Pedicle Screw System Market – Global Forecast to 2023: Rising Geriatric Population, Technological Advancements & Growing Preference for Minimally Invasive Surgeries

DUBLINOct. 17, 2018 /PRNewswire/ —

The “Pedicle Screw System Market by Product Type (Monoaxial & Polyaxial Pedicle Screw), Surgery (Open, Minimal Invasive), Indication (Spinal Deformities, Spinal Trauma), Application (Thoracolumbar, Cervical Fusion) – Global Forecast to 2023” report has been added to ResearchAndMarkets.com’s offering.

The global pedicle screw systems market is expected to reach USD 724.23 million by 2023 from USD 538.64 million in 2018, at a CAGR of 6.1%.

The major factors driving the growth of this market are the increasing incidence of spinal cord injuries, the growing preference for minimally invasive surgeries, and a rising geriatric population.

By product type, the pedicle screw systems market is segmented into monoaxial, polyaxial, and other pedicle screw systems. In 2018, the polyaxial pedicle screw systems segment is estimated to command the largest share of the pedicle screw systems market. The large share of this segment can be attributed to the increasing incidences and prevalence of spinal cord injuries.

On the basis of surgery type, the pedicle screw systems market has been segmented into open surgery and minimally invasive surgery. The open surgery segment is expected to account for the largest share of the pedicle screw systems market in 2018. The large share of this segment can be attributed to the rising geriatric population and increasing incidence of spinal deformities.

Based on indication, the pedicle screw systems market has been segmented into spinal degeneration, spinal trauma, spine deformities, and other indications. In 2018, the spinal degeneration segment is projected to account for the largest share of the pedicle screw systems market. The increasing incidence of degenerative spinal disorders is the major driving factor for this market.

By application, the market is categorized into thoracolumbar fusion and cervical fusion. In 2018, thoracolumbar fusion is expected to command the largest share of this market. The increasing incidences of lumbar degenerative disc diseases and the launch of new products are key factors driving the growth of the thoracolumbar fusion segment.

The market is dominated by North America, followed by EuropeNorth America will continue to dominate the market during the forecast period. The rising geriatric population and increasing incidence of spinal disorders in this region are the major factors supporting the growth of the pedicle screw systems market in North America.

Stringent regulatory frameworks and time-consuming product approval processes may hinder the growth of the pedicle screw systems market to a certain extent.

The major players in the pedicle screw systems market include Globus Medical (US), DePuy Synthes (US), Zimmer Biomet (US), B. Braun (US), Stryker (US), and Medtronic (Ireland).

Key Topics Covered:

1 Introduction

2 Research Methodology

3 Executive Summary

4 Premium Insights
4.1 Pedicle Screw Systems Market Overview
4.2 Asia Pacific: Pedicle Screw Systems Market, By Product Type (2018)
4.3 Pedicle Screw Systems Market, By Region (2018)
4.4 Geographical Snapshot of the Pedicle Screw Systems Market

5 Market Overview
5.1 Introduction
5.2 Market Dynamics
5.2.1 Drivers
5.2.1.1 Increasing Incidence of Spinal Injuries
5.2.1.2 Rising Geriatric Population
5.2.1.3 Technological Advancements
5.2.1.4 Growing Preference for Minimally Invasive Surgeries
5.2.2 Opportunities
5.2.2.1 Emerging Economies Present Significant Growth Opportunities
5.2.3 Challenges
5.2.3.1 Stringent Regulatory Framework and Time-Consuming Approval Process
5.2.3.2 Product Failures and Recalls

6 Pedicle Screw Systems Market, By Product Type
6.1 Introduction
6.2 Polyaxial Pedicle Screw Systems
6.3 Monoaxial Pedicle Screw Systems
6.4 Other Pedicle Screw Systems

7 Pedicle Screw Systems Market, By Surgery Type
7.1 Introduction
7.2 Open Surgery
7.3 Minimally Invasive Surgery

8 Pedicle Screw Systems Market, By Indication
8.1 Introduction
8.2 Spinal Degeneration
8.3 Spinal Trauma
8.4 Spinal Deformities
8.5 Other Indications

9 Pedicle Screw Systems Market, By Application
9.1 Introduction
9.1.1 Thoracolumbar Fusion
9.1.2 Cervical Fusion

10 Pedicle Screw System Market, By Region
10.1 Introduction
10.2 North America
10.2.1 US
10.2.2 Canada
10.3 Europe
10.4 Asia Pacific
10.4.1 China
10.4.2 India
10.4.3 Japan
10.4.4 Rest of Asia Pacific
10.5 Rest of the World

11 Competitive Landscape
11.1 Overview
11.2 Market Ranking Analysis, 2017
11.3 Competitive Scenario
11.3.1 Product Launches and Approvals
11.3.2 Acquisitions
11.3.3 Expansions

12 Company Profiles

  • Alphatec Spine, Inc. (A Subsidiary of Alphatec Holdings, Inc.)
  • B. Braun Melsungen AG
  • Depuy Synthes (A Subsidiary of Johnson & Johnson)
  • Globus Medical, Inc.
  • KM Group Holdings, Inc.
  • Medtronic PLC
  • Orthofix International N.V.
  • RTI Surgical, Inc.
  • Stryker Corporation
  • Zimmer Biomet Holdings, Inc.

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Bone Therapeutics announces single intra-articular injection of viscosupplement JTA-004 delivered higher pain reduction than the reference in first study in knee osteoarthritis

Gosselies, Belgium, 17 October 2018, 6 pm CEST – BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the bone cell therapy company addressing high unmet medical needs in orthopaedics and bone diseases, today announces results of the first efficacy study of the Company’s enhanced viscosupplement, JTA-004, in patients with moderate symptomatic knee osteoarthritis, supporting future clinical development of the product.

