|Data transmitter--Courtesy of Senseonics|
After a reverse merger in December the blood glucose monitor implant company Senseonics ($SENH) is already publicly traded, albeit on the OTC markets. Now, it's filed to raise up to $51.8 million in an IPO-like offering, after which it proposes to bump up to the NYSE market and trade under the ticker symbol "SENS."
Senseonics' filing is more of a whisper than a shout--unlikely to gain too much attention with its rather meek voice. Founded in 1996, the continuous glucose monitor player had already blown through more than $150 million as of Sept. 30. Alongside the difficult market atmosphere, that could make it tough to get a financing done and secure a decent valuation.
Senseonics is still pre-regulatory approval, a difficult state for a med tech public market company. In July, the startup applied for a CE mark for its Eversense continuous glucose monitoring (CGM) system. It expects to receive that and begin marketing Eversense in select European markets during the first half of this year.
The company just started a pivotal U.S. trial for Eversense this quarter. It expects to submit a PMA application to FDA as early as the second half of 2016; it anticipates an FDA approval could come within 6 to 18 months.
|The Senseonics sensor--Courtesy of Senseonics|
If it receives a CE mark, the Eversense CGM would be the first approved glucose monitor implant. It is expected to be usable for a 90-day period. In addition to the implant, the Senseonics system also includes a data transmitter and a mobile app. The implanted sensor measures only about 3 mm by 16 mm and is inserted into the upper arm or abdomen.
Like other diabetes CGM players, Senseonics is working on the holy grail--the elimination of finger sticks. Daily or twice-daily calibration via that traditional blood glucose measurement is typically called for in most CGM regulatory labels. In Europe, both Abbott ($ABT) and Dexcom ($DXCM) have laid claim to obviating that daily calibration.
Post reverse merger, venture firm NEA is the largest investor in Senseonics with a 33% stake. Other stakeholders include Delphi Ventures (13.4% pre-offering stake), Roche Finance (10.5%), Energy Capital (9.9%), HealthCare Ventures (7.4%) and Kato Consulting (5.3%).
- here is the SEC filing