List of Regenerative Medicine Companies with Phase 1 Active Clinical Trial - 42

Founded in 2016, AffyImmune is a clinical-stage biotechnology company that optimizes CAR T cells for the treatment of solid tumors using our Tune & Track platform. AIC100, our first product, spares healthy cells through our unique affinity-tuning, enhancing its safety and efficacy. The initial indication for AIC100 is refractory thyroid cancer, which has a very poor prognosis and very few effective therapies. The antigen targeted by AIC100 is also overexpressed in a variety of additional cancers, including stomach, triple negative breast cancer and a number of others.

Aspen is developing induced-pluripotent stem cells (iPSCs) to address diseases with high unmet medical need, beginning with autologous neuron replacement for Parkinson’s disease (PD) and extending across the brain and affected organs.

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.

Founded in 2019, Brexogen is at the forefront of biotechnological innovation, dedicated to transforming the treatment of incurable diseases through our proprietary BG-Platform technology. As a pioneering bioventure, we specialize in the development of cell-free therapies, leveraging the untapped potential of stem cell derived exosomes. Our mission intertwines groundbreaking research with practical healthcare solutions. As we gear up for global expansion, our strategy emphasizes understanding local markets, forging strategic partnerships, continuous innovation, and engaging with the medical community to promote the benefits of exosome therapy. Rooted in South Korea, Brexogen is on a trajectory to enhance healthcare outcomes worldwide. We're dedicated to leading the charge in biotechnological innovation, offering accessible, effective treatments on a global scale. Join our journey as we strive for a healthier future across communities globally.

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.

CellProthera, a biotechnological company, has developed a unique therapeutic technique which enables the structural and functional regeneration of severe post-infarctus cardiac lesions. After European and national (FR/GB) authorization was obtained , CellProthera has started its I/IIB clinical trial in Humans.

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.

Elixirgen Therapeutics is a biotechnology company advancing its controllable self-replicating RNA technology to develop therapies for a broad spectrum of diseases, including rare diseases, aging-related disorders, and cancer. Elixirgen Therapeutics is located in the Science + Technology Park at Johns Hopkins in Baltimore.

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.

Emmecel - Emmetrope Ophthalmics LLC, (aka “Emmecell”) is a privately-held, clinical stage biotechnology company developing cell-based therapies. Emmecell’s platform technology leverages magnetic nanoparticles to effectively localize and integrate cell therapies to the appropriate target tissue. Our lead product EO2002 is a cell therapy for treatment for corneal edema, the most common indication for corneal transplantation. Cell Manufacturing and Production LLC (CellMP) was founded in 2018 and is a subsidiary of Emmecell providing GMP manufacturing services in Menlo Park, CA.

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.

HRGN is a clinical-stage biotechnology company that uses a patient’s own stem cells that are grown on a hollow tubular scaffold to regenerate organ tissue damaged from cancer, trauma, birth defects or other diseases.

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.

Juvena Therapeutics is a biopharmaceutical company that focuses on developing innovative therapies for various medical conditions.

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.

Minerva Biotechnologies is a clinical stage biopharmaceutical company focused on developing immunotherapies for solid tumor cancers and cellular therapies for regenerative medicine. NCT04020575 is Minerva’s first-in-human trial of huMNC2-CAR44, a CAR T that targets the MUC1* growth factor receptor, for the treatment of metastatic breast cancers, 95% of which express a MUC1*. We are now expanding the current clinical trial to include our second CAR-T product that greatly increases persistence. The Company is rapidly accelerating its pipeline that includes next-gen CAR-T products, a straight antibody therapeutic and a small molecule therapeutic which are both for the treatment of cancer metastasis. Our track record of scientific breakthroughs is a testament to our visionary team and our collaborative culture. Join us in changing the world.

