Small Bone Innovations, Inc. Announces Key Lower Limb Acquisitions and Licensing Agreements

7 Acquisitions and Deals Dedicated to the Lower Limb


NEW YORK, March 16, 2007 (PRIME NEWSWIRE) -- Small Bone Innovations, Inc. (SBi), a single-source provider of innovation, products, technology and education for the small bone & joint sector of the orthopedic industry, is pleased to announce seven key acquisitions and licensing agreements, dedicated to its portfolio expansion of the lower limb. The 7 transactions include:



  Acquisition of Euromedic International Groups's Suite of Fixation
                       Devices for Small Bone
                   Euromedic International Group

    Acquisition of Significant Intellectual Property for a "Reverse"
                         Great Toe Prosthesis
             Designed & Developed by Dr. Shane Hollawell

   Acquisition of Significant Intellectual Property & Related Assets
                        for a Hemi MTP Joint
     Designed & Developed by Dr. Charles Sorbie & Mr. Gerald Saunders

    Licensing Agreement for the ROTO-glide(tm) Three Part Anatomical
                         Great Toe System
     Designed & Developed by Dr. Hakon Kofoed & Implants International

         Licensing Agreement for a Unique Ankle Distraction System
                        using External Fixation
             Designed & Developed by Dr. S. Robert Rozbruch

         Licensing Agreement for Variable Angle Locking Plate & 
                             Screw Technology
   Designed & Developed by Prof. D. F. Wolter and LITOS GmbH & Co.  KG

   Licensing Agreement for SBvF(tm) Small Bone Void Filler (Beta-TCP)
                  Designed & Developed by Therics, LLC

Since its official launch in February 2005, SBi has diligently addressed diseases, reconstruction and trauma of its anatomic focus - finger to shoulder, and toe to below the knee - through surgeon-innovative, indication-specific, data-driven devices and implants. Never before have small bone & joint surgeons and their patients had as many pain-relieving, motion-preserving, tissue-sparing options for treatment, at any stage of disease or injury. After directing the majority of its acquisition activity and development towards the upper limbs in 2006, SBi has boldly announced 2007 as its "Year of the Lower Limb" and expects to be a significant and rapidly growing force in treatment of the anatomy of the lower limb.

Euromedic Acquisitions

Small Bone Innovations, Inc. has acquired a full suite of fixation devices for small bone reconstruction and repair from France's Euromedic International Group. These products have broad applications in the foot and ankle as well as the hand and arm. The suite includes a number of "envelopes soleau" - essentially, pre-patent intellectual property filings - also acquired to expand SBi's lower limb internal fixation product portfolio. Additionally, key members of the Euromedic team have joined SBi.

The new SBi products with lower limb applications, acquired from Euromedic, include: a Break-off K-Wire for internal fixation, StaFIX, a stainless steel staple fixation system, with threaded prongs, indicated for various osteotomies and fusions; MemoFIX, a shapeable memory compression staple; PreciFIX, a titanium compression break-off screw system that allows compression across the fracture while reducing the instrumentation needed for the procedure, indicated for Metatarsal and Phalangeal Osteotomy, Arthrodesis, and percutaneous surgery; TwistoFIX, a titanium twist off fully threaded compression screw for use during a Weil or closing wedge osteotomy; ForeFIX, a titanium open wedge osteotomy plate, indicated for basal osteotomy and metatarsus varus; FusiFIX, a compression screw for cancellous bone; AutoFIX, a stainless steel compression screw, indicated for scarf, phalangeal and Weil osteotomies; and ArtFix, a titanium auto compression screw, indicated for rear and mid-foot arthrodesis.

These products, currently available only outside of the U.S., will be brought in the U.S. upon an anticipated rapid regulatory clearance process.

Reverse Great Toe Prosthesis

SBi's new Metatarsal implant is a patented, anatomically designed one-piece Metatarso-Phalangeal surface replacement implant. The goal of the Metatarsal implant is surgical replacement or resurfacing of the 1st Metatarso-Phalangeal joint. The Metatarsal implant was invented by Dr. Shane M. Hollawell, DPM, FACFAS.

Commenting on Small Bone Innovations, Dr. Hollawell said, "Small Bone & Joint surgeons have been waiting for a long time for a company, purely focused on the needs of our patients. Trauma and disease of the lower limbs have gone without an indication-specific focus and patients have historically suffered needlessly. It gives me great pleasure to work with SBi, a company committed to addressing these needs. Their innovative and expanding lower limb portfolio, including my Reverse Great Toe, will help revolutionize this industry."

Hemi MTP "Trihedron" Great Toe Prosthesis

The Trihedron(tm) Great Toe hemi implant is a patented, anatomically designed implant to fit the intramedullary canal of the proximal phalanx of the great toe. The goal of the Trihedron(tm) is to relieve pain in the first metatarsal joint incurred from inflammatory arthritis and restore joint kinematics by replacing the damaged bearing surface. The implant is constructed of cobalt chromium and is uniquely designed with an anatomically shaped stem complementing the SBI SR(tm) arthroplasty product line. The device is currently US FDA 510(k) cleared to market and is also approved in Canada. The Trihedron(tm) was invented by Dr. Charles Sorbie MB, ChB, FRCS(E), FRCS (C) and Gerald Saunders.

