ATLANTA, July 02, 2018 (GLOBE NEWSWIRE) — Medovex Corp. (OTCQB:MDVX) (“Medovex” or the “Company”), the developer of the DenerveX® System, a new and novel device designed for enduring relief of Facet Joint Syndrome related to chronic back pain, a non-addictive, non-opioid drug alternative capable of restoring a patient to a more normal and active lifestyle, today announced the release of patient data that demonstrates clinical benefits of its DenerveX System in patients suffering from low back facet joint pain at 6 months post-treatment.

Facet Joint Syndrome (FJS) is among the leading causes of low back pain and affects millions globally. Typically manifesting from spinal osteoarthritis (OA), FJS is a painful, chronic condition whose treatment options, often temporary in nature, have remained unchanged in the past four decades.

Medovex’s DenerveX is a novel, minimally invasive system developed to provide potential long-term relief via a combination of controlled thermal energy and rotational capsular tissue shaving of the bony structure to disrupt nociceptive signals and receptors. The Company hypothesized that use of this novel system would result in sustained pain relief and improved health metrics associated with mobility.

Methods

This prospective multicenter European cohort included patients with chronic intractable pain of the low back resulting from FJS who had failed conservative treatments for pain. Patients who were treated between July 2017 and February 2018 were evaluated for joint groupings treated, pain and quality of life as measured by the visual analog score (VAS), medication log, Oswestry Disability Index (ODI) and EQ-5D-5L. Follow-up was conducted at 1, 3, and 6 months post-treatment; data reported correspond to these time points.

Results

Results from 61 patients (60.7% females; average age 55.1±11.5 years) were evaluated. Prior to treatment, 47 patients regularly used one or more prescribed analgesics and had predominately undergone either physiotherapy (81.4%), spinal injections (86.4%), or both to help alleviate pain. A total of seven joint groupings were treated, with L3 – S1 (45.6%) and L4 – L5 (17.5%) being the most common. Baseline average VAS_back prior to treatment was 74.7±14.2mm, a 42.0±16.6 ODI score with a EQ-5D-5L score of 3 (out of 5). At 1, 3, and 6 months post-treatment, VAS_back decreased to 31.7±17.5mm (-57.5%), 25.5±22.9mm (-65.8%), and 17.7±18.3mm (-76.3%). Similarly, ODI 1, 3, and 6 months post-treatment decreased to 19.9±14.4 (-52.7%), 20.1±15.0 (-52.3%), and 14.1±9.9 (-66.4%). These decreases from baseline were consistently observed in more than half of the population. EQ-5D-5L scores post-treatment remained, on average 32% below baseline values.

Conclusions

Review of real world cases from five independent sites across Europe demonstrated reduction in pain scores and general improvement of health metrics up to 6 months following treatment as evidenced by VAS_BACK, ODI and EQ-5D-5L.

Jill Schweiger, Medovex Senior Vice President of Regulatory, Clinical and Quality stated, “We are pleased to present these initial results which affirm our belief that the DenerveX System provides significant quality of life improvement and relief from pain associated with facet joint syndrome. We look forward to releasing one-year data as soon as it is available.”

The Company also plans in upcoming months to attend EuroSpine 2018 in Barcelona, Spain, NASS 2018 In Los Angeles, California and the annual DWG Meeting in Wiesbaden, Germany to support further sales and marketing activities. It also presented its DenerveX in Adelaide, Australia during the SSA (Spine Society of Australia) with sizeable audience interest, followed by ten successful first cases.

After successful INVIMA product approval in Colombia, first DenerveX cases are scheduled for July 14, 2018 in Medellin followed by additional cases in Bogota and other areas throughout Colombia.

In April, the Company was issued two US patents and a trademark covering the EU for “Rotacapsulation”.

• Patent No: US D810,290S Surgical Portal Driver
• Patent No: US 9,883,882 Minimally Invasive Methods for Spinal Facet Therapy to alleviate pain and associated surgical tools, kits and instructional media

About Medovex

Medovex was formed to acquire and develop a diversified portfolio of potentially ground breaking medical technology products. Criteria for selection include those products with potential for significant improvement in the quality of patient care combined with cost effectiveness. The Company’s first pipeline product, the DenerveX System, is intended to provide long lasting relief from pain associated with facet joint syndrome. To learn more about Medovex Corp., visit www.medovex.com.

Safe Harbor Statement                                                     

Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Company’s filings with the Securities and Exchange Commission (the “SEC”), not limited to Risk Factors relating to its business contained therein. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.

Contact Information

• Medovex Corp.
  Jason Assad
  470-505-9905
  Jassad@medovex.com

June 27, 2018

IRVINE, Calif., June 27, 2018 (GLOBE NEWSWIRE) — GS Solutions Inc., DBA GS Medical USA (GSM), a leader and innovator of surgeon-driven spinal technology that advances patient care, today announced the launch of the AnyPlus® Extended Tab Minimally Invasive Pedicle Screw system.

The AnyPlus® Extended Tab Minimally Invasive Pedicle Screw System was engineered to offer a less invasive surgical option for pedicle screw placement. The system incorporates anatomically driven solutions and ergonomic designs that allow for a simple, precise and efficient solution to spinal fixation, adding benefits to minimally invasive approach with less OR time.

