Medical Device Daily

It is estimated that half of women who have children will experience some form of pelvic organ prolapse in later life, a condition that can cause great discomfort for the women who suffer from it.

For many of these women, open surgery is prescribed to lift the prolapsed tissue back into place. While some non-surgical methods do exist to treat pelvic organ prolapse, there is a better way to treat the condition, according to an Israeli company.

Endogun Medical Systems (Kiryat Shmone, Israel), a developer of solutions for minimally invasive fastening of soft tissue, has launched a human clinical study for the treatment of pelvic organ prolapse. The clinical study is being performed in leading medical centers in Western Europe.

According to Endogun, pelvic organ prolapse occurs in women, often following births or excess weight and develops as a result of weakening of the pelvic muscles, which support internal organs such as the womb, bladder, rectum and vagina.

Associated symptoms include discomfort, a feeling of heaviness, pain, and the condition may carry the risk of infection.

Elad Naggar, Endogun's CEO, in a telephone conversation from Israel, told Medical Device Daily that because the vast majority of women with this condition are 60-years old or older, open surgery is associated with many risks and side effects and the possibility of complications.

The company's EndoFast Reliant system, as applied to prolapse treatment, provides a minimally invasive alternative that involves fastening mesh to tissue between the vagina and the collapsing organ through an entirely transvaginal procedure.

"Basically it's a device that enables [the physician] to simplify the prolapse procedure, repair it safely through a shorter procedure," Naggar said.

And, because the procedure would require less operating room time, shorter hospital stay and much-reduced recovery time, the device has the important benefit of reduced cost to the system, Naggar said.

"At the end of the day it will save the patient a lot of pain, hopefully, and save payors money," Naggar told MDD.

Endogun was granted FDA clearance in September 2006 to market its first soft-tissue attachment product in the U.S. The company is now working towards obtaining CE-marking for the product.

Although estimates suggest that close to 7 million women are in need of prolapse repair, only about 500,000 procedures are performed annually in the U.S, and Europe combined, according to Endogun.

Naggar said that another benefit of the product is to encourage more women to receive treatment.

The company said in a statement: "The launch of the clinical study is a key milestone towards bringing Endogun's prolapse product to market. We believe that our solution has significant advantages over what is available today, for patients, physicians, payors and providors, as a result of the ability to increase the safety level and reduce the overall costs associated with prolapse repair."

The company also has a pipeline of other soft tissue attachment products for markets including gynecology, urology and hernia.

Endogun has completed two rounds of financing, led by Pontifax Funds. Pontifax also holds Endogun shares indirectly, through its holding of Biomedix, the major shareholder in Meytav Technology Incubator. Key shareholders of Endogun, in addition to Pontifax, include Meytav, Promed Fund of the USA, and Dr. Adrian Paz, founder of Endogun.

Other companies developing solutions for pelvic organ prolapse include Cook Women's Health (Spencer, Indiana), a division of Cook (Bloomington, Indiana), Synovis Life Technologies (St. Paul, Minnesota), American Medical Systems Holdings (Minnetonka, Minnesota) and Mentor (Santa Barbara, California).

Derma Sciences in C-Boot licensing deal

Derma Sciences (Princeton, New Jersey), a manufacturer and supplier of wound and skin care products, reported obtaining a licensing agreement with C-Boot (Kibbutz Yiron, Israel) for the marketing and distribution of C-Boot's advanced therapeutic devices for the treatment of chronic venous insufficiency (CVI), deep vein thrombosis (DVT) prevention, venous ulcers, lymphedema, and other conditions that require compression therapy. These include the enhancement of blood circulation during recovery from coronary artery bypass graft surgery and orthopedic hip and knee replacements.

C-Boot's products, to be marketed by Derma Sciences under the MOBILITY-1 brand, include a lightweight wearable dynamic compression device that periodically inflates and deflates thereby producing segmented and therapeutically significant compression.

The technologies are covered by several U.S. patents.