Decellularized Fish Skin Technology

Kerecis® Marigen™

Evidence

Kerecis® Marigen™ has had numerous trials supporting its efficacy, safety and cost-effectiveness.

Efficacy

■ Kirsner et al. performed a doubleblind, prospective, randomized clinical trial comparing the efficacy of FSG with dehydrated human amnion/ chorion membrane allograft (dHACM) in the treatment of full-thickness wounds3

■ The study had 85 healthy volunteers aged between 19 and 51 years. Full thickness wounds were created using punch biopsies

■ Acute wounds treated with FSG healed faster than wounds treated with dHACM, with a p-value of 0.0014

■ Similar results were obtained in another randomized control trial that compared FSG with porcine smallintestine submucosa

■ Kerecis® has demonstrated its proficiency in creating lipidcontaining tissue matrices from fish skin, and it has been shown that the material is safe, non-toxic and structurally sound

Infection

■ There is no risk of viral or prion disease transmission between humans and Atlantic cod

■ Fish skin does not need the same level of processing as mammalian tissue does5

■ Less processing of the tissue helps it retain a structure similar to human skin as most of the lipids can remain in the tissues6

Costs

■ Winters et al. conducted a retrospective comparative cohort study to compare the cost of FSG versus standard of care for the treatment of diabetic foot ulcers (DFUs)

■ The study showed that the fish skin treatment could result in lower costs, more wounds healing (83.2% vs. 63.4%), fewer amputations (4.6% vs. 6.9%), and a higher quality of life (0.676 vs. 0.605 quality-adjusted life year (QALY) than the standard of care7

“Fish skin grafts show promising results in treating diabetic foot ulcers (DFUs), venous leg ulcers…. many uses in clinical applications of the future.”

Fiakos et al.7

“Acellular fish skin xenografts may represent an effective, low-cost alternative in treatment of superficial- and partial-thickness burns.”

Luze et al.8

“Management with fish skin has shown faster granulation rates in burn wounds for skin grafting, resulting in improved patient outcomes with no documented infections.”

Reda et al.9