The study will include patients aged 22 to 60 years who did not respond to conservative treatments and have cartilage lesions. Credit: Chinnapong / Shutterstock.com.

Nanochon has secured the Panamá’s Ministry of Health approval to begin its first-in-human trial of Chondrograft, an implant intended to treat articular cartilage defects in the knee.

The trial is set to assess the safety and performance of Chondrograft in patients presenting with focal chondral defects.

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It will take place at The Panama Clinic in Panamá City, with Dr Juan Osorio serving as principal investigator and Dr Emilio Tufiño as co-lead. Both are sports medicine surgeons.

The study will include patients aged between 22 and 60 years old who did not respond to conservative treatments and have one or two femoral condyle and/or trochlear cartilage lesions.

According to Nanochon, this approval marks a milestone in the company’s ongoing clinical and regulatory development efforts for Chondrograft.

Nanochon co-founder and CEO Ben Holmes said. “This approval marks a significant milestone for Nanochon and validates the momentum behind our clinical development programme.

“Panamá’s streamlined regulatory environment and strong clinical ecosystem provide an excellent foundation for advancing innovative orthopaedic technologies like Chondrograft into human studies.”

Nanochon chose Panamá for the study because of its regulatory processes, established clinical facilities, and access to different patient groups.

Alongside the approval in Panamá, Nanochon has also received permission from Health Canada to conduct its study in the country, with patient recruitment under way in Ontario.

Chondrograft is designed to be a minimally invasive implant, aiming to offer prompt mechanical support and encourage longer-term cartilage regeneration in patients with knee cartilage injuries, while not precluding future treatment options.

It has been granted breakthrough device designation by the US Food and Drug Administration.

Nanochon focuses on developing medical devices for cartilage repair in individuals who are not yet considered candidates for joint replacement.