Agenta Biotechnologies, Inc. is in the business of discovering and developing new technologies to improve healing, repair, and regeneration in the injured. Our work has produced the following technologies that will create both near-term commercial operations and high-value long-term development opportunities:
a patented process for creating a dense glucosamine wound dressing that enhances wound healing for ulcers, lacerations, burns, and eczema.
a patented synthetic bone graft with published superiority to the leading competitor
a strong, pliable, yet dissolvable, surgical barrier membrane made from a specialized sugar in a patented manner for application to bone, cartilage, ligament, skin, breast reconstruction, and hernia repair
a new, skin substitute for the healing of deep skin ulcers or chronic ulcers of the foot and leg associated with diabetes and aging
Devices Our work has been directed at engineering devices (e.g. membranes, sponges, or micro-particles) to stimulate and improve the healing and repair process. Our work has resulted in a superior patented barrier membrane and a superior proprietary wound dressing/skin substitute. These wound dressings are being commercialized to aid in skin healing without the need for premarket regulatory approval through device registration. The wound dressing (see Magenta Membranes tab) is an FDA class I exempt product that is an excellent wound dressing for which we are gathering clinical data to support its ability to enhance the healing of ulcers, incisions, burns, and eczema while minimizing pain and scarring. The membrane also serves well as an implantable barrier membrane for which we have prepared two clinical trials that await funding.
US Patent # 8,735,571; DeCarlo A, Ellis A, Dooley T P, and Belousova M.; "Composition, preparation, and use of dense chitosan membrane materials"; Issued May 2014
Biologics Our work has also established a patent portfolio for the creation and delivery of a biologic family with enormous potential to regulate healing and tissue regeneration, namely the family of proteoglycans. The technology is based on DNA sequences for proteoglycans allowing us to extensively modify the DNA pro-drugs with ease, manufacture them with relative simplicity.
AGENTA PATENT FAMILY
US Patent # 7,141,551; DeCarlo, A and Whitelock, J; "Wound and cutaneous injury healing with a nucleic acid encoding perlecan"; Issued Nov. 2006
US Patent # 7,488,719; DeCarlo A and Whitelock J; "Wound and cutaneous injury healing with a nucleic acid encoding perlecan"; Issued Feb. 2009 (CIP)
US Patent # 7,666,852; DeCarlo A, Whitelock J, and Ellis AL; "Wound and cutaneous injury healing with a nucleic acid encoding a proteoglycan polypeptide"; Issued Feb. 2010 (CIP)
US Patent # 7,772,204; DeCarlo A and Whitelock J; "Perlecan and growth factor for wound and cutaneous injury healing"; Issued Aug. 2010 (CIP)
The technology enables localized proteoglycan expression with or without growth factors in a way that is customized for the expression site and personalized for each individual patient.
This class of proteoglycan molecules can promote healing through a variety of known mechanisms; as required carriers and activators for important growth factors in healing; providing structure; increasing blood supply; and increasing tissue hydration. Accordingly, these therapeutics can be applied to bone, cartilage, ligaments, discs in the spine, and to skin, or serve as coatings for vascular stents and implants. It is an aspect of Agenta Biotechnologies’ mission to be the world leader in manipulating proteoglycans for therapeutic use.
Combination Devices We have devised protocols for incorporating our DNA pro-drug technology with our device implant technology to generate unsurpassed levels of healing, repair, and regeneration from what are classified as combination devices.
What it Means Our work can be translated into improvements in how well, and how fast, broken bones or implants heal, and into improvements in spine and vertebral disc treatments, possibly in a way that could be done without surgery. Our work can be translated into better skin healing after burn wounds, and healing of sores that won’t respond to current therapies in diabetic patients or in the elderly, or even for repairing skin that is damaged from sun or age. Our technologies are the foundation for regenerating complex organs or limbs, something we are working towards.
Leading Product Candidates and Target Markets
Barrier Membrane/Dermal Substitute: pre-clinical in vivo model tested and published; regulatory approval applied for; additional pre-clinical in vivo data planned.
Our beachhead market for the patent-pending barrier membrane is in dental and craniofacial use. Here, our enriched target market consists of periodontists, oral surgeons, and general practitioners that are practicing exodontia and/or other surgical procedures, the sum of which is estimated at ~ 31K in the US [Source: US Dept. of Labor - Bureau of Labor Statistics - Occupational Outlook Handbook, 2010-2011]. Reaching peak market penetrance of 10% for the estimated 790,000 dental membrane units sold per yr. would yield a profitable small business with $10.4MM in sales using median pricing. We anticipate that the dense chitosan membranes will also have excellent utility as implantable surgical membranes in orthopedic, general, plastic, and dermatologic surgeries, among other uses.
Synthetic Bone Graft: pre-clinical in vivo model tested and published; additional pre-clinical in vivo data planned. The following link provides an explanation from the lead scientist Dr. DeCarlo about the potential for this bone graft technology. The link considers placing the the technology in a corporate entity named Bonenta.
Our beachhead market for the patented combination bone graft technology is in the repair of large bone defects, specifically in the head, that occur from disease or trauma. Buyers are hospitals, neurosurgeons, oral surgeons and orthopedic surgeons who treat disease or trauma of the craniofacial complex including the skull. The bone graft substitutes market is forecast to reach $3.3B globally and $2.2B in the US by 2017 (GlobalDatas 2011 Bone Graft Substitutes Market Forecast).
Wound Dressing; pre-clinical in vivo model tested; human clinical data accumulating; FDA 510(K) exempt as occlusive dressing (ready for sale and manufacture)
Considering Agenta's wound dressing technology, chronic wound care involves the treatment diabetes-related (predominately foot ulcers), venous leg ulcers, and pressure ulcers, as well as burns, traumatic ulcers, and surgical incisions. While the etiology of these chronic wound types is different, the use of advanced wound dressings for each is applicable so little distinction is needed for market segmentation except in seeking FDA approval for a particular indication, and in advertising. Without specific claims for application or functionality, the membrane is exempt from the 510(K) review process and sales can begin immediately. However, we will seek specific approval for diabetes-related chronic ulcers first and follow with approval for venous leg ulcers and pressure ulcers, each requiring clinical data and 510(K) review. In the United States, chronic wounds affect at least 6.5 million patients and that number is growing rapidly due to a sharp rise in the incidence of diabetes and obesity, and an aging population. According to a report by Global Industry Analysts, the annual wound care products market is $16 billion and our calculations estimate the skin substitute segment of that market to be $10 billion.
Agenta Biotechnologies, Inc. is an Alabama C-corp that currently has its primary business and research activities at the Innovation Depot, a business incubator, in Birmingham, Alabama near a major medical research institute providing an excellent environment to advance biomedical research.