Case Studies of Patients with Diabetic Foot Ulcers Showed 90 to 100 Percent Wound Closure at 12 weeks Following Weekly Treatment with Novel OMEZA® OCM™

-Three case studies reinforce clinical trial data demonstrating dramatic healing rates among patients with diabetic foot ulcers treated with OCM™ -

CLEVELAND, June 12, 2024 /PRNewswire/ -- Omeza^®, a regenerative skincare company that develops marine-based therapies for nonhealing wounds that are hard to treat, presented three case studies showing that diabetic foot ulcers (DFUs) treated weekly with Omeza^® OCM™ demonstrated 90 to 100 percent wound closure at 12 weeks. Results of the case studies were presented at the WOCNEXT annual conference, hosted by the Wound, Ostomy, and Continence Nurses Society™ (WOCN^®).

"Treating diabetic foot ulcers is a persistent challenge because they frequently fail to respond to what are considered topline treatments, and many patients suffer for months or years without relief, severely impacting their quality of life and jeopardizing their health status," said Mary Cheney, CNP, CWS, of Jobst Institute, Toledo, OH.

"The ongoing results of individual case studies and clinical trials consistently show that Omeza^® OCM™ has the ability to move hard-to-heal DFUs from chronic to healing—even wounds of more than a year in duration—within a period of 12 weeks, which is truly encouraging, given the massive toll they take on patients' lives, added Susan Shuman, BS, RN, of Jobst Vascular institute, Toledo, OH.

Diabetic foot ulcers are not only painful and burdensome to patients, but they often lead to serious complications such as severe infections, limb amputations, and loss of life. According to the American Diabetes Association, more than 154,000 people with diabetes in the United States undergo amputations each year, and up to 80% of non-traumatic lower limb amputations are due to diabetes complications.¹

OCM™ is a novel platform comprised of cold-water fish peptides and other pharmaceutical-grade components that harness an individual's innate immune processes to activate healing at the site of the wound. The current data on OCM™ were collected by the Jobst Vascular Institute at ProMedica Health System in Toledo, Ohio, which previously conducted a clinical trial comparing OCM™ to current standards of wound care.

Case Study Patient Outcomes

• Patient one, age 60: At treatment visit 1, his wound of 1-year duration measured 0.37cm. The patient's 12-week percentage area reduction (PAR) was 100%; however, walking caused its reopening, so he reentered the study. His 4-week PAR was 76%, and the wound closed by treatment visit 5.
• Patient two, age 53: At treatment visit 1, his wound of 12-week duration measured 11.6cm and was reduced to 2.09cm by treatment visit 5. His 4-week percent area reduction (PAR) was 87% and 12-week PAR was 99%.
• Patient 3, age 65: At treatment visit 1, his wound of 36-week duration measured 25cm and was reduced to 10.1cm by treatment visit 5. His 4-week PAR was 60% and 12-week PAR was 90%, with a wound size of 2.59cm.

"We continue to be encouraged by the positive results we're seeing in real-world settings and across clinical trials showing that OCM™ addresses many of the challenges that are inherent to diabetic foot ulcers, but which other wound care treatments have been unable to overcome," said Desmond Bell, DPM, Chief Medical Officer at Omeza^®. "We are continuing to evaluate OCM across many wound types and in multiple settings to replicate our findings and expand its usage to more patients whose unmet needs require a novel platform such as OCM™.

References:

1 https://diabetes.org/advocacy/amputation-prevention-alliance#:~:text=Amputations%20are%20on%20the%20rise,make%2C%20and%20where%20you%20live.

About OMEZA

Omeza^® is a commercial-stage regenerative skin and wound-care company that develops marine-based products comprising containing cold water fish peptides and other pharmaceutical-grade components designed to reduce inflammation, increase tissue proliferation, and support skin remodeling in adults with a range of chronic, non-healing wounds. Founded in 2014, the company currently markets OCM™ for the treatment of nonhealing wounds. OCM™ is also being evaluated in real-world settings and in multiple clinical trials to compare the effects of OCM™ versus standard of care on wound healing, pain reduction, quality of life, and other secondary endpoints in patients with diabetic ulcers, chronic venous leg ulcers, and multiple other wound types. The company is headquartered in Sarasota, Florida, and has research, manufacturing, and analytical facilities located throughout Florida.

Media Contact:
Bernadette Cupit
[email protected]
908-334-4554

SOURCE Omeza LLC