Company Description
Regenerex Pharma, Inc. (OTC: RGPX) is a Nevada corporation focused on advanced wound closure systems for chronic and acute wounds. According to its public communications, the company develops, manufactures, and markets proprietary wound care products that aim to accelerate healing and reduce amputations associated with stalled wound healing. Regenerex positions its technology for conditions such as diabetic foot ulcers, venous ulcers, burns, and pressure ulcers, with an emphasis on chronic, non-healing wounds.
The company’s wound care platform centers on its proprietary QBx™ technology, which is derived from oak bark extract. Regenerex states that QBx™ contributes to creating a suitable environment for wound closure by down regulating the production of certain proteases and matrix metalloproteases (MMPs), protein enzymes that are described as impeding the healing of a majority of chronic wounds. The company highlights that elevated protease levels are present in a large proportion of chronic wounds and that its approach targets this biochemical barrier to healing.
Core Products and Wound Care Focus
Regenerex Pharma describes a product line built around sterile wound dressings and topical formulations incorporating QBx™. Its stated offerings include:
- Xcellderma™ – OTC Liquid Bandage Skin Protectant: A sterile wound dressing product described as effective for treating diabetic foot ulcers, pressure ulcers, and other chronic wounds. The company links Xcellderma™’s effectiveness to QBx™, which it states down regulates certain proteases and MMPs associated with impaired wound healing.
- Accelerex – Sterile Wound Cream: Presented as a medical device for a wide variety of chronic and acute wounds. Regenerex describes Accelerex as an FDA and CE approved unit-dose, sterile wound dressing impregnated with an ointment containing QBx™. The product is positioned for chronic wounds such as diabetic ulcers, burns, pressure ulcers, and venous stasis ulcers.
- Accelerex – Impregnated Sterile Wound Dressing: A prescription-only, FDA-cleared combination device for managing pressure ulcers (stages I–IV), stasis ulcers, diabetic skin ulcers, skin irritations, cuts, and abrasions. The company states that this product combines a protective dressing and moisturizing ointment with two drug components, rubidium chloride and potassium chloride, providing three modes of action for acute and chronic wounds.
Regenerex emphasizes that its products are intended to heal wounds effectively in a shorter period of time compared to traditional methods, and that multiple clinical evaluations have shown a high rate of wound closure within a defined time frame. The company characterizes its wound care line as technologically advanced and clinically proven, with a focus on both effectiveness and convenience.
Technology and Clinical Approach
The company’s description of its technology highlights the role of proteases and MMPs in chronic wound pathology. Regenerex states that its QBx™ ingredient down regulates these enzymes, addressing what it describes as a key barrier to healing. It contrasts this mechanism with other modern wound dressings such as hydrocolloids and collagens, which it notes primarily absorb wound fluids and act as coverings without altering the cellular environment.
Regenerex reports that its products have been evaluated in multiple clinical settings, with a large proportion of chronic wounds demonstrating complete closure within a specified period under its protocols. The company links these outcomes to the combination of QBx™-based dressings, defined treatment protocols, and proprietary electronic medical record (EMR) systems that support consistent application of its wound care approach.
Manufacturing and Operations
In its corporate updates, Regenerex Pharma states that it manufactures its wound care products from a facility in Memphis, Tennessee. The company has also reported the establishment of a comprehensive management team to support manufacturing plans and growth strategies. Its communications describe a focus on bringing its full line of advanced chronic wound care products to market and expanding their use in clinical practice.
Regenerex identifies itself as providing clinically proven products that aim to heal wounds more quickly, conveniently, and cost effectively than traditional methods. The company’s stated mission is to address chronic wound closure and reduce amputations resulting from stalled healing processes, positioning its technology as a response to broader human health challenges related to chronic wounds.
Collaboration with Holista Colltech and Ovine Collagen
Regenerex Pharma has announced a series of agreements with Holista Colltech Ltd., a producer of high-purity ovine collagen based in Perth, Australia. Through a licensing agreement, Regenerex plans to integrate ovine nano-collagen into its wound healing protocols alongside its QBx™ technology. The company describes ovine nano-collagen as a highly refined biomaterial with an ultra-small molecular size that provides an ideal scaffolding matrix to support and accelerate cellular growth, particularly in cases requiring deeper tissue regeneration.
In addition to licensing, Regenerex has entered into a binding supply and development agreement under which Holista will exclusively manufacture and supply its proprietary ovine collagen, including patented intact collagen and nano-collagen technologies, for Regenerex’s use in advanced wound care products. Regenerex states that it has exclusive worldwide rights to market Holista’s collagen products for wound care applications and that it will conduct and fund clinical studies and regulatory approvals with the U.S. Food and Drug Administration and other authorities.
The company notes that the initial commercial focus for products incorporating ovine collagen will be the United States, with planned expansion into other global markets. Regenerex also highlights joint innovation efforts with Holista to explore new applications of nano-collagen in advanced wound care, with joint ownership of any resulting intellectual property.
Regulatory and Corporate Filings
Regenerex Pharma, Inc. files reports with the U.S. Securities and Exchange Commission. In a Form 8-K, the company reported that its Board of Directors approved a change in fiscal year end from March 31 to December 31, with a transition report on Form 10-K to cover the period from April 1 to December 31 of the transition year. The filing identifies the company as an emerging growth company under applicable SEC definitions.
In a Form 12b-25 (Notification of Late Filing), Regenerex explained that it was unable to file a Form 10-Q for a specified quarter within the prescribed time period due to unanticipated delays in compiling and reconciling financial data and the need for additional time to obtain and verify information from third-party service providers. The company indicated that all other required periodic reports during the relevant period had been filed and that it did not anticipate significant changes in results of operations compared to the corresponding period of the prior year.
Business Model and Market Positioning
Based on its disclosures, Regenerex Pharma’s business model centers on the development, clinical evaluation, regulatory clearance, manufacturing, and marketing of advanced wound care products built on QBx™ and, through collaboration, ovine nano-collagen. The company emphasizes chronic wound care as a primary focus, with particular attention to conditions that have not responded to standard treatments.
Regenerex contrasts its approach with other wound dressings that primarily manage exudate and protect the wound surface, stating that its products are designed to influence the biochemical environment of the wound. Its communications describe a combination of proprietary formulations, defined treatment protocols, and supporting EMR systems as the foundation of its wound care strategy.
Corporate Identity and Mission
Regenerex Pharma articulates a mission to provide what it characterizes as a significant advancement in addressing human health crises related to chronic wounds. The company’s statements focus on solving chronic wound closure challenges and reducing amputations associated with non-healing wounds. It presents its product line as clinically proven and technologically advanced, with the goal of improving quality of life for individuals affected by chronic and acute wounds.