HDH Medical Ltd., which has developed an innovative hermetic docking head (HDH) vascular device for suture-less treatment of aorta and blood vessel trauma, has launched human clinical trials. The Ministry of Health approval is valid only for marketing in Israel. HDH is in initial contact with the US Food and Drug Administration (FDA) and EU CE-Mark certification. HDH plans to use the present clinical trials for the trial protocols it will submit for the FDA and CE-Mark approval.
HDH’s device is aimed at helping in the treatment of abdominal berry aneurism, in which blood vessels, including major arteries, in the abdominal cavity become thinner and liable to rupture. 5% of people over 60 suffer from berry aneurism, and the death rate without early diagnosis and treatment is 50%. HDH says Albert Einstein died of a berry aneurism.
The current treatment for abdominal berry aneurism is to manually suture a vascular graft to the blood vessel. The procedure takes three and a half hours, during which blood flow to the lower body is blocked for an hour. This halt in blood flow can cause complications, including embolisms in the legs, and heart and kidney malfunction.
HDH’s implant has mechanical hook-like devices at its extremities, which easily attach to standard vascular grafts, thereby shortening surgery to three to four minutes and greatly reducing surgical and post-surgical complications. HDH’s entrepreneurs estimate the market for its device at $70 million a year.
HDH was founded by Igor Vaysbein, whose father died of a berry aneurism, who has a M.Sc. in mechanical engineering; medical director Dr. Boris Yoffe , a vascular surgeon and head of the Department of General and Vascular Surgery at Barzilai Medical Center in Ashkelon; senior researcher Dr. Yuri Urin, who has 40 years experience in mechanical equipment and experimental systems R&D; and CEO Irina Vaysbein, an expert in biomaterials and polymers, who has an MBA.
Based at Yozmot Ha'Emek -- Ofek La'Oleh Technological Incubator, HDH is currently operating on a $260,000 grant from the Office of the Chief Scientist, and an investment from Adel Engineering Ltd.
Yozmot Ha'Emek is now being privatized.
Published by Globes [online], Israel business news - www.globes.co.il - on November 6, 2005