Senseonics yesterday registered for an initial public offering worth up to $51.8 million as it gears up to get its Eversense implantable continuous glucose monitor on the market.
Germantown, Md.-based Senseonics said the Eversense system is designed to continuously monitor a patient’s glucose levels for up to 90 days. It uses a subcutaneous sensor and an external, removable smart transmitter linked to a mobile app designed to deliver real-time glucose levels, alerts and other data.
Senseonics, formed last month via a merger with ASN Technologies, said it applied for CE Mark approval in the European Union last July for Eversense and expects it to hit the market there during the 1st half of this year. A 90-patient U.S. pivotal trial is under way and the company said it could file for pre-market approval from the FDA as soon as the 2nd half of 2016, with a PMA nod expected 6 to 18 months later.
A post-market study in Europe is aimed at winning approval for a 180-day indication both there; Senseonics said it also plans to use that data to back its PMA bid.
Senseonics posted losses of -$21.5 million for the 9 months ended Sept. 30, 2015, a 34.7% increase over the same period in 2014. The company, which is backed by New Enterprise Associates, Delphi Ventures and the finance arm of Roche (PINK:RHHBY), raised $10 million last summer.