KALAMAZOO, Michigan, USA, Oct. 8, 2018 /PRNewswire/ — Stryker’s Advanced Guidance Technologies business (formerly known as Stryker’s Navigation business) announced today it has entered into strategic partnerships with Synaptive Medical and Ziehm Imaging, strengthening Stryker’s position as a leader in surgical guidance.

Through the partnership with Synaptive Medical, Stryker will offer the BrightMatter™ Plan software, which automatically generates high-fidelity, dynamic, whole-brain tractography.  Surgeons can easily review tracts and explore multiple surgical approaches to create powerful pre-operative plans—for every case.  Tractography can be used, without disrupting surgical workflow, to confirm the data is concordant with the intended approach and determine whether detailed surgical planning is required. Then, the surgical plans can be easily exported for navigation in the operating room.

BrightMatter Plan is the only tractography offering that is automated and whole-brain.  Other solutions on the market require a neuroradiologist or other tractography expert to generate tracts, which is both time consuming and a road block for surgeons.

“We are committed to providing our customers with a complete solution for surgical guidance,” said Lisa Kloes, General Manager of Stryker’s Advanced Guidance Technologies business. “The partnerships with Synaptive Medical and Ziehm Imaging are an important step in that direction.”

The Ziehm Vision RFD 3D C-arm, which Stryker will now offer as part of its agreement with Ziehm Imaging, offers the latest flat-panel technology for CT-like image quality, giving surgeons access to detail-rich imaging that provides the accuracy and efficiency required in demanding orthopaedic, trauma or spinal procedures, all with minimized dose and less time.

Over the last several years, Stryker’s Advanced Guidance Technologies’ product and service offerings have evolved beyond the traditional scope of navigation to also include Imaging, Augmented Reality and Planning Software. With the addition of BrightMatter Plan and Ziehm Vision RFD 3D C-arm to its portfolio, Stryker’s Advanced Guidance Technologies reinforces its commitment to providing customers with better and complete surgical guidance solutions.

To learn more about this expanded portfolio, please visit booth #1529 at The Congress of Neurological Surgeons (CNS).

About Stryker
Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical, Surgical, Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com.

Media contact
Jennifer Lentner 
jennifer.lentner@stryker.com

SOURCE Stryker

Related Links

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SAN DIEGO, Oct. 4, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced it will highlight several of its latest spinal innovations to treat complex spinal deformities at the Scoliosis Research Society (SRS) Annual Meeting held October 10-13, 2018 in Bologna, Italy. As a Double Diamond Sponsor of SRS, NuVasive continues to demonstrate a strong leadership position in offering transformative solutions within the complex adult and pediatric deformity market segments.

“The NuVasive deformity portfolio is one of the most differentiated portfolios in the market offering surgical efficiency, operative reliability and procedural versatility,” said Matt Link, executive vice president, strategy, technology and corporate development for NuVasive. “This latest expansion of the NuVasive deformity portfolio is a further testament of our commitment to building out comprehensive treatment options for both adult and pediatric patients.”

NuVasive’s complex spine technologies are recognized as best-in-class solutions. Since the introduction of the RELINE® posterior fixation portfolio in May 2015, the overall complex fixation business line, defined as cases with more than five levels of spinal correction, has experienced double-digit revenue growth. This validates NuVasive’s solutions are being utilized by more surgeons to help treat some of the most high-risk patients, and the Company continues to look for new opportunities to further invest in this growing market.

During the meeting, NuVasive will demonstrate several of its latest technologies for complex spinal deformities:

