Our first focus: Surgery & trauma
Major surgical and traumatic wounds occur 1 million times per day worldwide in a variety of healthcare settings -- all of them are opportunities for contamination and infection.
Our two lead investigational products, Amicidin-α Surgical and Amicidin-β Solution¹, broadly cover all wound classifications of surgery and trauma and are designed for use in operating rooms and other controlled settings. As first-in-class products intended to prevent and treat infection in surgery and trauma, both are expected to become breakthrough biological therapeutics.
In response to requests for additional products designed for special settings, we are also developing Amicidin-α PFC (Prolonged Field Care) for military use, with support from the U.S. Department of Defense, and Amicidin-β/EF (Extended Formulation) for traumatic wounds and emergency cesarean delivery, including in low- and middle-income countries, with support from the Global AMR Innovation Fund (GAMRIF) and CARB-X.¹
Four ground-breaking products in development to prevent and treat infection in surgery & trauma
(1) This work has been supported by US Army Medical Research & Materiel Command through the Military Burn Research Program under Award No. W81XWH-15-2-0065 and by the Assistant Secretary of Defense for Health Affairs through the Peer Reviewed Medical Research Program under Award No. W81XWH-16-1-0561. Opinions, interpretations, conclusions and recommendations are those of Macro Biologics and are not necessarily endorsed by the Department of Defense. Ongoing support comes from CARB-X and is provided by the Department of Health & Human Services Asst. Secretary for Preparedness & Response (BARDA), Wellcome Trust, and UK Secretary of State for Health and Social Care (DHSC) through Boston University subaward 4500004446, as well as by the US Army Medical Research & Material Command through the Medical Technology Enterprise Consortium under Award No. MTEC-21-03-WI-021.
Amicidins in every major surgical procedure and traumatic wound
(and some other places too)
Amicidin-α Surgical™ is an investigational product designed for direct application by surgeons to exposed tissues. It is intended primarily for clean (Class I) and clean-contaminated (Class II) surgical procedures, which represent 88% of operating room procedures in the United States. Amicidin-α Surgical mimics the dual protective activities of skin: physical barrier (like collagens and keratins) to block and microbicidal activity (like defensins) to kill. Intraoperative use on incisions and excisions, including mastectomy, melanoma removal, and open colorectal procedures is anticipated.
Amicidin-α Surgical™ is intended to prevent life-threatening infections that can follow surgery
Amicidin-α PFC™ is an investigational product designed for military use in prolonged field settings. It is intended to be directly applied to wounds in the field to treat contamination and prevent infection for up to 72 hours. It is also designed to be lightweight and compact for inclusion in military packs. Amicidin-α PFC is a dry powder formulation that will gel quickly when introduced to moisture, creating an active barrier that will kill microbes already present and prevent new microbes from entering the wound.
Amicidin-α PFC™ (Prolonged Field Care) is intended for protection of injured warfighters
Amicidin-β Solution™ is an investigational product designed for direct application to contaminated and infected tissues. It is expected to be used primarily in operating room settings for contaminated (Class III) and infected/dirty (Class IV) surgical procedures. Amicidin-β Solution combines surfactant (detergent-like) activity to cleanse and debride with broad, microbicidal activity to kill. High-priority clinical targets include interventional management of skin & soft tissue infections, as well as treatment of prosthetic joint infections (PJI) and osteosynthesis site infections.
Amicidin-β Solution™ is intended as an adjunct to surgical treatment of life-threatening infection
Amicidin-β/EF™ is being developed to prevent and treat infections in emergency settings, such as trauma and emergency cesarean delivery, including in low- and middle-income countries. It maintains the surfactant and microbicidal dual mode of action of the Amicidin-β protein, while increasing tissue coverage (including cavities) through specialized formulation. Applicable as a liquid or foam, high priority clinical targets include open fracture and emergency cesarean delivery.
Amicidin-β/EF™ (Extended Formulation) is intended for traumatic wounds and emergency settings, including in low- and middle-income countries.