Dr. George K. Lewis, President ZetrOZ, a government-backed company, is a pioneer in developing wearable mechanical biologic devices, the first to be approved by the FDA for treating soft tissue pathology. Unlike many pharmaceutical devices, the company’s technology addresses the root cause of soft tissue injuries and underlying inflammatory responses. Its wearable devices utilize long-duration ultrasound stimulation, also known as sustained acoustic medicine (SAM). ZetrOZ expanded its platform over the years to include new FDA-approved indications and technologies, resulting in effective and rapid treatment delivery.
“We focus on healing rather than just inhibiting the pain response,” says Dr. George K. Lewis, president of ZetrOZ.
The company strives to help more than 100 million American patients by providing them with mechanical devices that address ailments with insufficient treatment alternatives. ZetrOZ has also achieved significant milestones, including the launch of SAM 2.0 technology, the first FDA-cleared prescription home-use mechanical biologics, and the approval of its wire-free SAM X1 product line. ZetrOZ’s product portfolio also features the SAM 2.0 and the SAM X1, which use wired and wireless technology, respectively. SAM X1 stands out as a noteworthy innovation as it provides untethered mechanobiology treatment without the use of bulky wires, thereby gaining considerable market traction.
However, a pivotal development occurred in mid-2023 when ZetrOZ received additional FDA indications for its platform, including knee osteoarthritis, patellar and shoulder tendinopathy, and chronic back pain. This refinement in technology aims to therapeutically heal tissues, establish new product lines, and enhance its presence in the US market.
ZetrOZ’s unique FDA-approved technology’s safety and efficacy make it a compelling alternative, especially when other treatments pose gastrointestinal or cardiovascular risks. The intricate interplay of chemical, mechanical, and electrical aspects of humans governs bodily functions. Mechanical biology, enhanced by long-duration mechanical stimuli like SAM, disrupts these gradients, resulting in a tailored, localized, and non-systemic approach to tissue repair.
This technology has garnered healthcare providers’ attention due to its potent efficacy in treating illnesses that were traditionally treated with injections or oral medications. Its effectiveness lies in biohacking cells and facilitating nutrient transfer in the signaling cascade over time. Unlike pain management devices that block nerve conduction or regenerative medicine treatments that rely on surgical procedures or injections, ZetrOZ’s wearable devices function automatically on the body for several hours daily. Orthopedic surgeons or sports medicine doctors prescribe these devices to improve circulation, nutrient transfer, cellular proliferation, and migration.
The ability to be attached and worn whenever required is what distinguishes this wearable technology, which is essential for promoting the healing cascade.
This time-dependent therapy requires daily use, drawing parallels to antibiotic or pharmacotherapy regimes. Similar to how antibiotics are administered for a specified period, this device is prescribed for six to eight weeks to remodel most soft tissue pathology, with shorter durations for younger individuals whose cells multiply faster.
We focus on healing rather than just inhibiting the pain response
Undergoing rapid expansion into the orthopedics segment, the company significantly shifted from SAM’s origins in sports medicine as a non-operative technology. It gained traction among professional and collegiate sports medicine providers before extending to high school and active-duty military providers. ZetrOZ’s technology has been used in high-activity roles like the US Air Force, Marines, and special operations, as well as in workplaces with physically demanding jobs. It addresses on-the-job injuries and collaborates with self-insured companies to avoid surgical interventions.
ZetrOZ’s technology has roots in research conducted by the National Institutes of Health (NIH), the Department of Defense (DOD), and NASA. Over the course of nearly two decades, the evolution of its technology has progressed from animal research to first-in-human studies, randomized placebo-controlled trials, and real-world health and economic studies. The data, which is published in peer-reviewed literature, showcases ZetrOZ’s journey spanning 30 years, with 17 years spent on development and utilization in the healthcare system.
SAM technology has been prescribed a lot more by physicians in 2024, as it is a viable non-operative healing solution in orthopedics to prevent knee osteoarthritis and injuries. ZetrOZ, a company primarily operating in the US, is dedicated to improving individual lives in its commitment to leading a transformative journey towards holistic well-being.
