Small Bone Innovations, Inc. Announces Its New Lateral rHead for Treatment of Radial Head Fractures and Diseases in the Elbow




      * Allows for lateral access and placement
      * Less invasive
      * Strengthens the SBi Elbow Management System

NEW YORK, Feb. 15, 2007 (PRIME NEWSWIRE) -- Small Bone Innovations, Inc. (SBi), a single-source provider of innovation, products, technology and education for the small bone and joint sector of the orthopedic industry, has announced the latest technology addition to its growing and impressive family of Elbow Management System products, its new Lateral rHead(tm) implant.

SBi has debuted its Lateral rHead(tm) at the American Academy of Orthopaedic Surgeons (AAOS) 2007 Annual Meeting in San Diego, California -- on display at Booth No. 2532 in the San Diego Convention Center, 9:00am to 5:00pm, Wednesday, February 14th through Friday, February 16th.

The Lateral rHead(tm) is comprised of a uniquely designed mechanical couple between the head and stem components. The couple does not require a set screw and is provided with an easy-to-use assembly tool that can be used in vivo or on the "back table" to quickly assemble the head to the stem component.

Similar to SBi's rHead(tm) and rHead(tm) Recon products, the head and stem components are fully modular. The Lateral rHead(tm) head is highly polished cobalt chrome (CoCr). The stem is cobalt chrome (CoCr) with the stem and collar buttress coated with plasma-sprayed commercially pure titanium (CPTi). The Lateral rHead received a 510(k) clearance from the U.S. FDA in December, 2006.

SBi's Lateral rHead(tm) provides surgeons with yet another option for treating radial head fractures and disease. The unique design allows for lateral access and placement, which is less invasive in terms of surgical site exposure and soft tissue dissection, minimizing ligamentous release required during the surgical procedure. It also facilitates placement and repair in this restrictive anatomy, requires minimal resection of the lateral collateral ligament (LCL) and preserves the annular ligament.

The new Lateral rHead(tm) complements SBi's rHead(tm) Recon implant, which facilitates alignment of the radio capitellum and provides for greater anatomic positioning.

SBi's Lateral rHead(tm) augments the growing SBi Elbow Management System, a suite of the most comprehensive products and technology systems in the industry designed to treat all conditions of fracture reconstruction and disease management of the elbow. In addition to the new Lateral rHead(tm), this suite of Elbow Management System products also includes:

The rHead(tm) Radial Implant System

This modular design accommodates specific patient physiology, with four stem sizes and three head sizes. The stems are designed with a rough finish, yielding a more receptive surface for bony in-growth, with a uniquely shaped and patented curve for accurate medullary canal alignment.

The rHead(tm) Recon Radial Implant System

When proper alignment of the proximal radius cannot be achieved, the added flexibility of the rHead(tm) Recon can compensate for misalignment. The bipolar design facilitates proper radio capitellar position throughout flexion/extension and forearm rotation.

Both the rHead(tm) and the rHead(tm) Recon are available as 6mm Extended Collar implants, for use in patients with distally integrated fractures or where poor bone quality makes proper implant/bone interface problematic.

This innovative design does not require the use of spacers or washers like other systems, and promotes stability. They are also available (with a Size 1 implant stem (with a patented, curved stem, in an identical design to the full-size rHead(tm) and rHead(tm) Recon) for use in very small patient anatomies. Even with a smaller stem geometry, the Size 1 implant can be used with all existing rHead(tm) components.

The UNI-Elbow(tm) Radio Capitellum Implant

Used for post-traumatic reconstruction, degenerative joint disease, the correction of functional deformities, and for revision procedures where other treatments have failed, the UNI-Elbow(tm) is anatomically designed for minimal resection to restore normal articulation. When used in conjunction with the rHead(tm) prosthesis, the system represents the first uni-compartmental elbow implant commercially available in the United States.

The implant replaces the Radio Capitellum joint and preserves a normal, healthy ulno-humeral joint and, when implanted using SBi's Precise Guidance Technology(tm) (PGT) system, is tissue-sparing and less invasive than performing a total elbow replacement.

AutoFIX(tm) Cannulated Compression Screws

Available in 2.0mm and 2.5mm sizes, these stainless steel headless screws are optimal for use in articular surfaces of joints and in areas of minimal soft tissue coverage. An opposing buttress thread design facilitates compression towards fracture/osteotomy.

Commenting on his company's new elbow implant, Founder, Chairman & CEO Anthony G. Viscogliosi said, "SBi is committed to being the worldwide leader in the design and development of upper and lower limb arthroplasty implants and related medical devices. The Lateral rHead is the latest in a solid line of ground-breaking, surgeon-driven, patient-focused implants that will revolutionize the treatment strategy for fractures and diseases of the elbow. SBi will continue to push the envelope, seeking new and innovative ways for patients to get relief from pain as well as restoration of function."

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 innovation, products, technologies and education to treat trauma and diseases in small bones and 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 and 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.

For more information on SBi, please visit: www.totalsmallbone.com

The Small Bone Innovations, Inc. logo is available at http://www.primenewswire.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.



            

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