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 and a Verified-Accredited Wholesale Distributor (VAWD).
Axoguard® Nerve Protector and Axoguard® Nerve Connector
- FDA 510(k) clearance
Avance® Nerve Graft
- The Axogen 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)
- November 2010: The U.S. FDA has issued an Enforcement Discretion Letter allowing continued sales of Avance® Nerve Graft under the controls applicable to a HCT/P pursuant to section 361 of the Public Health Service Act and 21 CFR Part 1271 of FDA’s regulations, in accordance with a transition plan with the FDA in which Axogen transitions to compliance with the Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), the current good manufacturing practice regulations in 21 CFR Part 210 and 211, and the applicable regulations and standards in 21 CFR Part 600-610. Axogen conducts a phase 3 clinical trial to demonstrate safety, purity and potency of the Avance® Nerve Graft, and Axogen continues to comply with the regulations and standard for 21 CFR Part 1271
Avive® Soft Tissue Membrane
- Avive® Soft Tissue Membrane is processed and distributed in accordance with U.S. FDA requirements for Human Cellular and Tissue-Based Products (HCT/P) under 21 CFR Part 1271 regulations, U.S. State regulations and the guidelines of the American Association of Tissue Banks (AATB)
Acroval® Neurosensory & Motor Testing System (NSMTS)
- FDA 510(k) clearance
Axotouch® Two-Point Discriminator
- Class 1 medical device under 21 CFR Part 882.1200 and is exempt from premarket notification
safe harbor 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,” 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 on our internal control over financial reporting, our growth, our 2018 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 subject to risks and uncertainties, which may cause results to differ materially from those set forth in the statements. Forward-looking statements in this release should be evaluated together with the many uncertainties that affect Axogen’s business and its market, particularly those discussed in the risk factors and cautionary statements in Axogen’s filings with the Securities and Exchange Commission. Forward-looking statements are not guarantees 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 law, Axogen assumes no responsibility to update any forward-looking statements, whether as a result of new information, future events or otherwise.