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Entrepreneur Works to Build Next-Generation of Biometric Medical Devices

device approved to aid in the detection of early-stage pressure ulcers – an urgent, unmet need and public health challenge. BBI’s product pipeline is focused on the detection of two other problematic medical conditions: diabetic foot ulcers and orthopedic implant failures.

Pressure ulcers, commonly known as bedsores, are chronic wounds to the skin and tissue. Pressure ulcers are an area of localized damage to the skin and underlying tissue – usually around an area of bony prominence – that results from pressure involving shear and/or friction.

Pressure ulcers are a common medical problem among the elderly and patients with limited mobility in hospitals and nursing homes.The ulcers can lead to pain, disfigurement, infection and death. In fact, pressure ulcers kill more people annually than any form of cancer except lung cancer.

Across Europe and the United States, it is estimated that 18 to 25 percent of patients in both acute care and long-term care settings suffer from pressure ulcers. Pressure ulcers cost the U.S. healthcare system $11 billion annually, some 2.5 million Americans develop pressure ulcers each year in acute care facilities, and 60,000 Americans die annually from pressure ulcer complications such as cancer, sepsis, cellulitis, and MRSA.

Until now, diagnosis has relied on visual inspection by nurses, which is subjective and which can only identify pressure ulcers once visible damage to the skin has already begun. Scientific findings show that by the time damage is visible, it is far too late.

SEM Scanner uses bioimpedance technology to assess sub-epidermal moisture (“SEM”), a biophysical marker that has been found to detect early-stage pressure ulcers beneath the skin as much as 10 days earlier than visual inspection by nurses.

Moisture accumulates locally in the early inflammatory phase of pressure ulcers development. SEM Scanner evaluates the moisture level under the skin, taking a series of readings over sites at risk for developing an ulcer and delivering a calculation on whether the tissue is healthy or compromised. The Scanner measures tissue electrical capacitance through the application of low amplitude signals from electrodes placed on the patient’s skin. The electrical capacitance value indicates changes to SEM.

SEM Scanner has been approved for use in the European Union and Canada where it has been commercially launched. BBI plans to file for U.S. FDA approval in the first quarter of 2017.

R&D: What was the development process for SEM Scanner?

MB: SEM Scanner was conceived by UCLA nursing professor and wound care expert Dr. Barbara Bates-Jensen.  Upon discovering that no reliable technology exists to measure changes in tissue damage associated with pressure ulcers, Dr. Bates-Jensen partnered with Dr. William Kaiser, co-chair of the UCLA Wireless Health Institute, and his colleague Dr. Majid Sarrafzadeh, to develop the scanner.

Dr. Kaiser is an engineer who previously worked at the Ford Motor Company and at Jet Propulsion Laboratory.  In developing SEM Scanner’s ability to look for clues about ulcer development beneath the skin surface, Dr. Kaiser borrowed the concept of “seeing the unseen” from seismometers on NASA’s Mars landing craft that enable scientists to delve deep beneath the planet’s surface for seismological clues about planetary formation.

It took approximately three years for the UCLA professors to develop the technology before it was licensed to BBI.

BBI also is developing OrthoSonos, a device that listens to sound waves for early warnings of orthopedic joint failure, based in part on acoustic technology for detecting wear and tear on commercial Boeing jetliners.

Because all of our technologies are new to their respective fields, we have had to develop knowledge of the clinical marker of damage (e.g. inflammation); the methods of detecting that marker (e.g. bioimpedence); the technology to read the marker (e.g. the Scanner) and the clinical deployment of the technology within the medical system for the desired impact.

Achieving impact in the forms of improvements to patients’ health, reductions in the number and severity of cases and their associated costs is the ultimate sign of success:  without achieving impact, the technology is meaningless.

BBI applies our Claims-Data-Value framework to identify which data which will be needed and our Design Control method to develop the technology. The former is a method of building the right data in the right sequence at the right time, so we avoid the trap of trying to get all data at once while satisfying the burdens of proof at each stage of development.  The latter is an iterative design process which starts and ends with understanding and satisfying customer needs.

R&D:  Did you run any test trials? What were the results?

MB: We run controlled, FDA-quality trials, support independent studies and deploy the technology in real-world settings that can be observed.

In 2016, seven of 13 hospitals participating in pressure ulcer prevention programs incorporating SEM Scanner completely eliminated the occurrence of new pressure ulcers, and three of the hospitals achieved reductions ranging from 11 to 90 percent. The programs involved over 1,200 patients at hospitals in the United Kingdom, Canada and Spain between 2014 and 2016.  These were run in real world settings independently of BBI and of each other.

Glenn Smith, a nurse overseeing the program at St. Mary’s Hospital on the Isle of Wight, off the coast of England, said: “We reduced pressure ulcers in the ward concerned to zero during our Scanner trial – an achievement that, if we rolled out across our hospital, we estimate could save our hospital nearly £600,000 and release 1,420 hours of nurse productivity annually.”

In an earlier independent study by the Royal College of Surgeons in Ireland’s School of Nursing, SEM Scanner improved the time for detecting pressure ulcers by an average of 3.9 days when compared to visual observation of skin by nurses.

This study, involving 47 patients in an acute care hospital ward, found that average time to detection was 1.1 days with SEM Scanner versus five days for visual observation. The findings were presented in September, 2015, at the 18th Annual Meeting of the European Pressure Ulcer Advisory Panel in Ghent, Belgium.

R&D: Are you presenting at the JPMorgan Healthcare Conference?

MB: We are using the conference to meet with potential distributors and partners.

R&D: What are BBI’s plans for the rest of 2017?

MB: In the United States, BBI recently completed a multi-center, pivotal clinical trial to demonstrate the clinical utility of the SEM Scanner to the FDA.  BBI expects to announce the results of the study and to file for FDA approval in the first quarter of 2017, and to launch SEM Scanner in the U.S. in the second half of the year. BBI also plans to expand availability of the Scanner in Europe, where it is currently in use in the U.K., Ireland, Spain and Portugal.