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October 28-29 - Musculoskeletal New Ventures Conference
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Oct 29 @ 8:30 AM ET - Dentsply International
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Stryker reported financial results for 3Q:14. Total revenue was $2.4 billion in 3Q:14, beating consensus estimates by 3% and representing an increase of 11% compared to $2.2 billion in 3Q:13. Gross margin for 3Q:14 decreased to 65.6%, from 68.3% in 3Q:13. The company's segments grew by: Knees +6%, Hips 4%, Trauma & Extremities +12%, Instruments +20%, Endoscopy +19%, Medical +13%, Spine 2% and Neurotechnology +11% respectively in 3Q:14. International revenues grew by 9% in 3Q:14 compared to 3Q:13 and represented 32% of total revenue in 3Q:14. All growth rates are on a constant currency basis.
Victrex reported financial results for its fiscal year 2014. The company's Invibio revenues were £53.4 million ($86.7 million) representing an increase of 5% compared to £50.8 million ($82.0 million) in 2013. Management attributes the growth to an improvement in the global spine market. For 2015 the company plans to initiate the roll-out of its PEEK-OPTIMA HA-Enhanced product. Pending U.S. and European regulatory approval, adoption and roll-out is anticipated to commence during the first half of the company's fiscal year.
Zimmer reported financial results for 3Q:14. Total revenue was $1.11 billion in 3Q:14, beating consensus estimates by 1% and representing an increase of 3% compared to $1.07 billion in 3Q:13. Gross margin for 3Q:14 increased to 73.0%, from 69.4% in 3Q:13. The company's segments grew at: Knees +6%, Hips 3%, Extremities +2%, Dental (2%), Trauma (1%), Spine 6% and Surgical & Other 4% respectively in 3Q:14. The company's Americas, Europe and Asia-Pacific segments grew at 1%, 6% and 7% respectively in 3Q:14. All growth rates are on a constant currency basis.
Materialise NV entered into an agreement to acquire the U.K.-based OrthoView Holdings Limited, a leading provider of 2-D digital pre-operative planning and templating solutions for orthopedic surgeons for an enterprise value of up to £7.6 million ($12.3 million), or 2.3x LTM revenues, or approximately 8.2x LTM EBITDA. Management believes the deal better positions Materialise to provide surgeons and hospitals with more cost-effective patient-specific anatomical models and instrumentation.
PRODUCT INTRODUCTION & UPDATE
Bacterin International launched a demineralized allograft, 3Demin Cortical Fibers, intended for a number of orthopedic and reconstructive applications, particularly spinal procedures. The fibers are demineralized utilizing the company's proprietary processing technology.
Medtronic launched its Pure Titanium Coating (PTC) platform of interbody fusion devices indicated for spinal procedures. The platform consists of four products: the CAPSTONE PTC Spinal System, CLYDESDALE PTC Spinal System, ANATOMIC PEEK PTC Cervical Fusion System and CORNERSTONE-SR Ti- Coated Anatomical Cervical Cage. These devices are utilized to treat patients experiencing pain caused by compression of the spinal cord or nerve roots by helping to restore normal disc height. Additionally, the company announced the launch of its DIVERGENCE Anterior Cervical Fusion System for the treatment of single-level cervical disc disease. DIVERGENCE represents a new approach to one-level anterior cervical discectomy with fusion (ACDF) procedures, which traditionally use a four-hole plate and interbody fusion cage. DIVERGENCE's plate and interbody cage can be inserted simultaneously using a common set of instrumentation and one surgical technique.
The Orthopaedic Implant Company (OIC) launched its anatomic lower extremity and straight plates, the company's largest product launch to date. Consisting within the launch are distal fibula and tibia plates, proximal tibia plates, and straight compression and tubular plates, all addressing numerous small bone fragment indications. The plates provide lag screw fixation for comminuted patterns, non-locking screws to obtain compression across simple patterns and locking fixation in osteopenic bone and multi-fragmentary fracture patterns.
X-spine Systems launched its Axograft product portfolio, a broad line of biologics products. The line consists of Axograft DBM Putty, Axograft Cancellous Crushed Allograft, Axograft Crunch Allograft and Axograft Amniotic Membrane. Axograft complements the company’s comprehensive line of spinal fixation products and will be utilized to promote spinal fusion, bone healing and wound treatment in spinal arthrodesis procedures.
Cerapedics announced results from its first prospective clinical study evaluating the safety and efficacy of its i-FACTOR bone graft in anterior lumbar interbody fusion (ALIF). The non-blinded study was published in the peer-reviewed Journal of Neurosurgery: Spine, treated 110 patients with i-FACTOR and evaluated for fusion rates and clinical outcomes with a mean follow-up of two years. Treatment was shown to provide favorable clinical outcomes in patients who undergo ALIF surgery for degenerative spine conditions by facilitating successful fusion of two or more vertebrae, also known as arthrodesis. The study also demonstrated a statistically significant improvement between preoperative and postoperative scores when assessing patients using the Oswestry Low Back Pain Disability Questionnaire (ODI), Short Form-12, Odom's criteria score, and a visual analogue scale for pain (VAS).
Osiris Therapeutics entered into an exclusive commercial and development partnership with Arthrex for its cartilage product, Cartiform, a viable chondral allograft intended to repair and restore damaged cartilage in the knee, foot, ankle, and other major joints. The Agreement provides Arthrex with exclusive commercial distribution rights to Cartiform. Osiris will continue to be responsible for the manufacturing, research and product improvement activities. The responsibilities related to the design and conduct of future clinical development programs will be shared between both organizations.
