Sunday, October 30, 2016
Saturday, October 29, 2016
News: AMNIOX Highlights Study Demonstrating Improved Outcomes in Patients Treated with CLARIX® Regenerative Matrix as an Adjunct to Lumbar Discectomy
Company is Introducing its Proprietary Technology at North American Spine Society (NASS) Annual Meeting
ATLANTA--(BUSINESS WIRE)--AMNIOX Medical, Inc., a TissueTech™, Inc., company, announced the results of a prospective randomized clinical study of its proprietary cryopreserved Amniotic Membrane (AM) as an adjunct to lumbar discectomy. The findings will be presented at the North American Spine Society 2016 Annual Meeting, by the study’s lead investigator, D. Greg Anderson, M.D. of the Rothman Institute in Philadelphia, PA.
“Equally important to the clinical benefits observed are the enormous health economic implications of this study. Reductions in the rate of rehospitalization and in the number of future operations for reherniation make this a technology that will be embraced by payers as well as providers.”Tweet this
The study included 80 patients, with half of the patients receiving CLARIX 100 in the disc space following removal of the disc herniation and half receiving the standard of care which involved removal of the herniation alone. Patients treated with CLARIX saw statistically significant improvement in Oswestry Disability Index (ODI) scores and SF-12 (Physical Composite Scale) at six weeks and two years. The ODI quantifies disability due to low back pain and the SF-12 assesses the patients’ physical and mental well-being. The study also reports that there were no recurrent herniations in the CLARIX treatment group during the 2-year follow-up period, compared to a 7.5 percent recurrence rate in the control group.
“Degenerative disc disease is the most common source of back pain and lumbar discectomy is the most common surgical intervention to treat this condition. However, residual back pain and recurrent herniations can be as high as 20%” said Dr. Anderson, Professor in the Departments of Orthopaedic and Neurological Surgery at Thomas Jefferson University and Clinical Director of the Spine Section of the Orthopaedic Research Laboratory. “These results indicate that the application of CLARIX can influence the healing response to significantly improve post-surgical outcomes. Patients experience reduced pain and a faster and sustained return to activities of daily living. Additionally, although it was not an endpoint identified in the study protocol, we observed a reduction in the use of narcotics in the patients treated with CLARIX.”
“This Level 1 study is the first one to evaluate the benefits of placental tissue in conjunction with discectomy and is clear evidence that the benefits of CLARIX that have been observed in other orthopedic procedures can be brought to patients undergoing spinal surgery” said Tom Dugan, Chief Executive Officer of Amniox Medical. “Equally important to the clinical benefits observed are the enormous health economic implications of this study. Reductions in the rate of rehospitalization and in the number of future operations for reherniation make this a technology that will be embraced by payers as well as providers.”
Amniox parent TissueTech pioneered the commercialization and clinical application of human umbilical cord and amniotic membrane to promote regenerative healing. This restorative ability is innate to these placental tissues and can be preserved and transplanted to adults. Heavy chain hyaluronic acid/pentraxin-3 (HC-HA/PTX3) is the key protein complex present in these tissues to orchestrate that regenerative healing process. Amniox utilizes its proprietary CryoTek® process, a cryopreservation technology, to preserve the biological and structural integrity of these tissues more effectively than other available technologies. Since the company’s inception, clinicians have performed more than 250,000 human transplants of its products and published more than 300 peer-reviewed studies supporting its technology platform.
About Amniox Medical, Inc.
Founded in 2011 to serve the orthopedic and wound care markets, Amniox Medical is dedicated to developing and marketing regenerative therapies processed from umbilical cord and amniotic membrane utilizing its proprietary CryoTek technology. This process has been proven to preserve the innate biological and structural properties of the matrix, which can then be transplanted to adult wound and surgical environments. Amniox Medical procures its tissue through elective donation following healthy live birth via Cesarean section. Thorough donor screening is performed to ensure safety of its products. For additional information, please visit http://www.amnioxmedical.com.
About TissueTech, Inc.
