Contacts: David Lown, General Manager
(212) 583-0250 ext. 2111 dlown@mcra.com

MUSCULOSKELETAL CLINICAL REGULATORY ADVISERS, LLC
EXPANDS REIMBURSEMENT DEPARTMENT

New York, NY: November 5, 2007: Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA), an independent orthopedic consulting firm focusing on regulatory, clinical, intellectual property and reimbursement strategy execution, is pleased to announce a significant expansion in its reimbursement resources and capabilities. Key staff additions include Tim Hunter (Director of Reimbursement), Machelle Morningstar (Coding Manager) and Robert Hoehn (Senior Associate).

With the multitude of micro and macro dynamics transpiring within the orthopedic industry both start-up and established orthopedic companies are recognizing the necessity to integrate reimbursement planning throughout the entire product lifecycle. Mr. Hunter, Ms. Morningstar and Mr. Hoehn join Vice President of Reimbursement Charles Schneider as the most recent additions to the MCRA team. Mr. Schneider explained, “the addition of these three individuals will add tremendous strength to the MCRA organization, and provide clients unparalleled experience to address their coverage, coding and payment needs.

Mr. Hunter, Director of Reimbursement, joins MCRA from Ortho Biotech, LLP, a subsidiary of Johnson & Johnson. While at Ortho Biotech, Mr. Hunter, developed coverage strategies for novel technologies, prepared coding applications, developed patient assistance programs and crafted Reimbursement tools for use by Johnson & Johnson customers. Mr. Hunter also has held management positions within the United States Department of Health and Human Services, where Mr. Hunter was the lead analyst for the federal budgets of the Food and Drug Administration and Substance Abuse and Mental Health Services Administration, and the Biotechnology Industry Organization, the national trade association that represents the biotechnology industry.

Ms. Morningstar, Coding Manager, joins MCRA as a 26 year veteran of the healthcare industry, serving in key leadership functions supporting hospitals, physician practices and revenue cycle management organizations. Most recently, Ms. Morningstar served at the Walter Reed Army Medical Center, managing in-patient physician service coding. Ms. Morningstar has recently been elected as President of the American Association of Professional Coders (AAPC), Washington DC Chapter, where she mentors coding experts and leads quality reimbursement initiatives.

Mr. Hoehn, Senior Associate, has transitioned his responsibilities from Regulatory Affairs of MCRA, to Reimbursement. Formerly, Hoehn prepared PMA and 510(k) filings for MCRA clients, worked with clinical study sites to ensure appropriate study management and provided counsel to clients seeking FDA and Canadian regulatory approval. As a Senior Reimbursement Associate, Mr. Hoehn will work with clinical study sponsors to effect proper coverage, coding and reimbursement, assist with coverage policy development and evaluate proposed rules issued by the Centers for Medicare & Medicaid, Department of Health and Human Services and key legislation to provide MCRA’s clients on how best to achieve Reimbursement objectives.

“Understanding the Reimbursement landscape, anticipating future payor requirements while assisting clients in demonstrating superior value are hallmark services offered by MCRA. We are pleased with the addition of these three individuals who bring diverse, and much needed, services to medical device and biologic firms seeking patient access to their technologies,” Mr. Schneider noted.

General Manager David Lown commented, “MCRA’s expansion in its reimbursement services is a reflection of our organization’s commitment to creating the preeminent orthopedic consulting organization. We try to foster an environment where the integration of all of our departments has multiple positive externalities for our clients. With these recent additions, I believe MCRA is positioned for continued growth in 2008.”

About MCRA, LLC
MCRA was founded in 2003 and provides “first-in-class” service to its clients through its superior knowledge base, global surgeon relationships and deeply experienced management team. The true value of MCRA is the integration of 5 business value creators – regulatory, reimbursement, clinical, intellectual property and quality assurance. MCRA places particular emphasis on working with companies at all stages of development, whether they are single-product companies or companies with several thousand technologies.