JTA-004 is a patented, non-cellular viscosupplement product for the treatment of knee osteoarthritis (KOA), which Bone Therapeutics has been developing in parallel with its core cell therapy pipeline and addressing its mission of bringing innovative solutions to orthopaedic conditions.

The Company believes the favourable safety and efficacy profile of JTA-004 observed in this first efficacy study supports the move to registration studies and will begin dialogue with the regulatory authorities to determine next steps.

About the trial

The trial was a prospective, multicentre, randomised, double-blind, controlled study including three JTA-004 strengths and one reference product, hylan G-F 20, the global market leader in viscosupplements(1). The main objective of the study was to demonstrate the superiority of a single intra-articular JTA-004 injection to the reference product.

164 patients were randomly assigned to the reference group or one of the three JTA-004 groups. The primary endpoint of the study was the mean change in WOMAC® VA 3.1 pain subscale score (ranging between 0 and 100 mm) between baseline and 6 months after treatment.

Trial results

The single intra-articular injection of JTA-004 was generally well tolerated. At six months, patients in the three JTA-004 groups showed an improvement in pain vs. baseline ranging from 23.6 mm to 25.9 mm, while patients in the reference group only showed a 14.3 mm improvement. Due to high variability in primary endpoint at six months, statistically significant differences between the individual JTA-004 groups and the reference group were not achieved.

Analysis of the results revealed that the three JTA-004 strengths had a similar efficacy. Therefore, a post hoc exploratory analysis was subsequently performed between the reference group and all pooled JTA-004 treated patients. The exploratory analysis showed a 26.1 mm improvement for the pooled JTA-004 group vs. 15.6 mm(2) for the reference group at month 6, demonstrating a statistically significant superiority of the pooled JTA-004 group compared to the leading viscosupplement on the market.

Professor Jean-Francois Kaux, Head of the department of Physical and Rehabilitation Medicine at University Hospital CHU, Liège, Belgium, commented: “Globally, millions of patients are suffering from knee osteoarthritis which is a leading cause of chronic pain and disability. The management of this condition represents a continuing challenge for clinicians and patients, who are seeking stronger and longer-lasting pain relief alternatives for this painful disease. The strong safety and efficacy profile demonstrated by JTA-004 in this clinical study, in comparison with the most scientifically validated reference product, suggests potential for it to become one of the preferred treatments for patients suffering from knee osteoarthritis. I look forward to the future development of this unique product.

Osteoarthritis is a progressive disease of the joints and is the most prevalent joint disorder globally. It is characterized by joint pain, tenderness, limitation of movement and stiffness. Knee osteoarthritis, the most common form, affects approximately 250 million people worldwide(3). The prevalence of KOA is expected to increase at a rate of 8% per year in the coming years due to increasingly aging and obese population. The worldwide sales of viscosupplements, one of the commonly used treatments for KOA, had an estimated value of $2.1B in 2016(1).

Viscosupplements are injectable solutions containing hyaluronic acid (HA), a main component of knee joint’s synovial fluid and aim to provide added lubrication and protection to the cartilage of the arthritic joint. JTA-004, which consists of hyaluronic acid, an analgesic and anti-inflammatory agent and an enriched protein solution, showed distinct advantages in preclinical studies over other viscosupplements due to its anti-inflammatory and lubrication properties.

Thomas Lienard, Chief Executive Officer of Bone Therapeutics, added: “We’re delighted with the data from this first trial of JTA-004 in patients with moderate symptomatic knee osteoarthritis, which shows the potential of this enhanced viscosupplement. Based on the favourable efficacy and safety profile observed in this trial, JTA-004 can offer advantages over currently available viscosupplements on the market and we plan to continue the development of this promising product. JTA-004 is a promising addition to our existing pipeline of bone cell therapy clinical programmes, and highly complementary to our broader goal of bringing to market innovative, best-in-class solutions to orthopaedic conditions and bone diseases.

Continued clinical and manufacturing progress

The positive JTA-004 data complement recent positive clinical and manufacturing developments at Bone Therapeutics which support the continued progress of its pipeline and the increased focus on preparing for commercialisation. Notable recent progress includes:

·In September, Bone Therapeutics announced a positive final readout in the Phase I/IIA delayed-union study of allogeneic bone cell therapy product, ALLOB, adding to a growing body of clinical efficacy and safety data.

·Also in September, the Company presented preclinical in vitro and in vivo results at the 26th Annual Meeting of the European Orthopaedic Research Society (EORS) in which the scientific community acknowledged the potent bone-forming properties of its allogeneic platform.

·Bone Therapeutics also recently announced an optimized production process for ALLOB which allows the Company to achieve a consistent, easy to scale up and economical (around 100,000 doses per donor) manufacturing process and to offer an easy to use, cryopreserved product, all critical parameters required for future commercialisation. The Company plans to implement this optimized process for all future clinical development programmes. Bone Therapeutics received positive feedback on the quality control programme and non-clinical strategy for ALLOB from a Regulatory Agency for the optimization of the manufacturing process.

·The Company’s focus over the next few years is on progressing the clinical development of ALLOB in delayed union fractures and lumbar spinal fusion, subsequently leading to Phase III clinical trials in EU and USA.

·In addition, Bone Therapeutics expects to present the conclusions of the interim analysis after a one-year follow-up of the Phase III study of PREOB, its autologous cell therapy product, in osteonecrosis of the hip in Q4 2018.

