OMEZA® CLINICAL STUDY TO EVALUATE OCM™ WOUND MATRIX FOR THE TREATMENT OF CHRONIC CUTANEOUS WOUNDS/ULCERS OF MULTIPLE ETIOLOGIES HAS COMPLETED ENROLLMENT AND FINAL DATABASE LOCK. FULL RESULTS WILL BE SUBMITTED TO A PEER REVIEW JOURNAL.

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Jun 06, 2024, 07:00 ET

SARASOTA, Fla., June 6, 2024 /PRNewswire/ -- Omeza^®, a regenerative skincare company that develops marine-based therapies for wounds that are hard to treat, today announced completion of a multi-center clinical study which evaluated OCM™ Wound Matrix in the treatment of a variety of chronic non-healing wounds/ulcers. The primary objective of the trial was to evaluate the effectiveness of OCM™ Wound Matrix in promoting healing and reducing ulcer size of chronic, stalled wounds in the investigator's patient population. This objective was to evaluate multiple types of hard to heal wounds in a population which is more typical of the patients routinely treated by health care practitioners; a population which are generally excluded from controlled trial designs due to factors such as serious comorbidities, age of patients, and size and complexity of wounds. Secondary objectives included evaluating changes in quality of life, including pain perception, change in wound exudate and infection assessments, and time to maximum or complete closure.

A total of 111 patients were enrolled for the trial. All patients were seen weekly for wound evaluation and dressing changes and treated with OCM™, a drug/device containing cold water fish peptides and other pharmaceutical-grade components. OCM™ creates an absorbable matrix which conforms to the wound bed and supports the synthesis of new tissue.

The average age of the patient population was 65 years, and ranged from 36 to 100 years. The Body Mass Index (BMI) of patients ranged from 16 to 53, with an average BMI of 33. (A BMI of 30 or above is classified as Obesity). Wound etiologies included diabetic foot ulcers (DFU), venous leg ulcers (VLU), Pressure Injuries, Pyoderma Gangrenosum, Surgical wounds, Arterial, and Unclassified recalcitrant wounds. The initial size of wounds ranged from 2.1cm² to 63.2cm² with an average wound size of 10.6cm². Comorbidities of patients included chronic and active tobacco use, hypertension, diabetes, chronic opioid use, peripheral arterial disease, chronic hepatitis C, anemia of chronic disease, depression, osteoporosis, hypothyroidism, asthma, bi-polar disorder, neuropathy, hypercholesterolemia, Gastro-esophageal reflux disease (GERD), rheumatoid arthritis, deep venous thrombosis.

Chronic, non-healing wounds (CNHW) impact about 8.2 million Medicare beneficiaries.¹Medicare cost projections for all wounds ranged from $28.1 to $96.8 billion, including costs for infection management, among which surgical wounds and diabetic ulcers were the most expensive to treat.¹

Developing clinical evidence demonstrating benefit in chronic advanced wounds which are typically found in the Medicare beneficiary population is critical to assist payers, providers and patients in determining how to manage treatment.²Previous publications established that Randomized Clinical Trials in wound care, almost without exception, exclude patients with significant comorbid diseases to evaluate the efficacy of the study agent, resulting in the ineligibility of more than half the wound care patient population.³

"Results from Omeza's Multiple Etiology Trial will demonstrate the importance of studying the impact of OCM™ on patients who not only present with wounds that previously did not show indications of healing but would otherwise not qualify for inclusion in typical wound clinical trials, due to their respective wound etiologies and extensive comorbidities" reports Dr. Desmond Bell, DPM, Omeza's Chief Medical Officer.

References:

¹Human Wound and Its Burden:Updated 2020 Compendium of Estimates
Adv Wound Care (New Rochelle) 2021 May; 10(5):281-292
Human Wound and Its Burden: Updated 2020 Compendium of Estimates - PubMed (nih.gov)

²Publicly Reported Wound Healing Rates: The Fantasy and the Reality
https://www.liebertpub.com/doi/full/10.1089/wound.2017.0743

³Evidence supporting wound care end points relevant to clinical practice and patients' lives. Part 3: The Patient Survey - PubMed (nih.gov)
Wound Repair Regen 2021 Jan; 29(1):60-69. doi: 10.1111/wrr.12872

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 and manufactures in Sarasota, Florida.

Media Contacts:
Bernadette Cupit
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908-334-4554

SOURCE Omeza LLC