Michael Barbella, Managing Editor07.11.22
OssDsign AB's spinal fusion study is officially underway.
The Swiss company has finished enrolling patients in its TOP FUSION trial and will conduct follow-ups over 24 months. The trial will primarily evaluate the safety and efficacy of OssDsign Catalyst in patients undergoing spinal fusion surgery. The study’s primary endpoint will be assessed by the rate of bone fusion as well as a lack of device-related adverse events.
“We are very pleased to have completed the enrollment in this clinical trial and delivered on yet another major milestone. As TOP FUSION will provide key clinical data going forward, it is an important achievement in our aim to establish OssDsign Catalyst on the global market,” CEO Morten Henneveld said.
The study is led by Dr. Péter Pál Varga and Dr. Àron Lazary at the National Center for Spinal Disorders at the Buda Health Clinic in Budapest, Hungary, the only hospital in the country that treats the entire spectrum of spine disorders.
OssDsign Catalyst is a synthetic bone graft based on a patented nanocrystalline solution that stimulates the formation of healthy bone. The product received U.S. Food and Drug Administration clearance in 2020 and debuted on the U.S. market in August 2021.
OssDsign develops and provides next-generation bone replacement products. Based on cutting-edge material science, the company develops and markets products that support the body’s own healing capabilities and thereby improve the clinical outcome in a wide range of orthopedic areas with high medical needs. With a product portfolio consisting of patient-specific implants for cranial surgeries and an off-the-shelf synthetic bone graft for spine surgeries, OssDsign has a strong commercial presence in the United States, Europe, and selected Asian countries.
The Swiss company has finished enrolling patients in its TOP FUSION trial and will conduct follow-ups over 24 months. The trial will primarily evaluate the safety and efficacy of OssDsign Catalyst in patients undergoing spinal fusion surgery. The study’s primary endpoint will be assessed by the rate of bone fusion as well as a lack of device-related adverse events.
“We are very pleased to have completed the enrollment in this clinical trial and delivered on yet another major milestone. As TOP FUSION will provide key clinical data going forward, it is an important achievement in our aim to establish OssDsign Catalyst on the global market,” CEO Morten Henneveld said.
The study is led by Dr. Péter Pál Varga and Dr. Àron Lazary at the National Center for Spinal Disorders at the Buda Health Clinic in Budapest, Hungary, the only hospital in the country that treats the entire spectrum of spine disorders.
OssDsign Catalyst is a synthetic bone graft based on a patented nanocrystalline solution that stimulates the formation of healthy bone. The product received U.S. Food and Drug Administration clearance in 2020 and debuted on the U.S. market in August 2021.
OssDsign develops and provides next-generation bone replacement products. Based on cutting-edge material science, the company develops and markets products that support the body’s own healing capabilities and thereby improve the clinical outcome in a wide range of orthopedic areas with high medical needs. With a product portfolio consisting of patient-specific implants for cranial surgeries and an off-the-shelf synthetic bone graft for spine surgeries, OssDsign has a strong commercial presence in the United States, Europe, and selected Asian countries.