MCRA Responsible for Regulatory Strategy and
Support for FDA Submission Process
WASHINGTON, May 7, 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 Orthobond with achieving a granted
US Food and Drug Administration (FDA) De Novo for the Mariner
Pedicle Screw System with Ostaguard™ coating. This De Novo
grant marks the first spine device to be treated with a coating
that reduces bacterial contamination in the operating room.
MCRA Responsible for Regulatory Strategy
and Support for FDA Submission for Orthobond's Ostaguard.
Orthobond engaged MCRA in March
2020 to help support their pre-submission efforts in gaining
FDA feedback to their proposed performance testing suite for their
Ostaguard antibacterial technology. MCRA's Spine team developed the
regulatory strategy with subsequent pre-submission and supported
Orthobond through the entirety of the FDA process and submitted the
De Novo on Orthobond's behalf. On April
5th, the FDA granted the Ostaguard antibacterial coating on
the SeaSpine Mariner Pedicle Screw System for commercial use.
Justin Eggleton, Vice President,
Head of Musculoskeletal Regulatory Affairs, states "This De Novo
grant is a testament to Orthobond's relentless innovation and marks
a significant leap forward in patient care and safety. The FDA's
favorable decision demonstrates Orthobond's vision and Ostaguard's
potential to make a major difference in healthcare. MCRA takes
immense pride in supporting Orthobond's important regulatory
milestone, which resonates with our fundamental mission to
facilitate the introduction of safe and effective medical
innovations into our healthcare system."
David Nichols, CEO of Orthobond,
states "Having worked with MCRA on other first-to-market
technologies, I knew they would be the right partner for Orthobond
when we began the DeNovo process for our antibacterial surface
technology, Ostaguard. MCRA possesses the breadth and depth of
talent necessary to not only deal with the regulatory plans and
overall strategy, but the critical daily tactics such as regulatory
research, documentation and writing. What MCRA brings to a project
like this is a diversely talented team focused on ensuring a
submission of this magnitude is done with expertise."
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 Orthobond Corporation: Orthobond Corporation is a
surface technology company that has developed proprietary
antibacterial surfaces, with broad applications in the medical
device industry and more such as commercial, industrial,
automotive, and beyond. Orthobond is the first company to utilize
surface modifications that can be permanently bound to any surface,
killing bacteria by mechanically rupturing pathogens without using
eluting antibiotics.
For more information, please
contact:
Alyssa Howard,
Vice President, Business Development
Phone: 215.870.3952 | Email: ahoward@mcra.com
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SOURCE MCRA, LLC