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Strategic Initiatives

ALPHATEC SPINE (ATEC) entered into a license agreement with HELIX POINT to develop Helifix and Helifuse, proprietary concepts for interspinous devices to treat lumbar spinal stenosis. (See ORTHOKNOW™, 3/09.) ATEC is the exclusive worldwide licensee of the intellectual property, excluding the right to sell the products in China.
 (Alphatec Holdings, Inc., 2/23/09)

ARTIMPLANT and SMALL BONE INNOVATIONS (SBi) revised terms of existing license and distribution agreements relating to biodegradable spacers for the hand and wrist. The agreements are converted to non-exclusive status in exchange for lower minimum sales commitments from SBi, and Artimplant will supply additional clinical documentation in exchange for a higher share of profit from SBi sales. (See BARE BONES, 1/08.)
(Artimplant, 2/2/09)

CURATIVE BIOSCIENCES entered into small molecule research agreement with the MUSCULOSKELETAL TRANSPLANT FOUNDATION (MTF) to evaluate the potential of Curative’s small molecule (DMA). Curative’s products integrate bone- and cartilage-forming peptides and small molecule therapeutics with osteostimulating matrices to expedite native tissue healing and regeneration processes.
(Curative Biosciences, Inc., 2/24/09)

EXACTECH (EXAC) extended its relationship with the HOSPITAL FOR SPECIAL Surgery to introduce a new knee implant as part of its Optetrak® brand. Limited release of the Optetrak Logic™ knee is expected in the 2nd half of 2009.
(Exactech, Inc., 2/23/09)

RTI BIOLOGICS (RTIX) entered into an agreement to process cervical and lumbar spinal grafts from designs developed by AESCULAP IMPLANT SYSTEMS (AIS).
(RTI Biologics, Inc., 2/9/09)

SBi completed its acquisition of LINK ORTHOPAEDICS and certain assets related to the Scandinavian Total Ankle Replacement (S.T.A.R.® Ankle) from WALDEMAR LINK. (See BARE BONES, 2/08.)

SBi acquired its German distributor and divested its manufacturing operations in France. Further, the company established its 1st regional hub in France to serve the European market.
(Small Bone Innovations, Inc., 2/3/09 and 2/17/09)

SMITH & NEPHEW ORTHOPAEDICS (SNN) and BRAINLAB entered into an exclusive agreement to develop computer-assisted surgical technologies for hip and knee implants. The PiGALILEO ACCULIGN™ motorized positioning guide will be central to future developments, and will remain exclusive to SNN implant-specific applications. SNN will cover marketing, training and post-installation clinical support, while BrainLAB will manage sales of the navigation equipment, training and service.
(Smith & Nephew, 2/25/09)

Product/Company

AIS launched its Alternative Surface technology in 2/09. The zirconium nitride coating for knee implants has been used in >1,200 procedures, to date. Zirconium nitride coating for knee implants has been shown to almost eliminate metal ion release while also reducing polyethylene wear by up to 60%. AIS also introduced the Metha short hip stem. To date, the device has been implanted >15,000 times since its introduction in Europe 4 years ago. Recent studies of the device indicate that Harris Hip Scores increased quickly to 91% after the first 3 months, rising to 97% after 1 year.
(Aesculap Implant Systems, 2/5/09 and 2/9/09)

ATEC launched the Universal Novel® Anterior Lumbar Interbody Fusion (ALIF) System for Novel PEEK and AlphaGRAFT® Allograft implants, and commenced full commercial release of its OsseoFix+ Cement and Vacuum Infusion Packaging (VIP) systems. VIP can now be used with the AlphaGRAFT Profuse Demineralized Bone Scaffold and Alphagraft posterior lumbar implants.
(Alphatec Holdings, Inc., 2/24/09)

An Audit Committee has identified certain improper practices in insurance billing and healthcare compliance practices associated with ARTHROCARE’s (ARTC’s) spine business unit. Further, the U.S. Securities and Exchange Commission (SEC) issued a formal order of investigation into ARTC’s restatement of financial results. As a result, the SEC staff now has the authority to subpoena witnesses and documents. ARTC and its DISCOCARE subsidiary are also the subjects of certain U.S. Attorney’s office investigations. ARTC is in the process of implementing remediation measures, including recent cessation of direct billing to insurers by the company’s Sports Medicine and Spine Business units.
(ArthroCare Corp., 2/18/09)

