Lotus Pharmaceutical Co., Ltd (“Lotus” or “the Company”, Taiwan OTC ticker: 1795) today announced the approval of Kerecis Omega3 Wound granted by TFDA. Lotus pointed out that it licensed in acellular-fish-skin based Kerecis Omega3 Wound from the Icelandic biotech company Kerecis, and Lotus has received Korea MFDS approval for the same as well. This marked as the Company’s first Class II medical device approval indicated for chronic wound treatment including diabetic wound.
Commenting on the partnership, G. Fertram Sigurjonsson, Chairman and CEO of Kerecis said, “Kerecis develops regenerative technologies based on fish skin and Omega3 polyunsaturated fatty acids. We noticed that more than 60 percent of the diabetics in the world live in Asia. Non-healing leg wounds are a tragic consequence of diabetes and often lead to amputations. Skin substitutes are not commonly used in Asia and we believe that Lotus is the right partner to introduce this new treatment option to the region to meet medical needs.” Lotus Chairman Andrew Lin was encouraged about the partnership. He said, “The technology is patented in the United States and multiple other countries. Kerecis Omega3 Wound has been approved by the FDA and European regulatory authorities for wound healing. We are proud to be introduced to such an exciting, much needed technology through Alvogen group. We believe that Kerecis Omega3 Wound is a strong addition to our hospital portfolio and the collaboration shows our commitment in improving healthcare quality in Asia.”
Kerecis Omega3 is intact fish skin from Iceland. When grafted onto damaged human tissue such as a diabetic wound, the material provides a template for cellular ingrowth that facilitates healing and regeneration. This has relevance in wound closure as shown by several clinical trials.
According to the International Diabetes Association, more than 9 million people suffer from diabetes in Asia. Worldwide, people with diabetes are 25 times more likely to lose a leg than people without the disease. And roughly 50 percent of amputees undergo another amputation within one to three years. Yet it is estimated that 85 percent of all amputations due to diabetes could be prevented.