Kerecis, a medical device company focused on the treatment of tissue damage with Omega3-based regenerative technologies, has announced that its recent clinical trial found no allergenic reactions to its fish-skin-composed MariGen Omega3 technology.
MariGen Wound, which is the advanced product, is indicated for the management of chronic wounds, including diabetic, vascular and other hard-to-heal wounds.
The products that are based on MariGen Omega3 technology are intact, decellularized fish skin sheets that have had all cells and antigenic materials removed.
Kerecis Medical Director Baldur Tumi Baldursson said that the 40-patient clinical study further demonstrates the safety of the MariGen Omega3 tissue-regeneration technology.
"More than 100 patients have now participated in our clinical studies and no one has demonstrated any allergenic or otherwise adverse reaction to the material," Baldursson added.
Kerecis Clinical R&D director Hilmar Kjartansson said that the allergy study is one of two studies that the US Federal Drug and Food Agency (FDA) required to execute before clearing MariGen Omega3 for use as a wound-treatment product.
"We are pleased that we are now half-way through the FDA-required program, and plan to have regulatory clearance before the end of the year," Kjartansson added.