Could the answer for diabetic ulcers and other chronic wounds be found under the sea? A new wound healing treatment is one part tissue regeneration technology and one part Little Mermaid. It isn’t often FDA device approval news makes us wow, particularly if it’s a 510(k) clearance. But an Icelandic healthcare startup, Kerecis, got FDA clearance for its fish-skin chronic wound treatment. The benefits from fish oil are the crux of why this method could be preferable over other chronic wound healing options.
The technology, Marigen Omega3, uses skin from cod harvested from the Atlantic Ocean (watch out, little guys!), then takes out all the cells and antigens, leaving a sheet that can be put into or onto human skin. The Omega3 lipids found in fish oil are the not-so secret, as they reduce inflammation. According to a company statement:
Fish skin is largely made from the same material as human skin, with the addition of Omega3 polyunsaturated fatty acids. When the product is inserted into or onto damaged human tissue, protease activity is modulated, the fish skin is vascularized and populated by the patient’s own cells, and ultimately converted into living tissue.
Behavioral Health, Interoperability and eConsent: Meeting the Demands of CMS Final Rule Compliance
In a webinar on April 16 at 1pm ET, Aneesh Chopra will moderate a discussion with executives from DocuSign, Velatura, and behavioral health providers on eConsent, health information exchange and compliance with the CMS Final Rule on interoperability.
The FDA has cleared the device for use on chronic wounds, “problem” wounds, such as the ones diabetics and patients with circulatory problems suffer. The company said that can add up to 6 million Americans a year, with more than a million new cases added every year. Globally, that number jumps to 34.5 million chronic wounds treated annually.
Using fish, instead of skin from other humans or pigs, means cheaper manufacturing and lower risk of disease transfer, according to the company website. “Since it is derived from fish, the material is both kosher and halal compatible, eliminating cultural and religious constraints to usage, with equivalent or better clinical performance than alternative approaches,” the website says.
The 4-year-old company plans to use similarly fish-y technology (sorry, couldn’t help myself) for hernia repair and dura matter reconstruction. Kerecis is currently in the midst of closing a Series B round of funding, according to the company website.
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