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Sunday, August 14, 2011

New hope for chronic wounds - Israeli product

MacroCure CEO Dr. Mitchell Shirvan

Israeli product provides the right ingredients to help the body repair wounds that refuse to heal.

Chronic wounds - injuries that just will not heal - are a condition many elderly and ill individuals are forced to live with. When the body loses its capacity to heal, wounds can remain open for months and even years, with concomitant pain. Unfortunately, it's a common problem. Fortunately, Petah Tikvah-based MacroCure could have a solution.

Dr. Mitchell Shirvan, company CEO, says MacroCure's trademarked CureXcell offers "the most comprehensive approach to the problem of chronic wounds, showing a very significant reduction of the mortality rate in patients with deep sternal wound infections and a markedly improved healing rate for severe pressure ulcers."

CureXcell uses a novel approach to wound repair - white blood cells from healthy donors that generally are discarded by blood banks.

"Usually, doctors infuse just red blood cells and plasma when they give blood transfusions," says Shirvan. "The white blood cells are usually not used in transfusions, but actually, they are very valuable for those suffering from chronic wounds, since this is where the core capacity of the body's ability to repair wounds is located. We developed CureXcell based on these cells, injecting it into the layer of the healthy cells just below the damaged tissue. The body absorbs those cells and uses them to begin repairing the wounds."

Patients begin to see an improvement in their condition within weeks.

A safe product

CureXcell lends a helping hand at the most crucial stage of the self-repair process, the inflammatory stage. When a wound occurs, the body automatically dispatches blood and fluids to the area of the wound to deliver healing substances. This causes inflammation, which is necessary for repair.

Until barely 50 years ago, "Doctors would treat wounds by putting a bandage on it and hoping for the best," Shirvan says. The development of treatments using collagen and human growth factors have advanced the field of wound repair significantly, but these solutions only deal with specific aspects of wound repair. "The white blood cells we use contain all the elements the body needs to repair itself," says Shirvan, adding that the product contains the full complement of various cells that produce the cell messenger and growth factor molecules that might be missing as the body attempts to repair the wound.

In addition, Shirvan says, "the cells are safe. We do all the tests that are done by blood banks for donors, and add on some other tests to insure product safety."

CureXcell was developed several years ago by Prof. David Danon of the Israeli national blood service, Magen David Adom, and was since acquired by MacroCure, which has enhanced the product and markets it. So far, says Shirvan, "CureXcell has been administered by physicians to over 4,500 patients with severe chronic wounds who would probably have remained with those wounds for years."

The product has been approved for reimbursements under Israel's National Health Insurance program, and Shirvan says that, thanks to its success in the field in Israel, CureXcell is set to directly enter the last stage of the process for getting approval by the US Food and Drug Administration. "We anticipate receiving approval in the US in 2014 with completion of a successful Phase 3 development program for the treatment of chronic lower-extremity ulcers in patients with diabetes," Shirvan says.

MacroCure's 20 employees are further refining CureXcell and working on new treatments as well. The company, established in 2008, recently raised $26 million. The last financing round of $13 million was led by Viola Private Equity and Pontifax.

"We've received a substantial amount of interest from doctors, hospitals and HMOs in Israel," says Shirvan. "Besides helping cure chronic wounds for patients, which can lead to a reduction in amputations and even save lives, we save money for health-care providers and systems. We expect to grow significantly over the coming years."