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

MUSCULOSKELETAL CLINICAL REGULATORY ADVISERS, LLC (MCRA)
HIRES DIRECTOR, ORTHOPEDIC REGULATORY AFFAIRS, HOLLACE RHODES

Former FDA Lead Reviewer Joins Orthopedic Consulting Team

New York, NY: February 9, 2007: Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) announced that Hollace Rhodes will join the firm’s Regulatory Team as the Director, Orthopedic Regulatory Affairs. Ms. Rhodes joins the firm from the Food and Drug Administration (FDA) where she was a lead reviewer in the Orthopedic Devices Branch and Orthopedic Joint Devices Branch.

Ms. Rhodes brings to MCRA a wealth of knowledge from the FDA, where she worked for 17 years. While at the FDA, Ms. Rhodes was a lead reviewer on over 400 510(k) applications, 25 Investigational Device Exemptions (IDEs) and 10 Premarket Approvals (PMAs). During her tenure, Ms. Rhodes evaluated the first PMA-approved spinal device and the first cervical interbody fusion device. She was also the focal point for all total ankle devices and was the point person for reclassification petitions of the porous coated total hip and the mobile-bearing ankle.

Ms. Rhodes received her Bachelor of Science in Engineering from Duke University. After her matriculation, Ms. Rhodes worked in Cleveland’s Mt. Sinai Medical Center where she coordinated a CME program for more than 300 orthopedic surgeons and published a paper on survivorship analysis of cemented and porous hip implant systems. Ms. Rhodes said, “MCRA has assembled an impressive team of experts to assist firms in bringing innovative orthopedic technologies to market. I am very excited to join MCRA and I look forward to using my extensive experience to help companies smoothly navigate the U.S. regulatory process.”

Marc R. Viscogliosi, President of MCRA, said, “To have Ms. Rhodes join the MCRA team is truly a reflection of our company’s vision and commitment to success. Ms. Rhodes performance and reputation is unquestioned in US FDA regulatory history. With her joining the MCRA team, I am sure Ms. Rhodes will help MCRA build the regulatory team toward the common vision of offering best in class services to the orthopedic industry.”

David Lown, General Manager of MCRA, noted, “One of MCRA’s operational goals is to be the nexus of regulatory, clinical, reimbursement and intellectual property information within the orthopedic industry. This goal will allow for efficiencies that will improve the performance and execution for both, regulatory agencies and our clients.”

Lown added, “With joining the team, we believe Ms. Rhodes will help MCRA in both, the short term and long term. In the short term, Ms. Rhodes gives MCRA experience in anatomies and niches not previously attained. In the long term, we hope Ms. Rhodes’ tutelage will inspire and educate our junior and senior team members to build MCRA to the Company’s vision.”

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