Inspire Medical Systems
(NYSE: INSP)
announced today that it received FDA approval for its Inspire V therapy system.
Inspire V includes a next-generation neurostimulator and associated Bluetooth patient remote and physician programmer. It marks the latest innovation for the Minneapolis-based obstructive sleep apnea (OSA) treatment developer.
The pacemaker-like device delivers mild electrical stimulation to the hypoglossal nerve, which controls tongue muscles.
“We are thrilled to announce the FDA approval of our next generation Inspire neurostimulation system,” said Tim Herbert, chair and CEO of Inspire Medical Systems. “The FDA approval marks a key milestone for the future of Inspire therapy and reinforces the many years of hard work by our team members.”
Inspire Medical said in a news release that its focus remains centered on operational readiness following this approval. That includes product manufacturing and establishing inventory to support a full commercial launch in the U.S. Inspire Medical targets a soft launch for Inspire V in late 2024, followed by a full launch in 2025.
Inspire Medical’s sleep apnea treatment market share continues to grow since a severe recall knocked traditional PAP maker Philips out of the market for a while. Just last week, the company reported 30% year-over-year revenue growth in the second quarter of 2024 and increased its full-year sales guidance.
Last month, the company also won CE mark for its Inspire therapy under the new EU MDR regulations as well.
