By Industry News
Omeza Receives FDA Clearance for Omeza® Collagen Matrix
Sarasota, FL, September 2, 2021—Omeza, a skin science company, announced that the U.S. Food and Drug Administration (FDA) cleared Omeza® Collagen Matrix through the FDA 510(k) premarket notification process. Omeza® Collagen Matrix is Omeza’s first Rx product, and the first drug/device combination matrix of its kind for chronic wound care.
“No one is taking on the challenge of making advanced wound care products both effective and affordable, yet preventable amputations are on the rise. We are determined to bridge that gap,” said Sarah Kitlowski, President of Omeza. “Our mission is to give practitioners groundbreaking new tools to help protect and manage the wound during the natural processes of wound closure.”
Omeza® Collagen Matrix (OCM) is a wound care matrix comprised of hydrolyzed fish collagen infused with cod liver oil, which acts as an anhydrous skin protectant, and other plant-derived oils and waxes. When applied to a wound surface, the matrix is naturally incorporated into the wound over time. Omeza® Collagen Matrix is designed for intimate contact with both regular and irregular wound beds to provide a conducive environment for the patient’s natural wound healing process.
The product features a no-prep application supplied in easy to use, unit dose vials.
Omeza® Collagen Matrix is indicated for the management of wounds including partial- and full-thickness wounds, pressure injuries, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh’s surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, superficial partial-thickness burns, skin tears) and draining wounds.
In the United States, chronic ulcers are conservatively estimated to cost health care systems $28 billion each year as a primary diagnosis and $31.7 billion as a secondary diagnosis. According to the American Diabetes Association (ADA), over 9–12 million Americans suffer from chronic ulcers. The mortality rate for leg ulcers after the first amputation has dramatically doubled from 20% to 50% in the first 3 years to 70% after 5 years. 1
Omeza Appoints New Director of Sales – East Region
Sarasota, FL. Oct. 13,2021 – Omeza, LLC announced that James “Jim” McSweeney is joining the company in the role of Director of Sales – East Region effective October 11, 2021. Mr. McSweeney has worked for 3M/KCI since 2018 and currently holds the position of Director Corporate Accounts.
In his new role, Mr. McSweeney will be central to Omeza’s strategy of wound healing delivered simply and completely to restore patient quality of life. Omeza recently received 510(k) approval of its lead drug-device combination product, Omeza® Collagen Matrix, and FDA clearance to go to market.
Company Founder and CEO Tom Gardner, commented, “Jim brings significant expertise into this new, critical role for our organization. His extensive experience in chronic wound care, ability to drive sales organizations, and depth of knowledge about customer requirements will be valuable in the commercial launch of our lead Rx only Omeza® Collagen Matrix as well as our 2 OTC drugs, Omeza® Lidocaine Lavage and Omeza® Skin Protectant. I am confident that Jim will be successful in helping to drive our growth.”
Mr. McSweeney began his career at Novartis, progressing to Senior Account Specialist in the Specialty Tissue Engineering Division -- which was sold to Organogenesis in 2003. He became Regional Sales Manager for Organogenesis, building sales for their Apligraf® Tissue Substitute product before leaving to join advanced wound care startup Spiracur, Inc. in 2012 as Regional Sales Manager Northeast to help launch Spiracur’s novel Negative Pressure Wound Treatment called SNAP®. Spiracur was acquired by KCI in 2015, and KCI was acquired by 3M in 2019.
Mr. McSweeney commented, “I am excited to help drive the growth of Omeza and look forward to bringing the technology to underserved markets.”
Omeza Announces Contract with Marathon Medical
Sarasota FL. Nov. 5, 2021 – Omeza, LLC announced a contract with Marathon Medical, Inc., a distributor for Veterans Affairs hospitals and medical facilities. Marathon Medical is a certified Service-Disabled Veteran-Owned Small Business. The contract will permit Omeza to ramp up its internal VA sales force, according to Jim McSweeney, Omeza’s Director of Sales – East Region.
Marathon Medical distributes medical and surgical devices, drugs, supplies, and related apparatus. Selling through Marathon’s Federal Supply Schedule/General Services Administration contract will allow Omeza to sell Omeza® Collagen Matrix, recently cleared by the FDA, Omeza® Lidocaine Lavage, and Omeza® Skin Protectant to VA hospitals and clinics, Indian Health Service hospitals and clinics, as well as other federal agencies.
Mr. McSweeney commented, “Marathon is very well known. They will open doors for us, including within the VA and Department of Defense, expediting the availability of Omeza products to patients nationwide.”
John St. Leger, founder of Marathon Medical, states “We are excited to be partnering with a great organization like Omeza. The product offering and vision are excellent, and we share common values and goals to support Veterans and Vet-owned businesses. We are looking forward to helping them grow the market.”
About Marathon Medical:
Marathon Medical was founded in 2002 by Vietnam-era veteran, John St. Leger. Based in Aurora, CO, the company distributes medical supplies nationally using LTL and package contracts with major carriers, utilizing EDI to streamline its ordering process. Marathon Medical partners with manufacturers recommended by VA physicians and purchasing clients, and has established a Tampa, FL distribution facility to increase its coverage of the Southeast.
1. Human Wounds and Its Burden: An Updated Compendium of Estimates, by Chandan K. Sen, https://www.ncbi.nlm.nih.gov/
Omeza is a skin science company dedicated to equitable access to better wound care outcomes for patients at all sites of care. The company is based in Sarasota, FL USA. Inquiries from medical and health professionals should be directed to firstname.lastname@example.org.
The views and opinions expressed in this blog are solely those of the author, and do not represent the views of WoundSource, HMP Global, its affiliates, or subsidiary companies.