New Clinical Data Demonstrate >90 Percent Area Reduction in Diabetic Foot Ulcers within 12 Weeks or less Using Novel Omeza® Platform plus Offloading
SARASOTA, Fla., Dec. 6, 2023
SARASOTA, Fla., Dec. 6, 2023 /PRNewswire/ -- Omeza®, a regenerative skincare company that develops marine-based therapies for the treatment of chronic wounds, today announced interim clinical trial results showing that Omeza® combination therapy plus standard of care (offloading) achieved a 91 percent area reduction (PAR) rate in diabetic foot ulcers (DFUs) within twelve weeks, and a 63 percent PAR within four weeks. PAR is considered a surrogate endpoint of complete wound healing, with a PAR of 50 percent at four weeks in diabetic wound patients considered a strong predictor of subsequent complete healing.1
Interim data from the study, conducted by ProMedica Jobst Wound Care, affiliated with the University of Toledo College of Medicine, will be presented at the 2023 Desert Foot Multi-Disciplinary Limb Salvage and Wound Care Conference Dec. 6-9.
"Diabetic foot ulcers are one of the leading causes of mortality, morbidity, and lower extremity amputations in patients with diabetes, and the medical community continuously strives to identify novel therapies to prevent or reduce these complications and their significant burden to patients, families, and the healthcare system at large," 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.
"In evaluating Omeza®'s platform, the first twelve patients treated in the study have demonstrated significant healing—and in some cases, complete closure—of their diabetic wounds in twelve weeks or less, which is a notable achievement, given the resistance to standard treatments that DFUs often display," said Simman, principal investigator at the Promedica clinical trial site.
In the study, patients with DFUs were treated with OCM™, Omeza® Lidocaine Lavage, and Omeza® Skin Protectant. OCM™ is a drug/device containing cold water fish peptides and other pharmaceutical-grade components that create an absorbable matrix which integrates into the wound bed to support the synthesis of new tissue. Patients also received standard of care, which included offloading—minimizing weight placed on the foot to help prevent and heal ulcers along with diabetes control.
By week four of treatment, the average PAR was 63 percent, with two patients achieving complete wound closure. By week twelve, the average PAR was 91 percent, with two additional patients achieving complete closure of their DFUs. Both of these cases were of ≥1 year duration prior to Omeza® combination therapy and standard of care. No adverse events related to treatment were reported during the study.
"We continue to be encouraged by the high rates of wound closure experienced by patients in our three studies that are currently underway, and we look forward to obtaining further confirmation of OCM's™ ability to treat advanced wounds from day one, as well as to 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 of the components in our platform are natural, pharmaceutical-grade ingredients that are known to be safe and have been shown to harness an individual's innate immune processes to activate healing at the site of the wound," Bell said. "Our ongoing in vivo and in vitro studies will further elucidate the mechanisms of action that underlie the exciting results we're accumulating in clinical trials and the real-world setting."
Omeza® is a commercial-stage regenerative skin and wound-care company that develops marine-based products comprising cold water fish peptides and other pharmaceutical-grade ingredients. Founded in 2014, the company currently markets three products (OCM™, Omeza® Lidocaine Lavage, and Omeza®Skin Protectant) designed to reduce inflammation, increase skin proliferation, and support skin remodeling in adults with a range of chronic, non-healing wounds. Three clinical trials underway are evaluating the Omeza® platform in diabetic foot ulcers, venous leg ulcers, and wounds of multiple etiologies in the real-world setting. The company is headquartered in Sarasota, Florida, and has research, manufacturing, and analytical facilities located throughout Florida.
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SOURCE Omeza LLC