BALTIMORE, Aug. 14, 2026 /PRNewswire/ -- 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.
Nanochon Receives Regulatory Approval from Panamá's Ministry of Health to Initiate First-in-Human Clinical Study of Chondrograft™
2 min read Premium comments
#kneeNanochonChondrograftarticular cartilage defectsPanamaClinical study
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.
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.
Media Contact:
Rachel Offenburg
Chief of Strategy
Rachel.offenburg@nanochon.com
View original content to download multimedia:https://www.prnewswire.com/news-releases/nanochon-receives-regulatory-approval-from-panamas-ministry-of-health-to-initiate-first-in-human-clinical-study-of-chondrograft-302851955.html
SOURCE Nanochon
Author
TH
TJ Halvorson
The De Angelis Group | Orthopedics This Week | MSK Innovations
Why This Matters
Two Perspectives
MBA Lens: Economic and industry impact
Nanochon secured regulatory approval from Panama's Ministry of Health for its First-in-Human clinical study of Chondrograft™, a significant step in its market entry strategy for articular cartilage defect treatment. This approval, alongside Health Canada authorization, leverages efficient regulatory pathways in Panama, a strategic destination for medical innovation. The study aims to validate the device for future larger trials and market penetration, supported by its U.S. FDA Breakthrough Device Designation.
- Panama and Canada approvals mark key regulatory milestones, enabling initial market access and clinical data generation for future commercialization.
- Chondrograft™'s "burn-no-bridges" design and Breakthrough Device status position it competitively in the challenging cartilage repair market.
PhD Lens: Clinical and outcomes impact
Nanochon's Chondrograft™ implant, designed for focal articular cartilage defects, has received regulatory approval in Panama for its First-in-Human clinical study. This prospective trial will evaluate the safety and performance of the minimally invasive device, which aims to provide immediate mechanical support and promote long-term cartilage regeneration. The study targets patients aged 22-60 with specific femoral condyle and/or trochlear lesions who have failed conservative treatment.
- Chondrograft™ is a minimally invasive implant providing immediate mechanical support and promoting long-term cartilage regeneration.
- The FIH study in Panama will assess safety and performance in patients (22-60 years) with focal chondral defects who failed conservative treatment.
React:
Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
Join the conversation
Orthopedic professionals are discussing this. Sign in and upgrade to read every comment and add your voice.