CleveX, Inc. Receives FDA Clearance To Market ExiClipTM Skin Biopsy With Wound Closure Device

Main Category: Dermatology
Article Date: 10 May 2007 - 10:00 PDT

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CleveX, Inc., a developer and marketer of innovative, surgical devices for dermatologic procedures and cosmetic surgery, announced today that the Food and Drug Administration ("FDA") has granted 510(k) clearance to market and sell its ExiClipTM skin biopsy with wound closure device in the United States. The Company plans to launch ExiClipTM sales through its direct and dealer sales force in the 3rd quarter of 2007.

ExiClipTM is a sophisticated, disposable, hand-held surgical instrument that in a single action removes small skin lesions and closes the site in a fraction of the time it currently takes physicians to perform that procedure. It also leaves minimal scarring. The device contains a proprietary, internal surgical blade and a novel external clip that simultaneously allow the excision of the lesion and closure of the wound in one quick motion, without a surgeon or dermatologist having to suture. The disposable ExiClipTM device will sell for $35 - $50 and makes the skin lesion removal procedure faster and easier for both the physician and the patient.

"CleveX is creating technologies and products which will facilitate the diagnosis and treatment of skin cancers and other dermatologic diseases more effectively," said Gary Smith, president and CEO of CleveX. "ExiClipTM is our flagship product. With the 510(k) clearance, we are now well-positioned to move forward with our sales and marketing plans in the United States. The FDA decision lays the groundwork for moving forward in gaining clearance in Australia, Europe and other international markets as well."

"Whether for diagnostic biopsy or cosmetic preference, our skin biopsy and wound closure technologies will help improve patient outcomes and enhance practitioner efficiency," said Warren Williamson, CTO and Co-founder of CleveX. "We are very pleased with the rapid turnaround and approval of our submission and we look forward to bringing this technology to healthcare practitioners."

CleveX headquartered in Columbus, Ohio, is a medical device company focused on creating and marketing innovative, surgical devices for dermatologic and cosmetic procedures. CleveX was founded in 2003 as a joint venture between Cleveland Clinic Innovations and IDx Medical Ltd. in Cincinnati, Ohio and based on concepts developed by Cleveland Clinic surgeons.

http://www.clevex.com.