Arobella Medical - Sound Touch for Wound Care™

FOR IMMEDIATE RELEASE

Health Canada issues Medical Device Licence to Arobella Medical, LLC

Minneapolis, Minn.(June 25, 2016) - In accordance with Health Canada Medical Devices Regulations, Section 36, Arobella Medical, LLC issued Medical Device Licence (Class 2 MDL LN97205) for the Qoustic Wound Therapy System™ platform, its variants and accessories.

This licence represents another major milestone for Arobella Medical’s passionate pursuit to advance the standard of care when it comes to treating and healing wounds.

Eliaz Babaev, CEO and President of Arobella Medical, LLC, “Currently in negotiations with several distributors, we are trying to bring this technology all across Canada and all the various provinces."

He added, "We are glad we can finally bring this improved standard of care to current wound care practices and facilities and offer another tool to improve the quality of life for patients with a wide variety of chronic and other types of troublesome wounds.”

The Qoustic Wound Therapy System™, Model AR1000 Series and its variants had previously received, under FDA 510(k) clearance (K131096), new and expanded claims and indications for use, as indicated below:

The Qoustic Wound Therapy System™ is indicated for producing and delivering low frequency ultrasound used to promote wound healing via:

  • Selective and non-selective dissection and fragmentation of soft and/or hard tissue
  • Surgical, excisional or sharp-edge wound debridement (acute and chronic wounds, burns) for the removal of nonviable tissue including but not limited to diseased tissue, necrotic tissue, slough and eschar, fibrin, tissue exudates, bacteria and other matter
  • Site cleansing irrigation and lavage of wound tissue (acute and chronic wounds, burns, diseased or necrotic tissue)
  • Contact and/or non-contact maintenance debridement for the removal of debris, exudates, fragments, bacteria, slough, fibrin, excised or fragmented tissue, and other matter
  • Preparing the wound bed for graft or other subsequent procedures using contact and/or non-contact techniques to achieve wound debridement

It is prescribed for patient population of any age with one or more wounds and/or that may also exhibit Diabetes Mellitus (DM)1

We are very excited at what this represents in the advancement of wound care, improved treatment methodologies and trajectories, and better patient compliance and outcomes.

About the Qoustic Wound Therapy System®

The Qoustic Wound Therapy System® is specifically designed to maintain sufficient momentum throughout the wound healing process for optimal healing. The Qoustic Wound Therapy System® is an ideal choice for treating a variety of wounds, including:

  • Pressure Ulcers
  • Arterial Wounds
  • Chronic Wounds
  • Diabetic Foot Ulcers
  • Osteomyelitis
  • Fistulas
  • Burns
  • Biofilm
  • Compromised Surgical Wounds
  • Venous Insufficiency Ulcers
  • Infected, Eczematous, Ulcerated or Devitalized Skin

The Qoustic Wound Therapy System® provides a superior debriding process for both treatment providers and patients. The unique domed shape of the Qoustic Qurette™ gives the treatment provider more control for gentle and selective volumetric removal of necrotic tissue. This state-of-the-art technology targets focused low frequency ultrasonic energy through saline to the wound bed. It is this unique delivery of low frequency ultrasonic energy that optimizes healing while potentially minimizing patient discomfort. Please contact us for more information.

About Arobella Medical, LLC

Arobella Medical, LLC is Minnetonka-based medical device company specializing in low-frequency ultrasound in wound management therapies. Arobella Medical, LLC is positioned to become the leader in advanced ultrasound wound care technologies and devices. Arobella Medical, LLC co-founder and CEO Eliaz Babaev has more than 45 years of experience developing, designing and commercializing medical devices that use ultrasound.

If you want to find out more about the Qoustic Wound Therapy System® or to evaluate the device at your site, call 866-968-6970 or 952-345-6840, e-mail service@arobella.com, or visit www.arobella.com today.

System Components