Axogen’s products are subject to international, federal, state and local regulations as healthcare products. Axogen meets the regulations for human tissue products and medical devices as required by the appropriate international and domestic regulatory agencies (e.g., FDA). Additionally, Axogen is an accredited tissue bank with the American Association of Tissue Banks (AATB), and Axogen is an ISO 13485 registered company.
Axoguard® Nerve Protector and Axoguard® Nerve Connector
- Class III – TUV-SUD (NB no. 0123), EC Certificate no. G7130639164084
Avance® Nerve Graft and Avive® Soft Tissue Membrane – Human tissue products
- The Axogen’s Quality System meets the requirements set forth under 21 CFR Part 1271 for Human Cells, Tissues, and Cellular and Tissue-Based Products, including Good Tissue Practices (GTP).
- Axogen’s Quality System meets the following EU Directives for human tissue products:
- Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells
- Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells
- Commission Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells
- Additionally, Axogen’s quality system meets each EU country’s quality system requirements as assessed at time of product registration in the EU country.
- For non EU countries, Axogen’s quality system meets each country’s quality system requirements as assessed at time of product registration in the country.
safe harbour statement
This website contains “forward-looking” statements as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations or predictions of future conditions, events, or results based on various assumptions and management’s estimates of trends and economic factors in the markets in which we are active, as well as our business plans. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “projects,” “forecasts,” “continue,” “may,” “should,” “will,” “goals,” and variations of such words and similar expressions are intended to identify such forward-looking statements. The forward-looking statements may include, without limitation, statements regarding our assessment of our internal controls over financial reporting, our growth, our current guidance, product development, product potential, financial performance, sales growth, product adoption, market awareness of our products, data validation, our visibility at and sponsorship of conferences and educational events. The forward-looking statements are and will be subject to risks and uncertainties, which may cause actual results to differ materially from those expressed or implied in such forward-looking statements. Forward-looking statements contained in this website should be evaluated together with the many uncertainties that affect our business and our market, particularly those discussed under Part I, Item 1A, “Risk Factors,” of our Annual Report on Form 10-K for the fiscal year ended 31 December 2018, as well as other risks and cautionary statements set forth in our filings with the US Securities and Exchange Commission. Forward-looking statements are not a guarantee of future performance, and actual results may differ materially from those projected. The forward-looking statements are representative only as of the date they are made and, except as required by applicable law, we assume no responsibility to publicly update or revise any forward-looking statements, whether as a result of new information, future events, changed circumstances, or otherwise.