- MCRA's CRO and Regulatory Teams assisted Active Life Scientific, Inc. with integrated regulatory and clinical research services to support the successful granting of an orthopedic de novo by the U.S. Food and Drug Administration (FDA), allowing Active Life Scientific, Inc. to initiate commercialization in the US for the OsteoProbe®, a new tool to measure bone tissue.
- The OsteoProbe® will provide a new way to quantify bone material quality in the clinic, informing physician decision making, resulting in improved patient management, and ultimately helping prevent fragility fractures. Bone quality assessment is a new concept with great potential.
WASHINGTON, Dec. 8, 2021 /PRNewswire/ -- MCRA, LLC, a leading medical device and biologics advisory firm and clinical research organization (CRO) integrating U.S. and International Regulatory, Clinical Research, Reimbursement, Healthcare Compliance, Quality Assurance, and Cybersecurity is pleased to announce its role in the granting of the de novo by the U.S. Food and Drug Administration (FDA) for Active Life Scientific, Inc.'s OsteoProbe®. The OsteoProbe® is a portable handheld impact microindenter that measures the ability of bone material to resist indentation.
The OsteoProbe® is differentiated from other radiological or imaging methods (X-ray, DXA and CT) that measure bone mineral density and bone mineral structure. The OsteoProbe® measures bone material quality, which is an independent component of bone health. It uses Reference Point Indentation (RPI) technology to investigate the bone material's ability to resist a localized force and is further quantified by the Bone Material Strength index (BMSi) or Bone Score™.
Dr. Peter Burks, Chief Executive Officer at Active Life Scientific said, "We've worked with MCRA since late summer 2019. Interactions began with regulatory assistance on our Q-sub related to our De Novo application, then evolved into a successful IDE application followed by CRO services to support the IDE clinical trial execution. I understand the challenges of selecting a CRO as a small biotech company, and I evaluated many prior to choosing MCRA. I have been extremely happy with our decision to work with MCRA in support of our regulatory and clinical needs which is evidenced by this de novo achievement."
Dave McGurl, MCRA's Senior Director of Regulatory Affairs, said, "MCRA is at the forefront of helping companies navigate the de novo regulatory pathway to achieve success in bringing novel devices to the U.S. market." The "de novo pathway" is one that allows new technologies, like the OsteoProbe®, to find a pathway to the U.S. market and ultimately to patients.
Iman Ahmad, MCRA's Senior Director of Clinical Affairs, said, "The OsteoProbe® serves a valuable patient and physician need. It has the clinical benefit of being low cost and capable of being administered in a physician's office in under five minutes, whilst providing data regarding a significant bone health indicator that can be used for prophylactic bone healthcare and decisions regarding the suitability of medical interventions where bone health quality is an important medical consideration (e.g., longevity of orthopedic implants). MCRA's CRO is delighted to have supported Active Life Scientific in bringing this technology to the US market and in improving healthcare delivery globally."
To date, MCRA's clinical and regulatory teams have supported 6 successful de novos, including 4 out of the 8 orthopedic de novos granted by US FDA.
About MCRA, LLC: MCRA is the leading privately held independent medical device and biologics Clinical Research Organization (CRO) and advisory firm. MCRA delivers to its clients industry experience at integrating five business value creators: regulatory, clinical research, reimbursement, healthcare compliance, and quality assurance 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, and New York, NY, and served nearly 1,000 clients globally. Its core focus areas of therapeutic experience include orthopedics, spine, cardiovascular, diagnostic imaging, wound care, artificial intelligence, dental, general surgery, digital health, neurology, robotics, 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 specializes 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 Active Life Scientific, Inc: Active Life Scientific, Inc. is a medical technology company that has developed a fundamentally new approach to measuring bone. They develop life science research and diagnostic tools to quantify physical properties of tissues without the need for an invasive biopsy. The company is headquartered in Santa Barbara, California. www.activelifescientific.com
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