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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 BentrioTM 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). BentrioTM therefore meets all essential requirements for marketing BentrioTM across Europe under the so-called CE mark.
"We are very pleased and proud about reaching this important milestone with our BentrioTM 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 BentrioTM 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 BentrioTM 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 BentrioTM
BentrioTM (AM-301) is a drug-free nasal spray for personal protection against airborne viruses and allergens. Upon application into the nose, BentrioTM 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.
Posted In: EARS