• VersaTie® is a posterior band system designed to provide clinical versatility and flexibility in the treatment of complex spinal pathologies in both adult and pediatric patients. The system provides primary and supplemental fixation options for patients where traditional fixation may not be feasible. VersaTie supports advanced spine translation techniques in adolescent idiopathic scoliosis (AIS) patients by providing controlled, hands-free translation, and will be commercially available at the end of October 2018. For adult deformity patients, VersaTie offers an advanced solution for distributed loading across the fixation hardware. The band system’s independent locking connector and advanced tensioning device offers enhanced control to address the variable needs of spine surgery. VersaTie’s adult application will be commercially available by end-of-year, and feature a unique new band providing increased strength characteristics.
• RELINE Navigation.S consists of new instrumentation that offers a complete navigation-compatible solution with surgical navigation. Optimal screw placement and pullout resistance are key surgical objectives to building a strong fixation construct in the adult deformity market, and this new system offers surgeons navigation-compatible instrumentation to optimize clinical outcomes during complex cases.
• RELINE Small Stature (RSS), launched in July 2018, is the first pediatric deformity fixation solution to accept 4.5mm, 4.75mm and 5.0mm rods in a low-profile tulip, combining rod strength with low-profile implants. With RSS, surgeons have the ideal implant profile for young children without compromising on rod strength within the system. The RSS system was built to give surgeons heightened anatomical awareness through the instrumentation, and provide final fusion strength with a 5.0mm Cobalt Chrome rod option for reliable deformity correction. RSS is also compatible with NuVasive’s MAGEC® system to provide a comprehensive solution for the treatment of Early Onset Scoliosis.

NuVasive will also showcase LessRay®, its hardware and software technology that helps reduce radiation exposure in the operating room (OR), which is particularly important when treating pediatric patients. In addition, the Company’s new Pulse™ surgical automation platform will be on display with the Siemens Healthineers’ Cios Spin* advanced mobile 3D-imaging system, creating the industry’s first Spine Precision Partnership™. These integrated systems can be clinically utilized throughout all deformity and degenerative spinal cases, and has the ability to enhance the OR procedural workflow and offer real-time feedback to aid in clinical decision making.

*Cios Spin from Siemens Healthineers is pending 510(k) clearance, and is not yet commercially available in the U.S.

About NuVasive
NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally disruptive, procedurally integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With over $1 billion in revenues, NuVasive has an approximate 2,400 person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.

Forward-Looking Statements
NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA® platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

SOURCE NuVasive, Inc.

Related Links

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AUDUBON, Pa., Oct. 04, 2018 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal solutions company, announced today that a recent clinical study evaluating static versus expandable lateral lumbar interbody fusion devices was awarded best paper at the Society for Minimally Invasive Spine Surgery (SMISS) Annual Forum held last month.

The study, led by Dr. Richard Frisch, an orthopedic surgeon at Southeastern Spine Institute, compared clinical and radiographic outcomes of sixty-four patients who underwent minimally invasive lateral lumber interbody fusion (LLIF) for symptomatic degenerative disc disease. At one year postoperative follow up, patients treated with Globus Medical’s expandable technology experienced significantly greater segmental lordosis and a significantly lower subsidence rate than those in the static group, based on radiographic evidence.  Both the expandable and static spacer groups reported similar improvements in back pain scores with no significant differences in clinical outcomes.

“Subsidence of interbody spacers is a clinical concern due to loss of disc height and foraminal height, and the recurrence of symptoms that may result in revision surgery,” said Dr. Frisch. “The preliminary results of this study suggest that expandable lateral interbody spacers offer important clinical advantages by increasing and maintaining segmental lordosis while potentially decreasing the risk of endplate damage and subsidence.”

Andrew Iott, Senior Vice President of Global Product Development, commented, “Globus Medical would like to congratulate Dr. Frisch on receiving this best paper award at SMISS. We are proud to have sponsored this important research demonstrating the benefits of expandable interbody spacers. As the market leader in expandable interbody technologies, Globus is committed to developing next generation implants that provide innovative solutions to maximize lordosis and help address sagittal imbalance.”

To access the study and learn more about Globus Medical’s portfolio of lateral expandable interbody spacers, visit  www.GlobusMedical.com/LLIF

About Globus Medical, Inc.
Globus Medical, Inc. is a leading musculoskeletal solutions 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.

Contact:
Brian Kearns
Vice President, Business Development and Investor Relations
Phone: (610) 930-1800
Email:  investors@globusmedical.com
www.globusmedical.com

WILMINGTON, N.C. (PRWEB) OCTOBER 04, 2018

Power T Handle, LLC, a surgeon-driven, innovative company, announced today that it has received a Spine Technology Award from Orthopedics This Week during the 2018 National Association of Spine Surgeons (NASS) meeting in Los Angeles, CA last week. The Power T Handle is a surgical instrument that delivers operating room efficiencies through increased speed and reduced surgeon fatigue while preserving tactile feedback and precision in spinal and other surgical procedures. The Spine Technology Awards bring recognition to new, innovative spine surgery products and the teams that created them.

