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Orthopedic and Dental Industry News Complete Archive »

Musculoskeletal News Roundup 9-Dec-16 BY BLAKE MOSSY, DECEMBER 9, 2016

FUNDING
MinInvasive announced a new round of financing and strategic partnership with MicroPort Scientific Corporation, granting the company the exclusive right to distribute MinInvasive's OmniCuff in China. The OmniCuff is a disposable device enabling arthroscopic, transosseous rotator cuff repair that obviates the need for suture anchors.

M&A
Water Street Healthcare Partners and JLL Partners, two middle-market private equity firms, entered into an agreement to acquire MedPlast, Inc, a U.S.-based integrated custom plastic processing solutions company for finished medical devices. MedPlast offers a range of engineering and manufacturing capabilities for original equipment manufacturers (OEMs) that produce medical devices and related components for the diagnostic, orthopedic, surgical and other medical products industries. Water Street and JLL plan to expand the company's suite of capabilities into new areas to form a comprehensive, integrated portfolio of end-to-end product solutions focused on the health care industry.

REGULATORY
curasan received 510(k) approval from the FDA for its CERASORB Ortho FOAM synthetic bone material. The system is made of resorbable ceramic and porcine collagen and now can be used the treatment of bone defect in the extremities and pelvis.

KYOCERA Medical received 510(k) clearance from the FDA for its Initia Total Hip System, designed for use with the company's BIOCERAM AZUL (blue) zirconia-toughened alumina (ZTA) ceramic femoral heads. Initia is also available with cobalt chrome (CoCr) femoral heads, allowing surgeons the option of ceramic or metal heads matched to highly cross-linked polyethylene acetabular liners.

PRODUCT INTRODUCTION & UPDATE
International Cartilage Repair Society (ICRS) launched a global, web-based patient registry, to expand knowledge base for articular cartilage injury, history and treatment. The Registry aims to expand the body of evidence available to clinicians, companies and health founders, providing pooled data that can be harnessed to better understand the most effective, safe, economical and clinically-relevant treatments, devices and practices in the treatment of acute cartilage damaged and early osteoarthritis.

CLINICAL
Bioventus published clinical results from a study of its EXOGEN Ultrasound Bone Healing System. The system utilizes low-intensity pulsed ultrasound (LIPUS) to stimulate the body's natural healing process. The study results indicate increased patient compliance, which may lead to enhanced clinical outcomes and fracture healing.

IMPLANET published clinical results from a study of its JAZZ sublaminar implants in hypokyphotic idiopathic scoliosis patients. The study results indicate that the JAZZ implant can be used as an alternative to tradition device, such as screws, at up to 34 months for the treatment of hypokyphotic thoracic scoliosis. The study also suggest that use of JAZZ sublaminar bands allows the cost of surgery and the risk of medullary complication to be reduced with the decreased number of implants used.

RESEARCH
Researchers of the not-for-profit research organization, RAND Europe, determined that sleep deprivation leads to a higher mortality risk and lower productivity levels among a country's workforce, and can therefore significantly impede its economy. In this study entitled, "Why Sleep Matters - The Economic Costs of Insufficient Sleep", the research team quantified the economic losses due to lack of sleep among workers in five different countries: the United States, United Kingdom, Canada, Germany, and Japan. The research team noted that improving sleep habits and duration among individuals in the workforce, can result in drastic positive change. The team estimated that if the U.S. workforce demographic that sleep under six hours a night, increased their sleep duration to between 6-7 hours a night, this would add $226 billion to the U.S. economy.

INTELLECTUAL PROPERTY
Bodycad received two patents from the United States Patent and Trademark Office (USPTO) covering the accuracy, reproducibility and speed for 3-D constructs via MRI and CD images in long and small bone orthopaedic applications. These patents are critical to the company's proprietary approach to creating personalized orthopaedic restorations based on the patient's specific anatomy, which is accomplished with a suite of CAD/CAM software and individual patient imagery.

Paradigm Spine received coverage for its coflex Interlaminar Stabilization device from the International Society of the Advancement of Spine Surgery (ISASS) recommending coverage for decompression with interlaminar stabilization for select patients diagnosed with lumbar spinal stenosis (LSS). The system is a non-fusion device that aims to maintain motion, reduce leg and back pain, and preserve foraminal height. The policy states that interlaminar stabilization after direct decompression is a non-fusion surgical option that can provide the additional stability over decompression alone without rigidity of an instrumented fusion. Paradigm's coflex device is the only spine product that has received FDA Premarket Approval for up to Grade I spondylolisthesis with a concomitant decompression.

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