(1) Viscosupplementation: Global Analysis and Market Forecasts, April 2017, Global Data
(2) The difference in the mean improvement of the reference group at Month 6 between the two analyses was a consequence of the statistical adjustments for both sample size and sample variation.
(3) Vos et al., A systematic analysis for the Global Burden of Disease Study 2010. Lancet 2012; 380:2163-96

About Bone Therapeutics

Bone Therapeutics is a leading cell therapy company addressing high unmet needs in orthopaedics and bone diseases. Based in Gosselies, Belgium, the Company has a broad, diversified portfolio of bone cell therapy products in clinical development across a number of disease areas targeting markets with large unmet medical needs and limited innovation.

Bone Therapeutics’ technology is based on a unique, proprietary approach to bone regeneration, which turns undifferentiated stem cells into bone-forming cells. These cells can be administered via a minimally invasive procedure, avoiding the need for invasive surgery.

The Company’s primary clinical focus is ALLOB, an allogeneic “off-the-shelf” cell therapy product derived from stem cells of healthy donors, which is in Phase II studies for the treatment of delayed-union fractures and spinal fusion. In addition, the Company also has an autologous bone cell therapy product, PREOB, obtained from patient’s own bone marrow and currently in Phase III development for osteonecrosis of the hip, and JTA-004, a viscosupplement in development for the treatment of knee osteoarthritis.

Bone Therapeutics’ cell therapy products are manufactured to the highest GMP standards and are protected by a rich IP estate covering nine patent families. Further information is available at: www.bonetherapeutics.com.

About Knee Osteoarthritis

Osteoarthritis (OA), also known as degenerative joint disease, is the most common chronic joint condition in which the protective cartilage in the joints progressively break down resulting in joint pain, swelling, stiffness and limited range of motion. The knee is one of the joints that are mostly affected by osteoarthritis, with an estimated 250M cases worldwide.

The prevalence of knee osteoarthritis (KOA) is expected to increase in the coming years due to increasingly aging and obese population. Currently, there is no cure for KOA and treatments focus on relieving and controlling pain and symptoms, preventing disease progression, minimizing disability, and improving quality of life. Most drugs prescribed to KOA patients are topical or oral analgesics and anti-inflammatory drugs. Ultimately, severe KOA lead to highly invasive surgical interventions such as total knee replacement.

About WOMAC® Index

The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC®) is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. It can be self-administered and was developed at Western Ontario and McMaster Universities in 1982.

Contacts

Bone Therapeutics SA
Thomas Lienard, Chief Executive Officer
Jean-Luc Vandebroek, Chief Financial Officer
Tel: +32 (0) 71 12 10 00
investorrelations@bonetherapeutics.com

For Belgium Median Enquiries
Comfi
Laure-Eve Monfort and Sabine Leclercq
Tel: +32 (0)2 290 90 93, +32 (0)2 290 90 91
monfort@comfi.be, sabine.leclercq@comfi.be

International Media Enquiries:
Consilium Strategic Communications
Amber Fennell, Jessica Hodgson, Hendrik Thys and Lindsey Neville
Tel: +44 (0) 20 3709 5701
bonetherapeutics@consilium-comms.com

For French Media and Investor Enquiries:
NewCap Investor Relations & Financial Communications
Pierre Laurent, Louis-Victor Delouvrier and Nicolas Merigeau
Tel: + 33 (0)1 44 71 94 94
bone@newcap.eu

For US Media and Investor Enquiries
Westwicke Partners
John Woolford
Tel: + 1 443 213 0506
john.woolford@westwicke.com

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors` current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person`s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

SPINEWAY : Marketing of new Mont-Blanc Evo product line authorized in the United States

Ecully, October 17 2018

Spineway, specialist in surgical implants and instruments for treating disorders of the spinal column (spine), completed all the regulatory steps and can market its Mont-Blanc Evo product line (presented at the Eurospine conference) in the United States.

This development of the flagship Mont-Blanc line that is already distributed on territory provides surgeons with an implant that can be screwed twice as fast, and with more efficient insertion tools. There will be a standard version (non-sterile) and a “ready-to-use” sterile version, a differenciating feature which is to become popular with US surgeons.

Spineway has already begun production of these new implants and instruments, and should be able to record its first US sales during the first quarter of 2019. In addition, the EC label should be granted in 2019 for distribution throughout Europe and the rest of the world.

Spineway has thus taken its first step toward reconquering the US market and will be accelerating the reorganization of its US subsidiary as per its strategic plan.

SPINEWAY IS ELIGIBLE FOR THE PEA-PME (EQUITY SAVINGS PLANS FOR SMES)
Find out all about Spineway at www.spineway.com

Next communication: Half-year results for 2018 – 24 October 2018

This press release has been prepared in both English and French. In case of discrepancies, the French version shall prevail.

