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AMDT Holdings, Inc. Gains FDA Clearance for the SixFix™ System

Posted On September 14, 2018 By OrthoSpineNews In Extremities, Regulatory /  

COLLIERVILLE, Tenn., Sept. 5, 2018 /PRNewswire/ — AMDT Holdings, Inc. (AMDT) is pleased to announce FDA clearance for their patented SixFix deformity analysis and correction software and instrumentation. AMDT Holdings, Inc. develops new products to address the existing and emerging needs of the multi-billion-dollar extremity medical device market.

Spatial frame fixators usually consist of two rings connected by six adjustable connectors called struts. This type of construct can also be referred to as a hexapod. Fixation elements connect the rings to bone fragments; small, simultaneous changes in the lengths of multiple struts alter the alignment of the bone fragments in relation to one another. Currently, surgeons manually measure and input values, many derived from patient radiographs, into optional software to create a prescription consisting of daily adjustments over a period of weeks or months. The end result is a corrected deformity and a healed fracture.

The SixFix system, which is indicated for use with the Smith & Nephew Taylor Spatial Frame®, dramatically reduces the time and effort involved in manual input of measurements and their values as required by currently available alternatives, and generates a prescription defining the incremental strut adjustments that will ultimately correct the deformity.

With the SixFix system, the surgeon attaches the system’s six radiopaque fiducial markers to the rings of a spatial frame external fixator, and inputs readily available spatial frame characteristics, such as ring diameter, strut length and axial rotation, into the SixFix software. This information is used to graphically map the deformity with line segments that define the axes of the bone fragments. The software utilizes sophisticated algorithms to correct imperfections present in all radiographs, such as variable magnification and perspective distortion, in the process of creating a precise 3-D replica of the frame and the deformity. SixFix software offers the surgeon options to specify waypoints, customized treatment milestones that the surgeon uses to set the order and duration of each correction.

“This is truly a medical innovation that can offer advantages to both my patients and me,” says Paul Freudigman, M.D. An orthopedic surgeon in the Dallas-Fort Worth, TX, area who has treated patients with spatial frames for almost 20 years, Freudigman is eager to utilize the SixFix technology. “The reduction in time and effort to generate a deformity correction prescription using SixFix is remarkable. Even more exciting will be to assess how much the image correction capabilities of the software can improve my outcomes.”

Stephen J. Frania, DPM, FACFAS, a surgeon in Mentor, Ohio, who specializes in reconstructive foot and ankle surgery including lower limb deformity correction, says, “Of all the advantages offered by the SixFix software, time-savings is one benefit that I will realize right away.” He goes on to explain, “The current devices require a great deal of time and manual effort during my clinic hours to measure and record the data necessary to describe the frame and the deformity as represented by their radiographs. I bring these patients in weekly to evaluate the progress of their correction. The time I save and the improved accuracy when using the SixFix software is significant over these repeat visits.”

Samir Mehta, M.D., Chief of Orthopaedic Trauma and Fracture Service for the University of Pennsylvania Health System, who is at the forefront of fracture fixation and deformity correction, also expresses interest in the benefits the SixFix system provides. “The intuitive, graphical nature of the SixFix software reduces my time and effort when treating a deformity. In addition, it works with one of the devices I currently use. The end result is a deformity correction prescription requiring surprisingly little manual input and time.”

The SixFix system was developed under the direction of Michael Mullaney, VP of Product Development at AMDT Holdings, Inc., who created the web-based implementation of the forward kinematic solution that solved the challenge of the crooked frame on a crooked bone when the Smith & Nephew Taylor Spatial Frame® was first widely used. In reference to the SixFix system, Mullaney says, “The six radiopaque markers provide full descriptive positional data to the SixFix software that enable it to create an accurate 3-D replica of the frame and deformity regardless of how the radiographic images were taken. The SixFix is a far more powerful and accurate tool than my prior deformity correction application as well as more intuitive, faster and easier-to-use.”

Patrick Mullaney, President and CEO of AMDT Holdings, Inc., has also been involved in this segment of orthopaedic devices since its inception in the mid-1990s. “While the SixFix software represents significant advantages in ease-of-use to the surgeon, these major benefits will be compounded with the introduction of a truly innovative hexapod that is currently in development. Initial test results of the hexapod are impressive. We plan to submit this 510(k) application to FDA shortly.”

