Royal Wound-X Receives IRB Approval and Commences Randomized Controlled Trials for Pivotal Products

HACKENSACK, N.J., September 11, 2024 (Newswire.com) - Royal Wound-X, a division of Royal Biologics dedicated to advancing wound care through cutting-edge research and development, is pleased to announce the commencement of two national Randomized Controlled Trials (RCTs) for its innovative products: Derm-Maxx™ Dermal Matrix and Amnio-Maxx® Dual Layer Amnion Patch.

Derm-Maxx™ Dermal Matrix and Amnio-Maxx® Dual Layer Amnion Patch Trial Details

The trial for Derm-Maxx™, titled "A Randomized Controlled Multicenter Trial, Examining the Effect of Derm-Maxx™ on the Healing Rate of Chronic Diabetic Foot Ulcers," and the trial for Amnio-Maxx®, titled "A Randomized Controlled Multicenter Trial, Examining the Effect of Amnio-Maxx® on the Healing Rate of Chronic Diabetic Foot Ulcers," underscores Royal Wound-X’s commitment to patient-first care and providing a comprehensive range of products tailored to patient needs. 

Guided by industry experts Sarah Moore (CRO, Capsicure) and Dr. Windy Cole, DPM (Medical Monitor, Capsicure), both renowned for their contributions to some of the most significant and impactful studies in the field, this trial represents a collaborative effort towards advancing wound care solutions. 

Dr. Cole, who also serves as the Director of Wound Care Research for Kent State University College of Podiatric Medicine, expressed her enthusiasm for the initiative: “I am pleased to be an integral part of these carefully designed clinical trials investigating the utility of two unique advanced CAMP technologies in the management of hard-to-heal diabetic foot ulcers." She added, "Through this collaboration with Royal Biologics and Capsicure, we have established a team committed to ensuring high integrity in clinical trial management, leading to quality study results that will be translatable to the Medicare population and beyond." 

The leadership team also includes Salvatore Leo (CEO and Founder, Royal Biologics), Jim Blasingame (Business Development, Royal Wound-X), and Mary Jo Murino (Operations, Royal Wound-X), ensuring robust oversight and operational excellence. Salvatore stated, “We are very excited to receive IRB approval for two pivotal randomized control trials, utilizing our advanced skin graft substitute technologies. We are looking forward to collaborating with Capiscure and Dr. Windy Cole to highlight the efficacy of these products and treat patients who are in need of advanced modalities in wound care.”

The studies aim to determine the efficacy of Derm-Maxx™ and Amnio-Maxx® in conjunction with the standard of care (SOC) versus SOC alone in achieving complete closure of non-healing diabetic foot ulcers. These 12-month-long studies involve over 20 highly recognized physicians and practices nationwide.

Derm-Maxx™ Dermal Matrix

Derm-Maxx™, an acellular human dermis graft, is derived from dehydrated dermis of donated human tissue and processed using the Tutoplast® tissue sterilization process. This method preserves the three-dimensional collagen structure, maintaining the multidirectional mechanical properties of the original dermal tissue. Regulated as a 361 human cell and tissue product (HCT/P) as defined in USFDA 21 CFR 1271, Derm-Maxx™ is restricted to homologous use for the repair, replacement, reconstruction, or augmentation of soft tissue by a qualified healthcare professional.

Amnio-Maxx® Dual Layer Amnion Patch 

Amnio-Maxx ® Dual Layer Amnion Patch is an allograft derived from donated human birth tissue and sterilized using radiation. The Amnio-Maxx Dual Layer Amnion Patch is designed to serve as a barrier and provide protective coverage from the surrounding environment for both acute and chronic wounds. 

Processed using aseptic techniques, the Amnio-Maxx® Dual Layer Amnion Patch is treated with a saline solution, dehydrated, and aseptically packaged in a peel pouch within a dual peel tray configuration. The allograft has been sterilized using radiation in accordance with ANSI/AAMI/ISO 11137 and is secured in an outer container.

Advancing Wound Care Together

Royal Wound-X is enthusiastic about the collaborative support from its partners and is committed to sharing the study findings, contributing to the broader medical community's knowledge and improving patient outcomes. The inclusion of both Derm-Maxx™ Dermal Matrix and the Amnio-Maxx® Dual Layer Amnion Patch in these trials exemplifies Royal Wound-X’s dedication to developing advanced wound care solutions that address a wide range of patient needs.

About Royal Wound-X: 

Royal Wound-X, a division of Royal Biologics, is at the forefront of wound care innovation, dedicated to developing and providing advanced solutions to meet diverse patient needs. With a patient-first mentality, Royal Wound-X offers a wide array of products designed to enhance healing and improve quality of life.

Media Contact: 

Mary Jo Murino  

Phone: 201.488.1549  

Website: www.royalwx.com

Source: Royal Wound-X