https://finance.yahoo.com/news/ce-mark-health-canada-regulatory-130000756.html
Expanding OSSIX Line in Europe, North America Following Prior FDA Clearance
LOD, Israel, June 18, 2018 /PRNewswire/ — Datum Dental, Ltd, leading provider of OSSIX® brand innovative solutions for bone and tissue regeneration for dentistry, proudly announces major regulatory clearances for OSSIX™ Bone with CE Mark in Europe and Health Canada approval. Powered by the company’s patented clinically proven GLYMATRIX® core technology, OSSIX Bone received FDA clearance in July 2017 and was launched commercially during 3Q2017 in the USA.
“This is a significant milestone,” noted Dr. Arie Goldlust, Datum Dental CEO and Co-Founder, “the full GLYMATRIX-based OSSIX line – OSSIX Plus, OSSIX Volumax, and now OSSIX Bone – is available to clinicians across Europe and North America, and other key regions. OSSIX Bone is a mineralized collagen sponge with unique ossifying characteristics and texture that enable simplified dental procedures in challenging cases as well as routine care. Unlike alternatives on the market including allograft/xenograft materials, OSSIX Bone promotes true bone with no remnants, no migration of material – offering a viable, naturally derived solution for clinicians.”
Dr. Barry Levin, DMD, PC, periodontist and implantologist, publishes and lectures on topics pertaining to dental implantology, periodontics and bone regenerative materials. He has been using OSSIX Bone in his practice since the product received FDA clearance last year. Dr. Levin noted, “based on my clinical experience, this biomaterial has changed the way I approach crestal sinus elevations and grafting extraction sites. The easy handling of OSSIX Bone translates into precise and safe augmentation, with predictable ossification and osseointegration without the risks of graft migration. This gives patients and clinicians a better option – providing a simplified and predictable way to preserve alveolar ridge dimensions for ideal implant placement, with no need for a membrane. Having a material like the OSSIX Bone collagen sponge that readily absorbs the patient’s blood, i.e. growth factors, and remains stable after placement, is a tremendous improvement over available grafting materials.”
Dr. Bach Le, DDS, MD, FICD, FACD, Clinical Associate Professor, Department of Oral & Maxillofacial Surgery at the USC School of Dentistry, integrated the product in his surgical practice and emphasized that “OSSIX Bone demonstrates good healing and bone formation.” A published author and lecturer on dental implants and bone regeneration, Dr. Le has been using OSSIX solutions such as legacy OSSIX Plus in his clinical practice and educational endeavors for over a decade.
Datum Dental’s partner network is gearing up to introduce OSSIX Bone regionally. Mr. Chris Carriere, Managing Director of HMI (Hesira Med Inc.) added, “We are passionate about delivering the best-in-class OSSIX line of dental regenerative materials to Canadian clinicians. We are bringing these unique and innovative materials to Canada so that patients may achieve optimal treatment outcomes. We are pleased to offer a simpler solution to socket preservations and crestal / closed sinus lift techniques with the newly Health Canada licensed OSSIX Bone.”
“With proven science and clinical efficacy of the OSSIX product family, we are thrilled that OSSIX Bone has received CE Mark,” noted General Manager of Salugraft Dental Spain, Juan De Dios Briones. He summarized, “Where regeneration procedures are required, European clinicians can now benefit from incorporating product innovations such as OSSIX Bone in clinical practice. Compared to commonly used bone graft substitutes such as xenograft and alloplastic materials, OSSIX Bone has the potential to provide predictable and sustainable results that will substantially benefit patient outcomes while reducing total treatment time and costs.”
OSSIX Bone to be Showcased at EuroPerio9 Amsterdam – Datum Dental Booth#11.04a
The company will showcase OSSIX Bone at the Datum Dental Booth#11.04a at EuroPerio9 in Amsterdam from June 20-23. Clinicians will have the opportunity to experience the product in the booth hands-on corner “Your Talent. Our Expertise.”
About Datum Dental
Datum Dental Ltd., a subsidiary of Datum Biotech, provides innovative dental regeneration products to support and enhance the future of implantology and oral care. The company markets its products for dental professionals through its extensive global network of over 20 partners worldwide. The company uses its patented GLYMATRIX core technology, a sugar cross-linking collagen biomaterial, for guided bone regeneration (GBR) and guided tissue regeneration (GTR); the technology is clinically proven in over a hundred scientific publications. Powered by GLYMATRIX, the OSSIX product family has enabled clinicians in hundreds of thousands of procedures spanning almost two decades to safely provide predictable, long-term results to their patients. The OSSIX portfolio includes legacy OSSIX Plus ossifying collagen barrier membrane, OSSIX Bone mineralized collagen sponge, and OSSIX Volumax ossifying, volumizing collagen scaffold. Datum Dental’s R&D pipeline continues to develop new products for GBR and GTR that simplify procedures and overcome major deficiencies in existing biomaterials through safe and transformational solutions.
Contact:
Ellen Fischl Bodner
Director of Marketing
Datum Dental