Royal Biologics Reports Cryo-Cord™, Amnio-Maxx™, Amnio-Maxx™ Lite and Derm-Maxx™ Receive High-Tier Reimbursement in the Hospital Outpatient Departments and Reimbursement in the Physician Office to Treat Chronic Non-Healing Wounds

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February 15, 2021

Royal Biologics, an Autologous and Live Cellular solutions-focused company, announced today that beginning Jan. 1, 2021, Cryo-Cord™ Placental Allograft, Amnio-Maxx™ Placental Allograft, Amnio-Maxx™ Lite Placental Allograft and Derm-Maxx™ Dermal Allograft will be placed in the high-tier reimbursement category for skin substitutes under the Center for Medicare and Medicaid (CMS) Hospital Outpatient Prospective Payment System.

With this new payment designation, hospital outpatient departments and affiliated wound care centers may now be able to receive a higher reimbursement when treating Medicare beneficiaries for chronic non-healing wounds with Cryo-Cord, Amnio-Maxx, Amnio-Maxx, Lite and Derm-Maxx. Additionally, physicians treating Medicare beneficiaries in their office may be able to receive reimbursement to cover the cost associate with these products.

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 Cryo-Cord™, Amnio-Maxx™, Amnio-Maxx™ Lite and Derm-Maxx™ from the low-cost skin substitute group to the high-cost skin substitute group.

“We are very pleased with the decision by CMS to reassign Cryo-Cord™, Amnio-Maxx™, Amnio-Maxx™ Lite and Derm-Maxx™ to the high-cost category for skin substitutes in the hospital outpatient setting while also providing for reimbursement in the physician office.  This higher Medicare reimbursement rate is more in line with actual costs wound care centers incur when treating non-healing wounds,” said Ryan Paul, Vice President of Royal Biologics Wound Care. “More importantly, this new reimbursement will, for the first time, allow physicians to treat chronic non-healing wounds with a viable umbilical cord graft outside of the operating room setting, which will significantly reduce the costs to our healthcare systems.”

Cryo-Cord™ is a non-DMSO cryopreserved human placental umbilical cord allograft. The proprietary non-DMSO cryoprotectant helps to retain the natural properties of placental tissue including nutrient-rich growth factors, cytokines, endogenous cells and Wharton’s Jelly. It is used to treat chronic non-healing wounds including but not limited to diabetic foot, venous leg, arterial and pressure ulcers. Studies have shown that essential components of placental tissue support wound healing functions, including providing an extracellular matrix and a protective barrier to infection.

Amnio-Maxx™ and Amnio-Maxx™ Lite are dehydrated and sterilized human placental membrane grafts derived from the amniotic layer. Amnio-Maxx™ is a dual-layer membrane and Amnio-Maxx™ Lite is a single layer membrane. They are both used as a scaffold for treating chronic non-healing wounds including but not limited to diabetic foot, venous leg, arterial and pressure ulcers.

Derm-Maxx™ is a dermal matrix allograft that 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.  Derm-Maxx™ is intended for support, protection, reinforcement and/or covering during integumentary applications.

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