Minnesota companies capitalize on America's sleep problems

It's not just you. A large percentage of Americans are not getting a good night's sleep, in many cases because of a sleep disorder — and a growing number of Twin Cities companies are developing new technology to treat the issues.

Take sleep apnea. It is the top issue for U.S. sleep clinics, said Dr. Ranji Varghese, medical director for the Hennepin Healthcare's Minnesota Regional Sleep Disorders Center.

"It can be so disruptive to someone's life," Varghese said. Untreated sleep apnea can also increase risks for stroke, heart attack and hypertension.

About 6 million Americans are diagnosed with the obstructive sleep apnea, which causes lapses in breathing during sleep, according to the American Academy of Sleep Medicine. However, it's estimated that 30 million people actually have the condition.

Local companies from Inspire Medical Systems to Sleep Number, Cryosa, Gem Health and NightWare are working on technology to help sleep apnea and other conditions impeding a good night's rest.

Inspire's growth has been explosive. The Golden Valley-based company's revenue in 2018 was $50.6 million. Last week, the company reported preliminary sales for 2023 would be almost $625 million.

The company, which spun off from Medtronic in 2007, makes a minimally invasive device that can be implanted in patients not benefiting from the standard treatment of using a continuous positive airway pressure, or CPAP, machine.

Some people find CPAP machines uncomfortably bulky and bothersome, or cannot sleep with the mask on.

"It's a difficult therapy to adjust to," said Tim Herbert, CEO of Inspire Medical. "The demand from the patients is still driving our growth today."

Inspire's device delivers pulses to airway muscles, keeping the airway open. Patients can turn the device on with an external remote. No other companies make a comparable therapy.

Mike Doman, 53, of Sartell has found the Inspire device "life-changing."

"I sleep amazingly well. If you're getting enough sleep, it changes everything about your life," Doman said.

After being diagnosed with sleep apnea in 2017, he struggled using a CPAP machine. A 2019 surgery did not resolve the issues. He said he has had no complications since the Inspire implant in 2020.

Sleep apnea is more common among men; obesity is a significant risk factor.

Over the summer, President Joe Biden started using a CPAP machine to treat sleep apnea.

While the president does not use an Inspire device, Herbert said he was encouraged that the news story brought attention to sleep apnea and he hopes it leads more people to take proactive steps to address their own sleep issues.

Hennepin Healthcare's Varghese said other sleep apnea treatments can include wearing a mouth guard, finding different sleeping positions, raising the head of the bed, losing weight and cutting back on alcohol.

But the new devices to treat sleep disorders means doctors can help more patients.

"These devices are very welcomed in the clinical community as new options," said Dr. Eric Olson, chair of Mayo Clinic's Division of Pulmonary/Critical Care and a Mayo Center for Sleep Medicine physician.

Laura Stoltenberg, CEO of Arden Hills-based Cryosa, said the Twin Cities area has both the expertise on developing sleep disorder treatments and ability to help companies go from startup phase to commercialization.

"We really have some of the best people in the country," Stoltenberg said.

Cryosa has progressed from a startup to a clinical stage company, developing a noninvasive obstructive sleep apnea treatment that uses cooling technology to reduce tissues that cause the condition. It has raised nearly $30 million from life sciences venture funds, including $21.5 million in a Series B round in September 2021.

Being in a community with other sleep companies has benefited Cryosa as well. Not only do physicians have multiple solutions to treat patients, Stoltenberg said there is a payer community here that appreciates the severity of the disease and is willing to cover treatments.

Getting buy-in from health insurers is a major step in commercialization of devices.

Many Twin Cities companies tackling sleep technology

Brian Sauer suffered from sleep apnea before he got treatment and said he is now a "sleep evangelist."

He also is CEO of Gem Health, a virtual sleep clinic he founded in 2022. So far, he has raised $5 million in seed financing and has 10 employees.

Gem helps people suffering from sleep apnea get diagnosed and connected with clinically sound treatment options.

Sauer said his clinic also has benefited from being surrounded by other sleep companies, organizations willing to fund them and health plans willing to pay for sleep treatments.

"We do see a really strong ecosystem in the Twin Cities for sleep," Sauer said. "I've been able to develop relationships with other sleep companies in the Twin Cities. It's really advanced our thinking at Gem."

On Wednesday, Gem Health announced an agreement with Minneapolis-based Sleep Number allowing its patients to receive a discount on new beds.

Sleep Number's sleep science

While Sleep Number at its core is a mattress maker and retailer, it has embraced sleep research to improve its products and emphasized that focus to both consumers and investors.

"At Sleep Number, we've known for quite a while that there's a lot going on during sleep that contributes to your health and wellness," said Dr. Mark Aloia, the head of sleep and behavioral sciences at Sleep Number. "We know that sleep contributes to your immune function, it can contribute to recovery from daily activities, from stress or even recovery from injury."

In 2015, Sleep Number acquired for $58 million BAM Labs, a Silicon Valley-based firm that developed sleep sensor technology. By 2017, all of its beds included smart bed technology that can help people biometrically track their sleep and improve it through adjustments.

Sleep Number now has partnerships with Mayo, the American Cancer Society, University of Pittsburgh and Northwestern University.

"I would say that our scientific work, our research, in collaboration with others, or individually, all contributes to our roadmap," said Aloia, who has 25 years' experience as a sleep researcher.

Sleep Number's research and study of scientific sleep literature continues to fuel innovation such as the addition of temperature controls in the company's Climate 360 beds.

Sleep Number beds have long been customizable, but with the smart bed advancements, it has evolved into "a sense and do company," Aloia said. By monitoring their sleep, users can now do something to improve it by changing the pressure, the angle your head rests or the temperature and create an individualized sleep experience.

While sleep apnea is perhaps the most recognized sleep disorder, there are a wide range of other conditions that Minnesota companies are trying to address. Minnetonka-based Halo Innovations concentrates on safe sleep for babies. Shoreview-based Dymedix provides sleep sensors for infants and adults.

Hopkins-based NightWare has developed technology to address nightmare disorder, which can affect people with post-traumatic stress disorder. The company's software uses heart rate and movement monitors on an Apple Watch to detect if a patient is experiencing a nightmare.

"It just nudges you enough to take you out of the nightmare without waking you," said Grady Hannah, co-founder and CEO of NightWare. The company has raised $5 million in financing and $2 million in government grants.

Transcend in Fridley has developed mini- and micro-sized CPAP machines. Founded in 2006 Respicardia developed the Remede system, an implantable neurostimulator, to treat central sleep apnea, which is less common than OSA. Massachusetts-based Zoll Medical Corp. acquired Respicardia in 2021; the business remains headquartered in Minnetonka.

Eagan-based REMastered Sleep has developed a water bottle, the REMplenish Myo-Nozzle, which can improve airway health associated with conditions such as snoring and sleep apnea. The company started selling its product in December 2020 for about $50 to $70. Mayo has a current clinical study looking at the REMplenish Myo-Nozzle's use with mild to moderate obstructive sleep apnea (OSA), said CEO Anders Olmanson.

"We are looking at a potential renaissance in the treatment of sleep disorders," said Dr. Michael Howell, division director for sleep medicine at the University of Minnesota Medical School.