TissueTech, Inc., the parent company of Amniox Medical, Inc. and BioTissue®, Inc., pioneered the development and clinical application of regenerative, amniotic tissue-based products. Amniox Medical develops and markets products for use in the musculoskeletal and wound care markets; BioTissue develops and markets products for the ophthalmology and optometry markets. The National Institutes of Health (NIH) has supported TissueTech’s research with more than 25 continuous years of research grants. Since the company’s inception, clinicians have performed more than 250,000 human implants of the company’s products and published more than 300 peer-reviewed studies supporting its technology platform. The Company’s first product, AmnioGraft®, is the only tissue graft designated by the FDA as homologous for promoting ophthalmic wound healing while suppressing scarring and inflammation.
News: LIFE SPINE® ACHIEVES 32% SALES GROWTH AND ANNOUNCES INDUSTRY’S LARGEST POST-PACKING CAPABILITIES FOR LATERAL FUSION
Huntley, IL, October 26, 2016 – Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today achievement of another astonishing growth milestone, with a sales growth rate of 32% in the third quarter of 2016, as compared to the same quarter in 2015.
Life Spine also announced today industry-leading post-packing capabilities with its e-LIF™ Expandable Lateral Interbody Fusion procedure, which includes the CENTRIC® Expandable Retractor System, the LONGBOW™ Expandable Lateral Interbody System, the SENTRY™ Lateral Plate System and the newly launched Graft Delivery Device. LONGBOW is the first lateral A/P expanding interbody, providing nearly double its width during in-situ expansion. LONGBOW reduces muscle retraction and potential nerve damage, and when LONGBOW is combined with the Graft Delivery Device, which seamlessly integrates with the LONGBOW in-situ, post-pack graft volumes of over 11cc can be delivered. For more information about products click here.
"We are excited to add another great product to our existing MIS thoracolumbar portfolio. The addition of the Graft Delivery Device has been very well received by surgeons, and the e-LIF procedure has the potential for increased fusion rates and improved patient outcomes," said Mariusz Knap, Vice President of Marketing at Life Spine.
Life Spine will be displaying its entire product portfolio at the 31st North American Spine Society (NASS) Annual Meeting, taking place this week in Boston, and will be located at Booth #1031.
About Life Spine
Life Spine is dedicated to improving the quality of life for spinal patients by increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Life Spine, which is privately held, is based in Huntley, Illinois. For more information, please visit http://www.lifespine.com.
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Friday, October 28, 2016
Education: Global 3D Printing in Education Market 2016-2020 with 3D Systems, EnvisionTEC, ExOne & Stratasys Dominating
Dublin, Oct. 28, 2016 (GLOBE NEWSWIRE) -- Research and Markets has announced the addition of the "Global 3D Printing in Education Market 2016-2020" report to their offering.
The analysts forecast the global 3-D printing market in education to grow at a CAGR of 28.57% during the period 2016-2020.
According to the report, ability to enhance learning process will be a key driver for market growth. The application of 3-D printing technology in education helps enhance the quality of illustration and also simplifies complex concepts through interactive visualizations. Furthermore, simulation and modeling tools designed through 3-D printing devices help explain concepts in 3-D and temporal scales. The use of data displays, timelines, and interactive maps offer visual links between lessons taught and new ideas. 3-D printing technology has transformed the learning process of subjects such as physics, environmental sciences, mathematics, and chemistry.
3-D printing is an evolving technology that caters to sectors such as automotive, education, healthcare, and aerospace. In the automotive and aerospace sectors, the use of 3-D printing enables manufacturers to make complex parts such as gears and fuel nozzles with high efficiency. This technology is expected to also find new applications in other sectors. For instance, in the medical sector, researchers are attempting to discover and identify ways to use this technology to make prosthetic parts with biological materials such as cartilage, bone, and skin.
The report covers the present scenario and the growth prospects of the global 3-D printing market in education for 2016-2020. To calculate the market size, the report presents the vendor landscape and a corresponding detailed analysis of the top-four vendors operating in the market.
Key questions answered in this report
- What will the market size be in 2020 and what will the growth rate be?
- What are the key market trends?
- What is driving this market?
- What are the challenges to market growth?
- Who are the key vendors in this market space?
- What are the market opportunities and threats faced by the key vendors?
