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Spiracur Announces FDA Clearance of Its SNaP Wound Care System Dressings With Hyperbaric Oxygen Therapy

SUNNYVALE, CA -- (Marketwired) -- 04/01/14 -- Spiracur today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the SNaP® Wound Care Dressing (with fittings and cartridge removed) for use in a hyperbaric oxygen therapy (HBOT) chamber for the treatment of chronic wounds. Spiracur develops the only mechanically powered advanced wound care solution that delivers the proven efficacy of Negative Pressure Wound Therapy (NPWT).

"At the O'Connor Wound Care Clinic, we utilize the latest and some of the most advanced treatment options including whole body HBOT for our patients who have wounds that won't heal because of diabetes or other health conditions," said Bruce Lerman, D.P.M., O'Connor Hospital, San Jose, Calif. "In fact, we just began using the ultraportable SNaP Dressing products with HBOT, as they are my first choice for NPWT, and the combination of the two therapies is proving to be a very effective treatment option for chronic, non-healing ulcers."

HBOT is the medical use of oxygen, which involves the breathing of pure oxygen while in a sealed chamber that has been pressurized at one-and-a-half to three times normal atmospheric pressure. A well-established treatment for decompression sickness, HBOT is also used to treat severe carbon monoxide poisoning; certain kinds of wounds, injuries and skin infections; delayed radiation injuries; and certain bone or brain infections(1).

"We are very pleased that SNaP Dressings are now able to remain in place while patients undergo HBOT for chronic wound treatment such as diabetic foot ulcers," said Linda LaMagna, vice president of global marketing for Spiracur. "Because the SNaP Dressings are cleared for use within a HBOT chamber, our SNaP System is a smart and convenient choice for wound care clinics looking for an advanced NPWT solution that is proven to be effective, safe for patients, and reimbursable by Medicare."

Spiracur is credited with creating a new category of chronic and acute wound management solutions that combine the benefits of advanced wound care with non-powered NPWT. The SNaP (Smart Negative Pressure®) System provides patients with a sophisticated, non-invasive NPWT system designed to promote wound healing, which weighs only 2.2 ounces and does not require batteries or electricity.

Spiracur's suite of products cleared by the FDA for use with HBOT include the SNaP Dressing Kit, a proprietary hydrocolloid dressing offering periwound protection and easy removal; the SNaP Bridge Dressing, a soft dressing with pressure points displaced away from the wound to minimize further pressure damage; the BLUE foam interface layer, which helps promote granulation tissue formation and may improve visualization of exudate; and the SNaP SecurRing® Hydrocolloid, a soft and moldable hydrocolloid that is designed to enable fast and easy sealing on uneven skin surfaces and wounds in challenging locations.

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 University Biodesign Innovation Program in 2007. Its first product, the SNaP Wound Care System for the treatment of chronic and acute wounds, is the result of patient and clinician feedback that current negative pressure wound therapies were too cumbersome. The company's ciSNaP® Closed Incision System with proprietary controlled tension relief is designed to improve healing of high-risk surgical incisions. Both devices have received 510(k) clearance from the U.S. Food & Drug Administration (FDA) and have received CE Mark approval. Spiracur's proprietary mechanically powered technology does not require batteries or electricity to operate. For more information, please visit http://spiracur.com.

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

(1) www.cancer.org/treatment/treatmentsandsideeffects/complementaryandalternativemedicine/herbsvitaminsandminerals/hyperbaric-oxygen-therapy

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