Alpha Healthcare Acquisition Corp. III Announces Merger with Carmell Therapeutics, a Phase 2 Stage Biotechnology Platform Company Developing Allogeneic Plasma-based Biomaterials for Bone and Soft Tissue Healing Indications
Alpha Healthcare Acquisition Corp. III, a special purpose acquisition company led by Mr. Rajiv Shukla, announced the execution of a definitive business combination agreement with Carmell Therapeutics Corporation, a Phase 2-stage biotechnology platform company developing allogeneic plasma-based biomaterials for bone and soft tissue healing indications.
Upon closing of the transaction, ALPA will be renamed Carmell Therapeutics Corporation (the “Combined Company”). Mr. Shukla will serve as Chairman and Mr. Randy Hubbell will serve as Chief Executive Officer of the Combined Company. The Combined Company’s common stock is expected to be listed on the Nasdaq Capital Market under the ticker symbol “CTCX.”
Carmell Highlights
1. Phase 2-stage biotechnology platform company with multiple product candidates designed to be:
- Allogeneic: no need for (a) extraction of blood from patients (b) capital equipment to harvest biomaterials at the clinical care facility (c) staff training.
- Ready to use off-the-shelf: (a) assured levels of biomaterials (b) formulated to be available over weeks and months, providing sustained local tissue bioavailability of growth factors and other bioactive molecules important for healing (c) eliminate waiting time for tissue processing (d) eliminate the need to harvest tissue from a patient with existing morbidity.
2. Anticipated clinical applications
- Orthopedic Healing:
- Tibia Fractures: to treat open fractures of the shinbone that require intramedullary rodding.
- Fusion hindfoot or ankle arthrodesis: to aid surgical fusion of foot/ankle joint in degenerative arthritis.
- Spinal Fusion: to aid surgical fusion of spinal vertebrae due to deformity, injury or degenerative disease.
- Dental Bone Graft: an alternative to bone grafting in dental restoration/implants.
- Soft Tissue Healing:
- Surgical/Chronic Wounds: to promote healing after surgical incisions or open wounds caused due to diseases such as diabetic foot ulcers.
- Alopecia: to promote regrowth of hair in men and women.
- Cosmetic Skin Rejuvenation: to improve the appearance of damaged/aged skin.
3. Clinical Proof of Concept: Previous Phase 2 trial (HEAL I) in open tibia fractures suggested that the product candidate may accelerate bone healing and reduce rate of infections.
4. Fast Track designation granted by the U.S. FDA for tibia fracture (lead) indication.
5. 21 issued patents. Proprietary biomanufacturing know-how and trade secrets.
6. In-house manufacturing with 11 release tests developed for lot-to-lot consistency. ISO 13485 certified.
Said Mr. Hubbell, CEO of Carmell, “The business combination of Alpha and Carmell, allows us to advance the clinical development of our platform technology, to add significant regenerative medicine experience to the Carmell™ board of directors and to access high-quality institutional investors.”
Said Mr. Shukla, Chairman & CEO of ALPA, “Carmell’s patent-protected technology is designed to enable the application of allogeneic biomaterials across a wide variety of orthopedic and soft tissue applications. By potentially accelerating healing time and reducing the rate of infections, Carmell’s product candidates, if approved, are expected to significantly improve patient outcomes and reduce cost to payors.”