- OSSIX® VOLUMAX is now commercially available in the US and Korea
- Data presented at the AAP 2016 shows OSSIX® VOLUMAX has the potential to augment thin tissue around implants, aesthetic deficiencies and correct residual dehiscence after regenerative procedures
- OSSIX® VOLUMAX is based on Datum Dental’s same proven GLYMATRIX® technology as OSSIX® PLUS
Datum Dental announced that OSSIX® VOLUMAX has received FDA 510(k) clearance, enabling the company to commercially market this new volumising (approximately 2mm), resorbable collagen scaffold in the US. It is the newest addition to the OSSIX® line of dental regeneration products for use in periodontics, oral surgery, dental implantology and dental aesthetic procedures.
Data presented at the American Association of Periodontology (AAP) Annual Meeting Research Forum Poster Session clearly demonstrates statistically significant improved bone growth using OSSIX® VOLUMAX vs. empty controls. The results also show OSSIX® VOLUMAX’ mineralisation and ossification progress.
Yuval Zubery, DMD, specialist in periodontics and Chief Medical Officer at Datum Dental, led the study and presented the findings during the poster session. Dr. Zubery will also be delivering an oral presentation at the European Association of Osseointegration (EAO) to be held later this month in Paris.
Dr. Zubery believes that OSSIX® VOLUMAX has significant potential to restore lost volume in guided bone regeneration (GBR), guided tissue regeneration (GTR) and soft tissue augmentation cases. “In implant surgery procedures where there is missing buccal bone, residual dehiscence or buccal dehiscence, this new thick collagen matrix is expected to restore volume. I foresee that clinicians may choose OSSIX® VOLUMAX for use in the aesthetic zone as well, especially for masking implants.”
Mr. Itay Itzhaky, Chairman at Datum Dental, said: “The new OSSIX® VOLUMAX and the well-known and decade-long proven OSSIX® PLUS both feature GLYMATRIX®. This proprietary technology uses sugars to cross-link collagen molecules, producing a collagen matrix that can be bio-programmed and tailored to deliver a range of products of varying physical properties, customised longevity and controlled rates of degradation. Over 100 publications have been published to date. We will continue to develop products featuring this unique technology, for the benefit of patients and healthcare around the globe.”
OSSIX® VOLUMAX is currently available in the USA (via OraPharma) & Korea (via Purgo Biologics). OSSIX VOLUMAX is pending the CE mark, Health Canada licence and MOH Israel certificate. OSSIX® VOLUMAX is currently available in four sizes, ranging from 10 x 12.5mm to 30 X 40mm.