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September 10-13 - The American Association for the Surgery of Trauma Annual Meeting
September 10-13 - Scoliosis Research Society Annual MeetingComplete Calendar »
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Tecomet entered into an agreement to acquire 3D Medical Manufacturing Inc., a contract manufacturer of critical high precision medical device components, implants, instruments, cutting tools and mechanical / electro-mechanical assemblies. The transaction will help Tecomet control cost, provide high quality complex components and reduce lead-times to meet customers’ most advanced requirements. Furthermore, 3D Medical provides advanced manufacturing expertise in the extremities market.
PRODUCT INTRODUCTION & UPDATE
Expanding Orthopedics announces the first implantation of its FLXfit, a 3-D expandable minimally invasive interbody cage. FLXfit helps allow for a wide anterior footprint coverage in minimally invasive, unilateral TLIF approaches and has articulated self-guidance features for to assist with placement after expansion.
A team of researchers at MIT have developed a new approach to bone regeneration and reconstruction called "layer-by-layer assembly".
The approach utilizes a very thin, porous, nanostructured, biodegradable poly(lactic-co-glycolic acid) scaffold sheet that incorporates a polyelectrolyte multilayer coating containing active bone morphogenetic protein-2 (BMP) and platelet-derived growth factor-BB (PDGF).
The coating carries physiologically relevant amounts of BMP and PDGFs, as little as 200 ng, which are eluted over readily adapted time scales to encourage bone regeneration. This feature differentiates this delivery methodology from other bioactive materials which tend to release growth factors too quickly, leading them to be rapidly cleared (by the body) from the treatment site before they can induce tissue repair. Based on electrostatic interactions between the polymer multilayers and growth factors alone, the team's implant sustained mitogenic and osteogenic signals with the chosen growth factors in an easily tunable and controlled manner to direct endogenous cell function.
Furthermore, the researchers observed that this delivery system helped facilitate vascular tissue growth in the affected area, providing a pathway for the stem cells and precursor osteoblasts (cells that produce bone) to reach the site and regenerate the bone and other tissues.
The team concluded that this approach could be clinically useful, and has benefits as a synthetic, off-the-shelf, cell-free option for bone tissue repair and restoration.
Last week, Glenn Coleman the CFO of Integra Lifesciences, expressed to analysts that the company is interested in exploring strategic alternatives for its Spine business.
Integra's management team believes that Integra's Spine unit would need a significant investment in order to compete in the market with Medtronic, Johnson & Johnson, Stryker and others, an investment that the company is not prepared to make. On the 2Q:14 earnings call, Integra's CEO, Peter Arduini, conveyed that for Spine, the company would rather plan to focus on organically running the business than going out and doing a large amount of acquisitions.
Integra's Spine segment offers comprehensive spinal fusion and orthobiologic technologies. Key spinal hardware products include integrated interbody fusion devices, minimally invasive solutions, and deformity correction. Key orthobiologic products consist of demineralized bone products, collagen ceramic matrices and pure synthetic bone grafting solutions.
For 2Q:14, the company reported that its U.S. Spine & Other segment grew 4% on a constant currency basis. This was the first year-over-year increase the segment has seen in five quarters.
Management imagines that a combined sale of the company's Orthobiologics and Spine Hardware businesses would be the most attractive to strategic and financial buyers.
Orthofix International determined that certain entries in its previously restated filed financial statements were not properly accounted for under U.S. generally accepted accounting principles (GAAP). Specifically, the company has determined that its historical method of accounting for certain revenue adjustments (related to uncollectible patient co-pay and self-pay amounts) as bad debt expense rather than as contra-revenue was incorrect. As a result of the foregoing, Orthofix expects to reduce equally both its historical net sales and its sales and marketing expense by approximately $6 million, $9 million, $2 million and $3 million for the fiscal years ended December 31, 2011, 2012 and 2013 and the fiscal quarter ended March 31, 2014, respectively. Therefore, due to foregoing corrections, Orthofix will again restate its financial statements for the fiscal years ended December 31, 2011, 2012 and 2013 (including the quarterly periods therein) and the fiscal quarter ended March 31, 2014. The company intends to include restated financial statements for these periods in amendments its 2013 Form 10-K and 1Q:14 10-Q.
Oxford Performance Materials (OPM) received 510(k) clearance from the FDA to market its OsteoFab Patient-Specific Facial Device, a 3-D printed facial polymeric implant that is custom-printed for each transplant patient using MRI or CT scan images. OPM prints the implants using its proprietary powder formulation, which are similar to bone and support bone attachment. Biomet will be the exclusive global distributor for the new implant.
PRODUCT INTRODUCTION & UPDATE
Ceterix Orthopaedics announced the results of a systematic literature review evaluating the success rate of repairing horizontal meniscus tears. The study, published online in the journal Arthroscopy, examined more than 16,000 articles and nine studies with evaluable data reporting results of horizontal cleavage tear repairs. A total of 98 repairs of horizontal tears were reported. Using reoperation as the criterion for treatment failure, 77 of the repairs were successful, resulting in an overall success rate of 78%, demonstrating that meniscus repair can be successful.
A team of researchers at Texas A&M University have developed a new shape-memory polymer (SMP) for craniomaxillofacial (head, face or jaw) reconstruction and filling of bone defects.
The "self-fitting" material expands with warm salt water and molds to the precise shape of the bone defect without becoming brittle, and as its porous, acts like a scaffold, supporting the growth of new bone tissue.
Currently, the most common method for filling craniomaxillofacial bone defects is autografting, a process in which surgeons harvest bone from elsewhere in the body, such as the iliac crest, and then try to shape it to fit the bone defect. Autograft though, is a rigid material that is difficult to shape, and complications can arise at the harvesting site. Another approach is to utilize bone putty or cement to plug gaps, but these materials can become brittle when they harden, and lack pores, or small holes, that would encourage new osteoblasts (the cells that produce bone), to move in and rebuild the damaged tissue.
SMPs are materials whose geometry changes in response to heat, and upon reaching 140 degrees Fahrenheit, become soft and malleable. Therefore during surgery, a surgeon could warm an SMP to that temperature and fill in a defect with the softened material. As the SMP cools to body temperature, it resumes its stiff texture and "locks" into place.
The research team created the new SMP by linking together molecules of poly(ε-caprolactone), an elastic, biodegradable substance, and coated it with polydopamine, a sticky material that helps lock the polymer into place by prompting the formation of a certain bone mineral. The researchers determined that an SMP utilizing a polydopamine coat, generated not only 5x more osteoblasts than those without a coating, but encouraged osteoblasts to produce greater quantities of runX2 and osteopontin, two proteins critical for new bone formation.
The next step for this new SMP are preclinical studies to test its ability to heal craniomaxillofacial bone defects in animals.