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Regenerative medicine and tissue engineering: Six companies leading the way

The field of tissue engineering blends principles from medtech and biotech. In the modern era, tissue engineering has seen rapid development, particularly with the advent of microfabrication and three-dimensional bioprinting technologies, with many companies being created in the field.

These advancements have enabled the creation of tissue constructs with greater precision and customization, improving outcomes in terms of biocompatibility, immune response reduction, and the integration and longevity of the engineered tissues. Big names in the biotech industry such as Abbvie have stakes in the market, and in this article, we take a closer look at six tissue engineering companies.

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    Founded in 1997 under the name TissueTech, the Miami-based company rebranded as BioTissue in November 2022. This biotech is focused on the field of regenerative medicine and is particularly known for its use of human birth tissue in creating products for ocular surface disease, surgical, chronic wound, and musculoskeletal applications. The company utilizes its proprietary CryoTek cryopreservation technology to maintain the structural and functional integrity of tissues in its products like Prokera, AmnioGraft, AmnioGuard for ocular application, Neox, and Clarix for surgical applications.

    The company’s technology relies on human birth tissues, specifically the heavy chain hyaluronic acid/pentraxin3 (HC-HA/PTX3) complex that plays a role in the healing process in the fetal environment. Their tissue processing technology, CryoTek allows the preservation of the structural integrity of the placental tissues and HC-HA/PTX3 in the graft. Through its “Sharing Miracles” program, BioTissue partners with organizations like Dakota Lions Sight & Health to promote birth tissue donation, promoting a circular model.

    BioTissue has conducted studies demonstrating the effectiveness of its CryoTek-preserved amniotic membrane in surgeries for pterygium, cataracts, and conjunctivochalasis, leading to improved patient outcomes. It has also shown that its amniotic allografts are effective in treating complex foot ulcers and traumatic wounds. In another study, the use of Prokera has led to improvement in moderate to severe dry eye disease.

    Cellular Logistics

    Cellular Logistics, based in Madison, Wisconsin, has developed CFX (Cardiac Fibroblast matriX), a therapeutic biomaterial produced using induced pluripotent stem cell technology. CFX is designed for local administration to prevent the pathological changes that lead to heart failure following myocardial infarction (heart attack). Moreover, CFX can also be used in conjunction with therapeutic stem cells to help remuscularize and restore function in scarred myocardium, particularly in cases of chronic heart failure.

    The CFX technology presents several advantages. It is a cell-free product that is immune-privileged, allowing it to be administered to patients without the need for immunosuppressive drugs. It can modulate immune cells to promote healing properties and allows for the production of injectable particulates or patches, with the ability to adjust sizes according to clinical needs. These formulations enhance the retention of injected stem cells, preventing their rapid dispersal in the heart.

    Earlier this year, Cellular Logistics and Allele Biotechnology entered into a partnership to develop regenerative medicine products for treating ischemic heart disease. The partnership leverages Allele’s cell reprogramming technology and aims to advance Solus to clinical-grade production for treating heart disease.

    Japan Tissue Engineering

    Japan Tissue Engineering (J-TEC), a company based in Gamagori, Aichi, Japan, is a pioneer in the field of regenerative medicine. Established in 1999, J-TEC has focused on developing, manufacturing, and selling tissue-engineered medical products. 

    J-TEC’s business is divided into three main segments: Regenerative medicine, custom development and manufacturing, and R&D support. Its flagship products include autologous cultured epidermis JACE, and autologous cultured cartilage JACK.

    J-TEC has developed autologous cultured epidermis products for treating severe burns, congenital giant pigmented nevus and epidermolysis bullosa. It is also working on treatments for vitiligo and second-degree burns using cultured epidermis.

    Its autologous cultured cartilage product, approved for traumatic cartilage defects or osteochondritis dissecans, is one of Japan’s first regenerative medical products. Ongoing clinical trials aim to expand its use to secondary knee osteoarthritis.

    In the field of ophthalmology, J-TEC has introduced autologous cultured corneal and oral mucosal epithelium products for treating corneal epithelial stem cell deficiency.