Life Spine announced the relocation of its headquarters to Huntley, IL. The new 58,400 square-foot facility sits on 10 acres and will allow the company to add about 25 employees by the end of 2015.
Seikagaku established a U.S. office to support sales and marketing of products such as its SUPARTZ multi-injection and Gel-One single-injection joint therapies. The company anticipates a greater demand for hyaluronic acid (HA) formulations in the U.S. as the age of the general population continues to rise, increasing the occurence of knee osteoarthritis (OA).
Materialise NV entered into an agreement to acquire the U.K.-based OrthoView Holdings Limited, a leading provider of 2-D digital pre-operative planning and templating solutions for orthopedic surgeons for an enterprise value of up to £7.6 million ($12.3 million), or 2.3x LTM revenues, or approximately 8.2x LTM EBITDA. The transaction closed simultaneously with the signing of the agreement.
Under the terms of the transaction, Materialise acquires OrthoView for a cash payment of £8.5 million ($13.7 million), and a possible additional earn out payment of up to £0.4 million ($0.6 million). At deal completion, OrthoView had an estimated £1.2 million ($1.9 million) in cash & cash equivalents and no financial debt.
OrthoView's 2-D template platform compliments Materialise's position in 3-D pre-operative planning tools, giving the company a comprehensive range of services and solutions for 2-D as well as 3-D planning tools for practically any type of medical images, supplemented with the ability to offer corresponding 3-D printed surgical guides and models. Management believes the deal better positions Materialise to provide surgeons and hospitals with more cost-effective patient-specific anatomical models and instrumentation.
Mazor Robotics appointed Christopher Prentice, the company's current Senior Vice President, America & Global Marketing, as the CEO of Mazor Robotics, Inc., the U.S.-based subsidiary of Mazor Robotics.
Mr. Prentice joined Mazor in 2010 after holding leadership positions with Johnson & Johnson subsidiary Ethicon Endo-Surgery and Intuitive Surgical.
Management feels the U.S. market represents the company's greatest growth opportunity for its Renaissance surgical guidance system, an intraoperative 3-D imaging system intended to assist with the use of surgical instruments in a variety of spine and brain procedures.
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Becton, Dickinson & Company (BD) entered into a definitive agreement to acquire CareFusion Corporation for $58.00 a share in cash and stock, equating to a total enterprise value of $12.2 billion, or 3.2x LTM revenues, or 13.4x LTM Adjusted EBITDA. The transaction builds upon BD's positions in medication management and patient safety solutions, and improves the company's capability to maximize outcomes in infection prevention, respiratory care, and acute care procedural effectiveness with an expanded product portfolio. The transaction is anticipated to close in 1H:15.
Bioventus entered into an agreement to acquire the OsteoAMP product line from Advanced Biologics. OsteoAMP is a tissue-based bone allograft designed to promote bone growth/regeneration and healing in spinal procedures by utilizing the bone morphogenetic proteins (BMPs) and growth factors found within human bone marrow. The acquisition of OsteoAMP, along with the 2013 agreement with Pfizer to develop a novel BMP product, constitute the foundation of Bioventus' Surgical Orthobiologics segment, a marketplace which the company has outlined as a priority.
Breg, Inc. and United Orthopedic Group, Inc. (UOG) entered into a merger agreement, creating a comprehensive suite of products and services to support orthopedic providers to prevent and rehabilitate orthopedic injuries. The combined company's product portfolio will feature four major product brands of orthopedic braces, cold therapy devices and deep vein thrombosis (DVT) prophylaxis products: Breg, Bledsoe Brace Systems, Hope Orthopedics and Cothera. Brad Lee, current President of Breg, has been appointed president of the newly combined company.
Episurf Medical secured CE Mark certification of its Episealer Trochlea product, intended to treat cartilage injury behind the patella (kneecap). Episealer is based on the company's personalized implants.
Precision Spine received 510(k) clearance from the FDA for its VAULT-C Anterior Cervical Interbody Fusion Device, intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-T1) at one disc level. VAULT-C is designed to allow for rigid screw fixation using a zero profile construct and aims to limit the risk of damage to surrounding vessels and adjacent soft tissue, while the large, open bone graft area allows for optimal graft containment.
PRODUCT INTRODUCTION & UPDATE
Globus Medical launched its SILC Fixation System (SILC), a low profile sublaminar fixation system for the correction of spinal curvatures without the need for pedicle purchase in all vertebrae. SILC consists of a polyethylene band that utilizes the strength of the laminar cortical bone as well as a top-loading clamp. It provides a solution for the full spectrum of patients ranging from pediatric to adult in order to address deformity correction, poor bone quality, and compromised anatomy.
Spine Wave launched its Lateral Access product portfolio, which consists of the previously released StaXx XDL Expandable Device and the just released StaXx IBL Expandable Interbody Device, the Abacus Lateral Spacer System, the XLR Lateral Access System and a full complement of disposable accessories, for full commercial launch. With this launch, the company now is able to offer spine surgeons multiple expandable implant options as well as a more traditional non-expandable PEEK implant.
Smith & Nephew launched its EVOS MINI Plating System for use in complex fractures of the long bones of the arms and legs. The system is designed specifically for traumatologists and includes the variety of mini, flat plates and screw sizes necessary to address both fracture reduction and short-term fixation while the final, load-bearing repair is being completed. Organized into a single tray, each EVOS MINI Plating System includes three different, color-coded, size modules that offer a variety of up to eight low-profile plate geometries.