SAM, according to the company, is the first and only multiple-hour bio-electronic wearable device for pain and accelerated healing. The device was created to address the growing demand for non-pharmaceutical and bio-regenerative alternatives to typical pharmaceutical-based pain treatments in the approximately $62 billion U.S. pain management market.
The technology received U.S. Food and Drug Administration (FDA) 510(k) clearance and was CE marked early in 2014 and is available for daily use in primary care.
ZetrOZ officials have described SAM as a “new weapon in the fight against arthritis and back pain.”
In recent months, good news has followed the small startup device company, which was founded in 2009.
SAM marked successful clinical trials supported by the National Institutes of Health for treating knee arthritis, upper back and tendonitis pain, and currently is in testing by the National Space Biomedical Research Institute for use on astronauts—on the ground and in space. The company also has reported positive results with elite Olympic athletes, including triathlete Sarah Crane and runner Diane Stokes.
In Canada and Europe, SAM is cleared for healing soft tissue, but not yet in the United States.
The technology also had its international debut during last fall’s Medica trade fair in Düsseldorf, Germany, which provided hospitals and medical device distributors outside the United States with the opportunity to demo and purchase SAM as well as meet with the biomedical scientist behind the technology, ZetrOZ inventor and Chief Scientific Officer George K. Lewis, Ph.D.
“SAM brings first-line therapy to acute pain sufferers before that pain becomes chronic,” said Lewis, who started ZetrOZ before he turned 30. “We are working to manage pain and resolve medical conditions for the 1.5 billion sufferers worldwide by introducing doctors, physical therapists and hospitals to sustained acoustic medicine.”
Since its U.S. introduction, SAM has been adopted by physiotherapists, athletic trainers, sports medicine specialists, and orthopedists who have documented measurable improvement in mobility, range of motion and overall health outcomes with a wide spectrum of patients, according to the company.
Maintaining such rapid forward momentum in the medical technology sector, however, takes cash, along with a lot of patience and ingenuity.
“We’ve been very creative with our funding,” Lewis told Medical Product Outsourcing. “We’ve brought a lot of resources together.”
In October, the company received a $5 million venture loan facility from Horizon Technology Finance Corp., a leading specialty finance company that provides capital in the form of secured loans to venture capital-backed companies in the technology, life-science, healthcare information and services, and clean-tech industries.
The funding will provide ZetrOZ with capital to expand its wearable ultrasound product marketing and sales beyond the professional market and into the consumer arena. Horizon funded an initial $1.5 million of its $5 million commitment under the venture loan security agreement.
“This financial commitment from Horizon marks a significant step forward in our company growth and vision of providing a drug-free, non-invasive alternative for pain sufferers,” ZetrOZ co-founder and CEO Bryant Guffey said at the time. “We look to them as important partners as we continue to expand access to our mobile, wearable SAM therapy system in the rehab and chronic pain markets.”
Current clinical outcomes demonstrate that sustained acoustic medicine is an effective non-pharmaceutical approach for treating pain symptoms such as knee arthritis and upper back pain—and, possible wound closure.
Late last year, ZetrOZ also announced a contract with the U.S. Army Military Health Command (USAMHC) to develop a bio-electronic wound dressing to accelerate healing via sustained acoustic medicine. The Phase I study, the first of its kind, is funded by a Small Business Innovation Research grant and the work will be performed in a collaboration between ZetrOZ and Prof. Stephen Davis, director of the Pre-Clinical Wound Healing & Infection Research Laboratories in the University of Miami Health System.
The $150,000 grant supports the study to determine the effects of SAM for accelerating the closure and complete healing of wounds such as trauma lacerations.
According to an official funding request from the USAMHC, there is a strong military need for an active wound dressing treatment that combines traditional wound coverage with innovative wound regeneration support approaches to enable rapid treatment of wounded troops, e.g, by negative-pressure application, wound irrigation, oxygenation support, and/or regeneration solution perfusion. SAM was selected for the study due to its efficacy in achieving the military’s need for a new wound dressing.
“The aim of this first phase is to verify early accelerated wound healing results on small animals by demonstrating the same benefits on large animals with direct relevance to human subjects,” said Lewis.
The animal model selected is a pig, due to the similar size of relevant tissues and anatomical structure. Upon validating success in an animal model specific to accelerated healing of trauma, the teams will work to develop and deploy innovative wound healing solutions for the U.S. Department of Defense relevant to current military concerns, including injuries from improvised explosive devices, burns and lacerations.
“Our aim is to provide treatments that accelerate recovery and reduce the risk of infection for our troops as well as civilians,” said Davis, “The SAM device offers just that potential.”
“The medical utility of sustained acoustic medicine is an evolving success story in the field of translational research using low-intensity ultrasound energy deposition for soft-tissue biomodulation and accelerated recovery. The clinical and scientific research behind SAM is growing quickly, and the current beneficiaries of these innovations are the injured weekend warrior and chronic pain sufferer,” said Lewis, who was practically born into his current profession.
“I was born and raised into ultrasound technology,” Lewis told MPO in a recent interview. “I was in my middle school years and early teens, I was working with my father on ultrasound transducer design, which set the stage for my undergraduate and doctoral research. I did my undergrad in biomedical engineering. My senior design project was focused on ultrasound—tissue characterization and properties.”
Lewis’ graduate work—doctoral studies in neurobiology, mechanical engineering and biomedical-chemical engineering—at Cornell University focused on ultrasonic applications for drug delivery in glioblastoma therapy. It was at Cornell where he met the other co-founders of ZetrOZ.
Going forward, part of Lewis’ near-term commercialization plan for SAM is physician education. Today’s objective is the doctor’s office—tomorrow, perhaps, you’ll find SAM on the shelf at your local Target or CVS Pharmacy.
“The goal is really educating physicians about the technology and how they can integrate it into their care,” he told MPO. “Longer term, I’d like to see this in everyone’s medicine cabinet.”