SOURCE: Spiracur Inc.

Spiracur Inc.

July 12, 2011 09:00 ET

Health Canada Issues Medical Device License to Spiracur Inc. for SNaP Wound Care System

Non-Powered Innovative Treatment Device Now Available in Canadian Market

SUNNYVALE, CA--(Marketwire - Jul 12, 2011) - Spiracur Inc., the developer of an ultraportable and disposable negative pressure wound therapy (NPWT) device, announced today that it has received a medical device license from Health Canada permitting the company to sell its SNaP® Wound Care System (Smart Negative Pressure) throughout the country. Spiracur's SNaP System is a clinically proven, non-powered device designed to treat patients suffering from chronic wounds.

"The Canadian marketplace offers Spiracur an excellent opportunity to expand the presence of our SNaP System to patients who would benefit from a new device that may improve their quality of life," said Gary Restani, president and CEO, Spiracur Inc. "There exists strong momentum in the North American wound care markets for negative pressure wound therapy and Spiracur is well positioned to save substantial treatment costs in addition to allowing patients greater freedom and mobility."

Spiracur's SNaP Wound Care System is changing the approach of how wound healing is delivered to patients. Its inventive design eliminates the electric or battery powered pump used to deliver NPWT. The SNaP System is completely silent and lightweight, weighing only 2.2 ounces. In addition, the device is discreet and can easily fit under a patient's clothing, which may result in significantly improved patient acceptance and compliance of the therapy.

A recent 12-center randomized-controlled trial (RCT) published in Wound Repair and Regeneration reported promising interim analysis supporting the efficacy and safety of the SNaP System, and a trend toward non-inferiority to the traditional electrically powered Vacuum-Assisted (VAC®) Closure System in the treatment of lower extremity wounds.

Patient exit survey data were collected including Quality of Life (QOL) measurements. When patients were asked if they were able to work and perform normal daily activities while being treated with the NPWT device, 92.4 percent agreed that they could work and perform daily activities using the SNaP System compared to 33.3 percent of patients using the VAC System. When asked about sleep disruption, 100 percent of patients using the SNaP System said the device did not bother them while trying to go to sleep, yet 41.7 percent of patients using the VAC System felt that their sleep was disrupted by the device. By and large, the SNaP System interfered less with overall activity. Final analysis of the RCT is currently underway.

Spiracur was awarded the prestigious American Podiatric Medical Association's (APMA) Seal of Approval for the SNaP System in March 2011.

About Spiracur Inc.
Spiracur Inc., headquartered in Sunnyvale, Calif., is a privately held medical device company focused on the development of innovative wound healing technologies. Spiracur was founded out of the Stanford Biodesign Innovation Program in 2007. Its first product, the SNaP Wound Care System, is the result of patient and clinician feedback that current negative pressure wound therapies were too cumbersome. The SNaP Wound Care System was cleared by the U.S. Food & Drug Administration (FDA) in August 2009 in a new therapy category defined as "non-powered" NPWT devices, and the company obtained CE Mark for the device in December 2010. The SNaP Wound Care System is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing through the removal of excess exudates, infectious material and tissue debris. The device is indicated for removal of small amounts of exudates from chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic and pressure), surgically closed incisions, flaps and grafts. For more information, please visit http://www.spiracur.com.

Spiracur, Spiracur logo and SNaP are registered trademarks of Spiracur Inc. SNaP & Design and Smart Negative Pressure are trademarks of Spiracur Inc.

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