ArthRegen takes on regenerative medicine

Joint regeneration pursued through three pillars…cell therapy, human tissue products and 3D implants

Market entry to begin with human tissue products…Sequential preparation underway based on manufacturing and preclinical pipeline

AI-based diagnosis and customized design to be linked with robotic surgery…to ultimately create bioartificial joints for arthritis

"The ultimate destination of arthritis treatment is artificial joints. ArthRegen aims to become a company that provides regenerative medicine so that patients can avoid artificial joints.”

As the aging population drives growing demand for joint disease treatment, artificial joint replacement has emerged as a key treatment option for arthritis. However, because the procedure replaces damaged tissue rather than regenerating it, patients still have limited options for preserving their natural joints.

ArthRegen plans to bridge this gap through regenerative medicine. Dailypharm met with ArthRegen CEO Joon Ho Wang to discuss the company’s vision for bioartificial joints and its business strategy.

Physician entrepreneurship… bridging the gap between research and treatment

Joon Ho Wang, CEO of ArthRegen

Wang, who leads ArthRegen, is both a clinician and researcher who has treated knee patients as an orthopedic surgery professor at Samsung Medical Center.

After witnessing the limitations of existing treatments in practice and conducting regenerative medicine research for 20 years, Wang chose entrepreneurship as a means of translating his research into actual treatment technologies.

His decision to establish the company stemmed from the disconnect between research findings and clinical practice.

When the articular cartilage or meniscus is damaged, procedures such as suture, transplantation, osteotomy, and cartilage regeneration may be performed, but they have limitations in restoring the tissue’s original function. Even after all available treatments have been exhausted, joint damage may continue to progress and ultimately require artificial joint replacement. Watching these patients, Wang realized the need for new regenerative treatments.

He continued his cell therapy and tissue engineering research through government-funded projects, but realized that academic papers alone could not produce treatments for use in patients, as advancing a product from cell production and preclinical testing to clinical trials and regulatory approval requires commercialization funding, specialized personnel, and manufacturing infrastructure.

Wang said, “During my 20 years of research, I hoped the findings would be used to improve clinical practice, but in reality, a considerable gap remained unfilled. This is when I realized entrepreneurship was a necessary platform for delivering research findings to patients.”

He added, “A physician’s role is to treat the patients who come to the clinic, but I believe entrepreneurship is about developing treatments for the many patients of the future whom I may never meet personally.”

Human tissue products should come first…Company to develop 3 pipelines sequentially

ArthRegen’s pipeline consists of three pillars. The first is a cell therapy for articular cartilage regeneration. The therapy uses mesenchymal stem cells derived from Wharton's jelly inside the umbilical cord, formed into 3D spheroids to induce the regeneration of damaged cartilage.

The company is focusing on the cells’ potential to modulate the damaged microenvironment within the joint and promote the formation of cartilage-like extracellular matrix.

The second is an acellular tissue regeneration product that uses extracellular matrix obtained by removing cells from human meniscal tissue. The company cites the product’s composition as a differentiating feature. Unlike skin-derived extracellular matrix products, which are primarily composed of type I collagen, meniscus-derived material contains cartilage components such as type II collagen and glycosaminoglycans.

ArthRegen plans to utilize this product in surgeries for articular cartilage and meniscus. The company views human tissue products as requiring a shorter period for market entry than new drugs or implantable medical devices, and is therefore pushing for commercialization first among its pipelines.

Wang said, “Human tissue products follow a different development pathway from new drugs and medical devices that require clinical trials, and may therefore enter the market relatively quickly. We are developing the product to generate our first sales in 2027.”

The company’s third pipeline is an AI-based, patient-specific 3D-bioprinted meniscal implant. The medical device analyzes images of the defect in a patient with meniscal loss and is designed and manufactured to fit the shape and structure of the individual defect.

ArthRegen is studying the use of polycaprolactone (PCL), a biodegradable material, to reproduce the meniscus’s shock-absorbing and joint-protective functions. Because the company is developing the product as a Class IV implantable medical device, it must complete material selection, animal studies, and clinical trials. ArthRegen is targeting commercialization within 3-4 years.

Production through external partnerships…Focus on development capabilities

Rather than building all of its own manufacturing facilities, ArthRegen has chosen to utilize the production and testing capabilities of specialized external companies. The company directly develops the pipeline concepts, target applications, product designs, and core technologies, while outsourcing production and testing.

For its cell therapy, the company signed a contract development and manufacturing agreement with Matica Biolabs. Matica Biolabs is responsible for developing and operating the process for isolating Wharton’s jelly-derived mesenchymal stem cells and supports ArthRegen’s preclinical research.

ArthRegen plans to establish the cell manufacturing process by mid-2027 and begin good laboratory practice-compliant preclinical studies required to enter clinical trials under the Ministry of Food and Drug Safety in the second half of the year. After completing domestic Phase I and II trials, it is also considering conducting a global Phase III trial, depending on its funding situation.

The 3D-bioprinted meniscal implant is likewise being developed in partnership with a specialized company. ArthRegen is responsible for analyzing each patient’s defect, designing the implant and developing its clinical application, while combining these capabilities with the external partner’s 3D-printing and manufacturing expertise. After confirming the product’s function and safety in animal studies, the company may pursue joint development with a global medical device company or out-license the technology.

Wang said, “It would be difficult for a startup to own all the facilities needed for cell therapy production, 3D printing, and preclinical testing. ArthRegen leads the product concept and technology, indications and design, while partnering with specialized companies on production.”

ArthRegen’s long-term goal is to connect its 3 pipelines into a single joint regeneration system.

The company will initially develop its human tissue product, cell therapy, and meniscal implant separately. Ultimately, however, it believes that complete tissue regeneration will require combining a scaffold on which cells can grow with a cell therapy.

The company also plans to integrate AI-based joint assessment and defect analysis, patient-specific implant design and 3D bioprinting. In the longer term, it intends to incorporate robotic surgical technology that helps surgeons place the implant in the precise position for which it was designed.

Wang emphasized, “ArthRegen is not simply a cell therapy or 3D-printed medical device company. We are pursuing a broader vision capable of changing the paradigm of joint treatment.”

He added, “Our goal is to become a comprehensive joint regeneration company that connects AI-based diagnosis, patient-specific implant design and 3D printing, to ultimately robotic surgery.”.