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Orthopedic and Dental Industry News Complete Archive »

Printable Weekly

Musculoskeletal News Roundup 27-Mar-15

Funding
Flower Orthopedics completed a $4.5 million series C equity raise. Proceeds will be used for growth strategies and working capital.

OrthoSensor raised $19 million in a private placement of series C preferred stock. Proceeds of the financing will be utilized for product development and for commercialization of the Company’s leading product, Verasense. The product is a disposable sensor-assisted total knee replacement instrument that assists surgeon decisions on implant position and tissue balance.

M&A
The Japan Fair Trade Commission granted Zimmer clearance of the acquisition of Biomet. The acquisition is still subject to clearances under Hart-Scott Rodino in the U.S. and under the European Union Merger Regulation

Product Introduction & Update
Cayenne Medical is launching two new products: the Quattro Bolt Tenodesis Screw, which is designed to arthoscopicaly screws tendon to shoulder socket and the Short SureLock System, a mini all-suture anchor for small bone indications.

ConforMIS announced the iTotal CR (cruciate-retaining) customized total knee replacement system, which is designed to reduce the number of interoperative steps required during a knee replacement surgery.

DePuy Synthes launched the TFN-ADVANCED proximal femoral nailing system (TFNA), for hip fracture surgery. Among the design features of the system are a lateral relief cut of the nail to help preserve bone, a bump cut design to make the nail stronger, a helical blade designed to hold the nail securely, and new instrumentation designed to reduce procedural complexity.

DePuy Synthes launched four products in its adult deformity portfolio. First, the EXPEDIUM Osteotomy System, a comprehensive instrument set for use during spinal reconstruction. Second, the VIPER Cortical Fix X-Tab, which is designed for minimal muscle trauma in percutaneous (under the skin) surgery. Third, the Synapse system, which is intended to provide posterior stabilization to the occiput (near the back and base of the scull) and upper spine. Finally, the VIVIGEN Cellular Bone Matrix, which can be used as an alternative to autograft (bone harvested from the patient's body).

DJO Surgical launched Exprt Precision System which is marketed to experienced total knee revision arthroplasty surgeons. The system features compact design, minimized waste, a streamlined setup and lower cost, compared to similar systems.

Exactech launched several products. In their knee portfolio, the company released the ExactechGPS (Guided Personalized Surgery) which provides real-time, patient specific information for use in total joint replacement, and the Optetrak Logic Porous, a cementless fixation solution for total knee arthoplasty. In the hip portfolio, the company launched the Alteon Tapered Wedge Femoral Stem, a single-taper, wedge-style femoral stem, and InteGrip, a porous ingrowth material for acetabular cups in revision.

Intellijoint Surgical introduced and launched the intellijoint HIP smart tool, which interoperatively assists the surgeon measure, position the implant, and accurately set the patient’s leg length. The product is U.S. FDA cleared and Health Canada licensed.

Medacta previewed the GMK Efficiency Single Use Knee Instrumentation, a single use, carbon neutral instrumentation set for total knee arthroscopy. The company plans to begin marketing the product in 2H:15

New Era Orthopedics (NEO) launched their knee system, which is designed to increase flexion stability while optimizing patellar tracking, rollback and rotation. NEO’s strategy is to market discount implants and instrumentation, focusing on the commonly performed procedures.

Smith & Nephew launched its Q-FIX All-Suture Anchor which is indicated for use in the shoulder and hip. The anchor utilizes a radially expansion that deploys at the same depth within bone and offers performance similar to larger, hard anchors.

Stryker announced that it received 510(k) clearance from the FDA for a total hip arthroplasty application for its MAKO surgical robotic system. With this approval, Stryker will now be able to offer proprietary femoral and acetabular implants for complementary use with its MAKO platform. This expanded indication for MAKO advances the company's strategic initiative to differentiate itself by offering implants through a robotic platform that aims to enhance patient outcomes compared to traditional manual orthopedic surgery.

Stryker launched the Tempus Anterior Cervical Plating System, which features secondary locking mechanism, graft windows, and low profile design.

X-spine launched its Irix-A Lumbar Integrated Fusion System which consists of an integrated titanium ring, surrounded by an outer PEEK ring and three screws. The device is intended for one or two contiguous levels in the lumbar spine and is implanted anteriorly.