- What are the strengths and weaknesses of the key vendors?
- 3D Systems
Other prominent vendors
- Graphene 3-D Lab
- Organovo Holdings
Key Topics Covered:
Part 01: Executive summary
Part 02: Scope of the report
Part 03: Market research methodology
Part 04: Introduction
Part 05: Market landscape
Part 06: 3-D printing in education
Part 07: Market drivers
Part 08: Impact of drivers
Part 09: Market challenges
Part 10: Impact of drivers and challenges
Part 11: Market trends
Part 12: Market segmentation by components
Part 13: Market segmentation by end-users
Part 14: Geographic segmentation
Part 15: Vendor landscape
Part 16: Key vendor analysis
Part 17: Other prominent vendors
PART 18: Appendix
CONTACT: Research and MarketsLaura Wood, Senior Manager | For E.S.T Office Hours Call 1-917-300-0470 | email@example.comFor GMT Office Hours Call +353-1-416-8900For U.S./CAN Toll Free Call 1-800-526-8630 U.S. Fax: 646-607-1907Related Topics: 3D PrintingFax (outside U.S.): +353-1-481-1716
News: Spinal Elements® and Mighty Oak Medical Announce Marketing Collaboration for FIREFLY® Patient-Matched, 3D Printed Spine Surgery Solutions
CARLSBAD, Calif.--(BUSINESS WIRE)--Spinal Elements, a spine technology company, announced that they will be working with Mighty Oak Medical to market the FIREFLY® surgical guidance system.
The FIREFLY® system consists of bone models and guides precisely matched to the patient’s anatomy through concierge pre-surgical planning and proprietary computer-designed guidance solutions. Using data from the patient’s computed topography (CT) scan, Mighty Oak Medical is able to make highly accurate patient-specific pedicle screw guides to be used intraoperatively. The guides and bone models are created using the latest 3D printing technologies.
Navigation has become increasingly more popular with surgeons as a way to achieve improved screw placement accuracy. Image-guided and robotic-assisted systems are available at some facilities, but can be extremely expensive, requiring capital equipment installations at the facility. This makes the technology less accessible to smaller centers and can require surgeons to wait on equipment availability.
The FIREFLY® Pedicle Screw Navigation Guide system has no capital equipment requirements, and intraoperative imaging (and thus radiation exposure) may be reduced due to the accuracy of the patient-matched guides. This makes FIREFLY® an attractive alternative to control costs and improve safety for all stakeholders.
Heidi Frey, President of Mighty Oak Medical, had this to say: “We are excited to partner with Spinal Elements on this technology. We feel confident that once surgeons experience the ease of use and accessibility of the FIREFLY® system, they will gravitate towards predetermined screw sizes and trajectories, implemented with 3D printed patient-specific guides, as a preferred course of treatment for their patients. Spinal Elements, being a technology leader, is a natural partner choice for us to market this technology.”
Spinal Elements will be exhibiting (Exhibit 1341) October 26th through the 28th at the North American Spine Society meeting in Boston. The FIREFLY® technology will be on display within the Spinal Elements exhibit.
About Spinal Elements
Spinal Elements, headquartered in Carlsbad, CA, is a spine technology company for spine surgeons who demand innovative, extremely high quality surgical solutions. From the company’s early work which helped make PEEK commonplace throughout the spine industry to recent advancements in Ti-Bond® porous titanium coated PEEK interbody implants and controlled delivery technology, Spinal Elements has built a reputation for being trustworthy, innovative and different. The company is focused on the development and marketing of progressive spinal treatment options and markets a complete portfolio of advanced spinal implant technologies. Additionally, the company distributes Hero® Allograft, the net proceeds from which are donated to charities benefiting children with life-threatening medical conditions. The company recently launched a warranty program for its Ti-Bond technology based on the success of over 10,000 devices implanted. For more information, please visit www.spinalelements.com.
Follow us on Twitter @SpinalElements and on LinkedIn for continuous company updates.
