AUDUBON, Pa., May 15, 2018 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal solutions company, today announced the results of the study “Clinical and radiographic analysis of expandable versus static lateral lumbar interbody fusion devices with two-year follow-up” published in the Journal of Spine Surgery, supporting benefits of Globus’ expandable lateral spacers.

The study co-authored by Joseph O’Brien, MD, orthopedic surgeon at Washington Spine and Scoliosis Institute and Dr. Richard Frisch, orthopedic surgeon at Southeastern Spine Institute, compared clinical and radiographic outcomes of fifty-six patients who underwent minimally invasive lateral lumber interbody fusion (LLIF) for symptomatic degenerative disc disease. At two-years post-operative, patients in both the expandable and static spacer groups reported similar improvements in back pain scores and no significant differences in clinical outcomes. Radiographic evidence confirmed solid fusion was achieved in 100% of levels treated in both groups, however, significant differences in the rate of implant subsidence were observed.

While no subsidence was found in patients treated with expandable LLIF spacers, implant subsidence occurred in 16% of levels treated with static LLIF spacers.  “Subsidence is a greater concern with the minimally invasive LLIF technique since it relies heavily on indirect decompression of the neural elements as compared to alternative posterior approaches,” said Dr. O’Brien. “The ability to insert Globus’ expandable spacers with less impaction and to control height expansion from within the disc space helps to minimize endplate damage and in this study resulted in a reduced risk of implant subsidence.”

Globus Medical is the market leader in expandable technology with over 20 expandable implant systems designed to be inserted at a minimized profile and expanded in situ to optimize fit and minimize endplate damage.

Access the full study and learn more about Globus Medical’s lateral expandable interbody spacers portfolio at 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

AUDUBON, Pa., May 10, 2018 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal solutions company, announced today it is sponsoring the Society of Lateral Access Surgery’s (SOLAS®) newly developed Partnership Program as that organization’s first corporate Alliance Partner.  SOLAS® is a non-profit organization that strives to shape the future of lateral access spine surgery through collaboration among members, exchange of ideas, and the promotion of new techniques that benefit patients, physicians and hospitals.  This sponsorship demonstrates Globus Medical’s commitment to supporting key educational and research initiatives important to advancing lateral access surgery.

“Globus Medical recognizes that SOLAS® is the largest surgeon organization focused primarily on advancing lateral access surgery through peer-to-peer interaction and clinical research”, said Andrew Iott, Senior Vice President Global Product Development. “As leaders in the musculoskeletal device industry, Globus Medical supports medical advancements in this area of spine surgery and recognizes its importance in improving patients’ lives.”

Globus Medical will attend the 11^th Annual SOLAS® Meeting being held May 17-19 in San Diego as a Corporate Alliance Partner at the Fairmont Grand Del Mar. Globus representatives will showcase their comprehensive lateral implant and instrument solutions including seven different expandable lateral interbody fusion devices that allow for minimized insertion, continuous expansion, and an optimized fit for each patient.

“This is an excellent opportunity to engage with clinical thought leaders and highlight some of the latest advancements Globus has made with our lateral expandable devices”, said Mr. Iott. “The adjustable lordosis spacer options for the RISE-L® and ELSA® expandable spacer systems have received excellent feedback. We are excited to share how this technology can help surgeons maximize correction and address sagittal spinal imbalance from a lateral approach.”

Globus Medical invites meeting attendees to their exhibit space to experience its most recent product innovations and discuss future lateral advancements with the company’s product development experts.

To learn more about the Globus full line of lateral expandable 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

SALT LAKE CITY, May 08, 2018 (GLOBE NEWSWIRE) — Amedica Corporation (NASDAQ: AMDA), an innovative biomaterial company that develops and commercializes silicon nitride for biomedical applications, today provided an update on its clinical study activities.

Single Center Retrospective Comparative Study

A clinical study comparing silicon nitride spinal implants to allograft spacers in cervical fusion showed faster and more effective outcomes with silicon nitride.  “While silicon nitride might have been expected to perform better in light of its properties, the surprising finding in our study was how good the outcomes with silicon nitride proved to be.  Significantly earlier and more effective bone fusion was observed with silicon nitride than allograft spacers at 3- 6-, and 12-month time points after surgery, all the way to 24 months” said Dr. Micah Smith, orthopaedic surgeon in Fort Wayne, Indiana, who is the principal investigator. Study findings have been submitted to for release at the December 2018 Cervical Spine Research Society meeting.

Multi-Center Retrospective Study

Amedica reported completion of an exhaustive retrospective survey of over 2,000 silicon nitride spinal implants implanted in more than 1,000 patients over the last eight years.  The study was designed to understand clinical outcomes from silicon nitride implants in spine fusion from four different clinics in the US.  “Preliminary data analysis toward publication of this study is very encouraging in this large cohort of patients derived from our long-term surgeon users.  Not only are the data consistent with our other clinical studies, but the outcomes corroborate our basic science understanding of the surface chemistry of the material, the key strength of silicon nitride,” said Dr. Sonny Bal, President of Amedica.

Silicon Nitride Against PEEK (SNAP)

SNAP, a 24-month double-blinded multicenter randomized controlled human trial for lumbar fusion comparing intervertebral cages from either silicon nitride or polyetheretherketone (PEEK), has been completed. The purpose of the study was to show that fusion using silicon nitride cages was at least non-inferior to PEEK devices. Preliminary data at 3, 6, and 12-months on the Roland Morris Disability Questionnaire and VAS back and leg pain scores, as well as quantitative radiographic data at 24 months appear to confirm the study’s hypothesis of silicon nitride’s non-inferiority. Additional detailed analyses are currently being conducted in anticipation of publishing the overall results in a prominent scientific journal later this year.

