Domain Surgical Receives FDA 510(k) Clearance for FMwand® Surgical Handpiece with Integrated Smoke Evacuation

Investment will be used to evolve Domain Surgical's ferromagnetic surgical product platform, produce additional outcomes evidence, and expand global sales and distribution

SALT LAKE CITY (May 29, 2014) - Domain Surgical, a leading developer of advanced thermal surgical technology, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market its next-generation FMwand surgical handpiece with integrated smoke evacuation.

The FMwand Ferromagnetic Surgical System is a thermal surgical system that is used for cutting and coagulation of soft tissue during complex surgical procedures. The FMwand uses pure thermal energy to cut and coagulate tissue, without passing electrical current through the patient. The FMwand minimizes collateral tissue damage, causing as little as 1/10th the depth of thermal damage compared to standard electrocautery in some tissue types, preserving more viable, healthy tissue beyond the incisional plane.

The FMwand surgical handpiece with integrated smoke evacuation was developed in response to surgeon feedback. The new surgical handpiece connects to a smoke evacuation or suction system, and provides effective evacuation of smoke created while operating the FMwand.

"We are pleased to have received FDA clearance for the FMwand with integrated smoke evacuation," said David McNally, President and CEO of Domain Surgical. "This achievement provides further evidence that our seasoned team is making steady progress in rolling out planned product extensions of our award-winning, advanced energy surgical platform."

In support of its FDA medical device submission, Domain Surgical successfully conducted several laboratory and pre-clinical studies with leading surgeons.

About Domain Surgical, Inc.
Domain Surgical, Inc. is a privately held company based in Salt Lake City, Utah. The company has commercialized a surgical platform for precise cutting and coagulation of soft tissue. Domain Surgical's patented technology produces surface-only tissue effects without passing electrical energy through the patient, and is designed to provide unparalleled safety and predictability in the most critical surgical applications. For more information, please visit www.domainsurgical.com.

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