Founded around the work of neonatal intensive-care nurse and co-founder Colleen John, R.N., RashEndZ, Inc. makes FDA-registered occlusive wound dressings that deliver continuous topical oxygen through standard medical oxygen supplies. Based in St. Petersburg with an executive office in New York City, the company’s patented GasPort™ platform is designed for hard-to-heal wounds as well as pediatric and perineal skin conditions, without proprietary equipment. Its clinical program includes an FDA-approved Florida hospital safety study and reported case results in pressure injuries and long-term-care wounds.
FDA-Registered Device under 21 CFR 878.4020
Registration
FDA Class I General Controls; 21 CFR 878.4020
Compliance program
CE Mark under EU MDR 2017/745 Rule 1
ISO 10993 Testing
Compliance program
FDA
Quality certification
GWR Medical, IncFounded in 1996 in Chadds Ford, Pennsylvania, privately owned GWR Medical develops FDA-cleared topical oxygen therapy devices for hard-to-heal open wounds and burns. Its home-based TO2 treatment is paired with WoundMatrix, the company’s wound-imaging and measurement technology, to help clinicians and insurers track healing remotely. GWR says its therapy has been provided to 15,000 patients and has been used by the Department of Defense and Veterans Administration.CHADDS FORD, PA
Ben Guard Health IncBen Guard Health makes FDA-approved medical wearables that protect pediatric patients with central lines and other treatment tubing. The company’s products grew from Benjamin’s six-year battle with brain cancer, during which his central line was pulled out, infected, and replaced more than 20 times. Women-owned and made in the USA, Ben Guard says its patented wearables have been clinically proven and validated by leading children’s hospitals.LOVELAND, OH
CathCareCathCare makes PortPouch®, a wearable IV catheter cover designed to protect insertion sites while reducing infection risk and accidental dislodgement. Based in Southampton, New York, the company focuses on patient-centered medical products that make IV treatment more comfortable and manageable in hospitals and at home, including for children and other vulnerable patients. CathCare is registered with the FDA and certified by the Women’s Business Enterprise National Council.SOUTHAMPTON, NY
DRW Medical, LLCDRW Medical develops neonatal respiratory-care equipment, including monitors that help clinicians manage airway pressure during Bubble CPAP and nasal high-flow therapy. Based in Aston, Pennsylvania, the company’s work is shaped by a respiratory therapist president and co-founder Robert Landis, a medical-device designer with 19 patents and a history in neonatal respiratory technology. Its NAPA monitors are built to make otherwise hard-to-see pressure changes visible at the bedside, while the company also develops safer suction equipment for infant care.ASTON, PA