Category Archives: Insulin Delivery

Omnipod Horizon Pivotal Trial Delayed

Insulet announced it will be pausing Omnipod Horizon pivotal trial due to a recently-discovered “software anomaly.” The updated software is expected to be available by the end of April 2020; however, the Omnipod Horizon launch timeline has been pushed back to early 2021. Below, FENIX provides potential insights on the delay as well as implications to other insulin delivery algorithm developers.

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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Insulet Q4 ’19 Earnings Update

Insulet hosted its Q4 ’19 earnings call (press release) and provided updates to its Omnipod business including the Omnipod Horizon closed-loop system. Of note, Insulet disclosed that it has completed enrollment in the Omnipod Horizon pivotal trial and indicated its intentions to deprioritize concentrated insulin 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.

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Purchase Blast$599.00

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Tandem t:slim Smartphone Control in H2 ’20; Tandem Q4 ’19 Earnings Update

Tandem hosted its Q4 ’19 earnings call and provided updates to its commercial and pipeline activities including the recent launch of Control IQ. Of note, for what is believed to be the first time, Tandem disclosed plans to launch a t:slim X2 remote bolusing feature in H2 ’20. 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.

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Purchase Blast$599.00

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

New Companion Medical 510(k) Clearance for Expanded Dose Calculator Modes

Today, a new record appeared on FDA’s 510(k) website that shows Companion Medical received clearance for additional bolus dose calculation modes in their connected app for InPen. Below, FENIX provides highlights and insights from the 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.

First Look at Sanofi’s Connected Insulin Pen Solutions?

During the ATTD 2020 conference, a slide was presented with what is possibly Sanofi’s connected insulin pen solutions. Below, FENIX provides pictures and brief thoughts on the potential Sanofi connected pen platform for disposable and reusable insulin pens.

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.

FDA Issues Final Rule on Definition of “biological product”; ATTD 2020 Key Press Releases (Feb 20)

On the second day of the ATTD 2020 conference, a series of diabetes-related press releases have been observed including Abbott Libre RWE, Tandem to file Control IQ for peds in March 2020, Roche’s new “InsulinStart” program, Companion Medical compatibility with Fiasp, and MannKind Afrezza PK and pulmonary function data. Separate from the conference, FDA announced that it has issued a final rule on the definition of a biological product ahead of the March 23, 2020 insulin reclassification from a drug to a biologic. 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.

Insulet Partners with Dexcom and Abbott; ATTD 2020 Key Press Releases (Feb 19)

With the start of the ATTD 2020 conference, a series of diabetes technology-related press releases have been observed including partnerships between Insulet/Dexcom, Insulet/Abbott, Dexcom/Dreamed, and Biocorp/iSage Rx. Additionally, Dario Health presented new data at ATTD 2020 for its connected BGM platform, and Diabeloop initiated a trial to support 510(k) clearance of its automated insulin delivery algorithm. 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 CY Q4 ’19 (FY Q3 ’20); Cigna Reimburses Eversense Implantable CGM; Diasome HDV-Lispro Ph2 Topline Data

Yesterday, a series of diabetes-related news were observed including Medtronic’s CY Q4 ’19 (FY Q3 ’20) earnings call, Senseonics’s positive coverage decision from Cigna for the Eversense implantable CGM, and Diasome’s topline data from its Ph2 OPTI-1 study. 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.

Insulet Omnipod DASH Software Bug; No Injuries Reported

Insulet announced it has initiated a “voluntary Medical Device Correction” for all Omnipod DASH devices. According to Insulet, on some rare occasions when the bolus calculator is left open or an alarm interrupts a bolus calculation, DASH may suggest incorrect boluses based on older glucose values. Below, FENIX provides thoughts on the Omnipod DASH issue in the context of Medtronic’s recent 630G/670G pump recall as well as potential readthrough to Tandem, Bigfoot, and Beta Bionics.

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 630G/670G Pumps After Thousands of Injuries and One Death

FDA’s medical device recalls website has been updated with a new recall alert regarding the Medtronic 600 series pump platform (630G and 670G products). According to the FDA website, the recall is based on a faulty or missing retainer ring which helps lock the insulin cartridge into place. Medtronic is said to have received over 26k complaints about the defect with at least 2,175 injuries and 1 patient death. Below, FENIX provides thoughts on the Medtronic insulin pump recall including insight as to why Tandem may be the big winner.

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.