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| Inspire device--Courtesy of Inspire Medical Systems |
Inspire Medical Systems snagged approval to provide its implantable sleep apnea device at U.S. military and veterans' hospitals, a win for the company as it looks to ramp up commercialization for the product and gain coveted reimbursement.
The Minneapolis, MN-based company's Inspire device will be included in the Government Services Administration (GSA) Federal Supply Schedule (FSS), allowing patients at Veteran Administration (VA) hospitals, military treatment facilities and Indian Health Services hospitals to access the therapy, Inspire Medical said in a statement. One in 5 war veterans has been diagnosed with obstructive sleep apnea (OSA) as opposed to one in 100 individuals in the general population, signaling an increased need for devices to treat the disorder.
And Inspire's product could offer an advantage over traditional therapy, which uses more cumbersome continuous positive airway pressure (CPAP) therapy to keep the airway open. The company's remote-controlled device stimulates muscles, mimicking a patient's natural breathing process to keep the airway open over time.
"With this approval, military personnel and veterans with sleep apnea who are unable to use continuous positive airway pressure will now have access to Inspire therapy and hopefully a better night's sleep," Tim Herbert, CEO of Inspire Medical Systems, said in a statement. "We are very proud of this achievement and happy that many veterans and military personnel will be able to benefit from Inspire Therapy."
The Tampa VA will be the first VA hospital to offer the therapy, but the company expects to roll out the device at several other VA and military hospitals during the second half of 2015, Inspire said in a statement.
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| Inspire Medical CEO Tim Herbert |
New approvals bode well for the company as it charts progress for its device. Last year, Inspire trumpeted results from a study showing its sleep apnea implant alleviated symptoms for two-thirds of patients. In May, the Medtronic ($MDT) spinoff roped in $40 million in a Series E round to launch its product and scored FDA's premarket approval (PMA) for the device shortly thereafter.
Now, with cash in its coffers and promising study data in tow, Inspire hopes to score more reimbursement deals and expand the reach of its product in the coming year. The company plans to offer its device at 70 hospitals by the end of this year and more than 100 in 2016, Herbert told FierceMedicalDevices in October. And while 22 local payers in the U.S. have covered individual cases, the company most likely will not see national coverage policy determination for another year or so, Herbert said earlier this year.
"We are just barely scratching the surface, mostly working with academic centers," he said. "We hope to finish this year with over 40 implant centers."
- read the release
Special Report: FierceMedicalDevices' 2014 Fierce 15 - Inspire Medical Systems