Nanochon announces Health Canada approval for first human study
Nanochon, a Washington, DC, and Baltimore, MD-based orthopedic device biotechnology company developing implants to treat knee cartilage defects, is pleased to announce that it has been granted Health Canada approval for its first-in-human clinical trial.
The study will be led by principal investigator Dr. Fathi Abuzgaya, who will collaborate with sports medicine specialists Dr. Joel Lobo, Dr. Kajeandra Ravichandriran and Dr. Marcin Kowalczuk as additional investigators at Durham Bone & Joint Specialists (DBJS), an orthopedic clinic in Ontario, Canada. Dr. Fathi Abuzgaya is an orthopedic surgeon and respected scientist with a track record of success over the past 25 years, having led over 600 clinical trials across all phases and therapeutic areas.
Our team is excited to be the first center to enroll participants in the Chondrograft™ trial, a novel, minimally invasive treatment for patients who have lost or damaged knee cartilage,” commented Dr. Abuzgaya. “DBJS is a multidisciplinary musculoskeletal center that provides non-surgical and surgical services and is staffed by specialists with diverse subspecialties. Our research site, staffed by dedicated investigators, allows us to better and more effectively recruit patients for clinical trials, and we are honored to support Nanochon.
The Nanochon Chondrograft™ System is being evaluated in a prospective early feasibility study of 10 patients for the reconstruction of knee cartilage in eligible patients aged 22 to 60 years with patellar and/or patellar cartilage lesions who have failed conservative treatment. The study is designed to evaluate the safety and efficacy of Chondrograft™, with the goals of the procedure being cartilage and bone matrix regeneration, improved knee function and pain reduction, and delayed need for arthroplasty.
With Health Canada approval, we can now obtain the clinical data we need to take a major step forward in planning and conducting a large pivotal North American trial,” said Ben Holmes, CEO of Nanochon. “We have great confidence in Dr. Abuzgaya and his clinical team at DBJS to help us recruit the right patients and execute the study protocol we have so carefully designed.
Although the first human trials are being conducted in Canada, this is only the first step towards a larger clinical program.
“Thousands of patients with chondral defects that can progress to osteoarthritis live a reduced quality of life. We are excited about this new treatment option and are excited to launch the Chondrograft™ trial at DBJS,” said Dr. Joel Lobo. “The results of this trial could open up a new minimally invasive surgical option to address this unmet need.”
HN Clinical Consulting (Missouri) assisted Nanochon throughout the clinical trial planning and regulatory approval process. “Improving the lives of young adults and athletes by providing a knee cartilage repair solution that we hope will help patients avoid costly knee replacements is a much-needed therapy in the orthopedic world,” said Heather Neill, Founder and Director. “We appreciate Health Canada’s thought-provoking questions throughout their review – this helped us to submit the best possible application that was ultimately approved.” HN Clinical Consulting will continue to support the entire Chondrograft™ lifecycle.
Apie „HN Clinical Consulting“
HN Clinical Consulting, LLC takes a strategic approach to each project while maintaining a goal of commercialization. Building strong relationships with all stakeholders and maintaining a clinical strategic goal of project-driven success to support the long-term strategy of sponsors or exit is a key requirement for developing clinical programs. The goal is to stay ahead of the curve when developing a clinical research plan by planning for participation in specialized forums, publishing, and providing for reimbursement.
Apie „Nanochon“
Nanochon is a biotechnology and medical device company focused on developing innovative orthopedic solutions. Chondrograft™ is a minimally invasive 3D printed implant that has demonstrated immediate weight-bearing and mobility in preclinical studies. The implant is based on research conducted at the Tissue Engineering and Nanotechnology Laboratory at George Washington University and is designed to integrate into healthy tissue over time, providing maximum stability and patient benefit. Nanochon can provide more successful and longer-lasting patient recovery compared to current standards of care. Our mission is to develop a new approach to treating cartilage defects so that hundreds of thousands of young, active patients with joint damage can return to their normal lifestyles without costly and invasive short-term measures.
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