SOURCE: Spiracur Inc.

Spiracur Inc.

January 25, 2011 09:00 ET

Spiracur Secures CE Mark Approval for SNaP Wound Care System

SUNNYVALE, CA--(Marketwire - January 25, 2011) - In an effort to enhance patient outcomes utilizing negative pressure wound therapy (NPWT), a new ultraportable, single-use NPWT device from Spiracur® Inc. is now approved for sale in the European Union (EU). The company announced today that it has obtained CE Mark approval for its SNaP® Wound Care System. The device may be used on patients who would benefit from a suction device for wound healing. It works by removing small amounts of exudate (fluid) from chronic, acute, traumatic, subacute and dehisced wounds, as well as ulcers (such as diabetic or pressure) and surgically closed incisions.

"We are extremely pleased to have obtained CE Mark approval for our SNaP Wound Care System, as it will enable clinicians throughout the European Union to treat patients suffering from chronic wounds with clinically proven negative pressure wound therapy," said Gary Restani, president and chief executive officer, Spiracur Inc. "There exists strong momentum in the United States for the delivery of NPWT using smaller, more discreet devices that can improve patient compliance and enhance their quality of life. Spiracur is well positioned to not only enhance the therapy of chronic wound conditions, but also improve the outcomes of treatment."

Spiracur's SNaP Wound Care System (Smart Negative Pressure) is changing the approach of how NPWT is delivered to patients. Its inventive design eliminates electric or battery power in the healing process; therefore, the delivery device is completely silent, as well as lightweight and small (less than 85 grams). The device is disposable and can easily fit under a patient's clothing, enabling patients to resume daily activity without exposing their wound care treatment to the world.

In September 2010, interim results from a clinical study highlighting the safety and efficacy of the SNaP Wound Care System for the treatment of chronic lower extremity wounds was presented at the Fall 2010 Symposium on Advanced Wound Care (SAWC) in Anaheim, Calif. The 12-center, randomized controlled trial (RCT) compares NPWT between the KCI Wound V.A.C. Therapy System and the SNaP Wound Care System, evaluating treatment for up to 16 weeks, or until there was complete closure of the ulcer. The interim analysis found no significant differences in the proportion of subjects healed between the two devices evaluated. According to principle investigator, David G. Armstrong, DPM, M.D., Ph.D., professor of surgery at the University of Arizona, "Spiracur's novel technology may prove to hold substantial potential for patients requiring smaller NPWT treatment options, as the device provides an important tool for treating these chronic conditions." 

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, grew out of the notion that current negative pressure wound therapies were too cumbersome for patients and clinicians. Spiracur strives to develop products that are truly patient-centric. For more information, please visit http://www.spiracur.com.

SNaP, Spiracur and the Spiracur Design are registered trademarks of Spiracur Inc.

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