Inspire Medical Systems (NYSE:INSP) announced today that the FDA approved an expanded indication for its sleep apnea therapy.
Minneapolis-based Inspire develops minimally invasive solutions for patients with obstructive sleep apnea (OSA). The proprietary Inspire therapy is the first and only FDA-approved neurostimulation technology that treats moderate to severe OSA. It offers an alternative to traditional positive airway pressure (PAP) therapy in the sleep respiratory market.
The expanded indication includes an increase on the upper limit of the Apnea Hypopnea Index (AHI). It raises the number of events per hour from 65 to 100. FDA also approved an increase in the Body Mass Index (BMI) warning in the labeling, changing from 40 to 32.
“We are excited that the FDA has approved Inspire’s application to expand our indication to include patients with AHI up to 100 events per hour. These patients experience severe OSA and have historically had limited treatment options available,” said Tim Herbert, Inspire president and CEO. “Data from our ADHERE registry demonstrated that Inspire is a safe and effective treatment for this patient population and we are grateful to our surgeon and sleep physician partners who participated in this registry.
“Furthermore, we are very pleased that the FDA raised the BMI warning in the labeling to 40 from 32.”
Inspire’s sleep apnea treatment market share continues to grow amid changes in the environment. Since a severe recall knocked traditional PAP maker Philips out of the market for a while, alternatives like Inspire therapy continue to draw interest.
Just this past quarter, Inspire posted better than 83% revenue growth and increased its full-year guidance. It now expects between $580 million to $590 million in sales, representing 42% to 45% year-over-year growth.