Senseonics is set to raise $41 million to support the anticipated commercialization of implantable continuous glucose monitoring (CGM) system Eversense. The fundraising attracted the support of major existing shareholders New Enterprise Associates (NEA) and Roche.
Germantown, Maryland-based Senseonics is raising money ahead of the approval of Eversense in the U.S. The company filed for premarket approval with the FDA in October, suggesting it can expect to get a regulatory nod or rejection within the next year. Senseonics had $13.8 million in cash at the last count, a small sum for a company preparing to fight for a piece of the big, competitive market for diabetes devices.
Senseonics’ attempt to muscle into the market is built on an implantable sensor. Once inserted by a doctor, the sensor uses fluorescence technology to measure glucose levels in the interstitial fluids. The sensor sends readings to a wearable patch that, in turn, processes the data and relays information to a smartphone app. Users are alerted when the technology forecasts glucose levels will exceed preset targets. The sensor lasts up to 90 days.
NEA and, in particular, Roche are playing key roles in equipping Senseonics to hit the ground running if it secures clearance from the FDA. Roche Finance, a wholly owned subsidiary of the Swiss Big Pharma, has agreed to buy more than 21 million Senseonics shares at $1.41 a piece. NEA is set to pick up another 7 million at the same price. That leaves 700,000 of the offered shares for the other, unnamed institutional investors involved in the round.
The financing cements Roche’s status a major investor in Senseonics. As of the close of the year, Roche owned 8 million shares, enough to give it an 8.5% stake in the company. Adding 21 million shares to its holdings will catapult Roche up the list of major shareholders. NEA topped the list at the last count, with its 28 million shares giving it close to a 30% stake.
Senseonics secured support for the financing and a series of earlier rounds on the potential of the device to make it easier for patients to monitor their glucose levels. That potential has also attracted the interest of nonfinancial teams at Roche, which has secured the rights to distribute the device in most of Europe, the Middle East and Africa while also investing in the company.
With Roche and Rubin Medical handling Europe, Senseonics is focused on preparing to sell the CGM device in the U.S. Mike Gill, formerly of Medtronic, has come on board as VP of sales in anticipation of Senseonics securing FDA clearance to sell Eversense.