Senseonics (OTC:SENH) said today it won CE Mark approval in the European Union for its Eversense continuous glucose monitoring system.
The Eversense system includes an implanted glucose sensor designed to last up to 90 days, as well as a wearable smart transmitter designed to calculate glucose levels. The devices work in tandem with a mobile application that allows for the real-time display of glucose readings, the company said..
“The CE Mark approval is a significant accomplishment for Senseonics as this application required rigorous regulatory review against high clinical and safety standards. The approval enables the company to market and sell the Eversense System in European Union member countries, and we are prepared to make this important medical device available to people with diabetes,” CEO Dr. Tim Goodnow said in a prepared release.
The company touts the system as the “world’s 1st long-term wear sensor,” which it claims eliminates the weekly sensor insertion required by current CGM systems.
“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,” Dr. Goodnow said in a press release.
The device is indicated for continually measuring interstitial fluid glucose levels in adults as an adjunctive device to complement information obtained from standard home blood glucose meters.
The Germantown, Md.-based company said plans to conduct post-market surveillance, including long-term safety and performance data now that the device has been cleared in the EU.
In March, Senseonics set the terms on a public stock offering that could fetch nearly $64 million, as the implantable glucose monitor maker looks to move to the New York Stock Exchange.
The company said it plans to float 18.2 million shares at $3.10 to $3.50 apiece; SENH shares traded at $3.30 each March 4, their last day of trading (only about 100,000 shares have changed hands since the stock’s debut Dec. 22, 2015). That works out to a range of $56.4 million to $63.7 million.