Zyga Technology launched the updated SImmetry Sacroiliac Joint Fusion System and announced the its first surgery. The device addresses conditions of sacroiliac joint disruptions and degenerative sacroiliitis.

Regulatory
K2M received FDA 510(k) clearance to market its NILE Alternative Fixation Spinal System for complex spinal deformity cases. The system features compatibility with its Mesa Rail system and an independent locking mechanism to the rod and band.

Clinical
FORCE-TJR (Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement) completed their database tracking implant performance and improvement of patient pain and physical function. The project identified and modeled risk adjusted benchmarks, including patient risk factors, and other clinical measures which surgeons can use to time surgery and optimal patient selection. With analysis, outcomes can now be compared across varied implants, surgical approaches and follow up programs.

Implanet announced publication of a retrospective study of the cost effectiveness of its JAZZ Band in scoliosis surgery. Researcher compared the cost of using all pedicel screw constructs to using a hybrid of screws and subliminal (beneath the arch of a vertebra) bands. The study concluded utilizing the hybrid approach saved $11,700 per procedure from a combination of a fewer number of implants per case, decreased procedure length, reduced blood loss, and reduced hospital stays.

Distribution
DePuy acquired exclusive worldwide distribution rights to market the Radlink Galileo Positioning System (GPS), which provides surgeons performing hip replacements with real-time intra-operative imaging, navigation and information on positioning, sizing, leg length and offset.

Synergy Disc Replacement Inc (SRDI) entered into a 7 year agreement for GM Medical Pacific to be the exclusive master distributor of the Synergy Disc in the Asia-Pacific region. SYNERGY Disc is a cervical disc replacement designed to correct pre-operative deformity, prevent post-operative misalignment and provide optimal stability for multi-level procedures. The system incorporates multiple alignment corrections to help provide surgeons with control of lordosis and sagittal balance.


Robotics Coming to a Head at Strategics

At the 2015 American Academy of Orthopaedics (AAOS) annual meeting this week, Stryker announced that it received 510(k) clearance from the FDA for a total hip arthroplasty application for its MAKO surgical robotic system.

With this approval, Stryker will now be able to offer proprietary femoral and acetabular implants for complementary use with its MAKO platform. This expanded indication for MAKO advances the company's strategic initiative to differentiate itself by offering implants through a robotic platform that aims to enhance patient outcomes compared to traditional manual orthopedic surgery.

Presently, Stryker utilizes MAKO to perform partial knee resurfacing, an application that has been one of the primary growth drivers of the company's knee business. In a recent Royal Bank of Canada (RBC) survey, surgeons cited three reasons for why they would use a surgical robotic system to perform orthopedic procedures: 1) ease of use, 2) the ability to assist in technically challenging procedures and 3) the capacity to replicate results.

To expand MAKO's application even further, management is aiming to receive FDA clearance for a total knee construction procedures later this year.

Additionally, Johnson & Johnson announced a partnership with Google this week to develop a robotic-assisted surgical platform directed at the cancer and women's health markets.

The collaboration aims to build a "radically different" system that is more flexible and cost-effective than what is currently available on the market (Intuitive Surgical). Various methodologies to add advanced imaging and sensors to surgical tools will be explored by both companies.

This partnership will help J&J build upon an existing robotic system prototype, and gives Google a greater presence in healthcare, an industry Google has been heavily investing in in recent years.

Although J&J and Google's partnership is not specifically targeting the orthopedics industry, it definitely underlines the surgical robotics market.


FORCE-TJR Completes Database Tracking Implant Performance and Patient Function

FORCE-TJR (Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement) completed their database tracking implant performance and improvement of patient pain and physical function. The project identified and modeled risk adjusted benchmarks, including patient risk factors, and other clinical measures which surgeons can use to time surgery and optimal patient selection. With analysis, outcomes can now be compared across varied implants, surgical approaches and follow up programs.

The FORCE-TJR was a $12 million national research project funded by the Agency for Healthcare Research and Quality (AHRQ). The population studied includes over 150 surgeons from all types of practice settings and regions of the U.S.FORCE-TJR collected data in four primary areas: both pre-and post- surgery patient reported measures; clinical measures, including smoking status http://www.aaos.org/news/aaosnow/jan14/clinical3.asp and body mass index (BMI); readmission rates, adverse effects and co-morbidities; and demographics. Results were also compared against cost.

