Royal Biologics Launches New Wound Care Division

The first product is Derm-Maxx Allograft, which is produced using a process that reduces native nucleic acids.

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Royal Biologics

Royal Biologics today announced the commercial launch of Derm-Maxx, an acellular dermal matrix allograft. Derm-Maxx is Royal Biologics' first launched product in their newly announced wound care division at Royal Biologics.

Derm-Maxx is intended to serve as a barrier and provide protective coverage from the surrounding environment for acute and chronic wounds. Additionally, Derm-Maxx Allograft is intended for support, protection, reinforcement, and/or covering during integumentary applications. Derm-Maxx can be applied with a dressing, sutured or stapled.

Derm-Maxx Allograft is produced using a process that reduces native nucleic acids, cells and other antigenic material while preserving the collagen matrix with vascular channels. The extracellular matrix supports cellular infiltration, attachment, and proliferation. The unique processing technique preserves the collagen and elastic tissue fibers while maintaining the open channels through which cells can migrate, proliferate, and form new blood vessels. This biologic process is crucial to the integration and remodeling of the allograft by host cells. In addition to epidermal appendages, such as sweat glands, hair follicles, and sebaceous glands, Derm-Maxx™ also contains mast cells, lymphocytes, and macrophages important to the immune system. Elastic fibers in the dermis are essential for maintaining the biomechanical properties of the skin.

“We are very excited to announce our U.S. commercial launch of Derm-Maxx for the intended treatment of acute and chronic wounds,” says Salvatore Leo, Chief Executive Officer at Royal Biologics. “Derm-Maxx is the first product launch planned in our newly formed wound care division here at Royal Biologics. We are expanding our industry-leading portfolio of orthobiologics with the addition of several options now to treat wounds in the United States."

In Transmittal 10541, January 2021 Update of the Hospital Outpatient Prospective Payment System (OPPS), issued Dec. 31, 2020, by CMS to its Medicare Administrative Contractors, CMS announced that they were reassigning Derm-Maxx from the low-cost skin substitute group to the high-cost skin substitute group.

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