Basel, 16 August 2018: The Straumann Group has resumed supply of its oral-tissue regeneration product Straumann® Emdogain® in the USA, following approval by the Food and Drug Administration of a change at the manufacturing facility in Sweden. Supplies to the rest of the world were not affected and global sales have continued to grow.
“Emdogain is unique and its proven regenerative properties have helped countless patients in the United States. We are very pleased that it is available again and would like to thank our customers for their understanding and patience while supply was interrupted”, said Guillaume Daniellot, Executive Vice President of the Straumann Group’s business in North America.
Straumann Emdogain is used to regenerate tissues that support teeth, which are damaged/lost in periodontal disease. Long-term clinical studies have shown it to be an effective method to help save teeth and reverse gingival recession1. Emdogain is one of the most established and widely-studied dental treatments. Having been used to treat more than 2 million patients over the past 22 years, it has become the gold standard for inducing safe and predictable regeneration of lost periodontal tissue.
Straumann is working with clinical experts to establish further periodontal applications (e.g. oral tissue wound healing and minimally invasive procedures), some of which have gained approvals in certain markets outside the US.
The Straumann Group (SIX: STMN) is a global leader in tooth replacement and orthodontic solutions that restore smiles and confidence. It unites global and international brands that stand for excellence, innovation and quality in replacement, corrective and digital dentistry, including Straumann, Neodent, Medentika, ClearCorrect, Dental Wings, and other fully/partly owned companies and partners. In collaboration with leading clinics, institutes and universities, the Group researches, develops, manufactures and supplies dental implants, instruments, CADCAM prosthetics, biomaterials and digital solutions for use in tooth replacement and restoration or to prevent tooth loss.
Headquartered in Basel, Switzerland, the Group currently employs approx. 5500 people worldwide and its products, solutions and services are available in more than 100 countries through a broad network of distribution subsidiaries and partners.
1 e.g. Sculean A et al. Ten-year results following treatment of intra-bony defects with enamel matrixproteins and guided tissue regeneration. J Clin Periodontol. 2008 Sep;35(9):817-24.; McGuire MK et al. Evaluation of human recession defects treated with coronally advanced flaps and either enamel matrix derivative or connective tissue: comparison of clinical parameters at 10 years.J Periodontol. 2012 Nov;83(11):1353-62; McGuire MK, Nunn M. Evaluation of human recession defects treated with coronally advanced flaps and either enamel matrix derivative or connective tissue. Part 1: Comparison of clinical parameters. J Periodontol. 2003 Aug;74(8):1110-25; The effect of enamel matrix protein on gingival tissue thickness in vivo. Al-Hezaimi K, Al-Fahad H, O'Neill R, Shuman L, Griffin T. Odontology. 2012 Jan;100(1):61-6.