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Orthopedic and Dental Industry News Complete Archive »

Printable Weekly

Musculoskeletal News Roundup 24-Oct-14

EARNINGS
Exactech reported financial results for 3Q:14. Total revenue was $57.9 million in 3Q:14, in-line with consensus estimates and representing an increase of 4% on a constant currency basis compared to $55.7 million in 3Q:13. Gross margin for 3Q:14 decreased slightly to 70.8%, from 71.0% in 3Q:13. The company's segments grew by: Knee (2%), Hip +4%, Extremity +23% and Biologic & Spine (10%) in 3Q:14 respectively. All growth rates, unless stated, are on a reported basis.

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.

FUNDING
ZipLine Medical received $5.7 million as an extension to its Series C funding from China Materialia. The new capital will help the company increase its marketing and sales efforts of its Zip surgical skin closure device.

M&A
Bone Biologics, Corp. completed a reverse merger with Bone Biologics, Inc. and AFH Acquisition X, Inc. Upon completion of the merger, the newly combined company changed its name to "Bone Biologics, Corp" and anticipates trading in the company's common stock will commence on the OTC Bulletin Board (OTCBB) following regulatory approvals. The company is developing a proprietary protein for use in bone regenerative medicine using the patented recombinant human protein known as UCB-1 (or Nell-1) for use with patients undergoing spinal fusion. Bruce Stroever, the President & CEO of Musculoskeletal Transplant Foundation (MTF), will serve as Chairman of the Bone Biologics' Board and Michael Schuler, MTF's Vice President of New Business Development, will serve as CEO. MTF is the largest shareholder of Bone Biologics.

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.

REGULATORY
SafeWire received CE Mark Certification for its line of Y-Wire Anchoring Guide Wires. The Y-Wire line incorporates a patented bifurcated tip and is designed to prevent inadvertent wire advancement and reduce the amount of fluoroscopy during MIS pedicle screw placement.

PRODUCT INTRODUCTION & UPDATE
Aesculap Implant Systems launched its Plasmafit Pro Acetabular System with the Vitelene liner, which consists of a cementless titanium acetabular shell and a highly crosslinked ultra-high molecular weight polyethylene (UHMWPE) vitamin E blended liner. The hemispherical and slightly flattened design of the Plasmafit PRO cup along with a rough titanium plasma spray on the outer surface aims to provide a high level of stability for strong primary and long-term implant fixation. The Vitelene liner is formulated with antioxidant protection that provides wear and oxidation resistance and balanced mechanical properties.

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.

INTELLECTUAL PROPERTY
Expanding Orthopedics (EOI) received a patent from the U.S. Patent & Trademark Office (USPTO). The patent covers the company's technologies in the area of expandable interbody cages and vertebral compression fractures (VCF) solutions.

CLINICAL
Bacterin International presented preclinical results of its antimicrobial coating for orthopedic hardware. The rifampin- and minocycline-containing coating is intended to address implant-associated infections, one of the most serious complications in orthopedic surgery, by inhibiting the microbial contamination of the implant that can lead to such an infection. The study demonstrated that the coating does inhibit infection progression in a rabbit model of pin track infection and helps the orthopedic hardware in maintaining anchoring strength.

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).

COLLABORATION
Aurora Spine entered into a worldwide distribution and co-marketing agreement with Sentio, LLC to distribute the SentioMMG nerve mapping system. Sentio's system locates and maps motor nerve roots and their peripheral extensions originating from spinal levels C3-T1 and L2-S2. It utilizes smart-sensors employing proprietary technology that use non-invasive accelerometer-based sensors to measure mechanomyography (MMG) activity, the mechanical "twitch" associated with muscle contraction.

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.

OPERATIONS
CMS released its Open Payments database last week. The database was mandated by the Affordable Care Act (ACA or Obamacare) and discloses the financial relationships between physicians and drug and device manufacturers.

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).

