LAKE FOREST, CA -- (Marketwire) -- 08/18/08 -- TRIMEDYNE, INC. (OTCBB: TMED) todayannounced it has entered into a Letter of Intent with FemSuite, LLC, aprivately held company based in San Francisco which develops, manufacturesand markets a variety of devices for use in the gynecology field. Underthe Letter of Intent, Trimedyne has offered to license seven of its U.S.patents and two U.S. patent applications (the "Patents") exclusively toFemSuite for any use in the fields of Gynecology and Gynecologic Oncology,and exclusively to FemSuite for use in anal (fecal) incontinence in thefields of Urology, General Surgery and GI Surgery. FemSuite will organizea 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 sidefiring laser energy delivery devices ("Devices") from Trimedyne for thelife of the last to expire of the Patents. FemSuite has also offered topay Trimedyne for its efforts in the further development of the Devices,including regulatory compliance costs and readying the Devices forproduction.
Subject to certain milestones being achieved, FemSuite has offered to issueto Trimedyne, without cost, up to twenty percent (20%) of the fully dilutedshares of the Subsidiary on the date these milestones are met by at leasttwo Devices (10% of the fully diluted shares of the Subsidiary if only oneof the Devices meets the milestones).
The first four Products that FemSuite plans to pursue are intended to beused in minimally invasive procedures to treat women and men on anoutpatient 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'sbusiness, Gerald Feuer, M.D., of Southeastern Gynecologic Oncology ofAtlanta, Georgia, who directs FemSuite's U.S. research and developmentprogram, said, "It has always been a dream of mine to create something thatyielded a significant contribution to medicine and society. I believe thatFemSuite's introduction of Trimedyne's Side Firing Laser Needles and Fibersfor use in a variety of new applications in gynecology, and for use in thetreatment of fecal incontinence in urology and surgery, will make thatcontribution. 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 adefinitive Exclusive License and OEM Supply Agreement, acceptable to theBoards of Directors of Trimedyne and FemSuite, respectively, theconsummation 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 EuropeanUnion and elsewhere, consisting of:
FemEyeOne(TM), an endoscope for vaginal examinations;
FemTest(TM), a device for performing endometrial (uterine) biopsies;
FemECC(TM), an endocervical curette (for scraping the interior of theuterus); and
FemSpec(TM) sterile and non-sterile prolapse speculums for vaginalexaminations.
FemSuite is developing the FemEyeTwo(TM), a disposable, uterine endoscope,and FemSeal(TM), a device for trans-cervical sterilization, with EU and FDAapprovals expected in the near future, as well as five other patent-pendingdevices.
FemSuite's CEO, Gerald (Jerry) Sanders, is an internationally recognizedentrepreneur, whose business career is a Harvard Business School casestudy. He is a member of the faculty at Oxford University's Said BusinessSchool, founder of the French American Conference of Entrepreneurs and thefounder and CEO of San Francisco Science, Inc.
About Trimedyne:
Trimedyne manufactures proprietary Holmium lasers and patented fiber opticlaser devices for a variety of minimally invasive surgical procedures,primarily in orthopedics and urology, many of which are performed on anoutpatient basis at substantially less cost than conventional surgery. Forproduct, press release, financial and other information, please visitTrimedyne'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 statementswithin the meaning of Section 27A of the U.S. Securities Act of 1933 andSection 21E of the Securities and Exchange Act of 1934, including wordslike "expect," "may," "could" and others. Such statements may involvevarious risks and uncertainties, some of which may be discussed in theCompany's Form 10-K-SB for the year ended September 30, 2006 andsubsequently filed SEC reports. There is no assurance such statements willprove to be accurate, and actual results and future events could differmaterially from those anticipated in such statements.
CONTACT:
Jeffrey Rudner
(949) 951-3800, Ext. 285
jrudner@trimedyne.com