ASCENSION ORTHOPEDICS released the Ascension® Silicone PIP System. The system is available in 6 sizes, features an anatomic pre-flexed design intended to reproduce the natural resting position of the proximal interphalangeal joint, and is designed to relieve pain, restore motion and improve the cosmetic appearance of the joint.
(Ascension Orthopedics, Inc., 2/13/09)

BIOSYNTECH achieved its objective of enrolling 80 patients in the Canadian-European pivotal trial of BST-CarGel®. The randomized trial is comparing treatment of cartilage lesions using BST-CarGel following microfracture vs. microfracture alone, and the primary endpoint is cartilage repair at 12 months. Final results are expected in 1Q10.
(BioSyntech, Inc., 2/2/09)

BONE BIOLOGICS received a U.S. Patent Office Notice of Allowance of patent claims protecting a method of production for the UCB-1 (NELL-1) recombinant protein used in its lead product. This platform technology is combined with MTF’s DBX® demineralized bone matrix to promote bone growth in spinal fusion.
(Bone Biologics Inc., 2/24/09)

BROOKHAVEN LAB and BIOSURFACE ENGINEERING TECHNOLOGIES (BioSET) were issued U.S. Patent No. 7,482,427 B2, “Positive Modulator of Bone Morphogenic Protein-2.” BioSET has developed AMPLEX, a combination of B2A osteoductive growth factor + ultra-high grade ceramic bone substitute for use in lumbar spinal fusion. Results from a 1st patient surgery in Canada revealed that AMPLEX handled as well as other ceramic graft alternatives.
(Brookhaven National Laboratory, 2/21/09)

CARDO MEDICAL announced that its Align 360 Uni-Compartmental Knee system may allow surgeons to intra-operatively choose between a tibial-first or femoral-first referencing and resection surgical technique and approach.
(Cardo Medical, Inc., 2/18/09)

CENTINEL SPINE successfully transitioned existing STALIF TT™ distributors into its own distribution network. The new distribution team comprises 35 partners that service both the STALIF TT and STALIF C™ products for lumbar and cervical Stand Alone Interbody Fusion procedures. (See BARE BONES, 1/09.) To date, The STALIF TT and STALIF C technologies have been used in nearly 10,000 patients worldwide.
(Centinel Spine, Inc.. 2/3/09)

In 2/09, CONMED launched the CONMED Linvatec hip system featuring the Bio Mini Revo® suture anchor, suture passers, the extended length Spectrum MVP™ and a full line of extended length accessory instrumentation; the Paladin™ suture anchor for rotator cuff repair; the Zen™ Wireless Footswitch and Adaptor; ReAct™ Arthroscopic Shaver Blades with the ability to reciprocate while rotating; and the Mpower® 2 Battery Power System for large and small bone orthopaedic and spine applications.
(CONMED Corp., 2/25/09)

CUREXO TECHNOLOGY submitted a 510(k) application to FDA for clearance of the ROBODOC® Surgical System for Total Knee Arthroplasty. ROBODOC comprises ORTHODOC®, a computer workstation for 3D preoperative surgical planning, and the ROBODOC Surgical Assistant, a computer-controlled surgical robot used for cavity and surface preparation for hip and knee replacement.
(CUREXO Technology Corp., 2/25/09)

DEPUY ORTHOPAEDICS launched the Sigma® High Performance  Partial Knee and Sigma® CR150 High-Flex Knee, as well as customized TruMatch™ Personalized Solutions for knee replacement. The company also introduced the aSphere™ M-Spec Femoral Head, a metal hip bearing option intended to reduce wear and potential ion release. All DePuy metal-on-metal bearings feature the company’s exclusive TrueGlide™ technology to facilitate a more fluid range of natural motion. Further, DePuy launched Anatomic Locked Plating Systems (A.L.P.S.), the company’s 1st plating system for complex metacarpal and phalangeal fractures.
(DePuy Orthopaedics, Inc., 2/25/09)

EXAC was granted U.S. Patent No. 7,422,605,B2 for its Optetrak® RBK™ rotating bearing knee prosthesis.
(Exactech, Inc., 2/24/09)

GLOBUS MEDICAL introduced the PATRIOT SIGNATURE™ TLIF Spacer system, designed for use in transforaminal lumbar interbody fusion. The system includes an articulating implant that enables surgeons to use one instrument from insertion through final placement to deliver the spacer into a biomechanically ideal position through a portal or small incision. The device is the latest addition to the MILDER™ (Minimally Invasive, Less Disruptive, Earlier Recovery) Spine Care line.

