Bonesupport Holding AB (STO:BONEX), a Swedish company that specialises in orthobiologics for the management of bone voids, announced on Wednesday that the patient enrolment schedule for the ongoing FORTIFY study has been extended.
Based on updated data regarding patient enrolment to the study, Bonesupport has concluded that the patient recruitment phase will be extended by six to nine months. Patient follow-up is 12 months and the FDA registration application is hence estimated to take place in late 2021.
According to the company, providing strong clinical evidence in support of its core technology, CERAMENT, is one of the cornerstones of its strategy. The FORTIFY study was initiated in 2017 with the purpose to evaluate the safety and efficacy of CERAMENT G as a part of surgical repair of open diaphyseal tibial fractures versus standard of care.
The results of this study are intended to support the FDA Pre-Market Approval (PMA) application for CERAMENT G in the US.
This study is designed to include up to 230 patients at clinics in the US and Europe and, like other trauma studies, the enrolment rate is difficult to predict.
Previously, the company had announced that it expected the patient recruitment to be completed by the end of 2019, followed by a PMA application to the FDA at the end of 2020.
Bonesupport develops and commercialises innovative injectable bio-ceramic bone graft substitutes that remodel to the patient's own bone and have the capability of eluting drugs.
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