Category Archives: Glucose Monitoring

Medtronic Acquires Nutrino Health

Medtronic announced plans to acquire Nutrino Health, a company focused on providing nutrition-related data services, analytics, and technologies. Recall, Medtronic has an existing relationship with Nutrino to integrate Nutrino’s FoodPrint app with the iPro2 professional CGM (previous FENIX insight). Below, FENIX provides thoughts on the acquisition and how Medtronic could leverage Nutrino’s capabilities moving forward.  With the launch of Medtronic’s Guardian Connect stand-alone CGM, the company is placing increased focus and resources toward the CGM market. As previously stated by FENIX, Medtronic is looking to create the “smart CGM” category through software-based features like Nutrino. Therefore, it makes sense for Medtronic to acquire……

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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Dexcom and Verily Update Agreement, Focus on T2DM Market

Dexcom and Verily recently announced an amendment to their collaboration and license agreement for the development of next-gen CGM systems. The updated agreement and shift in focus toward the second gen “Band-Aid-like” sensor is consistent with Dexcom senior management commentary during the Q3 ’18 earnings call. While the amendment to the agreement appears to suggest an underlying confidence in its product development, Wallstreet did not react as $DXCM has remained flat. Below, FENIX provides thoughts on the potential impact of the updated agreement on Dexcom and its competitors in the CGM 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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Purchase Blast$599.00

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Onduo Free Promotional Program; Insulet Dash Meets ISO Standards

Onduo announced it is giving away subscriptions to its virtual diabetes program to patients in Georgia. Additionally, Insulet announced it received ISO 27001 certification for its Omnipod Dash. Below, FENIX provides insight into how Onduo could be leveraging the giveaway with payers and the impact of digital security to Insulet’s smartphone-controlled pumps. Onduo Virtual Diabetes Care According to the press release, Onduo will giveaway a 12-month subscription to its virtual diabetes care program to the first 1,000 eligible patients in Georgia. Of note, the promotion coincides with National Diabetes Awareness month.  While it remains speculation, Onduo managed care coverage in Georgia could be lagging behind the……

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.

Livongo Recognized by CDC

Livongo announced the Centers for Disease Control (CDC) granted Livongo “full recognition,” which recognizes diabetes prevention programs that meet a CDC-approved curriculum for duration, intensity, and reporting requirements. “Full recognition” is part of the CDC’s National Diabetes Prevention Program. Below, FENIX provides thoughts on how Livongo will likely leverage the CDC recognition to help aid uptake for its diabetes program.  Despite the advances in diabetes-related medications, the prevalence of T2DM continues to rise, which is why organizations like the CDC have endorsed technological solutions that focus on changing patient behavior. Livongo is clearly looking to leverage the increased CDC focus on diabetes to aid……

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.

Medtronic CY Q3 ’18 (FY Q2 ’19) Earnings Update

Medtronic hosted its CY Q3 ’18 (FY Q2 ’19) earnings call and provided brief updates to its diabetes device pipeline and commercial activities including the ongoing launch of its standalone CGM, Guardian Connect. Below, FENIX provides key highlights of the earnings call as well as perspective on Medtronic’s push into the standalone CGM 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.

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.

Verily/Novartis Halts Glucose Sensing Contact Lens Development

Verily announced it has placed a hold on the development of its glucose-sensing contact lens that it had been working on in partnership with Novartis (Alcon). The announcement comes as no surprise given comments from Novartis’s Chairman, Joerg Reinhardt, in May 2017 saying “[The glucose-sensing lens is] a long-term project, not something where we were expecting a breakthrough in the first couple of years” and “I personally think it’s a highly risky project.” Below, FENIX provides thoughts on the Verily/Novartis product as well as the future of non-invasive glucose monitoring.

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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Thoughts on the Regulatory Environment in Diabetes

The regulatory environment in diabetes has greatly evolved in the last 10 years since the 2008 FDA CV risk guidance. As recently as ADA and now through EASD in 2018, FENIX considers the regulatory environment in the US and Europe to be highly favorable for sponsors developing diabetes drugs, devices, and technological solutions. Below, FENIX provides its perspective in a winners and losers analysis on how the highly favorable regulatory environment could be positively impactful to the key upcoming 2019 market events in diabetes from sponsors like Lexicon, Sanofi, AZ, Janssen, Novo Nordisk, Xeris, Lilly, BI, Dexcom, Senseonics, Abbott/Bigfoot, Tandem, Insulet, and Medtronic.

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 ’18 Earnings Update; Abbott FreeStyle Link Now Available

Senseonics hosted its Q3 ’18 earnings call and provided updates on the Eversense implantable CGM launch as well as pipeline activities. Additionally, Abbott recently announced the approval of Libre Link, an app that allows users to scan the Libre device with their iPhone. Below, FENIX provides thoughts on the Eversense launch, ongoing negotiations with Roche, and the potential impact of the Libre Link to accelerate Libre 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.

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Purchase Blast$599.00

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

New Dexcom Approvals; Dexcom and BD Q3 ’18 Earnings Updates

Dexcom and Becton Dickinson hosted Q3 ’18 earnings calls and provided updates to their respective businesses. Of note, Dexcom discussed two new 510(k) clearances based on the G6 iCGM regulatory pathway. Furthermore, BD said it has discontinued development of the FlowSmart infusion set in favor of other opportunities, notably the T2DM patch pump which is projected to file “in the coming months.” Below FENIX provides thoughts on how Dexcom is anticipated to leverage these new approvals for future product development and market shaping.

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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UPDATED: No Approval for Dexcom Verily G1

Yesterday, FENIX observed a J.P. Morgan analyst research publication from earlier in the week that reported Dexcom’s Verily G1 received approval based on an FDA 510(k) posting entitled “Dexcom G6 Glucose Program Continuous Glucose Monitoring System”. The research publication seemed highly credible since it was produced by the award-winning J.P. Morgan healthcare research analyst team and the FDA source was publicly available. Later, J.P. Morgan analyst Robbie Marcus admitted the incorrect reporting of the Verily G1 approval in a subsequent publication. Below are screenshots from each J.P. Morgan publication obtained by FENIX.

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.