CHICAGO--(BUSINESS WIRE)--Medacta International, the privately held, family-owned global leader in the design of innovative joint replacement and spine surgery products, announced today the successful completion of the first U.S. surgeries by Dr. Raymond Golish in Jupiter, Fla. and Dr. Arnold Vardiman in San Antonio, Texas utilizing its innovative and proprietary 3D-printed MySpine Low Profile Guide, part of the company’s award-winning MySpine Patient Matched Technology, following its recent FDA clearance. Medacta’s MySpine products will be on display starting today at the North American Spine Society (NASS) Annual Meeting (Booth #1651), being held October 26-29, 2016 in Boston.
“My work requires me to stay on the leading edge of new technologies and techniques for minimally invasive surgery”Tweet this
Demonstrating Medacta’s longstanding commitment to surgical education and training, Dr. Golish and Dr. Vardiman were introduced to the technology at one of Medacta’s industry-leading education forums focused on MySpine technology. “My work requires me to stay on the leading edge of new technologies and techniques for minimally invasive surgery,” Dr. Golish stated. “The MySpine Low Profile Guide sets a new standard for spine surgery and is well-positioned for safe, reproducible results in less invasive instrumentation of the lumbar and thoracic spine.”
Dr. Golish continued: “With the simple, yet thorough preoperative planning and 3D-printed spine guides, I was able to decrease overall operating room time and have better confidence in visualizing the screw trajectory while reducing the need for CT radiation. The patient from my first case is doing very well.”
Dr. Golish and Dr. Vardiman also utilized Medacta’s M.U.S.T. Pedicle Screw System, which requires only one set of dedicated instruments compatible with percutaneous, mini-open, and open procedures.
Orthopedics This Week named Medacta’s MySpine Standard Profile a Best New Technology for Spine Care when it was first released in 2014. The new Low Profile Guide builds on that success to better help spine surgeons identify pedicle entry points, screw trajectories, and implant specifications to potentially increase accuracy and outcomes. The recently launched MySpine Low Profile Guide lowers exposure for an even less invasive approach that is well-suited for degenerative and deformity surgeries of the thoracic and lumbar regions. The MySpine Low Profile Guide received 501(k) clearance from the U.S. Food and Drug Administration in August 2016.
“Our MySpine Low Profile Guide marks another step forward in Medacta’s continued focus on procedural innovation in spine surgery and adds to Medacta’s already impressive and extensive spine portfolio,” said Francesco Siccardi, Executive Vice President of Medacta International. “The Medacta difference stems from the strong emphasis we place on surgeon training and education, as well as better procedural focus to simplify the complex nature of spine procedures.”
In addition to showcasing its MySpine technologies at NASS 2016, Medacta will hold an educational workshop, the “M.O.R.E. Spine Workshop: Discover Medacta Spine Innovations,” in the conference’s Yellow Lab on Thursday, October 27 at 5 p.m. For more information on Medacta’s spine portfolio, visit https://www.medacta.com/en/usa/medical-professionals/products/spine/spine or firstname.lastname@example.org.
Medacta® International is a world leading manufacturer of orthopedic implants, neurosurgical systems, and instrumentation. Medacta’s revolutionary approach and responsible innovation have resulted in standard of care breakthroughs in hip replacement with the AMIS®system and total knee replacement with MyKnee® patient matched technology. Over the last 10 years, Medacta has grown dramatically by taking a different approach and placing value on all aspects of the care experience from design to training to sustainability. Medacta is headquartered in Castel San Pietro, Switzerland, and operates in over 30 countries. To learn more about Medacta International, please visit www.medacta.com or follow @Medacta on Twitter.
News: Mazor Robotics Commercially Launches Mazor X at the North American Spine Society (NASS) Annual Meeting
CAESAREA, Israel–(BUSINESS WIRE)– Mazor Robotics Ltd. (TASE:MZOR; NASDAQGM:MZOR), a pioneer and a leader in the field of surgical guidance systems, launched Mazor X, a transformative platform for spine surgeries at the North American Spine Society (NASS) annual meeting being held in Boston, Massachusetts from October 26 – 29. The Mazor X system represents a new surgical assurance platform for predictable surgery and patient benefit and it will be displayed at the Mazor and Medtronic booths, #931 and #1015, respectively.
