NEA's Senseonics aims to submit to FDA for diabetic monitor implant next half, as it raises $45M
|Eversense app--Courtesy of Senseonics|
It has been a long, hard road for glucose monitor implant startup Senseonics ($SENH) and its investors. Founded more than 20 years ago, the company is now hoping that it can get regulators to sign off on its continuous glucose monitor Eversense that's based on a tiny implant to track diabetics for up to 90 days. That's much longer than the typical 5- to 7-day span that's available for popular patch-based CGMs.
Last July, Senseonics submitted for a CE mark and expects to start marketing Eversense in Europe during this half. In addition, it expects to submit a PMA application for the device next half--with an anticipated review process of anywhere from 6 to 18 months.
Senseonics has now raised $45 million by selling 15.8 million shares at $2.85 each on the public markets to pursue these ambitions after reverse merging in December. It could raise an additional almost $8 million if underwriters exercise their option. Underwriters on the deal are Leerink Partners, Canaccord Genuity, Raymond James and BTIG.
The company's shares reacted positively to the financing, swinging up in early trading on March 18 by 6% to $3.45. This bumps the total raised by Senseonics to in excess of $205 million. That's a tough total for investors, unless the CGM manages to get past regulators and become a hit.
Ahead of the recent financing major device VC firm New Enterprise Associates held one-third of Senseonics with the remainder held by Delphi Ventures (13.4%), Roche Finance (10.5%), Energy Capital (9.9%), Healthcare Ventures (7.4%), SBLE (6.6%) and Kato Consulting (5.3%).
|Eversense transmitter--Courtesy of Senseonics|
The Eversense sensor is implanted subcutaneously into the upper arm. It uses a fluorescent, glucose indicating polymer that is encapsulated in a biocompatible material. The polymer signals changes in glucose concentration via a change in light output. That measurement is then relayed to an adhesive transmitter patch that's worn on the skin over the embedded sensor.
The transmitter then sends alarms and alerts to a mobile device when the patient reaches preset low or high glucose levels. The transmitter itself can also provide vibration alerts for these data, if a mobile device isn't at hand. This entire process is conducted automatically with no user activity required.
Unlike existing CGMs, which target Type 1 diabetics, Senseonics may also be aiming for the Type 2 population. The company also hopes that its regulatory approvals will not require twice-daily fingersticks for calibration as do most current CGMs.
|Eversense sensor--Courtesy of Senseonics|
An exception to that fingerstick rule is the FreeStyle Libre Flash Glucose Monitoring System from Abbott ($ABT) that won a CE mark in late 2014 with a patch-based sensor that is worn for up to 14 days and doesn't need fingerstick calibration. That CE mark was recently extended to use by children, a particular focus for CGM makers given their limited ability to self-monitor consistently. Abbott hasn't disclosed a timeline for a potential FDA submission.
- here is the announcement of the financing pricing
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