Since its inception in 2016, AMDT has been focused on designing, validating and commercializing innovative devices to address challenges faced by surgeons treating fractures and correcting deformities. Headquartered outside of Memphis in Collierville, Tennessee, AMDT also commercialized the AMDT Mini-Rail Fixator in early 2017, a modular unilateral external fixator that provides versatile fixation for simple or complex trauma, deformity correction and lengthening procedures. Arrowhead Medical Device Technologies, LLC, the sister organization to AMDT, was founded in 2010 to commercialize the patented ARROW-LOK® Digital Fusion System. Designed to effectively correct digital deformities of the foot, it has the distinction of being the world’s tiniest intramedullary nail. To learn more about AMDT, SixFix and the AMDT Mini-Rail Fixator, please visit www.AMDTHoldings.com. The ARROW-LOK can be viewed at www.ArrowheadDevices.com.

SixFix is a trademark of AMDT Holdings, Inc.
ARROW-LOK is a registered trademark of Arrowhead Medical Device Technologies, LLC.
Taylor Spatial Frame is a trademark of Smith & Nephew, Inc.

CisionView original content:http://www.prnewswire.com/news-releases/amdt-holdings-inc-gains-fda-clearance-for-the-sixfix-system-300707520.html

SOURCE AMDT Holdings, Inc.

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EOS imaging Reports First Half 2018 Financial Results

Posted On September 14, 2018 By OrthoSpineNews In Financial /  

September 13, 2018

PARIS–(BUSINESS WIRE)–Regulatory News:

EOS imaging (Paris:EOSI) (Euronext, FR0011191766 – EOSI – Eligible PEA – SME), the pioneer of 2D/3D imaging and data solutions for orthopedics, today announced its consolidated results for the six months ended June 30, 2018, as stated by the Board of Directors on September 12, 2018.

  • First Half 2018 Financial Results
in millions euros

(unaudited)

 H1 2018 H1 2017
Sales 17,54 16,46
Other Incomes 0,77 0,82
Total Income 18,31 17,28
Cost of good sales (8,73) (9,03)
Gross Margin as % of sales 50,3% 45,1%
Operating expenses (12,38) (10,91)
Operating Result (2,79) (2,66)
Financial Result (3,05) (1,06)
Net Result (5,84) (3,72)
June 30, 2018 December 31, 2017
Cash Position 8,9(2) 6,9
(2) Excludes Fosun Pharmaceuticals AG financing agreement signed post-closing

 

Marie Meynadier, Chief Executive Officer of EOS imaging, commented: “Our results for the first half of 2018 reflect a 520 points increase in gross margin to 50.3% of sales. This strong improvement is the combined result of our rising average selling price and reducing manufacturing and servicing costs. As previously reported, first half sales grew by 11%, excluding forex impact, following strong growth in Asia-Pacific and North America partially offset by forex effects and delayed sales in EMEA. The additional €15.1 million expected from our recent financing with Fosun will support our ability to accelerate growth in North America, Europe, and Asia-Pacific, our three major markets. We believe that EOS imaging is well positioned for a strong finish to 2018 and look forward to further establishing a solid foundation in the market for our EOS® system as we continue expanding our global presence with safe and superior technology.”

  • +11% sales growth over H1 2018 excluded forex impact

In the first half of 2018, EOS imaging generated sales revenue of €17.5 million, up +11% compared to the first half of 2017, i.e. +7% including forex impact. This increase in revenues was driven by strong sales in Asia-Pacific and North America, partially offset by postponed sales in Europe-Middle East-Africa.

The Company sold 34 EOS® systems during the first half of the year, in line with first half 2017, including a positive trend in average selling price. Revenues from equipment sales was €13.6 million, up +8% compared to 2017 (+4% including forex impact).

(1) The issuance of the new shares to Fosun Pharmaceutical AG and their admission to trading on Euronext Paris are expected to occur after the approval by the relevant Chinese government authorities and the visa from the AMF on the prospectus. The new shares will then be admitted to trading on the Euronext regulated market in Paris under ISIN FR0011191766 – EOSI. EOS imaging’s share capital will consist of 26,130,407 shares following the settlement-delivery.

Recurring revenues grew +19% to €3.9 million, including €3.5 million in maintenance revenue and €0.5 million revenue of consumables and services. The +22% increase in maintenance revenue reflects the continued increase in the installed base of EOS® systems under contract.

  • +19% increase in H1 2018 gross margin at €8.8 million, a 520 base point increase in Gross Margin rate

Gross profit for the first half of 2018 improved by +19% to €8.8 million representing 50.3% of sales, as compared to 45.1% during the same period last year. This reflects EOS® systems increasing pricing power, a solid North America contribution to the regional mix, as well as the company’s efforts to reduce manufacturing and maintenance costs.

  • Controlled increase of Operating Expenses

Operating expenses for the first half of 2018 totaled €12.4 million, up +13% compared to the same period last year to support EOS imaging’s business objectives. The increase was mostly associated with the development of the sales organization in all areas, and particularly in North America, initiated in the second half of 2017.

