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PRESS RELEASES
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.
For more information visit www.mcrallc.com
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.
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