Category Archives: Glucose Monitoring

Dexcom Loses Appeals Court Bid For AgaMatrix Lawsuit

Dexcom has reportedly lost its appeals court bid to reinitiate its patent dispute vs. AgaMatrix. Previously, Dexcom alleged that Agamatrix’s CGM technology infringed on Dexcom’s patents for improving sensor accuracy. Recall, AgaMatrix (and its subsidiary WaveForm) acquired CGM IP from iSense and Bayer in early 2016. Below, FENIX provides a brief overview of the litigation history between AgaMatrix and Dexcom as well as thoughts on potential resolutions.

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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Former Medtronic CMO Joins Senseonics

Senseonics announced the appointment of Francine Kaufman as Chief Medical Officer (pictured below). Kaufman is a pediatric endocrinologist and most recently worked at Medtronic as the CMO and VP of Global Clinical, Regulatory, and Medical Affairs. Below, FENIX provides thoughts on how Kaufman immediately provides significant credibility to Senseonics during the critical Eversense implantable CGM launch phase.

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 Glooko Business Model; Glooko Mobile App to be Given Away for Free

Glooko announced it is removing the subscription fee for its data management platform. Previously, users who did not have coverage through their insurance or employers were required to pay a fee to access the platform. Additionally, the Glooko/Senseonics data integration appears to be complete. Now, users can directly sync Eversense data to the Glooko platform via the Senseonics Cloud. Below, FENIX provides thoughts on Glooko’s new business model as well as insight into how the integration with Eversense likely benefits Senseonics more than Glooko.

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.

Dexcom Expands Customer Support; Q4 ’18 Earnings Update

Dexcom hosted its Q4 ’18 earnings call and provided updates to its diabetes business including an announcement that the company is expanding its customer and technical support capabilities through ex-US resources. As such, Dexcom is downsizing an undisclosed portion of its US workforce. Below, FENIX provides highlights and insights from the earnings 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.

Biocorp/DreaMed Partnership; Abbott Libre and Valeritas V-Go RWE

Three diabetes device-related press releases were observed today including a new Biocorp/DreaMed partnership, as well as Abbott Libre and Valeritas V-Go patch pump RWE, presented at ATTD 2019. Below, FENIX provides an overview of the news as well as thoughts on how the Biocorp/DreaMed partnership appears to favor DreaMed.

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 Pens: New Novo and Abbott Partnership for Data Integration

Today, Abbott and Novo Nordisk announced a non-exclusive partnership to integrate insulin dosing data from Novo’s connected insulin pens into Abbott’s digital health tools compatible with the FreeStyle Libre system. Below, FENIX provides insights into the Novo/Abbott partnership.

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 Pens: Novo Expanded Capability with Glooko; Biocorp/AgaMatrix Partnership

Prior to the start of the 2019 ATTD conference, two diabetes technology-related press releases have been observed. First, Glooko announced that its cloud-storage platform will integrate with Novo Nordisk’s connected pens and Dexcom’s G6 CGM. Second, Biocorp and AgaMatrix entered into a partnership for the distribution of Biocorp’s wraparound connected pen device now called “Mallya” (formerly Easylog). Below, FENIX provides insight into the respective news including thoughts on why the remote upload feature is critical for Novo.

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 Receives Breakthrough Device Designation; CY Q4 ’18 (FY Q3 ’19) Earnings Update

Medtronic hosted its CY Q4 ’18 (FY Q3 ’19) earnings call and provided brief updates to its diabetes device pipeline and commercial activities. Of note, Medtronic also announced that FDA granted Breakthrough Device Designation for its Personalized Closed Loop (PCL) insulin pump system (Breakthrough Devices Program Guidance was finalized in December 2018). Below, FENIX provides highlights from the earnings call as well as perspective why Medtronic chose to pursue Breakthrough Device Designation.

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.

Thoughts on iPump Special Controls

Yesterday, FDA approved the first interoperable pump through the de novo pathway and created a new pump category called “alternate controller enabled” (ACE) infusion pump. With the approval of the new class, FDA established “special controls” that must be met in order to qualify as an ACE pump, similar to Dexcom’s G6 iCGM approval in March 2018. Below, FENIX provides analysis and summary of these controls as well as thoughts on how achievable the ACE special controls are compared to the iCGM special controls.

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/Roche Renew Distribution Agreement; Acquisition Unlikely

Senseonics announced it has come to an agreement with Roche to extend the existing distribution agreement for the Eversense implantable CGM. Additionally, Senseonics held an investor webcast to discuss the updated agreement. Below, FENIX provides a summary of the webcast as well as thoughts on why it may have made more sense for Roche to extend the partnership than to outright buy Senseonics.

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.