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Nanochon was granted Health Canada Approval for their first in human clinical trial.
Nanochon describes its Chondrograft system as “a sturdy medical advancement that is one part orthopedic load-bearing implant, one part tissue growth scaffold and completely revolutionary.” The company is focused on developing a nylon-based 3D-printed implant that easily integrates into a surgeon’s workflow without adding steps like cell seeding.
Nanochon Chondrograft is being evaluated in a prospective, 10-patient, early feasibility study for use in knee cartilage restoration in eligible patients between 22 and 60 years of age having femoral condyle and/or trochlea articular cartilage lesions who have failed conservative therapy, in addition to meeting other criteria. The study is designed to assess the safety and performance of Chondrograft, and procedural goals include regrowth of the cartilage-bone matrix, improvement in knee function and pain, and delayed need for arthroplasty.
Principal Investigator, Dr. Fathi Abuzgaya, will collaborate with Sports Medicine Specialists Drs. Joel Lobo, Kajeandra Ravichandiran and Marcin Kowalczuk as Sub-Investigators, at the Durham Bone & Joint Specialists (DBJS), located in Ontario, Canada.
“Achieving Health Canada approval allows us to gain the clinical data needed to take a giant step forward towards design and execution of a large pivotal North American study,” said Ben Holmes, CEO of Nanochon. “We have the utmost confidence in Dr. Abuzgaya and his clinical team
to help us recruit the right patients and execute the trial protocol that we have so carefully designed.”
While the first in human trial will take place in Canada, this represents just the first step towards a larger clinical program.
Source: The LaunchPort
Nanochon was granted Health Canada Approval for their first in human clinical trial.
Nanochon describes its Chondrograft system as “a sturdy medical advancement that is one part orthopedic load-bearing implant, one part tissue growth scaffold and completely revolutionary.” The company is focused on developing a nylon-based 3D-printed...
Nanochon was granted Health Canada Approval for their first in human clinical trial.
Nanochon describes its Chondrograft system as “a sturdy medical advancement that is one part orthopedic load-bearing implant, one part tissue growth scaffold and completely revolutionary.” The company is focused on developing a nylon-based 3D-printed implant that easily integrates into a surgeon’s workflow without adding steps like cell seeding.
Nanochon Chondrograft is being evaluated in a prospective, 10-patient, early feasibility study for use in knee cartilage restoration in eligible patients between 22 and 60 years of age having femoral condyle and/or trochlea articular cartilage lesions who have failed conservative therapy, in addition to meeting other criteria. The study is designed to assess the safety and performance of Chondrograft, and procedural goals include regrowth of the cartilage-bone matrix, improvement in knee function and pain, and delayed need for arthroplasty.
Principal Investigator, Dr. Fathi Abuzgaya, will collaborate with Sports Medicine Specialists Drs. Joel Lobo, Kajeandra Ravichandiran and Marcin Kowalczuk as Sub-Investigators, at the Durham Bone & Joint Specialists (DBJS), located in Ontario, Canada.
“Achieving Health Canada approval allows us to gain the clinical data needed to take a giant step forward towards design and execution of a large pivotal North American study,” said Ben Holmes, CEO of Nanochon. “We have the utmost confidence in Dr. Abuzgaya and his clinical team
to help us recruit the right patients and execute the trial protocol that we have so carefully designed.”
While the first in human trial will take place in Canada, this represents just the first step towards a larger clinical program.
Source: The LaunchPort
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JV
Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.