Globus also launched the INDEPENDENCE™ Spacer System. INDEPENDENCE integrates a stabilization plate and PEEK interbody spacer designed to enable a less disruptive surgery than traditional ALIF. Globus’ MILDER initiative integrates minimally invasive techniques with implants, instrumentation and education designed to lessen disruption to a patient’s anatomic structures and natural range of motion.
(Globus Medical, Inc., 2/3/09 and 2/26/09)

ILLUMINOSS MEDICAL announced that the 1st procedure utilizing the IlluminOss Photodynamic Bone Stabilization System was performed on a 21 year old patient with a fracture of the 5th metacarpal. The system is designed to allow immediate joint mobility post procedure without the need for immobilization. The fracture also becomes partially weight-bearing immediately.
(IlluminOss Medical Inc., 2/19/09)

INCISIVE SURGICAL launched INSORB|25, a new version of the INSORB® Absorbable Staple. Results from a randomized prospective study of hip closures with the INSORB Stapler concluded that “A resorbable (skin) staple system can provide comparable wound closure to stainless steel staples following total hip replacement and may do so with less local discomfort or (inflammatory) reaction.”
(Incisive Surgical, Inc., 2/23/09)

KENSEY NASH (KNSY) submitted an Investigational Device Exemption to investigate use of its Cartilage Repair Device to treat articular knee cartilage defects. The device is a composite of bioresorbable biomaterials using KNSY’s proprietary collagen technology + beta-tricalcium phosphate suspended in a synthetic polymer Porous Tissue Matrix to treat chondral lesions.
(Kensey Nash Corp., 2/24/09)

KFX MEDICAL introduced the PASTAFx system for earlier intervention in rotator cuff repair, including Partial Articular Sided Tendon Avulsion (PASTA) tears.
(KFx Medical Corporation, 2/25/09)

MAKO SURGICAL introduced the RIO™ Robotic Arm Interactive Orthopedic System and the RESTORIS® MCK MultiCompartmental Knee System for use in MAKOplasty® partial knee resurfacing procedures.
(MAKO Surgical Corp., 2/24/09)

MEDARTIS debuted its APTUS Adaptive Watershed Plating System, designed to enable flexibility in plate placement according to the characteristics of a fracture. 
(Medartis, Inc., 2/25/09)

As of 3/11, MEDTRONIC (MDT) will voluntarily disclose consulting fees, royalties or honoraria for physicians who receive payments of $5,000 or more per year from the company. MDT will begin capturing payment data for all of its businesses on 1/1/10 and will report information annually and publicly on its website.
 (Medtronic, Inc., 2/24/09)

Study results sponsored by MEDTRONIC SPINE & BIOLOGICS suggest that balloon kyphoplasty may provide superior benefits vs. non-surgical treatment of vertebral compression fractures. The study, which tracked 300 patients at 21 centers in 8 countries, revealed that the benefits of balloon kyphoplasty were reportedly sustained on average throughout 12 months.
(Medtronic, Inc., 2/24/09)

MIKAI commenced market launch of Falena®, a titanium and PEEK-based winged Interspinous Decompression Device for the treatment of lumbar spinal stenosis. The procedure is typically performed in <1 hour under local or general anesthesia using dedicated instrumentation.
(Mikai S.p.A., 2/12/09)

NERITES was awarded an NIH grant to develop alternative methods of tendon repair using bio-adhesive technology. Nerites commercializes synthetic bio-adhesives that may enhance natural tissue repair, reduce postoperative complications and degrade safely when they are no longer needed. The hydrogel technology may be used to close internal tears or incisions, prevent leakage and infection, and affix synthetic or biologic medical devices.
(Nerites Corp., 2/19/09)

