dimecres, 25 de maig del 2016

Senseonics inks exclusive Eversense CGM EU distro deal with Roche

Senseonics, RocheSenseonics (OTC:SENH) said today it inked an exclusive distribution agreement with Roche (PINK:RHHBY) for the multi-country commercialization of the Eversense continuous glucose monitor.

Under the deal, Roche has the exclusive rights to promote, market and sell the Eversense product portfolio to diabetes clinics and patients in Germany, Italy and the Netherlands, Senseonics said.

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.

“We are pleased to have Roche as our partner, and our distribution agreement represents an important step to enable expanded market access to our product. 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. 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,” Senseonics CEO Tim Goodnow said in a prepared release.

Product development rights, regulatory approval, quality managmeent and manufacturing will be retained by Germantown, Md.-based Senseonics, while Roche will be responsible for sales, marketing, customer support and distribution in the 3 countries.

Senseonics said the agreement could be expanded in the future to include additional products and territories.

Earlier this month, Senseonics said it won CE Mark approval in the European Union for its Eversense CGM.

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. 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 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.

The post Senseonics inks exclusive Eversense CGM EU distro deal with Roche appeared first on MassDevice.



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