Business Summary: Carmell is developing an exciting new concept in orthobiologics: biologically-active materials manufactured from human blood plasma. These biomaterials contain a concentration of natural regenerative factors that promote healing, reduce complications, and save healthcare costs. The first product is a putty to treat traumatic bone injuries, reducing infections while accelerating healing of not only the fracture site but also surrounding soft tissues. Unlike competing approaches, these products are safe, consistent and inexpensive to produce – truly unique for the industry.

Market Need: There are approximately 60M musculoskeletal injuries in the U.S. each year, of which 16M involve bone fractures. Many of these fractures heal slowly and with complications and most are treated with antibiotics – antibiotic-resistant infections have become a $20B problem in the U.S. alone. There is a great need for an effective product that can safely accelerate the healing of both bone and soft tissues and reduce associated infections and complications.

Products: The Company’s first product is the REPAIR™ Putty designed to treat fractures. Carmell’s plasma-based biomaterials encourage the healing not only of the fracture site but also the surrounding soft tissues while naturally reducing infections. The putty also has applicability in other orthopaedic applications, and follow-on products are in development.

Clinical Study: The putty is currently being studied clinically on open tibia fractures. Early data demonstrate significantly reduced infections and complications along with accelerated bone fracture healing and more rapid wound closure compared to controls. No adverse events related to the use of the putty have been observed. These data support the value proposition that the use of the putty can reduce healthcare costs – reduced hospitalization time, reduced use of antibiotics, fewer complications requiring secondary procedures, and faster recovery time.

IP: Carmell has developed a strong portfolio that includes 6 issued US patents with additional patents pending. All broadly cover binding together proteins and growth factors into a variety of different physical forms without destroying the growth factors’ ability to function.

Competition: Carmell’s bone putty competes in the fracture management and bone void filler markets. No product is routinely used to augment fracture healing, and, while the bone void filler market is a crowded one, the Company’s putty stands apart with a ready to use product that contains naturally occurring regenerative factors that safely accelerate healing while recruiting the body’s own immune system to reduce infections. The technology also has a low cost to manufacture truly unique.

Product Roadmap: Carmell has been developing exciting follow-on products: antimicrobial releasing materials for use in contaminated wounds, 3-dimensional regenerative scaffolds for filling soft tissue injuries, and products that can be used arthroscopically for sports medicine injuries (e.g., rotator cuff, epicondylitis, meniscal tears). Unlike competing approaches, Carmell’s technology enables the manufacture of well characterized, biologically-active products that heal both bone and soft tissues. Heat sensitive drugs and proteins can be added to enable more controlled release of the drug in conjunction with regenerative factors that accelerate healing and which also protect cells from the cytotoxicity of delivering locally high doses of drugs – truly novel and game changing!