Operating loss for H1 2018 was (€2.8) million, compared with an operating loss of (€2.7) million in the same period last year, reflecting the positive effect of improved gross margin leveraging the increase of commercial expenses.

Net financial loss for H1 2018 totaled (€3.1) million, compared to (€1.1) million in the same period last year, reflecting the early reimbursement of €18.0 million debt financing.

Net loss for the first half of 2018 was (€5.8) million, compared with a net loss of (€3.7) million in the same period last year, mainly due to refinancing.

  • Improving Equity and Cash Positions

EOS imaging’s cash position at June 30, 2018 was €8.9 million, compared with €6.9 million at December 31, 2017.

Equity at June 30, 2018 was €21.1 million, compared with €23.2 million at December 31, 2017. It includes the period financial results, the exercise of options as well as an equity component associated with the successful raise of €29.5 million in convertible notes, which was followed by the full repayment of the Company’s venture debt. This has allowed the Company to enter into a first agreement to factor part of its receivables, that will be broadened in the second half year.

Additionally, EOS imaging entered into a binding agreement with Fosun Pharmaceuticals AG on July 17, 2018 to issue 3,446,649 new shares at a nominal value of €0.01, for a price per share of €4.37, issue premium included, which amounts to a total amount of €15.1 million. This is excluded from the June 30, 2018, cash position.

EOS imaging’s first half year 2018 financial report will be posted on its web site at www.eos-imaging.com.

Next financial release: Announcement of Q3 2018 Sales on October 16th, 2018

ABOUT EOS IMAGING

EOS imaging is listed on Compartment C of Euronext Paris
ISIN: FR0011191766 – Ticker: EOSI

EOS imaging designs, develops and markets EOS®, a major innovative medical imaging solution dedicated to osteoarticular pathologies and orthopedics combining equipment and services and targeting a $2B per year market opportunity. EOS imaging is currently present in 33 countries, including the United States under FDA agreement, Japan, China and the European Union under CE labelling, through the over 280 installed EOS® platforms representing more than one million patient exams every year. Revenues were €37.1M in 2017, e.g. a +32% CAGR over 2012-2017. For more information, please visit www.eos-imaging.com.

EOS imaging has been selected to integrate the EnterNext © PEA – PME 150 index, composed of 150 French, listed companies on the Euronext markets in Paris.

Contacts

EOS imaging
Marie Meynadier, +33 (0)1 55 25 60 60
CEO
investors@eos-imaging.com
or
Investor Relations (US)
The Ruth Group
Matt Picciano / Emma Poalillo, 646-536-7008 / 7024
EOS-imagingIR@theruthgroup.com

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Global Spine Market to Reach $18 Billion by 2023 According to New Analysis by iData Research

Posted On September 14, 2018 By OrthoSpineNews In Financial, Spine /  

September 13, 2018

VANCOUVER, British Columbia–(BUSINESS WIRE)–According to a new series of reports by iData Research, the global spine market is valued at over $14.4 billion USD and is projected to approach $18 billion by 2023. Researched regions include the United States, 15 countries in Europe, 3 countries in Latin America, and 5 countries in Asia-Pacific.

The largest among the regions is undoubtedly the U.S. market, valued at $7.7 billion in 2017. Of this total market share, 78% can be attributed to the traditional spine market, and the remaining, to the minimally invasive (MIS) segment. Growth in the former has slowed as newer, minimally invasive innovations gradually cannibalize the traditional spine market. Growth, at a CAGR of 3.6%, in the MIS implant market is largely driven by the advantages of minimally invasive surgery over open surgery, including reduced trauma, shorter hospital stays and lower postoperative medication use. Despite the strong competition, there are still notable areas of growth within the traditional spine markets, and of these, the motion preservation segment is the fastest-growing. New technology in motion preservation is creating new markets by taking away from the number of spinal fusions performed annually in the United States.

The European spinal market’s total value in 2017 measures just over one-quarter the size of the U.S. at $2.05 billion USD. Similar to the U.S., minimally invasive interbody options will continue to cannibalize areas of the standard interbody market, particularly ALIF and PLIF approaches.

By 2030, for many countries in Latin America, the number of people aged 60 or older will be 2.5-3.5 times larger than in 2000. The increase of this elderly population is expected to stimulate growth across all spinal implant markets. However, the recent surge of the U.S. dollar against local currencies has made it difficult for local importers to profit from these more expensive MIS devices, which are primarily imported from American and European manufacturers. This decrease in profitability has stunted market growth and slowed the transition to MIS techniques.

