In the United States and Western Europe alone, 360 million women suffer from some degree of pelvic organ prolapse. Of this number, about a one-fifth, or 70 million women, require some surgical intervention. However, despite this great need for treatment, only around 600,000 surgical procedures are annually done in America and Europe -- ministering to a small fraction of the women who would benefit from such intervention.
Endogun, a young high-tech start-up in Israel has identified the need, pinpointed the problem, and is providing a solution.
"We are not inventing a cure for a disease without any cure, but we can save lives and improve the quality of life for many women by mitigating many risks of treatment," Endogun CEO Elad Naggar said.
According to Naggar, the current surgical method is "traumatic for patients." It introduces a mesh net across the pelvic floor to support the organs, preventing their collapse down into the vagina. The mesh is suspended from four long arms embedded in tunnels within the tissue. These tunnels are created by deep-penetrating needles -- a procedure that requires at least five incisions, but can demand up to nine for certain types of prolapse. Then the arms are dragged through several inches of soft tissue in the groin or abdomen, creating enough friction to anchor the mesh.
Endogun's treatment, however, utilizes a novel fastener to secure the mesh support directly to the soft tissue. The fasteners, made of medical-grade stainless steel, are very strong. They eliminate altogether the need for dragging suspension arms through the soft tissue. And since these fasteners can be fitted transvaginally, only one incision is needed to position the mesh. This less complicated technique requires less anesthesia, demands shorter recovery time, and is thus less traumatic both during the procedure and afterward.
In addition to these clear benefits for the patient, the procedure makes the operation much simpler for the surgeon, as well. Because the procedure is entirely transvaginal, gynecologists can operate in the anatomical plane that they are most familiar with, and less surgical expertise is needed to perform this operation than is required for current prolapse surgeries. Thus, less skilled technicians can carry it out, reducing costs to patients and to health care companies. For these reasons, more physicians will be willing to treat prolapse using Endogun's method, just as more patients will be willing to undergo this less distressing procedure.
Naggar recalls that an associate first brought Endogun to his attention.
"I was very excited because the market need was very clear," he said. "[The Endogun treatment] "is so simple, so elegant, so really reasonable to the way gynecologists work and think.
"We believe that the main gap between potential and market size is that the current solutions are too invasive and not safe enough. It is really a question of reducing the level of invasiveness, and producing a higher level of confidence."
Based in the Meytav Technological Incubator program in Kiryat Shmona on Israel's northern border, Endogun is now busy developing other applications for its soft tissue attachment technology. These include a treatment for urinary incontinence, a disease with a huge clinical need. An application for men suffering from prostate cancer is also in the works, which will aid in one of the most common radical prostatectomy surgeries, providing a strong attachment of the bladder to the urethra. And a hernia treatment is also in the advanced stages of development.
Endogun currently employs almost 10 people, but according to Naggar, "We are growing very rapidly, more and more projects, and there's a demand for managers, engineers, and clinical people."
Israel is a natural home for the company, as there are many developers working in the medical technology segment of high tech, and there are also very accomplished gynecologists and urologists. The entire product is not only developed, but also produced in Israel.
Beyond its Israeli base, the company also has global connections, including many advisors in the United States -- notably a scientific advisory board, whose primary contribution is scientific input from leaders in urogynecology. Since receiving FDA clearance last September, Endogun has begun clinical trials in Western Europe, and there are plans to launch a clinical study in America in the next few months. The company is working on obtaining the CE mark for approval in European markets. Endogun hopes to start marketing in certain countries in early 2008, and is still considering where to launch.
"There is a lot of interest from clinicians and from the business side," said Naggar, who managed medical device companies for several years before heading Endogun. He has done a lot of learning along the way, and finds this area of medical technology fascinating: "The choice for prolapse, looking back, was a very wise one."
Even so, he confides, "I was surprised with the magnitude of this success."
Hannah Meyers is a freelance writer for ISRAEL21c, a media organization focusing on 21st century Israel.