Nanochon Performs First Case in the Chondrograft™ First-in-Human Clinical Study
Nanochon, a medical device company developing Chondrograft™, a novel 3D-printed patented implant for the treatment of articular cartilage defects of the knee, today announced the successful treatment of the first patient in its First-in-Human (FIH) clinical study.
The study is designed to evaluate the safety and performance of Chondrograft™ in patients with focal chondral defects of the knee. Dr. Juan Osorio and Dr. Emilio Tufiño, who both specialize in regenerative sports medicine, performed the first procedure at The Panama Clinic, Panamá.
“I am pleased to be the Principal Investigator for this important study, and we are excited to be the first to initiate clinical study enrollment. The team here in Panamá looks forward to contributing the data that will support a larger clinical study and subsequent market entry,” stated Dr. Osorio.
“The speed at which Dr. Osorio and the clinical team were able to identify, enroll, and treat the first patient underscores the significant unmet clinical need in cartilage repair,” said Ben Holmes, Co-Founder and Chief Executive Officer of Nanochon. “This milestone marks an important step forward for Nanochon as we continue generating the clinical evidence required to support a future Level 1 pivotal study.”
“The procedure is bone-sparing, minimally invasive, and streamlined, and the dedicated instrumentation set made the procedure simple and efficient,” stated Dr. Tufiño.
The prospective FIH study will enroll patients between the ages of 22 and 60 who have failed conservative treatment options and present with one or two femoral condyle and/or trochlear cartilage lesions.
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.
“Developing a solution that enables the body to regenerate durable cartilage with the strength and function of native tissue has long been considered one of the holy grails of orthopedic medicine,” said R. Sean Churchill, MD, MBA, Managing Director of cultivate(MD).
“Nanochon’s preclinical work has demonstrated highly encouraging results, and we are excited to see this technology now being evaluated in human patients.”
Chondrograft™ is designed to provide immediate mechanical support, be minimally invasive, and a “burn-no-bridges” solution for “pre-replacement” patients — those with cartilage damage who need more than temporary relief but aren’t yet candidates for joint replacement.
“Our vision is to fundamentally change the treatment paradigm for cartilage injuries and potentially delay or eliminate the need for revision surgery and knee replacement procedures in younger patients,” said Nathan Castro, Co-Founder and Chief Technology Officer of Nanochon. “We believe Chondrograft™ has the potential to provide physicians with a simpler, more effective approach to cartilage treatment.”
Following completion of the FIH study, Nanochon plans to initiate a Level 1 multi-center, randomized, controlled, pivotal clinical trial.
About Nanochon
Nanochon, Inc. is a medical device company developing innovative solutions for cartilage repair in patients who are not yet candidates for joint replacement. The company’s lead technology, Chondrograft™, is designed to address focal cartilage defects through a minimally invasive regenerative approach. Nanochon has received Breakthrough Device Designation from the U.S. Food and Drug Administration.
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