Follow-Up Study Demonstrates Safety and Efficacy of Omega3 Wound-healing Treatment
Reykjavik/Isafjordur, Iceland, May 18, 2012 — Kerecis, the emerging tissue-regeneration company, has successfully completed a 37-patient follow-up study of its MariGen Wound treatment product for chronic wounds.
MariGen Wound is a fish-skin-derived, extra-cellular matrix that contains Omega3 and intact proteins from fish skin. The product is manufactured according to a patent-pending method where all allergenic materials are removed. When used, MariGen is applied to the wound bed where it acts as a scaffold that is populated by the body’s own cells. Ultimately the product is converted into functional living tissue. MariGen is suitable for the treatment of chronic wounds, including diabetic, vascular and other hard-to-heal wounds.
The 37 patients in the study had chronic wounds that had not responded to conventional treatment. Some of the wounds had even deteriorated under such treatment. On the other hand, more than 90% of the wounds treated with MariGen Wound improved after four weeks and none got worse. No adverse effects, including allergies, were reported either clinically or in serology analysis.
Statistics show a large unmet need for wound care. Each year about 6 million Americans suffer from problem wounds caused by diabetes, circulatory problems and other conditions, with 1.1 to 1.8 million new cases added each year.
More than 20 million Americans have diabetes, almost 20 percent of whom are over the age of 60. A full 15 percent of all diabetics will develop problem wounds, and about 82,000 diabetics undergo amputation each year because of such wounds.
Dr. Baldur Tumi Baldursson (PhD) (MD), Kerecis Medical Director:
“In the study we monitored 37 patients for up to one year after treatment with MariGen Wound both for clinical results and for immunological effects. 36 of the wounds (97 percent) improved with treatment. The 37th wound did not improve but also did not get worse, and no immunological effects were recorded.”
Dr. Hilmar Kjartansson (MD), Kerecis Director for Clinical R&D:
“The study’s results indicate that the MariGen Omega3 Extra Cellular Matrix is free from allergens and other molecules that can potentially have immunological effects on the body. Those results are important for us as we move forward to develop matrices for other indications such as meshes for hernia surgery.”