* Booth No. 2532 at the San Diego Convention Center
* Upper and Lower Limb diseases addressed
* Both U.S. and Outside the U.S. products on display
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 & joint sector of the orthopedic industry, will debut 17 new small bone & joint products at this year's American Academy of Orthopaedic Surgeons (AAOS) 2007 Annual Meeting, February 13-18, in San Diego, California. With an extensive and expanding U.S. and outside the U.S. product portfolio, (fully on display at Booth No. 2532 in the San Diego Convention Center, 9:00 a.m. to 5:00 p.m., Wednesday, February 14th through Friday, February 16th), SBi is committed to being the worldwide leader in the design, development, and marketing of arthroplasty, internal and external fixation systems, and tissue repair technology, in the form of implants and related medical devices.
With an anatomical focus from the "finger to the shoulder" and the "toe to below the knee," SBi continues to serve the significant unmet clinical needs of small bone & joint orthopedic surgeons and their patients. SBi will publicly debut the following 17 products at a conference for the first time at the AAOS:
NEW SBi PRODUCTS
NOW AVAILABLE FOR SALE IN THE U.S.
Sigmoid Notch Total DRUJ System(tm) ('STABILITY System')
SBi will be pleased to show its STABILITY Sigmoid Notch Total DRUJ System(tm) ('STABILITY System'), incorporating Precise Guidance Technology (PGT) instrumentation.
The STABILITY System is currently the only anatomic surface replacement option for the DRUJ commercially available in the U.S. It replaces the sigmoid notch and ulna head in a conservative, bone-sparing procedure that restores the natural biomechanics of the wrist and forearm. The implant has 510(k) clearance from the U.S. FDA and is indicated for treatment of degenerative and post-traumatic arthritis in the DRUJ.
The first, post-launch procedure using the STABILITY System occurred in December at the Henrico Doctors Hospital in Richmond, VA. Sanjay Desai, MD, the operating surgeon, said, "The sigmoid notch component of this implant system greatly enhances the stability of the complete distal radial-ulnar joint by accurately re-creating the joint's natural bio-mechanics and anatomy. For cases of bone erosion or ligament laxity, the system's fully modular approach greatly simplifies the procedure and, as a result, should lead to more accurate implant positioning, thereby providing enhanced long term pain relief and motion restoration."
The STABILITY System includes two components: the Sigmoid Notch Implant and the uHead(tm) Ulna Head implant. The system is completely modular and articulates in a fashion allowing for the restoration of the near natural motion and function. The uHead(tm) Ulna Head Implant was developed in 1998 and has been used successfully in ulna head replacement procedures world-wide. The cobalt chrome anatomical stem is plasma coated with commercially pure titanium and is available with a standard collar or a revision collar. The Sigmoid Notch implant is made of cobalt chrome with a polyethylene insert designed to articulate with the uHead implant. The stem and back of the implant are plasma sprayed with commercially pure titanium and secured to the radius using a cancellous bone screw.
Precise Guidance Technology (PGT(tm)) is the proprietary instrument system utilized with the implant to facilitate the correct anatomical placement of the STABILITY System. The critical feature of the instrumentation is the uniquely developed PGT Saddle Trial that determines the position of the sigmoid notch implant and ensures correct articulation with the uHead implant.
UNI-Elbow(tm) Radio Capitellum System (UNI-Elbow)
Also publicly debuting at the AAOS will be SBi's new UNI-Elbow(tm) Radio Capitellum System (UNI-Elbow). The system incorporates SBi's Precise Guidance Technology(tm) (PGT) template and instrumentation.
Dr. Bernard Morrey, who co-designed the uni-compartmental implant under an agreement between SBi and the Mayo Clinic, in Rochester, MN, began the first, post-launch use of the system in November and December, 2006. The UNI-Elbow, designed primarily for use in association with SBi's rHead(tm) radial head prosthesis, is the first uni-compartmental elbow implant to become commercially available in the United States. The implant has 510(k) clearance from the U.S. FDA and is indicated for treatment of arthritic and traumatic conditions of the radio-capitellum joint.
