Orthofix International Schedules Third Quarter 2016 Earnings Release and Conference Call for October 31, 2016

Posted On October 21, 2016 By OrthoSpineNews In Financial /

October 21, 2016

LEWISVILLE, Texas–(BUSINESS WIRE)–Orthofix International N.V. (NASDAQ:OFIX) (the “Company”), a diversified, global medical device company, today announced that it plans to release third quarter 2016 financial results after market close on Monday, October 31, 2016. Brad Mason, Chief Executive Officer, and Doug Rice, Chief Financial Officer, will host a conference call and webcast to review the Company’s results at 4:30 p.m. EDT the same day.

Interested parties may access the conference call by dialing (888) 576-4398 in the U.S. and (719) 457-2601 outside the U.S., and referencing the conference ID 9383336. A replay of the call will be available for two weeks by dialing (888) 203-1112 in the U.S. and (719) 457-0820 outside the U.S., and entering the conference ID 9383336. A webcast of the conference call may be accessed by going to the Company’s website at www.orthofix.com, by clicking on the Investors link and then the Events and Presentations page.

About Orthofix:

Orthofix International N.V. is a diversified, global medical device company focused on improving patients’ lives by providing superior reconstructive and regenerative orthopedic and spine solutions to physicians worldwide. Headquartered in Lewisville, Texas, the Company has four strategic business units that include BioStim, Biologics, Extremity Fixation and Spine Fixation. Orthofix products are widely distributed via the Company’s sales representatives, distributors and its subsidiaries. In addition, Orthofix is collaborating on research and development activities with leading clinical organizations such as the Musculoskeletal Transplant Foundation and the Texas Scottish Rite Hospital for Children. For more information, please visit www.orthofix.com.

Contacts

Orthofix International N.V.
Investor Contact:
Mark Quick, 214-937-2924
markquick@orthofix.com
or
Media Contact:
Denise Landry, 214-937-2529
deniselandry@orthofix.com

Global Lumbar Spine Fusion Market 2016-2020: Key Vendors are DePuy Synthes, Medtronic, NuVasive, Stryker & Zimmer Biomet – Research and Markets

Posted On October 21, 2016 By OrthoSpineNews In Financial /

October 21, 2016

DUBLIN–(BUSINESS WIRE)–Research and Markets has announced the addition of the “Global Lumbar Spine Fusion Market 2016-2020” report to their offering.

The global lumbar spine fusion market to grow at a CAGR of 4.9% during the period 2016-2020.

Spinal fusion surgery is performed in many forms, and all are designed to help limit the pain caused by joints through surgery depending on conditions such as degenerative disc disease (DDD), spondylosyndesis or spondylodesis, and other small problems caused in spine vertebrae. Spine surgery is mostly recommended by surgeons when they pinpoint the source of pain in the individual. To determine this, physicians use imaging tests such as computed tomography (CT), magnetic resonance imaging (MRI), and X-rays.

The report covers the present scenario and the growth prospects of the global lumbar spine fusion market for 2016-2020. To calculate the market size, we consider revenue generated from the sales of lumbar spine fusion devices to key customer segments such as hospitals and ambulatory surgical centers (ASCs). The report also includes a discussion of the key vendors operating in this market.

Key questions answered in this report

What will the market size be in 2020 and what will the growth rate be?
What are the key market trends?
What is driving this market?
What are the challenges to market growth?
Who are the key vendors in this market space?
What are the market opportunities and threats faced by the key vendors?
What are the strengths and weaknesses of the key vendors?

Key vendors

DePuy Synthes
Medtronic
NuVasive
Stryker
Zimmer Biomet

Other prominent vendors

Aesculap Implant Systems
Alliance Spine
Alphatech Spine
Amedica
AOI Medical
Apollo Spine
Cook Medical
Crosstrees Medical
K2M
LDR Holding
MEDICREA
NuTech Medical
Orthofix International
Paradigm Spine
RTI Surgical
Smith & Nephew
Trans1
Vexim
VTI
Zavation

Key Topics Covered:

Part 01: Executive summary

Part 02: Scope of the report

Part 03: Market research methodology

Part 04: Introduction

Part 05: Market landscape

Part 06: Market segmentation by product type

Part 07: Global lumbar spine implants and instrumentation market

Part 08: Global lumbar spine fusion biomaterials market

Part 09: Market segmentation by procedure

Part 10: Market segmentation by end-user

Part 11: Geographical segmentation

Part 12: Market drivers

Part 13: Impact of drivers

Part 14: Market challenges

Part 15: Impact of drivers and challenges

Part 16: Market trends

Part 17: Vendor landscape

Part 18: Key vendor analysis

Part 19: Appendix

For more information about this report visit http://www.researchandmarkets.com/research/d5lqqt/global_lumbar

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Related Topics: Surgical Procedures

Zimmer Biomet Expands Foot and Ankle Portfolio Through Exclusive Global Distribution Agreement with Nextremity Solutions, Inc.

Posted On October 21, 2016 By OrthoSpineNews In Financial /

WARSAW, Ind., Oct. 20, 2016 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced an exclusive agreement with Nextremity Solutions, Inc. to globally distribute the company’s foot and ankle deformity correction products. The financial terms of the transaction were not disclosed.

“We’re excited to expand the clinical capabilities of our foot and ankle portfolio with Nextremity Solutions’ deformity correction products,” said Brad Quick, General Manager of Zimmer Biomet Foot and Ankle. “The agreement helps advance our commitment to provide customers with the broadest range of cutting-edge technologies and strengthens our position in the $2 billion foot and ankle market.”

Nextremity Solutions designs and manufactures the following procedure-ready, sterile implant systems for the correction of foot and ankle pathologies, which will be globally distributed by Zimmer Biomet:

Nextra^® Hammertoe Correction System, the industry’s only adjustable two-piece hammertoe implant.
MSP™ Metatarsal Shortening System, an osteotomy guide and implant in one. The innovative design provides precision and stability for metatarsal shortening procedures.
Re+Line^® Bunion Correction System, a unique, low profile tension-band compression plate designed for performing precise, repeatable bunion correction surgery.
Arcus^TM Staple System, an arc-styled staple design that provides greater and more uniform compression than conventional staples[1].

“The agreement with Zimmer Biomet allows us to expand the reach and influence of our forefoot portfolio by leveraging the commercial capabilities of a global musculoskeletal healthcare leader,” said Rod K. Mayer, President and Chief Executive Officer of Nextremity Solutions, Inc. “Our partnership with Zimmer Biomet enables us to focus on our current strategy of working with our surgeon partners to deliver innovative solutions that help advance the standard of care in the foot and ankle market with speed, efficiency and excellence.”

About Zimmer Biomet

Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products.

We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.

We have operations in more than 25 countries around the world and sell products in more than 100 countries. For more information, visit www.zimmerbiomet.com or follow Zimmer Biomet on Twitter at www.twitter.com/zimmerbiomet.

About Nextremity Solutions

Founded in 2010, Nextremity Solutions, Inc. is a privately held medical device company offering innovative solutions and approaches to foot and ankle surgical intervention. The Company’s procedure-ready, sterile implant systems for the correction of foot and ankle pathologies include uniquely precise, proprietary technology designed to achieve repeatable and superior clinical outcomes. Nextremity Solutions, Inc. continues to develop and introduce new, innovative products to the foot and ankle market. For more information, visit nextremitysolutions.com.

Cautionary Statement Regarding Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning Zimmer Biomet’s expectations, plans, prospects, and product and service offerings, including new product launches and potential clinical successes. Such statements are based upon the current beliefs and expectations of management and are subject to significant risks and uncertainties that could cause actual outcomes and results to differ materially. For a list and description of some of such risks and uncertainties, see our periodic reports filed with the SEC. These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in Zimmer Biomet’s filings with the SEC. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be set forth in our periodic reports. Accordingly, such forward-looking statements speak only as of the date made. Readers of this news release are cautioned not to place undue reliance on these forward-looking statements, since, while management believes the assumptions on which the forward-looking statements are based are reasonable, there can be no assurance that these forward-looking statements will prove to be accurate. This cautionary statement is applicable to all forward-looking statements contained in this news release.

[1] Comparison of Compressive Force for Bone Staples, Lisa A. Ferra, Ph.D., OrthoKinetic Technologies LLC and OrthoKinetic Testing Technologies, Southport, NC. Laboratory studies are not necessarily indicative of clinical results.

345 E. Main St.
Warsaw, IN 46580
www.zimmerbiomet.com

Logo – http://photos.prnewswire.com/prnh/20150624/225371LOGO

SOURCE Zimmer Biomet Holdings, Inc.

Paradigm BioDevices, Inc. Completes 25,000th Procedure with the QuickDraw MIS Bone Harvester™ and Reports Positive Independent Clinical Findings.

Posted On October 20, 2016 By OrthoSpineNews In Spine /

October 19, 2016

ROCKLAND, Mass.–(BUSINESS WIRE)–Paradigm BioDevices, Inc. announced today that it completed its 25,000th case with its proprietary MIS bone grafting system. The QuickDraw MIS Bone Harvester is a percutaneous and/or MIS access system for obtaining autogenous iliac crest bone graft for fusion procedures.

“Cancellous autograft remains the gold standard because it contains osteoconductive architecture, osteogenic stem cells and osteoinductive signaling factors.” said Michael O’Neill, President & CEO of Paradigm. “Not all autografts or bone graft materials meet this high standard. Iliac crest graft is widely accepted as the best bone graft available for fusion and we are able to obtain it through a minimal incision which is driving our success.”

An independent study with the QuickDraw MIS Bone Harvester found that 67% of patients could not tell they had a bone graft harvest, of the remaining only 14% of those were confident. The clinicians concluded, “(we) describe a minimally-invasive procedure to harvest iliac crest bone graft. Pain at the site was either non-existent or mild enough that patients were unable to accurately define their graft site.”

Paradigm BioDevices will be launching a new single use sterile kit version of the system at the North American Spine Society next week in Boston. The company expects CE clearance later this year and will expand its marketing and distribution efforts for sale of products outside the US.

About Paradigm BioDevices
Paradigm BioDevices, Inc. is an ISO 13485-2012 certified manufacturer of minimally-invasive orthopedic and spinal instrumentation and a master US national distributor of spinal fusion technologies. The company is a Boston-based privately-held organization founded in 1997.

For more information, visit http://www.paradigmbiodevices.com.

Contacts

Paradigm BioDevices, Inc.
Mike O’Neill, +1-781-982-9950
President and CEO

Global Trauma & Extremities Market Worth USD 15.9 Billion by 2024 – Analysis, Technologies & Forecasts Report 2016-2024 – Vendors: DePuy Synthes, Stryker, Zimmer Biomet – Research and Markets

Posted On October 20, 2016 By OrthoSpineNews In Financial /

October 20, 2016

DUBLIN–(BUSINESS WIRE)–Research and Markets has announced the addition of the “Trauma And Extremities Market Analysis By Type And Segment Forecasts To 2024” report to their offering.

The global trauma and extremities market was valued at USD 8.0 billion in 2015 and is expected to reach a value of USD 15.9 billion by 2024. The expansion is attributed to the increasing geriatric population base along with the growing incidence rate of target diseases such as osteoporosis.

Introduction of new technologies in terms of material, technique, and the non-invasive nature of the employed material are augmenting the market growth. In July 2016, DePuy Synthes launched a new hand locking system used for deformities and fracture fixation. This device is designed to reduce soft tissue irritation and facilitate healing.

Moreover, companies are investing in new product development, which is anticipated to aid the future growth of the market. In 2015, Smith & Nephew invested USD 222 million on research and development, yielding a promising product pipeline for 2016. It has already launched a new product, SUTUREFIX, a suture anchor in February 2015. The product is expected to improve hip and shoulder repair by providing additional fixation points.

In 2015, North America dominated the market with a revenue share of more than 40%. The Affordable Care Act includes a separate grant for trauma care.

Companies Mentioned:

DePuy Synthes
Stryker
Zimmer Biomet
Smith & Nephew
Wright Medical Technology, Inc.
Advanced Orthopaedic Solutions
Integra LifeSciences Corporation
Acumed
Bioretec Ltd.
Cardinal Health

Report Structure:

1 Research Methodology

2 Executive Summary

3 Market Snapshot

4 Market Variables, Trends& Scope

5 Market Categorization 1: Type Estimates & Trend Analysis

6 Market Categorization 2: Regional Estimates & Trend Analysis, by Type

7 Competitive Landscape

For more information about this report visit http://www.researchandmarkets.com/research/3d2rtw/trauma_and

Contacts

Titan Spine Expands Sales Force to Meet Growing Demand, Support Recent Full Launch of its New nanoLOCK® Surface Technology

Posted On October 20, 2016 By OrthoSpineNews In Spine /

October 20, 2016

MEQUON, Wis.–(BUSINESS WIRE)–Titan Spine, a medical device surface technology company focused on developing innovative spinal interbody fusion implants, today announced that it has doubled its sales management team with the addition of nine new members to meet the growing demand for its Endoskeleton® line of titanium interbody fusion devices and to support the recent full launch of its next-generation nanoLOCK^® surface technology.

Steve Cichy, Vice President of Sales for Titan Spine, commented, “The addition of nine new sales managers, all of which bring a tremendous amount of spine sales experience and success, was required to meet accelerating demand for our surface technology offerings. They will play a critical role in working closely with our distribution network partners across the United States to further drive surgeon adoption, to support the recent full launch of nanoLOCK^®, and to capitalize on the dramatically increased access to surgeons and hospital systems our recently-awarded Section X new technology code from CMS affords us. Our sales expansion initiative is ongoing and is made possible, in large part, from proceeds from our recent substantial round of financing with investor Southlake Equity Group.”

Titan Spine offers a full line of Endoskeleton® devices that feature Titan Spine’s proprietary nanoLOCK^® surface technology, consisting of a unique combination of roughened topographies at the macro, micro, and nano levels (MMN™). This unique combination of surface topographies is designed to create an optimal host-bone response and actively participate in the fusion process by promoting the upregulation of osteogenic and angiogenic factors necessary for bone growth, encouraging natural production of bone morphogenetic proteins (BMPs), downregulating inflammatory factors, and creating the potential for a faster and more robust fusion.^1,2 All Endoskeleton® devices are covered by the company’s risk share warranty.

About Titan Spine

Titan Spine, LLC is a surface technology company focused on the design and manufacture of interbody fusion devices for the spine. The company is committed to advancing the science of surface engineering to enhance the treatment of various pathologies of the spine that require fusion. Titan Spine, located in Mequon, Wisconsin and Laichingen, Germany, markets a full line of Endoskeleton® interbody devices featuring its proprietary roughened surfaces in the U.S. and portions of Europe through its sales force and a network of independent distributors. To learn more, visit www.titanspine.com.

¹Olivares-Navarrete, R., Hyzy S.L., Gittens, R.A., Berg, M.E., Schneider, J.M., Hotchkiss, K., Schwartz, Z., Boyan, B. D. Osteoblast lineage cells can discriminate microscale topographic features on titanium-aluminum-vanadium surfaces. Ann Biomed Eng. 2014 Dec; 42 (12): 2551-61.

²Olivares-Navarrete, R., Hyzy, S.L., Slosar, P.J., Schneider, J.M., Schwartz, Z., and Boyan, B.D. (2015). Implant materials generate different peri-implant inflammatory factors: PEEK promotes fibrosis and micro-textured titanium promotes osteogenic factors. Spine, Volume 40, Issue 6, 399–404.

Contacts

Titan Spine
Steve Cichy, 866-822-7800
ashepherd@titanspine.com
or
Media
The Ruth Group
Kirsten Thomas, 508-280-6592
kthomas@theruthgroup.com

Benvenue Medical’s Luna 3D Interbody Fusion System to Be Featured in Technology Innovation Session at NASS 2016

Posted On October 20, 2016 By OrthoSpineNews In Spine /

October 20, 2016

SANTA CLARA, Calif.–(BUSINESS WIRE)–Benvenue Medical, Inc., a developer of minimally invasive solutions for spine repair, today announced key presentations and company events featuring the Luna^® 3D Multi-Expandable Interbody Fusion System and Kiva^® VCF Treatment System at the North American Spine Society (NASS) 31^st Annual Meeting taking place Oct. 26-29 in Boston.

Benvenue is one of eight companies selected to present in the Innovative Technology Presentations Session. Dr. Jeffrey Coe of the Silicon Valley Spine Institute (Campbell, California) will provide an overview of the Luna 3D system and discuss early clinical results in the presentation, “Multiexpandable Cage for Minimally Invasive Posterior Lumbar Interbody Fusion,” on Oct. 26 at 8:30 a.m. in room 209.

“The Luna 3D System further advances minimally invasive lumbar fusion surgical techniques,” said Dr. Coe. “An important advantage of Luna’s multi-expandable cage for fusion is that it allows us to restore disc height using a well-established posterior surgical approach while providing stable fixation via a larger construct that is more often achieved using an anterior approach. Early experience with the Luna interbody cage is demonstrating encouraging outcomes, including restoration of disc height, segmental lordosis and foraminal height, along with lack of subsidence and maintenance of sagittal correction. Importantly, these results are being achieved without nerve retraction injuries, which are which are a risk of posterior lumbar fusion.”

Data Presentations

“Incidence of Serious Adverse Events Associated with Readmissions after Vertebral Augmentation Using an Expandable Implant: Follow-Up Analysis of KAST” (presentation #10) will be presented by Dr. Douglas Beall of Clinical Radiology of Oklahoma (Edmond, Oklahoma) on Oct. 26 at 10:47 a.m. in room 205A. The podium presentation will review serious adverse events requiring unplanned re-admission for patients who had vertebral augmentation using the Kiva VCF Treatment System as compared to balloon kyphoplasty.
“Community Practice Experience with Subsequent Vertebral Compression Fractures During the Year after Vertebral Augmentation Using an Expandable Implant” (presentation #88) will be presented by Dr. Arthur McCain of Vascular and Interventional Radiology Associates of Central Georgia (Macon, Georgia) on Oct. 27 at 3:10 p.m. in The Learning Place, Green Theater Technical Exhibition, booth #1900. The poster reviews the rate of subsequent vertebral compression fractures in the year following vertebral augmentation with the Kiva VCF Treatment System.
“Biomechanics of Expandable Lumbar Interbody Fusion Cage Deployed Through Transforaminal Approach” (ePoster #11) will be moderated by Dr. Avinash Patwardhan of Loyola University Medical Center Department of Orthopaedic Surgery (Maywood, Illinois). The poster highlights a novel posterior minimally invasive approach to safely access the lumbar disc without intrusion into the spinal canal by use of the Luna 3D interbody cage to restore disc height as a means to achieve indirect canal and foraminal decompression.

Benvenue is exhibiting at booth #1451, where it is hosting “Meet the Experts” sessions throughout the day on Oct. 26 and Oct. 27. The company is also sponsoring the following product demonstration labs in The Learning Place on the Convention Floor:

“Luna 3D, the MULTI-Expandable Interbody Implant” on Oct. 26 at 2 p.m.
“Luna 3D Expandable Interbody Fusion System Surgeon Training Lab” on Oct. 27 at 5 p.m.

About the Luna 3D Interbody Fusion System

The Luna 3D Interbody Fusion System is designed to provide one of the largest yet least invasive devices for posterior lumbar interbody spinal fusion. Cleared by the U.S. Food and Drug Administration in November 2014, the Luna 3D System is comprised of a PEEK implant designed to expand in multiple dimensions within the disc space, first in footprint and secondarily in height, allowing surgeons to effectively restore height via a posterior approach while providing the stability of a larger construct more often associated with an anterior approach. After a discectomy is performed, the Luna 3D Implant is delivered through a small diameter cannula into the disc space. After expanding its footprint, it is then expanded in height with the insertion of a middle section. When the cannula is removed, bone graft is placed in the middle of the implant and the implant is locked in place with a locking wire.

About the Kiva VCF Treatment System

The Kiva VCF Treatment System provides a new implant-based approach to vertebral augmentation in the treatment of painful VCFs. Kiva was recently launched in the U.S. and it is commercially available in Europe. Kiva has been shown, in at least three comparative studies with a total of more than 500 patients, to meet or exceed the performance of balloon kyphoplasty, the standard of care. Kiva is indicated for the reduction and treatment of spine fractures in the thoracic and/or lumbar spine from T6-L5. It is intended to be used in combination with the Benvenue Vertebral Augmentation Cement Kit.

About Benvenue Medical, Inc.

Founded in 2004, Benvenue Medical, Inc. provides next generation minimally invasive systems for spine repair that combine expandable implants with novel delivery instruments to provide enduring functional benefits for patients. The company is privately held and funded by DeNovo Ventures, Domain Associates, Esquilime Partners, InterWest Partners, Technology Partners and Versant Ventures. Its first products are designed for the treatment of vertebral compression fractures and degenerative disc disease, which have combined revenues of $9 billion globally. For more information, visit www.benvenuemedical.com.

Contacts

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

Amendia Partners with Global Spine Outreach

Posted On October 20, 2016 By OrthoSpineNews In Spine /

MARIETTA, GA (PRWEB) OCTOBER 19, 2016

Leading provider of innovative medical devices Amendia, Inc. is pleased to announce its partnership with and support of Global Spine Outreach (“GSO”), a charitable organization dedicated to establishing first-rate scoliosis treatment centers worldwide. Amendia is the primary industry sponsor of the Third Annual Spinal Deformity Symposium, to be held October 22, 2016 in Mexico City.

The symposium unites scoliosis experts and interested attendees in a combination of case presentations and workshops designed to improve and expand care to scoliosis patients. The symposium is followed by a fundraising reception to help improve the lives of children with complex spinal deformities around the world.

According to GSO’s figures, scoliosis afflicts nearly 200 million people worldwide. Over 60 million of those individuals, including children, are unable to receive treatment due to lack of access to basic surgical care. If left untreated, severe scoliosis can lead to chronic pain, difficulty breathing, paralysis, and early death. In order to improve the quality of care and availability of first-rate treatment, GSO focuses on spinal surgery education.

“At Amendia, we are committed to the continuous development of surgeon skills to treat scoliosis,” said Chris Fair, Amendia’s President and CEO. “Through our partnership with Global Spine Outreach, we are honored to play a role in surgeon training and improved patient outcomes for such a serious spine condition.”

“Through graduated, long-term educational models, GSO empowers surgeons to safely treat the most complex scoliosis cases,” said Lawrence G. Lenke, M.D., orthopaedic spine surgeon, GSO Board Member, and Surgeon-in-Chief at the Spine Hospital at New York Presbyterian/Allen. “The training is equally valuable to volunteer surgeons from the USA and abroad who can bring their experience back to their hospitals and patients.”

About Global Spine Outreach

Global Spine Outreach is a 501(c)(3) nonprofit organization providing medical treatment to children suffering from the effects of spinal deformities worldwide without charge to the patient or their families. GSO physicians are 100% volunteers, and all donations go directly to providing and improving the care of children with spinal deformities.

About Amendia

Headquartered in a state-of-the-art manufacturing facility in Marietta, Georgia, Amendia is a leading designer, developer, manufacturer, and marketer of medical devices used in spinal surgical procedures. Amendia’s mission is to exceed surgeon and patient expectations by creating balanced solutions with disruptive technologies for medical devices paired with biologics and instrumentation. Amendia’s vertically-integrated strategy focuses on improving surgical outcomes and the lives of patients with spinal disorders. For more information, please visit http://www.amendia.com.

Johnson & Johnson Innovation Announces New Collaboration with Texas Medical Center to Spur Development of Breakthrough Medical Device Technologies

Posted On October 20, 2016 By OrthoSpineNews In Financial /

HOUSTON, Oct. 18, 2016 /PRNewswire/ — Johnson & Johnson Innovation LLC (JJI) today announced the creation of the Center for Device Innovation at Texas Medical Center (CDI @ TMC), a broad, new collaboration between JJI and TMC that aims to accelerate end-to-end development of breakthrough medical devices. This expands on JJI’s collaboration with TMC established earlier this year with the opening of JLABS @ TMC, combining the resources of the world’s largest medical complex with the capabilities of the Johnson & Johnson Medical Devices Companies*, to advance the health and well-being of people around the globe.

William E. “Billy” Cohn, M.D., an internationally renowned cardiac surgeon and serial medical device entrepreneur will lead the CDI @ TMC. Dr. Cohn recently joined the Johnson & Johnson Medical Devices Companies from the Baylor College of Medicine and the Texas Heart Institute (THI), where he was the Director of THI’s Center for Technology and Innovation and the Cullen Cardiovascular Research Laboratory. In his role as Director of the CDI @ TMC, Dr. Cohn will work on cutting-edge internal research and development projects for the Johnson & Johnson Medical Devices Companies and with external entrepreneurs and innovators.

“By creating a nexus for innovation, where scientists and engineers of the Johnson & Johnson Family of Companies can collaborate with academicians, expert clinicians, and external entrepreneurs to leverage the unique size, scope, and capabilities of TMC’s member institutions, we are confident that we can dramatically enhance health care around the world,” said Paul Stoffels, Chief Scientific Officer of Johnson & Johnson.

The CDI @ TMC will include multiple components that will accelerate the development of new medical technologies from concept through commercialization, including a new medical device engineering studio housed at the TMC Innovation Institute. This state-of-the-art “maker space” will be home to R&D staff of the Johnson & Johnson Medical Devices Companies and will be used to accelerate both select internal projects and strategically aligned ventures of JJI partner companies. The facility will allow rapid prototyping and “fast failure” for early and mid-stage development. Through a series of collaborative agreements, the CDI @ TMC will also have broad access to the preclinical facilities of Baylor College of Medicine, Houston Methodist Research Institute, and THI that will permit the testing of novel devices for any organ system or disease-based application.

“We are eager for the opportunity to expand our collaboration with Johnson & Johnson Innovation,” said Robert C. Robbins, M.D., President and CEO, TMC. “Working together, we are creating a globally competitive innovation ecosystem here, and the new Center for Device Innovation @ TMC will enable us to expeditiously bring discovery and innovation to fruition, directly improving the health of patients.”

In addition to investing in a world-class innovation facility, JJI’s partnership is expanding innovation collaborations among several TMC member institutions. The alliance with Baylor College of Medicine will foster scientific discovery and promote the commercialization of medical devices using an open innovation model. The collaboration with Houston Methodist Research Institute will facilitate translational research activities in the anticipation of rapidly moving into human clinical trials. To this end, R&D staff and JJI partner companies will also have the use of the Methodist Institute for Technology, Innovation, and Education (MITIE^SM), a virtual hospital and hands-on clinical training facility, which develops strategies to optimize the introduction of novel device technologies into clinical practice. The relationship with Texas Heart Institute will deepen the scope of research currently devoted to surgical medical devices used to treat patients, helping to make more options commercially available. JJI will join forces with the TMC Clinical Trials Institute to develop and test new paradigms for accelerated medical device clinical trials. Lastly, the CDI @ TMC will have an affiliation with TMC Biodesign, a one-year innovation fellowship program, where Dr. Cohn will continue in his role as a faculty member.

* Comprising the surgery, orthopaedics, and cardiovascular businesses within Johnson & Johnson’s Medical Devices segment.

About Johnson & Johnson Innovation LLC

Johnson & Johnson Innovation LLC focuses on accelerating all stages of innovation worldwide and forming collaborations between entrepreneurs and Johnson & Johnson’s global healthcare businesses. Johnson & Johnson Innovation LLC provides scientists, entrepreneurs and emerging companies with one-stop access to science and technology experts who can facilitate collaborations across the pharmaceutical, medical devices and consumer companies of Johnson & Johnson. Under the Johnson & Johnson Innovation umbrella of businesses, we connect with innovators through our regional Innovation Centers, JLABS, JLINX, Johnson & Johnson Innovation – JJDC, Inc. and our Business Development teams to create customized deals and novel collaborations that speed development of innovations to solve unmet needs for patients. For more information please visit: www.jnjinnovation.com.

