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SMALL BONE INNOVATIONS, INC. EXPANDS ITS UPPER LIMB PORTFOLIO BUILDOUT THROUGH NEW PRODUCT DEVELOPMENTS AND LICENSING AGREEMENTS

  • Exclusive rights to elbow management treatment algorithm
  • Worldwide rights acquired for HUMELOCK™ trauma shoulder implant
  • Thomas B. Loring promoted to SVP Worldwide Product & Technology Development

NEW YORK, NY March 3, 2009 - Small Bone Innovations, Inc. (SBi), a leading provider of innovation, products, technology and education for the small bone & joint (SB&J) segment of the orthopedics industry, reported that it had substantially expanded its upper limb portfolio through a variety of new product developments and licensing agreements. The company also announced the promotion of Thomas B. Loring to Senior Vice President, Worldwide Product & Technology Development.

Elbow Management System
During 2008, SBi rolled out several new products to expand its Elbow Management System (EMS) including: the rHead™ Lateral Radial Head Implant System and the rHead™ Plating System for internal fixation of proximal fractures of the radius. Both products received 510(k) clearances from the U.S. Food and Drug Administration (FDA).

Surgeons using SBi’s EMS can now select from a range of three different radial implant arthroplasty systems as well as associated internal fixation products including the rHead Plating System and AutoFIX™ stainless steel compression screws.

EMS also includes SBi’s Precise Guidance Technology™ instrument system that assists surgeons with anatomical placement to achieve consistent, reproducible results in reconstructive surgery.

The Company also confirmed it has entered into a license agreement for the exclusive worldwide rights to develop products and surgical procedures for the treatment of acute and chronic radial head fractures based on the work of Bernard F. Morrey, M.D., Mayo Clinic, entitled, Algorithm for Management of Radial Head Fractures.

Anthony G. Viscogliosi, Chairman, & CEO of SBi, said: “This new agreement is an essential step in the evolution of our Elbow Management System offerings; several components of which were developed previously with the help of Dr. Morrey.”

Dr. Morrey said: “I welcome the opportunity to work with SBi in a field with the potential to improve patient outcomes.”

Fingers, Hand & Wrist Treatment LC
SBi has also entered into an amended licensing agreement with Artimplant AB of Västra Frölunda, Sweden, to develop resurfacing and interposition applications in the fingers, hand and wrist domain based on the Artelon® technology.

SBi intends to build on its existing line of six Artelon® spacers, including four FDA-cleared products for arthritic thumb repair and two European Union CE mark products.

Mr. Viscogliosi said: “The features and benefits of the Artelon® technology are potentially applicable to all the joints and bones in and around the fingers, hand and wrist. These products are tissue sparing, bone preserving and less invasive solutions for joint motion and pain relief.”

Alejandro Badia, M.D.*, at the Badia Hand-to-Shoulder Center, Doral, FL, said: “I am pleased to hear that surgeons will have a wider range of options for using Artelon® spacers in more hand and wrist indications, given its appeal among younger patients seeking an alternative to more surgically aggressive procedures.”

Shoulder
SBi recently signed an exclusive license agreement with CF&M Sarl, a French business, to market, distribute and sell the HUMELOCK™ Trauma Shoulder implant (‘HUMELOCK shoulder’) worldwide.

The HUMELOCK shoulder consists of an anatomical head and intra-medullary interlocked stem, or nail solution. It is designed for use in complex shoulder reconstruction procedures in patients with stage 3 or 4 fragments in the proximal humerus - a common occurrence in severely injured shoulders.

Stage 3 fractures refer to subchondral or crescent sign fractures with minimal depression of articular surface. Stage 4 fractures refer to the collapse of the joint surface and subchondral bone with fragmentation and secondary arthritis.

Modifications are underway to enable the HUMELOCK shoulder to address additional indications in the trauma shoulder market.

“The HUMELOCK shoulder provides us with a potentially superior trauma shoulder solution that we expect will augment and support sales of our upper limb product portfolio in the European market. Over time, our plan is to make the device available in all markets in which we currently distribute SBi products,” Mr. Viscogliosi noted.

Dr. Tristan Lascar*, an orthopedic surgeon at Princess Grace Hospital in Monaco, said: “The HUMELOCK shoulder is a valuable addition to treatment options for complicated shoulder fractures. I am eager to use this prosthesis as it is ideally suited for severe trauma reconstruction cases.”

The HUMELOCK shoulder may also be suitable for treating cases of failure of an existing shoulder prosthesis where a stem or other locking mechanism may be needed. The prosthesis has been implanted in 50 patients at centers in France and Monaco.

The device currently has an enveloppe soleau (comparable to an ‘applied for patent’ in the U.S.). The HUMELOCK shoulder is not yet available in the U.S.

Thomas B. Loring promoted
Thomas B. Loring, who joined SBi in 2006 from Osteotech, Inc., as Vice President, Worldwide Product Development, has been promoted to Senior Vice President, Worldwide Product & Technology Development. He has been instrumental in building and overseeing SBi’s global product development efforts in the U.S., France and, most recently, Germany. Prior to Osteotech, Mr. Loring was with Stryker Orthopaedics for eleven years in senior management positions and had developed a plan to create a dedicated business unit focused on the SB&J market.

* The surgeons quoted in this announcement provide consulting services to SBi.

About Small Bone Innovations, Inc.
Small Bone Innovations, Inc. (SBi) was founded in 2004 by Viscogliosi Brothers, LLC, (VB), a 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 bones & joints. By integrating established companies and professionals in the field, SBi offers a broad, clinically proven portfolio of products and technologies to treat trauma and diseases in small bones & joints. Today, SBi has more than 130 employees at facilities in New York, NY, Morrisville, PA, Bourg-en-Bresse, France, and Donaueschingen, Germany.

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 exclusively to the musculoskeletal/orthopedics sector of the health care industry. 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.

VB’s mission is 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.

The Viscogliosi brothers have pioneered more than 170 financial, strategic and management initiatives for companies in the musculoskeletal/orthopedic sector, from start-up, seed and development stage all the way to exit. These initiatives have helped people live better lives through the orthopedic and spinal products developed, marketed and sold by the companies VB has 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 SBi’s business including increased competition; the ability of SBi to expand its operations and to attract and retain qualified professionals; technological obsolescence; general economic conditions; and other risks.

 

 
 
 
 
 


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