The implant replaces the radio capitellum joint and preserves a normal, healthy ulno-humeral joint and, when implanted using PGT, is tissue-sparing and less invasive than performing a total elbow replacement. The PGT Axis Locator Clamp, a unique technology which positions around the radio capitellum joint and determines the anatomic axis of rotation of the elbow, is a critical element in ensuring precise implantation.
"There are some instances in which the stability and integrity of the radio-humeral articulation are essential, yet, the pathology requires reconstruction of both the proximal radius and the distal humerus," Dr. Morrey noted. "Under these circumstances, the prosthetic replacement, such as that offered in the Uni-Elbow design, seems to be the only viable option to adequately address the problem. The overall concept and the soundness of the procedure itself have prompted me to schedule several surgeries and we look forward to monitoring results."
The UNI-Elbow System is based upon two reciprocating implant components, the Radio Capitellum implant and rHead(tm) radial head replacement implant system. The Capitellum Implant is made of cobalt chrome and possesses a highly polished articulating surface. The stem of the implant is plasma sprayed with commercially pure titanium and is anatomically designed for minimal bone resection in order to restore normal motion. The Capitellum Implant is available in Left and Right configurations, and Small and Large sizes. The radial head is available in standard and bi-polar configurations. The rHead stem possesses a 12 degree-curved stem to match the canal of the radius and can be press fitted or cemented.
Lateral rHead(tm)
The Lateral rHead(tm) is comprised of a uniquely designed mechanical couple between the head and stem components. This mechanical 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 and rHead 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(tm) 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 restrictive patient anatomy, minimal resection of the lateral collateral ligament (LCL) and preservation of the annular ligament. The new Lateral rHead(tm) compliments SBi's rHead(tm) Recon implant, which facilitates alignment of the radio capitellum and provides for greater anatomic positioning.
SBi's Lateral rHead(tm) adds another treatment option to 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.
SBi OUTSIDE THE U.S. PRODUCTS
NOW AVAILABLE FOR SALE IN THE U.S.
BBR Adjustable Block Stop Wire (BBR)
Expanding on its series of technology systems designed to treat trauma of the wrist, SBi has brought home its successful Outside the U.S. product, the BBR Adjustable Block Stop Wire. The BBR reduces the risk of wire migration, preventing forward migration and eliminating skin perforation due to back-out.
When used for an articular fracture of the lateral humeral condyle, the BBR wire is inserted by hand (using a T-handle) or driver. The stop slides freely along the wire. The stop is advanced to the cortex and the wire is cut with wire cutters. The stop is moved 0.5mm backward to fully cover the cut end of the wire. It is tightened with an L-Key which is turned clockwise until it breaks off.
The BBR Adjustable Block Stop Wire facilitates easy placement compared to a standard K-Wire without a block stop, and reduces the risk of forward K-Wire migration by utilizing the ball fixed onto the wire which rests against the bone, combined with optional threaded wire at the far end. It also reduces the risk of backward K-Wire migration due to the larger, rounded surface area of the ball under soft tissue, in combination with optional threaded wire.
The spherical block stop reduces the risk of soft tissue and tendon irritation, and the ability to use a firm grip on the ball - compared to trying to grip a small, bent wire - facilitates easy removal. The complete package comes sterile, for quick, easy use.
MetaFLEX IM Nail System (MetaFLEX)
For the treatment of Metacarpal and Metatarsal fractures, SBi has brought to its U.S. product portfolio, its internationally successful MetaFLEX Percutaneous Flexible IM Nail System.
The MetaFLEX system is designed to facilitate improved results for both Metacarpal and Metatarsal fractures via a simple, minimally invasive procedure. For a Metacarpal procedure, following a stab incision at the base of the Metacarpal, an entry channel is created with a K-Wire or Awl in the metaphysis. The MetaFlex IM Nail is inserted under fluoroscopic guidance, advancing it into the medullary canal. The fracture is reduced, and the MetaFLEX IM Nail is further advanced under fluoroscopic guidance to the head of the Metacarpal. The MetaFLEX IM Nail is then cut at the appropriate level with wire cutters.
