Therapeutic Areas

Orthopedics

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Orthopedic Bone Applications

Fortune Business Insights reported that the global orthobiologics market size was valued at $5.830.1 billion in 2018 and is projected to reach $8,261.6 billion by 2026, exhibiting a CAGR of 4.5% in the forecast period 2019-2026. Orthobiologics have considerably impacted orthopedic surgeries. The concept which was earlier used for regenerative medicines, has now expanded its area of application to spinal fusion, dental, maxillofacial, cartilage repair, knee arthroscopies and many others.

Trauma Fixation Devices.

This program, CT-101, represents a significant test of the healing power of BHA, the first formulation of the core technology, PBM, which is intended to support a longer-term goal of being used in other areas where bone needs an accelerant for healing and regeneration.

Spinal Fusion

Spine fusion surgery often involves the use of grafting material to facilitate and accelerate the healing and fusion of two adjacent vertebral bodies. In the United States, medical facilities performed 667,400 spinal fusion surgeries in 2013. This is the largest bone market for products that are intended to facilitate or accelerate bone healing/fusion. Current product types used are autologous bone graft, taken from the patient’s own bone, synthetic products, allograft bone taken from cadavers and recombinant proteins. The Company is in early preclinical testing of BHA product as an orthobiolgoic, CT-102, to determine the capability of BHA to act as an enhancer to existing bone graft substitutes as well as a stand-alone new alternative to bone graft substitute products.

Other Bone Graft Substitute Applications.

The Company is exploring via market research, use of regulatory expert consultants and pre-clinical studies to determine the potential that BHA could be used as a bone graft substitute that has the potential to accelerate and enhance the bone healing due to the known bioactivity of BHA. Some of these applications under consideration are foot/ankle fusion, severe extremity fractures in addition to tibia such as radial, femur, humerus, etc.

Dental Bone Graft Substitutes

Autologous bone grafts or bone graft substitutes are frequently required for bone augmentation as a part of patients’ overall dental implant restorations. Sufficient high-quality bone is required for implantation of dental implants to allow for osteointegration and strong mechanical support of the implant.

Autologous bone grafting has been the gold standard technique for tooth extraction socket preservation, alveolar ridge augmentation (needed for alveolar ridge atrophy), or for maxillary lift procedures to provide adequate bone volume and strength to support the eventual implant post osteointegration and subsequent full restoration. Autologous bone grafts are harvested as separate procedures to obtain sufficient bone and are associated with some morbidity. Alternatively, bone graft substitutes can be used, avoiding the morbidity of autologous bone harvesting. Examples are allogeneic cadaver bone and synthetic bone graft substitutes. This market has a high growth rate with significant unmet clinical needs. Whatever bone graft material is used, nearly all patients require multi-staged reconstruction with an initial bone augmentation procedure followed several months later by placement of the implant post.

Following the implant post implantation, patients must wait another several weeks to a few months to allow for secure osteointegration of the post prior to final tooth restoration. Biologic products are being used adjunctively to try to enhance and accelerate the initial bone augmentation phase as well as the osteointegration phase. Carmell’s BHA product is undergoing preclinical testing as an orthobiologic dental bone graft substitute, alone or in combination with synthetic materials. The intent is to accelerate and improve the quality of bone augmentation in dental implants surgery in order avoid the need for autologous bone harvesting and, potentially, to reduce the time needed to achieve definitive success.

Aesthetics

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Androgenic Alopecia

The global alopecia market was valued at USD $2.65 billion in 2019 and is expected to reach a value of USD $5.25 billion in 2027. Androgenetic alopecia is growing the fastest, estimated at 11.3% CAGR between 2019-2027. (Grand View Research Report ID: 978-1-68038-856-5).

Androgenic Alopecia (“AGA”) is the most common form of hair loss in men and women. Current treatments include hair transplants, topical solutions, pharmaceuticals, and autologous Platelet Rich Plasma (“PRP”). Autologous PRP (“AA-PRP”) is considered standard routine for dermatologists and plastic surgeon experts in hair growth (“HG”). The efficacy of autologous PRP in patients who suffer AGA is clear and it has also been reported several times by authors [1–4,7–9]. A-PRP contain at least six major GFs, including basic fibroblast growth factor (b-FGF”), epidermal growth factor (“EGF”), transforming growth factor-β (“TGF-β”), insulin-like growth factor-1 (“IGF-1”), PDGF, and VEGF, which are released after platelet activation [2]. Each one of these major GFs is involved in a specific bio-molecular activity during Hair ReGrowth (“HRG”). In each case, the GFs serve to promote angiogenesis, follicular cell proliferation, and initiation of cell division, thus having a fundamental role in HRG [1–4,9]1.

