MALVERN, Pa.–(BUSINESS WIRE)–Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, appear that it accustomed 510(k) approval from the U.S. Food and Drug Administration to bazaar VITOMATRIX Cartilage Affix Substitute as a cartilage grafting absolute in assertive dental procedures.
VITOMATRIX is a resorbable, awful absorptive constructed arch that utilizes the amount proprietary technology from our VITOSS™ Cartilage Affix Substitute artefact line. VITOMATRIX is adumbrated for use in procedures to fill, augment or reconstruct periodontal or awkward defects of the articulate and maxillofacial region. An estimated 375,000 procedures are performed domestically anniversary year area VITOMATRIX can be used.
Orthovita is evaluating abeyant bartering ally to administer the artefact or authorization its basal technology.
About the Aggregation
Orthovita is an orthobiologics and biosurgery aggregation that develops and markets atypical medical devices. Our orthobiologics belvedere offers articles for the fusion, about-face and fixation of animal bone. Our biosurgery belvedere offers articles for authoritative intra-operative bleeding, additionally accepted as hemostasis. Our accepted admixture and about-face articles are based on our proprietary VITOSS™ Cartilage Affix Substitute technology and abode the non-structural cartilage affix bazaar with synthetic, bioactive alternatives to patient- and cadaver-derived cartilage tissue. CORTOSS™ Cartilage Augmentation Material, an injectable, polymer blended that mimics the structural characteristics of animal bone, provides the base for our fixation portfolio. Our hemostasis portfolio includes VITAGEL™ Surgical Hemostat, a unique, collagen-based cast that controls bleeding and facilitates healing, and VITASURE™ Absorbable Hemostat, a plant-based artefact that can be deployed bound throughout surgery.
This columnist absolution may accommodate advanced statements apropos Orthovita’s accepted expectations of approaching contest that absorb risks and uncertainties, including, after limitation, our adeptness to auspiciously administer or authorization the VITOMATRIX artefact or basal technology through a affiliation arrangement; the appeal and bazaar accepting of our articles and added aspects of our business. Such statements are based on management’s accepted expectations and are accountable to a cardinal of abundant risks and uncertainties that could account absolute after-effects or accommodation to alter materially from those addressed in the advanced statements. Factors that may account such a aberration are listed from time to time in letters filed by the Aggregation with the U.S. Securities and Exchange Commission (SEC), including but not bound to risks declared in our best afresh filed Form 10-K beneath the explanation “Risk Factors.” Further advice about these and added accordant risks and uncertainties may be begin in Orthovita’s filings with the SEC, all of which are accessible from the SEC as able-bodied as added sources. Orthovita undertakes no obligation to about amend any advanced statements.
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