China represents the largest and fastest-growing market in Asia-Pacific, having already surpassed the combined market value of fifteen countries in Europe at $2.73 billion USD. China’s spinal market continues to grow at a CAGR of 9%, similarly benefitting from the trends seen elsewhere for increased motion preservation and minimally invasive procedures.

More Information

For more information about the global spine and MIS device markets visit https://idataresearch.com/product-category/spine/. This global series covers 24 countries in detail with forecasted market values, unit sales, average selling prices, market shares, procedure volumes and much more.

Download a Free Whitepaper Here: The State of the Global Spine Market 2018

About iData

iData Research is an international consulting and market research firm dedicated to empowering confident strategic decisions within the medical device industry. For tracking competitor sales by SKU in the spine market, ask about MedSKU.

Contacts

iData Research
Joel Harrison, 604-266-6933
marketing@idataresearch.net

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Globus Medical Acquires Surgimap®

Posted On September 14, 2018 By OrthoSpineNews In Spine, Top Stories /  

AUDUBON, Pa., Sept. 13, 2018 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal solutions company, today announced the acquisition of Nemaris Inc., a privately held company that markets and develops Surgimap®, a leading surgical planning software platform. Surgimap® allows healthcare professionals to simulate potential surgical outcomes and share medical imaging globally to improve procedural workflow and patient care.

“The acquisition of Surgimap® bolsters Globus Medical’s efforts to advance the future of computer-assisted surgery with the goal of improving patient outcomes,” said Chief Executive Officer Dave Demski. “Software-enhanced solutions are critical components of the future of computer-assisted surgery, and Surgimap® is the leading surgical planning software technology in the spine market today. We are very excited about the strategic fit of this acquisition, which will allow us to further enhance the capability of our ExcelsiusGPS® navigation and robotic system to assist surgeons in planning complex spine procedures and placing screws more accurately and less invasively.”

Surgimap®’s intuitive, patient specific surgical planning and cloud-based infrastructure, with predictive algorithms and visual guides, is licensed to most of the leading spine implant manufacturers today to enable these customers to plan and simulate potential surgical outcomes in the course of treating complex deformities.  The addition of Surgimap® will further strengthen Globus Medical’s ExcelsiusGPS® platform by streamlining workflow and enabling superior data analytics. These existing platform features, in addition to the deep software expertise of the Surgimap® team, are also expected to accelerate the launch of new products in Imaging, Navigation, and Robotics.

“The acquisition will enable Globus to combine Surgimap®’s best-in-class spine surgery planning technology with the best-in-class robotic and navigation technology of ExcelsiusGPS®,” said Dr. Frank Schwab, Chief of Spine, New York City, and co-founder of Nemaris. “We think the synergies bring enormous benefit to the entire spine community and particularly surgeons who are interested in less invasive robotic and navigation based procedures.”

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 successfully integrate the operations of Nemaris and retain key employees, 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

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Benvenue Medical Completes Divestiture of its Vertebral Augmentation Systems Portfolio

Posted On September 14, 2018 By OrthoSpineNews In Spine, Top Stories /  

September 13, 2018

SANTA CLARA, Calif.–(BUSINESS WIRE)–Benvenue Medical, Inc., a developer of minimally invasive expandable implant solutions for lumbar fusion, today announced it has completed the divestiture of its vertebral augmentation systems portfolio for an undisclosed amount to IZI Medical Products, LLC. The completion of the sale of this business allows Benvenue Medical to devote its full resources to accelerating growth opportunities in the large market for its Luna 3D Interbody Fusion System.

The divested portfolio includes the Kiva® VCF Treatment System, Kiva® Pilot and Blazer® Vertebral Augmentation System devices.

“IZI Medical’s acquisition of the Kiva and associated VCF product franchise allows us to singularly focus on our minimally invasive spinal implant and procedure product line,” said Robert K. Weigle, CEO of Benvenue Medical. “Our best-in-class Luna 3D Expandable Interbody System is an ideal minimally invasive expandable spinal implant and platform technology, enabling Nitinol, PEEK and Titanium materials to be combined in a procedural solution for degenerative disc disease that can be treated in either the hospital or the ASC setting.”

Benvenue Medical also announced the addition of its new Orbit Discectomy Instrumentation that facilitates a circumferential and comprehensive discectomy and endplate preparation to achieve a fusion. This novel new tool kit can be used in open and minimally invasive surgery with the Luna 3D implants, including compatibility with a variety of surgical fusion approaches.

Benvenue Medical will continue its spine surgeon-focused product development and U.S. operations at its Santa Clara, Calif., facility.

