SOURCE: Trimedyne, Inc.

August 18, 2008 09:30 ET

Trimedyne Enters Into Letter of Intent With FemSuite, LLC

LAKE FOREST, CA--(Marketwire - August 18, 2008) - TRIMEDYNE, INC. (OTCBB: TMED) today announced it has entered into a Letter of Intent with FemSuite, LLC, a privately held company based in San Francisco which develops, manufactures and markets a variety of devices for use in the gynecology field. Under the Letter of Intent, Trimedyne has offered to license seven of its U.S. patents and two U.S. patent applications (the "Patents") exclusively to FemSuite for any use in the fields of Gynecology and Gynecologic Oncology, and exclusively to FemSuite for use in anal (fecal) incontinence in the fields of Urology, General Surgery and GI Surgery. FemSuite will organize a subsidiary (the "Subsidiary"), to which the license will be assigned, which plans to test and market up to four products covered by the Patents (the "Patents").

FemSuite has offered to purchase all its requirements for lasers and side firing laser energy delivery devices ("Devices") from Trimedyne for the life of the last to expire of the Patents. FemSuite has also offered to pay Trimedyne for its efforts in the further development of the Devices, including regulatory compliance costs and readying the Devices for production.

Subject to certain milestones being achieved, FemSuite has offered to issue to Trimedyne, without cost, up to twenty percent (20%) of the fully diluted shares of the Subsidiary on the date these milestones are met by at least two Devices (10% of the fully diluted shares of the Subsidiary if only one of the Devices meets the milestones).

The first four Products that FemSuite plans to pursue are intended to be used in minimally invasive procedures to treat women and men on an outpatient basis, as follows:

  (a) Female Stress Urinary Incontinence, which is estimated by FemSuite
      to affect about 14 million women in the United States and many
      more overseas;

  (b) Anal (Fecal) Incontinence, which is estimated by FemSuite to affect
      about 9 million women and men, mainly elderly women, in the
      United States and overseas;

  (c) The coagulation and vaporization of benign uterine fibroid tumors
      ("Fibroids"), which are diagnosed in about 30% of women aged 25 to
      45 and are the most common non-cancerous tumors in pre-menopausal
      women, for which FemSuite believes there is no existing effective
      therapy, as excessive bleeding occurs in the conventional surgical
      removal of fibroids; and

  (d) Coagulation and scarring of the fallopian tubes to close them as a
      permanent method of sterilization, without implanting a device in
      the woman's body or requiring surgery to clip and sever the tubes,
      which FemSuite estimates is a $2.6 billion market for fallopian
      tube closure procedures.
     

Commenting on the proposed addition of the above Products to FemSuite's business, Gerald Feuer, M.D., of Southeastern Gynecologic Oncology of Atlanta, Georgia, who directs FemSuite's U.S. research and development program, said, "It has always been a dream of mine to create something that yielded a significant contribution to medicine and society. I believe that FemSuite's introduction of Trimedyne's Side Firing Laser Needles and Fibers for use in a variety of new applications in gynecology, and for use in the treatment of fecal incontinence in urology and surgery, will make that contribution. I am excited to be a part of this great medical endeavor."

The letter of Intent is not binding and is subject to the execution of a definitive Exclusive License and OEM Supply Agreement, acceptable to the Boards of Directors of Trimedyne and FemSuite, respectively, the consummation of which cannot be assured. Also, the terms of the Agreement, if executed, may differ substantially from those of the Letter of Intent.

About FemSuite:

FemSuite currently markets four products in the United States, the European Union and elsewhere, consisting of:

FemEyeOne™, an endoscope for vaginal examinations;

FemTest™, a device for performing endometrial (uterine) biopsies;

FemECC™, an endocervical curette (for scraping the interior of the uterus); and

FemSpec™ sterile and non-sterile prolapse speculums for vaginal examinations.

FemSuite is developing the FemEyeTwo™, a disposable, uterine endoscope, and FemSeal™, a device for trans-cervical sterilization, with EU and FDA approvals expected in the near future, as well as five other patent-pending devices.

FemSuite's CEO, Gerald (Jerry) Sanders, is an internationally recognized entrepreneur, whose business career is a Harvard Business School case study. He is a member of the faculty at Oxford University's Said Business School, founder of the French American Conference of Entrepreneurs and the founder and CEO of San Francisco Science, Inc.

About Trimedyne:

Trimedyne manufactures proprietary Holmium lasers and patented fiber optic laser devices for a variety of minimally invasive surgical procedures, primarily in orthopedics and urology, many of which are performed on an outpatient basis at substantially less cost than conventional surgery. For product, press release, financial and other information, please 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 1933 and Section 21E of the Securities and Exchange Act of 1934, including words like "expect," "may," "could" and others. Such statements may involve various risks and uncertainties, some of which may be discussed in the Company's Form 10-K-SB for the year ended September 30, 2006 and subsequently filed SEC reports. There is no assurance such statements will prove to be accurate, and actual results and future events could differ materially from those anticipated in such statements.

Contact Information