OssDsign reports successful outcome at 6-month follow-up of clinical study on sinus augmentation
OssDsign AB (publ) today announced positive interim results from a clinical study titled: “Safety and performance of granular calcium phosphate in augmentation of the maxillary sinus floor”. This study represents the first use of OssDsign’s proprietary calcium phosphate material in the oral cavity.
As previously communicated, OssDsign has been sponsoring a clinical investigation of the safety and performance of the company’s proprietary calcium phosphate material to support bone growth in augmentation of the maxillary sinus floor. This open evaluation study is being performed on 20 consecutive patients at Akademiska University Hospital in Uppsala, Sweden, under the responsibility of principal investigator Professor Andreas Thor. Interim data from the study’s 6-month follow-up time point now show that implantation of the calcium phosphate material resulted in bone formation and firm anchoring of dental implants.
Professor Thor says: “The granular calcium phosphate material was easy to work with and provided the desired outcome. The rate of material resorption allowed a balanced bone replacement process to take place. While a number of the study patients suffered from severe bone loss prior to treatment and presented real challenges from a bone regeneration point-of-view, no loss of any dental implant has been observed. It will be very interesting to follow these patients further.”
OssDsign’s patented material has been successfully used in craniofacial applications in more than 1000 patients. The present study represents the first clinical use of the granular formulation of the material and also the first use by a new potential customer group representing the oral and dental implant market.
“These results show that our regenerative material can be applied in more ways, shapes and forms than we currently have available, and it opens up for addressing new clinical indications” says Henrik Hjort, Director of Marketing and Business Development at OssDsign. “This demonstrates that OssDsign, as a bone regeneration company, has the potential to target a new market segment. With this data at hand we can seriously start to plan how to address more markets in need of bone regenerative implant technologies.”
The global market for dental membranes and bone graft substitutes was valued at $ 620 million in 2018 according to a recent report by Transparency Market Research.
The goal of a sinus augmentation procedure is to create bone in the maxillary sinus so that a dental implant can be placed following tooth loss. Graft material from different sources has been used but bone mineral from bovine sources is the most widely used material today.
The details of the outcome of the study will be presented and published in a peer-reviewed medical journal in due course.
For further information, please contact:
Anders Lundqvist, CEO, OssDsign AB
Tel: +46 73 206 98 08, email: al@ossdsign.com
Certified Adviser
The Company’s Certified Adviser is Erik Penser Bank AB. 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 implants for improved healing of bone defects. Providing neuro and plastic surgeons with innovative implants, OssDsign improves the outcome for patients with severe cranial and facial defects worldwide. By combining clinical knowledge with proprietary technology, OssDsign manufactures and sells a growing range of patient-specific solutions for treating cranial defects and facial reconstruction. 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.
This information is information that OssDsign AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication through the agency of the contact person set out above, at 11:00 CET on August 21st, 2020
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