Nanochon, a medical device company developing Chondrograft™, a novel patented implant for the treatment of articular cartilage defects of the knee, today announced that it has received regulatory approval from Panamá’s Ministry of Health to initiate its First-in-Human (FIH) clinical study in Panamá.
The study will evaluate the safety and performance of Chondrograft™ in patients with focal chondral defects of the knee and represents a major milestone in the company’s clinical and regulatory development strategy.
The trial will be conducted at The Panama Clinic in Panamá City under the leadership of Drs. Juan Osorio and Emilio Tufiño, experienced sports medicine surgeons, with Dr. Osorio serving as Principal Investigator for the study.
Dr. Osorio stated, “I am pleased to be the Principal Investigator for this important study, and we look forward to contributing the data that will support a larger clinical study and subsequent market entry.”
Nanochon selected Panamá for its growing reputation as a strategic destination for medical innovation, supported by efficient regulatory pathways, internationally recognized clinical infrastructure, and access to diverse patient populations. The company also received Health Canada authorization to conduct the study in Canada and is actively recruiting patients in Ontario.
“This approval marks a significant milestone for Nanochon and validates the momentum behind our clinical development program,” said Ben Holmes, Co-Founder and Chief Executive Officer of Nanochon. “Panamá’s streamlined regulatory environment and strong clinical ecosystem provide an excellent foundation for advancing innovative orthopedic technologies like Chondrograft™ into human studies.”
Chondrograft™ is designed as a minimally invasive, “burn-no-bridges” solution intended to provide immediate mechanical support and longer-term cartilage regeneration while preserving future treatment options for patients suffering from focal cartilage injuries of the knee. The device was granted Breakthrough Device Designation from the U.S. Food and Drug Administration.
Articular cartilage injuries remain one of the most challenging conditions in orthopedic medicine, often leading to chronic pain, reduced mobility, and progressive joint degeneration. Current treatment approaches can involve lengthy rehabilitation periods and frequently do not restore durable, functional cartilage tissue.
The prospective FIH study will enroll patients between the ages of 22 and 60 who have failed conservative treatment and present with one or two femoral condyle and/or trochlear cartilage lesions.
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