Updated clinical data from 1,055 cranioplasty procedures 8-11% infection risk with competing implant technologies Important data points to promote further uptake Impressive updated post-market surveillance data OssDsign announced updated post-market surveillance data for its lead product – the cranial implant OssDsign Cranial PSI for 1,055 procedures (previously 670 procedures). At a median follow up time of 21 months (range, 0-70 months) 44 implants (4. 2%) have been explanted, i. e.
surgically removed due to complications. Only 2. 1% of the implants were explanted due to infections, which is a slight improvement from the previously reported 2.
4%. Furthermore, since most postoperative infections occur within 1-3 months, the majority of all patients (median follow-up time 21m) should be safe from such explantations going forward. Roughly 77% of the OssDsign Cranial implants were ordered by University hospitals with a high-level trauma unit, usually a sign of a new and groundbreaking technology being implemented.
Importantly, this constantly growing data set comes from 181 different hospitals across Europe, Asia and the US, showing that the outcomes are reproducible across different hospitals and countries. 2. 1% explantations due to infections is best-in-class As illustrated below, infection risk across competing materials for cranioplasty typically ranges between 8-11%.
Hence, it is one of the most common reasons for implant removal. These complications represent a significant economic burden. For example, the cost for managing a case of infection can cost ~USD 100K in the US.
This cost usually needs to be covered by the hospital’s budget, as most infections occur within the first three months after surgery, a period in which the hospital does not receive reimbursement from the insurers for corrective surgery. Important selling points for reimbursement and uptake We believe this is an important data point in terms of improving reimbursement and clinical up.
