Contacts: David Lown, General Manager
(212) 583-0250 ext. 111 dlown@mcrallc.com
ERNST & YOUNG TO HOST MUSCULOSKELETAL CLINICAL
REGULATORY ADVISERS, LLC IN ROUNDTABLE DISCUSSION FOR ISRAELI ORTHOPEDIC
COMMUNITY
New York, NY: March 23, 2007: Ernst & Young,
one of the world’s leading professional services organizations,
has joined forces with Musculoskeletal Clinical Regulatory Advisers,
LLC (MCRA) and Viscogliosi Brothers, LLC (VB) to host a professional
roundtable discussion, entitled Orthopedics – The New Era:
Technology, Business and Regulatory Trends, about current and future
key issues in the global orthopedic community for Israel’s
orthopedic industry leaders.
The panelists will discuss the state of the orthopedic industry for
Israel’s orthopedic company leaders, investors and surgeons.
Apart from discussing the orthopedic market at large, panelists will
focus their attention on the integration of clinical and regulatory
strategies for successful market entry. It will take place on March
27th at 3:30pm in the Dan Hotel (99 Hayarkon Street, Tel Aviv, Israel)
Anthony G. Viscogliosi, Principal of VB, will lead the panel in a
discussion on the worldwide musculoskeletal industry, as well as
presenting two case studies. The panel includes two experts from
MCRA, a “one-stop” source of consulting services for
innovative musculoskeletal companies seeking to bring new technologies
to market -- Glenn Stiegman, Vice President, Regulatory Affairs,
former Chief, Orthopedics Branch, U.S. Food and Drug Administration
(FDA) and Aviva Barber, Clinical Trials Manager. Mr. Stiegman has
reviewed over 700 regulatory protocols while at the FDA. Ms. Barber
is currently involved in overseeing four clinical studies. She was
a Clinical Development Manager for the Elias Sourasky Medical Center
in Israel.
“Given the highly innovative nature of Israeli medical device
companies, as they bring to market new devices into the US, they
may face significant regulatory hurdles from the FDA,” commented
Anthony G. Viscogliosi. “Business objectives must be married
to the increasingly complex regulatory and clinical strategies in
order to create the success to which most companies aspire. The fundamental
goal for this roundtable is to provide advice and counsel to surgeons,
companies’ executive officers and their investors in their
efforts to facing challenging regulatory and clinical pathways.”
Marc R. Viscogliosi, President of MCRA added, “In my many years
of being in this industry, I have seen hundreds of companies stumble
in their attempt to receive marketing approval in the US. I am glad
to see an influential company like Ernst & Young take the initiative
to educate those in need on current trends within orthopedics. This
intimate and interactive forum to discuss solutions for complex business,
regulatory and clinical strategies should prove fruitful for companies
and patients alike.”
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.
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 information, please visit VB’s website: www.vbllc.com
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