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

MUSCULOSKELETAL CLINICAL REGULATORY ADVISERS, LLC (MCRA) NAMES RICHARD JANSEN TO REGULATORY AFFAIRS STAFF

Former Spine-Tech executive brings 15 years of spine regulatory affairs experience.

New York, NY: November 22, 2006:  Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) announced that Richard Jansen, Pharm. D. has joined the firm as a Senior Regulatory Affairs Spine Specialist.

Mr. Jansen has an extensive knowledge of medical device regulations and regulatory pathways that drive orthopedic devices from conception to market acceptance. He has extensive experience with pre-market submissions in support of Class II and Class III spinal medical devices.

Mr. Jansen said, “I am excited to join such a unique organization whose experience and expertise is encouraging clients worldwide to bring innovative spinal technologies to the U.S. market.”

Mr. Jansen joined Spine-Tech. in 1991, to head its regulatory and clinical activities supporting the company’s BAK device from start-up through Pre-Market Approval (PMA). The BAK device was the first spinal PMA approved by the U.S. Food and Drug Administration (FDA). Mr. Jansen is one of a small group of individuals to guide a spinal implant product from conception through PMA approval. He is also a former chairman of a hospital Institutional Review Board (IRB) that scrutinizes all proposed device and drug applications to ensure their compliance with regulations.

He received his Bachelor of Science in Pharmacy and Doctor of Pharmacy degrees from the University of Minnesota.

Marc R. Viscogliosi, President of MCRA, said, “The spine market has inspired tremendous innovation in recent years, resulting in new regulatory and clinical challenges to the industry, thereby creating great demand for people with Rich Jansen’s experience and accomplishments.

“Obviously, we are delighted to share such assets with companies that may not otherwise be able to market their devices in the U.S. market and, most importantly, bring more treatment options to patients,” he added.

David W. Lown, General Manager of MCRA, said, “Since we formally reorganized and expanded the firm to serve a broader and more geographically diverse range of orthopedic device manufacturers earlier this year, we have attracted several highly regarded experts and strategists of whom Rich Jansen is a shining example.”

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.