Tag Archives: CGM

New CGM Player to Enter the Market

Allez Health announced it secured $60M in a Series A+ financing round led by Osang Healthcare Co. Ltd. and with participation from existing investors. For context, Allez (formerly called Zense-Life; view website) is an emerging biosensor venture founded by veterans in the CGM space. The company is said to be developing a CGM biosensor platform with novel sensor technology that aims to “disrupt today’s cost barrier while enhancing performance and user experience.” Stay tuned for an exclusive, in-depth FENIX interview with the Allez founders, Leif Bowman and Bob Boock. Below, FENIX provides initial insight into Allez and poses key questions about the novel sensor platform.

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Eversense CGM Receives iCGM Designation

Senseonics announced its implantable Eversense CGM has been granted iCGM designation by FDA. Following the iCGM designation, the company stated it plans to advance partnership discussions with various pump manufacturers for AID integration. Below, FENIX provides brief insight into the potential impact of receiving the iCGM designation for Senseonics/Eversense.

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Dexcom Q1 ’24 Earnings

Dexcom hosted its Q1 ’24 earnings call (press release; slides) and provided updates across its business. Unsurprisingly, much of the prepared remarks and Q&A portions of the call were dedicated to Stelo and the impending launch in Summer 2024. Below, FENIX provides highlights and insights from the call.

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Biomea and Fractyl Q4 ’23 Earnings; Glucotrack Implantable CGM Update; Costco Weight Loss Program; D&D Fast Track Designation in MASH; New Aligos Ph2a MASH Trial; Sernova Cell Pouch Updates

A series of cardiometabolic-related news items have been observed from Biomea Fusion, Fractyl Health, Glucotrack, Sesame/Costco, D&D Pharmatech, Aligos Therapeutics, and Sernova. Below, FENIX provides highlights and insights for the respective news items.

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Xeris Expanded Payor Coverage; Movano Q2 ’21 Earnings Update

Xeris announced it has reached a milestone for Gvoke payor coverage and Movano hosted its Q2 ’21 earnings update. Of note, Gvoke Medicare access has reached 91% and commercial insurance access is at 88%. Below, FENIX provides highlights and insights for the respective news items.

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Dexcom Q2 ’21 Earnings Update

Dexcom hosted its Q2 ’21 earnings call and provided updates to its clinical and commercial activities, including the G7 OUS launch anticipated later in 2021. Below, FENIX provides highlights and insights from the call.

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CGM Patent-infringement Suits: Dexcom Sues Abbott; Abbott Sues Dexcom

It has recently been observed that Dexcom filed a patent-infringement suit against Abbott for the sensors used in its Libre CGM. Subsequently, Abbott filed a suit claiming Dexcom is infringing on 12 patents. Of note, the two complaints were filed in separate courts with Dexcom filing its complaint on June 30, 2021 in US District Court for the Western District of Texas (Waco) and Abbott filing in the US District Court, District of Delaware (Wilmington) on July 1, 2021. Below, FENIX provides a summary of the filings and thoughts on the lawsuits.

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Nemaura Q4 ’20 earnings; MET409 POC Data Published in Journal of Hepatology

Two cardiometabolic-related news items have been observed: Nemaura Medical published its CY Q4 ’20 (FY Q3 ’21) earnings update and Metacrine announced the results of the MET409 proof-of-concept study were published in the Journal of Hepatology. Below, FENIX provides highlights and insights for the respective news items.

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Lifescan Redacts New CGM’s Latest Trial Record

Diabetes device company Lifescan, famous for its OneTouch portfolio of BGM products, partnered in May 2019 with Sanvita Medical to develop and commercialize a CGM system (previous FENIX insight). Below, FENIX describes how Lifescan/Sanvita redacted the details of a CT.gov record for its latest feasibility trial evaluating the Sanvita CGM system.

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Dexcom 2020 Investor Day Highlights

Dexcom hosted its 2020 Investor Day event and provided updates across its business, including its R&D roadmap, T2DM commercial focus, and international expansion. Interestingly, the event was patient and HCP-focused and comprised of three discussions with HCPs who use CGM in various capacities (including non-diabetes-related). Below, FENIX provides highlights from the event as well as insight into Dexcom’s ongoing transition to focus beyond T1DM and intensively managed T2DM patients.

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