App-based glucose monitor implant startup Senseonics reverse-merges to go public in anticipation of CE mark

Data transmitter--Courtesy of Senseonics

Venture-backed Senseonics has reverse-merged with OTC-listed ASN Technologies. The deal follows a $10 million cash infusion in August that was slated to enable the startup to complete European pivotal testing, obtain a CE mark and start pivotal U.S. testing of its implantable glucose sensor that works with a mobile app.

The combined company resulting from the merger will be named Senseonics Holdings and trade under the ticker "SENS" on the OTC market following approval from financial watchdog agency Financial Industry Regulatory Authority (FINRA).

"The completion of the merger marks a significant milestone for Senseonics as we debut as a public company, backed by a group of highly regarded investors who support our pursuit to commercialize our continuous glucose monitoring system for people with diabetes," said Senseonics CEO Tim Goodnow in a statement.

Reverse mergers have been used at least a couple of times this year already to get med techs publicly listed, thereby enabling them to tap into a fresh crop of potential investors. MRI-guided radiation company ViewRay used a reverse merger ($VRAY) to go public in July after pulling its IPO plans; it remains a micro-cap company with a valuation of less than $190 million. MRI-guided prostate therapy player Profound Medical ($PRN) also went public on the Toronto Stock Exchange via a reverse merger just ahead of nabbing a partnership deal in June with imaging giant Royal Philips ($PHG).

Senseonics venture investors include Anthem Capital, Delphi Ventures, Greenspring Associates, Healthcare Ventures and New Enterprise Associates. In late October, the startup said it had submitted for a CE mark for its fully implantable, long-term continuous glucose monitoring (CGM) system. It also reported interim results of its European PRECISE trial for the device; 180-day data from this trial are expected in early 2016.

The Senseonics sensor--Courtesy of Senseonics

In the first 90 days of use, researchers found that the CGM implant was relatively accurate as compared to regular lab reference glucose values. There was a mean absolute relative difference of 11.4% in the 75-400 mg/dL range when compared to blood reference values. The mean absolute difference was in the <75 mg/dL range was 13.5 mg/dL. Of the sensor values, 84% were within 20% of the lab reference values.

"Overall our patients were very satisfied with the device and regretted that they couldn't continue using it after the trial," concluded Dr. J. Hans DeVries, who is the study lead investigator from the Academic Medical Centre at the University of Amsterdam, on the 44-person, 7-site European study.

If it receives a CE mark, the Senseonics CGM would be the first approved glucose monitor implant and 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.

Most of the financial details of the reverse merger weren't disclosed. ASN Technologies shareholders are exchanging roughly 2.1 shares of ASN for each share in the new Senseonics. The sole executive officer of ASN, Daniel Davis, is departing the company with its legacy business assets in exchange for loan forgiveness of an undisclosed amount. The boards will be combined with 7 members, led by Senseonics CEO Goodnow.

- here is the announcement