Senseonics gears up for US launch as it awaits FDA green light

By Jonah Comstock
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Implantable longterm continuous glucose monitor company Senseonics is in a better place than its financials would suggest. The company posted a net loss of $9.9 million last quarter, up from an $8.4 million loss in the year prior, and is planning to borrow about $5 million from the Oxford Silicon Valley Bank that it’s already $20 million in debt to.

But Senseonic’s potentially game-changing Eversense CGM — a pill-sized, implantable sensor that can last 90 days without needing replacement — isn’t even FDA-cleared yet, and the company only recently began selling it in Europe, where they’re working with Roche as a distribution partner.

On a Q4 earnings call last month, CEO Tim Goodnow gave updates on the FDA process, a next generation device, and how the company plans to react to Dexcom’s landmark clearance news from late last year. He also shared some anecdotal feedback about the product.

“Feedback has been exceptional, with commentary specifically around the benefit of long-term use, convenience, and that [users] forget that they even have the sensor after insertion,” Goodnow said on the call. “The controlled launch has allowed us to learn more about the early adopters' usage of the system. We are delighted to hear of experiences from some of our more active users. As an example, we have a user in Germany who ran a marathon in Dubai while constantly monitoring his readings with his Eversense system. The system performed as usual despite extreme heat, humidity, and sweat.”

Goodnow says the company still expects FDA clearance by the end of the year. 

“Anticipating this, we are making initial preparations for our launch in the United States,” he said on the call. “We have begun the process to enlist a sales leadership executive, as well as select national accounts positions. We are also putting in place plans to prepare for necessary reimbursement discussions with the private payers.”

Now that the FDA has cleared one CGM (Dexcom’s G5) for non-adjunctive use, meaning it can be used for dosing without confirming readings with a fingerstick glucometer, investors and analysts on the call wanted to know if Senseonics would pursue the same kind of clearance for their device.

“Our submission did go in, actually, in late October, which was prior to the announcement from the agency on the Dexcom decision. So we have submitted as an adjunctive device,” Goodnow said. “We do feel it's best to get that approval underway, and then we will quickly shift via the supplemental process as Dexcom ultimately did for the dosing claim approval. … So it's high on our to-do list, but we do think instead of modifying the current submission that's in, and taking the chance of starting the clock over on a review, we think it's best to go ahead and push the approval forward and follow up quickly with the extended claim.”

Finally, Goodnow also announced on the call that the company has received CE Mark approval for the next generation of the Eversense transmitter, which is 50 percent smaller and lighter than the current model, is water-resistant, and has a year-long battery life. They are waiting on a CE Mark amendment to approve the implantable sensor for a 180-day life, rather than the current labeling for 90 days.