Spineway designs, manufactures and markets innovative implants and surgical instruments for treating severe disorders of the spinal column.
Spineway has an international network of over 50 independent distributors and 90% of its revenue comes from exports.
Spineway, which is eligible for investment through FCPIs (French unit trusts specializing in innovation), has received the OSEO Excellence award since 2011 and has won the Deloitte Fast 50 award (2011). Rhône Alpes INPI Patent Innovation Award (2013) – INPI Talent award (2015). ISIN: FR0011398874 – ALSPW      

Contacts :

Spineway

Investor relations
David Siegrist – CFO
finance.dsg@spineway.com
  Aelium

Financial communication
Jérôme Gacoin / Solène Kennis
skennis@aelium.fr

Attachment

OrthAlign, Inc. Announces First KneeAlign® Cases Using the All New Rotation and Soft Tissue Balancing System

Aliso Viejo, CA, Oct. 17, 2018 (GLOBE NEWSWIRE) — OrthAlign, Inc., a privately held U.S.-based medical device and technology company providing orthopedic surgeons with advanced precision technologies, announced the first cases of the KneeAlign® CFS™ system. The CFS system is an accessory that can be used during KneeAlign-assisted total knee arthroplasty (TKA) surgeries, that provides for rotation and soft tissue balancing. The cases were completed by David Mayman, M.D. at Hospital for Special Surgery in New York, NY.

OrthAlign technology provides real-time, actionable data for precise alignment and positioning of implant components. With surgical applications for Total Knee (KneeAlign®), Partial Knee (UniAlign™) and Total Hip arthroplasties (HipAlign®), OrthAlign deploys a platform of solutions directly into the surgeons’ hands via a hand-held device not much bigger than a cellphone. Now, with these new capabilities, the KneeAlign application applies the same levels of accuracy and simplicity to guiding rotation of the femoral component as well as balancing soft tissue in both the extension and flexion gaps during TKA.

“With the addition of rotation and soft tissue balancing, KneeAlign provides me with all of the information I need to achieve an aligned and balanced knee,” said David Mayman, M.D. “This now puts the capabilities of KneeAlign equal to any robotics or navigation system on the market, while at the same time being much faster, simpler, and easier to use.”

“KneeAlign has already powered more than 75,000 cases around the world, providing surgeons with the type of information that delivers confidence to their results on a daily basis,” said Eric Timko, OrthAlign’s CEO and Chairman. “After a diligent research and development process, we’re now bringing that same confidence to rotation and balance during a total knee procedure, which positions KneeAlign among the most complete navigation and robotics solutions available as we power the next 100,000 cases in the coming years.”

OrthAlign will be showcasing its full portfolio of products at this year’s AAHKS meeting in Dallas, TX, November 2-4, 2018 at booth #715.

About OrthAlign, Inc.

OrthAlign is a privately held medical device and technology company, developing advanced technologies that deliver healthier and more pain-free lifestyles to joint replacement patients, globally. We provide healthcare professionals with cutting edge, computer-assisted surgical tools that seamlessly and cost-effectively deliver vital data and clinical results to optimize outcomes for our patients. For more information regarding OrthAlign, please visit www.orthalign.com or contact Adam Simone (asimone@orthalign.com).

“ORTHALIGN®, KNEEALIGN®, HIPALIGN® and UNIALIGN™ are [registered] trademarks of OrthAlign, Inc.”

Adam Simone
OrthAlign
asimone@orthalign.com

Biedermann Motech to Launch MDS Injection Screw for its Polyaxial Humerus Plating Systems

Miami, FL – October 17, 2018 / Business Wire / – Biedermann Motech, the leading innovator of polyaxial screw technologies, announced today the launch of the first injection screw that can be used through, and in combination with, its polyaxial locking plate systems at the 2018 Orthopaedic Trauma Association (OTA) Annual Meeting in Kissimmee (Orlando), October 17-20, 2018.

The MDS Injection Screw can be utilized to deliver injectable bone void fillers to a surgical site and is compatible with MDS humerus plating systems. It was developed as an innovative option for the systems to offer stable fixation in osteoporotic and complex fractures.

The current MDS plating systems utilize Next Generation Polyaxial Locking TechnologyTM, which includes 40-degree polyaxial locking for optimal plate and screw placement, a strong and consistent locking mechanism at every screw angle and a low profile construct. By adding the MDS Injection Screw to the system, surgeons will have additional options in the treatment of complex humeral fractures. Biedermann Motech is the first company to offer such a technology for extremity surgery.

“Biedermann Motech first introduced the combination of fenestrated augmentable polyaxial screws for complex spine reconstructions more than 15 years ago,” said Markku Biedermann, Chairman of Biedermann Motech, Inc., “and we are very excited to now introduce this sophisticated technology for the fixation of bone fractures and bone reconstructions of the humerus.”

Biedermann Motech will showcase the MDS Injection Screw Technology Platform at the up-coming 2018 Orthopaedic Trauma Association (OTA) Annual Meeting in Kissimmee (Orlando), October 17-20, 2018 at booth number 1015.

More information is available at www.biedermann.com or call 866-622-6082. Follow us on LinkedIn https://www.linkedin.com/company/biedermann-motech/

About Biedermann Motech

Biedermann Motech is a mid-sized, family owned group of companies with headquarters in Germany (Villingen-Schwenningen) and the USA (Miami). Since 1916 we have been working in synergy with world-class surgeons to solve significant clinical challenges through the development of next-generation technology. Our core competency is the development, production, and distribution of innovative implants and instruments for spinal and extremity surgery. We research, develop, manufacture and distribute high-quality implant systems in collaboration with healthcare professionals, technology partners, scientific institutions and specialized companies with the goal of achieving improved clinical outcomes.

Contact: Serina Prado sprado@biedermann.com

Biedermann Motech, Inc – USA

7620 NW 25th Street, Unit 3 & 4

Miami, FL 33122

Implanet Opens Another Direct Market in Europe with the First Surgery Jazz® in Belgium

October 16, 2018

BORDEAUX, France & BOSTON–(BUSINESS WIRE)–Regulatory News:

IMPLANET (Paris:ALIMP) (OTCQX:IMPZY) (Euronext Growth: ALIMP, FR0010458729, eligible for PEA-PME equity savings plans), a medical technology company specializing in vertebral and knee surgery implants, is today announcing its first surgery Jazz® in Belgium, at the UZ Brussels University Hospital. A further illustration of its direct sales strategy that has proven effective in France and USA.

