Category Archives: Insulin Delivery

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.

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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.

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Purchase Blast$599.00

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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.

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Purchase Blast$599.00

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New iPump Pathway: Tandem t:slim X2 Approved as First Interoperable Pump

Today, FDA approved an interoperable version of Tandem’s t:slim X2 pump under the de novo pathway for a new insulin pump class called “alternate controller enabled” or ACE. Tandem has not yet issued a press release. This designation allows for the pump to be used with different components of an integrated insulin delivery system (e.g. CGM) with future iterations using the streamlined 510(k) process. As part of the approval, FDA has created special controls to meet the standard for ACE designation (similar to how FDA approved iCGM with special controls). Below, FENIX provides thoughts on the ACE category and implications to pump, CGM, and algorithm companies.

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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New Lilly and Novo uRAI pump trials: URLi ‘PRONTO-Pump-2’ and Fiasp in iLet Bionic Pancreas

Recently, FENIX has observed new Lilly and Novo pump trials on CT.gov. Lilly has posted a Ph3 trial for its ultra-rapid-acting insulin lispro (LY900014; URLi) for pumps in adults with T1DM called ‘PRONTO-Pump-2.’ Additionally, Novo has initiated a new Ph2 trial for Fiasp in an iLet Bionic Pancreas. Below, FENIX provides thoughts on the respective studies.

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.

No REWIND PRV Mentioned; Lilly Q4 ’18 Earnings Update

Lilly hosted its Q4 ’18 earnings call and provided brief updates to its diabetes business including its REWIND outlook, Jardiance tailwinds, URLi regulatory filing, and CAROLINA topline results. Of note, Lilly discontinued development of the Ph2 DACRA-042 compound from KeyBioscience. Below, FENIX provides highlights and analysis 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

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BD CY Q4 ’18 (FY Q1 ’19) Earnings Update

BD held their Q4 ’18 earnings call and provided a brief update on their diabetes business unit. Senior management disclosed they have filed their T2DM patch pump in the US and European and anticipate a launch in late 2019. When asked by an analyst about their market approach for the T2DM patch pump, senior management commented that BD is in the process of defining their channel strategy. Furthermore, management does not anticipate any new clinical data to presented at ADA 2019.

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.

JDRF Criticizes Medtronic/UHC For Reducing Patient Choice

JDRF has issued a press release criticizing UnitedHealthcare’s decision to extend Medtronic’s exclusive status for supplying insulin pumps to its covered lives. Recall, Medtronic first signed the deal with UHC in May 2016, which applied to patients 18 years of age and older. However, with FDA’s approval of the 670G pump in patients down to 7 years of age, UHC has extended the agreement to this population. Patients on existing pump therapy or patch pumps (e.g. Insulet Omnipod) are not impacted. Below, FENIX provides thoughts on UHC’s decision, the potential impact to Tandem’s pump business, and the potential irony of JDRF’s criticism.

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.

JPM 2019 Day 3: Becton Dickinson

The third day of the 2019 J.P. Morgan Healthcare conference included a presentation from Becton Dickinson, which is the final diabetes-related presentation of the conference. BD senior management briefly discussed their T2DM patch pump, called Swatch, which has already been filed with FDA with a limited launch scheduled before YE 2019. Below, FENIX provides key takeaways from the BD presentation and thoughts on the future T2DM pump market including a competitor comparison table. In case you missed it, here are links to FENIX’s Day 1 and Day 2 JPM 2019 insights. Becton Dickinson In response to an analyst’s question, BD management……

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.

JPM 2019 Day 2: LLY, SNY, LXRX, ABT, PODD, MYL

The second day of the 2019 J.P. Morgan Healthcare conference included diabetes-related presentations from Lilly, Sanofi, Lexicon, Mylan, Abbott, and Insulet. Separately, Lilly announced plans to further increase drug pricing transparency using Trulicity TV DTC. The commercials will include a portion directing patients to a Lilly website for more information on list price and average copays. Below, find a topline summary of key JPM takeaways by company followed by more in-depth coverage. In case you missed it, here is a link to FENIX’s Day 1 JPM 2019 insights. Lilly Lilly’s CEO provided a brief introduction to the company and referenced 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.

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.