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Orthopedic and Dental Industry News Complete Archive »

Printable Weekly

AcceleDent Wins Two Prestigious Awards for Orthodontic Device's Sleek Design, Ease of Use

OrthoAccel Technologies, Inc. announced that the company's groundbreaking AcceleDent device is a recipient of the GOOD DESIGN Awards Program and the Best in Biz Awards. Both awards are prestigious in their own right as the GOOD DESIGN awards have been given for the past 50 years by The Chicago Athenaeum Museum of Architecture and Design along with Metropolitan Arts Press Ltd., and the Best in Biz awards are the only independent business award program judged exclusively by members of the press and industry analysts.

An FDA-cleared, hands-free medical device that works in conjunction with orthodontics to speed treatment by as much as 50 percent, AcceleDent received a gold Best in Biz award in the most innovative consumer product of the year category and was recognized in GOOD DESIGN's medical category.

AcceleDent patients simply bite down on the device's mouthpiece for 20 minutes a day and safe, gentle pulsatile forces accelerate tooth movement. Since patient compliance is necessary to accelerate treatment, AcceleDent's design includes a USB connection that records usage, enabling orthodontists to better predict treatment completion via the device's FastTrac Usage Report.

"It's an honor for AcceleDent to have been selected from among several thousand of the world's leading manufacturers and industrial design firms by these two great business award programs," said Mike Lowe, OrthoAccel Technologies' president and CEO. "In addition to AcceleDent patients reporting extremely positive experiences with AcceleDent, these awards underscore our position as the leader of accelerated orthodontics and our desire to improve the treatment journey to a healthy, beautiful smile with our consumer-friendly product design."

Lowe adds that in a recent independent survey, 100 percent of patients reported that AcceleDent is easy to use and that they were satisfied with their experience using the technology. In that same survey, 81 percent of respondents said they would recommend AcceleDent to a family member or friend, which will accelerate OrthoAccel's already rapid market adoption.

AcceleDent joins leading national and international brands that received these two prestigious awards including Dell, HP, Logitech, Motorola, Toshiba and United Healthcare. A complete list of GOOD DESIGN winners can be found on the museum's website and the Best in Biz Awards listing can also be found online.


Musculoskeletal News Roundup 22-Jan-15

Earnings
Johnson & Johnson reported financial results for 4Q:14. Total revenue was $18.3 billion in 4Q:14, slightly missing consensus estimates and representing an increase of 4% compared to $18.4 billion in 4Q:13. Gross margin for 4Q:14 increased to 67.9%, from 67.5% in 4Q:13. Domestic sales increased 7%, while international sales increased 1% in 4Q:14. Total Orthopedic sales were $2.44 billion in 4Q:14 increasing 3%, compared to $2.46 billion in 4Q:13, with domestic and international orthopedic sales growing 2% and 3% respectively. Hips increased 5% worldwide on an operational basis driven by strong volume growth results in primary stem platform sales. Worldwide spine sales grew 3%, trauma grew 5% and knee sales increased 3%. Knee growth was driven by the launch of ATTUNE fixed bearing knee platform and was offset by pricing pressures. All percentages are on a constant currency basis.

Funding
K2M Group Holdings filed a registration statement with the U.S Securities and Exchange Commission (SEC) relating to a proposed follow-on public offering of its common stock. The company expects to raise approximately $40 million and is selling approximately 4.9 million shares of common stock. The proceeds of the primary portion of the offering will be used by the company for working capital and general corporate purposes, including expansion of the global distribution network and acquisition or investment in complementary products, technologies or businesses. Piper Jaffray, Barclays and Wells Fargo are acting as joint book-running managers for the offering.

M&A
Exactech entered into an agreement to acquire BlueOrtho SAS, a French-based computer-assisted surgical technology company, for up to €10.0 million ($11.8 million).

Regulatory
3D Medical Concepts received FDA 510(k) clearance to market the Vectrix External Fixation System, a treatment for long and short bone fractures in adult and pediatric patients. The system design is based on a ball collet pin clamp and allows lengthening of the transport component.

Dymicron Inc. received ISO 13485 certification of its Quality Management System and CE mark for certification for its Triadyme-C Cervical Total Disc Replacement (cTDR) device. The company believes the Triadyme-C is differentiated from other discs on the market due to its material composition, durability, wear characteristics, and ability to emulate of natural spinal motion.

