In an action that increases its potential market to more than $270 million a year, Trimedyne Inc. said it has received Food and Drug Administration approval to market a medical laser system for non-surgical treatment of cancerous and non-cancerous pulmonary tumors.
It is the fourth FDA-approved commercial application for the Santa Ana company's medical laser and adds a $30-million-a-year market to the arena in which Trimedyne competes.
Trimedyne said its non-surgical laser treatment may reduce hospitalization and lower the cost of treating tumors that grow and expand in the body's pulmonary system.
The cancer-treatment market is one of the toughest in which to compete because of the relatively low number of patients. Trimedyne is only a small player, according to Pieter Halter, president of Biomedical Business International, a Tustin-based trade journal.
But the pulmonary treatment is a key factor for Trimedyne because it provides an additional application for the company's laser systems. Being able to use the laser for more than one application is a selling point for hospitals, according to Peter Solyom, a marketing manager for the company.
Trimedyne received FDA approval earlier this year to market laser systems for treating gastrointestinal tumors and urological tumors and for treatment of arteriosclerosis.
The company said it is one of just four firms in the nation with FDA approval of a laser technique for killing pulmonary tumors.
Trimedyne officials said up to 200 hospitals are potential purchasers of the $80,000 system for treatment of various types of cancer.
But the larger market for medical lasers is in treatment of arteriosclerosis. Halter said most specialists believe that there is a $200-million annual market for laser treatment of circulatory disorders.
Trimedyne reportedly has the only laser probe and catheter device approved by the FDA for treatment of arteriosclerosis in leg arteries. Company officials predicted that competitors won't get their systems approved for at least 18 months.
Trimedyne has also received FDA approval for clinical trials of its laser system for treatment of arteriosclerosis in the heart.
The system for non-surgical treatment of arteriosclerosis in the leg has already had a dramatic impact on sales, according to Michael Henson, Trimedyne's president. He said he expects the company to report sales of $12 million to $13 million for its 1987 fiscal year ending Sept. 30, up from $5.7 million in fiscal 1986.