EndoFast ReliantTM may offer simpler, safer Prolapse and SUI repair procedures
HaOgen, ISRAEL, June 04, 2008 - Endogun Medical Systems Ltd., a leading developer and manufacturer of novel solutions for minimally-invasive fastening of soft tissue, announced today that it has received European CE approval to market its next-generation, single-incision, trans-vaginal EndoFast ReliantTM device for repair of Pelvic Organ Prolapse and Stress Urinary Incontinence ("SUI").
"The CE Mark was received in close proximity to the U.S. FDA approval that we got earlier this quarter for the single-use, disposable EndoFast ReliantTM product. These regulatory approvals welcome Endogun into the elite community of innovative urogynecology products, aimed to reduce the invasiveness of key women's health procedures, and offering quality of life solutions in a safe and effective manner. Along with very positive clinical validation from key opinion leaders, these approvals indicate a product with a unique value proposition, which may have significant advantages over what is available today, for patients, physicians, payers and providers," said Endogun's Chairman of the Board, Elad Naggar.
Pelvic Organ Prolapse occurs in women, often following multiple births or excess weight, and develops as a result of weakening of the pelvic muscles which support internal organs (womb, bladder, rectum and vagina). Side effects of this condition include discomfort, a feeling of heaviness, and pain, and the disorder carries the risks of inflammation and infection.
More than 600,000 procedures are performed annually in the USA and Europe (combined), with direct costs of associated surgical equipment reaching hundreds of millions of dollars. Estimates suggest that close to 7 million women are in need of such treatment; the gap between the potential market size and the actual number of procedures performed to date may stem from the fact that the current surgical offerings are significantly invasive, and require substantial surgical skills.
Endogun's product is aimed at offering a single-incision, simpler and safer procedure, which is performed entirely trans-vaginally.
Endogun Medical Systems Ltd. ("Endogun") was founded in March 2004 to offer improved soft tissue attachment technology and products to the world of Minimally Invasive Surgery (MIS). It offers procedures that are easier for surgeons to use and safer for patients than today's options. Endogun aims to significantly improve the quality and outcome of many minimally invasive procedures in the world of urogynecology and urology.