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PRESS RELEASES
Contacts: Marc R. Viscogliosi, President
(212) 583-0250 ext. 103 mviscogliosi@mcrallc.com
MUSCULOSKELETAL
CLINICAL REGULATORY ADVISERS, LLC (MCRA)
HIRES DIRECTOR, ORTHOPEDIC REGULATORY AFFAIRS, HOLLACE RHODES
Former FDA Lead Reviewer Joins Orthopedic Consulting Team
NEW YORK NY, February 12, 2007 - Musculoskeletal Clinical Regulatory
Advisers, LLC (MCRA) announced that Hollace Rhodes will join the firm’s
Regulatory Team as the Director, Orthopedic Regulatory Affairs. Ms.
Rhodes joins the firm from the Food and Drug Administration (FDA)
where she was a lead reviewer in the Orthopedic Devices Branch and
Orthopedic Joint Devices Branch.
Ms. Rhodes brings to MCRA a wealth of knowledge from the FDA, where
she worked for 17 years. While at the FDA, Ms. Rhodes was a lead reviewer
on over 400 510(k) applications, 25 Investigational Device Exemptions
(IDEs) and 10 Premarket Approvals (PMAs). During her tenure, Ms. Rhodes
evaluated the first PMA-approved spinal device and the first cervical
interbody fusion device. She was also the focal point for all total
ankle devices and was the point person for reclassification petitions
of the porous coated total hip and the mobile-bearing ankle.
Ms. Rhodes received her Bachelor of Science in Engineering from Duke
University. After her matriculation, Ms. Rhodes worked in Cleveland’s
Mt. Sinai Medical Center where she coordinated a CME program for more
than 300 orthopedic surgeons and published a paper on survivorship analysis
of cemented and porous hip implant systems. Ms. Rhodes said, “MCRA
has assembled an impressive team of experts to assist firms in bringing
innovative orthopedic technologies to market. I am very excited to join
MCRA and I look forward to using my extensive experience to help companies
smoothly navigate the U.S. regulatory process.”
Marc R. Viscogliosi, President of MCRA, said, “To have Ms. Rhodes
join the MCRA team is truly a reflection of our company’s vision
and commitment to success. Ms. Rhodes performance and reputation is
unquestioned in US FDA regulatory history. With her joining the MCRA
team, I am sure Ms. Rhodes will help MCRA build the regulatory team
toward the common vision of offering best in class services to the orthopedic
industry.”
David Lown, General Manager of MCRA, noted, “One of MCRA’s
operational goals is to be the nexus of regulatory, clinical, reimbursement
and intellectual property information within the orthopedic industry.
This goal will allow for efficiencies that will improve the performance
and execution for both, regulatory agencies and our clients.”
Lown added, “With joining the team, we believe Ms. Rhodes will
help MCRA in both, the short term and long term. In the short term,
Ms. Rhodes gives MCRA experience in anatomies and niches not previously
attained. In the long term, we hope Ms. Rhodes’ tutelage will
inspire and educate our junior and senior team members to build MCRA
to the Company’s vision.”
About MCRA, LLC
Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) is a highly
specialized, independently operated consulting firm serving the worldwide
orthopedic industry. MCRA is a group of leading strategists committed
to executing regulatory, clinical, intellectual property, and reimbursement
strategies to move your company to successful value creation. Founded
in 2003 by Viscogliosi Brothers, LLC, the firm provides "first-in-class"
service to its clients through its superior knowledge base, global surgeon
relationships and deeply experienced management team. MCRA places particular
emphasis on working with companies at all stages of development, whether
they are single-product companies or companies with multiple technologies.
The true value of MCRA is the ability to cover the entire lifecycle
of a product or technology by taking a product from the conceptual pre-clinical
stage to market approval.
For more information visit www.mcrallc.com
About Viscogliosi Brothers, LLC
Established by Marc R. Viscogliosi, John J. Viscogliosi and Anthony
G. Viscogliosi in New York City in 1999, VB was the first venture capital/private
equity and merchant banking firm dedicated to the musculoskeletal/orthopedics
sector of the health care industry. Today, VB is a leading independent
firm with a mission to create, build and finance companies founded on
innovations developed by surgeons and uniquely focused on "life-changing"
musculoskeletal/orthopedic technologies. VB has worldwide surgeon, industry
and trade relationships and significant financial expertise in the musculoskeletal/-orthopedic
sector.
As principals of VB, the Viscogliosi brothers have a combined total
of more than 35 years experience analyzing and investing in the musculoskeletal/orthopedics
sector. They have pioneered innovative financial, strategic and management
initiatives for companies in the sector, from start-up, seed and development
stage all the way to exit, while helping thousands of people lead better
lives through the orthopedic and spinal products marketed and sold by
the companies they have assisted in developing and financing.
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