News | February 13, 2001

PhotoMedex to market XTRAC Laser System for treatment of Vitiligo

PhotoMedex to market XTRAC Laser System for treatment of Vitiligo
(BUSINESS WIRE) -- PhotoMedex, Inc. announced that it has submitted an application for 510 (k) clearance from the U.S. Food and Drug Administration (FDA) to commercially market its XTRAC laser system for the treatment of vitiligo.

Vitiligo is a skin disease that, according to the National Vitiligo Foundation (NVF), afflicts approximately 1-2% of Americans (2-4 million). The disease causes the loss of pigmentation; patients' cells are destroyed and the pigment can no longer be produced, which results in the development of white spots of various sizes and in various locations.

The spots occur when pigment cells are destroyed and the pigment can no longer be produced. The NVF further reports that PUVA, the mainstay of treatment for vitiligo patients, can cost $6,000 or more per patient. This figure is based on 120 treatments over an eighteen-month period and includes medication, office visits, light therapy, lab tests and eye exams that are necessary because of the possible damage to the eyes as a result of the light therapy.

This figure does not include the patient's loss of work time, or travel expense to obtain treatments. Most insurance companies do not cover the cost of treatment; therefore, many patients are unable to receive proper care for the disease. As a result, some patients have lost their jobs or are unable to obtain work due to their cosmetic disfigurement, especially if the work involves interaction with the general public.

The company's President and CEO Jeff O'Donnell, commented, "The FDA filing for vitiligo reflects our commitment to expand the treatment capabilities of our XTRAC system to other skin diseases. We believe the preliminary clinical indications we have received to date support our hope for a timely approval, which approval would allow our doctors to begin offering an efficacious treatment to a patient population that up to now has had few options and is largely under served."

The company also announced that Timothy Driscoll has been hired as Manager of Field Services. In this newly enhanced position, Mr. Driscoll will be responsible for all field and technical support and maintenance activities for the company.

Prior to joining PhotoMedex, Mr. Driscoll spent one and one-half years in field service for Visx, Incorporated, the leading excimer laser company in vision correction, and well known for its product reliability and service.

Prior to his employment at Visx, Mr. Driscoll spent three years as manager of field and technical support at Cynosure, Inc., Chelmsford, MA. Cynosure manufactures and sells lasers primarily used for cosmetic dermatological applications. Mr. Driscoll's staff, which he built up from 3 to 20, supported both domestic and international customers, which at the time of Mr. Driscoll's departure numbered in excess of 1000.

Prior to his employment at Cynosure, Mr. Driscoll spent three years as a field engineer for Piller, GmbH, a German company.

Timothy Eberhardt, Vice President, COO, stated, "We are very excited to be able to add somebody of Tim's capability and experience to our staff to oversee a function that is vitally important to the future growth of our Company. We are committed to having the highest standards of system reliability and service in our industry, and we feel confident that Tim is the right person to ensure that those standards are met and maintained."

The company's excimer laser system generating 308-nm UV-B radiation is the first FDA-approved laser treatment for psoriasis, which is the second most common skin disorder in the U.S. The National Psoriasis Foundation estimates that psoriasis afflicts more than 7 million Americans and that between 150,000 and 260,000 new cases are diagnosed each year.

PhotoMedex is engaged in the development of proprietary excimer laser and fiber optic systems and techniques directed toward dermatological applications focusing on psoriasis.