ORTHOFIX (OFIX) and MTF intend to commence limited market release of Trinity® Evolution™ adult stem cell-based allograft on 5/1/09, 2 months ahead of schedule. Trinity Evolution is designed to advance the use of allografts by providing characteristics similar to an autograft used in spinal and orthopaedic procedures.
(Orthofix International N.V., 2/11/09)

The Board of OFIX will call a special general meeting of shareholders to vote on recent proposals made by RAMIUS, e.g. the appointment of new Board members. The Board has tentatively set close of business on 2/25/09 as the record date for the Special General Meeting, and 4/7/09 as the meeting date.
(Form 8-K for Orthofix International N.V., 2/10/09)

OFIX received a letter from one of its largest shareholders, opposing Ramius’ proposal for Board of Directors changes and the sale of BLACKSTONE MEDICAL. (See BARE BONES, 2/09.)
(Orthofix International N.V., 2/19/09)

ORTHOX received a >£1.6MM (US $2.3MM) research award which will support launch of a meniscal repair device. The company’s core technology is Spidrex® cartilage, a silk biomaterial combining the resilience, strength and bioresorption found in spider silk. Future Spidrex products will address spinal disc repair and bone regeneration. Orthox’s Spidrex scaffolds have been developed by parent company OXFORD BIOMATERIALS.
(Orthox Ltd, 2/17/09)

PEGASUS BIOLOGICS’ OrthADAPT® PR bioimplant has now been utilized in a rotator cuff repair procedure. The implant uses Pegasus’ collagen matrix technology combined with a polymer mesh for strength and to facilitate surgical delivery.
(Pegasus Biologics, Inc., 2/13/09)

By the end of 2009 QFX TECHNOLOGIES intends to file a 510(k) and launch its 1st product, the QFx Damage Control System for the external fixation of leg bones.
(Memphis Commercial Appeal, 2/26/09)

REGEN BIOLOGICS (RGBO) completed the 2nd of a 2-stage private placement of ~US $1.7MM in common stock for combined gross proceeds of ~$9MM. Funds from the transaction will support U.S. launch of the Menaflex™ collagen meniscus implant.

RGBO initiated the 1st surgeon training course in support of the U.S. launch of the Menaflex™ collagen meniscus implant.
(ReGen Biologics, Inc., 2/17/09 and 2/18/09)

Large animal study results indicate that meniscus processed with RTIX’s BioCleanse® sterilization method performed the same in vivo as did an aseptically processed meniscus, while providing additional implant safety through sterilization.

RTIX launched Matrix HD™ dermis graft and fresh-stored osteochondral (OC) talus allograft for use in sports medicine applications. Matrix HD acellular human dermis is sterilized using Tutoplast® processing technology. Fresh-stored OC talus is intended to enable the resurfacing of cartilage defects in the ankle with mature hyaline cartilage and healthy subchondral bone in a single procedure.
(RTI Biologics, Inc., 2/4/09 and 2/25/09)

SALIENT SURGICAL unveiled the Aquamantys™ Epidural Vein Sealer (EVS) bipolar device, designed to improve patient outcomes in spine surgery. EVS employs Transcollation™, a calibrated fusion of radiofrequency energy and saline, to seal tissues and significantly reduce bleeding in hard-to-reach areas.
(Salient Surgical Technologies, 2/25/09)

SNN plans to build an extremities unit in Memphis, Tennessee and will launch a shoulder device to select surgeons in 2009. Full launch of the Promos shoulder, a PLUS product, is planned for 2010.
(The Commercial Appeal, 2/13/09)

SNN unveiled the VISIONAIRE™ Patient Matched instrumentation system that uses MRI and x-rays to create custom instrumentation for use with SNN’s knee implants. The system will be launched in targeted U.S. markets throughout 2009, and SNN will expand its use across its portfolio of implants for knee and hip replacement and resurfacing.
(Smith & Nephew, Inc., 2/23/09)

SMITH & NEPHEW ENDOSCOPY launched the OSTEORAPTOR™ Anchor for hip and shoulder repair, reportedly the 1st hip anchor to use Polylactic Acid Hydroxyapatite.
(Smith & Nephew, 2/25/09)

