MCRA Assists Ceribell with Obtaining FDA Breakthrough Device Designation, FDA Marketing Authorization, and CMS NTAP Reimbursement for ClarityPro Device

WASHINGTON, Sept. 25, 2023 /PRNewswire/ -- MCRA, LLC, a leading medical device focused regulatory advisory firm and clinical research organization (CRO) integrating U.S. and International Regulatory Affairs, Clinical Trial Operations, Reimbursement and Market Access, Healthcare Compliance, Cybersecurity, Quality Assurance, and Japan Distribution Logistics (DMAH) is pleased to announce its role in obtaining U.S. Food and Drug Administration (FDA) Breakthrough Device Designation, FDA marketing authorization, and Centers for Medicaid & Medicare (CMS) New Technology Add-on Payment (NTAP) for ClarityPro, a new device from Ceribell, Inc. Clarity Pro utilizes a machine learning model to analyze signals recorded by Ceribell's EEG system. It is the first and only device indicated to diagnose Electrographic Status Epilepticus (ESE) – a life threatening condition.

MCRA's Neurology and Digital Health regulatory teams played a key role in successfully achieving both the Breakthrough Device Designation and clearance of the 510(k) premarket notification for Ceribell's ClarityPro device. MCRA's experts closely partnered with Ceribell's team at every step of the Breakthrough Designation and 510(k). In addition, MCRA's Reimbursement, Health Economics, and Market Access team provided Ceribell with valuable insights, analyses, and strategic guidance on the NTAP application. ClarityPro is the first and only ICU monitoring device to receive CMS NTAP reimbursement, which provides an add-on payment to hospitals when the device is used and minimizes the cost concerns that hospitals have when adopting new technologies. All three

accomplishments - FDA granting the breakthrough designation in October 2022, FDA clearing the 510(k) in May 2023, and CMS approving NTAP in August 2023 - were achieved within a one-year time period due to Ceribell's and MCRA's combined expertise and collaboration across multiple disciplines to achieve expedited patient access in this critical area of unmet need.

John Doucet, Vice President, Neurology Regulatory Affairs at MCRA, stated, "The Neurology Regulatory Affairs team is proud to have worked closely with Ceribell to achieve both the breakthrough designation and 510(k) clearance for their ClarityPro device. This device will assist physicians with recognizing ESE in acute-care environments where timely diagnosis and treatment is critical. MCRA's scientific and regulatory expertise in neurology, software, and machine learning provided critical strategy and analysis that enabled Ceribell to achieve these important milestones for the company, physicians, and patients."

John McDermott, MCRA's Vice President, Reimbursement Strategy and Policy, said, "MCRA's Reimbursement team provided insights and analyses for Ceribell during the NTAP application process. The ClarityPro device will be a tremendous advance in care for patients with seizure activity. By assisting with the NTAP application, we are thrilled to have helped the Clarity Pro device qualify for additional hospital payment, which can greatly accelerate product adoption at launch."

Raymond Woo, CTO of Ceribell said, "Ceribell feels extremely fortunate to have partnered with MCRA on ClarityPro as well as other projects. The FDA Breakthrough Device program is itself relatively new, and the CMS NTAP alternative pathway for breakthrough devices is an even more recent development. It is truly unique for MCRA to have deep expertise and experience in both. On this project, MCRA's involvement spanned the entire spectrum ranging from high-level strategic guidance down to detailed aspects of the submissions themselves."

About MCRA, LLC: MCRA is the leading privately held independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and advisory firm. MCRA delivers to its client's industry experience, integrating its six business value creators: regulatory, clinical research, reimbursement, healthcare compliance, quality assurance, and distribution logistics to provide a dynamic, market-leading effort from innovation conception to commercialization. MCRA's integrated application of these key value-creating initiatives provides unparalleled value for its clients. MCRA has offices in Washington, DC, Hartford, CT, New York, NY, and Tokyo, Japan and serves nearly 1,000 clients globally. Its core focus areas of therapeutic experience include orthopedics, spine, biologics, cardiovascular, diagnostic imaging, wound care, artificial intelligence, dental, anesthesia, general surgery, digital health, neurology, robotics, oncology, general and plastic surgery, urology, and in vitro diagnostic (IVD) devices and medical device cybersecurity. www.mcra.com

About Viscogliosi Brothers, LLC: Viscogliosi Brothers, LLC (VB), founded MCRA in 2004. VB is headquartered in New York City and specialized in funding venture capital, private equity, and merchant banking activities for the neuromusculoskeletal industry. VB is dedicated to financing healthcare innovation. www.vbllc.com

About Ceribell: Ceribell, Inc. (www.ceribell.com) is headquartered in Sunnyvale, CA. Ceribell deploys a cloud-linked, portable electroencephalogram (EEG) device to assess brain waves in minutes to identify the occurrence of seizures in emergency rooms and intensive care units. The Ceribell system can be quickly and easily applied to a patient by any healthcare provider and delivers brain monitoring results within minutes. Ceribell is focused on making EEG widely available, more efficient, and more cost-effective to improve the diagnosis and treatment of neurological conditions for patients at risk for seizures. The Ceribell EEG System first received FDA 510(k) clearance in 2017 and is commercially available in the United States. ceribell.com

For more information, please contact:
Alyssa Howard, Vice President, Business Development
Phone: 215.870.3952 | Email: [email protected]

SOURCE MCRA, LLC