APPOINTMENTS
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.


Materialise Acquires OrthoView for Up to $12.3M

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 Appoints CEO of U.S. Subsidiary

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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Musculoskeletal News Roundup 16-Oct-14

EARNINGS
Johnson & Johnson reported financial results for 3Q:14. Total revenue was $18.5 billion in 3Q:14, in-line with consensus estimates and representing an increase of 6% compared to $17.6 billion in 3Q:13. Gross margin for 3Q:14 increased to 70.8%, from 69.6% in 3Q:13. Domestic sales increased 12%, while international sales decreased 0.3% in 3Q:14. Total Orthopedic sales were $2.34 billion in 3Q:14 increasing 3% compared to $2.28 billion with domestic and international orthopedic sales growing 3% and 2% respectively. Hips increased 4% worldwide on an operational basis driven by strong volume growth results in primary hip stem platform sales. U.S. Hip sales grew 3%. Knee sales worldwide increased 5% on an operational basis, with U.S. sales growing 4%. Knee growth was driven by the launch of ATTUNE fixed bearing knee platform and offset by pricing pressures. Trauma grew 3% on an operational basis due to due to market growth.

M&A
European Union (EU) antitrust regulators will decide by March 11th, whether or not to approve Zimmer's proposed $13.4 billion acquisition of Biomet. Zimmer had sought EU approval in June, but the EU competition council halted its review due to certain details that were lacking in the company's merger submission. This latest extension was caused by concerns of reduced competition in certain medical device markets following the takeover.

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.

REGULATORY
The FDA issued a new final guidance document intended to clarify the process by which manufacturers of "custom" medical devices can comply with federal regulations. While much of the final guidance is identical to the January 2014 draft, there have been some changes made to this iteration in order to reflect comments the FDA has received. In this latest draft, the FDA has added a section to the guidance regarding its "five unit" definition, which maintains that the regulatory body will "take into account multiple considerations such as anatomical location, disease state, material, technology and indications", when examining a custom device.

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
Aurora Spine launched its next generation EOS minimally invasive (MIS) TLIF interbody fusion system. This line of MIS lumbar interbody cages is constructed from PEEK-OPTIMA material and feature Aurora's TiNano titanium spray coating technology.

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.

OPERATIONS
Aastrom Biosciences announced plans to change its corporate name to "Vericel Corporation" and move its corporate headquarters to Cambridge, MA. These changes mark the progression of Aastrom's transformation from a clinical-stage company to a fully integrated, commercial-stage specialty biologics company. Management believes the new name reflects the company's commitment to the cell therapy market, and the change in location expands the company's presence in the "vibrant" Cambridge biotechnology community. The company will continue to maintain manufacturing facilities in Cambridge, Massachusetts and Ann Arbor, Michigan.

CLINICAL
VEXIM initiated a new clinical study that will support its planned application for 510(k) regulatory clearance for its SpineJack. The prospective multicenter, randomized study will compare the safety and effectiveness at one year follow-up of SpineJack device with Medtronic's balloon on 150 patients suffering from vertebral compression fractures due to osteoporosis. The company expects to complete the study in 2 years’ time in support of a 510(k) submission in 2017.

COLLABORATION
nanoMAG LLC, a subsidiary of Thixomat Technologies, executed a license agreement with a strategic partner for the commercial development of its BioMg 250 bioabsorbable magnesium alloy. The collaboration with the strategic partner is focused on achieving certain milestones, including regulatory approval for this new class of materials for use in orthopedic applications. Magnesium alloy implants designed to be strong and dissolve over months as the bone recovers its original strength.

DISTRIBUTION
Amedica Corporation entered into a multi-year private labeling agreement with Spinal Kinetics, a developer of advanced artificial spinal disc technology. Under the terms of the non-exclusive agreement, Amedica will provide Spinal Kinetics with its sterile packed silicon nitride spinal interbody fusion devices for sale in worldwide markets.



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