What we know: - Currently, 106,000 people in the U.S. are on the waitlist for a life-saving organ transplant. - 60% of patients on the waitlist will not receive the organ they need. - 17 people in the U.S. die each day due to the lack of available organs. What we're doing: Miromatrix Medical was founded with the mission to eliminate the transplant waitlist. Headquartered in Eden Prairie, Minnesota, we bioengineer organs through our patented perfusion decellularization and recellularization technology. We take what nature designed -- a fully functioning liver or kidney -- and with our patented technology, remove all of the cells from discarded pig organs. What's left is a ‘scaffold'; all of the organ's natural design and architecture remains. Then, from the inside out, we seed new, living human cells back into the organ -- ultimately creating completely functional, transplantable organs with the potential to save thousands of lives every year.

Neobiosis, LLC is a privately owned, clinical stage, biomedical contract development and manufacturing organization (CDMO) with two production facilities in downtown Gainesville and a Research & Development laboratory located within the Sid Martin UF Innovate biotechnology Institute in Alachua, FL. The focus of Neobiosis is the isolation of tissues, cells and extracellular vesicles (EVs), with medicinal potential, from donated perinatal (birth) tissues, including umbilical cord, umbilical cord blood and amniotic fluid. The name Neobiosis ("new life") is derived from a series of experiments called Parabiosis ("living together") where it was discovered that tissues, cells and EVs from a young donor could be used to promote the healing of older individuals. Neobiosis produces innovative products from healthy, full-term births, for client organizations who wish to take biomedical products though FDA-approved clinical trials for commercialization in a global market. Neobiosis is also committed to advancing an in-house pipeline of intellectual property and biologicals for use in anti-aging and regenerative medicine.

NovaGo’s fully human monoclonal antibodies have the potential to become a safe and effective treatment in central nervous system indications. NovaGo’s proprietary antibodies block the function of Nogo-A, one of the most potent and well-studied vascular and nerve growth inhibitors.

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.)

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.

Sana Biotechnology is focused on utilizing engineered cells as medicines for patients. The ability to modify genes and use cells as medicines will be one of the most important advances in healthcare over the next several decades. Sana is building differentiated capabilities across the spectrum of cell and gene therapy. Three aspirations drive Sana as we look to discover treatments for patients with poor outcomes or currently untreatable diseases. The first is the ability to repair and control the genes in any cell in the body. We are advancing novel delivery technologies with the goal of being able to deliver any payload to any cell in a specific, predictable, and repeatable manner, paving the way for next-generation in vivo gene therapy. Next is the ability to differentiate pluripotent stem cells ex vivo into immune-cloaked functional cells with the aspiration of being able to replace any missing or damaged cells in the body. Last is a belief we can enable broader access to our therapies through focusing on scalable manufacturing solutions, the cost of manufacturing, and aligning with key stakeholders. Sana launched in early 2019 and has over 350 employees in Seattle, Cambridge, and South San Francisco. Sana was founded with the long view – bringing together great people and the best technologies to deliver on the challenging promise of using engineered cells to meaningfully change the outcome of many human diseases.

Revolutionizing cell therapy to address inflammatory diseases driven via neonatal cardiac progenitor cells and their secretomes.

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.

The vast majority of human disease is governed by the epigenome, the subtle machinery that controls the volume of gene expression in cells. Tune Therapeutics is pioneering the creation of epi-therapeutic medicines with its powerful and precise epigenomic control platform, TEMPO. Unlike genome editing, TEMPO dials the volume of gene expression up or down towards healthy levels, without breaking or permanently rewriting DNA – and it can do this in multiple genes at once. This genetic tuning approach allows us to change cell fate and function at will, unlocking the ability to reverse pathways of cancer, genetic disease and aging. Our approach effectively expands the potential reach of genetic medicine – from targeting a limited range of rare conditions, to overcoming thousands of complex and chronic diseases that currently have no curative treatment.

VERIGRAFT generates personalized tissue-engineered transplants for use in regenerative medicine. The company's unique technology platform turns donated allogeneic ("foreign") tissue into an autologous-like ("personalized") tissue and thus avoids transplant rejection and the need for life-long immunosuppression. Donated, allogenic tissue is patient-individualized by a combination of DC (Decellularization) and RC (Reconditioning/Recellularization) processes. VERIGRAFT's development pipeline comprises products in the areas of vascular regeneration as well as peripheral nerve repair.

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.