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Integrated Healing Technologies Receives FDA 510(k) Clearance for its Patented NewEra REVA Kit.

Nashville, TN., March 3, 2015 — Integrated Healing Technologies, a company with a mission to accelerate the healing of patients who suffer from acute and chronic wounds, announced today that it has received 510(k) clearance for its patented NewEra REVA negative pressure wound therapy system from the US Food and Drug Administration. The patented REVA Drain is the first of its kind to be used with Negative Pressure Wound Therapy (NPWT) and is an essential part of the Integrated Healing Technologies innovative wound care system.

“We are delighted that our patented NewEra REVA Kit has received FDA 510(k) clearance, it is a first of its kind system,” said Integrated Healing Technologies’ CEO Albert Rodewald. “As part of our total wound healing solutions, the NewEra System helps patients heal faster and delivers efficiency to caregivers and providers alike through simpler, faster dressing changes, allowing for better outcomes and lowered costs.”

The REVA Drain, comprised of a flat or round channel drain and an integrated occlusive skirt, facilitates rapid dressing application, and allows for the treatment of non-complicated shallow to deep wounds, and wounds that have undermining or tunneling.

Integrated Healing Technologies’s NewEra System is the only NPWT system to utilize Cutimed Sorbact as the primary filling material as part of its FDA 510(k) clearance.  This antimicrobial mesh is low adherent, hydrophobic, and poses no risk of pathogenic resistance. Nursing time at each dressing change is decreased due to the foam-free application and the patient will not experience the dressing change pain as previously associated with competitive NPWT systems.  The NewEra System is also the only NPWT system that incorporates the pure hypochlorous acid wound wash, PhaseOne, in every dressing kit.  Non-toxic PhaseOne is 80-100 times more effective than Dakin’s Solution and has show in-vitro to disrupt bacterial biofilms and eliminate 99.99% of pathogens in less than a minute, while preserving new tissue.

The NewEra REVA Kit is intended to be used with the NewEra pumps. The system creates an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formations and perfusion, and by removing exudate and infectious material.  NPWT is appropriate for use on the following wounds:

  • Pressure Ulcers
  • Diabetic/neuropathic ulcers
  • Venous insufficiency ulcers
  • Chronic, Acute, Traumatic, and Subacute wounds
  • Post-operative and dehisced surgical wounds

 

About Integrated Healing Technologies, Inc.

Integrated Healing Technologies (IHT) is a technology-enabled wound care services company that specializes in the delivery of negative pressure wound therapy (“NPWT”) devices and systems. Our mission is to accelerate the healing of patients who suffer from acute and chronic wounds. For more information on Integrated Healing Technologies, please visit www.ihtwoundcare.com.