OssDsign’s clinical study TOP FUSION is now fully enrolled

Uppsala, April 25, 2022. OssDsign AB (publ.) today announces that the company’s clinical study TOP FUSION is fully enrolled and patient follow-up will continue to run 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,” says Morten Henneveld, CEO, OssDsign.

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 FDA clearance in 2020 and was launched on the U.S. market in August 2021.

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 is a developer and global provider of 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 give back patients the life they deserve. The company has a strong commercial presence in the U.S., Europe and selected Asian countries. OssDsign’s share is traded on Nasdaq First North Growth Market in Stockholm, Sweden.

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