OssDsign AB: New clinical data from 1,055 cranioplasty procedures with OssDsign Cranial PSI continue to show low complication rates

Reconstruction of cranial defects can be a complex surgical procedure associated with an underestimated morbidity. This post-market surveillance report describes the outcome of 1,055 cranioplasties and cranial reconstructions using OssDsign Cranial PSI, a patient-specific implant made from a calcium phosphate material reinforced with 3D-printed titanium. All data were collected as part of post-market surveillance of product performance in Europe, US and selected Asian markets in compliance with MEDDEV 2.7/1 rev.4 and MDR 2017/745.

One of the most common causes of explantation of implants are early post-operative infections. In the medical literature, explantation rates due to infection is often seen to reach above 10%. The OssDsign post-market-surveillance data however shows that at a median follow up time of 21 months (range, 0-70 months) only 22 (2.1%) of the implants were explanted due to early postoperative infections.  A peer-reviewed clinical study of OssDsign Cranial reported similarly low rates of infections leading to implant removal (1.9%), as has previously reported post-market surveillance data. 

Histological analysis of several implants explanted ≥ 9 months following surgery revealed bony integration between the implant and the native bone, as well as new bone formation within and around the remaining calcium phosphate material. The capacity of OssDsign’s material to remodel into living bone tissue has been documented in previous peer-reviewed scientific literature as well. 

”We are extremely proud of this unique data that covers more than 1,000 implantations in a true multi-center setting” says Morten Henneveld, CEO of OssDsign. ”We have now consistently been able to present low levels of complications over several years in a growing cohort, and we can safely say that this data now sets the industry standard when it comes to implants for cranial reconstruction”.

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 is a Swedish medical technology company that develops and manufactures regenerative implant solutions for bone and tissue restoration. Providing neuro- and plastic surgeons with innovative solutions, OssDsign improves the outcome for patients worldwide. By combining clinical knowledge with proprietary technology, OssDsign works closely with surgeons to provide patients with personalized bone tissue restoration solutions. OssDsign’s technology is the result of collaboration between clinical researchers at Karolinska University Hospital in Stockholm and material scientists at the Ångström Laboratory at Uppsala University. OssDsign recently expanded its operations into the orthobiologic space via the acquisition of Scotland based Sirakoss Ltd.