List of Regenerative Medicine Companies with Phase 4 Active Clinical Trial - 29

Amgen Inc. discovers, develops, manufactures, and delivers human therapeutics worldwide. It focuses on inflammation, oncology/hematology, bone health, cardiovascular disease, nephrology, and neuroscience areas. The company’s products include Enbrel to treat plaque psoriasis, rheumatoid arthritis, and psoriatic arthritis; Neulasta that reduces the chance of infection due a low white blood cell count in patients cancer; Prolia to treat postmenopausal women with osteoporosis; Xgeva for skeletal-related events prevention; Otezla for the treatment of adult patients with plaque psoriasis, psoriatic arthritis, and oral ulcers associated with Behçet’s disease; Aranesp to treat a lower-than-normal number of red blood cells and anemia; KYPROLIS to treat patients with relapsed or refractory multiple myeloma; and Repatha, which reduces the risks of myocardial infarction, stroke, and coronary revascularization. It also markets Nplate, Vectibix, MVASI, Parsabiv, EPOGEN, KANJINTI, BLINCYTO, Aimovig, EVENITY, AMGEVITATM, Sensipar/Mimpara, NEUPOGEN, IMLYGIC, Corlanor, and AVSOLA. Amgen Inc. serves healthcare providers, including physicians or their clinics, dialysis centers, hospitals, and pharmacies. It distributes its products through pharmaceutical wholesale distributors, as well as direct-to-consumer channels. It has collaboration agreements with Novartis Pharma AG; UCB; Bayer HealthCare LLC; BeiGene, Ltd.; Eli Lilly and Company; Datos Health; and Verastem, Inc. to evaluate VS-6766 in combination with lumakrastm (Sotorasib) in patients with KRAS G12C-mutant non-small cell lung cancer. It has an agreement with Kyowa Kirin Co., Ltd. to jointly develop and commercialize KHK4083, a Phase 3-ready anti-OX40 fully human monoclonal antibody for the treatment of atopic dermatitis and other autoimmune diseases; and research and development collaboration with Neumora Therapeutics, Inc. and Plexium, Inc. Amgen Inc. was incorporated in 1980 and is headquartered in Thousand Oaks, California.

AVITA Medical (NASDAQ: RCEL, ASX:AVH) is a commercial-stage regenerative medicine company focused on first-in-class devices for wound care management and skin restoration. At the forefront of our platform is the RECELL® System, approved by the U.S. Food and Drug Administration for the treatment of thermal burn wounds and full-thickness skin defects, and for repigmentation of stable depigmented vitiligo lesions. RECELL harnesses the regenerative properties of a patient's own skin to create Spray-On Skin™ Cells, delivering a transformative solution at the point-of-care. This breakthrough technology serves as the catalyst for a new treatment paradigm enabling improved clinical outcomes. AVITA Medical also holds the exclusive rights to market, sell, and distribute PermeaDerm®, a Biosynthetic Wound Matrix, in the United States.

Axogen is the leading company focused specifically on the science, development and commercialization of technologies for peripheral nerve regeneration and repair. We are passionate about helping to restore peripheral nerve function and quality of life to patients with physical damage or discontinuity to peripheral nerves by providing innovative, clinically proven and economically effective repair solutions for surgeons and health care providers. Every day, people suffer traumatic injuries or undergo surgical procedures that impact the function of their peripheral nerves. Physical damage to a peripheral nerve, or the inability to properly reconnect peripheral nerves, can result in the loss of muscle or organ function, the loss of sensory feeling, or the initiation of pain. Axogen’s comprehensive portfolio of products focuses on helping patients touch, run, feel, kiss, smile and hug—some of the many things healthy peripheral nerves allow us to do.

Axolotl Biologix, located in Arizona is a dynamic biotech company focused on developing and producing human biologics and biological-related products to reduce inflammation and foster regeneration for many conditions that affect patients, including orthopedic, wound care, cosmetic and more. Axolotl is currently negotiating partnerships with universities and research hospitals to find ways to improve current technologies and procedures to improve patients’ quality of life.

