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FDA submission for 365-day CGM from Senseonics is ‘imminent’

February 29, 2024 By Sean Whooley

Marketing image Senseonics Eversense E3 Ascensia Diabetes Care
The Eversense E3 implantable CGM system. [Image from Ascensia/Senseonics]
Senseonics (NYSE:SENS) shares dipped after hours on fourth-quarter results that came in ahead of the consensus forecast.

The company also reported an “imminent” submission of its latest, longest-lasting continuous glucose monitoring (CGM) technology.

Shares of SENS fell 3.5% to 69¢ apiece after the market closed today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — closed the day down 0.6%.

The Germantown, Maryland-based long-term CGM maker posted losses of $17.2 million. That equals 3¢ per share on sales of $8 million for the three months ended Dec. 31, 2023.

Senseonics recorded a 48.3% bottom-line slide further into the red on 44% sales growth year-over-year. Losses per share topped Wall Street estimates by 1¢ while sales came in half a million dollars ahead of projections.

“2023 was a successful year across the business for Senseonics. We completed the ENHANCE clinical trial and data analysis to support the imminent FDA submission for our 365-day system, secured expanded Eversense coverage from UnitedHealthcare and Medicare, and strengthened our balance sheet to provide additional financial flexibility to continue executing our business plan,” said Tim Goodnow, president and CEO. “We are excited about Ascensia’s appointment of Brian Hansen, an industry veteran in the diabetes space with a successful track record of commercializing advanced technologies, who we believe can lead the acceleration of adoption of Eversense.

Goodnow added: “We believe the robust Eversense product innovation cycle, including expected approvals of the iCGM designation for the 180-day product and the 365-day product and the anticipated commercial launch of the 365-day product in Q4, will offer substantial additional benefits to diabetes patients and positions Senseonics for its next phase of growth.”

Senseonics expects global net revenue in the first half of 2024 to reach nearly $10 million. That marks growth of approximately 16% compared to the first half of 2023.

Filed Under: Business/Financial News, Diabetes, Featured, Food & Drug Administration (FDA), Implants, MassDevice Earnings Roundup, Patient Monitoring, Technology, Wall Street Beat Tagged With: Senseonics

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About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at swhooley@wtwhmedia.com.

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