FDA Clears NEXA™ NPWT System for Home Use — A Major Advancement in Portable Wound Therapy
Advanced Oxygen Therapy Inc. (AOTI) has announced that its NEXA™ Negative Pressure Wound Therapy (NPWT) system has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use in the home care setting. This expanded indication allows patients to receive the same advanced level of wound care outside of institutional environments, a breakthrough that could improve healing rates and reduce hospital readmissions for chronic and acute wounds.
The clearance (K241515), issued in August 2024, followed rigorous evaluation including a human factors study that confirmed the system’s safety and effectiveness when used by patients or caregivers at home. NEXA is now FDA-cleared for use across acute, extended, and home care environments, aligning with its previous CE Mark approval and international adoption.
“Bringing advanced wound care into the home is the future of healing,” said Dr. Mike Griffiths, CEO of AOTI. “With NEXA, we’re combining the ease and affordability of disposable NPWT with the performance and reliability clinicians expect from traditional systems.”
Key features of the NEXA™ NPWT System:
- Portable and discreet: Lightweight design with a convenient shoulder bag and quiet operation for patient comfort and mobility.
- Extended use: Each unit can be used for up to 56 days, with a rechargeable battery and replaceable dressing kits.
- Innovative fluid management: 120ml pouch-style canister and hydrodynamic pump that functions even with minor leaks.
- Visual-only alerts: Eliminates disruptive audio alarms while maintaining safety.
- Cost-effective care: Low daily cost and reduced need for frequent dressing changes may help healthcare systems save significantly.
Designed to support the healing of a wide range of wound types — including diabetic foot ulcers, venous leg ulcers, pressure injuries, and surgical wounds — NEXA aims to bring hospital-grade therapy to the patient’s doorstep.
Read the full press release on the AOTI website.
Keywords:
NEXA NPWT,
Negative Pressure Wound Therapy,
AOTI,
FDA 510(k) clearance,
Home wound care,
Portable NPWT,
Chronic wound healing