study. Below, FENIX provides an overview of the ADO09 Ph1b trial including thoughts on the market potential for ADO09 as a T1DM adjunctive therapy.

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.

Connected Care: Biocorp Receives CE Mark for Mallya

Biocorp announced it received CE Mark for the Mallya, a wraparound pen solution. Mallya turns any disposable or reusable insulin pen into a connected device that collects dosing information and sends it to a companion app. Below, FENIX provides insights and context to the impending Mallya launch including thoughts on how Mallya competes with Companion Medical or could be a compliment to Lifescan’s portfolio.

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.

ADA 2019 Key Press Releases (June 9 and 10)

14 major news items were observed over the past 2 days including Provention Bio’s teplizumab, dasiglucagon pivotal data, DECLARE and EMPA-REG subanalyses, Afrezza pediatric and fixed titration data, Tandem and Insulet hybrid-closed loop data, and more. Below, FENIX provides context and analysis for the 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.