LOS ANGELES and MANCHESTER, England, Sept. 22, 2015 /PRNewswire/ -- BBI, LLC, today announced that its SEM Scanner, a handheld device for detection of early pressure ulcers, improved the time to detection by, on average, 3.9 days earlier than the gold standard of care.
Findings from the independent study by the Royal College of Surgeons in Ireland's School of Nursing were presented at the 18th Annual Meeting of the European Pressure Ulcer Advisory Panel in Ghent, Belgium. The SEM Scanner assessed levels of sub-epidermal moisture (SEM) -- a marker of tissue damage -- in 47 patients in a hospital acute care unit. All patients exhibiting sustained deviation in SEM, as detected by the SEM Scanner, went on to develop visible signs of pressure ulceration (Grade 1 or 2). The study showed that the SEM Scanner detected damage more quickly than nurses (average time to detection: 1.1 days with SEM Scanner vs. 5 days for the gold standard), giving nurses 3.9 days of lead time when using the SEM Scanner.
"These findings are clinically meaningful and potentially transformative in how we assess and prevent pressure ulcer development. The real challenge today is that after a risk assessment is completed, nothing will be altered in the care plan until there are visual signs of pressure ulcer damage - by which time it is too late," said Zena Moore, the principal investigator of this study. "Our conclusion is that, conversely, SEM Scanner provides greater accuracy and a continuous alerting system to identify subtle changes in the patient's condition so that a care plan can be altered more quickly in response to actual patient need, thereby reducing the risk of development of more severe pressure ulcers."
Martin Burns, chief executive officer of BBI, added, "These findings build on clinical study and real-world usage data from users of the SEM Scanner. Clinicians know that pressure ulcer damage does not magically appear, rather healthy tissue deteriorates to a damaged state that leads to pressure ulcers over a period of time. Clinicians also know that by the time redness appears, the damage is already done. The SEM Scanner offers clinicians a tool to detect pressure ulceration before the damage becomes visible at the skin's surface and therefore can proactively treat them prior to chronic damage occurring. This improvement in the treatment paradigm is transformational to pressure ulcer reversal and prevention. Our clinical users have expressed that with early detection, more than 80% of pressure ulcers can be prevented."
About Pressure Ulcers
Pressure ulcers are a common medical problem that can lead to pain, disfigurement, infection and death. Also known as bedsores, pressure sores or decubitis ulcers, pressure ulcers are an area of localized damage to the skin and underlying tissue – usually around an area of bony prominence, such as the sacrum, coccyx, heels, and hips – that results from pressure involving shear and/or friction. Across Europe and the United States, it is estimated that 18%-25% of patients in both acute care and long-term care settings suffer from pressure ulcers, disproportionately impacting the elderly and patients with limited mobility. There are some 2.5 million pressure ulcer cases annually in the European Union, with nearly 500,000 of those cases in the United Kingdom: a 2.1bn problem to the NHS. 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.
About the SEM Scanner
SEM Scanner is a hand-held device to detect early-stage pressure ulcers and deep tissue injury (DTI). SEM Scanner uses non-invasive biosensor technology to measure sub-epidermal moisture (SEM), a biophysical marker associated with localized edema in the initial inflammatory phase of pressure ulcer formation. SEM has been found to indicate tissue damage three to ten days before visible symptoms or pressure ulcer formation. The SEM Scanner produces real-time information to clinicians for the objective evaluation of tissue health status. SEM Scanner is CE Mark approved and launched in the UK market in 2014. BBI is working with FDA to make the SEM Scanner available in the US market in 2016.
BBI, LLC, focuses on developing solutions for wound care, orthopedic care and real-time data capture, analytics and reporting. Leveraging BBI's passive sensor technology, the company's portable devices produce actionable data for evidence-based assessments. Innovation at BBI is realized through collaboration between the company's research and development and clinical teams, where every team member is an expert in his or her respective field. BBI applies rigorous scientific, technical and clinical standards to drive product development and address unmet and urgent clinical needs. BBI is based in Los Angeles and maintains a European office in Manchester, UK.
Chief Executive Officer
Matt Middleman, MD, Russo Partners
Amiad Finkelthal, Russo Partners
SOURCE BBI, LLC