Michael Barbella, Managing Editor04.25.22
OssDsign AB's spinal fusion registry is underway.
The company is in the early stages of establishing a multi-centre, prospective spinal fusion registry (PROPEL) that will evaluate real-world data from patients treated with OssDsign Catalyst. Following the principles of synthetic developmental engineering, the nanosynthetic bone graft putty OssDsign Catalyst is designed to engage dual bone formation pathways resulting in rapid, controlled bone formation at early time points. 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 100 percent of the studied subjects at 26 weeks, compared to 60 percent in the group where a comparable market-cleared device was used.
A bone graft putty, OssDsign Catalyst received U.S. Food and Drug Administration (FDA) clearance in 2020 and was launched in the United States in August 2021. This year, 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," commented 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.
OssDsign further expanded into the spinal bone graft market with the November 2020 acquisition of privately held Scottish bone graft specialist company Sirakoss Ltd.. The deal broadened OssDsign's product portfolio with OssDsign Catalyst and FDA 510 (k) cleared next-generation nanosynthetic bone graft substitutes that stimulats the formation of healthy bone tissue.
OssDsign develops next-generation bone replacement products. Based on 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. 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.
The company is in the early stages of establishing a multi-centre, prospective spinal fusion registry (PROPEL) that will evaluate real-world data from patients treated with OssDsign Catalyst. Following the principles of synthetic developmental engineering, the nanosynthetic bone graft putty OssDsign Catalyst is designed to engage dual bone formation pathways resulting in rapid, controlled bone formation at early time points. 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 100 percent of the studied subjects at 26 weeks, compared to 60 percent in the group where a comparable market-cleared device was used.
A bone graft putty, OssDsign Catalyst received U.S. Food and Drug Administration (FDA) clearance in 2020 and was launched in the United States in August 2021. This year, 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," commented 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.
OssDsign further expanded into the spinal bone graft market with the November 2020 acquisition of privately held Scottish bone graft specialist company Sirakoss Ltd.. The deal broadened OssDsign's product portfolio with OssDsign Catalyst and FDA 510 (k) cleared next-generation nanosynthetic bone graft substitutes that stimulats the formation of healthy bone tissue.
OssDsign develops next-generation bone replacement products. Based on 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. 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.