Contacts: Marc R. Viscogliosi, President, MCRA, LLC, (212) 583-9700
ext. 103, firstname.lastname@example.org
Chris Storer, (203) 705-9219, email@example.com
MUSCULOSKELETAL CLINICAL REGULATORY ADVISORS, LLC NAMES GLENN A. STIEGMAN,
III AS VICE PRESIDENT
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 – 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.
Glenn is joining MCRA from the US Food and Drug Administration, where
he was the Chief of the Orthopedics Devices Branch for the Office of
Device Evaluation. In his position, Glenn 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 Glenn 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, Glenn 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.
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, Inc. 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
MCRA was formed in early 2005 within the VB family of companies with
Marc R. Viscogliosi as President. The mission of MCRA is to enhance
the value of client companies by managing the Clinical Research and
Regulatory functions by assisting client companies through the complex
and difficult pathways of US FDA regulatory approval processes.
Focusing on entrepreneur-based orthopedic companies, MCRA brings together
in a synergistic manner the extensive network of VB along with specific
expertise of the complex processes involved in Clinical and Regulatory
management, making MCRA unique among this type of management company.
MCRA brings real cost effectiveness to companies primarily backed by
Venture Capitalists, Angel Investors, and Physician Founders and run
by an entrepreneur by providing highly experienced, talented and dedicated
professionals to manage the Regulatory and Clinical functions of these
About Viscogliosi Bros., 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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