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Sparta Biomedical has successfully implanted its Ormi device in patients with focal knee lesions as part of its first-in-human clinical trial. The ongoing prospective, multi-center, single-arm study is being conducted at sites in the Dominican Republic and Colombia, where patients have already been enrolled and treated.
The first-in-human study is assessing the safety of Ormi in patients experiencing knee pain due to the loss of articular cartilage in the femoral condyle. The device’s design allows surgeons to address cartilage damage with or without involvement of the underlying bone. Following implantation, study investigators will monitor patients closely using imaging, physical exams and patient-reported outcome measures.
The Ormi device leverages Sparta Biomedical’s Galene platform, a novel synthetic cartilage that closely replicates the properties of native hyaline cartilage. Ormi integrates Galene with a proprietary titanium stemmed base to ensure secure fixation during the repair of cartilage lesions.
Sparta’s technology received FDA’s Breakthrough Device Designation in 2021.
“Helping patients with knee focal lesions restore mobility and reduce pain quickly has been a long-standing issue. Our goal is to provide orthopedic surgeons with a simple, highly effective solution that is not dependent on patient biology. No approved device today has Ormi’s features. The reality is focal lesions in the knee affect the lives of hundreds of millions worldwide, and surgeons, depending on geography, have few to no solutions to treat their patients. We are excited to be one step closer to showcasing Ormi’s clinical benefits and helping clinicians get their patients feeling better soon,” said Dushyanth Surakanti, Co-Founder & CEO.
Source: Sparta Biomedical
Sparta Biomedical has successfully implanted its Ormi device in patients with focal knee lesions as part of its first-in-human clinical trial. The ongoing prospective, multi-center, single-arm study is being conducted at sites in the Dominican Republic and Colombia, where patients have already been enrolled and treated.
The first-in-human...
Sparta Biomedical has successfully implanted its Ormi device in patients with focal knee lesions as part of its first-in-human clinical trial. The ongoing prospective, multi-center, single-arm study is being conducted at sites in the Dominican Republic and Colombia, where patients have already been enrolled and treated.
The first-in-human study is assessing the safety of Ormi in patients experiencing knee pain due to the loss of articular cartilage in the femoral condyle. The device’s design allows surgeons to address cartilage damage with or without involvement of the underlying bone. Following implantation, study investigators will monitor patients closely using imaging, physical exams and patient-reported outcome measures.
The Ormi device leverages Sparta Biomedical’s Galene platform, a novel synthetic cartilage that closely replicates the properties of native hyaline cartilage. Ormi integrates Galene with a proprietary titanium stemmed base to ensure secure fixation during the repair of cartilage lesions.
Sparta’s technology received FDA’s Breakthrough Device Designation in 2021.
“Helping patients with knee focal lesions restore mobility and reduce pain quickly has been a long-standing issue. Our goal is to provide orthopedic surgeons with a simple, highly effective solution that is not dependent on patient biology. No approved device today has Ormi’s features. The reality is focal lesions in the knee affect the lives of hundreds of millions worldwide, and surgeons, depending on geography, have few to no solutions to treat their patients. We are excited to be one step closer to showcasing Ormi’s clinical benefits and helping clinicians get their patients feeling better soon,” said Dushyanth Surakanti, Co-Founder & CEO.
Source: Sparta Biomedical
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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.