The unique shape & design of the MetaFLEX provides easy centering in varying diameters of IM canals. The titanium wires are color coded for simple size identification. The use of two MetaFLEX wires improve stability over one slightly larger wire, and provides a cost effective treatment of simple Metacarpal or Metatarsal fractures.
NEW SBi PRODUCTS NOW AVAILABLE FOR SALE
OUTSIDE THE U.S. ONLY
The highly-successful and ground-breaking SBi Artelon(r) CMC Spacer system, available for sale in the United States, expands with 4 new versions, now available Outside the United States only. Artelon is a unique, patented biomaterial known as a polyurethaneura (PUUR) that acts as a temporary support to healing tissue, can be made into fibers, scaffolds and films and is used in a number of orthopedic applications and therapy areas. It degrades by hydrolysis over a period of several years after implantation. All 4 new Artelon(r) devices are manufactured by Artimplant AB of Sweden, and are marketed by Small Bone Innovations, Inc. under an exclusive licensing agreement.
Artelon(r) DRU Spacer (Available outside the U.S. only)
For use in the Distal Radioulnar joints, Artelon(r) DRU Spacer is designed to act as interpositional spacer between the distal radius and the ulna, relieving pain caused by Primary or Secondary Osteoarthritis or trauma-induced injury.
It is intended to be implanted in a joint with cartilage injury, and to serve as a separating device where the articular surface is not wider than 25mm.
The Artelon(r) DRU Spacer is designed to be tissue-sparing while maintaining the anatomy of the wrist. It is safe and well tolerated. Human biopsies have revealed excellent Artelon(r)/host tissue biocompatibility in both bone and soft tissues and In Vivo biocompatibility studies have shown no signs of adverse tissue reactions, inflammation or foreign body response.
Arteleon(r) CMC Spacer Arthro (Available outside the U.S. only)
Designed to champion a minimally invasive technique and minimal recovery time, the Artelon(r) CMC Spacer Arthro is intended to be implanted into the first carpometacarpal joint (CMC-I) as an interpositional spacer between the trapezial bone and the first metacarpal bone. The device is intended to be used in thumb disabilities caused by osteoarthritis. Over 1,200 patients have already been treated successfully with the original Artelon(r) CMC-I Spacer and studies show significantly better pinch strength after implantation.
The arthroscopically delivered Artelon(r) CMC Spacer Athro is designed to take advantage of the advancements in arthroscopic surgical techniques, creating a minimally invasive, motion preserving, tissue sparring, pain relieving surgical procedure. It preserves the anatomy of the joint while maintaining the CMC-I joint space.
Artelon(r) STT Spacer (Available outside the U.S. only)
The Artelon(r) STT Spacer is designed to relieve pain, weakness and stiffness in osteoarthritis of the STT joint. It is implanted into the scaphotrapeziotrapeziodal (STT) joint as an interpositional spacer between the scaphoid bone and the trapezial-trapezoid bones. The vertical portion of the "L" shaped Spacer separates the surfaces of the arthritic joint from one another, while the horizontal portion fixates the device.
Artelon(r) MTP Spacer (Available outside the U.S. only)
Designed to reduce joint pain, weakness and stiffness caused by osteoarthritis in an arthritic MTP joint at the base of the big toe (such as Hallux Rigidus), the Artelon(r) MTP Spacer is implanted into the metatarsalphalangeal (MTP) joint as an interpositional spacer between the metatarsal bone and the proximal phalanx.
The other, new Outside the U.S. only products now available from Small Bone Innovations, Inc. include: StaFIX, a staple fixation system; PreciFIX, a titanium compression break-off screw system that allows compression across the fracture while reducing the instrumentation needed for the procedure with its breakaway feature; TwistoFIX, a twist off fully threaded compression screw for use during a Weil or closing wedge osteotomy; ForeFIX, an open wedge osteotomy plate; FusiFIX, a compression screw for cancelous bone; ArtFix, a triple threaded compression screw; a new screw and wire system for wrist fractures; and Ulna-USD, an ulna shortening device.
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 diseases 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.
For more information on SBi, please visit: www.totalsmallbone.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.