CIMEX BioTech L.C. has introduced a new, cutting edge cryosurgery device, the CryoPen. It is the first and only cryosurgery device that does not utilize dangerous gas or liquid cryogens. The hand-held, portable CryoPen is simply removed from the cooling base and placed onto the lesion. The CryoPen will maintain a consistent ideal temperature for the duration of procedural time, thereby assuring safe and effective removal of unwanted lesions.
It is estimated that there are approximately seventy-five million skin lesions removed each year in the United States. The key to successful cryosurgical removal of skin lesions is extremely cold temperature. CIMEX's CryoPen utilizes solid state technology to achieve and maintain the extreme cold temperatures necessary for proper skin lesion removal.
The CryoPen will allow a multitude of physicians, including Family Practice, General Practice, and Gynecologists, to perform safe and effective cryosurgical procedures.
Unlike current cryosurgical devices, the CryoPen uses no dangerous gas or liquid cryogens. Until now, Nitrous Oxide, Liquid Nitrogen, and Carbon Dioxide were the commonly used methods capable of achieving the necessary cold temperatures to effectively remove most skin lesions. The Occupational Safety and Health Association (OSHA) require stringent safety guidelines regarding the proper usage and storage of cryogenic gases and liquids. The CryoPen offers a safe alternative to gas and liquid cryogens.
A 510(k) application with the U.S. Food and Drug Administration (FDA) has been submitted and CIMEX anticipates approval by the spring of 2002.