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INDEPENDENCE MIS™ enhances the ALIF surgical technique by offering fewer procedural steps and a less invasive surgical corridor than traditional integrated spacers
AUDUBON, Pa., Oct. 25, 2016 (GLOBE NEWSWIRE) -- Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal implant manufacturer, today announced the introduction of the INDEPENDENCE MIS™ System, an integrated ALIF plate-spacer system designed to simplify implantation and fixation of a commonly challenging procedure.
The INDEPENDENCE MIS™ system features advanced instruments that deploy three pre-loaded anchors through a small protected corridor no larger than the implant itself. Most integrated ALIF systems either use screws, which tend to require a much larger access to insert due to their orientation, or wide blades impacted into the bone that can be hard to retrieve. INDEPENDENCE MIS™ streamlines the anterior procedure into three simple steps: inserting the implant, deploying the anchors, and locking the anchors.
“This device is a game-changer,” commented Andrew Iott, Senior Vice President of Product Development. “It builds on the philosophy and success of the INDEPENDENCE® system by delivering a swift, streamlined procedure that enables surgeons to perform an ALIF in fewer steps while preserving the versatility to use screws. INDEPENDENCE MIS™ is another proud addition to our innovative suite of MIS products.”
INDEPENDENCE® (including INDEPENDENCE MIS™, INDEPENDENCE® TPS, and INDEPENDENCE MIS™ TPS) Spacers are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). INDEPENDENCE® Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.
The INDEPENDENCE® Spacer is a stand-alone interbody fusion device intended to be used with three titanium alloy screws which accompany the implant. The INDEPENDENCE MIS™ Spacer is an interbody fusion device to be used with three titanium alloy screws or anchors which accompany the implants. When used with screws, the INDEPENDENCE MIS™ Spacer is a stand-alone interbody fusion device. When used with anchors, the INDEPENDENCE MIS™ Spacer is intended for use with supplemental fixation (e.g. facet screws or posterior fixation). Hyperlordotic implants (≥25° lordosis) are intended for use with supplemental fixation (e.g. facet screws or posterior fixation).
About Globus Medical, Inc.
Globus Medical, Inc. is a leading musculoskeletal implant company based in Audubon, PA. The company was founded in 2003 by an experienced team of professionals with a shared vision to create products that enable surgeons to promote healing in patients with musculoskeletal disorders. Additional information can be accessed at http://www.globusmedical.com.
Safe Harbor Statements
All statements included in this press release other than statements of historical fact are forward-looking statements and may be identified by their use of words such as “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan” and other similar terms. These forward-looking statements are based on our current assumptions, expectations and estimates of future events and trends. Forward-looking statements are only predictions and are subject to many risks, uncertainties and other factors that may affect our businesses and operations and could cause actual results to differ materially from those predicted. These risks and uncertainties include, but are not limited to, factors affecting our quarterly results, our ability to manage our growth, our ability to sustain our profitability, demand for our products, our ability to compete successfully (including without limitation our ability to convince surgeons to use our products and our ability to attract and retain sales and other personnel), our ability to rapidly develop and introduce new products, our ability to develop and execute on successful business strategies, our ability to comply with changing laws and regulations that are applicable to our businesses, our ability to safeguard our intellectual property, our success in defending legal proceedings brought against us, trends in the medical device industry, general economic conditions, and other risks. For a discussion of these and other risks, uncertainties and other factors that could affect our results, you should refer to the disclosure contained in our most recent annual report on Form 10-K filed with the Securities and Exchange Commission, including the sections labeled “Risk Factors” and “Cautionary Note Concerning Forward-Looking Statements,” and in our Forms 10-Q, Forms 8-K and other filings with the Securities and Exchange Commission. These documents are available at www.sec.gov. Moreover, we operate in an evolving environment. New risk factors and uncertainties emerge from time to time and it is not possible for us to predict all risk factors and uncertainties, nor can we assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Given these risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements. Forward-looking statements contained in this press release speak only as of the date of this press release. We undertake no obligation to update any forward-looking statements as a result of new information, events or circumstances or other factors arising or coming to our attention after the date hereof.