Dr. Sorbie, Professor of Surgery, Queen's University, Kingston, Canada, said, "Mr. Saunders and I are delighted to have found a partner capable of becoming the world leader in the high growth potential market for treating orthopedic small bone and joint surgery. We have completed a successful clinical trial of the Trihedron(tm), which began in June 2000 and has a patient follow-up of at least 5 years. There has been high patient satisfaction and no evidence of loosening or wear. With SBi's significant financial resources and expertise in sales and marketing, the proven benefits of this technology will be extended to small bone & joint surgeons and their patients on a large scale."

ROTO-glide(tm) Three Part Anatomical Great Toe System

Available in multiple sizes, and designed to restore optimum anatomical motion while preserving primary bone stock, SBi's new ROTO-glide Great Toe System is an indication-specific implant, designed to address Osteoarthritis of the 1st Metatarso-Phalangeal Joint, post-trauma, and rheumatoid arthritis. The ROTO-glide is an uncemented, non-hinged surface replacement arthroplasty device which mimics the normal mobility and torque of the 1st MTP. It is a unique three-piece mobile bearing great toe prosthesis.

Ankle Distraction Ex Fix System

Dr. S. Robert Rozbruch will assist in the expansion of SBi's Lower Limb Portfolio and in the development of a unique Ankle Distraction External Fixation System. Dr. Rozbruch is the Director of the Institute for Limb Lengthening & Reconstruction, Co-Chief of the Limb Lengthening Service, and an active member of the Orthopedic Trauma Service at the Hospital for Special Surgery.

Commenting on his involvement with SBi, Dr. Rozbruch said, "Medical Education is a critical aspect to any medical device technology company, and SBi has broken new ground when it comes to catering to the educational needs of small bone & joint surgeons. Their global workshops and innovative training sessions will assist any surgeon in addressing trauma and disease of the lower limbs, at any level of severity. I look forward to contributing to the continued success of SBi through my Ankle Distraction External Fixation System."

Variable Angle Locking Technology

SBi has entered into a licensing agreement with Prof. D. F. Wolter and LITOS GmbH & Co. KG of Hamburg, Germany, for rights to their variable angle, multi-dimensional locking titanium plate and screw systems technology with applications in the upper and lower limbs. SBi has licensed worldwide rights for use in the upper limbs, as well as for applications in the ankle, tibia, and fibula of the lower limbs (with the exception of Germany). SBi plans to introduce a wide variety of products using this technology over the next 6-12 months and to upgrade many of its existing products in the very near future.

SBvF(tm) Small Bone Void Filler

Through a licensing agreement with Therics, LLC of Akron, OH and Morrisville, PA, SBi announces the release of its SBvF(tm) Small Bone Void Filler product line. The SBvF product line features an assortment of solid, Beta-Tricalcium Phosphate (Beta-TCP) bone void filler products made using Therics' proprietary Theriform(tm) Digital Fabrication Process, which produces precisely controlled macro and micro architectures resulting in slower graft remodeling and stronger, higher quality bone. The line will also include the SBvF(tm) Shape Putty, the only premixed, ready to use Beta-TCP available. This easy-to-use injectable conforms to the graft site, packs well, and stays in place. SBvF(tm) Shape will be packaged in convenient, economical sizes for use in a variety of small bone applications including those of the ankle and lower limbs.

Commenting on the seven transactions, SBi Founder, Chairman & CEO Anthony G. Viscogliosi said, "Small Bone Innovations is fiercely dedicated to serving the unmet clinical needs of small bone & joint surgeons and their patients. As we aggressively pursue new and exciting indication-specific, surgeon-centric, patient-focused and data-driven technologies, we will build a complete lower limb portfolio that treats the algorithm of the complete continuum of care, from early, to mid-stage, to late-stage disease and trauma."

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 & joint science. By integrating established companies and professionals in the field, SBi today offers a broad, clinically proven portfolio of innovation, products, technologies and education to treat trauma and disease in small bones & joints.

In establishing SBi, VB acquired several prominent U.S., Canadian and European orthopedic device companies and product technology licenses focused on small bone and joint treatment, including arthroplasty, internal & external fixation, trauma, and tissue technology.

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.

Medical Device & Diagnostic Industry Magazine named SBi to their list of "50 Companies to Watch" in 2006, noting, "Small Bone Innovations is going against the grain in its determination to become a market leader in the small bone & joint device sector."

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 merchant banking, venture capital and private equity 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 40 years' 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

The Small Bone Innovations, Inc. logo is available at http://www.primezone.com/newsroom/prs/?pkgid=3091

Forward-looking statements

This press release may contain 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.



            

Contact Data