BACKGROUND
The Predicate Bag Design
In 1990, Dr. Madalene Heng, MD, FRACP, FACD, FAAD was Chief of Dermatology at the VA Hospital (West Hills, CA) and clinical faculty at UCLA. She had been studying wound healing at the Veterans Administration Hospital in North Hills, California for 20 years. She noticed that the majority of her patients who never healed and needed continual care, had infected diabetic foot ulcers, a quarter of these who eventually needed limb amputation. Standard treatment was reoxygenation therapy using a hyperbaric oxygen chamber, the same device used by divers to prevent nitrogen toxicity. Patients who could afford it would pay up to $1000 per treatment with only an average of 56% success based on her experience. Those who could not afford or who did not respond well to the treatments needed limb amputation, or eventually did not survive.
1990: The Numobag® Predicate Device
Madalene Heng MD, FRACP, FACD, FAAD pioneered the methods for the Numobag®, an FDA-cleared medical device comprised of a thin, disposable bag that covered 75% of the torso and developed a specific method to optimize the re-oxygenation environment within the bag, ideal for blood vessel growth in acute and non-healing wounds. This method is effective, low-cost, and accessible to the global population. The Numobag is manufactured by Numotech Inc.
The Numobag® is currently used in hospitals in Florida and California, University of New Mexico Hospital, La Universidad Interamericana de Puerto, and used by First Responders and the Military, (50,000 kits per month).
Naturacur has secured exclusive use of Dr. Heng's methods with the AngioGenic Oxygen Therapy System for the purposes of Wound Healing.
Page references:
1. Heng, M.C. (2023). Mechanisms in Wound Healing: Mitigation of MPT-induced Apoptosis by Low Pressure Hyperbaric Oxygen. Journal of Wound Care, In Press.
THE PROBLEM
The Need for an Accurate Monitoring Device for Angiogenic Wound Healing with a Soft Chamber Bag
“The Numobag® is Effective and Simple, but needs a complementary device to make the technology repeatable, scalable, and easy to use.” – Madalene Heng, MD
Cutaneous wounds are defined as disruption to the structural and functional integrity of the skin. There are four phases to wound healing: hemostasis, inflammation, proliferation, and remodeling. In many cases, wounds fail to undergo the normal healing process, despite readily available treatments, and healing may not progress beyond the inflammation phase. As a result, these patients with chronic wounds risk reinjury, scarring, gangrene, disfigurement, limb loss, and inability to perform normal daily tasks, or remain gainfully employed.
Although only half of patients treated heal in a hyperbaric oxygen chamber, Hyperbaric Oxygen Therapy (HBOT) is still considered the gold standard for reoxygenation therapy of chronic wounds. However, oxygen therapy using the hyperbaric chamber has its limitations. First, the equipment is costly, not easily portable, and requires a specialized clinic location and staffing, which prohibits easy and affordable access to the procedure. In addition, since current hyperbaric oxygen therapy relies on legacy methods to prevent decompression sickness in divers, the therapy is administered at atmospheric pressures which are too high for optimal wound healing, and patients risk oxygen toxicity since they need to breathe the same air as that of what is required for the affected wound site. In addition, these non-disposable devices are subject to contamination by bacterial organisms because they are hard to clean. Suboptimal wound care affects racial and ethnic minority and low-income adult populations in the U.S. disproportionately, with many of these groups experiencing low survival rates once gangrene is diagnosed.
The Numobag is the most viable and effective option for a globally accessible wound healing medical device but had limitations. It required that a specialized technician to be physically present when monitoring the oxygen pressure and flow, which prevented the device from being widely commercialized outside of military use.
In Development: The AngioGenic Oxygen Therapy (AGOT) System
The AngioGenic Oxygen Therapy Monitoring Device
“Now, with the Naturacur medical device combined with the Numobag®, the entire system will be scalable, repeatable, and verifiable.” – MadaleneHeng, MD
Naturacur plans to market a wound healing system comprised of an electronic device and a custom soft chamber bag manufactured by Numotech that delivers oxygen to the non-healing wound at the concentration and pressures required for optimal healing. Naturacur has established a partnership with Dr. Heng to exclusively license the use of her methods, combined with a pre-FDA cleared component device to commercialize an accessible, accurate, consistent, and scalable wound healing system.
The AngioGenic Wound Healing System (AGOT) employs a method using an electronic monitoring device combined with the use of a soft-chamber bag based on research that narrows down the most effective environment ideal for wound healing. Our patent-pending solution achieves optimal wound-healing by using lower hyperbaric oxygen pressures, while still maintaining sufficient oxygen concentrations to achieve cell viability, therefore preventing the opening of the MPT megapore and mitigating ROS-induced worsening of the wounds. This treatment is effective in inducing angiogenesis, which is important in prevention of wound recurrence. The novel AGOT system aims to improve patient outcome, reduce complications, and care costs, as well as reduce risk of limb loss.
2023: The Numobag+ Naturacur
Naturacur Wound Healing has partnered with Dr. Heng for exclusive use of her methods utilizing the Numobag® for Wound Healing, pairing a simple and easy to use electronic medical device that monitors the oxygen pressure and flow to automate use of the system, improve documentation of treatment compliance, improve efficacy targets, and facilitate scalability of Dr. Heng's treatment model for wound healing.