Home Meeting notice MindMed Engages in Productive Pre-Submission Meeting with FDA for Development of MindMed Session Monitoring System

MindMed Engages in Productive Pre-Submission Meeting with FDA for Development of MindMed Session Monitoring System


NEW YORK, December 9, 2021 / CNW / – Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED), (DE: MMQ) (the “Company”), a leading biotechnology company that develops inspirational therapies psychedelic 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) regarding several key points for the ongoing development of MindMed Session Monitoring System (MSMS) in a pre-submission meeting that took place on 25 October 2021.

Mindmed Logo (PRNewsfoto / Mind Medicine, Inc. (Mindmed))

MindMed has presented an indication for use statement (IFU) and a development roadmap to the FDA. These describe the technology and infrastructure for the collection of precise, multimodal and versatile data that can be processed through machine learning, artificial intelligence, signaling processes, and other statistical methods to produce results clinically. significant to meet IFU requirements. The FDA provided key comments regarding the IFU project and the research methods that will form the basis for regulatory submissions.

“We view our regulators as key stakeholders throughout the device development process and seek meetings with the FDA as early and often as possible. These regulatory commitments provide the opportunity to discuss and thoroughly and continuously assess the alignment around the different considerations, which are critical to the success and adoption of the regulated components of MindMed’s session monitoring system, ”said Daniel R Karlin, MD MA, Medical Director of MindMed. “The FDA is supporting our plans to develop regulated devices that would enable the use of novel multimodal data analyzes to capture, model and map outlets which, if approved, could be useful to clinicians and patients in the delivery of psychedelics. and other substances altering perception. “

“We have found the feedback from CDRH and CDER to be invaluable as we seek to bring our innovative products to regulatory approval,” said Todd M. Solomon, PhD, Head of Digital Psychiatry at MindMed. “We look forward to continuing the engagement between CDRH and CDER and believe this opportunity to collaborate between centers will benefit MindMed as we continue to refine our development plans. “

About MindMed
MindMed is a clinical-stage psychedelic medicine biotechnology company that seeks to discover, develop and deploy psychedelically inspired drugs and therapies to combat addiction and mental illness. The Company is building a compelling drug development pipeline of innovative therapies based on psychedelics, including psilocybin, LSD, MDMA, DMT and an ibogaine derivative, 18-MC. The MindMed leadership team brings extensive biopharmaceutical experience to MindMed’s approach to develop the next generation of psychedelically inspired drugs and therapies.

MindMed trades on NASDAQ under the symbol MNMD and on the Canadian NEO Exchange under the symbol MMED. MindMed is also marketed Germany under the acronym MMQ.

Forward-looking statements
Certain statements in this press release concerning the Company constitute “forward-looking information” within the meaning of applicable securities laws and are forward-looking in nature. Forward-looking information is not based on historical facts, but rather on current expectations and projections regarding future events and is therefore subject to risks and uncertainties that could cause actual results to differ materially from future results. expressed or implied by forward-looking statements. . These statements can generally be identified by the use of forward-looking words such as “will”, “may”, “should”, “could”, “intend to”, “estimate”, “plan”, “anticipate” , “expect”, “believe”, “potential” or “continue”, or the negative of these or similar variations. Forward-looking information in this press release includes, but is not limited to, statements regarding the development of the MindMed session monitoring system and obtaining regulatory approval for our innovative products. Although the Company believes that the expectations reflected in this forward-looking information are reasonable, such information involves risks and uncertainties, and such information should not be relied upon because unknown or unforeseeable factors could have material adverse effects on the Company. the future results, performance or achievements of the Company. There are numerous risks and uncertainties which could cause the actual results and the plans and objectives of the Company to differ materially from those expressed in the forward-looking information, including historical negative cash flows; limited operating history; the appearance of future losses; availability of additional capital; lack of income produced; compliance with laws and regulations; difficulty associated with research and development; risks associated with clinical trials or studies; increased regulatory control; early stage product development; risks associated with clinical trials; regulatory approval process; the novelty of the psychedelic-inspired drug industry; as well as the risk factors discussed or mentioned herein and the risks described under the headings “Risk Factors” in the documents filed by the Company with the securities regulatory authorities of all the provinces and territories of Canada which are available under the Company’s profile on SEDAR at www.sedar.com and with the United States Securities and Exchange Commission on EDGAR at www.sec.gov. If one or more of these risks or uncertainties materialize, or if the assumptions underlying the forward-looking information prove to be incorrect, actual results and future events could differ materially from those anticipated in such information. Although the Company has attempted to identify risks, uncertainties and important factors that could cause actual results to differ materially, there may be others that could cause results not to be as anticipated. , estimated or planned. This subsequent written and oral forward-looking information and all subsequent forward-looking information are based on management’s estimates and opinions on the dates on which they are made and are expressly qualified in their entirety by this notice. Unless required by law, the Company does not intend and assumes no obligation to update this forward-looking information.

Media contact: [email protected]

Investor contact: [email protected]



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SOURCE Mind Medicine (MindMed) Inc.



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