Altamira Therapeutics Receives FDA Acceptance for Bentrio 510(k) Application
Altamira Therapeutics Ltd. (NASDAQ:CYTO) has announced that the FDA has accepted its 510(k) application for the Bentrio™ nasal spray, aimed at protecting against airborne allergens. This marks a significant milestone towards gaining access to the U.S. market. Following the acceptance, the application is set for a substantive review by the Agency. The company's initiatives focus on RNA therapeutics, allergy and viral infection protection, and inner ear therapeutics, with ongoing projects in various developmental phases.
- FDA acceptance of Bentrio™ nasal spray 510(k) application is a critical step towards market entry.
- Potential to expand product offerings in the U.S. market.
- None.
HAMILTON, BERMUDA / ACCESSWIRE / October 14, 2021 / Altamira Therapeutics Ltd. (NASDAQ:CYTO) ("Altamira" or the "Company"), a company dedicated to addressing unmet medical needs through RNA therapeutics, allergy and viral infection protection, and inner ear therapeutics, today announced that its 510(k) application for premarket clearance filed with the U.S. Food and Drug Administration ("FDA") for its Bentrio™ nasal spray for protection against airborne allergens has cleared the Agency's acceptance review. The application now moves to a substantive review by the FDA.
"This 510(k) submission is a major step towards gaining entry to the U.S. market for Bentrio and we look forward to working closely with the FDA as it proceeds through its review," said Thomas Meyer, Altamira's founder, Chairman and CEO.
About Altamira Therapeutics
Altamira Therapeutics is dedicated to developing therapeutics that address important unmet medical needs. The Company is currently active in three areas: the development of RNA therapeutics for extrahepatic therapeutic targets (OligoPhore™ / SemaPhore™ platforms; preclinical), nasal sprays for protection against airborne viruses and allergens (Bentrio™; commercial) or for the treatment of vertigo (AM-125; Phase 2), and the development of therapeutics for intratympanic treatment of tinnitus or hearing loss (Keyzilen® and Sonsuvi®; Phase 3). The Company was founded in 2003 and is headquartered in Hamilton, Bermuda, with its main operations in Basel, Switzerland. The shares of Altamira Therapeutics Ltd. trade on the NASDAQ Capital Market under the symbol "CYTO".
Forward-looking Statements
This press release may contain statements that constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical facts and may include statements that address future operating, financial or business performance or Altamira Therapeutics' strategies or expectations. In some cases, you can identify these statements by forward-looking words such as "may", "might", "will", "should", "expects", "plans", "anticipates", "believes", "estimates", "predicts", "projects", "potential", "outlook" or "continue", or the negative of these terms or other comparable terminology. Forward-looking statements are based on management's current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include, but are not limited to, the approval and timing of commercialization of AM-301, Altamira Therapeutics' need for and ability to raise substantial additional funding to continue the development of its product candidates, the timing and conduct of clinical trials of Altamira Therapeutics' product candidates, the clinical utility of Altamira Therapeutics' product candidates, the timing or likelihood of regulatory filings and approvals, Altamira Therapeutics' intellectual property position and Altamira Therapeutics' financial position, including the impact of any future acquisitions, dispositions, partnerships, license transactions or changes to Altamira Therapeutics' capital structure, including future securities offerings. These risks and uncertainties also include, but are not limited to, those described under the caption "Risk Factors" in Altamira Therapeutics' Annual Report on Form 20-F for the year ended December 31, 2020, and in Altamira Therapeutics' other filings with the SEC, which are available free of charge on the Securities Exchange Commission's website at: www.sec.gov. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those indicated. All forward-looking statements and all subsequent written and oral forward-looking statements attributable to Altamira Therapeutics or to persons acting on behalf of Altamira Therapeutics are expressly qualified in their entirety by reference to these risks and uncertainties. You should not place undue reliance on forward-looking statements. Forward-looking statements speak only as of the date they are made, and Altamira Therapeutics does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law.
Investor contact:
Stephen Kilmer
646.274.3580
sjk@altamiratherapeutics.com
SOURCE: Altamira Therapeutics Ltd.
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