Auris Medical Announces Completion of Bentrio Conformity Assessment Procedure for Marketing in EU

Rhea-AI Summary

Auris Medical Holding Ltd. (NASDAQ: EARS) announced its successful completion of the conformity assessment for its Bentrio^TM nasal spray, allowing marketing in the EU under the CE mark. The company aims to launch the product by the end of Q2 2021. Bentrio^TM is a drug-free spray designed to provide protection against airborne allergens and viruses by forming a gel layer in the nasal mucosa. Additionally, Auris Medical plans to submit a 510(k) pre-market notification to the FDA for allergy use in early Q3 2021.

Positive

• Successful completion of conformity assessment for Bentrio^TM enables marketing in EU.
• Launch of Bentrio^TM is expected by the end of Q2 2021.
• Production and launch activities for Bentrio^TM are ongoing.

Negative

• None.

• Meeting essential requirements for marketing Bentrio^TM in Europe under CE mark
• On track for first product launch in Europe towards end of Q2 2021

Hamilton, Bermuda, May 25, 2021 – Auris Medical Holding Ltd. (NASDAQ: EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology, rhinology and allergy and CNS disorders, and its affiliate Altamira Medica Ltd. today announced that it has successfully completed the conformity assessment procedure for marketing the Bentrio^TM nasal spray in the member states of the European Union (EU). The product, which is intended to help protect against airborne allergens and viruses, is considered a Class I medical device under the Medical Devices Directive (MDD). Bentrio^TM therefore meets all essential requirements for marketing Bentrio^TM across Europe under the so-called CE mark.

“We are very pleased and proud about reaching this important milestone with our Bentrio^TM program in line with our initial forecast”, stated Thomas Meyer, Auris Medical’s founder, Chairman and CEO. “The declaration of conformity will allow for launching Bentrio^TM in the first European country towards the end of June. Commercial production has started, and we are currently preparing launch activities for various on- and offline distribution channels. We look forward to bringing this innovative spray to consumers who wish or need to self-protect when exposed or at risk of being exposed to airborne viruses or allergens.”

The main content of the technical dossier for the European conformity assessment procedure for Bentrio^TM will be used also for the submission of a 510(k) pre-market notification application to the Food and Drug Administration (FDA), together with some additional data. The Company expects to file the submission package for the intended use in allergy with the FDA in early Q3 2021.

About Bentrio^TM

Bentrio^TM (AM-301) is a drug-free nasal spray for personal protection against airborne viruses and allergens. Upon application into the nose, Bentrio^TM forms a protective gel layer on the nasal mucosa. This thin film is designed to prevent the contact of viruses or allergens with cells; in addition, the composition serves to bind such particles and help with their discharge and to humidify the nasal mucosa. Together, this is designed to reduce the risk of upper respiratory tract viral infections and promote alleviation of allergic symptoms.

About Auris Medical

Auris Medical is a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology, rhinology and allergy and CNS disorders. The Company is focused on the development of intranasal betahistine for the treatment of vertigo (AM-125, in Phase 2) and for the prevention of antipsychotic-induced weight gain and somnolence (AM-201, post Phase 1b). Through its affiliate Altamira Medica, the Company is developing a nasal spray for protection against airborne viruses and allergens Bentrio^TM (AM-301). In addition, Auris Medical has two Phase 3 programs under development: Sonsuvi® (AM-111) for acute inner ear hearing loss and Keyzilen® (AM-101) for acute inner ear tinnitus. The Company was founded in 2003 and is headquartered in Hamilton, Bermuda with its main operations in Basel, Switzerland. The shares of Auris Medical Holding Ltd. trade on the NASDAQ Capital Market under the symbol “EARS.”

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 Auris Medical’s 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, Auris Medical’s 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 Auris Medical’s product candidates, the clinical utility of Auris Medical’s product candidates, the timing or likelihood of regulatory filings and approvals, Auris Medical’s intellectual property position and Auris Medical’s financial position, including the impact of any future acquisitions, dispositions, partnerships, license transactions or changes to Auris Medical’s 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 Auris Medical’s Annual Report on Form 20-F for the year ended December 31, 2020, and in Auris Medical's 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 Auris Medical or to persons acting on behalf of Auris Medical 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 Auris Medical 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:

investors@aurismedical.com     

FAQ

What is the significance of the CE mark approval for Bentrio^TM by Auris Medical (EARS)?

The CE mark approval allows Auris Medical to market Bentrio^TM in the EU, enhancing its commercial prospects.

When is Auris Medical (EARS) planning to launch Bentrio^TM in Europe?

Auris Medical is on track to launch Bentrio^TM by the end of Q2 2021.

What are the intended uses of Bentrio^TM nasal spray developed by Auris Medical (EARS)?

Bentrio^TM is designed to protect against airborne allergens and viruses.

What regulatory submission is Auris Medical (EARS) planning for Bentrio^TM in the US?

Auris Medical plans to submit a 510(k) pre-market notification application to the FDA for Bentrio^TM in early Q3 2021.