NEW YORK, Sept. 28 /PRNewswire-FirstCall/ -- Small Bone Innovations, Inc. (SBi), a single-source provider of products, technology and education for the small bone and joint orthopedic market sector, announced today the launch of the rHead(TM) Lateral Radial Head Implant System. To further augment its Elbow Management System, the company also launched the rHead(TM) Plating System for internal fixation of proximal radius fractures.
The rHead Lateral Implant is a side-loading radial head prosthesis that allows for a minimally invasive approach and exposure in radial head replacement surgery. The head and stem of the implant connect by the means of a dove-tail locking mechanism that does not require a set screw - saving time in the operating room.
The rHead implant and new plating systems have received 510(k) clearance by the FDA. The rHead Lateral is indicated for treatment of arthritic and traumatic conditions of the radial head.
Anthony G. Viscogliosi, Chairman & CEO of SBi, said: "The addition of the rHead Lateral implant and the complementary new plating system responds to surgeon demand for a full range of treatment options for every disease stage or severity of trauma in the elbow."
The stem of the rHead Lateral implant is plasma coated with titanium for immediate stability in the canal and optimum osteo-integrating properties. As with SBi's existing rHead implants, the stem has a 12-degree curve to match the anatomy of the radius. This stem is available with a 2 mm standard collar or a 6 mm extended collar.
"The modularity of treatment options now available from SBi is making the often complicated alignment challenges in elbow repair or reconstruction more manageable and predictable in outcome," said Amit Gupta, M.D, who completed the first procedure using the Lateral rHead at the Louisville Arm and Hand Center.
"A unique feature of the system is the coupling mechanism between the radial head and stem that enables the implant to be implanted sideways to reduce ligament disruption," Dr. Gupta added.
According to SBi, surgeons have been instrumental in creating the Elbow Management System. The first rHead(TM) device was released in 1999 by Avanta (later acquired by SBi) and two years later a bi-polar version, the rHead Recon was introduced.
This was followed last year with the introduction of the SBi UNI-Elbow Radio Capitellum System(TM) as the first commercially available uni- compartmental elbow arthroplasty system. The new rHead Lateral implant heads are approved for use with the UNI-Elbow System for patients requiring a uni- compartmental solution.
Surgeons using SBi's Elbow Management System are also benefiting from the company's Precise Guidance Technology (PGT(TM)) instrument system that assists anatomical placement of the rHead implants. The trialing system helps to size the implant to render it as minimally invasive as is practicable.
The new rHead Lateral implant comes with an assembly tool for quick engagement or disengagement of the head and stem. The accompanying impactor tool is configured to assure precise positioning of the implant by referencing the surrounding anatomy.
About Small Bone Innovations, Inc.
Small Bone Innovations, Inc. (SBi) was founded in 2004 by Viscogliosi Brothers, 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 can offer 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, and Bourg-en-Bresse, France.
SBi closed on the sale of $42.2 million of its securities in December 2005. At the time, 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, recognizing SBi 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(R) CMC-I Spacer, developed for patients with osteoarthritis at the base of the thumb, 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 its 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: http://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.
The Viscogliosi brothers 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 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: http://www.vbllc.com
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.
|SOURCE Small Bone Innovations, Inc.|
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