Trimedyne Gets OK to Market Its Cold Laser : Technology: The FDA approval will allow use of the Holmium laser in general surgery.
In the latest of a flurry of Food and Drug Administration approvals for its “cold laser” technology, Trimedyne Inc. said Monday that it has received permission to market its Holmium laser for use in general surgery, including gall bladder surgery.
The announcement sent Trimedyne’s stock, which has been highly volatile in recent years, spurting upward again Monday. It rose $1.375 in over-the-counter trading to close at $8.625 per share.
Trimedyne hopes the Holmium laser will win widespread acceptance in gall bladder surgery.
About 600,000 Americans have their gall bladders removed each year in surgery that often leaves large scars. However, up to 10% of gall bladder surgeries are now performed laparoscopically, using laser catheters and fiber-optic cables inserted through a five-millimeter incision in the navel.
Trimedyne officials said the Holmium cold laser will be useful in such surgery because it can cut tissue without burning nearby organs, sometimes a problem with “hot” or thermal lasers.
In early September, Trimedyne won FDA permission to market the Holmium laser and its Halocath laser catheter to remove fatty deposits in blood vessels below the waist. The Holmium has also been approved for use in orthopedic procedures, including arthroscopy in joints.
The FDA approval for general surgery clears the way for the laser’s use in stomach, lung, skin and gynecological procedures, as well as gall bladder surgery, said Richard A. Demmer, Trimedyne’s corporate secretary.
Trimedyne is also racing with competitors to win FDA approval for a laser that can be used to clear blocked arteries in the heart, a market that analysts say could be worth hundreds of millions of dollars. The company has been conducting clinical trials on two small catheters that can be threaded in the tiny, twisted coronary arteries, Demmer said.
Trimedyne stock peaked at $24 a share four years ago, but last year it traded as low as $1.625 per share. It soared to a 52-week high of $9.75 earlier this month on news of the FDA approvals, but after profit-taking closed Friday at $7.25.