ECA Medical Instruments received FDA 510(k) clearance to market the Intelligent Implant System (IIS) Revolution Spinal System, a disposable single-procedure torque-limiting and fixed-driver surgical instrument kit for open and minimally invasive surgeries. The company plans to begin selling the system in 2Q:15.

K2M received FDA 510(k) clearance to market the MESA 2 Deformity Spinal System, a pedicle screw system designed to address complex spinal pathologies. The MESA 2 screw, a top-loading, low-profile screw is designed with a dual-lead thread pattern and the ability to one-step lock without applying torsional stress to the spine.

Product Introduction & Update
Blue Belt Technologies, a medical technology company specializing in robotic solutions for orthopedic surgery, announced the results of a strong commercial performance in 2014, their first full year of commercialization. In 2014, Blue Belt sold 33 Navio Surgical Systems in multiple countries. Blue Belt’s customers include major teaching institutions, community hospitals, and a fast-growing market in ambulatory surgery centers. More than 900 partial knee replacements have been performed with five different implant partners and Blue Belt’s proprietary STRIDE™ Unicondylar Knee System. Blue Belt Technologies also received FDA clearance to market and sell a new application for patellofemoral joint replacement surgery, increasing the potential audience for robotic-assisted partial knee replacement procedures.

Flower Orthopedics released an anatomic Distal Radius FlowerCube, which is intended for use for internal fixation of fractures and reconstruction of bones. This product offering compliments its upper extremity product portfolio. The set comes with standardized, multi-use disposable instruments.

Integra LifeSciences announced the full market release of Integra Reinforcement Matrix, a biologic implant that can be used for any type of tendon injury that requires surgical reconstruction. The product has high tensile strength that provides reinforcement during the healing phase of tendon repair.

Legal
KFx Medical announced their $35 million patent infringement judgement against Arthrex was upheld on appeal. KFx had originally won the court case in 2013 and was awarded $29 million. The expanded award includes additional damages and interest.


Blue Belt Technologies Announces 2014 Results

Blue Belt Technologies, a medical technology company specializing in robotic solutions for orthopedic surgery, announced the results of a strong commercial performance in 2014, their first full year of commercialization.

In 2014, Blue Belt sold 33 Navio Surgical Systems in multiple countries. Blue Belt’s customers include major teaching institutions, community hospitals, and a fast-growing market in ambulatory surgery centers. More than 900 partial knee replacements have been performed with five different implant partners and Blue Belt’s proprietary STRIDE™ Unicondylar Knee System. Blue Belt Technologies also received FDA clearance to market and sell a new application for patellofemoral joint replacement surgery, increasing the potential audience for robotic-assisted partial knee replacement procedures.

“Blue Belt had a strong year and I am very pleased with our results” said Eric Timko, President and CEO of Blue Belt Technologies. “For our company, 2014 was about execution and growth in our first full-year of commercialization. We accomplished our goals, achieving significant milestones throughout the year, and will be riding tremendous momentum moving into 2015. We will continue to focus on our commercial expansion both in the U.S. and OUS as well as further expanding our application pipeline in both joint reconstruction and sports medicine.”

The Navio system provides robotic assistance for partial knee replacement procedures through proprietary CT-free navigation software and a unique handheld, computer-controlled, bone-shaping tool. The Navio system brings a high degree of implant placement accuracy along with soft-tissue balancing benefits for patients suffering from early to mid-stage osteoarthritis.


Exactech Acquires BlueOrtho for Up to $12M

Exactech entered into an agreement to acquire BlueOrtho SAS, a French-based computer-assisted surgical technology company, for up to €10.0 million ($11.8 million).

Under the terms of the transaction, Exactech will pay €2.0 million ($2.3 million) at the deal closing, and a potential earnout amount of up to €8 million ($9.3 million) based on the achievement of surgical case milestones.

BlueOrtho entered into a partnership with Exactech in 2009 to develop the ExactechGPS Guided Personalized Surgery system, a surgical technology which incorporates a proprietary camera system. This system provides orthopedic surgeons with real-time visual guidance and alignment data during total knee arthroplasty (replacement) procedures.

Exactech has strategically invested in this type of technology because management believes it will become the new standard of patient care in total joint arthroplasty. The company plans to expand the system’s application to other segments of its product portfolio.



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