FMRX- Get ready to rumble
FemRx Announces Commercial Shipments of OPERA STAR SL
Product Provides for Safer OPERA Procedures
SUNNYVALE, Calif., Oct. 7 /PRNewswire/ -- FemRx(TM), Inc. (Nasdaq:FMRX) today announced that it has begun commercial shipments of the OPERA STAR SL(TM), the first hysteroscope to allow the use of safer isotonic solutions, such as normal saline, in OPERA (Out-Patient Endometrial Resection/Ablation) procedures. The OPERA STAR SL incorporates the company's proprietary PEARL(TM) (Physiologic Endometrial Ablation/Resection Loop) technology.
''The OPERA STAR SL may be the most important advance in hysteroscopic surgery in 20 years,'' said David Olive, MD, and Chief, Division of Endrocrinolgy, Dept. of OB/Gyn, Yale University School of Medicine. ''The ability to transfer from hypertonic solutions to normal saline solutions will virtually eliminate the problems we have with fluid absorption, and make this a much safer and easier procedure to perform,'' he added.
''The commercial release of the OPERA STAR SL is an important milestone for FemRx,'' stated Andrew M. Thompson, FemRx president and chief executive officer. ''Together with the entire OPERA(TM) System, this new product will allow more gynecologists to offer women a safe, effective, minimally invasive alternative to hysterectomy.''
Thompson continued, ''During operative hysteroscopic procedures, a patient can absorb dangerous amounts of non-physiologic irrigation solution, potentially leading to disabling or fatal cerebral edema. That danger is eliminated with the OPERA STAR SL. We believe that the added safety this technology offers will encourage a larger number of mainstream gynecologists to adopt the OPERA procedure.''
The OPERA STAR SL received 510(k) clearance from the U.S. Food and Drug Administration (FDA) in April of this year and was introduced at the American Association of Gynecologic Laparoscopists meeting in Seattle last month.
FemRx, Inc., headquartered in Sunnyvale, Calif., has developed innovative surgical systems for the diagnosis and treatment of gynecologic disorders. FemRx's proprietary OPERA STAR(R) and Flo-Stat(TM) systems are used during a surgical intervention called OPERA(TM) (Out-Patient Endometrial Resection/Ablation) that provides a minimally invasive alternative to hysterectomy for patients suffering from abnormal uterine bleeding (AUB). The company's DIVA(TM) device, a proprietary laparoscopic morcellator, is used in surgical myomectomy as reproductive therapy (SMART(TM)) procedures to assist in the removal of fibroids. Under development is the SOPRANO(TM) cryo-ablation system. The company markets its products through its Center of Excellence and National Providers of Excellence programs which are partnerships between FemRx and healthcare providers aimed at increasing the awareness of the OPERA procedure through jointly sponsored patient and physician outreach and physician training. FemRx common stock is traded on the Nasdaq Stock Market under the symbol FMRX and the company's World Wide Web address is www.femrx.com. |