About the Luna 3D Interbody Fusion System

The Luna 3D Interbody Fusion System is one of the largest footprint yet least invasive devices for posterior lumbar interbody spinal fusion. The Luna 3D System is comprised of a PEEK implant designed to expand in multiple dimensions within the disc space, first in footprint, second in height and third in lordosis, allowing surgeons to effectively restore sagittal balance and height via a MIS posterior approach while providing the stability of a larger construct more often associated with an anterior approach. After a discectomy is performed, the Luna 3D Implant is delivered through a small diameter cannula into the disc space. After expanding its footprint, it is then expanded in height, diameter and lordosis with the insertion of a middle section. When the cannula is removed, a large volume of bone graft is placed in the middle of the implant to facilitate stabilization and an interbody fusion.

About Benvenue Medical, Inc.

Benvenue Medical, Inc. provides next-generation minimally invasive systems for lumbar fusion that combine expandable implants with novel delivery instruments to provide enduring functional benefits for patients. The company is privately held and funded by CRG. Its first products are designed for the treatment of degenerative disc disease and instability of the lumbar spine. For more information, visit www.benvenuemedical.com.

Contacts

Merryman Communications
Betsy Merryman, 310-560-8176
betsy@merrymancommunications.com

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Global $11.4 Bn Orthopedic Trauma Fixation Devices Market to 2023 by Type of Internal Fixator, Composition & Region – ResearchAndMarkets.com

Posted On September 12, 2018 By OrthoSpineNews In Financial /  

September 12, 2018

DUBLIN–(BUSINESS WIRE)–The “Global Orthopedic Trauma Fixation Devices Market – by Type of Internal Fixator, Composition, Region – Market Size, Demand Forecasts, Company Profiles, Industry Trends and Updates (2017-2023)” report has been added to ResearchAndMarkets.com’s offering.

The Global Orthopedic Trauma Fixation Devices Market was worth 7.52 Billion USD in 2017 and it is estimated to grow to 11.42 Billion USD by 2023 with a CAGR of 7.21% between 2017 and 2023.

The Orthopedic Devices are used for restoring skeletal structure and joint movements in various fractures, abnormal growth of bones, soft tissue damage, trauma or other deformities. These devices are implanted inside human body by surgical procedures or can be externally attached through minimally invasive procedures.

The North America is expected to hold the largest share of Global Orthopedic Trauma Fixation Devices Market while Asian-Pacific region is expected to witness fastest growth of this market with highest CAGR.

Drivers Vs. Constraints

The increasing prevalence of rheumatoid arthritis and osteoarthritis, growing number of traumatic orthopedic injury cases and rising demand for advanced facility in orthopedic trauma and surgery centers are the reasons for the growth of the market.

Industry Structure and Updates

In 2013 DePuy Synthes, a Johnson & Johnson company, is a leading player in the global market for Orthopedic trauma fixation devices, with a share of about 47.3%.

Key Topics Covered:

1. Research Methodology

2. Executive Summary

3. Market Overview

4. Market Dynamics

5. Global Orthopedic Trauma Fixation Devices Market Segmentation, Forecasts and Trends – by Type of Internal Fixator

5.1. Intramedullary Nail

5.2. Intramedullary Screw

5.3. Plate and Screw System

6. Global Orthopedic Trauma Fixation Devices Market Segmentation, Forecasts and Trends – by Composition

6.1. Metallic Fixators

6.2. Bioabsorbable Fixators

7. Global Orthopedic Trauma Fixation Devices Market Segmentation, Forecasts and Trends – by Region

8. North America

9. Company Market Share Analysis

10. Company Profiles

  • Advanced Orthopaedic Solutions
  • Arthrex
  • Ascension Orthopedics
  • Biomet
  • Bioretec
  • Conmed Linvatec
  • Depuy Orthopedics, Inc.
  • DGIMED Ortho
  • DJO Global
  • Emerge Medical
  • Hand Biomechanics
  • Integra LifeSciences
  • Intelligent Implant Systems
  • Internal Fixation Systems
  • Medtronic
  • Merlot OrthopediX
  • Orthofix
  • Osteomed
  • Rigid FX Corporation
  • Semprus Biosciences
  • Skeletal Dynamics LLC
  • Small Bone Innovations, Inc
  • Smith & Nephew
  • Stryker Corporation
  • Suspension Orthopaedic Solutions
  • Synthes
  • Tornier, Inc
  • TriMed, Inc
  • Vilex
  • Wright Medical
  • Zimmer Holdings, Inc
For more information about this report visit https://www.researchandmarkets.com/research/3ckxbl/global_11_4_bn?w=4

Contacts

ResearchAndMarkets.com
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Related Topics: Orthopedic Devices

