Bruin Biometrics announces SEM Scanner™ and the 'sixth vital sign' to assess pressure ulcers

-- Elimination of avoidable suffering for thousands of patients and savings of billions of Euro in Healthcare costs targeted

SOUTHAMPTON, England, March 28, 2014 /PRNewswire/ -- 2nd EPUAP Focus Meeting on Skin Health and the Microclimate, University of Southampton -- Bruin Biometrics, LLC ("BBI"), a biometric sensing medical device company today announced significant clinical breakthroughs in the assessment of pressure ulcers using BBI's SEM Scanner™, a CE marked medical device.

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Bruin Biometrics will present these data in detail during a two-week EU clinical and policy presentation series under the theme, "Making Pressure Ulcer Prevention Possible," between March 31 and April 11, 2014, including a presentation at the 2nd Focus Meeting of the EPUAP April 7 – 9, 2014.

"We are living through a healthcare transformation that holds the promise of sparing millions of patients from unnecessary pain and potential early mortality. Policy makers across Europe, many of whom consider pressure ulcers to be unacceptable quality events, have crafted and are implementing policies that are increasingly holding healthcare providers financially responsible for the billions of Euro required to treat pressure ulcers," said Martin Burns, CEO of Bruin Biometrics. "The SEM Scanner™ is coming to market, with breakthrough clinical data, at a critical time for healthcare systems and aging populations."   

Interim results from BBI's clinical studies show statistically significant SEM Scanner™ readings from patients with confirmed Stage I ulcers, as well as Deep Tissue Injury (DTI). Three clinical breakthroughs have thus far been observed:

• SEM readings at the center of a sacral pressure ulcers, where compromised tissue is present, are significantly lower than readings at the periphery of the pressure ulcer;  
• Around the periphery of the pressure ulcers, SEM readings converge toward those observed over vascularized, viable tissue as indicated by control site readings obtained from subjects' sternums; and,
• SEM readings at the center of existing sacral pressure ulcers are statistically different from SEM readings at the sacra in a population at risk for pressure ulcers and in healthy subjects.

These data patterns have been independently observed in subjects across two separate study sites under the auspices of two autonomous principal investigators.

"These data hold tremendous clinical and economic value for practitioners assessing patients at admission, at discharge and during stay for the existence of pressure ulcers and deep tissue injuries," Burns said.

The current standard of care in pressure ulcer prevention is based on visual assessment, which focuses on areas where pressure ulcers most commonly develop: sacra and heels, for example. Unfortunately, the quality of visual skin inspection is highly dependent on the skill of the caregiver, and wide and varying results occur. By the time pressure-induced tissue damage is visually evident at the skin's surface, significant damage has already occurred.

The SEM Scanner can be used by all healthcare practitioners. And SEM Scanner readings – the 6^th vital sign – are readily interpreted and tracked. The device uses integrated sensor technology to assess inflammatory changes associated with pressure-induced tissue damage.

"Pressure ulcers can be aggressively addressed as a problem if healthcare workers use the SEM Scanner™ as a part of their vital signs checks," Burns said. "Pressure ulcer scanning should be the sixth vital sign check of all at risk patients."

About Bruin Biometrics

Bruin Biometrics (BBI) is relentlessly committed to using technology to improve the way that health care is delivered. By developing innovative biometric medical device systems that can cost-effectively detect and monitor select medical conditions with urgent clinical need, BBI is helping inform clinical decisions, simplify patient care, and improve patient outcomes. BBI has developed the SEM Scanner™, a revolutionary wound information medical device to detect the inflammatory changes associated with pressure induced tissue damage. BBI's second product, the OrthoSonos™ is an innovative medical device to detect and monitor the health of native joints and prosthetic implants. Neither SEM Scanner™ nor OrthoSonos™ are currently approved by the FDA for sale in the United States. The SEM Scanner™ has been CE Marked and is currently in full commercial launch in geographies recognizing CE Marking. OrthoSonos™ is on track for commercial launch in early 2015. To learn more about BBI please visit www.bruinbiometrics.com.