A post-market clinical study has demonstrated that dental implant treatment with guided bone regeneration utilising the Striate+™ dental membrane of Orthocell Ltd (ASX:OCC, OTC:ORHHF) resulted in an “outstanding” 98.6% success rate.
Striate+™ is a market-leading resorbable collagen membrane used in guided bone and tissue regeneration procedures.
Orthocell points to the study’s “compelling real-world evidence” as confirmation that its dental membrane product, Striate+™, is the optimal medical device for all types of guided bone regeneration and dental implant procedures.
“Striate+ is a best-in-class dental membrane that facilitates the highest quality bone and tissue repair. Predictable and high-quality bone regeneration is of utmost importance to deliver functional and aesthetically pleasing outcomes for patients. We are delighted to share this compelling real-world data,” said chief investigator and dental surgeon Professor Giuseppe Luongo.
A significant market opportunity
Importantly, these study results will raise the profile of Striate+ with new and existing dental surgeons and greatly assist Orthocell’s exclusive global distributor, BioHorizons, in growing product adoption.
This is significant as the addressable market for the Striate+ product is estimated to be worth more than US$700 million per annum, in which Orthocell is already growing its revenue.
More on the Striate+ Study
The Striate+ Study aimed to further investigate the effect of the Striate+ collagen membrane on patient-related systemic factors as well as implant and procedure-related factors of peri-implant Marginal Bone Level (MBL) following GBR and implant placement.
Data were obtained from 99 patients receiving at least one dental implant and GBR procedure using Striate+ dental membrane. The result displayed that a desirable level of bone formation and stability was achieved in all areas, demonstrated by the high rate of treatment success.
Results of the study have been submitted for presentation at the upcoming European Association for Osseintegration (EAO) annual meeting in October 2024.
The results follow a successful collaboration between Professor Giuseppe Luongo at the Department of Neuroscience and Reproductive and Odontostomatological Science, University of Naples Federico II, Naples, Italy and Professor Minghao Zheng at the UWA Medical School, University of Western Australia.
The Striate+ Study followed on from the Post-Market Clinical Follow-up (PMCF) study, a key component of the clinical data package for re-certification of EU market approval under the new European Medical Device Regulations (MDR).