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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.
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.
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
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.
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 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.