Tuesday February 1, 2000
Company Press Release
(The following press release appears verbatim as it did in February 2000. The company subsequently changed its name to PhotoMedex in June 2000.)
Laser Photonics Receives FDA Approval for New
Excimer Laser System for Treatment of Psoriasis
CARLSBAD, Calif.–(BW HealthWire)–Feb. 1, 2000–Laser Photonics, Inc., (LPI) (OTC BB: LSPT) today announced that it has received U.S. Food and Drug Administration approval to market its excimer laser system to treat psoriasis. LPI’s excimer laser system is the first FDA-approved laser treatment for psoriasis, the second most common skin disorder in the U.S. The National Psoriasis Foundation estimates that psoriasis afflicts more that 6 million Americans, and that between 150,000 and 260,000 new cases are diagnosed each year. Psoriasis is a chronic inflammatory skin disorder characterized by red, scaly plaques that can cause considerable patient discomfort. A clinical study led by Dr. Charles Taylor at Massachusetts General Hospital (MGH) in Boston, demonstrated that the LPI laser system is safe and effective for treating psoriasis. Introduction of the system in the U.S. is planned for March 2000.
R. Rox Anderson, M.D., Associate Professor of Dermatology, Harvard Medical School, and a colleague of Dr. Taylor at MGH said,“ Excimer laser treatment of psoriasis can be much more efficient than conventional phototherapy. By avoiding exposure of healthy skin to Ultraviolet B (UVB), we can safely give the desired higher exposure doses needed for rapid clearing.” Dr. Anderson has pioneered various laser treatments in dermatology, and serves on LPI’s scientific advisory board.
The causes of psoriasis are not exactly known, however, recent studies have established that it is an immune-mediated disorder that can strike at any age and for which there is no cure. The disease most commonly appears on the scalp, knees, elbows, hands and feet. There are many different treatments, both topical and systemic, and often a patient is in constant search for a treatment that is effective. Even with the current therapy options, it is believed there are millions of unsatisfied psoriasis patients who lack effective treatment.
“The FDA approval of LPI’s excimer laser system means that millions of psoriasis sufferers in the U.S. will now have access to a new, safe, and effective treatment method for a serious disease that has a major impact on the patients’ quality of life,” commented Jeff O’Donnell, President and CEO of Laser Photonics, Inc. “I am very proud of the hard work and dedication of all the employees of LPI and the commitment from the outstanding medical professionals at MGH, who share in our goal of offering the dermatologist and their patients new effective treatment methods for psoriasis.”
The Company expects to announce in the near future that it has engaged the services of an investment bank to assist LPI in financing the worldwide commercial launch of its excimer laser system.
Laser Photonics’ technology is contrasted with conventional UVB treatment currently in use to treat psoriasis. Since 1930, UVB has been the most popular treatment for moderate-to-severe psoriasis. While generally effective, conventional UVB phototherapy has numerous shortcomings, including patient inconvenience, exposure of the whole body to ultraviolet light, and skin cancer and photo-aging risks, all of which have a detrimental impact on patient satisfaction. The Company’s excimer laser is designed to greatly reduce the number of annual treatments, decrease the duration of a course of therapy, and deliver ultraviolet energy specifically to the lesion sites via a fiber optic instrument, thereby reducing the cancer risk to non-affected skin.
Laser Photonics is engaged in the development of proprietary excimer laser and fiber optic systems and techniques directed toward the treatment of cardiovascular and vascular disease and dermatological applications focusing on psoriasis.
Some paragraphs of this press release, particularly those describing Laser Photonics’ strategies, operating expense reductions and business plans, contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1993, as amended and Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. While Laser Photonics is working to achieve those goals, actual results could differ materially from those projected in the forward-looking statements as a result of a number of factors, including difficulties in marketing their products and services, need for capital, competition from other companies and other factors, any of which could have an adverse effect on the business plans of the subsidiary companies of Laser Photonics, its reputation in the industry or its expected financial return from operations. Factors such as these could have an adverse effect on Laser Photonics’ results of operations. In light of significant uncertainties inherent in forward-looking statements included herein, the inclusion of such information should not be regarded as a representation by Laser Photonics and its subsidiaries will be achieved.