European Union Full Approval Finalized
ISO 13485:2003 FDA Approval in Place
Highest Standards of Quality Assurance and Regulatory
Compliance Maintained
NEW YORK, Sept. 5, 2006 (PRIMEZONE) --Small Bone Innovations, Inc. (SBi), a single-source provider of products, technology and education for the small bone and joint sector of the orthopedic industry, has received its CE Certificates and has completed all necessary steps to certify its quality system and devices.
CE certification is awarded to companies that demonstrate manufacturing procedures that synergize with essential health and safety requirements. With this CE certificate, SBi is approved to "CE mark" products made in its U.S. facilities and distribute them throughout the E.U. The company's SBi International division, based in Bourg-en-Bresse, France, holds its own "CE mark" certificates and currently distributes a wide range of small bone and joint orthopedic implants worldwide.
Combined with the ISO 13485:2003 approval that the company received last November, SBi is now fully qualified to design, develop, manufacture and distribute medical devices within its specified area of business and market them throughout the United States, Canada, the European Union, and other areas throughout the world that recognize these certifications.
ISO 13485:2003 specifies requirements for a quality management system where a company needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements, applicable to medical devices and related services. SBi's manufacturing facility in Morrisville, PA is a U.S. FDA registered facility, fully compliant with FDA Quality System Regulations, 21 CFR 820. The facility is registered with the State of Pennsylvania for machining and finishing manufacturing operations, and functions include contract management, manufacturing engineering, purchasing, manufacturing planning, machine operation, facilities management, quality control, shipping and receiving.
Anthony G. Viscogliosi, Chairman & CEO of SBi, said, "Small Bone Innovations, Inc. proudly provides safe and effective small bone arthroplasty and trauma devices that improve quality of life and meet all regulatory requirements. Our commitment to safety and reliability includes customer service and feedback, design controls and manufacturing processes. At the end of this safe and effective line of quality systems is the surgeon, confident they are working with the highest class of device, and the patient, relieved that their life-changing implant has been designed and manufactured to the peak of standards. The entire SBi family is to be commended for reaching this impressive goal."
About Small Bone Innovations, Inc.
Small Bone Innovations, Inc. (SBi) was founded in 2004 by Viscogliosi Bros., LLC, (VB), the New York-based merchant banking firm that specializes in the musculoskeletal/orthopedic sector. VB created SBi as the first company to focus purely on small bone and joint science. By integrating established companies and professionals in the field, SBi today offers a broad, clinically proven portfolio of products and technologies to treat trauma and diseases in small bones and joints. Today, SBi has more than 140 employees at facilities in New York, NY, Morrisville, PA, Minneapolis, MN and Bourg-en-Bresse, France.
VB's acquisitions and technology licenses included: Avanta Orthopaedics, Inc. (hand/wrist/elbow arthroplasty and trauma products -- U.S.A.); Envision, Inc. (implant manufacturing -- U.S.A.); Actipore(tm) (porous metal technology -- Canada); Artelon(r) (biologically active and biodegradable technology -- Sweden); Xtremi-T, LLC (resorbable trauma technology -- U.S.A.); and Fixano, S.A.S. (broad line of small bone and joint implants -- France).
SBi completed a Series B financing, raising a record total of $42.2 million, announced in January, 2006. Based on data provided by Venture Source, this was the largest venture capital investment ever recorded in the field of orthopedic devices. SBi was a 2006 recipient of Red Herring magazine's annual "Red Herring 100 North America" award, recognized as one of the nation's leading technology companies and the only orthopedic device company selected among an initial entry of more than one thousand firms. Additionally, SBi's Artelon CMC-I Spacer, developed for patients with thumb base osteoarthritis, was featured on the cover and highlighted within Medical Design Technology magazine's "Year of Innovation" issue as one of the most fascinating technologies influencing the medical device industry.
For more information on SBi, please visit: www.totalsmallbone.com
About Viscogliosi Bros., LLC
Established by Marc R. Viscogliosi, John J. Viscogliosi and Anthony G. Viscogliosi in New York City in 1999, Viscogliosi Bros., LLC (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 nearly half a century of experience analyzing and investing in the musculoskeletal/orthopedics sector, directing literally billions of dollars through the orthopedics industry. They have pioneered innovative financial, strategic and management initiatives for nearly 150 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 about VB, please visit: www.vbllc.com
Forward-Looking Statements
This press release contains forward-looking statements as defined in the U.S. Private Securities Litigation Reform Act of 1995. Readers are cautioned not to place undue reliance on these forward-looking statements. Actual results may differ materially from those indicated by these forward-looking statements as a result of risks and uncertainties impacting the Company's business including increased competition; the ability of the Company to expand its operations and to attract and retain qualified professionals; technological obsolescence; general economic conditions; and other risks.