Wound healing difficulties may arise from a variety of causes, such as severity of injury, age and co-morbidities such as obesity, diabetes, smoking, cardiovascular and peripheral vascular disease and other chronic conditions. The underlying etiology for different tissue healing challenges may vary. At a cellular level many of the problems with tissue healing are the same. Some of these problems are uncontrolled inflammatory processes and shortages of growth factors that are critical to healing and are part of the cell signaling pathways.
Carmell Therapeutics’ technology has been designed to deliver growth factors directly to the injured site over days and weeks to enhance and amplify the healing environment with important growth factors (PDGF, TGF-β, VEGF, IGF, FGF, EGF and others) and other regenerative factors found in platelet-enriched plasma.
Carmell’s second product candidate, THA, is formulated from the same active ingredient (API) as BHA, which is Carmell’s PBM. In a Phase II study using BHA to accelerate bone fracture healing, HEAL I, we observed that local soft tissue healing may also have been accelerated and that the risk for surgical site infection within 1 year may have been reduced relative to untreated wounds. Preclinical studies with THA have shown that it significantly promotes angiogenesis and reduces infections in bacterially contaminated surgical wounds (publication, Schwartzmann). Also, in a radiation burn model in rodents, THA substantially provided accelerated and enhanced healing (publication, Miller). The wound healing market is divided into acute and chronic, with the later accounting for most of the expenses due to the complexity and length of treatment.
Chronic wounds are wounds that have not appropriately closed after four weeks of treatment with traditional treatment such as dressings. Chronic wounds include: