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New PROTI 360° Family of Implants from DePuy Synthes Is Designed to Enhance Spinal Fusion Surgery Outcomes

Posted On April 27, 2018 By OrthoSpineNews In Spine, Top Stories /  

RAYNHAM, Mass., April 26, 2018 /PRNewswire/ — DePuy Synthes*, part of the Johnson & Johnson Medical Devices Companies**, today announces the U.S. launch of the PROTI 360° Integrated Titanium Family of interbody devices to advance care for patients who have degenerative disc disease in the neck and back.  This new offering underscores the commitment of DePuy Synthes to expand the company’s portfolio of interbody fusion devices designed to help improve outcomes after spinal fusion surgery.

Approximately 400,000 patients undergo spinal fusion surgery annually to help reduce pain and nerve root inflammation in the US alone.1 During this procedure, a disc is removed and an interbody spacer is implanted to potentially restore natural height between two vertebrae and create solid bone.

To maximize the potential for bone growth following this type of surgery, DePuy Synthes has introduced the PROTI 360° Integrated Titanium Family of Implants, the only titanium-integrated Polyetheretherketone (PEEK) that offers 360 degrees of titanium integration. PEEK is a biocompatible material with mechanical properties that resemble human bone, and the implants are radiolucent, which means surgeons can easily assess the bone healing process over time.2The new PROTI 360° Technology offering combines the benefits of PEEK and titanium in each device. The titanium integrated surface of the PROTI 360° Family of Implants creates a bioactive surface that promotes the attachment and growth of bone-forming cells.3,4

Data presented at a recent podium presentation during the International Society for the Advancement of Spine Surgery Meeting showed calcium deposition, which is an indicator of early bone formation, was 470.4% higher with the PROTI 360° Technology than PEEK alone and 305.1% higher than titanium alone just one day after device testing.5 The PROTI 360° Family of Implants is designed with enhanced bond strength between the materials, fortified titanium edges, and no exposed corners to prevent delamination, a process in which titanium coatings separate from the PEEK implant where the two materials meet.

“The ability to maximize the potential for bone growth is fundamental to achieving the best possible patient outcomes in most reconstructive spinal fusion surgery,” said L. Erik Westerlund, MD, Surgeon and Director of the St. Francis Spine Center, Columbus, Georgia***. “Utilizing innovative biomaterials like titanium-integrated PEEK designed to promote bone growth delivers a comprehensive alternative offering to surgeons that advances the standard for spine surgery patients.”

The PROTI 360° Family of Implants includes the ACIS PROTI 360° System for cervical fusion and the T-PAL PROTI 360° System and CONCORDE PROTI 360° System for lumbar interbody fusion. The PROTI 360° Systems are compatible with ACIS, T-PAL and CONCORDE Systems instrument sets.

“With the launch of the PROTI 360° Family of Implants we are responding to the needs of spine surgeons with a differentiated technology to help advance the care of patients undergoing spinal fusion surgery,” said Nadav Tomer, Global Platform Leader, DePuy Synthes Spine. “DePuy Synthes has one of the broadest spine portfolios in the world, and we continue to focus on innovation that strengthens our offering.”

About the Johnson & Johnson Medical Devices Companies
The Johnson & Johnson Medical Devices Companies’ purpose is to reach more patients and restore more lives. Having advanced patient care for more than a century, these companies represent an unparalleled breadth of products, services, programs and research and development capabilities in surgical technology, orthopaedics, cardiovascular and specialty solutions with an offering directed at delivering clinical and economic value to health care systems worldwide.

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.

*DePuy Synthes represents the products and services of DePuy Synthes, Inc. and its affiliates.
**The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, and cardiovascular businesses within Johnson & Johnson’s Medical Devices segment.
***Consultant to DePuy Synthes Spine

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 PROTI 360° Integrated Titanium Family of interbody devices. 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: 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,” and in the company’s subsequent Quarterly Reports on Form 10-Q and other 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 DePuy Synthes, 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.

1Rajaee, Ss et al. Spinal fusion in the United States: analysis of trends from 1998 to 2008. Spine. 2012 Jan 1;37(1):67-76.
2Nemoto, O. et al. Comparison of fusion rates following transforaminal lumbar interbody fusion using polyetheretherketone cages or titanium cages with transpedicular instrumentation. Eur Spine J. 2014 Oct;23(10):2150-5.
3Lincks, J. et al. Response of MG63 osteoblast-like cells to titanium and titanium alloy is dependent on surface roughness and composition. Biomaterials 19, 1998. Pages 2219–32
4Kurtz, S. M. & Devine, J. N., PEEK biomaterials in trauma, orthopedic, and spinal implants. Biomaterials. 2007
5TR-201801-B (ProTi Test Report)

089999-180411

 

SOURCE DePuy Synthes

Related Links

http://www.depuysynthes.com

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OrthoSpineNews Interview with Lane Major, Chief Operating Officer at K2M

Posted On April 25, 2018 By OrthoSpineNews In Spine, Top Stories /  

Good morning Lane, thank you for taking some time to talk with us this morning. If you wouldn’t mind introducing yourself to our readers and telling us a bit about your background to get started…

Sure thing, Mason. I truly appreciate the opportunity to share our K2M story with you. I have spent my entire career in the spinal devices space, beginning with a field-based role in Northern Virginia carrying primarily Stryker products. I was also exposed to several Globus products and some osteobiologics. Being in the operating room each day gave me a strong foundation in the spine industry. One that I keep with me today.

In January 2004, K2M was founded with a vision of improving the lives of people across the world with spinal deformities. I’ve been with the company ever since and am grateful for the work we do each day.

Thanks for that background, Lane. What is your biggest motivator for coming into work every day at K2M? 

When you are with a company that changes lives—particularly for children suffering from scoliosis—seeing the positive impact of our work is all that matters. The societal value we create has resulted in a corporate culture second to none. It’s something you feel when you walk through the door. We hear this all the time from surgeons and others who visit us from around the world.

Our commitment to social good begins in Loudoun County, VA—our global headquarters—as well as at a national and global level. One example is a program called Straight 2 Swimming. Just imagine children with scoliosis who never could swim because they’re embarrassed to take off their shirts. We help them build confidence; it’s a huge motivator for me. Another example is the FOCOS Hospital we helped found in Ghana. The fact that our products are used to treat the world’s most challenging deformity cases inspires us each day.

Wow, that is incredible, Lane. Thank you for sharing that with us. Furthermore, can you give us an overview of the various 3D Solutions K2M offers and how you first got into the space?

Absolutely. K2M is leading the way in the 3D printing of spinal devices. But this work started well before 3D printing became popular. It came about because we were seeking to overcome a challenge.

Because our products are used in 40 different countries around the world, we have gained valuable insights from surgeons on what tools they need to improve outcomes in patients. Years ago, we began hearing people talking about how there should be a better alternative to PEEK implants. So, we partnered with a team of global key opinion leaders to create the Alternative Materials Design Team. The design input from this team led us to solutions that simply couldn’t be manufactured traditionally. It required innovation.

To improve upon PEEK technology, we partnered with 3D Systems—the world’s foremost leader in 3D printing for medical purposes. Today, we have a world-class portfolio of 3D-printed devices that address a diverse range of degenerative, complex spine, and MIS procedures. All of which feature our innovative Lamellar 3D Titanium Technology™, which uses an advanced 3D-printing method to create structures that were once considered impossible with traditional manufacturing. It allows us to develop devices with a porosity and surface roughness that pre-clinical data have associated with bone growth activity, as well as a decreased radiographic signature. All of which help improve outcomes in patients undergoing spine surgery.

Having said that, what is your vision for where the company goes from here?

Our vision is to be the leader in complex spine and minimally invasive solutions. We have had consistently strong success in these areas, and today, patients and physicians are asking us to help in the other areas of treatment. Therefore, we are introducing new technologies—such as our Balance ACS® (BACS) platform—to help surgeons and patients in all phases of preoperative, intraoperative, and postoperative patient care. Balance ACS is game-changing, as it uses a 360-degree approach to the axial, coronal and sagittal planes so surgeons can take a more holistic and comprehensive approach to treatment. It also includes a suite of data management software that lets surgeons collect and analyze patient data to improve treatment.

As we move forward, we will continually find ways to drive costs down for the patient, make practices more intuitive for surgeons, ensure faster recovery time, and much more.

We are really looking forward to seeing everything that lies ahead for K2M. Can you leave us with some closing remarks or any predictions about the spine industry as a whole? 

There remains a significant opportunity for innovation in the spinal devices space. K2M is at the forefront of inventing solutions for the full continuum of care, not just limited to implants and instrumentation. The opportunity for innovation remains robust; we believe that K2M is well-positioned to position to continue leading.

Well Lane we really appreciate you taking the time to chat with us today. It was great to get some insights into the K2M story as well as what’s on the horizon. We wish you all the best moving forward. 

Thanks Mason, likewise. We really appreciate the opportunity. Take care.

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CoreLink Names David Castleman Vice President of Research and Development

Posted On April 25, 2018 By OrthoSpineNews In Spine /  

April 25, 2018

ST. LOUIS–(BUSINESS WIRE)–CoreLink, LLC, a fast growing, vertically integrated designer and manufacturer of spinal implant systems, announced today the recent appointment of David Castleman to the newly created position of Vice President of Research and Development.

“CoreLink draws on nearly half a century of surgical device manufacturing expertise. When combined with our robust internal capabilities, we are now well positioned to develop a wide array of new products to advance the state of spine care,” said Jay Bartling, founder and CEO of CoreLink, LLC. “We are excited to create this new position and believe David to be the perfect candidate for it. His engineering insight and product development rigor will help focus and leverage our capabilities in pursuit of our commitment to empower our surgeons’ performance and help improve their patients’ lives.”

Under the product development leadership of Mr. Castleman, CoreLink expects to launch multiple new implant systems in 2017 including a full direct lateral platform of products, Foundation™ 3D ALIF*, M3™ Stand-alone ALIF*, and Foundation Corpectomy*, all of which will feature the patent pending Mimetic Metal™ and StrutSure™ 3D printed titanium technologies. (*Not currently available for sale in the United States)

“I am pleased to join such a young and nimble yet broadly capable company,” said Castleman. “The vertical integration of CoreLink’s manufacturing provides significant advantages with regard to product development. The more intimate working relationship between engineering and manufacturing not only enhances its speed to market, but also facilitates better quality control and product improvement. We are going to make some great stuff.”

David adds more than 25 years of orthopedic device experience including 14 years in the spine industry. He gained expertise in international business development, marketing, and product development in positions with Smith & Nephew, Medtronic, and Zimmer Biomet, respectively. David received his Master of Business Administration from the University of Memphis and a Bachelor of Science degree in Mechanical Engineering from the University of Tennessee.

For more information, visit: www.corelinksurgical.com

About CoreLink

CoreLink, LLC internally designs and manufactures more than 99% of its broad portfolio of spinal implant systems. CoreLink leverages this expertise through collaboration and a dedication to empowering surgeons with the highest quality and most effective instruments and implants possible. That is how CoreLink came to be known as The Source.

Be a part of something at The Source.

Contacts

CoreLink, LLC
Matthew Linhardt, 888-349-7808
m.linhardt@corelinksurgical.com

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EOS imaging Announces New EOS® System Installations in Two U.S. Private Orthopedic Practices

Posted On April 25, 2018 By OrthoSpineNews In Extremities, Spine /  

April 25, 2018

EOS imaging (Paris:EOSI) (Euronext, FR0011191766 – EOSI – Eligible PEA – PME), the pioneer of 2D/3D imaging and data solutions for orthopedics, today announced that University Orthopedics in Providence, Rhode Island, and the Hey Clinic for Scoliosis and Spine Surgery in Raleigh, NC, have installed the EOS® system for low-dose, 2D and 3D imaging of patients. Both practices are part of the U.S. private practice sector, which amounts to 73 percent of all orthopedic practices in the country.

University Orthopedics is a multiple facility private practice in Rhode Island for patients with orthopedic related conditions and injuries. University Orthopedics directs many clinical research efforts intended to innovate new orthopedic surgery techniques, new surgical implant devices that improve the success of various procedures, and new ways to prevent orthopedic injury.

“We believe in using advanced technology to provide the safest and best healthcare possible” said Dr. Alan Daniels, Adult Spine Deformity Orthopedic Surgeon and Partner at University Orthopedics. “EOS® provides extremely high-quality full-body images for pediatric and adult patients at lower radiation doses than traditional x-rays, increasing patient safety. The EOS® images allow us to carefully assess the entire skeleton, so we can provide optimal individualized patient-specific care.”

Weber Shill, CEO of University Orthopedics, added: “I saw the clinical and educational benefits of the EOS® system immediately and was enthusiastic about getting behind a project that our surgeons were so motivated about and I knew our patients would appreciate. Like any healthcare organization today, we have to be cognizant about our capital expenditures, and EOS imaging custom finance program for the private sector facilitated our acquisition.”

For more than 13 years, the Hey Clinic has served patients with spinal conditions from North Carolina and beyond through a full array of treatment options. The clinic, recently relocated to a new facility on the Duke Raleigh Hospital campus, is committed to personalized attention, generous appointment times and a strong emphasis on patient education and engagement.

“When we decided to update our imaging options, we thoroughly researched available technologies and determined that the EOS® system would best serve our patients with its high image quality for diagnostics, low radiation to decrease cancer risk and 3D modeling capabilities for treatment planning,” commented Dr. Lloyd Hey, Orthopedic Surgeon and Founder of the Hey Clinic. “In addition, EOS® will help us facilitate educating patients and families about their condition and treatment choices. We are excited to work with EOS imaging to improve patient care.”

“We are encouraged to see a growing number of private practices adopting the EOS® system” said Marie Meynadier, Chief Executive Officer of EOS imaging. “Our technology has received strong recognition from academic and non-academic hospitals, both clinically and in terms of operational value. Private practices play an important role in orthopedic care, and we will do our best to support them in providing our low dose, 2D/3D solutions to a growing number of patients.”

About EOS imaging
EOS imaging designs, develops and markets EOS®, a major innovative medical imaging solution dedicated to osteoarticular pathologies and orthopaedics combining equipment and services and targeting a $2B per year market opportunity. EOS imaging is currently present in 31 countries, including the United States under FDA agreement, Japan, China and the European Union under CE labelling, through the over 250 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
Press Relations (US)
Joanna Zimmerman
The Ruth Group
Ph: 646-536-7006
jzimmerman@theruthgroup.com
or
Investor Relations (US)
Matt Picciano / Emma Poalillo
The Ruth Group
Ph: 646-536-7008 / 7024
EOS-imagingIR@theruthgroup.com

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NuVasive Sponsors AANS 2018, Hosts Workshops And Presentations On Latest Innovations

Posted On April 24, 2018 By OrthoSpineNews In Spine, Top Stories /  

SAN DIEGO, April 24, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced the Company is a sponsor of the American Association of Neurological Surgeons (AANS) Annual Scientific meeting being held April 28-May 2, 2018, in New Orleans, at the Earnest N. Morial Convention Center. NuVasive will host a hands-on workshop featuring the latest advances in Lateral Single-Position surgery, technology to reduce OR radiation and developments in 3D-printed implants.

The NuVasive Industry Lunch and Learn Workshop, Single-Position Lateral Surgery Solutions to Treat L4-S1, Featuring Advanced 3D-Printed Implants and LessRay® Radiation Emission Reduction Technology, by Kaveh Khajavi, M.D., Robert Issacs, M.D. and Juan Uribe, M.D., will take place on Monday, April 30 from 1:10-1:55 p.m. in Room 272-273. For more information, visit the AANS Program Schedule.

“The interactive workshop provides a forum to discover our commitment to Safer, Faster and Smarter surgery through Surgical Intelligence as well as our leadership position in Lateral Single-Position surgery and how it fits in with our industry-leading lateral procedural solutions,” said Matt Link, executive vice president, strategy, technology and corporate development for NuVasive. “Lateral Single-Position benefits include reducing the number of times a patient has to be repositioned for greater OR efficiency. Attendees will hear directly from early adopters of the technology and also learn what NuVasive is doing to incorporate advanced materials into its surgical implants and how Surgical Intelligence includes proactively combatting radiation exposure in the OR with LessRay technology.”

Additionally, AANS attendees can visit NuVasive Booth #529 to experience the latest innovative spine solutions and systems firsthand from the NuVasive team of experts and meet NFL great and NuVasive spokesperson Archie Manning. The College Hall of Fame and former NFL Pro Bowl quarterback will discuss his firsthand experience with the life-changing NuVasive XLIF® procedure at the Lunch and Learn and in the booth on Monday, April 30. Manning continues to proudly share his personal story of how the XLIF spine procedure changed his life by restoring height and stability to the collapsed disc space on the left side of his lumbar spine. XLIF is the leading lateral spine procedure, supported by over 10 years of clinical evidence.

Individual NuVasive booth stations will focus on a variety of spine solutions, including Lateral Single-Position Surgery, Surgical Intelligence, Advanced Materials Science™, Cervicothoracic and TLIF.

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

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

 

SOURCE NuVasive, Inc.

Related Links

http://www.nuvasive.com

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Ortho Sales Partners Announces the Appointment of Chris Stewart as Senior Vice President and General Manager of Hospital Strategy

Posted On April 24, 2018 By OrthoSpineNews In Recon, Spine, Top Stories /  

Ortho Sales Partners, the global leader in commercialization services for the orthopedic industry, is pleased to announce the addition of Chris Stewart to the companies executive team. Mr. Stewart is a very well regarded leader and innovator that brings an in-depth knowledge of the supplier, hospital and physician relationship. In addition to having a cross functional leadership role, Mr. Stewart will lead the organization and its clients in strategies related to hospital access and supply chain value analysis illustration as well as enhancing Ortho Sales Partners software and logistics platforms developed to optimize supply chain delivery and clinician user experience.

Prior to joining Ortho Sales Partners, Mr. Stewart was the Assistant Vice President and Business Unit Leader of Medical Device Management for HealthTrust. Mr. Stewart managed consulting services for hospital IDN memberships comprised of approximately 1,600 acute and 2,000 ASC facilities. He oversaw a team of orthopedic, spine, osteobiologic and cardiovascular specialists who worked with hospital clients to actively manage their clinically sensitive implant service lines. Using data as an asset, his team developed strategic roadmaps to help hospitals and physicians achieve financial and clinical alignment, so they could plan, not just react, to financial pressures and complex market changes.

Mr. Stewart holds a bachelor’s degree in economics and business administration from the University of Tennessee, Knoxville. He has presented at numerous healthcare forums on topics that include physician engagement, clinical best practice, alternative service models for the OR, strategic alliance of GPOs, shifting reimbursement models, new technologies, changing population demographics and the future of supply chain delivery.

About his new role, Mr. Stewart said: “I am excited to be joining this team of accomplished industry thought leaders who share the same vision and passion for enhancing value within this ever-changing healthcare environment”

Kevin McGann, CEO of Ortho Sales Partners, said: “We are very pleased to announce the addition of Chris Stewart to our team at Ortho Sales Partners.  Chris is a well-respected healthcare executive, who has tremendous knowledge of the hospital networks, ambulatory surgery centers and group purchasing organizations.  His experience in creating value added programs, and the utilization of data to direct purchasing behaviors is a tremendous asset to manufacturers, healthcare providers and physicians across the entire industry”

_____________

About Ortho Sales Partners

Ortho Sales Partners has created a unique platform to help companies in any stage commercialize their products in a very efficient way. We have worked closely with many organizations and produced results that have profoundly impacted each client’s business.

Our services are geared to meet you where you are today and help your business grow by utilizing proven industry executives that bring you an objective analysis and recommendations going forward. Our market knowledge is based on current trends and competitive analysis from industry stalwarts from some of the highest growth companies.

Ortho Sales Partners’ headquarters are in Scottsdale, Arizona but we have several offices across the US. (http://www.orthosalespartners.com).

 

Additional Product Platforms

Surg.io (http://www.surg.io)

OrthoEx (http://www.orthoex.com)

The De Angelis Group (http://www.orthospinesearch.com)

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SpineGuard® Announces First Spinal Deformity Surgery in China with PediGuard® by Prof. Yong Qiu

Posted On April 19, 2018 By OrthoSpineNews In Spine, Top Stories /  

April 18, 2018

PARIS & SAN FRANCISCO–(BUSINESS WIRE)–Regulatory News:

SpineGuard (FR0011464452 – ALSGD), an innovative company that develops and markets instruments designed to secure the placement of surgical implants by bringing real-time digital technology into the operating room, announced today that Professor Yong QIU performed the first spinal deformity surgery in China with the PediGuard® device.

Pr. Yong QIU is the Chairman of Orthopedic Surgery at Nanjing Drum Tower Hospital, President of the Chinese Scoliosis Research Society, and Vice-President of the Chinese Association of Orthopedic Surgeons and one of the leading scoliosis surgeons in China. His spine center is the largest scoliosis center in China, performing around 600 scoliosis surgeries per year, the majority of which are among the most complex cases in China.

This surgery case demonstrates the ability of XinRong Medical to quickly bring to market PediGuard enabled surgeries with the most preeminent surgeons in China, and highlights Xinrong’s ability to assist leading foreign brands in navigating the local tendering and hospital approval process.

“PediGuard increases safety for better screw placement, reduces surgical time by 15%, decreases X-ray exposure for patients, surgeons and staff and also helps train the young surgeons. It is a very useful and convenient device that is effective without any other supplementary equipment for complex spine surgery, especially for spinal deformity cases,” said Professor Yong Qiu, Chairman of Orthopedic Surgery of Nanjing Drum Tower Hospital.

“It is an immense honor for SpineGuard that Professor Yong Qiu performed the first spinal deformity surgery in China with the PediGuard device to secure pedicle screw placement. Professor Yong Qiu, who was trained in France, is the most experienced surgeon for spinal deformity in China with over 3,000 spinal deformity surgeries to his credit,” added Patricia Lempereur, International Director of Sales and Marketing at SpineGuard.

“We are honored by the use of PediGuard for spinal deformity cases at the Nanjing Drum Tower Hospital, one of the world most famous hospitals for spinal deformity with over 9,000 cases since their opening. We look forward to extending our collaboration with Pr. Yong Qiu with the use of PediGuard technology in training junior surgeons in China for pedicular screw placement. China market is growing rapidly, with spine surgery cases expected to grow around in the mid double digits in next 5 years. XinRong covers 2600 hospitals in China. We have great confidence that with the wide application PediGuard by Chinese surgeons will continue to dramatically enhance surgery case outcomes,” concluded Christine Zhang, XinRong Medical Group’s CEO.

The event was also reported by Chinese television news program, watch here.

More information on the DSG® technology and surgeons’ testimonials here.

Next financial press release: 2018 Half-year revenue: July 11, 2018

About SpineGuard®

Founded in 2009 in France and the USA by Pierre Jérôme and Stéphane Bette, SpineGuard’s mission is to make spine surgery safer by bringing real-time digital technology into the operating room. Its primary objective is to establish its proprietary DSG™ (Dynamic Surgical Guidance) technology as the global standard of surgical care, starting with safer screw placement in spine surgery and then in other surgeries. PediGuard®, the first device designed using DSG, was co-invented by Maurice Bourlion, Ph.D., Ciaran Bolger, M.D., Ph.D., and Alain Vanquaethem, Biomedical Engineer. It is the world’s first and only handheld device capable of alerting surgeons to potential pedicular or vertebral breaches. Over 60,000 surgical procedures have been performed worldwide with DSG™ enabled devices. Numerous studies published in peer-reviewed medical and scientific journals have demonstrated the multiple benefits that PediGuard® delivers to patients, surgical staff and hospitals. SpineGuard is expanding the scope of its DSG™ platform through strategic partnerships with innovative medical device companies and the development of smart instruments and implants. SpineGuard has offices in San Francisco and Paris. For further information, visit www.spineguard.com.

About XinRong Medical Group

XinRong Medical Group, a leader in medical technology, is dedicated to increasing patient affordability and providing the most advanced solutions for surgeons such that they can deliver the best patient care. XinRong Medical offers innovative solutions in orthopedic surgery, neurosurgery, reconstructive surgery, and minimally invasive therapy. Established in 2000 in Jiangsu Province, China, XinRong Medical was one of the first companies in China cleared by CFDA to manufacture Orthopedic Implants. In 2014, the Company received a strategic investment from The Blackstone Group (NYSE: BX). For additional information about XinRong Medical, please refer to our website www.XRBest.Com, or contact us directly at +86-512-58100828 or info@xrmed.com.

Disclaimer

The SpineGuard securities may not be offered or sold in the United States as they have not been and will not be registered under the Securities Act or any United States state securities laws, and SpineGuard does not intend to make a public offer of its securities in the United States. This is an announcement and not a prospectus, and the information contained herein does and shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the securities referred to herein in the United States in which such offer, solicitation or sale would be unlawful prior to registration or exemption from registration.

Contacts

SpineGuard
Stéphane Bette
Chief Executive Officer
Tel: +33 (0)1 45 18 45 19
s.bette@spineguard.com
or
Manuel Lanfossi
Chief Financial Officer
m.lanfossi@spineguard.com
or
Europe / NewCap
Investor Relations & Financial Communication
Mathilde Bohin / Pierre Laurent
Tel: +33 (0)1 44 71 94 94
spineguard@newcap.eu

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Two Data Presentations Highlight the Unique Potential of Spineology’s Duo™ Implant

Posted On April 16, 2018 By OrthoSpineNews In Spine, Top Stories /  

April 16, 2018

ST. PAUL, Minn.–(BUSINESS WIRE)–Spineology Inc., an innovator in anatomy-conserving spine surgery, is excited to announce that two laboratory studies relating to the Spineology Duo™ Lumbar Interbody Fusion System were presented at the recent annual meeting of the International Society for the Advancement of Spine Surgery (ISASS) in Toronto, Canada.

The Duo implant is the first to combine PEEK, titanium, and graft containment mesh elements. The unique hybrid design includes lateral PEEK supports integrated with an expandable porous mesh that serves to contain bone graft. The Duo implant, filled with bone graft after it is placed in the disc space, provides a large, endplate-conforming graft pack up to 30mm in width, to help maintain spinal alignment and support fusion. Due to the unique design of the implant, the Duo System requires minimal retraction for placement of the implant which may reduce direct and indirect injury to the neural elements and potentially decrease the postoperative complications commonly associated with the lateral decubitus transpsoas approach.

Pierce Nunley, M.D., Director of The Spine Institute of Louisiana and Lisa Ferrara, Ph.D., President of OrthoKinetic Technologies LLC, co-authored a study titled “Size Matters: A Novel Interbody Fusion Cage Design Increases Contact Area for Bone Exchange and Graft Incorporation.” A unique test methodology using pressure-sensitive contact film demonstrates that the Duo device design facilitates load-sharing contact between bone graft and endplates to support graft incorporation during fusion healing. Pressure profiles were generated during testing for the Duo implants and for monolithic PEEK interbody cages (Spineology Rampart™ L). The results showed that the expandable porous mesh of the Duo implant allows for direct contact between bone graft and the viscoelastic vertebral endplates, improving the endplate and graft interface mechanics.

Barbara Boyan, Ph.D., Dean of Engineering at Virginia Commonwealth University, presented the results of an in vitro cell culture model used to assess whether the Duo implant’s polyethylene terephthalate (PET) mesh would have an impact on migration of osteoprogenitor cells from vertebral endplates onto bone graft in interbody fusion, and to assess the biological response of these cells to the bone graft. The study, titled “Effect of PET Mesh on Mesenchymal Stem Cell Response to Bone Autograft”, indicated that the presence of the porous mesh does not negatively impact the ability of osteoblast lineage cells to attach to bone particles, nor does it impede the cells’ ability to proliferate or differentiate along an osteoblastic pathway.

“The graft containment mesh is a key component of the Duo implant design,” said John Booth, CEO, Spineology Inc. “Not only does it allow for the implant to be placed with minimal retraction and expand in width up to 30mm once filled in situ, it also provides improved graft loading properties compared to traditional monolithic PEEK cages and has a positive impact on osteoprogenitor cell activity, as demonstrated by the studies presented at ISASS.”

Spineology is currently conducting a prospective post-market lateral interbody fusion study with the Duo System. The primary study objectives are to gather data related to the new on-set of thigh symptoms, quality of life measures, and fusion outcomes. The company believes the minimal amount of retraction required to place the Duo implant will have a positive impact on post-operative thigh symptoms.

About Spineology Inc.
Spineology Inc. provides innovative, anatomy-conserving spinal technologies for surgeons and their patients. Spineology surgical techniques conserve spinal bone, ligament and muscle tissue. Spineology is committed to increasing procedural efficiency, reducing surgical morbidity and accelerating patient recovery. Learn more at spineology.com.

Contacts

Spineology Inc.
John Booth, 651-256-8511
jbooth@spineology.com
or
Risdall
Dave Folkens, 651-286-6713
dave@risdall.com

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Lumbar Artificial Disc Replacement with the activL® Artificial Disc to be More Effective at Delaying the Progression of Adjacent-Level Disease which Spinal Fusion has been Found to Accelerate

Posted On April 12, 2018 By OrthoSpineNews In Spine, Top Stories /  

CENTER VALLEY, Pa., April 12, 2018 /PRNewswire/ — Aesculap Implant Systems, LLC today announced the publication of “Progression of Adjacent-level Degeneration after Lumbar Total Disc Replacement: Results of a Post-hoc Analysis of Patients with Available Radiographs from a Prospective Study with 5-year Follow-up” in Spine.1 This is another significant milestone in Aesculap’s commitment to enhancing patient access to lumbar total disc replacement as a gold standard of care.

The post-hoc analysis, which used all available radiographic data from the activL® Artificial Disc Investigative Device Exemption (IDE) study, examined the rate at which radiographic adjacent-level degeneration (ALD) occurred five years following lumbar total disc replacement (LTDR) with either the activL Artificial Disc (Aesculap AG, Tuttlingen, Germany) or the ProDisc-L (Centinel Spine, West Chester, PA) control arm. The authors found an extremely low incidence rate of radiographic adjacent level deterioration at five years (only 9.7% of patients) compared to previous reports of deterioration at levels superior to fusion (28% of patients) and an even lower rate of clinically-significant ALD that resulted in additional surgery (in just 2.29% of patients).

These newly published outcomes from the activL Study show that, in a select patient population, LTDR is more effective at slowing the adjacent segment degenerative cascade than fusion, which is consistent with previously reported LTDR ALD rates from both the U.S. and Europe (9.2%-10.7%).2,3

As part of the analysis, the authors also sought to answer the question of whether patients with asymptomatic x-ray findings of adjacent level degeneration at the time of the index procedure experienced a clinically-relevant progression of this ALD at five years follow-up.

According to author Jack Zigler, MD (Center for Disc Replacement at Texas Back Institute, Plano, TX), “Spine surgeons who believe in motion preservation are often frustrated by U.S. payers whose medical policies state that the written reporting of even the smallest trace of anatomic deterioration at an adjacent but clinically-asymptomatic level will exclude their coverage of a lumbar TDR at the symptomatic level. Our analysis found that no patients who exhibited asymptomatic radiographic ALD changes at the time of preoperative assessment required any additional surgery at those levels at five years. In other words, even five years later, the implantation of a LTDR did not accelerate radiographic, non-pain-generating ALD to the point of requiring surgical treatment. This data shows how important it is to educate health plan decision makers about the medical necessity of allowing treatment with LTDR to treat single-level chronic degenerative disc disease.”

While the overall LTDR five-year rate of ALD was 9.7%, there was a statistically-significant difference in ALD rates between patient groups. The activL patients experienced an 8.8% ALD progression at five years, while ProDisc-L patients experienced a 19% progression (p=0.05).4 The authors hypothesized that these differences in progression rates between earlier versus later generation ProDisc-L discs may be related to the protective effect of improved of range of motion on ALD. The activL Disc, which has been shown to have a higher rate of motion preservation at five years than ProDisc-L (6.2° vs. 4.0°, p=0.004)5 also had a lower rate of ALD.

The activL Artificial Disc and ProDisc-L are currently the only commercially available lumbar artificial disc devices that have undergone the rigor of biomechanical and clinical studies to satisfy the safety and efficacy requirements for Food and Drug Administration approval and the only devices that have been evaluated for ALD rates. The activL Disc was approved in 2015.

In the interest of improving the evidence base for LTDR, Aesculap has sponsored Open Access to this landmark publication. The full text can be found on the Spine website. https://journals.lww.com/spinejournal/Abstract/publishahead/Progression _of_Adjacent_level_
Degeneration_After.95075.aspx

“It is evidence like this that will hopefully move the needle with health plans in favor of a procedure that is less costly in the short- and long-term,” said coauthor Scott Blumenthal, MD (Center for Disc Replacement at Texas Back Institute, Plano, TX), who performed the first lumbar disc replacement eighteen years ago. “It is time we acknowledge the strength of the current evidence base for this life-improving procedure.”

Over the last eighteen months, U.S. commercial payers have begun to adopt coverage of lumbar total disc replacement due largely in part to the availability of long-term evidence such as the data presented in this publication.

Last year, major health care insurance carriers such as Humana, BlueCross BlueShield of Louisiana and Highmark BlueCross BlueShield established positive coverage policies for LTDR. Aesculap offers a patient advocacy platform, the Patient Assistance Line, to patients who are candidates for single-level LTDR with the activL disc to help them overcome commercial payer hurdles for those plans still denying access to this proven procedure.

In 2017, a panel of surgeons at the North American Spine Society Annual Meeting (Orlando, FL) concluded that the evidence now supports that lumbar artificial disc replacement is a standard of care for a subset of degenerative disc disease patients.

The full dataset of five-year safety and efficacy outcomes from the activL Artificial Disc IDE study are currently in submission to Spine.

About Aesculap Implant Systems, LLC
Aesculap Implant Systems, LLC, a B. Braun company, is part of a 175-year-old global organization focused on meeting the needs of the changing healthcare environment. Through close collaboration with its customers, Aesculap Implant Systems develops advanced spine and orthopaedic implant technologies to treat complex disorders of the spine, hip and knee. Aesculap Implant Systems strives to deliver products and services that improve the quality of patients’ lives. For more information, call 800-234-9179 or visit aesculapimplantsystems.com.