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Johnson & Johnson Medical GmbH Acquires Emerging Implant Technologies GmbH to Enhance Global Offering of Interbody Spine Implants

Posted On September 12, 2018 By OrthoSpineNews In Spine /  

The Acquired Technology Will Complement Johnson & Johnson Medical Devices Companies’ Advanced Portfolio of Interbody Implants For Both Minimally Invasive and Open Spinal Fusion Surgery

NORDERSTEDT, Germany, Sept. 12, 2018 /PRNewswire/ — Johnson & Johnson Medical Devices Companies*, through its subsidiary Johnson & Johnson Medical GmbH, announced today the acquisition of Emerging Implant Technologies GmbH (EIT), a privately held manufacturer of 3D-printed titanium interbody implants for spinal fusion surgery, based in Wurmlingen, Germany. The products in this portfolio leverage EIT’s proprietary advanced cellular titanium, which consists of an open and interconnected porous structure designed to allow bone to grow into the implant. As an industry leader across the full range of orthopaedic and spine specialties, Johnson & Johnson Medical Devices Companies will leverage its global commercial infrastructure to bring EIT’s technologies to patients around the world.

This acquisition allows DePuy Synthes, the orthopaedics business of Johnson & Johnson, to enhance its comprehensive interbody implant portfolio that includes expandable interbody devices, titanium integrated PEEK technology and now 3D-printed cellular titanium, for both minimally invasive and open spinal surgery. The EIT technology complements DePuy Synthes’ investment in the interbody implant segment in spine, including the recent introductions of the CONCORDE LIFT Expandable Interbody Device, and in the U.S., the PROTI 360°™ Family of Titanium-Integrated Interbody Implants, designed to treat patients with degenerative disc disease.

“Our goal is to offer a complete portfolio of interbody solutions that provides surgeons with even more options for the treatment of their patients,” said Aldo Denti, Company Group Chairman of DePuy Synthes. “We are excited to welcome the skilled team at EIT, and together, we aspire to bring to market technologies that allow surgeons to perform spinal fusion procedures reliably and with consistent outcomes.”

This acquisition underscores the companies’ commitment to building an innovative portfolio of spine solutions to improve the standard of care for patients. Moving forward, DePuy Synthes will continue to focus on the spinal disease states with the most potential for surgeons and their patients – degenerative disc disease, deformity and complex cervical – and introduce technologies in the fastest-growing segments within these disease states; specifically, interbody implants, enabling technologies, minimally invasive spine (MIS), and biomaterials.

Financial terms of the transaction will not be disclosed.

About DePuy SynthesDePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopaedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.

About the Johnson & Johnson Medical Devices CompaniesAs the world’s most comprehensive medical devices business, we are building on a century of experience, leveraging science and technology, to shape the future of healthcare. With unparalleled breadth, depth and reach in surgery, orthopaedics and interventional solutions, we’re working to profoundly change the way care is delivered. We are in this for life. Learn more about our latest innovations by visiting: https://www.jnjmedicaldevices.com.

Cautions Concerning Forward-Looking StatementsThis press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding the acquisition of EIT. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson Medical GmbH, any of the other Johnson & Johnson Medical Devices Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: the potential that the expected benefits and opportunities of the acquisition may not be realized or may take longer to realize than expected; challenges inherent in product research and development, especially at an early stage of the development program, including the uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success for new products; manufacturing difficulties and delays; product efficacy or safety concerns resulting in product recalls or regulatory action; competition, including technological advances, new products and patents attained by competitors; challenges to patents; and changes to applicable laws and regulations, including tax laws and global health care reforms. In addition, there are risks and uncertainties related to the ability of the Johnson & Johnson family of companies to successfully integrate the technology, products, operations and employees of EIT, as well as the ability to ensure continued development, performance or market growth of EIT products. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 31, 2017, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither the Johnson & Johnson Medical Devices Companies nor Johnson & Johnson undertake to update any forward-looking statement as a result of new information or future events or developments.

*The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, cardiovascular and specialty solutions businesses within Johnson & Johnson’s Medical Devices segment.

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SOURCE Johnson & Johnson Medical Devices Companies

Copyright (C) 2018 PR Newswire. All rights reserved

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Vertos Medical Announces MILD® Procedure Long-term Safety and Efficacy Data

Posted On September 11, 2018 By OrthoSpineNews In Spine /  

ALISO VIEJO, Calif., Sept. 11, 2018 /PRNewswire/ — Vertos Medical Inc., a leader in the development of innovative, minimally invasive treatments for lumbar spinal stenosis (LSS), today announced the publication of two-year data from a Centers for Medicare & Medicaid Services (CMS)-approved study, MiDAS ENCORE. The data affirms long-term safety and efficacy of the mild® lumbar decompression procedure, a clinically proven outpatient procedure that removes the cause of the stenosis through a portal the size of a baby aspirin and requires no implants, no general anesthesia, no stitches, and no overnight hospital stay.