CartiHeal, a privately-held medical device company with headquarters in Israel, develops proprietary implants for the treatment of cartilage and osteochondral defects in traumatic and osteoarthritic joints. CartiHeal’s cell-free, off-the-shelf implant is CE marked for use in cartilage and osteochondral defects. Agili-C has been implanted in over 400 patients with cartilage lesions in the knee, ankle and great toe in a series of trials conducted in leading centers in Europe and Israel. In these trials, the implant was used to treat a broad spectrum of cartilage lesions, from single focal lesions to multiple and large defects in patients suffering from osteoarthritis. In the United States the Agili-C implant is not available for sale - it is an investigational device limited for use in the IDE study.

CellOrigin Biotech has a long term focus on iPSC-derived innate immune cells and its applications in new cancer immune cells. Dr. Jin Zhang, the scientific co-founder of CellOrigin used to be trained as a research fellow at the Boston Children’s Hospital and Harvard Medical School. His team worked closely with clinicians at the First Affiliated Hospital of Zhejiang University and for the first time reported the induced pluripotent stem cell or iPSC-derived CAR-macrophages (CAR-iMac), and its applications in cancer immunotherapies. As for now, CellOrigin Biotech holds its proprietary technologies for iPSC-derived CAR-Macrophage. With this platform, they are collaborating with research groups in genome engineering and synthetic biology at Harvard and MIT to fully unleash the potential of iPSC-derived immune cells, which are highly editable, expandable and clonal. Eventually, they would like to achieve a goal of bring more effective, universal and safe immune cell products to cancer patients, especially for those with solid tumors. The investigator initiated trials has been initiated at the First Hospital of Zhejiang University. The core proprietary technology platform and the core patents including the engineered macrophages from pluripotent stem cells has been authorized and is in the process of entering the US, Australia, South Africa, etc.

Collagen Matrix is a biotechnology company that specializes in developing medical devices and products for regenerative medicine using collagen as a key component.

Advancing regenerative medicine through the development of a natural biomaterial that restores mother nature’s template to treat disease and injury. ECM scaffolds, in solid form, have been successfully used in more than 10 million human patients to repair a variety of body systems such as musculoskeletal tissues, cardiovascular structures, and non-healing skin wounds, among others. These products have all received FDA clearance. ECM Therapeutics'​ patented ECM hydrogel technology allows for expanded, less invasive applications in multiple disease areas. The first clinical product, EsophaGel, treats Barrett’s esophagus, a precancerous condition that currently has no effective therapy.

Embody, Inc. is a commercial-stage company pioneering the next generation in collagen-based tendon and ligament healing for the fast-growing sports medicine market. Founded in 2014, the company is developing unique biomaterials with an initial focus on orthopedic applications including Achilles, rotator cuff and knee ligament repair.

Endogenex, in partnership with Mayo Clinic, aims to revolutionize treatment options for individuals with type 2 diabetes (T2D). Endogenex's innovations focus on resetting the body's metabolic signaling system by harnessing its natural regenerative capabilities to improve metabolic function. Through the development of the ReCET System and the novel application of precise, controlled, non-thermal pulsed electric fields, Endogenex is establishing a new era in treatment options for people living with T2D, helping patients regain control of their blood glucose levels and slow disease progression. Endogenex is a privately held, clinical-stage company based in Minneapolis, MN.

Geistlich is a global leader dedicated to advancing regenerative medicine. Geistlich has been the world market leader in the field of regenerative dentistry for many years. In addition, Geistlich is committed to providing comprehensive support to clinicians in the field of regenerative medicine through scientific research, innovative developments as well as educational programs. Geistlich is a Swiss family-owned company with tradition since 1851. With 15 subsidiaries and 60 distributors, the company reaches around 90 markets and employs over 800 people. The ownership structure enables the company to plan long-term and to consistently develop innovative products. Geistlich Pharma AG continuously invests in developing its research and technology and relies on its qualified and specialized employees. Currently Geistlich Pharma is - the global market leader in regenerative dentistry - the leader in biological bone and cartilage regeneration - supplies drugs and medical devices in selected application areas

InGeneron is a clinical-stage biotechnology company developing novel, safe, and evidence-based cell therapies. We are setting new therapeutic standards by enabling minimally invasive treatments that unlock the healing potential of each patient’s own regenerative cells processed at the point of care for same-day treatment. We currently focus on helping patients impacted by orthopedic conditions and are conducting several clinical trials to validate our technology as a disease-modifying treatment. Based on more than 20 years of research, InGeneron is dedicated to developing therapies supported by clinical evidence and approved by the FDA.

