Our Patented, Plasma-based Bioactive Materials Promote Healing

Carmell has developed a platform technology through significant laboratory, small and large animal research and a Randomized Clinical Trial (“RCT”), conducted in South Africa, over more than fourteen years to generate the current applications across broad fields of use. The platform is our PBM, a proprietary formulation of multiple Growth Factors (“GF”) and other regenerative factors contained in platelet enriched plasma which is intended to accelerate and enhance tissue regrowth in bone, skin, hair, collagen, and other tissues. PBM is designed to be delivered locally at the injured site with a controlled degradation profile specific to the clinical application to allow for the regenerative properties to reside in the local tissue for an extended period of time. The Company obtained the rights to the patents from Carnegie Mellon University that protect the technologies.

Safe, Stable and Off-the-Shelf Platelet-enriched Plasma

Numerous published studies explore the use of autologous PRP for applications including bone healing¹, wound healing², sports injuries^3,6, improvements in scarring⁴, and dental applications⁵, among others. While some studies report positive outcomes, there is no consensus for the effectiveness of PRP treatments in this body of literature^1,2,3,6.

Several factors influence the variable outcomes of autologous PRP treatments. Because there are no standard preparation techniques for autologous PRP, results may vary from clinic to clinic. Additionally, the PRP quality may change with each patient, and can differ based on factors such as age, gender and platelet count^7,8. Platelet counts have even been shown to be highly variable for the same patient across repeated blood draws⁹.

To overcome these inconsistencies associated with autologous PRP, Carmell’s PBMs are processed with a number of controls in place. Platelet-enriched plasma source material has incoming specifications for several properties, including a minimum platelet level. To further standardize biological content, PBM batches are created by pooling plasma from donors to achieve a consistent level of regenerative factors from batch to batch. PBMs are produced using established standard procedures to remove variability caused by differing preparation techniques. To verify that these controls are effective, in-process and release testing is performed to confirm bioactivity levels and growth factor content of the PBMs.

	PRP	Carmell PBM
Presence at the Application Site	24 hours	Up to 3 months
Form	Liquid	Multiple (putty, paste, screw, plate, sheet, ribbon, etc.)
Quality of Platelets	Variable – Autologous (individual and process dependent)	Low variability Allogenic units are pooled from healthy volunteers Guaranteed platelet counts Manufactured via a highly regulated process
Prep Required	Blood draw, centrifuge, etc.	Off-the-shelf, ready-to-use
Data	No regulatory oversight, Lacking Rigorous and Reliable Data	Robust FDA Regulatory Requirements & Oversight Preclinical and Phase II Complete, data available Phase II/III - IND Approved

Footnotes:

E. M. Van Lieshout and D. D. Hartog, "Effect of platelet-rich plasma on fracture healing," Injury, vol. 52S2, pp. S58-S66, 2021.
J. P. Frechette, I. Martineau and G. Gagnon, "Platelet-rich Plasmas: Growth Factor Content and Roles in Wound Healing," J Dent Res, vol. 84, no. 5, pp. 434-439, 2005.
E. Kon, G. Filardo, A. Di Martino and M. Marcacci, "Platelet-rich plasma (PRP) to treat sports injuries: evidence to support its use," Knee Surg Sports Tramatol Arthrosc, vol. 19, pp. 526-527, 2011.
K. K. Middleton, V. Barro, B. Muller, S. Terada and F. H. Fu, "Evaluation of the Effects of Platelet-rich Plasma (PRP) Therapy Involved in the Healing of Sports-related Soft Tissue Injuries," The Iowa Orthopaedic Journal, vol. 32, pp. 150-163, 2012.
O. H. Alser and I. Goutos, "The evidence behind the use of platelet-rich plasma (PRP) in scar management: a literature review," Scars, Burns & Healing, vol. 4, pp. 1-15, 2018.
A. Albanese, M. E. Licata, B. Polizzi and G. Campisi, "Platelet-rich plasma (PRP) in dental and oral surgery: from the wound healing to bone regeneration," Immunity & Ageing, vol. 10, no. 23, pp. 1-10, 2013.
Y. Taniguchi, T. Yoshioka, H. Sugaya, M. Gosho, K. Aoto, A. Kanamori and M. Yamazaki, "Growth factor levels in leukocyte-poor platelet-rich plasma and correlations with donor age, gender, and platelets in the Japanese population," Journal of Experimental Orthopaedics, vol. 6, no. 4, pp. 1-8, 2019.
R. Evanson, M. K. Guyton, D. L. Oliver, J. M. Hire, R. L. Topolski, S. D. Zumbrun, J. C. McPherson and J. A. Bojescul, "Gender and Age Differences in Growth Factor Concentrations From Platelet-Rich Plasma in Adults," Military Medicine, vol. 179, no. 7, pp. 799-805, 2014.
A. D. Mazzocca, M. B. R. McCarthy, D. M. Chowaniec, M. P. Cote, A. A. Romeo, J. P. Bradley, R. A. Arciero and K. Beitzel, "Platelet-Rich Plasma Differs According to Preparation Method and Human Variability," The Journal of Bone and Joint Surgery, Vols. 94-A, no. 4, pp. 308-316, 2012.