Dr. Amelia Hausauer conducted a randomized clinical study showing PRP was successful at increasing hair volume and density at six months by 29% respectively compared to baseline. Carmell's technology, (THA) is intended to be delivered into the scalp where the material will reside for days to weeks, constantly bathing the area with GFs and other regenerative factors. Utilizing the work by Dr. Hausauer and others that have shown autologous PRP to have some benefit in regrowing hair as a proof of concept, Carmell is developing its THA that is intended to be off the shelf, ready-to-use as a substitute for the Autologous PRP. Clinical studies will be designed to show improvement versus baseline for hair volume and hair density at six months. The company’s hypothesis it seeks to prove in a clinical study, if allowed to proceed, is that the PBM technology is effective at regrowing hair at six months with greater than 30% increase in volume and density based on the PBM’s ability to reside in the scalp for days and weeks, delivering active GFs and other regenerative molecules with a very favorable benefit/risk profile.

Wound Care Overview

Wound healing difficulties may arise from a variety of causes, such as severity of injury, age and co-morbidities such as obesity, diabetes, smoking, cardiovascular and peripheral vascular disease and other chronic conditions. The underlying etiology for different tissue healing challenges may vary. At a cellular level many of the problems with tissue healing are the same. Some of these problems are uncontrolled inflammatory processes and shortages of growth factors that are critical to healing and are part of the cell signaling pathways.

Carmell Therapeutics’ technology has been designed to deliver growth factors directly to the injured site over days and weeks to enhance and amplify the healing environment with important growth factors (PDGF, TGF-β, VEGF, IGF, FGF, EGF and others) and other regenerative factors found in platelet-enriched plasma.

Advanced Wound Care Market

Multiple Advanced Wound Care Research reports value the Global Advanced Wound Care market at $9 billion in 2021, with a CAGR of 3.5% to 4.6% over the next ten years and expected to reach over $14 billion by 2030.

The Advanced Wound Care market is sub segmented into advanced wound dressings, biologics, negative pressure wound therapy and other treatments. The biologics segment represents about a quarter of the global opportunity, about $1.5B, and is made up of skin substitutes and growth factors. GFs may be used in combination with Standard of Care (“SOC”) or skin substitutes to enhance and accelerate wound healing. Acceleration and enhancing the healing of both acute and chronic wounds is associated with significant health care savings.

Carmell Solution

Carmell’s second product candidate, THA, is formulated from the same active ingredient (API) as BHA, which is Carmell’s PBM. In a Phase II study using BHA to accelerate bone fracture healing, HEAL I, we observed that local soft tissue healing may also have been accelerated and that the risk for surgical site infection within 1 year may have been reduced relative to untreated wounds. Preclinical studies with THA have shown that it significantly promotes angiogenesis and reduces infections in bacterially contaminated surgical wounds (publication, Schwartzmann). Also, in a radiation burn model in rodents, THA substantially provided accelerated and enhanced healing ( publication, Miller). The wound healing market is divided into acute and chronic, with the later accounting for most of the expenses due to the complexity and length of treatment.

Chronic Wounds

Chronic wounds are wounds that have not appropriately closed after four weeks of treatment with traditional treatment such as dressings. Chronic wounds include:

  • Venous Leg Ulcers (VLUs): chronic cutaneous and deeper wounds that occur in the leg caused by localized elevated venous blood pressure with reduced local perfusion pressure with resultant reduced nutrient blood flow.
  • Diabetic Foot Ulcers (DFUs) chronic cutaneous and deeper wounds in diabetic patients caused by poor tissue perfusion related to macro and microvascular arterial disease, These predominantly occur on the bottom of the foot.
  • Pressure Ulcers: localized injuries to the skin and/or underlying tissues as a result reduced local nutrient circulation as a result prolonged mechanical pressure.
  • Surgical Wounds: acute wounds caused by surgical incisions that become chronic wounds if they do not heal properly.

Footnotes:

  1. Systematic Review of Platelet-Rich Plasma Use in Androgenetic Alopecia Compared with Minoxidil®, Finasteride®, and Adult Stem Cell-Based Therapy
    Pietro Gentile 1,* and Simone Garcovich2
    1Department of Surgical Science, Plastic and Reconstructive Surgery, “Tor Vergata” University, 00133 Rome, Italy
    2Institute of Dermatology, F. Policlinico Gemelli IRCSS, Università Cattolica del Sacro Cuore, 00168 Rome, Italy; simgarko@yahoo.it

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