A new CPT III code application, if approved by the U.S. Food and Drug Administration (FDA), is an agreement between MAPS PBC and COMPASS Pathways to expedite reimbursement and, ultimately, access to psychedelic therapy in the United States. It was the result of cooperation. The two companies are working to develop psychedelics as part of a new treatment paradigm for individuals with mental illness and commercialize them subject to FDA approval. COMPASS Pathways is Phase 3 program Investigational COMP360 Psilocybin Therapy in Treatment-Resistant Depression (TRD) positive result in the New England Journal of Medicine From the Phase 2b trial of COMP360 in TRD, it is the largest trial of its kind. MAPS PBC completed Two Phase 3 clinical trials We evaluated MDMA-supported therapy as a potential treatment for post-traumatic stress disorder (PTSD), both meeting prespecified primary and secondary endpoints. This new code could provide a mechanism for reimbursement of these new treatments being developed by COMPASS and MAPS PBC if they are approved by the FDA.
Kabir Nath, CEO of COMPASS Pathways, said: “Our collaboration with MAPS PBC to develop the new CPT Code will ensure that, once approved, psychedelic therapies will be integrated into the healthcare system, reimbursed by payers, and made available to those who need them. purpose.”
AMA on March 3, 2023 It was published Summary of panel actions, including approval of the new CPT III Code. The application was titled “Continuous face-to-face monitoring and intervention during psychedelic drug treatment.” CPT III codes are a series of temporary codes assigned to new technologies, services and procedures. They are intended to be used for data collection to demonstrate broader use or to provide documentation for the FDA approval process.
MAPS PBC CEO Amy Emerson said: “A strong collaboration like this shows that, together, we can move closer to our overall goal of helping people who currently fall short of existing treatments for their mental health conditions.”
About the COMPASS pathway
COMPASS Pathways plc (Nasdaq: CMPS) is a mental health care company dedicated to advancing patient access to evidence-based innovation in mental health. Our focus is on improving the lives of people who suffer from mental health problems and cannot be helped by current treatments. We are pioneering the development of new models of psilocybin therapy. In this model, his COMP360, a proprietary synthetic psilocybin formulation, is administered in combination with psychological support. COMP360 has Breakthrough Therapy Designation by the US Food and Drug Administration (FDA) and has received Innovative License and Access Pathway (ILAP) designation for Treatment-Resistant Depression (TRD) in the UK. TRD has initiated a Phase 3 clinical program for COMP 360 psilocybin therapy. We have previously completed a Phase 2b trial with topline data showing statistically significant results (p
Availability of other information about COMPASS Pathways
Investors and others may use our website (www.compasspathways.com), investor website (ir.compasspathways.com) and social media (LinkedIn) to communicate with investors and the public. Please note that we are communicating. Investor presentations and investor fact sheets, US Securities and Exchange Commission filings, press releases, public conference calls, and webcasts. The information you post on these channels and websites may be considered material information. As a result, we encourage investors, media and others interested in our company to regularly review information posted on these channels, including our IR website. This list of channels may be updated from time to time on our Investor Relations Website and may include additional social media channels. The content of our website or these channels, or any other website accessible through our website or these channels, shall not be deemed to be incorporated by reference into any filings under the Securities Act 1933. .
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, forward-looking statements are “may,” “could,” “could,” “could,” “may,” “expect.” , “intends,” “plans,” “anticipates,” and other terms. , “believe”, “consider”, “seek”, “could”, “continue”, “ongoing”, or the negatives of these terms or other equivalent terms. Forward-looking statements include, among other things, our plans, the expected timing of TRD’s Phase 3 program, the potential for its or other trials to support regulatory filings and approvals, its safety. or express or implied statements of validity. COMPASS expectations regarding the potential impact of the CPT III Code on investigational COMP360 psilocybin therapy, including the treatment of TRD, anorexia nervosa, and PTSD, and reimbursement and access for COMP360 psilocybin therapy if FDA approval is obtained. Forward-looking statements in this press release are neither promises nor guarantees. These forward-looking statements involve known and unknown risks, uncertainties and other factors, many of which are beyond the control of COMPASS, which may , performance or outcomes could differ materially from those expressed or implied by these forward-looking statements.
These risks, uncertainties, and other factors include, among others: Clinical development takes time and results are uncertain. It is possible that our efforts to obtain marketing approval from the applicable regulatory authorities in your jurisdiction for COMP360 or any of our future product candidates may fail. The American Medical Association says he may change the scope of the CPT III code before it is published in July 2023. This may adversely affect our expectations regarding reimbursement of his COMP360 psilocybin therapy if approved, and our efforts to obtain coverage and reimbursement for his COMP360 psilocybin therapy during clinical trials. , if approved, may fail. COMPASS’s most recent annual report on Form 10-K or quarterly report on Form 10-Q and other reports filed with the U.S. Securities and Exchange Commission (“SEC”) under the heading “Risk Factors” Risks and Uncertainties described in ), available on the SEC’s website at www.sec.gov. Except as required by law, COMPASS disclaims any intention or responsibility to update or revise any forward-looking statements contained in this press release, whether as a result of new information, future developments or otherwise. These forward-looking statements are based on COMPASS’s current expectations and speak only as of the dates indicated herein.
About Maps Public Service Corporation (MAPS PBC)
MAPS Public Benefit Corporation (MAPS PBC) focuses on the development and commercialization of prescription psychedelics, bringing better treatments to people with mental health conditions. Founded in 2014, MAPS PBC is a subsidiary of the Multidisciplinary Association for Psychedelic Research, a 501(c)(3) non-profit organization. For more information, please visit www.mapsbcorp.com.
inquiry
Compass Media: Amy Lawrence, media@compasspathways.com, +44 7813 777 919
COMPASS Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324
MAPS PBC: Blair Clark-Schoeb, media-inquiries@mapsbcorp.com
window.REBELMOUSE_LOWEST_TASKS_QUEUE.push(function(){
var scrollableElement = document.body; //document.getElementById('scrollableElement');
scrollableElement.addEventListener('wheel', checkScrollDirection);
function checkScrollDirection(event) { if (checkScrollDirectionIsUp(event)) { //console.log('UP'); document.body.classList.remove('scroll__down'); } else { //console.log('Down'); document.body.classList.add('scroll__down'); } }
function checkScrollDirectionIsUp(event) { if (event.wheelDelta) { return event.wheelDelta > 0; } return event.deltaY < 0; } }); window.REBELMOUSE_LOWEST_TASKS_QUEUE.push(function(){ !function(f,b,e,v,n,t,s){if(f.fbq)return;n=f.fbq=function(){n.callMethod? n.callMethod.apply(n,arguments):n.queue.push(arguments)}; if(!f._fbq)f._fbq=n;n.push=n;n.loaded=!0;n.version='2.0'; n.queue=[];t=b.createElement(e);t.async=!0; t.src=v;s=b.getElementsByTagName(e)[0]; s.parentNode.insertBefore(t,s)}(window,document,'script','https://connect.facebook.net/en_US/fbevents.js'); fbq('init', '2388824518086528'); });