After the opening of Implanet UK, which along with its Jazz® platform has recently been approved by the UK’s National Health Service, and the opening of Implanet GmbH in Germany, this first surgery in Belgium demonstrates that Implanet is continuing to roll out its products directly in European markets.

Jazz® technology is an excellent solution to be used in addition to screw fixation for preventing pullout in treating degenerative spine disease in adults. In pediatrics Jazz® can also be a replacement for screws in complex spinal deformities. The clinical benefit of Jazz® is undeniable, providing patients with additional safety. I am delighted to have access to the entire Jazz® product range at the University Hospital UZ Brussel, Belgium” says Dr David Van Schaik, orthopedic spine surgeon.

Ludovic Lastennet, CEO of Implanet, said: “This first surgery, which took place only shortly after we announced the opening of Implanet UK and Implanet GmbH in Germany, accelerates the roll-out of our direct sales strategy. We are confident that this model is the right one and will positively impact our earnings going forward.”

Implanet will be attending the following scientific conferences during Q4 2018:

SOFCOT in Paris from November 12 to November 15, 2018, stand F07
BSS (British Scoliosis Society) in Belfast from November 29 to November 30, 2018, stand 9
DWG in Wiesbaden (Germany) from December 6 to December 8, 2018, stand 102

About IMPLANET

Founded in 2007, IMPLANET is a medical technology company that manufactures high-quality implants for orthopedic surgery. Its flagship product, the JAZZ® latest-generation implant, aims to treat spinal pathologies requiring vertebral fusion surgery. Protected by four families of international patents, JAZZ® has obtained 510(k) regulatory clearance from the Food and Drug Administration (FDA) in the United States and the CE mark. IMPLANET employs 46 staff and recorded 2017 sales of €7.8 million. For further information, please visit www.implanet.com.

Based near Bordeaux in France, IMPLANET established a US subsidiary in Boston in 2013.

IMPLANET is listed on Euronext™ Growth market in Paris. The Company would like to remind that the table for monitoring the BEOCABSA, OCA, BSA and the number of shares outstanding, is available on its website: http://www.implanet-invest.com/suivi-des-actions-80

Contacts

IMPLANET
Ludovic Lastennet
CEO
Tel. : +33 (0)5 57 99 55 55
investors@implanet.com
or
NewCap
Investor Relations
Julie Coulot
Tel. : +33 (0)1 44 71 20 40
implanet@newcap.eu
or
NewCap
Media Relations
Nicolas Merigeau
Tel. : +33 (0)1 44 71 94 98
implanet@newcap.eu
or
AlphaBronze
US-Investor Relations
Pascal Nigen
Tel.: +1 917 385 21 60
implanet@alphabronze.net

DePuy Synthes Announces Agreement with Ortho Development® Corporation to Promote its KASM® Knee Articulating Spacer Mold

OCTOBER 16, 2018 Warsaw, IN – Johnson & Johnson Medical Devices Companies* today announced that DePuy Synthes Sales, Inc. has entered into an exclusive agreement with Ortho Development® Corporation to co-promote in the U.S. its KASM® Knee Articulating Spacer Mold. This is a sterile, disposable cement spacer mold for patients who develop an infection after primary knee replacement. This new offering builds upon DePuy Synthes’** commitment to innovative knee solutions focused on helping patients along the care continuum.

Of the five percent of patients who require total knee revision surgery1, prosthetic joint infections are among the leading cause2, with the majority occurring within the first two years after surgery3. Treating this type of infection requires a two-stage process. The primary knee implant is removed and replaced with a temporary antibiotic knee spacer. When the infection has cleared, the patient then undergoes a second surgery to replace the knee, known as a revision procedure.

Knee spacers are typically either static or articulating. Static spacers require patients to keep the infected knee immobilized for up to six months until the infection has cleared. Articulating spacers allow patients to weight bear with the use of crutches or a walker and possibly maintain motion during their recovery. KASM is designed to help preserve range of motion, joint space and soft tissue tension. Additional KASM features include:

  • Smooth articulating surface for both femur and tibial sides
  • Open mold design that allows surgeons to customize the fill of each component to accommodate for existing bony defects and other patient-specific conditions
  • Three sizes to account for a variety of patient anatomies

“KASM provides us with the unique opportunity to help surgeons whose patients have developed an infection to maintain some mobility and freedom they might not otherwise have had throughout the healing process,” said Juan-José Gonzalez, President, DePuy Synthes U.S. “This exclusive agreement with Ortho Development adds to our existing knee portfolio that spans treatment from early intervention to surgical replacement, with the goal of helping people return to living active and fulfilling lives.”

Ortho Development Corporation designs, develops, manufactures, and markets devices for knee and hip joint reconstruction, spine treatment, and trauma. KASM is one of Ortho Development’s products and received FDA clearance in 2014. This product has also been on the market in Japan for several years.

DePuy Synthes will begin to promote KASM in the latter part of 2018.


About Johnson & Johnson Medical Devices Companies
As the world’s most comprehensive medical devices business, we are building on a century of experience, merging science and technology, to shape the future of health and benefit even more people around the world. With our unparalleled breadth, depth and reach across surgery, orthopaedics and interventional solutions, we’re working to profoundly change the way care is delivered. We are in this for life. For more information, visit www.jnjmedicaldevices.com.

