Auris Medical Announces Completion of Bentrio Conformity Assessment Procedure for Marketing in EU
May 25 2021 - 9:00AM
- Meeting
essential requirements for marketing BentrioTM 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 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.
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 BentrioTM (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
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