Prosurg Inc has been awarded CE Mark Approval for ImageL™ –Gel Injection system for Breast and Uterine Fibroid ablation treatment, in physician’s office. The Minimally Invasive Gel Injection Treatment for Breast & Uterine Fibroid ablation is a safe & cost effective alternate to hysterectomy for millions of women.
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San Jose, Calif. June 15, 2006--Prosurg Inc announced today that it has been awarded CE Mark, European Regulatory approval to commence marketing of ImageL™– Gel Injection system using an ultrasound imaging guidance, for treatment of Breast fibro adenomas and Uterine Fibroids in the physician's office. The novel, minimally invasive treatment of injecting proprietary Sclerosing Gel formulation directly into the target fibroids, myomas and fibro adenomas, is safe and cost effective alternate to myomectomy and hysterectomy for millions of women.
The injection of Sclerosing Gel formulation under ultrasound imaging guidance for controlled ablation of fibroid vasculature is relatively safe, and simple procedure compared to surgical Myomectomy and Hysterectomy. The Gel injection procedure for uterine fibroid ablation can be carried out in Gynecologist’s office or outpatient surgery center, using only local anesthesia. The ImageL™ - Gel injection treatment is applicable to all types, sizes & locations of breast fibro adenomas & uterine fibroids, including Intramural, Subserosal,, Submucosal and Intracavity myomas, located anywhere in the uterus.Additionally, the Doppler ultrasound imaging can monitor the blood flow in the vasculature surrounding the uterine fibroids and provide ‘Real Time’ visual feedback of vascular destruction to the physician, during entire Gel injection treatment.
The ImageL™– Gel Injection system for treatment of Breast & Uterine fibroids, using ultrasound imaging guidance is designed to shrink the fibroids and stop excessive bleeding by destroying the blood flow and vascular structure surrounding the target fibroids. The vascular destruction and tissue ablation by sclerosing gel causes fibroids to shrink, thus minimizing patient’s pain, discomfort and excessive bleeding. “The preliminary results based on the multi-center Clinical Study, involving +100 patients with six month follow up, are very promising and suggests that the Image guided sclerosing Gel injection treatment for uterine fibroid ablation, under local anesthesia, is potentially safe and effective treatment for the Gynecologist’s office,” commented Ashvin Desai President and Chief Executive Officer of Prosurg, Inc. “The ImageL- Gel injection treatment is designed to deliver proprietary sclerosing gel formulation with 20 ga needle, into target uterine fibroids via Percutaneous, Trans Vaginal or Laparoscopic delivery approach using conventional ultrasound or endoscopic imaging guidance”. The ImageL procedure kit is available as a sterile, single use tray containing 20 / 18 ga echogenic Injection needle device and 3.00 cc pre- filled Gel Syringes.
ImageL™ - Gel Injection System does not require purchase of any capital intensive equipments or expensive electromagnetic energy systems , such as Laser ,RF, Cryo, Ultrasound or Microwave generators, currently marketed by major medical device companies like Boston Scientific (NYSE: BSX), American Medical Systems (Nasdaq: AMMD) , Gynecare / Johnson & Johnson (NYSE: JNJ) , Insightec, Microsulis, Cytyc Surgical (Nasdaq: CYTC), Biosphere Medical (Nasdaq: BSMD) & others.
The ImageL- Gel Injection treatment for uterine fibroids has a potential to be the first line of defense and treatment of choice for millions of women, before submitting to hysterectomy.
About Prosurg, Inc
Prosurg, Inc. designs, manufactures and market innovative products based on the state of the art technology platform for treatment of Urological, Uro-Gynecological & Gynecological diseases and disorders .These products are based on safe and proven injection technology platform to provide cost effective solution for physicians, patients, and health care .providers. For additional information, please visit www.Prosurg.com
Contact: Mirth Vargas
Tel: (408) 945 4044