Innovative BioTherapies (IBT) is a small biotechnology company located in Ann Arbor, MI, focused on developing medical devices to solve unmet medical needs.

KiOmed Pharma is a biotechnology company based in Belgium that focuses on developing, manufacturing, and distributing chitosan-based medical devices. The company, a spinout from KitoZyme, utilizes exclusive natural chitosan chemistry to create solutions for high-impact medical conditions, particularly in osteoarthritis, dermatology, and ophthalmology. Headquartered in Herstal, Liège, KiOmed Pharma emphasizes therapeutic innovations through its proprietary KiOmedine® technology platform. One of its key products is KioMedine(vs)one, a single-injection soft implant designed to relieve pain and improve mobility in knee osteoarthritis patients. The company is also developing additional products targeting joint health, skin aging, and eye-related disorders. KiOmed Pharma maintains a commitment to biocompatibility and safety by using non-animal-derived chitosan in its formulations. In April 2024, KiOmed Pharma formed a strategic alliance with Aptissen to globally commercialize KioMedine(vs)one, enhancing patient access to its treatments while generating revenue through royalties and milestone payments. Under the leadership of CEO Houtaï Choumane, the company aims to create long-term value and improve patient outcomes in chronic diseases.

MED Institute accelerate product development. MED Institute is dedicated to bringing new medical device products to market that are safe and effective for patients. From concept to commercialization, our team has the knowledge and experience to guide your products through the complex steps required for market approval.

MIMEDX Group is a biotechnology company that specializes in regenerative medicine and tissue engineering products.

OssDsign is a developer and global provider of next generation orthobiologics products. Based on cutting edge material science, the company develops and markets products that support the body's own healing capabilities, giving patients back the life they deserve. Website: www.ossdsign.com Newsroom: https://news.cision.com/ossdsign-ab (Always consult Instructions for Use which accompany the products for complete indications, contraindications, warnings and precautions.)

RegenLab is recognized as a global leader in medical biotechnologies, specializing in cellular therapies, manufactured in the USA. RegenLab is at the forefront of innovation, with an expertly designed medical device for the preparation of platelet rich plasma from the patient's own blood. Regen® A-PRP® is FDA cleared and developed with a focus on product quality, patient safety, and preparation efficiency. Our patient-centered technology has led to over one million treatments worldwide using RegenLab products. As we look to the future, we are committed to guiding new standards for emerging categories within the field of regenerative medicine.

RevBio was started with one goal in mind—to end medicine's 50 year search for a biocompatible bone adhesive. Effective for bone-to-bone as well as bone-to-metal wet field applications, Tetranite® is a revolutionary biomaterial that promises to transform bone repair—for both patients and clinicians. Inspired by the marine animal the sandcastle worm, Tetranite is simple chemistry. Bioengineered from the worm's secreted protein, our synthetic adhesive is the only patented biomaterial which satisfies both the required and desired properties for a bone adhesive: wet field performance, multi-surface bonding, rapid mechanical stability, and controlled biodegradability. The properties of Tetranite™ include the ability to provide immediate fixation of bone to bone and bone to metal. This adhesive has been shown in multiple animal studies to be a non-toxic and effective way of repairing bone fractures and defects as well as securing implant devices. Existing data has also shown that Tetranite™ is reabsorbed and replaced with new bone during the natural process of bone remodeling by acting as a scaffold to facilitate bone growth over time.

