Musculoskeletal Clinical Regulatory Advisors, LLC (MCRA) announced that Glenn A. Stiegman, III, has joined as Vice President, Regulatory Affairs. MCRA is a portfolio company of Viscogliosi Bros., LLC (VB), a venture capital, private equity and merchant banking firm dedicated to the musculoskeletal/orthopedics sector of the health care industry.
Glenn is joining MCRA from the US Food and Drug Administration, where he was the Chief of the Orthopedics Devices Branch for the Office of Device Evaluation. In his position, Glenn supervised a team of 17 engineers, material scientists and physicians on the regulation of orthopedic Class II and Class III medical devices. He has extensive knowledge about medical device regulations and regulatory pathways to drive a device from conception to market. Prior to becoming Branch Chief Glenn had been Team Leader for Carotid Stents and Team Leader for Spinal Devices, in which he authored Industry Guidance Documents for seeking 510(k) market clearance.
While at the FDA, Glenn received the FDA Group Recognition Award and numerous performance awards. He has a Bachelor of Science in Biomedical Engineering from Tulane University and a Master of Science in Bioengineering from Clemson University.
Stiegman said, "I am excited to have the opportunity to help the VB family of portfolio companies bring their outstanding products to the US market by working through the US regulatory process. My experience as Branch Chief for Orthopedics Devices will enable us to work efficiently with the FDA as we design and conduct clinical trials and seek marketing clearance for Class II devices."
Marc R. Viscogliosi, President of MCRA, LLC said, "We are thrilled to have someone with Glenn's background and enthusiasm in the VB family. The fact that he rose so quickly to Branch Chief at the FDA speaks to his talent and drive for results, attributes which will help MCRA offer a level of service, strategy and counsel to its clients that will be unparalleled."
Gary L. Lowery, MD, PhD, Executive Vice President of Research and Technology with Paradigm Spine, LLC said, "Very few people in the world possess the insight, experience and knowledge of the regulation of orthopedic devices that Glenn possesses. I look forward to working very closely with Glenn on multiple spine non-fusion products and projects."
John J. Viscogliosi, Chief Executive Officer of Raymedica, Inc. said, "I am excited to work with Glenn and to benefit from his knowledge, experience and insight into the burgeoning new field of Nucleus Arthroplasty(TM)."
Anthony G. Viscogliosi, Chief Executive Officer of Small Bone Innovations, Inc. said, "Conditions associated with the treatment of small bones and joints affects every person in their lifetime. There is an enormous opportunity for the development of products to help surgeons treat their patients and with Glenn's involvement, we are confident that thousands of patients in US will benefit from bringing these products to market."
Glenn's initial priority will be to work closely with Paradigm Spine, Raymedica and Small Bone Innovations on their various product portfolios. Over time, Glenn will also closely work with other MCRA client companies that may benefit from his experience and expertise.
About MCRA., LLC
MCRA was formed in early 2005 within the VB family of companies with Marc R. Viscogliosi as President. The mission of MCRA is to enhance the value of client companies by managing the Clinical Research and Regulatory functions by assisting client companies through the complex and difficult pathways of US FDA regulatory approval processes.
Focusing on entrepreneur-based orthopedic companies, MCRA brings together in a synergistic manner the extensive network of VB along with specific expertise of the complex processes involved in Clinical and Regulatory management, making MCRA unique among this type of management company. MCRA brings real cost effectiveness to companies primarily backed by Venture Capitalists, Angel Investors, and Physician Founders and run by an entrepreneur by providing highly experienced, talented and dedicated professionals to manage the Regulatory and Clinical functions of these companies.
About Viscogliosi Bros., 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 on Paradigm Spine, please visit http://www.paradigmspine.com. For more on Raymedica, please visit http://www.raymedica.com. For more on Small Bone Innovations, please visit http://www.totalsmallbone.com.
Source: Musculoskeletal Clinical Regulatory Advisors, LLC
