Eversense, the first-ever implantable continuous glucose monitor (CGM), is making a comeback — after its manufacturer, Senseonics, nearly went belly-up due to the COVID-19 crisis — thanks to a massive cash infusion from pharma giant Ascensia Diabetes Care.
Senseonics was forced to halt sales of this unique diabetes tool in late March, going into “hibernation mode” as it awaited investment or an appropriate partnership, according to Chief Medical Officer Dr. Francine Kaufman.
That saving grace has now arrived in the form of a commercialization and collaboration agreement with Ascensia, the Switzerland-based fingerstick glucose meter manufacturer formerly known as Bayer. The agreement grants Ascensia exclusive global distribution rights for current and future Eversense CGM products for at least the next 5 years.
The current Eversense sensor is approved for only 3 months’ use, which many believe is too short a period for something that requires a surgical skin incision. But Maryland-based Senseonics is expected to file its highly anticipated 6-months’ wear version with the Food and Drug Administration (FDA) “very soon,” so Ascensia is well poised to compete in the CGM market.
The need for a small surgical procedure every 90 days to insert the Eversense sensors under the skin was already a hard sell for some patients. But when the global pandemic caused providers to cancel most in-person appointments, Eversense was struck hard. Just as the company was starting to gain some traction — and just as they had closed the deal for Medicare coverage — their investors basically pulled the plug, according to Kaufman.
But this Ascensia agreement now provides the company with a lifesaving financial bolus of $35 million now and then another $15 million once the 180-day Eversense XL product gets FDA approval.
Along with the currently approved 90-day sensor and coming-soon Eversense XL, Ascensia will eventually also help sell the future 365-day implantable sensor under development.
This exclusive global distribution agreement is expected to last through 2025. Starting in late 2020, we’ll begin seeing Ascensia’s name attached to certain marketing and sales activities for Eversense CGM products, we’re told. In Europe, Ascensia will start commercializing the Eversense products once the existing distribution partnerships conclude.
At this time, the Senseonics and Eversense brand names will remain. Ascensia says they are “working with Senseonics to investigate ways that we can include the Ascensia name, but we cannot confirm how at this stage.”
Ascensia will take over customer support calls once it assumes distribution rights in each market — the U.S. in Q4 2020; Germany, Italy, Switzerland in Q1 2021; and Sweden in Q4 2021. For troubleshooting, they will “draw on input from Senseonics, where needed.”
As of August 2020, many healthcare providers who were unable to conduct insertion procedures are back on track. So Senseonics has, for the most part, addressed the backlog, Kaufman says. The company has contacted and been contacted by many of its users. But if anyone is still having issues, they are encouraged to contact Senseonics directly.
While this current deal isn’t a merger or acquisition, it certainly seems like a direction in which Ascensia is looking.
“This partnership is the next step in building a world-class diabetes care franchise for Ascensia, as we look to expand our business beyond (fingerstick) blood glucose monitoring,” says Robert Schumm, Ascensia Diabetes Care president and diabetes management director. “It will enable us to establish a presence in the CGM market, especially in the U.S. and Europe, and will further strengthen our existing portfolio of products.”
“We believe that the combination of our commercial expertise and infrastructure, alongside Senseonics’ product development and clinical expertise, will help to get the Eversense and Eversense XL products into the hands of people with diabetes who can benefit from them. Our aim is to work together to bring these highly effective technologies to more people with diabetes, therefore providing further choice in CGM for diabetes management,” Schumm adds.
Even if a future acquisition isn’t in the works, this is still a huge boon for Senseonics, which has struggled since first getting FDA approval for its implantable sensor in 2018. The launch of its remote monitoring app in May 2020 made the system more complete.