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ApniCure Joins Race to Replace CPAP


Posted by Jamie Hartford on September 14, 2012

Obstructive sleep apnea (OSA) is a common disorder with an established and effective treatment option. The only problem is that a significant number of patients recommended for the therapy don’t use it. ApniCure (Redwood City, CA), is one of a number of startups hoping to steal some of the OSA market share with by providing a more patient-friendly alternative to the standard of care.

Patients with OSA experience a narrowing or blockage of their upper airway, which disturbs their breathing and causes them to snore or wake up. Continuous positive airway pressure (CPAP) machines have been proven to alleviate OSA by providing a steady flow of air to keep the airway open, but patients complain that the devices, which require a mask to be worn over the nose and mouth during sleep, are noisy and uncomfortable. Studies show that long-term compliance rates for CPAP therapy are as low as 50%.

ApniCure founder and chief technology officer Matt Vaska learned about the problems associated with CPAP machines after his father was diagnosed with OSA several years ago. As a mechanical engineer and veteran of the medical device industry, he saw an opportunity in the 20 million people who suffer from sleep apnea. “I realized there’s just a major need for something better,” he says.

Highlights

June 2004: St. Jude Medical acquires Vaska-cofounded Epicor.
December 2007: ApniCure founded.
March 2012: Winx receives 510(k) clearance.
September 2012: Company presents positive results from ATLAST trial of Winx.

Vaska, who previously worked in R&D for Stryker Endoscopy and Heartport, had the idea to treat OSA using negative pressure applied in the mouth, as opposed to forced air. He started tinkering in his garage and came up with a prototype. When CT scans showed it was successful in opening the airway, he filed the necessary patents and founded ApniCure in 2007 to develop and market the technology. The company is Vaska’s second medical device startup; he previously cofounded Epicor, a developer of minimally invasive treatments for atrial fibrillation that St. Jude Medical bought in 2004.

ApniCure received 510(k) clearance to market the Attune Sleep Apnea System for home use in treatment of OSA in adults in March 2012. The device, the name of which has since been changed to the Winx Sleep Therapy System (The name "Attune" just “didn’t click,” Vaska says). It consists of an electronic console and a soft polymer mouthpiece, which are connected by a flexible polymer tube. Patients use the mouthpiece during sleep to deliver gentle negative pressure that keeps their tongue and soft palate from blocking the airway.

While CPAP masks cover the nose and mouth, the Winx mouthpiece fits inside the user’s mouth. Winx is also quieter and significantly smaller than a CPAP machine. “You could probably fit five of these things inside of a CPAP bag,” Vaska says.
Study results show that the Winx works as well as CPAP to alleviate symptoms of OSA, and perhaps more importantly, patient compliance was high. Participants used the Winx for more than four hours per night nearly 90% of the time, and more than three-quarters indicated that they would use the system to treat their OSA.

But Winx faces competition from other devices positioned as alternatives to CPAP. Provent Sleep Apnea Therapy, from Ventus Medical, a device that uses single-use valves secured inside users’ nostrils by adhesive to treat OSA, received 510(k) clearance in 2008. Several firms are also working on neurostimulation devices to treat OSA. One,ImThera Medical, of San Diego, received CE Mark approval in Europe this past March.

Focus Going Forward

  • Soft launch of Winx by end of 2012.
  • Broader rollout of Winx in 2013.
  • Obtain Medicare reimbursement for Winx.
  • 510(k) approval for OPT product for treatment of OSA due to tongue collapse.

ApniCure hopes to complete a soft launch of Winx in the United States by the end of the year and has a broader distribution plan for 2013. The product isn’t currently eligible for Medicare reimbursement, but Vaska says the company is working toward that goal. Some private insurance companies already provide coverage for Winx, and ApniCure is working to get more on board. Winx is priced competitively with high-end CPAP machines, Vaska says, adding that the price could go down as volumes increase.

Instead of working through durable medical equipment suppliers, ApniCure plans to sell Winx directly. The company will also provide accompanying services, such as maintenance and customization, which Vaska says could bring in 2 to 3 times the revenue of the machines themselves.

ApniCure’s investors include Kleiner Perkins Caulfied & Byers, Headwaters Capital Partners, U.S. Venture Partners, and Capricorn Investment Group. The company has already completed three rounds of financing, the last of which took place in 2010. “We raised a substantial amount so that we don’t anticipate the need to raise any more money before becoming profitable,” Vaska says, though he doesn’t rule out the possibility of another round to accelerate growth.

Besides Winx, the company's proprietary oral pressure therapy technology also lends itself to other products, Vaska says. Winx is targeted at patients whose OSA is caused by soft palate collapse, but the company is working on another version to treat OSA caused by tongue-based collapse. “We’ve got a great product right now, but in the future we have a huge opportunity to build on the platform,” Vaska says.

Leadership

Steve Carlson, president and CEO
Matt Vaska, chairman of the board, chief technology officer, founder
Lawrence Siegel, chief medical officer
Chris Daniel, executive vice president of operations, founder

 

Contact

ApniCure
Redwood City, CA | 650/361-9300
www.apnicure.com

Jamie Hartford is the associate editor of MD+DI. Follow her on Twitter @readMED.


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