Goat Study

 An interbody fusion study using a goat model comparing silicon nitride to PEEK was just accepted for publication in the Journal of Biomedical Materials Research, Part B – Applied Biomaterials. The results of the study showed improved fusion and greater bone volume using silicon nitride implants versus PEEK at the study’s six-month end-point. These results also suggest that silicon nitride is not inferior to PEEK and that silicon nitride implants may be more effective in promoting arthrodesis.

About Amedica Corporation
Amedica is focused on the development and application of medical-grade silicon nitride ceramics. Amedica markets spinal fusion products and is developing a new generation of wear- and corrosion-resistant implant components for hip and knee arthroplasty. The Company manufactures its products in its ISO 13485 certified manufacturing facility. Amedica’s spine products are FDA-cleared, CE-marked, and are currently marketed in the U.S. and select markets in Europe and South America through its distributor network and its OEM partnerships.

For more information on Amedica or its silicon nitride material platform, please visit www.amedica.com.

Forward-Looking Statements

This press release contains statements that constitute forward-looking statements within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. These statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of various factors and uncertainties. For example, silicon nitride and our products may not have the impact we expect, the outcomes of our ongoing studies may not be positive, and the results of our studies may not come in the anticipated timeframes.   Other factors that could cause actual results to differ materially from those contemplated within this press release can also be found in Amedica’s Risk Factors disclosure in its Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on March 29, 2018, and in Amedica’s other filings with the SEC.  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:
Amedica IR
801-839-3502
IR@amedica.com

NEW YORK, May 3, 2018 /PRNewswire/ — Paradigm Spine, LLC, a leader in providing motion preservation solutions for the treatment of lumbar spinal stenosis, today announced that the North American Spine Society (NASS) has issued a coverage policy recommendation for Lumbar Interlaminar Device without Fusion and with Decompression. This is particularly significant for coflex because it provides the evidence private health insurance companies require to allow access for patients to benefit from this important, proven technology. The coflex device is the exclusive lumbar motion preservation solution with proven long-term outcomes for durable pain relief and stability for patients with moderate to severe lumbar spinal stenosis.

NASS is the preeminent U.S. spine society in which health insurance companies and health care providers look to for guidance when determining appropriate coverage decisions for state-of-the-art technologies, such as coflex. NASS’ multi-disciplinary team of spine specialists systematically review available scientific literature. Searches include meta-analyses, clinical guidelines, and the highest level of clinical data with randomized controlled trials, of which there are two such trials for coflex.

The recently issued NASS coverage policy recommends the use of coflex for the treatment of patients with lumbar spinal stenosis. The recommendations only apply to devices that are used in conjunction with a direct decompressive procedure, which currently and in the foreseeable future is only coflex, and states, “More recently ISP devices have been used in conjunction with direct decompression via laminotomy. Some devices, such as coflex, according to its FDA labeling and available published data, are specifically approved for use in this manner.”

“It’s gratifying to see the NASS Coverage Committee issue a coverage recommendation for coflex,” said Dr. Richard D. Guyer of the Texas Back Institute and past-President of NASS. “I’ve been a member of NASS for over 20 years and trust in their process and recommendations for new technologies. I know the process is thorough and evidence-based which gives me confidence in offering the latest and proven technologies to my patients. In particular with coflex, I think we as surgeons have the opportunity and responsibility to utilize the abundant clinical evidence and our experience to provide a superior alternative to decompression alone or spinal fusion for our patients with lumbar spinal stenosis.”

“The NASS coverage policy recommendation for coflex is a major milestone for validating our technology and allows us to reach more private payors in the U.S. market,” said Marc Viscogliosi, Chairman and CEO of Paradigm Spine. “Over the past decade, Paradigm Spine has worked diligently to build the pieces of the puzzle in establishing coflex as the new standard of care for the treatment of moderate to severe lumbar spinal stenosis. Those pieces have been 1)  the FDA IDE clinical trial which demonstrated positive, long-term Level I evidence of coflex compared to fusion, 2) establishment of CPT and site-of-service facility coding pathways 3) the recent publication of the landmark Level 1 ESCADA clinical trial which demonstrated superiority of coflex compared to decompression alone, and now 4) the stamp of approval from NASS with their coverage recommendation in support of coflex. As a company, we believe these achievements provide the evidence private payors require to create access to this important technology for patients suffering from lumbar spinal stenosis.”

About Lumbar Spinal Stenosis (LSS)

Lumbar spinal stenosis (LSS), affecting 1.6 million patients annually in the United States, is a debilitating and degenerative disease often associated with significant leg and back pain, leg numbness and weakness, and significant reduction in an active lifestyle. Historically, the two traditional surgical treatment options for LSS included decompression alone or decompression with lumbar fusion. Decompression alone has proven effective at relieving pain symptoms caused by lumbar spinal stenosis, however, patients may not experience long term symptomatic relief, resulting in subsequent opioid pain control, epidural injections for pain management, or additional surgeries for conversion to a fusion. Decompression with fusion has proven to provide pain relief and stabilize the diseased segment, but may lead to adjacent level disease requiring subsequent surgeries.

About NASS

The North American Spine Society (NASS) is comprised of more than 8,000 members from several disciplines, including orthopedic surgery, neurosurgery, physiatry, neurology, radiology, anesthesiology, research and physical therapy. Its mission is to foster the highest quality, evidence-based and ethical spine care.

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

Related Links

http://www.paradigmspine.com