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Polyheal announces positive clinical results of its lead product, Polyheal-1


Polyheal announces positive clinical results of its lead product, 'Polyheal-1', for the treatment of chronic wound healing

Significant and superior efficacy results in hard to heal wounds caused by Diabetes, Vascular disease and Post traumatic wounds

Yavne, Israel, December 14th, 2009: Polyheal Ltd., announces positive clinical trial results of its lead product 'Polyheal -1' for the treatment of deep and chronic wounds.
The trial is a randomized double blind controlled comparing 'Polyheal-1' to standard of care therapy. The trial was conducted in five medical centers in Israel and included 66 patients who were treated for 4 weeks with either 'Polyheal-1' or standard of care and followed for another 8 weeks with standard of care in both groups. The patients had suffered from these wounds 16 months on average, and had been treated previously with 2-3 previous treatment options on average.

Polyheal achieved the primary and secondary endpoints of the study.

· More Polyheal patients achieved coverage with red granulation tissue than the control (65% vs. 19%, p= 0.0006)
· Polyheal patients had greater 4 week surface area reduction (40% vs. 15%, p = 0.02) than control.
· The number of wounds that closed completely in the Polyheal group was twice that of the control group.
· No significant side effects were observed in connection with 'Polyheal-1'.

“This trial is unique in that it took deep complex ulcers that had failed to respond to available treatments and demonstrated improvement rates that we would expect to see in superficial ulcers. This is particularly important since it is precisely these complex wounds that put patients at greatest risk of complications such as infection and amputation,” says Prof Jan Apelqvist, at the Diabetic Foot Center in Malmö, Sweden and an international expert in the field of wound healing. “These encouraging preliminary clinical results put Polyheal among the most promising new wound healing technologies in an area with a substantial need of additional treatment strategies.”

According to Dr. David G. Armstrong, a prominent Professor of Surgery and the Director of the Southern Arizona Limb Salvage Alliance (SALSA) at the University of Arizona College for Medicine, 'The data from this initial randomized study appears promising. These results compel us to take notice of this therapy.'

“This trial represents another major step forward and confirms the excellent results we have seen in Polyheal’s previous clinical trials,” says Mr. Jordan Rubinson, Polyheal CEO. “We believe that these results, combined with receiving recent EU approval, will give further support to our promotional and partnering efforts, and will enable us to heal many more complex ulcers in the future'.

About Polyheal

Polyheal Ltd., a subsidiary of Clal Biotechnology Industries Ltd. (TASE: CBI) has developed a technology for treating hard to heal wounds, such as wounds caused by Diabetes, Cardiovascular disease and Post trauma and Post surgical wounds, which until now do not have effective treatments that are easy to use and do not require hospitalization.

Approximately 2% of the population suffers from chronic wounds which significantly reduce patient quality of life and result in high costs to the patients and their families. The innovative treatment developed by Polyheal can significantly reduce the healing period, diminish patient suffering, and save numerous health care costs. Polyheal-1's technology is based on chemically charged polymer microspheres, which help to reactivate the body's natural healing processes to cure hard to heal wounds. The product has been tested on many patients and proved exceptionally efficient, especially in the most severe cases.

The market for medicines and devices for treating chronic wounds is estimated at seven billion dollars per year.

Media Contact:
Yamit Nissanov, PR for Polyheal
Tel:+972-9-9514666; +972-52-5541810
Email: yamit@idancom.com

###


Publisher Contact Information:

PR for Polyheal
+972-9-9514666
yamit@idancom.com

Company profile of Polyheal
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