REDONDO BEACH, CA / ACCESSWIRE / January 20, 2016 / BioLargo, Inc. (BLGO) recently announced that its subsidiary, Clyra Medical Technologies, secured a $5.75 million financing package for Its Advanced Wound Care Products. Cash of $750,000 is earmarked for FDA Application and approval, and a $5 million line of credit is dedicated to commercialization once FDA approval is complete.
Wound Care refers to the promotion of effective healing and the prevention of infections in post surgery and trauma wounds, diabetic ulcers, pressure ulcers (bed sores), and any chronic wound that has difficulty healing. CLYRA Medical Technologies boasts that its products feature the most potent, broadest spectrum, antibacterial, antifungal & antiviral advanced oxidation system known and yet are gentle and cost effective.
The National Center for Health Statistics reports that 51.4 million inpatient surgical procedures were performed in the United States in 2010, followed closely by 31.5 million outpatient surgeries. Estimates for the size of the Wound Care market range widely from $6 billion to as high as $25 billion, but whatever the number is, the need for post-surgical wound care is large and sharply on the rise.
A further complication of Wound Care is that since over 50 million surgical procedures are performed in hospitals each year, and since an open wound is a known pathway for transmission of infection, hospitals are the focus of a national effort to reduce Hospital Acquired Infections such as MRSA and Clostridium difficile, and the economic burden caused by them.
The CDC tells us that each year there are over 1.7 million Hospital Acquired Infections and more than 100,000 deaths. Reducing infections in wound care could result in significantly fewer deaths as well as a reduction in government healthcare spending that is estimated by the CDC to be close to $20 billion annually. An article published by the U.S. National Library of Medicine, "Human Skin Wounds: A Major and Snowballing Threat to Public Health and the Economy," details the acute need for more effective Advanced Wound Care.
In the first week of 2016, Frost & Sullivan awarded BioLargo, Inc. its 2015 North American Frost & Sullivan Award for New Product Innovation. This coveted award recognizes BioLargo's game-changing iodine-based technology in the water treatment industry. The Award was limited to the water industry and did not even attempt to address BioLargo's robust and award winning technologies for disinfection, decontamination, odor control, and wound care.
In August 2015, a team of researchers at the University of Alberta unveiled BioLargo's AOS Filter/Reactor that uses one of the company's three different platform technologies based on iodine. Findings from over 100 studies on the AOS Filter for water disinfection were presented and demonstrated its ability to disinfect pathogens 100 times more effectively than chlorine, at 10 times the speed, and at only 1/20th of the cost of the closest competitor. One year earlier, the AOS Filter/Reactor received the Technology Star Award from New Technology Magazine, known as the First Word on Oil Patch Innovation.
University of Alberta Professor Lynn McMullen, evaluated test results and commented, "At the foundation of the AOS Filter is its efficiency in generating a highly oxidative state. Extremely high levels of performance [disinfection] were achieved during testing and we are excited to expand the work with BioLargo to other applications targeting food safety concerns." The tests demonstrated unprecedented effectiveness in destroying highly concentrated contaminants in sample water, including Listeria and Salmonella. Test results at the University of Alberta demonstrated that the iodine based AOS Filter killed 10,000,000 salmonella cells in 2 minutes compared to the industry standard chlorine dioxide that killed 100,000 cells in 60 minutes. That is 100 times more effective and 30 times faster than the industry standard methodology. And the energy requirements are negligible.
Formulations of CLYRA's antimicrobial hydrogel and liquid wound cleanser products have passed rigorous third party laboratory testing validating both efficacy and safety. Independent testing has verified both rapid and effective control against a host of dangerous pathogens commonly encountered in the wound care field. Testing of the company's liquid formula verified efficacy against antimicrobial resistant species referred to by the CDC as the "ESKAPE" pathogens - enterococcus faecium (VRE), staphylococcus aureus (MRSA), klebsiella species, acinetobacter baumannii, pseudomonas aeruginosa, and enterobacter. The next step is to now prepare these products for FDA application.
BioLargo is targeting early 2017 for its new Advanced Wound Care products to be commercially available.
The business of Wound Care is highly fragmented with several dozen companies competing for a share of this fast growing market.
Smith & Nephew (NYSE:SNN) is one of the current leaders in Wound Care and offers a wide range of products for the treatment of acute and chronic wounds, including leg, diabetic and pressure ulcers, burns, and post-operative wounds. The company also provides traditional and single-use negative pressure wound therapy and hydrosurgery systems; and biologics and other bioactive technology products for debridement and dermal repair/regeneration. The company primarily serves the providers of medical and surgical treatments and services. Smith & Nephew reported annual sales of $4.6 billion for the year ending December 2014.
Derma Sciences (DSCI) is a tissue regeneration company providing products for the management of acute and chronic wounds, and burns. Their portfolio provides a broad product line including MEDIHONEY(R), XTRASORB(R), BIOGUARD(R), ALGICELL(R) Ag, TCC-EZ(R), AMNIOEXCEL(R), and AMNIOMATRIX(R). Derma Science's products are intended to help advance healing for patients suffering from complex chronic or acute wounds such as diabetic foot ulcers, venous leg ulcers, pressure ulcers and burns. Derma Sciences reported sales of $84 million for the year ending December 2014. Annual sales of $84 million in a $6 billion market, indicates the absence of a breakthrough product yet.
Osiris Therapeutics, Inc. (OSIR) uses allogeneic stem cell technology in their line of Advanced Wound Care products that include Grafix, a cryopreserved placental membrane for treating hard-to-treat acute and chronic wounds, venous leg ulcers and other products for bone healing. Osiris reported 2014 year-end revenues of $60 million.
Vericel Corporation (VCEL) Vericel Corporation is a stem cell company developing patient-specific expanded cellular therapies for use in the treatment of patients with severe diseases and conditions. It markets two autologous cell therapy products in the United States, including Carticel (autologous cultured chondrocytes), an autologous chondrocyte implant for the treatment of cartilage defects in the knee; and Epicel (cultured epidermal autografts), a permanent skin replacement for the treatment of patients with deep-dermal or full-thickness burns comprising greater than or equal to 30 percent of total body surface area. Vericel reported annual revenues of $29 million for the year ending December 2014.
With the new $5.75 million funding package in place, and what appears to be a very valuable technology, BioLargo's Subsidiary Clyra Medical Technologies now has the financial resources to complete the preparation work and apply to the FDA for approval to market its Advanced Wound Care products and when successful, has the potential to gain a meaningful portion of a large and fast-growing market that is in need of better products and technologies. The depth and breadth of the BioLargo technology portfolio looks to have multiple game changers in the wings.