SEM Scanner Detects Bedsores Before Visual Diagnosis, Pivotal Study Finds

BBI's New Device Takes Aim at $11B Public Health Problem

Company Files for FDA Clearance

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Jun 20, 2017, 13:56 ET

LOS ANGELES and MANCHESTER, England, June 20, 2017 /PRNewswire/ -- A wireless handheld scanner detected bedsores developing under the skin earlier than visual inspection of the surface of the skin. This gives clinicians an "alert" that enables them to intervene early and reverse damage before the sores break through the skin and turn potentially deadly, researchers have found.

The pivotal study involved 182 patients at risk for bedsores at 12 hospitals, nursing home and long-term rehabilitation centers in the United States and the United Kingdom -- the first large-scale study of the scanner to be conducted simultaneously in both countries, according to Bruin Biometrics ("BBI, LLC"), which developed the device, known as the SEM Scanner.

BBI included the study findings in a filing to the U.S. Food And Drug Administration for approval to market the device in the U.S. SEM Scanner is currently available in the United Kingdom, Ireland and Canada.

Bedsores (or "pressure ulcers") can lead to pain, disfigurement, infection and deadly complications that kill more people annually than any form of cancer except lung cancer at a total annual cost of $11B to the U.S. economy. The sores result from pressure involving shear and/or friction causing localized damage to the skin and underlying tissue, usually around areas of bony prominence -- such as the vertebra, tailbone, heels, and hips.

In the new study, investigators conducting daily visual skin assessments and scans for up to twenty days found that the SEM Scanner detects pressure damage to skin earlier than visual skin evaluation by nurses. Investigators are presenting topline results today at the scientific session of Wound Care: From Innovations to Clinical Trials 2017, a medical conference in Manchester, U.K.

"Having a lead on pressure-induced tissue damage over visual skin assessment gives nurses valuable advance notice to institute additional preventive treatment tailored to the patient's unique needs," said Dr. Ruth Bryant, a study investigator, certified wound ostomy continence nurse and scholar-in-residence at Providence Health Care and Washington State University. "The advance notice ultimately translates into fewer pressure ulcers, decreased costs, increased quality of patient care, increased patient satisfaction, and decreased risk for adverse events such as in-hospital mortality, prolonged length of stay, discharge to an extended care facility rather than to the home, and infection."

Henry Okonkwo, a study investigator providing skilled wound care to nursing homes and acute care facilities, said: "The study results indicate that the SEM Scanner can detect changes before they are visible. Objective, scientific data from the scanner would give me confidence to take action in my clinical practice."

BBI's vice president of product, Rachael Lester, said: "With these new findings, we expect that early detection technology will move to the forefront of bedsore prevention. The holy grail in prevention has been the search for a biophysical indicator that could reliably signal the presence of a condition at an early enough stage to meaningfully alter the progression of the disease. Our SEM Scanner technology uses sub-epidermal moisture, or SEM, to monitor changes occurring at the cellular level where there is pressure damage."

The new research builds on earlier evidence from 1,200 patients participating in a BBI-sponsored program incorporating SEM Scanner into existing hospital bedsore prevention protocols. Seven hospitals in the U.K. and Canada eliminated bedsores and two achieved reductions of nearly 90 percent as a result of the program.

Findings from the program, presented last November at the Wounds UK annual conference, include research from Virgin Care and from St. Mary's Hospital on Isle of Wight that represent real-world evidence of SEM Scanner's effectiveness and upend the prevailing view that pressure ulcers cannot be diagnosed and treated until there is visible and irreversible damage at the skin's surface.

"We hope that today is a turning point in the war on pressure ulcers," BBI CEO Martin Burns declared. "We aim to massively decrease unnecessary patient injury and cost through a simple bedside scan that can detect developing wounds when they are at a preventable stage."

About Bedsores

Across the United States and Europe, an estimated 18%-25% of patients in both acute care and long-term care settings suffer from pressure ulcers, which disproportionately impact the elderly and patients with limited mobility. In the U.S., some 2.5 million Americans develop pressure ulcers annually in acute care facilities, and 60,000 Americans die annually from pressure ulcer complications such as cancer, sepsis, cellulitis, and MRSA. There are some 2.5 million pressure ulcer cases annually in the European Union, and nearly 500,000 in the United Kingdom, which spends £2.1bn, or 4% of the NHS budget, on the condition.

About BBI

Bruin Biometrics ("BBI LLC"), a pioneer in biometric-sensor based medical devices, develops point-of-care diagnostic solutions for early detection and monitoring of chronic, preventable conditions. The company's first product is the SEM Scanner, a hand-held non-invasive device that assesses sub-epidermal moisture, a biomarker for pressure ulceration. Pressure ulcers affect approximately 25 percent of acute care hospital and long-term care patients – typically the elderly and immobile. SEM Scanner is CE Mark approved. It is currently in full commercial launch in the United Kingdom, Ireland and Canada. SEM Scanner is pending approval from FDA, and is not available for sale in the United States.

BBI is also developing OrthoSonos, a non-invasive device for real-time orthopedic joint monitoring and assessment of prosthetic implant failure; and P02M, the first device for monitoring tissue oxygenation at a specific location in real time. P02M is initially being tested for continual monitoring of tissue and vascular viability in the feet of diabetics. Diabetes can cause peripheral artery disease and peripheral neuropathy, putting patients at risk for foot ulcers.

BBI is based in Los Angeles and maintains a European office in Manchester, UK.

For additional information, visit www.bruinbiometrics.com. Follow BBI on Twitter at https://twitter.com/bruinbiometrics.

SOURCE Bruin Biometrics, LLC