Justin Iorio, MD, orthopedic surgeon at Syracuse Orthopedic Specialists, Syracuse, NY, noted, “The Power T Handle addresses an unmet need in complex spine surgical procedures, and the success of this product can be directly attributed to the benefits it offers surgeons, hospitals and patients. I rely on the Power T Handle in my complex spinal fusion procedures as it saves time in the OR, reduces the strain on the surgeon while providing the feel and precision needed to perform surgical procedures with excellent outcomes.”

This first-of-its-kind, wireless power solution allows for seamless integration of a low speed, high torque power driver that preserves the tactile feel and manual capabilities of a traditional T handle. The low-profile design does not interfere with an intra-operative fluoroscopy, and is compatible with existing surgical instruments. The Power T Handle delivers hassle-free power by eliminating many of the cumbersome features of current power equipment. The Power T Handle is also economical as there is no investment in capital equipment, no reprocessing, no maintenance costs and no batteries to recharge.

Kevin Cahill, MD, PhD, President and Co-founder of Power T Handle, LLC stated, “We are honored to have received The Spine Technology Award. Our team at Power T Handle, LLC is committed to developing disruptive technologies and better power solutions for surgeons.”

About Power T Handle, LLC 

The Power T Handle was developed by a team of experienced medical device engineers led by Kevin Cahill, MD, PhD. The Power T Handle was designed to overcome the many limitations of existing power instruments currently available to surgeons. The Power T Handle provides surgeons with the power, precision and feedback necessary to perform surgery without the fatigue, hassle and cost of traditional instrumentation.

SALT LAKE CITY, Oct. 03, 2018 (GLOBE NEWSWIRE) — Amedica Corporation (NASDAQ: AMDA) today announced that it has completed the previously-announced sale of its spine business to CTL Medical, a Dallas, TX-based privately held medical device manufacturer, on October 1, 2018, all as more fully described below.

As previously announced, Amedica and CTL Medical entered in an asset purchase agreement, dated September 5, 2018, whereby CTL Medical agreed to acquire all of Amedica’s commercial spine business for total consideration of up to $10 million. As a result of the closing, CTL Medical is now the exclusive owner of Amedica’s portfolio of metal and silicon nitride spine products, which are presently sold under the brand names of Taurus, Preference, and Valeo, with access to future silicon nitride spine technologies. Manufacturing, R&D, and all intellectual property related to the core biomaterial technology of silicon nitride remains with Amedica in Salt Lake City. Amedica will serve as CTL’s exclusive OEM provider of silicon nitride products.

“We are pleased to have closed this transaction so quickly after the September announcement. Amedica is now free of the considerable costs and complexity attendant to retail spine sales, allowing the company to focus on the core biomaterials and OEM business instead. We will fully support CTL spine sales in terms of clinical and basic science, surgeon education, and any other necessary sales support. Most importantly, as a debt-free company, Amedica can now focus on revenue opportunities outside of spine where our R&D program is particularly strong, such as in the dental and arthroplasty markets,” said Dr. Sonny Bal, Chairman of the Board at Amedica Corporation. “In our opinion, this is the leanest, most efficient, and overall best position that Amedica has ever been in as a company, from a cash position or otherwise, with multiple strategic options going forward,” added Dr. Bal.

Daniel Chon, President and CEO of CTL Medical noted, “The depth of science behind silicon nitride research continues to impress us. We, at CTL Medical, the only company to possess such highly differentiated biomaterial in spine, are extremely bullish on the outlook and opportunities in our industry. The closing of the acquisition now gives us the green light to unleash the talents of our engineers to drive innovation by applying the attributes of silicon nitride across our entire product portfolio. The sheer amount of energy, interest, and excitement that this acquisition has created is already noticed worldwide and was clearly visible during the North American Spine Society (NASS), hosted in Los Angeles last week. The responses from our global partners, surgeons and distributors were extremely positive and equally encouraging. We believe that as our two organizations come together, each with distinct strengths, as one pulls from the front and the other pushes from the back, a new era, movement, and momentum in our industry will be seen and felt.”

