Senseonics, the Germantown, Maryland-based company which went public in January and is working on a longterm implantable continuous glucose monitor, has submitted its PMA application to the FDA, President and CEO Tim Goodnow said on the company's third quarter earnings call last week. In addition, the company continues to work on a second generation device and its first pediatric clinical trial.
"I take great pride in the tremendous effort that the entire Senseonics team has put into pulling together what we believe to be a very strong package," Goodnow said. "This is comprised of substantial information beyond the accuracy and safety data collected during the clinical trial. The submission also includes comprehensive information on all the preclinical testing, design controls, in accordance with the Quality Systems Regulation, and manufacturing processes in accordance with current GMPs. We look forward to working with the FDA to gain approval as soon as possible."
Senseonics' Eversense offering is a pill-sized sensor that is entirely implanted in the user’s upper arm so that it can continuously monitor glucose levels. The device is meant to last at least 90 days -- and, in more recent trials, up to 180 days -- before it needs to be replaced, in contrast to the five to seven days that current not-quite-so-invasive CGMs last. Data is sent to a receiver patch and then to a mobile app.
Eversense received CE Mark clearance in May and has already launched in Sweden and Norway (the latter just last week) with distribution partner Rubin Medical and in Germany with distribution partner Roche Diabetes Care. Roche will also distribute the device in Italy and the Netherlands by the end of the year. The FDA clearance would allow Senseonics to finally begin offering Eversense in the US.
Meanwhile, a new clinical trial announced on the call is being administered with pediatric patients in Canada. If all goes well it would allow the company to extend its labelling in Europe to make Eversense available to patients aged 12 to 18.
Goodnow said the company is also working on a second generation of the device that strives to eliminate the need for calibration, among other improvements.
"This sensor will incorporate a completely redundant glucose sensing capability to further improve the accuracy, longevity, and functionality of the sensor. A key design goal for this next-generation system is to eliminate the need for fingerstick calibration," he said. "We are very excited about the progress that we are making with this advanced sensor, and we anticipate additional clinical testing in the first quarter to help demonstrate its real-world capabilities."
Because of a lot of spending on R&D, expenses related to the PMA, and rolling out the product in so many countries, Senseonics is continuing to operate at a loss -- a loss of $10.9 million this quarter. That's more than the $8.6 million loss in Q3 2015, but less than last quarter, when the company lost $11.9 million.