Senseonics, a Germantown, Maryland-based company working on a longterm implantable continuous glucose monitor, has filed to go public with an IPO that, for now at least, is valued at $51.75 million.
Senseonics singular offering is a pill-sized sensor that is entirely implanted in the user’s upper arm so that it can continuously monitor their glucose levels. The device is meant to last at least 90 days before it needs to be replaced — in contrast to the five to seven days that current not-quite-so-invasive CGMs last.
Senseonics’ Eversense sensor is not yet FDA or CE-cleared (though the CE Mark is anticipated in the first half of 2016) and therefore the company is not currently profitable, as it has no product in the market.
The sensor sends data to a transmitter that a users wears on their upper arm. When on the user’s upper arm, the transmitter can take readings from the implanted sensor and send them to a companion smartphone app. The transmitter can also connect to the user’s computer via USB to upload glucose history.
The company has raised at least $94 million to date, including a $10 million round in August last year and a $20 million round in June 2014. They also have $20 million in debt funding from Oxford and Energy Capital, according to their S-1.
“We have never been profitable and our net losses were $18.8 million and $18.9 million for the years ended December 31, 2013 and 2014, respectively and $21.5 million for the nine months ended September 30, 2015,” the company writes. “As of September 30, 2015, our accumulated deficit totaled $152.4 million, primarily as a result of expenses incurred in connection with our research and development programs and from general and administrative expenses associated with our operations. We expect to continue to incur significant expenses and increasing operating and net losses for the foreseeable future.”
Senseonics was founded in 1996 but began focusing in earnest on the CGM in 2010. Last year, the company was acquired by ASN Technologies, which sold off its other business interests and renamed itself Senseonics Holdings.
The IPO prospectus includes a number of insights about the company, including the details of the European clinical trial the company is using to support its CE Mark bid and its plans to launch a similar trial in the US this quarter.
The Eurpoean trial included 44 subjects who wore the sensor for 90 days. The trial found Eversense to be as accurate as existing CGM sensors, it produced an average reduction in A1c levels of 0.5 percent, and 39 of the 44 sensors made it to day 90 without failing.
The company also talks about how its mobile app creates a consumer experience that improves upon existing CGMs.
“The ability of Eversense to display glucose readings on mobile devices will allow people with diabetes to seamlessly blend the monitoring of their glucose levels with other uses of their mobile devices,” they write. “People with diabetes will not need to carry a separate handheld receiver to display glucose readings, which is required by currently available CGM systems. In addition, our easily removable smart transmitter will allow people with diabetes to conveniently remove and reapply the transmitter at will without having to also remove the sensor. We believe these convenient features will greatly improve the quality of life and peace of mind for people with diabetes by enhancing their ability to effectively manage their condition across a wide range of activities, from sleeping to higher intensity activities, including sports.”
Senseonics has 350 issued and pending patents. This includes 37 issued United States patents, 202 patents issued in countries outside the United States and 111 pending patent applications worldwide.
Finally, the S-1 includes the company’s roadmap for future product development. Over the next three years, the company hopes to double the sensor life to 180 days, reduce the size of the transmitter, develop a version of the device approved for pediatric use, integrate with insulin pumps, introduce on-demand monitoring, and eliminate the need for fingerstick calibration.