NEWS

 

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

 

 
 
Phone: 202.552.5800
Fax: 202.552.5798
Email: info@mcra.com