FISHERS, Ind.--(BUSINESS WIRE)--Wearable tech company Recovery Force LLC has reached two major milestones this week in its quest to produce next-generation devices that improve blood flow and enhance recovery for people battling serious health issues, including deep vein thrombosis.
The company announced today that it has received U.S. Food & Drug Administration (FDA) clearance to market its Class II 510(k) Active Compressions™ product, the RF 1400, and also that the National Institutes of Health (NIH) has awarded Recovery Force a $244,167 Phase I Small Business Innovation Grant to further its research with its patented shape-change technology.
“Our team has worked tirelessly to create a paradigm shift in the sequential-compression market and FDA’s clearance is a major milestone for our first medical-grade product specifically designed for the healthcare space,” said Matt Wyatt, Recovery Force’s president and chief executive officer. “Receiving an NIH grant to advance our research is further validation that we are on the right path. We believe that the NIH’s decision to support this research is the result of identifying an innovative technology to improve the current standard of care for blood clot prevention and patient compliance to make DVTs a never event.”
According to the Surgeon General's Call to Action to Prevent Deep Vein Thrombosis and Pulmonary Embolism (PE), this dangerous medical condition impacts as many as 600,000 Americans and results in 100,000 annual deaths. In comparison, DVT/PE events cause more deaths each year than the more well-publicized conditions of breast cancer, AIDS, and motor vehicle accidents.
The limitations of current pneumatic compression or air bladder technology are commonly found in the uncomfortable, “heat trapping” plastic wraps that work in conjunction with noisy electric pumps that produce the inflation and deflation of air bladders needed to cause compressions. Several research studies have identified that patient compliance in the prevention of DVT is a significant issue. In some cases, patients will remove the cuffs without notifying a nurse due to the sweating, itching and discomfort felt from the cuff’s inflation. There is also the risk of falling from getting entangled in the air hose tubing, and the genuine lack of mobility due to the need to be tethered to a wall’s electrical outlet.
“Preventing blood clots and improving poor blood circulation is our mission,” stated Polina Feldman, PhD, MBA, who is director of research and human performance at Recovery Force. “We are driven to successfully launch our active compressions™ product to engage patients and clinical professionals to help reduce the risk of DVT. We feel strongly that our low-profile DVT product, which has no hoses, no motors, no pumps or external power cords, and generates no noise whatsoever, will be well received among patients and caregivers.”
The State of Indiana will also provide up to an additional $50,000 for the grant award from the matching program with the Indiana Economic Development Corporation (IEDC) and Elevate Ventures. As a recipient of a Phase I SBIR grant, Recovery Force will have the opportunity to submit a Phase II SBIR with funding up to $1.5M for complete commercialization. Recovery Force will collaborate with David Armstrong, DPM, MD, PhD, the sub-awardee for the grant and professor of vascular surgery at the University of Arizona College of Medicine and the Director of Southern Arizona Limb Salvage Alliance (SALSA), to conduct the clinical usability testing.
An additional Phase I SBIR was submitted Jan. 5, 2017 for a diabetic shoe application using the patented active compressions™ technology. According to Dr. Armstrong, “Recovery Force’s technology has applications that have the potential to transform how we help our patients move through their world. The possibility to safely provide segmental compression while protecting a high-risk limb is nothing short of game changing”.
“Our key focus for 2017 remains the rigorous and timely clinical testing of our 510(k) medical product, which is the first of its kind for the healthcare industry. We will also be launching the first of several consumer products at the end of the year,” said Brian Stasey, co-founder and chief technology officer at Recovery Force. The company has a portfolio of products that address key needs of endurance athletes, consumer pain, and even elite war fighters who need to recovery faster without the use of drugs or bulky equipment.
Jeff Schwegman, Recovery Force’s director of engineering, is leading the product development and commercialization of the active compressions medical device. In addition, Mark Gummin, PhD, a world leader in shape-memory alloy design and performance, is involved with the grant. “As a scientist with over 20 years of experience working with shape-memory alloys, I am genuinely impressed with what Recovery Force has accomplished,” Dr. Gummin said. “Where large corporations have tried and failed, Recovery Force is succeeding and surpassing.”
Research reported in this press release was supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health under the Award Number R43HL132624-01A1. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
About Recovery Force LLC
Recovery Force (“RF”) is a US-based company targeting a $3B market opportunity. The company’s patented, shape-changing technology is embedded into wearable garments to effectively produce variable compressions on extremities, and targets sore and fatigued muscle groups. The product platform provides a unique and tactile user experience, aiding recovery by facilitating blood flow, reducing pain, and improving user compliance. It’s simple to use and just feels good! The technology has applications in healthcare, consumer pain, athletics, the military and pets. Recovery Force has moved into production with a publicly traded contract manufacturer, and is preparing to bring its products to market in late 2017 through a business model that includes product licensing arrangements with large strategic corporations, as well as Direct to Consumer.
The company’s Class II 510(k) medical product, the RF 1400 Active Compression Wrap, contains the company’s patented technology. The intended uses as disclosed are: Aid in the prevention of DVT; Enhance blood circulation; Diminish post-operative pain and swelling; Reduce wound healing time; Aid in the treatment and healing of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency, chronic lymphedema, and reduction of edema in the lower limbs; prophylaxis for DVT by persons expecting to be stationary for long periods of time; Reduction of edema associated with soft tissue injuries, such as burns, postoperative or post-immobilization edema or ligament sprains.
Recovery Force LLC is headquartered in Fishers, IN at Launch Fishers, a premier technology office space and business accelerator. The Company is also a member and maintains a satellite office at MATTER, a healthcare business incubator in Chicago, Illinois.
For more information, please visit the Company’s website at www.recoveryforceusa.com.