About DePuy Synthes
DePuy 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.

*The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, and interventional solutions businesses within the Johnson & Johnson’s Medical Devices segment.
**DePuy Synthes represents the products and services of DePuy Synthes, Inc. and its affiliates.
1 M. Khan, K. Osman, G. Green, F. S. Haddah (2016). The epidemiology of failure in total knee arthroplasty. The Bone & Joint Journal, 98-B (1 Suppl A), 105-12.
2 Current epidemiology of revision total knee arthroplasty in the United States. Delanois R, Mistry J, Gwam C, Mohamed N, Choksi U, Mont M. J Arthroplasty. 2017 Mar; 32:2663-2668.
3 Prosthetic joint infection. Tande A, Patel R. Clinical Microbiology Reviews. 2014; 27(2)302-345.

Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding the agreement with Ortho Development to exclusively promote KASM. 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 DePuy Synthes, 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 related to the collaboration may not be realized or may take longer to realize than expected; uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; manufacturing difficulties and delays; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of health care products and services; and trends toward health care cost containment. 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,” in the company’s most recently filed Quarterly Report on Form 10-Q, including under the caption “Cautionary Note Regarding Forward-Looking Statements,” and in 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 undertakes to update any forward-looking statement as a result of new information or future events or developments.

EOS imaging Reports Third Quarter 2018 Sales

October 16, 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 (non-audited) consolidated sales for the third quarter ended September 30, 2018.

Marie Meynadier, Chief Executive Officer of EOS imaging, commented, “We continue to build a solid foundation for future growth with strong commercial traction, particularly in the North America and Asia-Pacific regions. This continued momentum was partially offset by temporary delays with several accounts, primarily in EMEA. We view this timing setback as short-term and anticipate a strong catch up in the last quarter of the year, leading to a solid growth for the full year. We are confident and committed to accelerating growth across all three of our major markets as we continue to see our solutions gain traction amongst hospitals and private practices.

  • Nine Month 2018 Sales by Product Line
Sales / non-audited / € millions

As of September, 30

9M 2018 9M 2017 % Change

% Change
excl. forex
impact

Equipment Sales 19.10 19.89 -4% -1%

As % of total sales

75% 80%

Sales of Maintenance

5.76

4.29

+34%

+39%

As % of total sales

23%

17%

Sales of consumables and services

0.65

0.74

-12% -12%

As % of total sales

2%

3%

Total Sales 25.51 24.93 +2% +5%

 

In the first nine months of 2018, EOS imaging generated revenue of €25.5 million, up +2% including forex impact compared to same period prior year, and €26.3 million, up +5%, excluding forex impact.

46 EOS® systems have been sold year-to-date (vs. 51 for the same period last year), with a solid average selling price. Total revenues from equipment sales was €19.1 million, compared to €19.9 million in the same period in 2017.

Due to the increased installed base of EOS® systems, recurring revenues grew +27% to €6.4 million, including €5.8 million in maintenance revenue (+34%) and €0.7 million in consumables and services revenues.

  • Nine Month 2018 Sales by Geography

Revenues / non-audited / € millions
As of September 30

9M 2018 9M 2017 % change
(excl. forex
impact)
EMEA 8.19 11.52 -29%
North America 10.86 9.18 +18% (+27%)
Asia-Pacific 5.75 4.23 +36%
LATAM 0.71
Total revenues 25.51 24.93 +2% (5%)

 

Total revenues for the first nine months of 2018 benefited from the strong commercial traction in North America and Asia-Pacific and were partially offset by continued delays in EMEA regions, where revenue decreased -29% primarily attributed to the three largest EMEA markets of the company (France, United Kingdom, and Germany). In this area, several sales were delayed and are expected to contribute to a strong commercial catch-up in the fourth quarter of 2018.

  • Third Quarter Sales by Product Line
Revenues / non-audited / € millions Q3 2018 Q3 2017 % change
Equipment sales 5.49 6.74 -19%
Sales of maintenance 2.30 1.47 +56%
Sales of consumables and services 0.17 0.25 -32%
Total sales 7.96 8.46 -6%

 

In the third quarter of 2018, the Company generated revenue of €7.96 million, down 6% compared to the third quarter of 2017 (4% excluding forex impact).

The Company sold 12 EOS® systems during the third quarter of 2018, compared to 17 systems in the same period last year. Revenue from equipment sales was €5.5 million, down 19% compared to 2017.

Recurring revenues grew +44% to €2.5 million and represented 31% of total sales compared to 20% of total sales in the same period last year. This includes €2.3 million in maintenance revenue (+56%) and €0.2 million revenue of consumables and services.

About EOS imaging

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 around 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.

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

Contacts

EOS imaging
Marie Meynadier
CEO Ph: +33 (0)1 55 25 60 60
investors@eos-imaging.com
or
Investor Relations (US)
Matt Picciano / Emma Poalillo
The Ruth Group
Ph: 646-536-7008 / 7024
EOS-imagingIR@theruthgroup.com
or
Press Relations (US)
Kirsten Thomas
The Ruth Group
Ph: 508-280-6592
kthomas@theruthgroup.com

UCHealth University of Colorado Hospital now one of the state’s few Level I trauma centers

Aurora, Colo., Oct. 16, 2018 (GLOBE NEWSWIRE) —

The Colorado Department of Public Health and Environment (CDPHE) and American College of Surgeons have verified and designated UCHealth University of Colorado Hospital (UCH) on the Anschutz Medical Campus as a Level I trauma center, making it one of only five hospitals in the state with the highest capabilities for trauma care. The Level I distinction recognizes the hospital’s ability to treat the most severe and complex injuries, giving residents of Aurora, metro Denver, eastern Colorado, and the broader Rocky Mountain region rapid access to the most advanced trauma care.

