Debridase dissolves damaged tissue, helping the body heal itself and reducing the need for skin grafts in the treatment of burn wounds.An Israeli health care startup called MediWound has developed a treatment that replaces surgery in curing burn wounds and can save as much as 50 percent of the loss of healthy skin by lessening dependence on skin grafts and enabling the body to regenerate new tissue.
The MediWound treatment, known as Debridase, promotes a process called enzyme debridement, which is designed as a replacement for surgical debridement. Surgical debridement, the current treatment practice, has a host of drawbacks, according to MediWound.
When a person suffers a severe burn, doctors surgically remove the entire skin layer in all of the burned area, with the patient under full anesthesia. Doctors must remove all the skin, healthy and unhealthy, because they have no way of knowing the depth of the burn, or of knowing whether some parts of the skin are still healthy.
In addition, if 10 percent of the body surface is burned, the patient loses that 10 percent, and another 10 percent of the skin, which is taken from other areas of the body for grafting onto the burned area. The patient also suffers severe pain and loss of blood from the surgery.
Debridase, which comes in the form of a lotion, dissolves only the tissue damaged by the burn and leaves the healthy tissue undamaged, said MediWound co-founder Lior Rosenberg. In some cases, skin grafts are not required, saving expensive hospitalization days and operating room, anesthesia, and surgical labor costs. At the end of the four-hour treatment, the bandages are removed, and the extent of the original tissue damage can be estimated.
“In many cases, a person can grow healthy skin without grafts after about a year, because there is a reserve of healthy cells there,” said Rosenberg, who is head of the plastic surgery and burns unit at Soroka Medical Center in Beersheva, Israel. “When the burn extends to large areas of the body, it is a matter of life or death.”
The preparation has been undergoing trials at Soroka. Since the trials began, the annual number of surgical debridement procedures has dropped from between 350 and 400 to 50. The technology has been tried on 250 burn patients to date and yielded recovery rates of about 85 percent. About 70 percent of burn areas have healed completely without any skin grafts at all, the company said. The patients needed less surgery and less grafting and have had less scarring than those treated with surgery alone. They’ve also had much shorter hospital stays.
At the end of August, MediWound obtained authorization for Phase II clinical trials in the United States; the U.S. Food and Drug Administration recognized the trials conducted to date as Phase I. The company has also obtained Orphan Drug status in Europe for the burn treatment, which means that if the drug is approved for marketing, the treatment will benefit from patent protection and exclusivity in the European Union for the first 10 years of marketing.
If Debridase clears FDA trials, the U.S. market for such savings in pain and suffering and recovery time could be significant. An estimated 700,000 Americans are treated for burns in hospital emergency rooms each year and 75,000 of them require hospitalization, according to MediWound.
MediWound’s enzyme debridement technology was originally developed by an American doctor named Gerald Klein, now deceased, who did research into an enzyme produced from pineapple, from which he developed a chemical used for things like meat softening and beer purifying. Shortly afterwards, he discovered the chemical had another function; it dissolved and removed burn-damaged tissue without harming still-healthy skin layers.
Rosenberg licensed the technology from Klein’s heirs after seeing a demonstration of its effectiveness at a medical conference in Switzerland and doing some research on his own.
It took Rosenberg a year to obtain approval in Israel to conduct clinical trials on humans.
MediWound has received the majority of its funding from Israel’s Clal Biotechnology Industries, which now owns 80 percent of the company. MediWound was the first company to enter Clal’s biotech incubator in Yavne, Israel, which was founded to provide research and manufacturing facilities to Clal’s portfolio companies.