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Integrated Healing Technologies Receives FDA 510(k) Clearance for its Proprietary NewEra Dome Kit

Nashville, TN., February 24, 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 NewEra Dome negative pressure wound therapy system from the US Food and Drug Administration. The NewEra Dome used with Negative Pressure Wound Therapy (NPWT) and is an essential part of the Integrated Healing Technologies innovative wound care system.

“We are committed to providing patients and caregivers with state of the art wound care therapies and we are very excited to receive a 510(k) from the FDA for our proprietary New Era Dome Kit,” said Integrated Healing Technologies’ CEO Albert Rodewald. “Our Dome Kit is designed to facilitate rapid dressing application which helps lead to a faster dressing change and better outcomes.”

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 associated with foam-based NPWT systems.  The NewEra System is also the only NPWT system that incorporates PhaseOne, a pure hypochlorous acid wound wash, 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 Dome 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
  • Explored fistulas
  • Skin flaps and grafts

 

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.