Therapeutic Areas

Published evidence suggests that PBMs in different forms (paste, putty, liquid, etc.) can be a viable treatment for various medical challenges. Carmell’s revolutionary technology can be applied to address tremendous unmet need across orthopedics, soft tissue healing, burn, dermatology and other aspects of medicine. Below is just the sampling of applications were Carmell’s PBMs are likely to have a lasting impact.

Orthopedics

Bone fracture requiring open reduction surgery

It is estimated that 12.9 million extremity bone fractures occur annually in the U.S., of which 1.3M are open reductions. The most complex and most difficult to treat are open compound fractures (skin is penetrated) due to bacterial contamination and exposure with a prevalence of over 300,000 / year in U.S. In addition, 125,000 of open tibia fractures are treated each year of which 20% (~24,600) will become infected with bacteria, further compromising healing. The data for injuries in the military are much worse, with the majority of blast injuries being grossly contaminated and infected. Bacterial infection has been identified as one of the major contributors to the complications of bone healing. Antibiotics are typically administered systemically to patients with contaminated bone fractures at high doses and for long terms, ideally for at least 4-6 weeks. Growing resistance to antibiotics is an urgent healthcare concern providing significant motivation for the healthcare providers to find treatment solutions that don’t include the use of antibiotics.

Joint (hip and knee replacements)

With more than 2 million joint replacements per year in the US and a very strong growth rate due to the aging population, there is a significant opportunity to improve the healing time and reduce the complication rates associated with these procedures (particularly fixation and infection). The PBM in Carmell’s putty and paste would be used to deliver biologics to both the bone and soft tissue areas where the healing is needed. Faster healing and stronger fixation (i.e. coating the porous stem of implants) allows for faster mobility/rehab and higher quality rehab, which has been documented to be directly related to improving outcomes for joint procedures. Of particular need, is to reduce the infection rates associated with joint replacement.

Knee repairs

The major reason why tears in the red/white zone of the meniscus heal poorly is the lack of blood flow. By providing a concentrated form of clot that slowly degrades, the healing cascade in these settings can be stimulated. Carmell’s PBM materials may offer significant improvement to the healing of menisci and ACL surgical repairs.

Spine

A product that not only promotes bone fusion but also the repair of soft tissues while reducing infections would have enormous potential in the spine and related markets. Pre-clinical data suggests that Carmell’s first PBM product, Bone Healing Accelerant, can be used with DBM to allow for less DBM usage and produce a stronger bone.

Shoulder Repair

Delivered endoscopically at the end of a shoulder repair (tendon to bone attachment) substituting gas for saline, the product could be delivered to the repair site to deliver regenerative factors with the hope of improving the rate of tendon attachment long-term.

Surgical Site Healing Market

Surgical site infections (SSI) are common in the hospital setting, accounting for 37% of all hospital-acquired infections in surgical patients. Approximately 780,000 SSIs occur annually in the US, at a rate of 2.0% of total procedures. Unmet needs for managing SSI are very similar to bone healing; requiring ready-to-use, off the shelf, biologically adaptive technology/device that can reduce surgical site healing time, lower infection rates, reduce pain and improve ambulation time. Carmell’s second product, Tissue Healing Accelerant is being developed to be delivered to and spread onto the subcutaneous tissue before definitive closure of the surgical wound. It is designed to degrade over 14 days while releasing regenerative growth factors. The company is currently conducting preclinical experiments to demonstrate the acceleration of angiogenesis from use of the Tissue Healing Accelerant.