The clarity came during the company’s 2nd quarter earnings call last week, with CEO Tim Goodnow saying the company expected the federal watchdog to look to an advisory panel, similar to its actions with Dexcom‘s (NSDQ:DXCM) G5 non-adjunctive approval last year.
“In the United States, our PMA application continues to be evaluated by the FDA and we are in active discussions with the agency and are responding to inquiries in earnest. As we have said previously, Eversense is a novel product and is the first of a kind as a long-term implantable sensor. It is our belief that the agency will convene an advisory panel to explore the communities’ feedback on the safety elements of an implantable sensor as well as the training programs designed to introduce endocrinology, diet/pathology professionals to the in-office procedures of sensor placement. This process will allow the interested medical community to comment on an implantable product,” CEO Goodnow said, according to a SeekingAlpha transcript of the call.
The Eversense system includes an implanted glucose sensor designed to last up to 90 days, as well as a wearable smart transmitter designed to calculate glucose levels. The devices work in tandem with a mobile application that allows for the real-time display of glucose readings, the company said.
Senseonics submitted its application for premarket approval to the FDA last October, supported by data from a 90-patient pivotal trial of the device. The trial followed adults with Type 1 or Type 2 diabetes over 90 days of CGM sensor wearing.
Goodnow said the company is confident that data from both a US pivotal trial and a European pivotal trial would support the safety and efficacy of the device, and that the company was beginning advanced preparations for a US launch.
“We are confident that the strong patient data demonstrated in our U.S. pivotal trial, our European pivotal trial and our robust post-market surveillance program currently underway in Europe will support and confirm the efficacy and safety of the Eversense system. We continue to anticipate the advisory panel will likely be held in the late fall and that our final approval will closely follow this conclusion. Additionally, we have begun early preparations activities in advance of our U.S. approval and launch,” Goodnow said during the earnings call.