RTI Surgical (RTI) is a leading CDMO pushing the boundaries of innovation and tissue engineering to meet patient needs in regenerative medicine. We are expert partners to Original Equipment Manufacturers (OEMs), working with them to identify clinical problems and develop customized solutions that promote healing, accelerate recovery, and help prevent complications. We focus on specialized clinical segments, including breast and plastic surgery, sports medicine and orthopedics, and neuro and spine surgery. Our Mission is to enhance patients' lives by creating the best clinical outcomes through innovative, high-quality medical solutions.

Spiderwortisdeveloping a novel biomaterial that will offer new avenues in 3D in vitro research and in regenerative medicineusing plant derived cellulose to create a variety of scaffold architectures.

Tempo Therapeutics is a biotechnology company that specializes in tissue engineering using proprietary MAP material science technology to build functional tissue and organs within patients in real time for disease treatment.

Although our primary product is high-quality human amniotic tissue grafts, we are really in the business of helping people. Tides Medical® sources and acquires donated placentas to make advanced skin substitutes available to the patients who need them. Then we work with physicians and their staff to help them navigate the complex reimbursement process. Our goal in providing these advanced products and expert service is that we will remove the barriers that might prevent patients from accessing the full range of treatment options they deserve. It’s a challenge that our team takes personally.

TISSIUM was founded in 2013 to address one of the most persistent medical challenges since the inception of surgical procedures: to reconstruct damaged tissue and restore its natural function. Since the discovery of our first polymer at the labs of Bob Langer and Jeff Karp at MIT, we recognized the exceptional potential for our technology to revolutionize the field of tissue reconstruction in multiple therapeutic areas. Our unique approach to product development leverages the knowledge gained from the development of our technology platform comprised of proprietary polymers, activation technologies, and delivery devices. We have developed a fully integrated innovation, design, commercialization and manufacturing platform to support our internal programs as well as co-development partnerships with leaders in the medtech industry.

Tissue Regenix is a leading medical devices company in the field of regenerative medicine. Tissue Regenix was formed in 2006 when it was spun-out from the University of Leeds, UK. The company's patented decellularisation ('dCELL®'​) technology removes DNA and other cellular material from animal and human soft tissue leaving an acellular tissue scaffold which is not rejected by the patient's body and can then be used to repair diseased or worn out body parts. Current applications address many critical clinical needs such as sports medicine, heart valve replacement and wound care. In November 2012 Tissue Regenix Group plc set up a subsidiary company in the United States - 'Tissue Regenix Wound Care Inc.'​, rebranded 'TRX BioSurgery'​ in February 2018. January 2016 saw the establishment of joint venture GBM-V, a multi- tissue bank based in Rostock, Germany. In August 2017 Tissue Regenix acquired CellRight Technologies®, a biotech company that specializes in regenerative medicine and is dedicated to the development of innovative osteoinductive and wound care scaffolds that enhance healing opportunities of defects created by trauma and disease. CellRight's human osteobiologics may be used in spine, trauma, general orthopedic, foot & ankle, dental, and sports medicine surgical procedures.

United Therapeutics Corporation is a biotechnology company focused on the development and commercialization of unique products to address the unmet medical needs of patients with chronic and life-threatening conditions. We currently have five approved products on the market, and a long-term mission of providing an unlimited supply of transplantable organs for those who need them! Our employees can be found collaborating across the United States, Europe and Asia. As a group, we are relentless in our pursuit of “medicines for life” and continue to research and develop treatments for cardiovascular and pulmonary diseases, pediatric cancers, and other orphan diseases.

Volumina Medical is a multi-award-winning start-up active in the field of medical devices supported by a solid network of investors. The company develops breakthrough innovations for plastic and reconstructive surgery. The first product is an implantable polymeric biomaterial and targets the regeneration of soft tissue of the human body which are damaged after tumor excision, genetic malformation or trauma.

Xeltis is developing artificial vessels and valves that are gradually replaced by patients’ own living healthy tissue. www.xeltis.com

ZimVie is a global leader in dental implants and spine innovations. Advancing clinical technology foundational to restoring daily life.