Trimedyne Announces Important FDA Clearance
IRVINE, Calif. --(Business Wire)-- May 18, 2005 -- Trimedyne, Inc. (OTCBB:TMED) today announced it received clearance from the Food and Drug Administration (FDA) to market its new, patented VaporMAX(TM) Side Firing Laser Fiber which, based upon animal tissue bench testing and published data, vaporizes tissue faster and lasts longer than other currently marketed side firing laser fibers. Marketing of the VaporMAX(TM) Fiber will commence in June.
The VaporMAX(TM) Laser Fiber has been cleared for sale by the FDA for use with Trimedyne's 80 watt Holmium Lasers and Lumenis (Coherent) 60-100 watt Holmium Lasers, which are cleared for the treatment of benign prostatic hyperplasia or BPH, commonly referred to as an enlarged prostate. BPH affects approximately 50% of men over age 55, and about 200,000 procedures are performed to treat BPH each year in the United States.
Many hospitals in the United States and overseas already own, lease or rent a high power Trimedyne or Lumenis (Coherent) Holmium Laser. These hospitals can buy Trimedyne's VaporMAX(TM) Fiber to treat BPH, without having to buy a new laser. Laser vaporization of the prostate procedures to treat BPH are now being reimbursed by Medicare under the New Technology Ambulatory Payment Classification (APC) Code 2525 (CMS Transmittal 132, Publication 100-04) at $3,750 per treatment, about twice the old reimbursement rate.
Laser vaporization of the prostate is rapidly replacing surgical resection of the prostate, because it typically eliminates the 1-3 day hospital stay and reduces the bleeding, general anesthesia risk, impotence and incontinence of the surgical procedure. Rapid vaporization of the prostate minimizes procedure and costly operating room time, and the higher reimbursement rate makes these procedures attractive to physicians, hospitals and outpatient surgery centers.
Trimedyne manufactures lasers and proprietary fiber optic devices for a variety of minimally invasive surgical procedures, many of which are performed on an outpatient basis at substantially less cost than conventional surgery. For product, financial and other information, visit Trimedyne's website, http://www.trimedyne.com.
"Safe Harbor" Statement Under the Private Securities Litigation Reform Act:
Statements in this news release may contain forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1993 and Section 21E of the Securities and Exchange Act of 1934. Such statements may involve various risks and uncertainties, some of which may be discussed in the Company's most recent report on Form 10-KSB and subsequently filed SEC reports. There is no assurance any new products can be successfully commercialized or any forward-looking statements will prove accurate, as actual results and future events could differ materially from those presently anticipated.