Inspire Medical Systems Inc, a medical technology company focused on the development of solutions for patients with obstructive sleep apnea, reported second-quarter business results, marked by a series of US Food and Drug Administration (FDA) regulatory approvals and submissions.
During the quarter, Inspire received FDA approval for apnea-hypopnea index indication expansion and increased body mass index labeling. The update increased the upper limit of the apnea-hypopnea index to 100 events per hour from 65 and raised the body mass index warning in the labeling to 40 from 32.
Inspire also received FDA approval for the SleepSync physician programmer and submitted the Inspire V neurostimulator premarket approval (PMA) supplement application to the FDA.
“We achieved several important milestones in the second quarter,” says Tim Herbert, president and CEO of Inspire, in a release. “Most importantly, we submitted our Inspire V neurostimulation PMA supplement application to the FDA for review. In addition, we received two key FDA approvals, including an expanded indication…and approval for our SleepSync physician programmer.”
Further, Inspire added 72 new implanting centers in the US, bringing the total to 1,045 US medical centers providing Inspire therapy. Inspire is maintaining its guidance relating to the opening of new US medical centers of 52 to 56 per quarter for the remainder of 2023.
During Q2, Inspire also strengthen its leadership team with the additions of Carlton Weatherby as chief strategy officer and Charisse Sparks, MD, as chief medical officer.
“We are excited about the expertise and skills these individuals bring to our executive leadership team and are confident their contributions will position us for sustained organic growth over the long term, fulfilling our mission of serving the many patients with untreated OSA,” says Herbert in a release.