Altamira Submits FDA 510(k) Premarket Notification For Bentrio

Altamira Therapeutics Ltd CYTO has submitted a 510(k) premarket notification to the FDA for Bentrio for hay fever.
Once cleared, the Company anticipates partnering Bentrio for the U.S. market rather than commercializing it there on its own.
Bentrio is a nasal spray for protection against airborne viruses and allergens.
Bentrio was launched first in Germany under the CE mark in late July and subsequently also in Austria.
During the initial launch stage, the nasal spray product has been marketed solely through leading online pharmacies.
In the next phase of the European launch in Q4 2021, the Company will also target traditional 'brick-and-mortar' pharmacy stores.
Altamira has also executed letters of understanding with distributors in two key Southeast Asian countries.
Concurrent with the commercial activities outlined above, the Company is also advancing its clinical development programs for Bentrio.
Two studies are moving through the approval process in allergy: one for house dust allergy as a challenge study and another for seasonal allergic rhinitis.
These studies will be conducted in Canada and Australia, with data read-outs expected for Q1 and Q2 2022.
In a viral infection, Altamira is awaiting the approval of a placebo-controlled COVID-19 study by the Drugs Controller General of India.
Related content: Benzinga's Full FDA Calendar.
Price Action: CYTO stock is down 4.60% at $2.28 during the market session on the last check Monday.