SPINAL KINETICS marked the successful implantation of the 1st M6-L artificial lumbar disc and initial commercial launch of the device in Europe. The M6-L’s compressible polymer nucleus is designed to simulate the function of the native nucleus, while a surrounding multi-layer high tensile strength fiber annulus is intended to facilitate a controlled range of motion in multiple directions.
(Spinal Kinetics, 2/18/09)

SPINESOURCE launched the SHELL™ Cervical PEEK Optima® ACIF Cage for use in anterior cervical discectomy and interbody fusion. SpineSource holds U.S. rights to the device, which is manufactured by ADVANCED MEDICAL TECHNOLOGIES. The device allows the ability to implant a 12, 14 or 16 mm width while providing a CONVEX-LORDOTIC shape designed to fit the anatomy of the cervical disc space.
(SpineSource, Inc., 2/16/09)

A former sales representative pleaded guilty to a charge of felony misbranding of a medical device. It is understood that the rep worked for STRYKER, and that this is the 2nd instance of a rep admitting to similar activity. (See BARE BONES, 12/08.)
(Boston Business Journal, 2/10/09; Massachusetts U.S. District Court Case #1:08-cr-10379; New York Times, 2/20/09)

VG INNOVATIONS’ VerteLoc Minimally Invasive Spine Stabilization System has been implanted in >230 patients in the U.S. to date. The device is designed to address minor spinal instabilities by effectively stabilizing the spinal facets.
 (VG Innovations, LLC, 2/23/09)

In 2/09, WRIGHT MEDICAL debuted PROPHECY™ Pre-Operative Navigation Guides for knee replacement, STATURE™ Modular Hip Reconstruction products with a variety of stem options, the G-FORCE™ Tenodesis Screw System for soft-tissue fixation in foot and ankle surgery, etc.
(Wright Medical Group, Inc., 2/23/09)

ZIMMER (ZMH) filed a complaint in a U.S. District Court, alleging that SNN’s Trigen nail infringes upon U.S. Patent No. 6,355,043 (Bone Screw for Anchoring A Marrow Nail).
(Case 209-cv-021, U.S. District Court, Northern Indiana, 2/2009)

New product launches from ZMH in 2/09 included DeNovo® NT Natural Tissue Graft for treatment of focal cartilage defects; the Natural Nail; the Periarticular Elbow Locking Plate and the Trabecular Metal Glenoid featuring ZMH’s exclusive porous technology for biological fixation.

Data from a 10-year comparative clinical study demonstrated bone-to-implant gap filling and positive clinical outcomes up to 10 years following total hip arthroplasty using products made with ZMH’s Trabecular Metal. Further noted was a zero revision rate for aseptic loosening throughout the study, with no incidence of implant migration nor radiographic evidence of gross polyethylene wear.
(Zimmer Holdings, Inc., 2/25/09)


Regulatory/Reimbursement

BENVENUE MEDICAL received CE Mark approval for the Kiva™ Vertebral Compression Fracture Treatment System. The PEEK-based implant is introduced via a percutaneous over-the-wire technique, and is designed to reduce and stabilize the fracture and provide containment during delivery of PMMA bone cement.
(Benvenue Medical, Inc., 2/23/09)

BIOCOMPOSITES received regulatory clearance to market geneX synthetic bone graft in China.
(Biocomposites, 2/22/09)

ETEX received approval under the CE Mark for both Beta-bsm™ Injectable Paste and Gamma-bsm™ Moldable Putty. The next-generation bone substitute materials are based on the company’s proprietary nanocrystalline calcium phosphate technology.
(ETEX Corporation, 2/23/09)

GENZYME received FDA clearance to market Synvisc-One™, a single-injection viscosupplement for the treatment of knee osteoarthritis. Nearly 10,000 patients have been treated with Synvisc-One since clearance in 2008.
(Genzyme Corporation, 2/26/09)

K2M received FDA 510(k) clearance to market its CAYMAN™ Buttress and Thoracolumbar plates, designed to address trauma and tumor applications. CAYMAN comprises multiple implant systems, including a buttress plate to address graft expulsion, a lower lumbar sacral plate and additional plating to stabilize the anterior column.
(K2M, Inc., 2/10/09)

SBi received CE Mark approval for its PRECISE SD Distal Volar Radius Plating System for wrist trauma repair and reconstruction.
(Small Bone Innovations, Inc., 2/19/09)