Contacts: Marc R. Viscogliosi,
President
(212) 583-0250 ext. 103 mviscogliosi@mcrallc.com
MUSCULOSKELETAL CLINICAL REGULATORY ADVISERS,
LLC NAMES
GLENN A. STIEGMAN, III AS VICE PRESIDENT, REGULATORY AFFAIRS
Former Chief of Orthopedics Devices Branch of FDA to lead regulatory
process for Viscogliosi Bros., LLC portfolio companies, including
Paradigm Spine, LLC, Raymedica, Inc. and Small Bone Innovations,
Inc.
New York, NY: January 30, 2006: Musculoskeletal
Clinical Regulatory Advisors, LLC (MCRA) announced that Glenn A.
Stiegman, III, has joined as Vice President, Regulatory Affairs.
MCRA is a portfolio company of Viscogliosi Bros., LLC (VB), a venture
capital, private equity and merchant banking firm dedicated to the
musculoskeletal/orthopedics sector of the health care industry.
Mr. Stiegman is joining MCRA from the U.S. Food and Drug Administration,
where he was the Chief of the Orthopedics Devices Branch for the
Office of Device Evaluation. In his position, Mr. Stiegman supervised
a team of 17 engineers, material scientists and physicians on the
regulation of orthopedic Class II and Class III medical devices.
He has extensive knowledge about medical device regulations and regulatory
pathways to drive a device from conception to market. Prior to becoming
Branch Chief, Mr. Stiegman had been Team Leader for Carotid Stents
and Team Leader for Spinal Devices, in which he authored Industry
Guidance Documents for seeking 510(k) market clearance.
While at the FDA, Mr. Stiegman received the FDA Group Recognition
Award and numerous performance awards. He has a Bachelor of Science
in Biomedical Engineering from Tulane University and a Master of
Science in Bioengineering from Clemson University.
Mr. Stiegman said, “I am excited to have the opportunity to
help the VB family of portfolio companies bring their outstanding
products to the US market by working through the US regulatory process.
My experience as Branch Chief for Orthopedics Devices will enable
us to work efficiently with the FDA as we design and conduct clinical
trials and seek marketing clearance for Class II devices.”
Marc R. Viscogliosi, President of MCRA, LLC said, “We are thrilled
to have someone with Glenn’s background and enthusiasm in the
VB family. The fact that he rose so quickly to Branch Chief at the
FDA speaks to his talent and drive for results, attributes which
will help MCRA offer a level of service, strategy and counsel to
its clients that will be unparalleled.”
Gary L. Lowery, MD, PhD, Executive Vice President of Research and
Technology with Paradigm Spine, LLC said, “Very few people
in the world possess the insight, experience and knowledge of the
regulation of orthopedic devices that Glenn possesses. I look forward
to working very closely with Glenn on multiple spine non-fusion products
and projects.”
John J. Viscogliosi, Chief Executive Officer of Raymedica, LLC said
“I am excited to work with Glenn and to benefit from his knowledge,
experience and insight into the burgeoning new field of Nucleus Arthroplasty™.”
Anthony G. Viscogliosi, Chief Executive Officer of Small Bone Innovations,
Inc. said “Conditions associated with the treatment of small
bones and joints affects every person in their lifetime. There is
an enormous opportunity for the development of products to help surgeons
treat their patients and with Glenn’s involvement, we are confident
that thousands of patients in US will benefit from bringing these
products to market.”
Glenn’s initial priority will be to work closely with Paradigm
Spine, Raymedica and Small Bone Innovations on their various product
portfolios. Over time, Glenn will also closely work with other MCRA
client companies that may benefit from his experience and expertise.
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 (IP), 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.
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.
For more on Paradigm Spine, please visit www.paradigmspine.com.
For more on Raymedica, please visit www.raymedica.com.
For more on Small Bone Innovations, please visit www.totalsmallbone.com. |
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