Our proprietary blood plasma-based technology enables the development of game-changing products designed to improve the lives of patients and reduce the costs of healthcare.
Our plasma-based materials (PBMs) utilize the entire solids content of the blood plasma, allowing for higher total product yields and retention of valuable regenerative factors native to platelets and plasma. Our production process utilizes allogenic pooled plasma that has been screened and processed by a FDA registered and AABB (American Association of Blood Banks) accredited U.S. blood bank and is therefore considered free of known blood-borne pathogens. We then rescreen the pooled plasma as a safety precaution using sensitive nucleic acid amplification technology (NAT), and then use the steps of pasteurization and irradiation to remove any viral contaminants that may have been missed by screening. The final product is additionally terminally sterilized after packaging. These methods meet FDA’s and EMA’s (Europe) stringent requirements for pooled blood products to ensure safety. In this way we ensure that every product is free of both known and unknown blood-borne pathogens.
A first-in-man, clinical trial was completed in South Africa on the use of REPAIR Putty to treat open tibia fractures (trauma). Data demonstrated 4X fewer infections through 1-year of follow-up, 2X faster bone healing at 6 months, and 4X faster wound healing at 30 days compared to the current standard of care. There were no adverse events related to the use of the putty. The trial was a double-arm, randomized controlled clinical study. A total of 20 treatment patients and 10 controls were enrolled in the study at two hospitals in Cape Town, South Africa. Follow-up examinations, including X-ray and clinical assessments, occurred at 14, 30, 60, 90, 180, and 365 days. This first, relatively small study demonstrated a statistically significant acceleration of bone healing and infection reduction along with faster wound closure. Ours is a platform technology that has applications in numerous clinical areas where there are unmet clinical needs. Accelerating wound healing and reducing complications safely and naturally is truly transformational.