Newswise – SARASOTA, Florida, March 14, 2024 – Omeza®a regenerative skin care company developing marine-based therapies to treat chronic wounds, today presented positive interim data from a diabetic foot ulcer (DFU) clinical trial showing that Omeza® OCM™ plus relief of the affected foot, an area reduction rate (PAR) of 91 percent for DFUs was achieved within twelve weeks and a PAR of 63 percent within four weeks. PAR is considered a surrogate endpoint for complete wound healing, with a PAR of 50 percent after four weeks considered a strong predictor of subsequent complete healing in diabetic wound patients.
Preliminary data will be presented at the Cellular, Acellular, and Matrix-Like Products Wound Care Summit (CAMPs) March 13-14 in Miami, and the full data set, showing even stronger results, will be published in a paper published by experts examined wound submitted diary.
“Diabetic foot ulcers are a leading cause of mortality, morbidity, and lower extremity amputations in patients with diabetes, and the medical community continually strives to find new therapies to prevent or prevent these complications and their significant burden on patients, families, and others “The health care system as a whole,” said Dr. Richard Simman, professor of plastic surgery at the University of Toledo College of Medicine, Jobst Vascular Institute at ProMedica Health System in Toledo, Ohio. Promedica conducted the DFU clinical trial.
“When evaluating Omeza®The first twelve patients treated in the study demonstrated significant healing – and in some cases complete closure – of their diabetic wounds in twelve weeks or less, a remarkable achievement given the resistance to standard treatments that DFUs often exhibit,” said Simman, principal investigator at the Promedica clinical trial site.
In the study, patients with DFUs were treated with OCM™, a drug/device containing cold-water fish peptides and other pharmaceutical components that form an absorbable matrix that conforms to the wound bed and supports the synthesis of new tissue. Patients also received standard care, which included offloading – no weight bearing on the foot – to aid healing.
By the fourth week of treatment, the average PAR was 63 percent, with two patients achieving complete wound closure. By week 12, the average PAR was 91 percent, with two additional patients able to completely close their DFUs. Both cases lasted at least 1 year before treatment with OCM™ and unloading. No treatment-related adverse events were reported during the study.
“We continue to be encouraged by the high wound closure rates in patients in our three ongoing studies and we look forward to further confirmation of OCMs.”™ “Ability to treat advanced wounds from day one and transition chronic wounds from a stalled state to a healing state more quickly and completely than other products on the market,” said Desmond Bell, DPM, Chief Medical Officer at Omeza®.
“All components of our platform are natural, pharmaceutical-grade ingredients that are considered safe and proven to harness an individual’s innate immune processes to activate healing at the wound site,” Bell said. “Our ongoing in vivo and in vitro studies will further elucidate the mechanisms of action underlying the exciting results we are collecting in clinical trials and real-world settings.”
About OMEZA
Omeza is a commercial regenerative skin and wound care company developing marine-based products containing essential omega fatty acids and hydrolyzed fish collagen enriched with cod liver oil. Founded in 2014, the company currently markets Omeza Complete Matrix (OCM).™) designed to reduce inflammation, increase tissue proliferation and support skin remodeling in adults with a range of chronic, non-healing wounds. Omeza is currently conducting three clinical trials in patients with diabetic ulcers, chronic venous leg ulcers and multiple other causes to evaluate the effects of Omeza combination therapy compared to standard treatment on wound healing, pain reduction, quality of life and other secondary endpoints. The company is headquartered in Sarasota, Florida, and has research, manufacturing and analytical facilities throughout Florida.