Senseonics nabs CE Mark for implantable glucose monitor, as it readies for FDA next half

Eversense app--Courtesy of Senseonics

Senseonics ($SENS) has been nothing if not creative. It's got a novel approach to blood glucose monitoring with its subcutaneous implant system. And it took a somewhat unique approach to fundraising--listing on the public markets via a reverse merger last year followed by a $45 million fundraising this spring.

Now, its gumption may start to pay off a bit. It's received a CE mark approval for its Eversense Continuous Glucose Monitoring (CGM) System for use in diabetics. The small cap company hasn't laid out a commercialization timeline yet--but it did divulge that it would start its European commercial efforts in Sweden.

Senseonics is also gearing up for an FDA submission, which it has previously said will come next half with an anticipated 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, will be its next challenge in Europe. The company is likely to offer more details when it reports first-quarter earnings on May 12.

"The CE Mark approval is a significant accomplishment for Senseonics as this application required rigorous regulatory review against high clinical and safety standards," said Senseonics President and CEO Dr. Tim Goodnow in a statement. "The approval enables the company to market and sell the Eversense System in European Union (EU) member countries, and we are prepared to make this important medical device available to people with diabetes."

Eversense transmitter--Courtesy of Senseonics

The 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.

Eversense sensor--Courtesy of Senseonics

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.

"We look forward to introducing the Eversense CGM System in Europe beginning with commercialization efforts in Sweden in partnership with our exclusive distributor, Rubin Medical," concluded Goodnow.

- here is the release