Research: No Complications With OssDsign Cranioplasty Solution

Independent clinical research supports positive treatment outcomes with OssDsign AB’s patient-specific cranial implant. 

The New York, N.Y.-based team led by Ralph Rahme, M.D., published its clinical findings, describing treatment outcomes with OssDsign PSI in the largest U.S. cohort to date. The study of 18 patients who underwent cranioplasty showed the procedure was successful in all cases, and that no implant-related complications occurred during a six-month median follow-up period. The clinical paper is published in World Neurosurgery.

“We are excited by the uplifting data presented by Dr. Rahme and his clinical research team. The results from the largest U.S. case series to date point toward the uniqueness of our osseointegrative technology and add to a growing body of evidence and publications in peer-reviewed journals highlighting the low complication rates seen with the use of OssDsign Cranial PSI,” CEO Morten Henneveld said.
 
OssDsign Cranial PSI is a patient-specific cranial implant that—built on OssDsign’s material science—reduces the risk of infection and implant failure in treating cranial bone defects. 
 
The scientific paper reports results from a single-center, retrospective study—“Skull reconstruction using a custom-made, 3D-printed, hydroxyapatite-titanium cranioplasty implant: largest single-center U.S. experience”—which evaluated treatment outcomes in 18 patients who received OssDsign Cranial PSI following extensive craniectomy due to traumatic brain injury, hemorrhagic stroke, or ischemic stroke, between February 2019 and February 2022. The evaluation indicated that cranioplasty was successful in all patients and that only minor postoperative complications—all unrelated to the implant—occurred in three patients. At a median six-month follow-up period (one to 38 months), no patients suffered implant-related complications such as reoperation or explantation due to infection. Furthermore, the cosmetic result was rated good to excellent in all of the patients. 
 
“In our single-center evaluation of OssDsign Cranial PSI, our preliminary findings indicate that the use of this implant is associated with favorable results, including a 0% rate of implant-related complications and good-to-excellent cosmetic outcomes in all patients. Those results are well in line with previous studies, lending further support for the routine use of this implant in clinical practice,” said Rahme, the primary study investigator, Division of Neurosurgery at SBH Health System, New York, N.Y.
 
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 improve the clinical outcome in various orthopedic areas. Its product portfolio consists of patient-specific implants for cranial surgeries and an off-the-shelf synthetic bone graft for spine surgeries. The company has a strong commercial presence in the United States, Europe, and selected Asian countries. OssDsign’s share is traded on Nasdaq First North Growth Market in Stockholm, Sweden.