Contacts: Marc R. Viscogliosi, President
(212) 583-0250 ext. 103 firstname.lastname@example.org
CLINICAL REGULATORY ADVISERS, LLC (MCRA) NAMES RICHARD JANSEN TO REGULATORY
Spine-Tech executive brings 15 years of spine regulatory affairs experience.
NEW YORK NY, November 22, 2006 - Musculoskeletal Clinical Regulatory
Advisers, LLC (MCRA) announced that Richard Jansen, Pharm. D. has
joined the firm as a Senior Regulatory Affairs Spine Specialist.
Mr. Jansen has an extensive knowledge of medical device regulations
and regulatory pathways that drive orthopedic devices from conception
to market acceptance. He has extensive experience with pre-market submissions
in support of Class II and Class III spinal medical devices.
Mr. Jansen said, “I am excited to join such a unique organization
whose experience and expertise is encouraging clients worldwide to bring
innovative spinal technologies to the U.S. market.”
Mr. Jansen joined Spine-Tech. in 1991, to head its regulatory and clinical
activities supporting the company’s BAK device from start-up through
Pre-Market Approval (PMA). The BAK device was the first spinal PMA approved
by the U.S. Food and Drug Administration (FDA). Mr. Jansen is one of
a small group of individuals to guide a spinal implant product from
conception through PMA approval. He is also a former chairman of a hospital
Institutional Review Board (IRB) that scrutinizes all proposed device
and drug applications to ensure their compliance with regulations.
He received his Bachelor of Science in Pharmacy and Doctor of Pharmacy
degrees from the University of Minnesota.
Marc R. Viscogliosi, President of MCRA, said, “The spine market
has inspired tremendous innovation in recent years, resulting in new
regulatory and clinical challenges to the industry, thereby creating
great demand for people with Rich Jansen’s experience and accomplishments.
“Obviously, we are delighted to share such assets with companies
that may not otherwise be able to market their devices in the U.S. market
and, most importantly, bring more treatment options to patients,”
David W. Lown, General Manager of MCRA, said, “Since we formally
reorganized and expanded the firm to serve a broader and more geographically
diverse range of orthopedic device manufacturers earlier this year,
we have attracted several highly regarded experts and strategists of
whom Rich Jansen is a shining example.”
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
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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