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last updated:  Tuesday, April 8th, 2008

 
Strategy   Technology   Entrepreneurship   Profitability      Strategy   Technology   Entrepreneurship   Profitability  
 

Growing (Without) Pains
By Rachel Neiman
Mar 30, 2008, 12:58

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There's nothing good about a broken leg. Or maybe there is. A technology for resetting fractures and lengthening limbs is being adapted to treat not only severe bone injuries, but disproportionate limbs due to congenital defects, accident or illness. The new treatment, developed by Israel's Orthogon, enables limb lengthening without suffering.

Orthogon is developing a magnetically activated, telescopic, intramedullary (IM) orthopedic nail for treatment of long bones. Traditionally, IM nails are inert rods inserted into the bone marrow to align and stabilize fractures in the femur or tibia.

Orthogon's device magnetizes parts in the rod mechanism, so the nail can be manipulated via an external magnetic coil, allowing it to vibrate, compress or elongate the bone.

The new feature will be applied to limb elongation which, to date, was achieved by "external fixation", a surgical procedure in which the bone is cut, holes drilled into the surrounding areas, and rods screwed into the holes. An external metal armature is used to induce "bone distraction", generating bone tissue, millimeter by millimeter, over a period of weeks.

The process is extremely painful, can damage the neural-vascular system and leaves many scars. Plus, infections around the rods sites are common.

Orthogon's all-internal device avoids these complications. Once the IM nail is implanted, patients are treated daily by placing their leg into a coil system that creates a magnetic pulse. The magnetic force inside the nail is amplified by mechanical means, in steps of 0.5 microns, to a distraction force of over 100k, forming a flexible callus tissue that is pulled incrementally.

There are other treatments on the market: US company Orthofix's ISKD (Intramedullary Skeletal Kinetic Distractor), an IM nail with two telescoping pieces controlled by the patient's leg movement that unwind to lengthen the limb; and Germany's Fitbone, a fully-implantable electromechanical IM nail operated by an electronic motor powered by external high frequency transmissions.

CEO Dr. Mordechay Ilovich tells ISRAEL21c that Orthogon's solution will far outstrip the others in terms of effectiveness, accuracy, durability and price, with treatment performed at hospitals, clinics and at the patient's home, workplace or even while on vacation.

And does the IM rod stay in the body forever? "Some doctors recommend removal after the bone has hardened, others don't. There are different schools of thought," explains Ilovich.

The patent pending device is still in development, with FDA approval anticipated in the last quarter of 2009. The development project was awarded funding of $1.8 million from the Israel-United States Binational Industrial Research and Development Foundation (BIRD); the remainder is funded by Orthogon and its US partner.

Orthogon was founded in 2003 by orthopedic surgeons Dr. Dror Robinson and Dr. Yona Kosashvily within the framework of the Ofakim High-Tech Ventures incubator.

The company's management team is headed by Ilovich and chairman Yacha Sutton, an Israeli medtech industry veteran and former CEO of Lumenis, a developer of laser and intense pulsed light devices.

The Scientific and Medical Advisory Board includes Dr. Dror Paley, and Dr. John Herzenberg, both of Sinai Hospital, Baltimore and co-directors of The International Center for Limb Lengthening (ICLL), and Dr. Robert Rozbruch, director for limb lengthening and reconstruction at the Hospital for Special Surgery, New York.



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