WASHINGTON, April 3rd, 2024/PRNewswire/ -- MCRA, the leading privately held independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and healthcare advisory firm is proud to announce its role in supporting Bone Health Technologies in achieving its De Novo clearance from the US Food and Drug Administration (FDA).
Bone Health Technologies retained MCRA for regulatory support with its De Novo submission for OsteoBoost in October of 2022. MCRA’s Orthopedic regulatory team jumped in to review and provide feedback on the submission. With MCRA’s expert feedback, Bone Health Technologies submitted their De Novo request to the FDA in February of 2023 and the De Novo was granted in January 2024.
Dave McGurl, Vice President of Regulatory Affairs states, “We are thrilled to have supported Bone Health Technologies in achieving this significant milestone with the FDA. The granting of this De Novo submission underscores our commitment to regulatory excellence and our dedication to helping innovative companies navigate complex regulatory pathways. OsteoBoost is a breakthrough treatment filling a critical treatment gap for women with osteopenia, demonstrating the shared dedication of Bone Health Technologies and MCRA to enhancing healthcare outcomes. We're excited about the positive impact OsteoBoost will have on countless individuals and look forward to continuing our partnership with Bone Health Technologies as they bring their groundbreaking solutions to market, ultimately improving lives and advancing healthcare.”
Laura Yecies, CEO of Bone Health Technologies states, “Bone Health Technologies was pleased to partner with MCRA for our first in class, de novo submission of Osteoboost - a class II prescription device. This approval marks the first ever non-pharmacological prescription treatment approved for the enormous unmet need of low bone density. It is also the first ever treatment approved that is specifically designed for osteopenia - as a key early intervention for bone loss. Our wearable medical device, a vibration belt, dramatically reduced the loss of bone strength and bone density, measured by CT scan in post-menopausal treatment. Given the novelty of this submission, our partnership with the regulatory experts at MCRA played a critical role in the successful approval of this breakthrough device. Now, Bone Health Technologies looks forward to working with MCRA’s reimbursement team to support its reimbursement strategy and position OsteoBoost for successful commercialization.”
Anthony Viscogliosi, CEO of MCRA states, “MCRA’s track record of success for orthopedic De Novo submissions to the FDA highlights the inherent value and standing our experts have in the medical device industry. We are proud to continue supporting these critical innovations by delivering exceptional support to all of our clients around the world.”
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 seven business value creators: regulatory, clinical research, reimbursement, healthcare compliance, quality assurance, cybersecurity 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, London, England, Winterthur, Switzerland, Eschborn, Germany 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, respiratory, ENT, general surgery, digital health, neurology, robotics, oncology, general and plastic surgery, urology, and in vitro diagnostic (IVD) devices. 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
For more information, please contact:
Alyssa Howard, Vice President, Business Development
Phone: 215.870.3952 | Email: ahoward@mcra.com