Pressure ulcers, including bedsores, are a huge drain on health care. These painful, disfiguring infections cost the industry up to $27 billion annually.

For decades, prevention relied on slow, manual methods: visual skin checks and the constant, routine turning of bedridden patients. A Westwood-based UCLA spin-off has been pushing to disrupt that status quo. Founded in 2009, Bruin Biometrics Inc. is among the first of now a handful of companies that have developed scanners aimed at detecting precursor conditions for bedsores and other pressure ulcers before they form.

While Bruin Biometrics’ scanning device has taken years to develop and get regulatory clearance, its arrival is none too soon for specialists who have to contend with pressure ulcers in their patients.

“Before this, all we could really do is wait for clinical symptoms to show, such as swelling, redness or edemas, and by then it was too late to avoid pressure injuries,” said Dr. Oscar Barreto, a foot and ankle specialist in Miami-Dade County in Florida who started using the device at the beginning of the year. “This is the first instrument I’m aware of that can detect things early on, before the ulcer forms on the skin.”

And the stakes are high: the National Pressure Injury Advisory Panel estimates that there are roughly 2.5 million pressure injuries each year across the country. The American Hospital Association projects that roughly 60,000 patients die each year from complications from hospital-acquired pressure ulcers – more than the total nationwide number of fatalities from vehicle accidents or gunshot wounds.

For the millions who get pressure injuries each year and survive, treatment can be expensive – as much as $70,000 to treat a single pressure ulcer, according to the hospital association.

One local expert has tallied up this cost. William Padula, associate professor of pharmaceutical and health economics at the USC Mann School of Pharmacy, has put the price tag at roughly $27 billion a year.

“This cost is burdened on health care providers,” Padula said.

‘Ounce of prevention’

Bruin Biometrics’ sub-epidermal moisture scanner, called ProVizio, can alert caregivers in advance that one is likely forming and will break the skin. The company’s primary markets are hospitals, skilled nursing facilities and even home-care settings – anywhere that has non-ambulatory patients.

A nurse or other caregiver presses the device against key pre-determined points in the skin, mostly in the patient’s heel or near the base of the spine. If the moisture reading is above a certain threshold, then the caregiving team can implement treatment measures to alleviate the constant pressure. Those measures include turning the patient, applying topical gels and putting the patient on a mattress that can inflate and deflate to adjust the contact pressure.

By implementing these care measures early on, the caregiving team can nip the formation of pressure ulcers in the bud, before they break the skin and take months and tens of thousands of dollars to treat.

“This device is truly the ounce of prevention,” said Joyce Black, professor of nursing at the University of Nebraska Medical Center in Omaha and immediate past president of the National Pressure Injury Advisory Panel.

UCLA origins

The key to Bruin Biometrics’ scanner lies in the detection of moisture buildup that impacts surrounding tissues below the skin, where conventional inspection techniques can’t reach.

“It’s giving the care provider information about tissue damage that they cannot see,” said Martin Burns, chief executive of Bruin Biometrics. “It pulls the care regimen forward earlier and makes it much more targeted.”

The genesis of Bruin Biometrics arose out of research that was done at UCLA in the first decade of this century at the Henry Samueli School of Engineering and Applied Science and at the Wireless Health Institute. Co-founders Joseph Boystak, Michael Flesch, William Kaiser and Majid Sarrafzadeh spun the company out roughly 17 years ago.

In the ensuing years, the company honed its technology into a marketable portable scanning device. Burns said Bruin Biometrics was the first company in the nation to develop this kind of device able to detect sub-epidermal moisture. As such, getting approval from the U.S. Food and Drug Administration took longer than usual. The agency approved the device for detection of potential bedsores in late 2018.

“The FDA had to set up a new framework for us because we were the first company out of the block with this technology,” Burns said. “That’s why it took so many years.”

Nurse and pressure ulcer expert Black said she is aware of a handful of other companies developing similar scanning technologies – including one that she is helping in Milwaukee, Wisconsin.

But Burns said none of these other companies have yet received FDA approval, giving his company a first-mover advantage.

The company to date has raised more than $60 million. The largest component of that was $24 million in 2020 from Arjo, a Malmo, Sweden-based medical device supplier.

Gaining traction

While the market for Bruin Biometrics’ device may be huge, getting hospitals, skilled nursing facilities and other care providers to use Bruin Biometrics’ ProVizio scanning device has been challenging. Few were willing to pay for several $10,000 devices up-front, so the company switched to a subscription model, in which the device is free, but the care provider pays for each scan.

The other major hurdle is the federal Centers for Medicare and Medicaid Services (CMS).

According to Padula, Medicare and Medicaid programs do not reimburse for treatment of pressure ulcers that form during stays at hospitals or skilled nursing facilities.

“It comes directly off the bottom line of hospitals,” he said.

In 2024, CMS did recognize the Bruin Biometrics scanner as a way to measure sub-epidermal moisture. The next step is to get CMS to reimburse care providers for the cost of the scanner.

In the meantime, the company has to prove to hospital and skilled nursing administrators that subscribing to the scanning device technology can save them thousands of dollars in pressure ulcer treatment costs.

‘Hooked’ on the device

Bruin Biometrics has had considerable success on that front. Burns said the company now has an order backlog of about $80 million in the North American market. The company has third-party manufacturing facilities in Carlsbad and in Minneapolis.

Barreto, the Florida foot and ankle specialist, was convinced almost immediately.  When a vendor came by his offices in January, he agreed to a trial run for the Bruin Biometrics ProVizio device.

“I was a bit skeptical as I have been asked to try many wound management devices,” Barreto said. “But I had never seen a product that could predict the formation of a pressure wound. I tried it and I was hooked.”

He said he used the scanner on diabetic patients and patients with circulatory problems.

“This device tells you if inflammation is taking place before you can see any changes in the skin,” he said.

Barreto said it’s especially useful on patients with dark skin that does not show visual signs of persistent redness that can indicate a pressure ulcer is forming.

He said that when the trial run is over, he intends to sign up for a subscription package for his practice.

Seeking expanded use FDA authorization

So far, the FDA has cleared the ProVizio device for early detection of pressure sores in bedridden patients. But Burns said the company is preparing to seek FDA clearance for use on patients with diabetes and circulatory problems, as Barreto has done.

Burns said the ProVizio device has been approved by regulatory agencies in about 30 other countries besides the U.S.

“For now, that’s enough,” Burns said. “Our focus now is turning to increasing our market penetration for the approved uses. We’ve solved the early moisture detection problem for one of the highest priority hospital safety issues. Now we want to make sure everybody can benefit.”