Category Archives: Glucose Monitoring

Insulet Omnipod 5 Tale-of-the-tape Analysis

In March 2021, Insulet presented Omnipod 5 pivotal data at the ENDO conference in which Omnipod 5 was shown to reach 68-74% TIR with low rates of hypoglycemia (time spent 54 mg/dL of 0.17% in adults and 0.23% in pediatrics). Below, FENIX provides a tale-of-the-tape comparative analysis between Omnipod 5, Tandem’s Control IQ, and Medtronic’s 780G AHCL, as well as additional thoughts on how Omnipod 5 may effect new entrants to the market.

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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New BI/Zealand Trials in NASH and Obesity; vTv Granted BTD for TTP399; Jaguar Gene Therapy $139M Series B; CeQur $115M Series C5; Nemaura Launches BEATdiabetes App and proBEAT CGM Pilot; BioCorp/Roche Launch Mallya in France; Amarin CEO to Retire

A series of cardiometabolic-related new items have recently been observed from Boehringer Ingelheim/Zealand, vTv Therapeutics, Jaguar Gene Therapy, CeQur, Nemaura Medical, Biocorp/Roche, and Amarin. 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.

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Purchase Blast$599.00

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Novo Connected Pens Now Integrate with mySugr; Abbott Partners with Olympic Runner for Libre Sense Glucose Biosensor; New Non-invasive Glucose Monitoring Meter?

A series of diabetes-related news items have recently been observed: mySugr announced the integration of the Novo Nordisk NovoPen 6 and NovoPen Echo Plus connected pens into the mySugr Logbook on iOS; Abbott announced a partnership with Olympic runner, Eliud Kipchoge, and the NN Running Team to support their athletic training program through the use of Abbott’s Libre Sense Glucose Sport Biosensor; and Dongwoon Anatech is seeking US and Korean regulatory approvals for a saliva-based glucose monitor, called D-SaLife. 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.

Provention Bio Delay Appears Inevitable; Better Therapeutics To Go Public; Dexcom G6 Direct Distribution in the Netherlands; Sanofi Furthers Social Responsibility Outreach; Medtronic Commits to Three Initiatives to Address Healthcare Equity; Expanded Access to CGM and Insulin Pumps in Canada

A series of cardiometabolic-related news items have recently been observed from Provention Bio, Better Therapeutics, Dexcom, Sanofi, Medtronic, and JDRF Canada. Below, FENIX provides highlights and insights for the respective news items, including thoughts on how bad the teplizumab delay may really be.

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.

Dexcom and Welldoc Expand Partnership for T2DM

Dexcom and Welldoc announced “the first customer for a new integrated offering to drive improved health for people with Type 2 diabetes,” which is thought to mean the companies are transitioning from an integration/development focus to a commercial collaboration. According to the press release, the expanded partnership will combine real-time CGM and “AI-driven digital health coaching” to improve the management of T2DM. Below, FENIX provides thoughts on why the Dexcom/Welldoc collaboration makes sense as well as insight into the impending battle between AI and human coaching tools.

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 Medtronic/InPen MDI Basal+Bolus Advisement Connected System

A trial for a new Medtronic Guardian Connect CGM + connected insulin pen has been observed (view CT.gov record). Interestingly, the CT.gov record states the trial will use the Guardian Connect CGM, smart insulin pens, InPen Diabetes Management app, and a new device referred to as the “InPen Basal smart cap.” Below, FENIX provides an overview of the trial, insight into the potential features of the InPen Basal smart cap, and why this new product may be a reason to adopt a Medtronic solution over a Dexcom solution.

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 STEP 4 Sema Obesity Results @ ENDO 2021; Oramed Second Oral Insulin Ph3 Trial Update; Dexcom Promotes Jereme Sylvain to CFO; vTv Granted New Patent for TTP399

A series of diabetes-related news items have been observed: Novo Nordisk presented results from the STEP 4 semaglutide 2.4mg obesity trial at the ENDO 2021 conference (view press release); Oramed announced it has screened the first patients in its second oral insulin Ph3 trial; Dexcom has promoted Jereme Sylvain to CFO, allowing Quentin Blackford to take over Steve Pacelli’s responsibilities for strategy and corporate development (view press release); and vTv announced the USPTO issued patent 10,952,993 protecting methods of treatment using TTP399, a novel GKA. Below, FENIX provides highlights and insights from the respective news items, including updated perspective on Oramed’s potential regulatory timeline.

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 Implantable CGM Study from Indigo; Gilead/Novo Expand NASH Collaboration; Metacrine Q4 ’20 Earnings Update; Cytokinetics to Present GALACTIC-HF Analysis at ACC 2021

A series of cardiometabolic-related news items has been observed: Indigo Diabetes announced the first three participants in the GLOW early feasibility study have been implanted with Indigo’s “YANG sensor” for continuous glucose, ketone, and lactate monitoring; Gilead and Novo announced the companies have expanded their clinical collaboration in NASH following positive Ph2 POC data evaluating the combination of semaglutide+cilofexor+firsocostat; Metacrine hosted its Q4 and FY ’20 earnings call and provided development updates on MET642 and MET409 in NASH; and Cytokinetics announced a secondary analysis of GALACTIC-HF will be presented at ACC 2021 (May 15-17). 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.

Zealand Q4 ’20 Earnings Update; Nemaura Submits for sugarBEAT Reimbursement in Germany

Two diabetes-related news items have been observed: Zealand hosted its Q4 and FY 2020 earnings call (press release; slides); and Nemaura announced it has submitted sugarBEAT for reimbursement in Germany. In case you missed it, FENIX provided coverage of Zealand’s R&D Day on March 5, 2021 (previous FENIX insight). Below FENIX provides highlights and insights from the respective news items, including an analysis on whether Beta Bionics, who is partnered with Zealand for dasiglucagon, would launch the insulin-only iLet configuration or if it would wait for the bi-hormonal 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.

Senseonics Q4 ’20 Earnings Update; Provention Bio Extended Follow-up Data Published; Voluntis Collaborates with Zendesk for Global Customer Support

A series of diabetes-related news items have been observed: Senseonics hosted its Q4 and FY ’20 earnings call; Provention Bio announced the extended follow-up data from the pivotal “At-Risk” TN-10 Study has been published in Science Translational Medicine; and Voluntis announced a collaboration with Zendesk to upgrade its global customer support infrastructure. 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.