|The GlySens long-term ICGM system consists of an implantable sensor (left) and an external receiver--Courtesy of GlySens|
San Diego, CA-based startup GlySens expects that its implanted continuous glucose monitor could offer convenient long-term monitoring for diabetes patients. It's been able to use its sensor implant for up to 18 months in the preclinical setting.
Just a year after getting a $12 million Series C infusion, now it's grabbed a $20 million Series D round from undisclosed new investors to back a 12-month trial of its CGM implant, which it is aiming to connect wirelessly to a smartphone app.
"The clinical performance of our fully implanted ICGM system … was instrumental in our ability to secure incremental funding on terms highly supportive of the company's long term vision and viability," said GlySens President and CEO William Markle in a statement.
"Our current clinical trial being conducted in San Diego, under an FDA-approved IDE, is continuing to emphatically demonstrate the viability of the GlySens Eclipse ICGM system to continuously monitor interstitial glucose in subjects with diabetes for a minimum of 12 months, with essentially zero impact to body image, and with the intended requirement of finger stick calibration only once or twice per month, he added.
CGM sensors typically are placed on the skin; they also usually require daily calibration via traditional finger stick blood glucose device. Although GlySens is hardly alone in aiming for a CGM implant. Recently, another CGM implant startup, Senseonics, reverse-merged to become publicly listed. Like GlySens, it's also expecting a CE mark for its system soon to enable it to market in Europe.
The GlySens ICGM System requires the implant to be placed in the patient's abdomen. It also currently requires a dedicated controller, although the company aims to have the data go directly to a smartphone in the longer term. The system is currently in an ongoing, 20-patient IDE clinical trial that's slated to have final data in July.
Investors in GlySens have largely remained undisclosed, although Windham Venture Partners has a board seat at the startup.
"The proceeds from this Series D investment, in combination with the significant remaining balance from our prior Series C round, places us in an enviable position to further expand our clinical trials to support a CE-Marking application, hire additional staff, and complete the build-out of a new modern facility and optimized manufacturing plant," said GlySens co-founder and CTO Joseph Lucisano.
He continued, "We are making rapid progress on both the optimization of the sensor itself and on its attendant signal processing algorithms, and are pleased also to be nearing completion of our first commercial-version receiver. Plans are additionally in process for pushing our sensor data directly to a smartphone."
- here is the announcement