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

MUSCULOSKELETAL CLINICAL REGULATORY ADVISERS, LLC UNVEILS SERVICES TO WORLDWIDE ORTHOPEDIC DEVICE INDUSTRY

New York, NY: September 22, 2006:  Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) of New York, told surgeons and industry leaders attending the annual North American Spine Society (NASS) conference that it will offer its advisory services to innovative orthopedic device companies seeking entry into the U.S. market. MCRA, formed in 2003 by Viscogliosi Brothers, LLC (VB) to help develop the firm’s portfolio of technologies, has since assembled a group of experienced strategists with successful track records in executing regulatory, clinical, intellectual property, and reimbursement strategies in the orthopedic industry, including Glenn A. Stiegman, former Chief of the FDA’s Orthopedics Devices Branch in Washington, DC, Justin Eggleton, formed lead reviewer in Orthopedic Device Branch of the FDA and Tram Anh Nguyen, former patent examiner at the U.S. Patent and Trademark Office.
 
MCRA will provide comprehensive clinical and regulatory services that leverage the firm’s knowledge, global surgeon relationships and accomplishments of nearly one thousand approved orthopedic devices. Since 2003, MCRA has provided its services predominantly to VB portfolio companies, such as Paradigm Spine LLC, Raymedica LLC and Small Bone Innovations, Inc., but is now offering its services to the worldwide orthopedic industry.
 
Marc R. Viscogliosi, President of MCRA, said: “Our value is centered on the integration of regulatory, clinical, intellectual property and reimbursement disciplines at the highest possible level of achievement.
 
“MCRA is able to run the gamut from advising a client on product trials, for example, to actually directly managing the entire process,” he added.
 
“We will tailor strategies to specific client needs. One may engage us to provide perspective on the scope and goals of a pre-clinical study, yet we are fully capable of developing and executing a Premarket Application from start to finish,” Marc Viscogliosi noted.
 
MCRA’s staff of 14 professionals now offers an aggregate of 100 years of orthopedic knowledge and expertise that extends from regulatory and clinical services to include the increasingly complex and critical aspects of intellectual property and reimbursement.

Anthony G. Viscogliosi, Principal of Viscogliosi Brothers, LLC. said: “I am both excited and confident that the orthopedics world, which is rapidly approaching $30 billion in revenues, is ready for MCRA. We already have contacts and relationships with more than 1,500 private, public and not-for-profit companies – large and small – many of whom have essentially demanded that we make these services available on the broadest possible basis.”
 
David Lown, General Manager of MCRA and a veteran of the orthopedics business, said: “I am honored to lead the operational direction of MCRA. The talent that has been assembled at MCRA is special and over the course of the next twelve months, we plan to continue adding both highly accomplished strategists and young professionals with ambitions to learn by performing with the best.”

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 a company to successful value creation. 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.