Tag Archives: Medtronic

Novo to Initiate Oral Sema Alzheimer’s Ph3 Program; Novo Ph3 High-dose Rybelsus Trial in 2021; Lilly to Initiate Tirzepatide HFpEF Trial; Highmark and BI Announce Jardiance OBC Results; Medtronic’s Sean Salmon Takes on CV Responsibilities; + Five Other News Items

A series of diabetes-related news items have recently been observed from Novo Nordisk, Lilly, BI/Highmark, Medtronic, Diamyd, Provention Bio, Zealand, and Sensyne Health. 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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Medtronic CY Q3 ’20 (FY Q2 ’21) Earnings Update; Dario Signs New Deal with Fortune 500 Company; Oramed Screens First Patients in the Ph3 ORMD-0801 Trial

A series of diabetes-related news items have been observed: Medtronic hosted its CY Q3 ’20 (FY Q2 ’21) earnings call (press release; slides); Dario signed a deal with a Fortune 500 company (press release); and Oramed announced it has screened the first patients in its Ph3 oral insulin (ORMD-0801) trial. Below, FENIX provides highlights and insights from 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 Launches InPen with Integrated Guardian Connect

Medtronic announced it has launched the InPen connected insulin pen that now integrates real-time data display with Medtronic’s Guardian Connect CGM. Recall, in August 2020, Medtronic disclosed plans to acquire Companion Medical and InPen (previous FENIX insight). Below, FENIX provides thoughts on the new InPen CGM data display integration in the context of the evolving regulatory environment as well as questions about Lilly and Novo Nordisk’s connected pen solutions.

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 2020 Investor Day Highlights

Medtronic hosted its 2020 Investor Day (view slides) and provided updates across its business, including plans to reinvigorate its diabetes business. Importantly, Medtronic disclosed that just yesterday (October 13), the company completed enrollment in its next-gen Synergy CGM sensor pivotal trial. Below, FENIX provides highlights and insights from the diabetes-related portion of the event.

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Lilly and Dexcom Partner to Promote Lyumjev and G6 CGM; Omar Ishrak to Retire from Medtronic; Patia BioPharma and Precision Diabetes Partner for Diabetes Diagnostics; Capillary Bio Receives $1.5M Loan from Helmsley

A series of diabetes-related news items have been observed: Lilly and Dexcom announced a partnership to launch a joint program for US HCPs, focusing on Lyumjev and G6 CGM’s role in PPG control; Medtronic announced its former CEO, Omar Ishrak, will retire as Executive Chairman and Chairman of the Board, succeeded by CEO, Geoff Martha; Patia Biopharma and Precision Diabetes announced a partnership for diabetes diagnostics; and Capillary Biomedical announced it has received a $1.5M loan from the Helmsley Charitable Trust to conduct trials for an extended-wear infusion set. Below, FENIX provides highlights and insights from 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 Recalls Guardian Connect App After Data Upload Disruptions

FDA’s medical device recalls website has been updated with a new recall alert regarding the Medtronic Guardian Connect CGM app. According to the FDA website, the recall is based on a Medtronic CareLink Personal website software update which resulted in the iOS app not automatically uploading its data to the website. Of note, the Guardian Connect app is compatible with both iOS and Android, though the recall only mentioned iOS issues. Below, FENIX provides thoughts on the Guardian Connect app recall and what it could mean for Medtronic and CGM-competitors Dexcom and Abbott.

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 to Restructure Business; Nemaura proBEAT and sugarBEAT Launch Updates

Two diabetes-related news items have been observed: yesterday, Medtronic filed a form 8-K, reporting that the company is reorganizing its current business with the intention of saving ~$450M annually (view Form 8-K) and Nemaura Medical presented at the LD 500 virtual investor conference and discussed updates to its sugarBEAT and proBEAT US and ex-US commercial plans (press release; view presentation). Below, FENIX provides insight into how the Medtronic reorganization may impact its diabetes business as well as an updated perspective on the potential impact of Nemaura’s non-invasive CGM.

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Medtronic’s 770G Pump Approved in Peds Down to 2 Years of Age

FDA has approved Medtronic’s MiniMed 770G hybrid closed-loop system in patients down to 2 years of age (view FDA press release). At the time of this publication, Medtronic had not yet issued its own press release. Recall, the 770G pump uses the same hybrid closed-loop algorithm that is available with the current 670G system, but 770G is BLE-enabled. Below, FENIX provides brief thoughts on the 770G approval.

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 ’20 (FY Q1 ’21) Earnings Update

Medtronic hosted its CY Q2 ’20 (FY Q1 ’21) earnings call (press release; slides) and briefly discussed its diabetes business. Of note, Medtronic rescheduled its Investor Day event for October 14, 2020. 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 to Acquire Companion Medical; Thoughts on What It Could Mean for Insulin Delivery

Medtronic announced plans to acquire privately-held Companion Medical and its InPen connected insulin pen platform. According to the press release, the acquisition is expected to close within the next 1-2 months, and terms were undisclosed. Below, FENIX provides thoughts on the Companion Medical acquisition, Medtronic’s first under new President Sean Salmon, and additional insight into possible strategy changes that could affect other insulin delivery stakeholders (e.g. Novo Nordisk, Lilly, Sanofi, Dexcom, Tandem, Insulet, Beta Bionics, and especially Bigfoot+Abbott).

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.