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OssDsign

OssDsign

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OssDsign AB: OssDsign receives approval to establish a clinical registry in the U.S. to collect real-world data on OssDsign Catalyst

14:50 / 13 January 2022 OssDsign Press release

Uppsala, January 13th, 2022. OssDsign AB (publ.) today announces that the Western Institutional Review Board (WIRB), one of the largest institutional research review organizations in the U.S., has approved the company's application to establish PROPEL, a multi-centre, prospective spinal fusion registry, providing opportunity to study real-world data from patients who have been treated with OssDsign Catalyst.

OssDsign Catalyst received FDA clearance in 2020 and was launched in the U.S. in August 2021. During 2022, clinics will gradually be enrolled to the registry, with the objective to evaluate the use and outcome of OssDsign Catalyst in a real-world clinical practice. The primary endpoint of the study will be measuring the rate of spinal fusion, using computer tomography (CT) or radiography, 12 months postoperatively. Additionally, patients' quality of life and neurological function, as well as the clinical safety profile of the spinal implant will be recorded.

"The registry represents one of the core pillars in our long-term strategy and I am pleased that we continue to deliver on the strategic plan. Robust clinical data is key to establish our products on the market and PROPEL allows us to collect clinical data on large numbers of patients, receiving care in diverse clinical settings, among U.S. surgeons," comments Morten Henneveld, CEO of OssDsign.

PROPEL will play an important role in bridging the gap between the device performance in clinical trials and their use in routine practice over time. The registry is the latest step in OssDsign's strategy to collect clinical evidence of its synthetic bone graft OssDsign Catalyst. Concurrently, the company's clinical study TOP FUSION, evaluating the long-term safety and efficacy of OssDsign Catalyst in patients, is continuing to enroll subjects in Hungary.

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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