List of Tissue Engineering Companies with Phase 1 Active Clinical Trial - 12

Anteris Technologies is a structural heart company focused on developing innovative solutions to the biggest challenges facing aortic stenosis patients and their physicians. Our DurAVR™ Transcatheter Heart Valve (THV) System is designed for younger patients who need a heart valve that will last their lifetime. DurAVR™ THV is a unique, single-piece valve and its first-in-class biomimetic design replicates the normal blood flow of a healthy human aortic valve. | $AVR | ASX: AVR | #DurAVR #ADAPT #structuralheart #TAVR #TAVI #cardiology

Atreon Orthopedics is a tissue regeneration company powered by breakthrough regenerative technology and renowned scientific expertise. Tendon and ligament injuries affect ten million people yearly, spanning all lifestyles and demographics. Atreon is committed to dramatically improving healing and long-term outcomes for patients encountering these soft-tissue injuries. ROTIUM®, our initial product for rotator cuff repair, is a bioresorbable wick designed as a scaffold to harness and hold biologically active substances at the repair site providing a pro-healing environment that promotes healthy tissue and native tissue regeneration. Recently published human and animal studies and over 10,000 cases have shown a safe and effective solution to improving biology, restoring function, and improving rotator cuff success rates.

Cerapedics is a global, commercial-stage orthopedics company that aspires to redefine the standard of care for bone repair by healing bones faster and at higher rates, without compromising safety, so that patients can live their healthiest lives. Bone grafts, including Cerapedics’ products, are used in over four million annual spine, orthopedics, trauma and interventional procedures world-wide. Cerapedics’ product, i-FACTOR®, is FDA approved for single-level cervical spinal fusions in the United States. Cerapedics’ next-generation product is currently being evaluated for use in lumbar interbody fusion through ASPIRE, a pivotal IDE study, and has been granted a Breakthrough Device Designation by the FDA. Cerapedics is headquartered in Westminster, CO.

Frontier Bio creates engineered tissues to replace animal testing and save lives.

Discover the limitless potential of human induced pluripotent stem cells (iPSCs) for groundbreaking research at Greenstone, a leading Bay Area biotech company. We combine cutting-edge technology with AI, computational biology, and pharmacogenomics to accelerate drug discovery and development, transforming the future of therapeutics. Our vision is to transform drug discovery from a slow, sequential, and high-failure process into a rapid, integrated, and novel computational platform. By harnessing the power of iPSCs and our advanced technologies, we revolutionize the traditional drug discovery paradigm, paving the way for a faster, more efficient approach. With our curated and diverse collection of iPSCs, sourced from both healthy individuals and those affected by various diseases, we offer a comprehensive platform for disease modeling, uncovering novel mechanisms, and advancing drug discovery. Our high-quality iPSCs provide researchers with patient-specific and disease-specific cells, enabling the development of personalized treatment strategies. At Greenstone, collaboration and innovation are at the core of our values. We proudly offer our iPSCs to academic investigators free of cost, fostering an environment of shared knowledge and progress. Together, we can unlock new insights, accelerate drug discovery, and shape the future of personalized medicine. Join us on the frontier of biomedical research and tap into the immense potential of iPSCs. Together, let's transform drug discovery into a rapid, integrated, and computational platform that propels us towards groundbreaking therapeutics. #Biotech #iPSCs #DrugDiscovery #BiomedicalResearch #PersonalizedMedicine #Innovation

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.

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.

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.

Vascudyne Inc is a biotechnology company based in Minnesota, focused on regenerative medicine through engineered biological tissues. Founded in 2014 and headquartered in Stillwater, with operations in Saint Paul, Vascudyne develops acellular in-vitro grown allograft tissues that mimic the properties of natural human tissue. The company’s TRUE™ Tissue Technology is a proprietary platform that produces 100% biological soft tissue implants. Their product portfolio includes the TRUE™ Graft for vascular access in hemodialysis, the TRUE™ Valve for engineered valved conduits, and the TRUE™ Patch for tissue repair. Vascudyne emphasizes the use of biologically derived extracellular matrix materials and tunable anisotropic tensile properties in their manufacturing processes. Vascudyne has achieved significant milestones, including successful First-in-Human studies for the TRUE™ Graft and preclinical validations for their products. The company operates within Minnesota’s "Medical Alley," benefiting from the region's medtech ecosystem, and has raised a total of $19.63 million in funding to support its innovative work in regenerative biomaterials.

VenoStent is a tissue engineering medical device company developing bioabsorbable polymer wraps for better outcomes in vascular surgery.