  1. Zigler JE, Blumenthal SL, Guyer RD, Ohnmeiss DD, Patel L. Progression of Adjacent-level Degeneration after Lumbar Total Disc Replacement: Results of a Post-hoc Analysis of Patients with Available Radiographs from a Prospective Study with 5-year Follow-up. Spine 2018: published online ahead of print, March 21, 2018.
  2. Zigler JE, Glenn J, Delamarter RB. Five-year adjacent-level degenerative changes in patients with single-level disease treated using lumbar total disc replacement with ProDisc-L versus circumferential fusion. Journal of Neurosurgery. Spine 2012;17:504-11.
  3. Aghayev E, Etter C, Barlocher C, et al. Five-year results of lumbar disc prostheses in the SWISSspine registry.
    Eur Spine J 2014;23:2114-26.
  4. Blumenthal, SL et al. Adjacent Segment Degeneration After Lumbar Total Disc Replacement: 5-Year Results of a Multicenter, Prospective, Randomized Study with Independent Radiographic Assessment. In NASS 32nd Annual Meeting Proceedings NASS, The Spine Journal 17 (2017) S111–S165.
  5. Yue JJ, Garcia R, Jr. Five-Year Results of a Randomized Controlled Trial for Lumbar Artificial
    Discs in Single-Level Degenerative Disc Disease. Spine; in submission.

SOURCE Aesculap Implant Systems, LLC

Related Links

https://www.aesculapimplantsystems.com

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Spineology U.S. Clinical Trial for Interbody Fusion

Posted On April 12, 2018 By OrthoSpineNews In Spine /  

April 12, 2018

ST. PAUL, Minn.–(BUSINESS WIRE)–Spineology Inc., an innovator in anatomy-conserving spine surgery, is excited to announce that John Chi, M.D., M.P.H, Associate Professor of Neurosurgery at Harvard Medical School and the Director of Neurosurgical Spinal Oncology at Brigham and Women’s Hospital in Boston MA, has presented the first 12-month outcomes data from Spineology’s SCOUT clinical trial. The results were presented at the recent annual meeting of the International Society for the Advancement of Spine Surgery (ISASS) in Toronto, Canada.

The SCOUT study (Spineology Clinical Outcomes Trial), conducted under an FDA-approved IDE protocol, is a prospective multicenter non-randomized performance goal investigation, designed to evaluate safety and effectiveness outcomes in instrumented lumbar interbody fusion procedures for the treatment of degenerative disc disease (DDD).

The fusion implant used in the SCOUT Study is Spineology’s porous graft containment mesh that deploys within the disc space as it is filled, permitting the packed bone graft to conform to the prepared vertebral body endplates. The system’s design allows for disc space preparation and implant placement through a small cannula.

The SCOUT trial includes 102 patients who were experiencing painful lumbar degenerative disc disease of at least six months’ duration. Patients are skeletally mature adults with single-level symptomatic lumbar DDD requiring interbody fusion. Patients have been enrolled at ten participating study sites. Dr. Chi and his co-authors reported on 84 treated subjects, with 60 completing 6-month follow-up and 29 completing 12-month follow-up. Study enrollment was completed in January of this year.

Statistically significant improvements were seen at both six months and twelve months in scores for low back pain and functional limitations, as recorded by Visual Analog Scale (VAS) and Oswestry Disability Index (ODI) respectively. At 12-month follow-up, all 29 subjects (100%) were fused, as read on CT by two independent radiologists. Twenty-seven of 29 subjects (93%) reported “Excellent” or “Good” satisfaction with their surgery. There were no serious device-related serious adverse events.

“These favorable interim results indicate the Spineology system’s potential to provide good arthrodesis and pain relief while minimizing tissue trauma,” said Dr. Chi. “We have seen shorter operating times, less blood loss, shorter hospital stays and excellent satisfaction for the patients treated in this trial.”

The list of nationwide study sites participating in the SCOUT IDE includes Brigham and Women’s Hospital, University of Vermont, the Spine Institute of Louisiana, Florida Orthopaedic Associates, and Georgetown University, among others. Details of the study may be found at the NIH clinical trials website, https://clinicaltrials.gov/ct2/show/NCT02347410?spons=spineology&rank=1.

Spineology’s OptiMesh® deployable implant received 510(k) clearance from FDA in 2003 for graft containment within the vertebral body. The SCOUT trial is designed to provide clinical data in support of a regulatory submission to FDA for expanded indications, allowing the company to market the implant to be used with bone graft and supplemental posterior fixation in support of lumbar interbody fusion for treating painful DDD.

“We are grateful to Dr. Chi and all the SCOUT investigators for their dedication in helping us to complete this important clinical trial,” said John Booth, Spineology CEO. “We look forward to completing the patient follow-up and gaining the market clearance that will allow us to market this unique fusion device to spine surgeons and their patients.”

About Spineology Inc.

Spineology Inc. provides innovative, anatomy-conserving spinal technologies for surgeons and their patients. Spineology surgical techniques conserve spinal bone, ligament and muscle tissue. Spineology is committed to increasing procedural efficiency, reducing surgical morbidity and accelerating patient recovery. Learn more at spineology.com.

Contacts

Spineology Inc.
John Booth, 651-256-8511
jbooth@spineology.com
or
Risdall
Dave Folkens, 651-286-6713
dave@risdall.com

Read More