  • Level I is the highest trauma center designation.
  • University of Colorado Hospital is home to the only American Burn Association Verified Burn Center in Colorado.
  • University of Colorado Hospital has the largest neurological intensive care unit in the state and is one of the few Comprehensive Stroke Centers. 
  • University of Colorado Hospital is home to a full-service orthopedic trauma service and the Limb Restoration Program, dedicated to the treatment of conditions that can put limbs at risk.
  • Nationally recognized surgeons, emergency and trauma physicians from University of Colorado School of Medicine provide expert care for patients.

The hospital received official designation by the Colorado Department of Public Health and Environment on Oct. 12, 2018.

“Earning this Level I designation has taken years of planning and advancements,” said Will Cook, UCHealth University of Colorado Hospital’s president and CEO. “The CU School of Medicine and UCH have recruited some of the nation’s best trauma surgeons, led important research, and improved every aspect of our trauma patient care. This preparation, and the Level I designation, will result in more lives being saved.”

Hospital trauma designations are determined according to established state and national criteria. Key elements required to be a Level I trauma center include around-the-clock coverage by trauma surgeons and prompt availability of the most comprehensive group of specialists in orthopedics, neurosurgery, and anesthesiology, among others. Such facilities also must be leaders in trauma prevention and education, conduct research, and meet volume requirements for treating severely injured patients.

The majority of trauma cases involve blunt injuries that are often the result of incidents such as motor vehicle crashes, pedestrians or bicyclists hit by vehicles, falls, and penetrating trauma injuries such as gunshot wounds and stabbings. UCH also serves as a regional referral destination for patients from dozens of hospitals in Colorado, Wyoming, Kansas and Nebraska.

“Excellent trauma care depends on a large team of specialists, nurses, surgeons, therapists and support staff. Only by working together can we provide patients with the highest level of care possible,” said Dr. Robert McIntyre, the hospital’s trauma medical director and CU School of Medicine professor. “Not only are we providing excellent trauma care today, but the research and education we are leading will help define the future of trauma medicine.”

Patients with the most serious burns often include life-threatening trauma injuries as well, and UCH now provides these patients with the most advanced capabilities for both types of injuries.

“As the first and only Burn Center in our region verified by the American Burn Association, University of Colorado Hospital already cares for patients from a multi-state region, providing a comprehensive team approach to care,” said Dr. Anne Wagner, medical director of the Burn Center and associate professor, CU School of Medicine. “Now these patients can benefit from the highest burn and trauma capabilities at the same location.”

Dave Repsher, a flight nurse and paramedic, was critically injured and burned when the medical transport helicopter he was flying in crashed in Summit County in July 2015. He was rushed to the Burn Center at UCH where he spent more than a year recovering from his injuries.

“I was flown to University of Colorado Hospital, desperately critical, and subsequently received care from an army of caregivers and staff,” Repsher said. “I spent 397 days in the hospital. I have been seen by over 42 specialties and ancillary services, have had 51 major surgeries and countless procedures, all here at the Anschutz Medical Campus. My recovery is due, in no small part, to having all of the dedicated services and specialties I needed including: burn, trauma and transplant all coordinated and centralized in one location.”

EDITORS’ NOTE: Downloadable photos and videos are available here.

About UCHealth

UCHealth is an innovative, nonprofit health system that delivers the highest quality medical care with an excellent patient experience. UCHealth combines Longs Peak HospitalYampa Valley Medical CenterMemorial Hospital CentralMemorial Hospital NorthPoudre Valley HospitalMedical Center of the RockiesUCHealth Medical GroupBroomfield HospitalGrandview HospitalPikes Peak Regional Hospital and University of Colorado Hospital into an organization dedicated to health and providing unmatched patient care in the Rocky Mountain West. With more than 150 clinic locations, UCHealth pushes the boundaries of medicine, providing advanced treatments and clinical trials and improving health through innovation.

Paula Freund
UCHealth
720-848-5809
Paula.Freund@UCHealth.org

Sports Medicine Market is Anticipated to Witness Immense Growth: Knee and Hip Applications Accounted for Highest Revenue Share

10-10-2018

According to the latest study published by AnalystView Market Insights, by the end of 2025, global sports medicine market is expected to reach USD 11.98 billion with the CAGR of 7.5%.

Sports medicine includes the medicines that can be used for treatment and prevention of injuries related to the exercise and sports. Sports medicine is a broad team that involves kinesiologists, physiologists, athlete trainers, physical therapists, physical educators, and many others. The market for sports medicine is primarily driven by the rise in a number of sports injuries across the globe. According to the National Ski Areas Association (NSAA), around 56,714 people were injured while participating in the winter sports that required immediate attention. Winter sports included sports like snowboarding, snowmobiling, and ice skating.

The main objective of introducing sports medicine is to prevent and treat injuries caused to the participants while performing the sports activities. Thereby, a steady introduction of new treatment modalities and products is expected to surge in demand for sports medicine. This, in turn, is expected to drive the market growth. In addition to this, constant developments in regenerative medicine field are expected. This will establish a healthy platform for market growth during the forecast period in this sector. It is also noticed that many multinational companies are planning to increase their investment in the development of 3D printed orthopedic implants which support the market growth to great extent. For instance, in January 2017, Sweden based OssDsign AB received US FDA approval of 3D Printed Cranial Implant Technology to commercialize the product in the U.S. market.