The mild procedure, which received broad coverage from CMS in 2016, has been performed on more than 20,0000 patients, and its safety and efficacy have been demonstrated in more than 13 clinical studies and 20 publications. The new long-term data, which appears in the September 7, 2018 issue of Regional Anesthesia and Pain Medicine, the official publication of the American Society of Regional Anesthesia and Pain Medicine, showed excellent long-term durability and revealed no evidence of spinal instability or fracture for patients who had the mild procedure. All outcome measures demonstrated clinically meaningful and statistically significant improvement from baseline through two-year follow-up. Additionally, the mild procedure had no device- or procedure-related serious adverse events, and a significantly lower rate of complications than other, more invasive spine interventions.

Authors of the journal article reporting the data, “Long-term Safety and Efficacy of Minimally Invasive Lumbar Decompression Procedure for the Treatment of Lumbar Spinal Stenosis with Neurogenic Claudication: Two-year Results of MiDAS ENCORE,” also noted that the mild procedure is an excellent early spinal decompression intervention choice for patients with thickened ligamentum flavum. Thickened ligamentum flavum causes narrowing of the spinal canal, resulting in pain and numbness of the lower back, legs and buttocks. The study further revealed that LSS patients having additional back conditions such as a bulging disc, facet hypertrophy and foraminal narrowing also achieved statistically significant pain relief and improvement in mobility, noting that the presence of these conditions should not exclude a patient from being considered for the mild procedure.

“Given the minimally invasive nature of this procedure, its safety profile, robust success rate, and durability of outcomes, mild is an optimal early intervention for patients suffering from lumbar spinal stenosis,” said Dr. Peter Staats, a principal investigator of the MiDAS ENCORE study, lead author of the journal article and founder of the Division of Pain Medicine at the Johns Hopkins School of Medicine. “These results are exciting, and further reinforce the mild procedure as a clinically validated, low-risk interventional pain treatment that directly removes the cause of stenosis, and provides long-term symptom relief.”

Vertos Medical Inc. is a medical device company committed to developing innovative, minimally invasive treatments for lumbar spinal stenosis (LSS). Its proprietary technologies include the mild instrumentation kit, which enables a safe, outpatient, minimally invasive, fluoroscopically guided therapeutic LSS treatment that requires no general anesthesia, no implants, and no stitches. LSS is primarily a degenerative, age-related narrowing of the lower spinal canal that causes symptoms of pain and numbness in the lower back, legs, or buttocks. mild treats this condition by restoring space in the spinal canal using specialized mild devices to remove hypertrophic ligamentum flavum through a 5.1-mm treatment portal. Clinical studies show that the mild procedure can help LSS patients stand longer and walk farther with less pain1, and no major device-related complications have been reported in any clinical trial.2 Vertos Medical headquarters is located in Aliso Viejo, CA. To learn more about how the mild procedure treats LSS, go to www.vertosmed.com/products/.

CONTACT:

Amy Scott

VP Marketing & Education

Vertos Medical

(949) 349-0008

SOURCE Vertos Medical

Related Links

http://www.vertosmed.com

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Nanovis Licenses Key Nanosurface Technology Patent from the University of Nevada, Reno

Posted On September 11, 2018 By OrthoSpineNews In Spine /  

CARMEL, IND. (PRWEB) SEPTEMBER 11, 2018

Nanovis, a leader in nanomedicine for the spine, today announced a licensing agreement with the University of Nevada, Reno for a key nanosurface technology patent covering the use of ceramics on implants with nanopores.

This foundational patent allows development of ceramics for medical implants with nanosurfacing that enhances cell binding and drug delivery depending on the purpose of implantation.

The ceramic nanosurfacing technology dovetails with Nanovis’ technology, offering a range of spinal implant nanosurfaces designed to increase bone to implant growth. The addition of ceramic nanosurfacing allows Nanovis to extend its lead in the development of superior fixation technology for medical implants with greater strength, osseointegration and bactericidal properties.

“We are delighted to work with the University of Nevada, Reno on this nanotechnology,” says Matt Hedrick, Nanovis CEO. “Adding ceramics to nanopores provides important capabilities to influence cells attaching to the surface and for drug delivery. This technology used in combination with our nanotube surface will further bolster our portfolio of interbodies, screws and other implants as the superior fixation technology choice for surgeons to heal their patients and distributors to grow their business.”

