Consumers have been stuck with the same topical antibiotics since the 1950’s and 60’s. Brands like Neosporin® and Polysporin® became household names with no real medical clearance, and homeopathic management products were passing themselves off as medical devices for the management of chronic wounds (e.g., honey and silver). In view of these limited options, I saw an opportunity to innovate.
The search for solutions for my own resistant infection began in Europe – they take their antibiotic resistance seriously and make even the safest first aid antibiotics prescription only. Conversely, antimicrobial cleansers such as quaternary ammonias (Chloraprep, Hibiclens, PHMB, Benzalkonium Chloride) are used liberally and regularly. These cleansers kill superficial pathogens effectively, but are too strong to leave on biological tissue for more than a few seconds. These non-antibiotic, resistance-free chemicals for killing pathogens already existed, however the medium for delivering them in an extended-release, non-irritating/toxic/sensitizing manner did not.
The point: Someone who could deliver a biocide (such as benzalkonium chloride) at an effective dose over an extended period of time without damaging tissue might well have a breakthrough. With this in mind, I got to work.
Dispensing with the notion that polar and non-polar (water and oil) could not be mixed without a binding agent, after many tries, the PermaFusion® process was born. PermaFusion is the permanent fusion of polar, water soluble ingredients and non-polar petrolatum without an emulsifier. The process has been constantly refined and patented, leading to the formulation marketed today—a permanent fusion of polar, water soluble ingredients including water, Benzalkonium Chloride, and PHMB with non-polar petrolatum without an emulsifier.
In August of 2015, a soft launch of our OTC offering, CurX® , was done to test market response. Six months later, academic institutions and practitioners nationwide had begun to write up miracle case studies involving CurX use on stalled, chronic wounds, including diabetic ulcers, venous/arterial ulcers, and trauma wounds. It was clear CurX was not just for first aid, but in order to market in the chronic wound space, I needed 510k clearance. To be cleared as a prescription medical device, the CurX formula was subjected to rigorous testing by FDA licensed laboratories. The results of these tests were astounding: The product had universal biocidal effectiveness, zero adverse reactions of any kind on human skin across even 400+ occluded applications, zero cytotoxicity, irritation, or sensitization (ISO 10993), and weeks of antimicrobial effectiveness with a single application (USP 51). After being granted its clearance as a prescription medical device, CurX became Hexagen Wound Dressing and was subsequently removed from the OTC space.