After analyzing the data, three insights were seen. First, there is an optimum timing for hip and knee replacement surgery which maximizes the level of improvement after TJR. Second, there are pre-operative patient risk factors which influence post surgical patient pain and function, and influence readminssion rates. Finally, outcome data on working-aged adults was collected. Previously, only medicare (over 65 year old patient) data was collected. The FORCE-TJR was the first to collect data on working age patients, who actually have more musculoskeletal risk factors, like low back pain or multiple painful joints, compared to older patients.

As the project continues, FORCE-TJR plans to continue monitoring the originally assessed patients and expand enrolled surgeons and hospital beyond the original AHRQ funded sites.


Musculoskeletal News Roundup 19-Mar-15

Earnings
Bacterin reported financial results for 4Q:14. Total revenue was $9.1 million in 4Q:14, beating consensus estimates by 1%, and representing an increase of 10% compared to $8.3 million in 4Q:13. EBITDA was ($1.1) million in 4Q:14, increasing 31% compared to ($1.6) million in 4Q:13. Gross margin for 4Q:14 increased to 63.5%, from 49.5% in 4Q:13. Management attributes the increase in gross margin to an increased focus on operations which yielded improved manufacturing efficiencies. All growth rates are on a reported basis.

K2M Group reported financial results for 4Q:14. Total revenue was $49.3 million in 4Q:14, beating consensus estimates by 1% and representing an increase of 16% compared to $42.6 million in 4Q:13. Adjusted EBITDA was ($0.6) million in 4Q:14, increasing from ($2.0) million in 4Q:13. Gross margin for 4Q:14 increased to 67.1%, from 64.2% in 4Q:13. The company's U.S.-based segments grew on a reported basis by: Complex Spine +21%, Minimally Invasive +24% and Degenerative +28% in 4Q:14. The company's International segment decreased by 1% and represented 28% of the company's total revenue in 4Q:14. All growth rates are on a constant currency basis.

Funding
Implanet raised €11.2 million ($12.4 million) in an equity offering, total demand for shares was €16.5 million ($18.1 million). The initial amount of the offering was €9.7 million ($10.7 million). ODDO & Cie and SwissLife Banque Privée have acted as Joint Lead Managers of the offering.

M&A
M.H. Carnegie, an Australian private equity/venture capital group acquired Simplify Medical, a manufacturer of non-metallic, cervical spine, artificial disc implants. the company's cervical discs PEEK-on-ceramic articulation is designed for low levels of wear to optimize long-term durability.

Regulatory
Silver Bullet Therapeutics received CE Mark certification for of its antimicrobial OrthoFuzIon Cannulated Bone Screw System. The system consists of a antimicrobial platinum plated cannulated titanium bone screw and silver plated nitinol insert that fits into the screw cannula. The system galvanically produces silver ions, which are a demonstrated bactericide.

Simplify Medical received IDE approval from the FDA to initiate its clinical trial comparing Simplify Disc with anterior cervical discectomy and fusion (ACDF) as a control. The low-profile disc is composed of non-metallic, MRI-friendly PEEK and ceramic materials.

Product Introduction & Update
Blue Belt Technologies, a medical technology company specializing in robotic solutions for orthopedic surgery, announced the first Navio-assisted surgery performed in Australia and the first implanted Navio-assisted GRU Knee System from corporate partner Global Orthopaedics Technology. The procedure was performed by Dr. Bill Walter, Orthopedic Surgeon at Mater Hospital in Sydney, Australia.

Zimmer initiated a voluntary recall of its Persona Trabecular Metal Tibial following an increase in complaints of radiolucent lines and loosening. All sizes of the device are being removed from distribution.

Zimmer announced its first shoulder replacement in the U.S. utilizing its Vivacit-E liner for the Trabecular Metal Reverse Shoulder System. The liner could be used in the setting of irreparable rotator cuff tear, shortening revision surgery, since the stem would not need to be removed.

Legal
The Department of Justice informed Biomet that the Deferred Prosecution Agreement (DPA) and independent compliance monitor appointment the Company entered with the DOJ in 2012 have both been extended for an additional year. This is a continuation of the possible violations of the Foreign Corrupt Practices Act.

Distribution
Bacterin extended its contract for an additional year to supply Novation members with OsteoSponge, OsteoSelect DBM Putty, and other proprietary Bacterin allografts. Approximately 25% of Bacterin's 2014 revenues were generated by Novation members.



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