MCRA is pleased to announce its role in the successful 510(k) clearance decision by the U.S. Food and Drug Administration (FDA) for Curiteva’s Inspire Porous PEEK Cervical Interbody System with HAFUSE Technology. Curiteva partnered with MCRA on the project and utilized our biocompatibility and strategic expertise to navigate the FDA’s questions and testing requirements.
WASHINGTON, April 24th, 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 the successful 510(k) clearance decision by the U.S. Food and Drug Administration (FDA) for Curiteva’s Inspire Porous PEEK Cervical Interbody System with HAFUSE Technology.
Curiteva pioneered and received FDA Clearance on the world’s first 3D printed, fully interconnected porous PEEK structure, utilizing an internally developed Fused Filament Fabrication novel process and printer. These proprietary printers create a unique porous scaffolding, resulting in a PEEK structure with superior biomechanical strength compared to traditional PEEK implants. This unique architecture and capability to print bone-like scaffolding structures, with the addition of the patented HAFUSE nano-texturing, creates a superior biological environment for bone in-growth throughout the entirety of the implant structure. Curiteva partnered with MCRA late in the process on the project and utilized our biocompatibility and strategic expertise to navigate the FDA’s questions and testing requirements.
Glenn Stiegman, Senior Vice President of Clinical and Regulatory Affairs at MCRA, said “Curiteva engaged with the FDA for over a year on several issues, many of which were biocompatibility and manufacturing in nature. MCRA was able to leverage our internal expertise and experiences to guide Curiteva across the goal line. It was great being a part of this groundbreaking 510(k) clearance decision to help improve implant biomaterials that enhance healing and improve patient outcomes.”
“A typical FDA 510(k) is a 90-day process from submission to clearance. Inspire took 18 months. Partnering with MCRA and utilizing their expertise to evaluate our strategy, and work with the team to navigate the FDA’s questions and testing requirements, couldn’t have gone any better. Their interactions with the FDA, input on responses, support in analysis and presentation of data, provided a high level of confidence for us leading to FDA clearance,” commented Curiteva’s Chief Scientific Officer, Erik Erbe PhD.
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 Curiteva: Curiteva is a privately held technology and manufacturing company dedicated to advancing spine surgery and improving clinical outcomes by partnering with providers and suppliers to deliver innovative and intuitive implant systems to the market. Our business is founded on a commitment to building world-class manufacturing, accelerating research and development, maintaining lean operational discipline, and delivering novel technology to meet the evolving needs of our customers and the patients they serve. For more information, please visit www.curiteva.com.
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