Germantown’s Senseonics Holdings Inc. (NYSE: SENS) is seeking regulatory approval for its 180-day implantable continuous glucose-monitoring system for diabetes patients more than six months after suspending U.S. commercial sales and initiating a strategic review of the business.
The med-tech company, which currently has a 90-day CGM called Eversense on the market, filed an application to the Food and Drug Administration to extend the medical device’s wearable life from 90 to 180 days, it said Monday. That Sept. 30 filing came after a successful clinical trial for the longer-lasting Eversense product, which is already available to patients in Europe, though that version lacks new improvements to its calibration.
The company expects a decision from the FDA in the first half of 2021.
Senseonics did not immediately return a request for comment. We will update this post as we hear back. Its stock was trading at 41 cents per share around 2:30 Tuesday, up 0.64% from Monday’s close.
Agreement with partner Ascensia
A green light from the FDA would also give the go-ahead to Ascensia Diabetes Care, Senseonics’ new partner in getting the device to market, to initiate sales of the 180-day device in the U.S.
In an agreement that President and CEO Tim Goodnow described in a statement as "the next phase of growth for the company," Senseonics inked a strategic partnership in August with Basel, Switzerland-based Ascensia, a global manufacturer with a portfolio of self-monitoring blood glucose devices. The agreement gives the larger company five years of exclusive distribution rights of Senseonics's Eversense CGM systems, during which it will handle sales, marketing, patient and provider onboarding, and customer support. Meanwhile, Senseonics will focus on product development and manufacturing.
That deal also gave Senseonics up to $80 million in financing, including up to $50 million from Ascensia’s parent, Tokyo-based PHC Holdings Corp., and up to $30 million from Masters Special Situations LLC — key after Senseonics suspended its U.S. operations in March to contend with the financial effects of the pandemic. The new capital is funding regulatory efforts, future product development and support for U.S. patients using Senseonics’ devices, the companies said in August.
The local company said it plans to restart U.S. sales and marketing activities in the fourth quarter of 2020 — this time, with Ascensia. And there are separate plans to initiate clinical trials for Eversense in pediatric patients, slated to kick off in the first half of 2021.
“Moving forward, we are in a stronger position to help patients with diabetes,” Goodnow said in an August statement. “Our collaboration with Ascensia represents a mutual commitment to penetrating the CGM market.”
Senseonics's cost-cutting proves beneficial in Q2
Senseonics took in a modest $261,000 in total net revenue during the second quarter of this year, a far cry from the $4.6 million it reported in the second quarter of 2019. That’s because of the company’s postponement of U.S. commercial operations and the result of patients putting off care during the pandemic. But it also underwent cost-cutting measures that helped; the business shaved down sales and marketing expenses in the second quarter by $11.0 million year-over-year to $3.1 million, and reduced research and development costs by $6.7 million down to a total of $3.8 million.
Overall, the company got its second-quarter net loss down by $23.6 million — to $7.5 million — relative to the second quarter of 2019.
The company also received a $5.8 million loan from the Small Business Administration’s Paycheck Protection Program.
As of June 30, the company had $21.6 million in cash, cash equivalents and restricted cash, as well as outstanding debt totaling $106.4 million. But with the latest financing agreements, it expects to fund operations through 2021, it said. Senseonics is set to report third-quarter earnings in November.
