Contacts: Marc R. Viscogliosi, President
(212) 583-0250 ext. 103 mviscogliosi@mcrallc.com

MCRA TO LEAD PANEL AT MEDTECH INSIGHT’S “IN-SPINE & ORTHOPEDICS” MEETING

New York, NY: December 1, 2006: Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) will host a panel on legal, regulatory and clinical issues during MedTech Insight’s “In Spine & Orthopedics” conference on December 11th, 2006.

Entitled Creating Your Legal & Regulatory Roadmap for Clinical Success, panelists will discuss the need to integrate clinical data, intellectual property protection and regulatory strategy to achieve greater efficiency in guiding orthopedic devices through the approvals process.

Anthony G. Viscogliosi, Chairman & CEO of Small Bone Innovations, Inc. (SBi) will moderate and lead the panel. Panelists will include several experts from MCRA, a “one-stop” source of consulting services for device manufacturers seeking to bring new technologies to market. They are: Dr. Gary Lowery, Executive Vice President and renowned orthopedic and spine surgeon; Tram Nguyen, Director, Intellectual Property, former patent attorney and examiner in the Medical Devices Unit at the U.S. Patent and Trademark Office; and, Richard Jansen, Pharm. D., Senior Regulatory Affairs Spine Specialist, who oversaw the first Premarket Approval in the spine industry of the BAK cage.

Delegates will learn first hand about the current attitudes toward new orthopedic devices and the increasingly stringent regulatory environment in Washington, D.C. – and how their companies must adapt to these changing conditions.

Commenting on the event, Anthony Viscogliosi said: “Due to the rapid growth in the use and acceptance of orthopedic implants and devices worldwide, increasingly complicated legal and regulatory pathways have begun to hamper the ability of manufacturers to bring more innovative technologies to surgeons and their patients. I expect the panel to offer highly effective advice and field many questions from company executives who have without a doubt, struggled to clear these hurdles.”

Anthony’s brother, Marc R. Viscogliosi, President of the four-year-old MCRA, added: “During our 15 years or so of developing technologies and advising others on the process, the challenge of bringing life-changing products to market is becoming overshadowed by concerns about reimbursement, protecting intellectual property and satisfying a host of regulatory concerns. One of our fundamental goals is to persuade people, especially surgeons, that help is at hand – genius need not be sacrificed on the altar of expediency.”

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.