Nanochon Receives Health Canada Approval to Launch First-in-Human Trial of 3D Printed Knee Implant

Health Canada, the federal regulatory authority, has approved U.S. medical device startup Nanochon’s clinical trial design, authorizing the launch of a first-in-human study for its 3D printed Chondrograft knee implant. The trial will assess the implant’s ability to repair damaged cartilage and reduce recovery times for patients with limited treatment options. This approval represents a significant step forward in validating Nanochon’s minimally invasive joint repair technology.

Although the study will be conducted in Canada, the startup views it as the beginning of a broader North American clinical program focused on advancing alternatives to invasive joint repair procedures.

Illustration showing how Nanochon’s Chondrograft restores damaged cartilage. Image via Nanochon.

Chondrograft: A 3D Printed Implant 

Chondrograft is a 3D printed, minimally invasive implant developed to support knee cartilage regeneration. Originating from research at the Tissue Engineering and Nanotechnology Lab at George Washington University, the device is engineered for immediate weight-bearing and motion. Preclinical studies suggest that it promotes integration with surrounding tissue and may shorten recovery time compared to traditional interventions.

Nanochon positions the implant as a next-generation alternative to cartilage restoration techniques that often involve invasive surgery or short-term solutions. The company’s goal is to provide a durable and effective treatment for articular cartilage lesions, helping patients return to mobility without undergoing early joint replacement.

The Chondrograft Implant. Image via Nanochon.

Study Design and Patient Population

The approved early feasibility study will evaluate the safety and performance of the Chondrograft implant in a small patient cohort. A total of 10 individuals between the ages of 22 and 60 will be enrolled, all of whom present with articular cartilage damage in the femoral condyle and/or trochlea articular cartilage and have failed to respond to non-surgical treatments.

The study will assess outcomes such as cartilage-bone matrix regeneration, improvements in knee function and pain, and the potential to delay or avoid future arthroplasty. The collected data will help inform future large-scale trials and support regulatory pathways in other regions.

The trial will be led by Dr. Fathi Abuzgaya, an orthopedic surgeon with over 25 years of experience and a record of more than 600 clinical trials across various phases and therapeutic areas. Dr. Abuzgaya will be joined by sports medicine specialists Drs. Joel Lobo, Kajeandra Ravichandiran, and Marcin Kowalczuk at Durham Bone & Joint Specialists (DBJS) in Ontario, Canada.

“Achieving Health Canada approval allows us to gain the clinical data needed to take a giant step forward towards design and execution of a large pivotal North American study. We have the utmost confidence in Dr. Abuzgaya and his clinical team at DBJS to help us recruit the right patients and execute the trial protocol that we have so carefully designed,” said Nanochon CEO Ben Holmes.

3D Printed Medical Implants

This trial is expected to contribute to ongoing advancements in 3D printed medical implants. In April, Austrian ceramic 3D printing company Lithoz achieved a 92% success rate in a clinical long-term follow-up study of its beta TCP patient-specific implants (PSI). The study confirmed that its 3D printed implants made using Lithoz’s CeraFab printer are effective bone substitutes, showing strong osteoconductive and osteoinductive properties with no post-surgical complications. 

In 2023, the first surgeries using a 3D printed spinal implant made from Evonik’s VESTAKEEP i4 3DF PEEK filament were performed. Developed by U.S.-based firm Curiteva, the device is the first commercially available spinal implant made from fully interconnected porous PEEK.

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Author: Paloma Duran