The company’s technology already offers interbodies with the best combination of deeply porous bone interface scaffold and bridging bone visualization with a nanotube surface. Adding nanoscale ceramic technology further advances Nanovis’ surface technology lead and extends the company’s portfolio of implant offering the superior fixation technology choice.

“We can control the length, the height, the pore openings and the pore volumes within the ceramic nanosurface,” says Mano Misra, professor of materials science and engineering at the University of Nevada, Reno. “The sizes and shapes of the nanosurface pores can be changed so the ceramic coating releases drugs over a longer period of time, providing superior anti-infection properties.”

“Bringing discoveries into the marketplace is the way that university research benefits society,” says Ellen Purpus, University of Nevada, Reno assistant vice president for Enterprise & Innovation.

For more information about how to help patients, or better serve surgeons with Nanovis’ nanotechnologies, please visit us during the North American Spine Society (NASS) 2018 meeting September 26-29 in Los Angeles at Booth #2260 or call 1-317-507-1058.

For more information about distribution opportunities, please contact Jeff Shepherd, Vice President of Sales, at jeff.shepherd(at)nanovistechnology(dot)com.

About Nanovis
Nanovis’ mission is to develop science-enhanced, life-improving technologies. The Company’s patented and proprietary regenerative technology platforms provide differentiated surface advantages enabling the potential for existing medical devices to achieve new outcomes. Focused on aggressive, sustainable growth across multiple markets, Nanovis is commercializing science-driven platforms: the deeply porous scaffold currently available with the FortiCore® line of interbody fusion devices; an advanced nano-surface technology in development; and a surface technology with anti-colonization and anti-microbial capabilities in pre-clinical studies.

About University of Nevada, Reno
Nevada’s land-grant university founded in 1874, the University of Nevada, Reno ranks in the top tier of best national universities by U.S. News and World Report and is steadily growing in enrollment, excellence and reputation. The University serves more than 22,000 students. Part of the Nevada System of Higher Education, the University is home to the University of Nevada, Reno School of Medicine and University of Nevada Cooperative Extension. Through a commitment to world-improving research, student success and outreach benefiting the communities and businesses of Nevada, the University has impact across the state and around the world. For more information, visit http://www.unr.edu.

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CoreLink Surgical, LLC, Today Announced 510(k) Clearance to Market the M3™ Stand-Alone Anterior Lumbar (ALIF) System

Posted On September 11, 2018 By OrthoSpineNews In Regulatory, Spine /  

September 11, 2018

ST. LOUIS–(BUSINESS WIRE)–CoreLink Surgical, LLC, today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the M3™ Stand-Alone Anterior Lumbar (ALIF) System.

Jay Bartling, CEO, said, “M3 is our first stand-alone interbody fusion device to feature 3D printing – I continue to be impressed by the ability of our design teams to rapidly turn direct feedback and market demand into commercially competitive products.”

The M3 system is a sterile packed, 3-screw, integrated fixation device for ALIF procedures, featuring a universal bi-directional design with a simple and intuitive locking mechanism. M3 was also developed utilizing CoreLink’s proprietary Mimetic Metal™ technology and features unique patent pending StrutSure™ technology, which creates a combination of load-sharing support structure and interconnected lattice minimizing material density for imaging.

With this new clearance, the CoreLink 3D printed ALIF portfolio, both Foundation 3D ALIF and M3™ ALIF, feature the largest footprint size available on the market, allowing for additional options to accommodate an ideal anatomical fit. “I’m always in pursuit of sizing cages to capture as much of the cortical ring that borders the endplates as possible. A larger cage option allows me a more appropriate fit for some patients. Additionally, a larger cage can be helpful for greater surface contact with the endplates, which can enhance stability for a higher likelihood for fusion,” said Neurosurgeon, Justin L. Owen, MD, FAANS (Slidell, LA).

“Our R & D team concentrated on creating a product that would feature our additive manufacturing capabilities, while also streamlining procedural efficiency. We’re extremely proud of the unique universal instruments offered with M3,” said David Castleman, VP of Research and Development for CoreLink.

CoreLink will be exhibiting at the North American Spine Society’s annual meeting in Los Angeles, September 26-28, where a full display of the Foundation 3D Products will be featured.

About CoreLink

CoreLink, known as The Source for Spine™, internally designs and manufactures more than 99% of its broad portfolio of spinal implant systems and leverages this expertise through collaboration and a dedication to empowering its surgeons and improving the lives of their patients.

Be a part of something at The Source.

www.corelinksurgical.com

(Photo: Business Wire)

Contacts

CoreLink, LLC
Courtney Sheedy, 888-349-7808

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