New preclinical data shows that OssDsign’s innovative synthetic bone graft outperforms a comparable device in bone formation following spinal fusion surgery
OssDsign AB (publ) (“OssDsign” or the “Company”) today announced that the recently aquired orthobiological product OssDsign Catalyst (previously named Osteo3 ZP Putty) has been evaluated in a preclinical study examining bone formation and function following spinal fusion surgery. The results show that OssDsign Catalyst induced rapid and reliable bone formation and that successful fusion was achieved in 100% of the studied subjects at 26 weeks, compared to 60% in the group where a comparable market-cleared device was used.
OssDsign develops patient-specific regenerative implants aimed at restoring cranial bone defects. Following the recent acquisition of Sirakoss Ltd, OssDsign widened its’ product portfolio with innovative orthobiologic solutions, including the synthetic bone graft now named OssDsign Catalyst. This innovative product is based on a unique nanocrystalline structure and chemistry, designed to stimulate the formation of healthy bone tissue. Initially, OssDsign Catalyst is being developed for spinal fusion surgeries, a market valued at USD 2.6 billion in 2021. Today, up to 35 percent of patients treated with spinal fusion do not achieve the desired clinical effect, hence there is a substantial need for new innovative products that can improve healing and bone formation and thereby improve the clinical outcome.
In the recently published study, researchers used a validated and widely recognized challenging preclinical fusion model to evaluate OssDsign Catalyst’s efficacy in healing bone tissue following spinal fusion surgery. The researchers compared the use of an autograft (the subject’s own bone tissue) to the use of OssDsign Catalyst in combination with an autograft, and to a predicate device in combination with an autograft. To evaluate the success rate, measurements and biochemical tissue analyses were conducted at four timepoints, 6, 9, 12 or 26 weeks, following spinal fusion intervention. After 26 weeks, the OssDsign Catalyst group exhibited a 100% success rate in the spinal fusion by all measures, whereas the predicate device group showed 60% success rate. Furthermore, tissue analyses at 26 weeks showed consistent bone formation in the OssDsign Catalyst group, whereas this was not observed in the predicate device group.
In summary, the study showed that OssDsign Catalyst in combination with an autograft, achieved superior fusion and healing in comparison to a market-approved device. These preclinical data add to the current scientific foundation of OssDsign Catalyst and substantiates further development efforts of the platform.
“We are very pleased that OssDsign’s newly acquired state-of-the-art orthobiologic product shows a high efficacy rate in the research study, and receives interest from the international scientific community. Our recent strategic acquisition has put us a in favorable position by broadening our portfolio with yet another highly innovative solution to help treat patients who have suffered from debilitating injuries and conditions,” comments Morten Henneveld, CEO, OssDsign AB.
To read the study in its entirety, please follow the link: a link to the study
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 be 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.
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