Cautions Concerning Forward-Looking Statements

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 related to a new collaboration and product research and development. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson Innovation, LLC, the 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; challenges inherent in new product research and development, including the uncertainty of clinical success and obtaining regulatory approvals; competition, including technological advances, new products and patents attained by competitors; uncertainty of commercial success for new products; the ability of the company to successfully execute strategic plans; impact of business combinations and divestitures; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; and global health care reforms and trends toward health care cost containment. A further list and description 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 January 3, 2016, including in Exhibit 99 thereto, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov,www.jnj.com or on request from Johnson & Johnson. Johnson & Johnson Innovation, LLC, the Johnson & Johnson Medical Devices Companies and Johnson & Johnson do not undertake to update any forward-looking statement as a result of new information or future events or developments.

Media Contact
Ryan Flinn
Johnson & Johnson Innovation
+1 510-207-7616
rflinn1@its.jnj.com

Stryker Spine to demonstrate its 3D printed Tritanium® Posterior Lumbar Cage at NASS 2016

Posted On October 20, 2016 By OrthoSpineNews In Spine /

Allendale, N.J.—Oct. 20, 2016—Stryker’s Spine division will demonstrate its 3D-printed Tritanium Posterior Lumbar (PL) Cage, an interbody fusion device designed to aid in lumbar spinal fixation for patients with degenerative disc disease, including up to Grade 1 spondylolisthesis, and degenerative scoliosis, at the North American Spine Society (NASS) Annual Meeting, Oct. 26-29, 2016, in Boston (booth No. 1415).

As part of the exhibit, Stryker’s proprietary Tritanium In-Growth Technology will be featured in a virtual reality “tour,” providing surgeons with a unique perspective on how 3D printing, also known as additive manufacturing, allows Stryker to produce highly porous implants that would be difficult or impossible to create using traditional manufacturing techniques.

Stryker’s Tritanium Technology, which reflects years of extensive research and development, allows for the creation of porous structures designed to mimic cancellous bone, a type of spongy bone tissue, with the goal of bone in-growth.¹

“We are excited to showcase the Tritanium PL Cage and unveil our new 3D virtual reality experience to surgeons during the NASS conference,” said Bradley Paddock, president of Stryker’s Spine division. “Oculus headsets will take surgeons on a journey through the evolution of Stryker’s pioneering additive manufacturing technology. They will then ‘travel’ to Stryker’s state-of-the-art additive manufacturing facility in Ireland for an up-close view of Tritanium and explore how our highly porous Tritanium implants may benefit their patients.”

Also at NASS, results will be presented from a pre-clinical animal study, titled, “Biomechanical and Histologic Comparison of a Novel 3D-Printed Porous Titanium Interbody Cage to PEEK,” that evaluated the biomechanical performance and bone in-growth potential of various lumbar interbody fusion implants utilizing different materials, including the Tritanium PL Cage.

The Tritanium Posterior Lumbar Cage features fully interconnected pores that span endplate to endplate. It is available in a variety of widths, lengths, heights, and lordotic angles that can adapt to a variety of patient anatomies. Its large lateral windows and open architecture allow visualization of fusion on CT and X-ray,² and its solid-tipped, precisely angled serrations are designed to allow for bidirectional fixation and to maximize surface area for endplate contact with the cage.

About Stryker
Stryker is one of the world’s leading medical technology companies and, together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. Stryker is active in over 100 countries around the world. Please contact us for more information at www.stryker.com.

Media Contact
Barbara Sullivan, Sullivan & Associates
bsullivan@sullivanpr.com, 714/374-6174

Editor’s note: For images, video footage, or animation of the Tritanium PL Cage and Stryker’s 3D additive manufacturing process, contact Barbara Sullivan at 714/374-6174 or bsullivan@sullivanpr.com. A media backgrounder about Tritanium and the Tritanium PL Cage also is available at www.stryker.com/builttofuse.

References

Karageorgiou V, Kaplan D. (2005) Porosity of 3D biomaterial scaffolds and osteogenesis. Biomaterials, 26, 5474-5491.
Abbushi A, Cabraja M, Ulrich-Wilhelm T, Woiciechowsky C, Kroppenstedt S. The influence of cage positioning and cage type on cage migration and fusion rates in patients with monosegmental posterior lumbar interbody fusion and posterior fixation. Eur Spine J. 2009;18: 1621–1628.

Content ID TRITA-PR-5_11874

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