"Break a leg," we say enthusiastically to actors before an opening night, not intending that they actually break it, but still in a mindset that views a fracture as a trauma that one can joke about. In practice, bone fractures are painful and debilitating injuries, painful especially for the economy, since they take many people out of the labor market for extended periods, or at least harm their productivity. The average wrist fracture can take six weeks to unite, and leg fractures can often take even longer, following which a further period of rehabilitation is needed before normal activity is resumed. There are also risks, such as fractures that don't unite properly, and which have to be corrected surgically, necessitating a further prolonged recovery period. Some other fractures are difficult to heal, and don't unite at all.
Appiades Meditech Ltd. was set up with the goal of finding a rapid solution for healing fractures. The first goal was the bone union itself - to create the osseous tissue bridge between the two bone parts faster, and so avoid the damage caused to the body as result of the fixing that has to be maintained until the bone has united. Over time, the company realized that its technology had an effect on the entire healing process. It reduced the swelling of the limb beneath the plaster cast, probably by reducing inflammation, thus preventing pain, restricted movement of the limb and unpleasantness to the patient. It also significantly reduced the extent of the atrophy of the muscle through lack of use both directly, and as an indirect result of the shorter healing time, since the atrophic process happens principally during the final weeks of the limb's fixation period.
Marked improvement in trials
"We stimulate the fracture area by applying a stimulation similar to that exerted by the force of gravity when we use our feet to walk," explains Appiades co-founder Prof. Moshe Revach. "The stimulation is carried out through Pulsed Electromagnetic Field Therapy (PEMF), a technology which stimulates the area through a varying electromagnetic field."
The company is entering a minefield here, and both Revach and his fellow founder Joseph Elad appear to be well aware of the difficulty. Magnets have been on the fringes of conventional medicine for centuries, and every period had its own magnets charlatan. The most infamous of all was the 18th century researcher Dr. Franz Anton Mesmer of Austria, who claimed that magnets could be used to heal a wide range of diseases. When he discovered that he could "cure" those diseases without magnets as well, he concluded that he had managed this thanks to his own internal magnetic forces. Many researchers and companies now claim that magnets can cure pain and improve blood flow, although conventional medicine has never adopted this view.
On the other hand, conventional medicine does consider varying magnetic fields that induce a surrounding electrical field, as a promising breakthrough in the treatment of certain diseases. For example, serious research has been conducted into the use of technology in the treatment of neurological (brain) diseases by using a varying magnetic field to manipulate electrical fields between nerves (another Israeli company Brainsway Ltd. (TASE:BRIN), has also been researching this field, and has reported good results so far). The technology is also being assessed as a method for treating bone factures, Appiades's field of expertise, and a number of trials that support its efficacy have already been published.
If so, what is novel about Appiades's method? Elad and Revach explain that their innovation lies in the development of the treatment protocol, which defines precisely the changes that must be made to the magnetic field applied to the limb in order to generate a response. According to them, many companies have tried to create a therapy like theirs, but no company has as yet managed to demonstrate significance in clinical trials. Appiades has conducted three trials, on cell cultures, on animals with broken bones, and on humans (23 patients), and is currently carrying out a further trial with 40 patients. The three trials all showed a marked improvement in the speed of the generation of new bone cells in the union area and a reduction in muscular atrophy caused by fixing.
How does it actually work?
"When a person is recovering from a fracture, the doctor encourages him to walk as much as possible," says Revach. "Something in the process of movement against the force of gravity creates an electrical stimulation in the injured area. Astronauts, however, who operate their muscles but not against gravity, suffer from muscle and bone atrophy, because this stimulation is lacking. We talk to the body in this frequency, the exact same frequency that the cell responds to." The secret probably lies in the signal which promotes bone building cells on the one hand, while stifling inflammation caused by the trauma of the fracture and the fixing of the limb, which create discomfort and cause muscular atrophy during the fixing process.
"I am confident that a good many in-depth articles will be written about the operating mechanism," says Revach. "We're happy just to see it working. It is now known that a fixed magnetic field does not generate a change in the healing process. A varying magnetic field does, but until we came along, nobody had managed to find the precise frequency and magnetic force needed to create the necessary stimulation.
"In addition, our device is a generator that produces varying magnetic fields, even though it is small enough to be worn in a strap on the foot or hand. It is also manufactured at a low cost, so that we can sell it at a price that patients can afford."
Appiades was founded by Elad, an accountant by profession with a background in management, and Revach, former director general of the Rambam Medical Center in Haifa. The company's product was developed by the late Dr. Joseph Tenenbaum, formerly head of the biotechnology laboratory at Hadassah Medical Center in Jerusalem. "He dedicated his life to the research of electro-magnetic fields," says Elad.
Appiades has received $1 million in investment to date, from Yozmot Granot Initiative Center, and private investors. The modest sum was enough to finance Appiades's clinical trials, since all its clinical and laboratory services were outsourced.
The next stage for Appiades will be further clinical trials and the development of devices for treating fractures as well as soft tissue trauma (not necessarily related to fractures), for which the company will need several million dollars more. It has also set its sights on osteoporosis, a larger market than fractures. Osteoporosis features the loss of bone density, leading to small fractures along the spine, increasing the risk of fractures that are impossible to heal. Osteoporosis is a leading cause of high-risk fractures such as in those of the hip or thigh. If Appiades's device can manage to stimulate the proliferation of bone-building cells, it could help treat this disease.
Published by Globes [online], Israel business news - www.globes.co.il - on August 27, 2007
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