NEW YORK, Dec. 9, 2021 /CNW/ -- Mind Medicine (MindMed)
Inc. (NASDAQ: MNMD), (NEO: MMED), (DE: MMQ) (the "Company"), a
leading biotech company developing psychedelic-inspired therapies
recently met with the United States Food and Drug Administration
(FDA) Center for Devices and Radiological Health (CDRH) with
consultation from the Center for Drug Evaluation and Research
(CDER) concerning several key points for ongoing development of the
MindMed Session Monitoring System (MSMS) in a device pre-submission
meeting that took place on October 25,
2021.
![Mindmed logo (PRNewsfoto/Mind Medicine, Inc. (Mindmed)) Mindmed logo (PRNewsfoto/Mind Medicine, Inc. (Mindmed))](https://mma.prnewswire.com/media/996320/Mindmed_Logo.jpg)
MindMed presented FDA with a working Indications for Use
statement (IFU), and a development roadmap. These describe
technology and infrastructure for the collection of precise,
multimodal, multivalent data that can be processed via machine
learning, artificial intelligence, signal processes, and other
statistical methods to yield clinically meaningful output to
satisfy the requirements of the IFU. FDA provided key feedback
regarding the draft IFU and the research methods that will lay the
foundation for regulatory submissions.
"We regard our regulators as key stakeholders throughout the
device development process and seek meetings with FDA as early and
often as feasible. These regulatory engagements provide the
opportunity to thoroughly and continually discuss and assess
alignment around the various considerations, which are essential to
the success and adoption of MindMed's Session Monitoring System's
regulated components" said Daniel R Karlin, MD MA, Chief Medical
Officer of MindMed. "The FDA is supportive of our plans to develop
regulated devices that would allow the use of novel analyses of
multimodal data to capture, model, and map outputs that, if
cleared, could be useful to clinicians and patients in the delivery
of psychedelic and other perception-altering substances."
"We found the feedback from both CDRH and CDER to be invaluable
as we look to bring our innovative products toward regulatory
approval," said Todd M. Solomon,
PhD, Head of Digital Psychiatry at MindMed. "We look forward to
continued engagement across both CDRH and CDER and believe this
opportunity to collaborate across centers will benefit MindMed as
we continue to refine our development plans."
About MindMed
MindMed is a clinical-stage psychedelic
medicine biotech company that seeks to discover, develop and deploy
psychedelic-inspired medicines and therapies to address addiction
and mental illness. The Company is assembling a compelling drug
development pipeline of innovative treatments based on psychedelic
substances including psilocybin, LSD, MDMA, DMT and an Ibogaine
derivative, 18-MC. The MindMed executive team brings extensive
biopharmaceutical experience to MindMed's approach to developing
the next generation of psychedelic-inspired medicines and
therapies.
MindMed trades on the NASDAQ under the symbol MNMD and on the
Canadian NEO Exchange under the
symbol MMED. MindMed is also traded in Germany under the symbol MMQ.
Forward-Looking Statements
Certain statements in this
news release related to the Company constitute "forward-looking
information" within the meaning of applicable securities laws and
are prospective in nature. Forward-looking information is not based
on historical facts, but rather on current expectations and
projections about future events and are therefore subject to risks
and uncertainties which could cause actual results to differ
materially from the future results expressed or implied by the
forward-looking statements. These statements generally can be
identified by the use of forward-looking words such as "will",
"may", "should", "could", "intend", "estimate", "plan",
"anticipate", "expect", "believe", "potential" or "continue", or
the negative thereof or similar variations. Forward-looking
information in this news release include, but are not limited to,
statements regarding the development of the MindMed session
monitoring system and bringing our innovative products toward
regulatory approval. Although the Company believes that the
expectations reflected in such forward-looking information are
reasonable, such information involves risks and uncertainties, and
undue reliance should not be placed on such information, as unknown
or unpredictable factors could have material adverse effects on
future results, performance or achievements of the Company. There
are numerous risks and uncertainties that could cause actual
results and the Company's plans and objectives to differ materially
from those expressed in the forward-looking information, including
history of negative cash flows; limited operating history;
incurrence of future losses; availability of additional capital;
lack of product revenue; compliance with laws and regulations;
difficulty associated with research and development; risks
associated with clinical trials or studies; heightened regulatory
scrutiny; early stage product development; clinical trial risks;
regulatory approval processes; novelty of the psychedelic inspired
medicines industry; as well as those risk factors discussed or
referred to herein and the risks described under the headings "Risk
Factors" in the Company's filings with the securities regulatory
authorities in all provinces and territories of Canada which are available under the
Company's profile on SEDAR at www.sedar.com and with the U.S.
Securities and Exchange Commission on EDGAR at www.sec.gov.
Should one or more of these risks or uncertainties materialize, or
should assumptions underlying the forward-looking information prove
incorrect, actual results and future events could differ materially
from those anticipated in such information. Although the Company
has attempted to identify important risks, uncertainties and
factors that could cause actual results to differ materially, there
may be others that cause results not to be as anticipated,
estimated or intended. These and all subsequent written and oral
forward-looking information are based on estimates and opinions of
management on the dates they are made and are expressly qualified
in their entirety by this notice. Except as required by law, the
Company does not intend and does not assume any obligation to
update this forward-looking information.
Media Contact: media@mindmed.co
Investor Contact: ir@mindmed.co
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SOURCE Mind Medicine (MindMed) Inc.