|Eversense sensor--Courtesy of Senseonics|
Roche's Diabetes Care has signed a deal with implantable glucose sensor company Senseonics to sell its Eversense Continuous Glucose Monitoring System in Germany, Italy and the Netherlands. The deal comes just after a CE mark for the system earlier this month.
Senseonics ($SENS) reverse-merged late last year to become a public company and then raised $45 million. It plans to submit for FDA approval of its tiny glucose monitor implant, which feeds data to a smartphone app via small transmitter patch, during the next half of this year. It's said previously that it expects a review time of 6 to 18 months. Data for its U.S. pivotal trial is due in June.
Securing reimbursement, which happens on a country-by-country basis in the EU, likely would have been a challenge for the startup--but the massive Roche Diabetes Care ($RHHBY) seems much more better-equipped to handle that process.
Under the deal, Roche has the exclusive right to sell Eversense to diabetes clinics and patients in those specific European countries. The startup noted that the distribution agreement could be expanded upon in the future with additional products and territories. Senseonics already has a distribution partner in Sweden, Rubin Medical.
"Roche Diabetes Care is a trusted and highly respected market leader with a broad customer base and deep knowledge of the needs of people with diabetes, and is ideally suited to market and commercialize the Eversense CGM System," said Senseonics President and CEO Tim Goodnow in a statement. "Together with Roche's market presence, and extensive sales and support network, we aim to deliver a truly innovative continuous, long-term glucose monitoring solution to millions of people with diabetes."
The rice-sized Eversense sensor is implanted subcutaneously into the upper arm and lasts for 90 days. It uses a fluorescent glucose-indicating polymer that is encapsulated in a biocompatible material. The polymer signals changes in glucose concentration via a change in light output. That measurement is then relayed to an adhesive transmitter patch that's worn on the skin over the embedded sensor. Like most other continuous glucose monitors, it requires twice-daily finger sticks for calibration--although the company hopes to demonstrate sufficient accuracy eventually to avoid that on its labeling.
The transmitter then sends alarms and alerts to a mobile device when the patient reaches preset low or high glucose levels. The transmitter itself can also provide vibration alerts for these data, if a mobile device isn't at hand. This entire process is conducted automatically with no user activity required.
Senseonics shares were up almost 10% in early trading on the news, giving the Germantown, MD-based company a market cap of more than $325 million. If it's successful and expanded upon, the deal could prove a shot in the arm, so to speak, for Roche's ailing diabetes business.
- here is the release