NEW YORK, Jan. 18, 2022 /PRNewswire/ -- Mind Medicine
(MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED), (DE: MMQ) (the
"Company"), a clinical-stage biopharmaceutical company developing
psychedelic-inspired therapies for the treatment of mental health
and addiction, today announced that it has enrolled the first
subjects into its Session Monitoring System (SMS-01) study
evaluating the passive collection of sensory data during a
consciousness-altering therapeutic session. SMS-01 utilizes
MindMed's Session Monitoring System (MSMS), which it believes could
have therapeutic applications in the treatment of psychiatric
disorders.
![Mindmed logo (PRNewsfoto/Mind Medicine, Inc. (Mindmed)) Mindmed logo (PRNewsfoto/Mind Medicine, Inc. (Mindmed))](https://mma.prnewswire.com/media/996320/Mindmed_Logo.jpg)
MindMed recently consulted with the U.S. Food and Drug
Administration's (FDA) Center for Devices, Radiological Health
(CDRH) and Center for Drug Evaluation and Research (CDER) and
received positive feedback supporting the planned development
strategy. The objective of the meeting was to review the devices
Indications for Use (IFU) statement, discuss the study design and
facilitate early communication and guidance through the regulatory
submission process.
"We have welcomed FDA input throughout the device development
process, giving us a clear roadmap for the success and adoption of
MSMS," said Daniel R Karlin, MD MA, Chief Medical Officer of
MindMed. "The launch of this study is an important milestone for
MindMed and for the future development of regulated devices and
software-as-medical-devices (SaMD) products designed to support
novel analyses of multimodal data in the delivery of psychiatric
care. By refining the techniques used to capture, model and map
these outputs, we aim to improve the experience of clinicians and
outcomes for patients in the delivery of psychedelic and other
perception-altering substances."
"Our team has worked incredibly hard to advance this product
into the clinic and we remain dedicated to rolling out these novel
approaches to improving mental health outcomes," said Todd M. Solomon, PhD, Head of Digital Psychiatry
at MindMed. "We look forward to leveraging data from this study,
and as we continue to advance our product development efforts, I
would sincerely like to sincerely thank our team, study
investigators, partners and most importantly the subjects who have
agreed to participate in this study."
About MindMed Session Monitoring System (MSMS)
MindMed
Session Monitoring System (MSMS) is a technological platform and
product that provides the foundation for the development and
implementation of a suite of regulated and unregulated products for
use by clinicians and patients during treatment sessions that may
also include the use of consciousness altering medications.
About MindMed
MindMed is a clinical-stage
biopharmaceutical company developing the next generation of
psychedelic-inspired therapies for the treatment of mental health
and addiction. MindMed leverages rigorous drug development
principles and advanced digital therapeutics to address these
highly pressing, unmet patient needs. MindMed's differentiated
pipeline features innovative treatments based on psychedelic
substances including psilocybin, LSD, MDMA, DMT and an ibogaine
derivative, 18-MC. Led by an executive team with extensive
pharmaceutical industry experience, MindMed has forged strategic
collaborations with leading research and academic institutions to
accelerate new medicines to patients as quickly as possible.
MindMed is headquartered in New York
City. For more information, please visit
https://mindmed.co/.
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.
Media Contact: media@mindmed.co
Investor Contact: ir@mindmed.co
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SOURCE Mind Medicine (MindMed) Inc.