Category Archives: Insulin Delivery

Insulet Q1 ’19 Earnings Update

Insulet hosted its Q1 ’19 earnings call and provided updates to its Omnipod business including the recent launch of the Omnipod Dash PDM as well as development of the Omnipod Horizon hybrid closed-loop. 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.

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.

Tandem Q1 ’19 Earnings Update

Tandem hosted its Q1 ’19 earnings call and provided updates to its diabetes business including the Control IQ (hybrid closed-loop) and t:sport (with smartphone control) development programs. 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.

REWIND Filed; Empa T1DM, Nasal Glucagon Delayed; Lilly Q1 ’19 Earnings Update

Lilly hosted its Q1 ’19 earnings call and provided updates to its diabetes business. Of note, Lilly disclosed that it submitted REWIND (US and EU), URLi (EU, Japan, and maybe the US), a connected prefilled pen (US), and the empa+lina+metXR triple combination (US). Furthermore, Lilly also disclosed two regulatory delays. FDA refused to accept the sNDA for Jardiance in T1DM for “technical reasons,” and the review for Lilly’s nasal glucagon rescue product was extended by 3 months after FDA requested additional data. Below, FENIX provides thoughts and context to the significant Q1 ’19 regulatory events in diabetes.

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.

Sign UpFREE

You’ll be able to access the full article from your FENIX Library after signing up.

New Valeritas V-Go HEOR Data

Valeritas announced the publication of new HEOR data for its V-Go daily insulin patch pump for T2DM. The V-GoAL study was a randomized trial of 415 T2DM patients which resulted in 24% less total daily insulin as well as statistically significant reductions in A1C compared to standard treatment optimization. Below, FENIX provides thoughts on the V-Go system in the context of the emerging patch pump 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.

New Medtronic/BCBS CGM Outcomes-Based Contract

Medtronic announced it has signed an outcomes-based contract (OBC) with BCBS of Minnesota for the standalone Guardian Connect CGM. According to the press release, the OBC is based on time-in-range metrics. In return, Guardian Connect will be distributed through the BCBS Minnesota pharmacy benefit. While the press release does not specify, it is believed that both insulin-dependent T1DM and T2DM patients are eligible. Below, FENIX provides thoughts on the Medtronic CGM OBC and how it could impact other CGM manufacturers, notably 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.

Glytec Partners with Dario For Outpatient Insulin Titration

DarioHealth announced a joint marketing agreement with Glytec to allow Dario’s connected BGM to integrate into Glytec’s Glucommander Outpatient insulin titration solution. Below, FENIX provides thoughts on why the partnership between Glytec and Dario makes sense for both 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.

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.

Cellnovo to Close Operations?

Cellnovo announced that it does not have sufficient capital to support a broader launch of its Gen 3 tubed patch pump which is negatively impacting the company’s overall operations. According to the press release, Cellnovo “[intends] to continue contacts initiated with strategic partners and investors in order to protect the value of the assets.” Given the financial situation, Cellnovo initiated collective proceedings in the UK and conciliation proceedings in France. Below, FENIX provides thoughts on Cellnovo’s market position and the potential closure of its operations.

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 Potential Livongo IPO

Yesterday, The Wall Street Journal reported that Livongo is preparing for an IPO in 2019. According to the story, Livongo has already approached Morgan Stanley, Goldman Sachs, and JP Morgan to underwrite the IPO with a company valuation >$1B. Recall, in March 2017, Livongo raised $52.2M in a growth round, and in April 2018, it raised an additional $105M with a total of $240M in private financing (previous FENIX insight). Below, FENIX provides additional thoughts on the Livongo IPO.

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.

Tandem Control-IQ Pivotal Trial Problem

Tandem Diabetes Care announced that it is using the Tandem Device Updater to “resolve a Control-IQ technology software anomaly identified during the ongoing DCLP3 phase of the International Diabetes Closed Loop (IDCL) clinical trial.” According to the press release, Tandem is in discussion with the IDCL study investigators to evaluate any impact on the clinical or regulatory strategy. Recall, Tandem had been planning to launch Control-IQ as early as Summer 2019. Below, FENIX provides insight on the potential impact to the initial Control-IQ regulatory approval as well as thoughts on how Tandem has already started to spin the news as a positive indicator.

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.