OssDsign AB (publ) today announced that the first patient has been included in the company’s clinical study TOP FUSION to investigate the long-term safety and efficacy of OssDsign Catalyst in patients undergoing spinal fusion surgery. The study will be conducted at the National Center for Spinal Disorders under the leadership of Dr Péter Pál Varga and Dr Áron Lazary.
OssDsign Catalyst is a market cleared synthetic bone graft based on a patented nanocrystalline solution that stimulates the formation of healthy bone tissue. Data from a recently published pre-clinical study show that OssDsign Catalyst induced rapid and reliable bone formation and that successful fusion was achieved in all subjects included in the treatment group. The product received market clearance from the Food and Drug Administration (FDA) in 2020 and was recently launched in the U.S. The initiation of TOP FUSION together with world-renowned experts in spinal surgery is an important step in OssDsign’s efforts to establish OssDsign Catalyst on the global market.
The clinical study will run over 24 months and include 17 patients suffering from degenerative disc disease, degenerative spondylolisthesis or lumbar spinal stenosis. TOP FUSION will primarily evaluate the safety and efficacy of OssDsign Catalyst in patients undergoing spinal fusion surgery. The study’s primary endpoints will be assessed by the rate of bone fusion as well as device-related adverse events within the study time period.
The study is led by Dr Péter Pál Varga and Dr Áron Lazary, who are internationally renowned clinicians and researchers in spinal surgery at the National Center for Spinal Disorders at the Buda Health Clinic in Budapest, Hungary. Dr Varga is the founder of the National Center for Spinal Disorders, the only hospital in the country that treats the entire spectrum of spine disorders. Over 2,500 surgeries are performed annually.
”We are glad to take the next important step in the clinical development of OssDsign Catalyst which has previously shown a promising effect in spinal fusion. We look forward to working closely with Dr Varga and Dr Lazary, two of the world’s foremost experts in spinal surgery, who will lead TOP FUSION. The initiation of TOP FUSION is an important milestone in our clinical research efforts. We are committed to gather meaningful clinical data and in doing so continually take steps to deliver on our 2025 strategy,” says Morten Henneveld, CEO, OssDsign.
For further information, please contact:
Morten Henneveld, CEO, OssDsign AB
Tel: +46 73 382 43 90, email: morten.henneveld@ossdsign.com
Certified Adviser:
Erik Penser Bank AB is the company’s Certified Adviser. Contact information: Erik Penser Bank AB, Box 7405, 103 91 Stockholm, Sweden, phone: +46 (0)8-463 80 00, email: certifiedadviser@penser.se.
About OssDsign
OssDsign’s vision is to provide regenerative solutions to all patients with cranial or spinal bone defects, so they can b e restored and healed as naturally as possible. Driven by a commitment to give patients back the lives they deserve, OssDsign collaborates with surgeons to engineer better healing by integrating biomaterials with clinical design. Headquartered in Sweden, OssDsign supplies hospitals worldwide with implants for use in cranial reconstructions and other orthopaedic surgery applications.