Get access to exclusive PDF brochure of this study @
www.analystviewmarketinsights.com/request_sample/av118/

This introduction is a definite approval as regards the products in this market arena. For instance, a product for cranial bone reconstruction will provide a healthy platform for future market growth. This product segment is divided into Body Monitoring, Body Reconstruction, Body Support, as well as the Sports Accessories. Body reconstruction and support devices collectively captured more than 50% share of the global market. High usage coupled with technological advancement has supported the market growth of these segments. Body monitoring segment is categorized as Cardiac, Hemodynamic, Musculoskeletal, and others. Body Reconstruction is further divided into Surgical equipment, Soft tissue repair, and Bone reconstruction devices. Body support device category is classified into various products like Braces devices, Compression clothing, and Hot & cold therapy. Hot and cold therapy is mainly used to control swelling. It also helps in dilating the blood vessels which supply ample blood to the site providing a stimulus to the process of healing the damaged tissue.

Accessories in this category include bandages, tapes, disinfectants, wraps, along with other instruments such as scissors, cutters, blister packs, etc. Bandages have dominated accessories segment in the year 2016. A sharp increase in incidents of injuries is observed. Thus, infection preventing product range is anticipated to contribute to the growth of this segment. Sports medicine market involving the application segment is categorized as Knees, Shoulders, Back & Spine, Hips, and Others. Knee devices accounted for the largest share of the global market in the year 2016. This segment is anticipated to maintain its leading position with a rising volume of knee surgeries.

Regionally, the market is categorized as North America, Europe, Asia Pacific, and Rest of the World. Around 49.36% share of the global market revenue is captured by North American countries, dominated by the U.S. market. Increase in a number of orthopedic procedures is anticipated owing to the high prevalence of accidents caused during a physical activity. This has supported the sports medicine market growth in this region. For instance, according to the CDC, around 51.4 million orthopedic procedures were performed in the U.S. in the year 2015. The highest prevalence of orthopedic conditions coupled with the high adoption of advanced treatment procedures is fuelling the growth of the market in the U.S.

Asia Pacific region is seen as a promising market growing at 9.1% growth rate over the forecast period. Countries such as India, Japan, and China exhibit their great potential to capture significant revenue share of the total Asia Pacific market. For example, Japan has the presence of a large number of implant manufacturers in this segment. The country has higher healthcare expenditure as compared to the other countries in the region. Moreover, the high adoption rate of the new technology and presence of various accident-prone individual sports in the region are expected to fuel the growth of the sports medicine market.

Companies such as Medtronic, Smith & Nephew, Stryker, Conmed, Wright Medical Technology, and others are present in this market. Company merger & acquisition strategies are being utilized for expanding their geographic presence. It is important to note that Mergers and acquisitions also enable widening of product portfolio as well as the customer base of the companies.

Click here to obtain more highlight on “Sports Medicine Market, By Products, By Application and Geography – Analysis, Share, Trends, Size, & Forecast From 2014 – 2025” study @
www.analystviewmarketinsights.com/report-highlight-sports…

Global Sports Medicine Market: Snapshot

Market, By Products
Body Monitoring (Cardiac, Hemodynamic, Musculoskeletal and Others), Body Reconstruction (Surgical equipment, Soft tissue repair and Bone reconstruction devices), Body Support (Braces devices, Compression clothing and Hot & cold therapy), and Sports Accessories (Bandages, Tapes, Disinfectants, Wraps and others)

Market, By Application
Knees, Shoulders, Back & Spine, Hips and others
Market, by Region
North America (U.S. and Canada), Europe (France and Germany), Asia Pacific (India and China), Middle East and Africa, Latin America and Rest of the World

Key players profiled in this report with special attention on competitive landscape includes, (can be further customized to include additional 10 profiles of companies):
– Medtronic
– Smith & Nephew
– Stryker Corporation
– Conmed
– Wright Medical Technology

USP of our key vendor analysis:
– Well-designed strategic framework design for these key players will help to understand the market movement including regional expansion, mergers & acquisitions, and new product developments
– Thorough SWOT i.e. Strength, Weakness, Opportunities and Threat for individual company profiling is analyzed in order to present a detailed market opportunity assessment.

Key benefits of the report:
• The report presents a macro and micro-level outlook regarding the industry. Thus, it becomes easy for our clients to perceive the business landscape and take a glimpse of their own standing in it.
• A thorough analysis of relevant statistical data to estimate the market paradigms
• Exceptional understanding of region and country-specific markets. The report will answer some of the toughest questions regarding the market shares, sizes, forecasts segmentations, and growth specific to the countries.
• Well-designed strategic framework analyzes the market movements including regional expansion, mergers & acquisitions, and new product developments

Research Methodology:
– Preliminary Data Mining: Secondary Research, Paid Databases, Primary Research
– Data Synthesis & Analysis: Top-Down Approach, Bottom-Up Approach, Supply Side and Demand Side
– Market Formulation: Market Dynamics, Total Addressable Market and Machine Learning Technique
– Data Verification: Quality Assurance and Reach a Conclusion

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AnalystView Market Insights is a market research and consulting firm that adopts a proactive approach to provide the diverse need for accurate and precise market research, custom research, and consulting solutions across geographies and industry verticals. We strive to develop meaningful and evidence-based research data that helps our clients, empowering organizations and brands of all sizes with strategic analysis, accurate data, and consumer trends for various industries such as Healthcare, Bulk Chemicals, Semiconductors, Electronics, and Foods and Beverages.

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This release was published on openPR.