The Food & Drug Administration has finally set a panel date for the MelaFind, a hand-held device designed to determine whether skin moles and lesions are cancerous, possibly eliminating the need for biopsies.
The agency’s General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee set a Nov. 18 date for MELA Sciences Inc. (NSDQ:MELA), the Irvington, N.Y.-based maker of the device, which originally filed a pre-market approval application with the federal watchdog in June 2009, more than 14 months ago.
The company says its MelaFind instrument uses a computer-controlled multi-spectral dermoscope, employing light to image the skin through a thin layer of liquid (alcohol or oil), making lesion structures under the skin surface visible to dermatologists. The device records the images, which are sent to a computer that uses an algorithm to compare it with pictures of thousands of malignant and benign lesions to determine the likelihood of skin cancer.
Mela claims the procedure can help reduce, or even eliminate, the need for biopsies.
A clinical trial of 1,300 patients in 2009 showed that the MelaFind’s ability to detect cancerous lesions was 2.5 times greater than a dermatologist’s, according to media reports.
Earlier this summer, the company, which changed its name from Electro-Optical Science Inc. in 2009, filed a public offering of about 2.2 million shares at $7.50 each to raise funds to complete the commercialization of the device. Needham & Company LLC and Leerink Swann LLC acted as joint book-running managers for the IPO, which added about $13.8 million to the company’s coffers, according to a regulatory filing.
Shares of MELA, however, dropped on an announcement last month that the FDA had put off its panel date, which was originally scheduled for late August. The stock price has since regained its footing and closed at $6.50 per share August 13.
The FDA panel will release material on the device two days ahead of the hearing.