“Getting the right feedback and insight from surgeon partners is at the forefront of our research and development,” Andrea Watt, Product Development Manager said. “We believe surgeons can drive engineering to develop cutting edge implants and instrumentation that continue to revolutionize the spine industry because they have the right experience and insight for the products and procedures.”

Succeeding the Q4 2017 launch of the AnyPlus® Direct Lateral Interbody Fusion system and the Anterior and Posterior Disc Prep Sets, both of which are currently being used successfully in surgeries, GSM experienced a strong start to the year with sales growth in Q1 2018 versus Q1 2017.

“As we continue to expand our portfolio of spinal solutions with innovative technology and build out a robust national distributor network, we expect to see solid, positive growth throughout the remainder of 2018,” said James Shin, CEO.

To complement the company’s expanding portfolio of solutions, GSM hosted a cadaver lab and bioskills course in early May in Las Vegas. The course featured presentations by current GSM surgeon users, and attendees were provided with technical, hands-on training on the various systems offered by GSM. The surgeons who attended expressed positive feedback on both the DLIF and percutaneous systems, as well as the strategic direction of the company.

“Given the rapid expansion of our portfolio of solutions, we recognize the continued need to partner with our surgeons and distributors to provide expert instruction on our spinal systems,” said Kurt Neesley, U.S. Sales and Business Development Director.

“We are committed to a platform for multi-faceted surgeon education, and we value the opportunity to collaborate with surgeons in a cadaveric setting,” Kurt said. “We look forward to working with surgeons and distributor partners to improve patient care with our new and advanced products and technology.”

GSM leadership and sales representatives plan to exhibit at NASS, September 26-29. To schedule a meeting with the team or to inquire about distributor partnership opportunities, please contact sales@gsmedicalusa.com.

Media Relations Contact:
Amanda Collins
I Phone: 949.380.6385 x213
FAX: 866.600.9712
6 Wrigley
Irvine, CA 92618
www.gsmedicalusa.com

AUDUBON, Pa., June 26, 2018 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal solutions company, announced today a new clinical milestone with the successful implantation of over 3,000 screws using ExcelsiusGPS®,  the company’s revolutionary robotic guidance and navigation system. Since the launch of ExcelsiusGPS® in late 2017, orthopedic and neurosurgeons have used the system with three compatible imaging modalities (preoperative CT, intraoperative CT, and fluoroscopic imaging) across a variety of spine surgery procedures to minimize radiation exposure, streamline workflow, and assist in screw placement.  A recent white paper comparing robotic-assisted versus conventional screw placement demonstrates some of the benefits of this technology.

“Having completed installations and surgeon training programs through the first half of 2018, we see surgeons using this technology in open and minimally invasive spine procedures including posterior cervical fusion, sacroiliac joint fusion, and thoracolumbar fusion with posterior and single position lateral approaches,” said Chief Executive Officer Dave Demski. “Surgeons are realizing the benefits of the ExcelsiusGPS® platform and the potential to significantly improve surgical techniques as demonstrated in the recent cadaveric study.”

The study, led by Dr. Alexander R. Vaccaro, MD, Ph.D, M.B.A and performed by 10 board certified surgeons in a simulated surgical environment, evaluated pedicle screw placement time, accuracy, and radiation dose for ExcelsiusGPS® in open and MIS approaches compared to conventional surgical techniques. Results demonstrated the ExcelsiusGPS® robotic navigation significantly improved pedicle screw accuracy, allowed placement of larger screw diameters and lengths than conventional techniques, and reduced radiation exposure to the clinician.  Additionally, ExcelsiusGPS® significantly reduced screw insertion time compared to the conventional MIS technique.

To learn more about the benefits of ExcelsiusGPS®, visit globusmedical.com/ExcelsiusGPS

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

26th June 2018

US spine care providers have a brand new tool to measure and improve patient care: a diagnosis-based clinical data registry that tracks patient care and outcomes.  Launched by the North American Spine Society (NASS), this web-based platform will allow health care providers to collect and analyse their spine care data and compare it to the de-identified data in the entire registry. Because it is diagnosis-specific, not procedure-specific, the NASS Spine Registry will enhance understanding of spine care treatments, their outcomes, and examine the natural history of spine disorders.

“In order to prove or disprove the effectiveness of spine treatments, the spine field needs to gather evidence,” says Zoher Ghogawala (Lahey Hospital & Medical Center, Burlington, USA), NASS research council director. “With its national reach and comprehensive nature, the NASS Spine Registry will help the spine care field make substantial progress on improving quality, developing best practices, and closing the gaps in medical evidence for spine care.”

From the initial idea to the implementation of a pilot program, the NASS Spine Registry was developed over the past eight years. NASS has made every effort to minimise potential barriers to participation, including cost, privacy concerns, administrative burden, and institutional review board (IRB) participation, a press release states.

“The really exciting and unique thing about the NASS registry is that it is multidisciplinary,” says Daniel Resnick (University of Wisconsin, Madison, USA), NASS president and chair of the NASS Registry Committee. “Despite the fact that more than 90% of spine care is managed without surgery, most existing registries are focused around surgical specialties or procedures. Thanks to the comprehensive nature of this registry, we will be able to see what care approaches are actually helping patients restore their function and reduce pain.”

READ THE REST HERE