    Moreover, J-TEC’s involvement in the broader landscape of regenerative medicine in Japan is significant, where the regulatory environment, such as the Regenerative Medicine Promotion Act of 2014, has catalyzed the development and approval of cell therapies. Japan’s strategic focus on regenerative medicine, supported by institutions like the Agency for Medical Research and Development (AMED), positions J-TEC in a thriving ecosystem.

    Lattice Medical

    Lattice Medical, established in 2017, is a French company specializing in the development of innovative implants for reconstructive surgery using tissue engineering, biomaterials, and 3D printing technologies. The company’s flagship products include Mattisse, a 3D-printed resorbable breast implant, and rodin, designed for hypodermal reconstruction. 

    Mattisse stands out for being a 3D-printed, bioresorbable tissue engineering chamber designed for women who have undergone mastectomy due to breast cancer. This implant is made from a medical-grade resorbable biomaterial that naturally degrades over a few months post-implantation and is currently tested in the TIDE clinical trial in France. The design of Mattisse includes a porous base for fixing the autologous tissue to be regenerated and a dome that helps achieve the desired volume and shape.

    Tissue Regenix

    Tissue Regenix is a medical technology company headquartered in Leeds, England, specializing in regenerative medicine. The tissue engineering company is focused on the development and commercialization of regenerative products utilizing its proprietary technologies, dCELL and BioRinse.

    The dCELL technology is a decellularization process that removes DNA and cellular material from animal and human tissue, leaving an acellular scaffold that can be used for the repair of damaged body parts without being rejected by the patient’s body. This technology has applications in sports injuries, foot and ankle surgery, and wound care. 

    BioRinse is a technology used to sterilize bone allografts, minimizing tissue damage and preserving the quality of the grafts used primarily in sports medicine for tendon and ligament reconstruction.

    Tissue Regenix has shown notable business growth, with a reported turnover of $29.5 million in 2023, indicating a substantial increase from the previous year. Additionally, Tissue Regenix has successfully expanded its market reach with new distributor agreements in Turkey and Ireland.

    Vericel Corporation

    Vericel Corporation, based in Cambridge, Massachusetts, specializes in advanced therapies for the sports medicine and severe burn care markets. Founded in 1989 and initially known as Aastrom Biosciences, Vericel underwent significant transformation after acquiring Sanofi’s cell therapy and regenerative medicine business in 2014, which led to its name change.

    Their key products include Maci, Epicel, and NexoBrid, each utilizing different biotechnological approaches.

    Maci (autologous cultured chondrocytes on porcine collagen membrane) is a product used for knee cartilage repair. It involves cultivating a patient’s own cells, which are then expanded and placed onto a collagen membrane. This membrane is then implanted into the damaged cartilage area, where it integrates with the surrounding tissue to repair the defect. MACI is specifically tailored to the size and shape of the cartilage damage, ensuring complete coverage and optimal healing​​.

    Epicel (cultured epidermal autografts) is a skin graft technology used for treating patients with severe burns. It involves growing skin grafts from a small sample of the patient’s own skin, which can then be expanded to cover extensive burn areas​.

    NexoBrid is a topical treatment used for the removal of eschar in patients with deep partial-thickness or full-thickness thermal burns. It contains proteolytic enzymes derived from pineapples that selectively remove nonviable burn tissue without harming surrounding healthy tissue. This process is crucial for the subsequent healing and treatment of severe burn injuries​.

    The tissue engineering company is currently exploring other applications for its products as Maci is also in phase 3 clinical trial for the treatment of ankle cartilage defects, and a phase 3 clinical trial is ongoing for NexoBrid pediatric usage. 

    Tissue engineering: an evolving industry

    The current state of the tissue engineering industry is marked by a growing enthusiasm, driven by increasing clinical studies in regenerative medicine and tissue engineering. The market faces challenges such as high development costs and ethical issues surrounding stem cell research. Orthopedics, musculoskeletal, and spine applications dominate the market due to the rising prevalence of related disorders. The industry is also experiencing significant advancements in cardiology and vascular segments, fueled by the development of stem cell therapies and regenerative treatments for heart tissue.

    Regionally, North America leads the market, supported by strong investment in research and development. The Asia Pacific region is also emerging as a significant player, with countries like Japan at the forefront of technological advances in the field.

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