Study to Replicate Accuracy and Speed to Detection Previously Demonstrated in Pilot Study
BBI, LLC, a developer of innovative sensor-based diagnostic products, today announced the initiation of a multi-center, pivotal clinical trial to evaluate performance of the SEM Scanner in detecting early-stage pressure ulcers, as compared to today’s standard of care.
BBI, LLC, a developer of innovative sensor-based diagnostic products, today announced the initiation of a multi-center, pivotal clinical trial to evaluate performance of the SEM Scanner in detecting early-stage pressure ulcers, as compared to todays standard of care.
The start of the study brings BBI closer to an FDA review of the handheld scanner, which BBI expects to launch in the United States early in 2017. SEM Scanner is currently available in the United Kingdom and Ireland and was recently approved for commercial use in Canada.
The study is expected to enroll up to 400 at-risk patients at ten sites in the United States and United Kingdom including acute care, nursing home and long-term rehabilitation institutions.
The study is expected to replicate results of an independent study conducted at Royal College of Surgeons Ireland in 2015 demonstrating that the SEM Scanner is able to accurately detect early-stage pressure ulcers up to 11 days ahead of clinical judgment. The results of this study were presented at the 2015 European Pressure Ulcer Advisory Panel. The SEM Scanner recently received the Frost & Sullivan 2015 European Product Innovation Award (for information about the award, see http://bit.ly/1YiYPIc).
BBI has been working with FDA to make the SEM Scanner available in the US market in 2016. Initiation of this trial represents a significant step toward FDA approval.
For additional study details please visit www.clinicaltrials.gov
Rachael Lester, Vice President of Product at Bruin Biometrics, said, “This clinical trial is an important step in bringing a technology that is revolutionizing detection and prevention of pressure ulcers to US clinicians and patients. We have seen outstanding results in the UK where several hospitals have been able to reduce hospital-acquired incidence to zero using the SEM Scanner. The initiation of this trial underscores our commitment to addressing the needs of clinicians and patients suffering from avoidable pressure ulcers, and to saving billions of dollars in associated healthcare costs.”
Henry Okonkwo, PA, SWOCS, DWC, an investigator in the clinical trial and a skilled wound care provider to nursing homes and acute care facilities, said, “Pressure ulcers are one of the leading causes of morbidity and mortality in hospitalized patients and are considered “never events” by payers and regulators. We see great opportunity for the SEM Scanner in the US, pressure ulcers are responsible for more deaths than most cancers. This trial will provide important data on the effectiveness of the SEM Scanner to detect early pressure damage, and enable clinical strategies for pressure ulcer prevention before skin breaks or damage is irreversible.”
Glen Cunningham RN, MBA, Corporate Director of Planning and Quality at Samaritan Health and investigator of the clinical trial, said, “We are excited to participate in a study for this groundbreaking technology. A successful study would be a big step forward in wound management and put an end to avoidable pressure ulcers. The SEM Scanner would be the first significant innovation in wound care for some time which has the potential to revolutionize the standard of care for pressure ulcer detection and prevention.”
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, costing the US health system $11B. Each year, 60,000 Americans die annually from pressure ulcer complications such as cancer, sepsis, cellulitis, and MRSA.
Bruin Biometrics LLC, a pioneer in biometric-sensor based medical devices, is committed to the development of 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 which has been found to detect early-stage pressure ulcers as much as 10 days earlier than visual observation. Pressure ulcers affect approximately 25% of acute care hospital and long-term care patients typically the elderly and immobile. SEM Scanner is CE Mark approved and is currently in full commercial launch in the EU and Canada. SEM Scanner is not currently 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.
Chief Executive Officer
Amiad Finkelthal, Russo Partners
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