Senseonics, a Germantown, Maryland-based company working on a longterm implantable continuous glucose monitor, announced preliminary results from its US pivotal trial, a major step toward receiving premarket approval from the FDA, on the same day as the company's second quarter earnings call.
"We are at a significant point of change for not only acceptance and utilization but the recognition by the regulators of the value of CGM," Senseonics CEO Tim Goodnow said on the call. "Now that we have very high confidence that we have a very accurate CGM, it is our expectation we will be working aggressively with the FDA on understanding what is the best way for us to put our product out as quickly as we can for people in the US."
Senseonics' Eversense 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 -- 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 and then to a mobile app.
Eversense received CE Mark clearance in May and has already launched in Sweden with distribution partner Rubin Medical. Senseonics has partnered with Roche Diabetes Care to distribute Eversense in Germany in September and in Italy and the Netherlands by the end of the year.
The US trial of 90 patients showed a high level of accuracy, with a mean absolute relative difference (MARD) of 8.8 percent across the 40-400 mg/dL range when compared to YSI blood reference values.
On the Q2 call, Goodnow talked about the recent FDA panel that greenlighted would-be competitor Dexcom's request for a new dosing claim allowing Dexcom's CGM to replace fingerstick glucometers. He said that Senseonics will follow Dexcom's lead and attempt to get that same dosing claim for their own product from the get-go.
"With the completion of our pivotal trial, it’s our objective to show in our PMA submission that our Eversense platform is safe and effective," he said. "We will naturally be working with the FDA during the submission process to provide all the information required to work towards a premarke approval. We also intend to work collaboratively during the PMA process to determine the right approach to pursue a dosing claim for the Eversense CGM system as quickly as possible."
As is to be expected with a company that has for the most part not launched its products, Senseonics lost money this quarter. The company's net loss was $11.9 million, or $0.13 per share, in the second quarter of 2016, compared to $7.2 million, or $3.68 per share, in the second quarter of 2015.
Though FDA clearance is currently the company's top priority -- they intend to file in the next few months -- they are working on some other things as well, including a new version of the Eversense receiver that's "55 percent smaller and more ergonomically attractive" than the current hardware. Goodnow also announced the company's first pediatric trial, in Toronto, which starts the process of proving Eversense safe and effective for children as well as adults.
