Vaporox Announces FDA Clearance for Its Next Generation Wound Care Medical Device
Monday, March 27, 2023
Vaporox, a Denver based medical device company, has received clearance from the US Food and Drug Administration for its next generation VHT-200 medical device system for healing chronic wounds, which are wounds that do not respond to conventional wound treatment, meeting a significant unmet medical need for millions of sufferers of diabetic foot ulcers.
Vaporox’s Vaporous Hyperoxia Therapy (VHT™) is a breakthrough technology that has been clinically validated as a safe and effective adjunct treatment for healing skin wounds.
The VHT-200 brings advanced wound care technology into the private practice setting. By delivering healing rates exceeding 80% for chronic wounds, the VHT-200 allows providers to deliver Advanced Wound Care in their practice.
VHT delivers a unique combination of elements that have been shown to accelerate healing: ultrasonic mist and concentrated oxygen. Vaporox’s patented and FDA-cleared delivery system for these elements promotes revascularization and tissue growth.
Three separate clinical studies and thousands of successfully billed commercial treatments have demonstrated that adding VHT to standard wound care consistently doubles or triples healing, delivering results in 20 weeks or less.
The company’s Medical Director, Dr. Dustin Kruse, is a double-board-certified podiatrist in private practice. As Primary Investigator for Vaporox’s second and third clinical studies, Dr. Kruse said, “Overseeing the clinical study was eye opening. We consistently observed incredible healing in 20 weeks or less, even on the most complex patients, with the only variable being the addition of VHT.”
Ken Reali, the CEO of Bioventus, the company’s largest corporate investor, said, “We’re excited to see Vaporox’s technology become available to the mass market. It has the potential to transform wound healing.”
Louis Woodhill, the Chairman of Vaporox’s Board of Directors, said, “It has been profoundly satisfying to have played a role in bringing this lifesaving and life-changing technology to market. The VHT-200 represents a major step forward toward a world where all wounds heal.”
Vaporox plans to immediately begin placing VHT-200 devices with podiatrists and M.D.s in private practices in the U.S.