The description of the asset purchase agreement and the transaction set forth above is qualified in its entirety by reference to the full text of the agreement, which was included as part of the Company’s Form 8-K filed with the Securities and Exchange Commission on September 6, 2018.

About Amedica
Amedica is an innovative biomaterials and OEM company that develops and commercializes silicon nitride for various biomedical applications including orthopedic, dental and arthroplasty.

About CTL Medical
CTL Medical is a forward thinking medical device design, development and manufacturing company that produces a full line of cervical, thoracic, and lumbar products (hence “CTL”) at its manufacturing headquarters in Dallas, Texas.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (“PSLRA”). Such forward-looking statements include but are not limited to statements about the benefits of the transaction, including future accretive value to CTL and Amedica’s future financial results, operating plans, objectives, expectations and intentions, and other statements that are not historical facts. These forward-looking statements are subject to risks and uncertainties that may cause actual results or events to differ materially from those projected, including but not limited to the risks that the benefits from the transaction may not be fully realized or may take longer to realize than expected, including as a result of changes in general economic and market conditions, interest and exchange rates, monetary policy, laws and regulations and their enforcement, and the degree of competition in the geographic and business areas in which Amedica and CTL operate; the ability of CTL to promptly and effectively integrate Amedica’s commercial spine business; the reaction to the transaction of the companies’ customers, employees, and counterparties; and the diversion of management time on transaction-related issues. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management’s current estimates, projections, expectations and beliefs. Amedica undertakes no obligation to publicly revise or update the forward-looking statements to reflect events or circumstances that arise after the date of this report.

Contacts: Amedica IR 801-839-3502 IR@amedica.com

NEW YORK, Oct. 3, 2018 /PRNewswire/ — Paradigm Spine, LLC, a leader in providing solutions for the treatment of lumbar spinal stenosis, today announced the issuance of a Priority Health of Michigan Medical Policy. The policy, effective August 20 2018, now includes coverage of the coflex®  Interlaminar Stabilization® device for lumbar spinal stenosis with no prior authorization required. This issuance adds to the continual growth of positive commercial payor policies for coflex^®.

Lumbar spinal stenosis (“LSS”), affecting 1.6 million patients annually, is a debilitating and degenerative disease in older patients (>50 years) often associated with significant leg and back pain, leg numbness and weakness, causing a significant reduction in an active lifestyle. Traditional surgical treatment options for LSS includes a decompression that removes bone and soft tissue and may also require a fusion to stabilize the spine.  The coflex^® device is a non-fusion, motion-preserving stabilization implant, that is FDA PMA-approved for the treatment of lumbar spinal stenosis and is used in conjunction with a decompression, or used in lieu of a spinal fusion.

Marc Viscogliosi, Chairman & CEO of Paradigm Spine, said, “This coverage policy by Priority Health of Michigan reflects the continued adoption and understanding of the benefits coflex^® offers patients with lumbar spinal stenosis. We look forward to expanding patient access to the coflex® technology to the more than 786,000 lives covered by Priority Health of Michigan – Michigan’s second largest health plan that is nationally recognized for improving the health and lives of the people it serves by providing quality care that’s accessible and affordable.”

To learn more about coflex^® Interlaminar Stabilization^®, please visit www.coflexsolution.com.

About Paradigm Spine, LLC
Paradigm Spine, LLC, founded in 2004, is a privately held company and remains focused on the design and development of solutions for the disease management of spinal stenosis.  The Company’s signature product is the coflex^® Interlaminar Stabilization^® device, which is currently used in over 60 countries worldwide. coflex^® is the only lumbar spinal device that has produced Level I evidence in two separate prospective, randomized, controlled studies against two different control groups, changing the standard of care for lumbar spinal stenosis treatment.  For additional information visit www.paradigmspine.com or www.coflexsolution.com.

SOURCE Paradigm Spine, LLC

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