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Paltamira therapeutics Altamira Therapeutics Provides Business Update and Reports First Half 2021 Financial Results September 8 , 2021 12:30 PM EDT TM • Commercial launch of Bentrio ™ nasal spray in first EU markets , with plans to expand to additional European and international markets in the second half of 2021 • Enrollment in Phase 2 trial of AM - 125 for acute vertigo reached its midpoint in May 2021 and completion is expected in the autumn of 2021 • Transformative acquisition of Trasir Therapeutics completed and strategic repositioning around RNA therapeutics well underway HAMILTON , BERMUDA / ACCESSWIRE / September 8 , 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 provided a business update and announced first half 2021 financial results . " Following intense preparations during the first half of 2021 , Altamira recently reached a significant milestone by launching Bentrio TM in parts of Europe , marking our transition from a development - stage to a commercial - stage company , " stated Thomas Meyer , Auris Medical's founder , Chairman and CEO . " As we look forward to introducing Bentrio TM to additional markets , we will also continue to execute on our repositioning strategy by progressing the preclinical development of AM - 401 , our first RNA therapeutic based on the OligoPhore TM delivery platform . In addition , we plan to explore other applications of this newly acquired platform , which holds the promise of overcoming the well - known challenges associated with therapeutic nucleic acid delivery . " Development Program Updates Commercial Launch of Bentrio ™ Nasal Spray ( AM - 301 ) • Transitioned to a commercial - stage company with the market roll - out of Bentrio ™ , TM Altamira's drug - free nasal spray for protection against airborne viruses and allergens , in late July 2021 . The Company initially launched Bentrio ™ under the CE mark in Germany , followed by Austria , and intends to expand market coverage to other EU countries in the second half of 2021 . Sales through leading on - line pharmacies have started , and promotional activities are being progressively expanded . • Continued to progress towards submitting a 510 ( k ) premarket notification to the U.S. Food and Drug Administration ( " FDA " ) . Based on the FDA's feedback obtained during its May 6 , 2021 pre - submission meeting , Altamira has been working to complete the application for the intended use in allergy . The Company expects to file the 510 ( k ) submission shortly . The Company is also working to develop various other markets around the world through local or regional distributors . • In addition , final preparations are being made to initiate a planned clinical investigation in India to evaluate the efficacy of Bentrio ™ in the prevention and treatment of acute COVID - 19 . The study is pending approval by the Drugs Controller General of India and local ethics committees . • In order to help ensure this significant market opportunity is well - protected , four provisional patent applications were filed with the U.S. Patent and Trademark Office in support of the Bentrio TM program . Altamira is pleased to report these patent filings have recently been converted into a non - provisional application , with the assignment of a patent examiner currently pending . The patent application's key claim is directed towards aqueous compositions comprising a mucoadhesive polymer and clay particles . • Bentrio ™ has been tested for its tolerability , safety and efficacy in numerous preclinical models and clinical studies , including : • SARS - CoV - 2 : in a human nasal epithelium model with reconstituted cells from donors , daily