Boston Scientific Announces Positive Results from WHISPER Spinal Cord Stimulation Study

MARLBOROUGH, Mass.Jan. 12, 2018 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) today announced positive results from the WHISPER randomized controlled trial (RCT). The data, presented at the 2018 Annual Meeting of the North American Neuromodulation Society in Las Vegas, demonstrated that patients who are given the choice to use both sub-perception and paresthesia-based spinal cord stimulation (SCS) therapy achieve superior outcomes in comparison to patients who have only one SCS therapeutic option.

SCS works by sending low electrical pulses, which vary in frequency, pulse width and amplitude, to the spinal cord to interrupt pain signals and provide pain relief. Paresthesia-based therapy provides pain relief with a light tingling sensation while sub-perception therapy works without that sensation. The WHISPER RCT is a multi-center, prospective, cross-over, randomized, and controlled study that evaluated the long-term safety and effectiveness of sub-perception SCS therapy. Participants had been implanted with an SCS system for an average of four years at the beginning of the study and were treated with both paresthesia and sub-perception therapy.

“The WHISPER RCT evaluated both patients who had successfully controlled their pain using SCS and those who could benefit from additional options and optimization of their therapy,” said James North, M.D., Carolinas Pain Institute, and coordinating principal investigator of the WHISPER RCT. “This study provides data on people who have suffered with chronic pain for years and who pose some of the biggest challenges in the long-term use of SCS. The results demonstrated that giving patients the choice to use sub-perception or paresthesia-based therapy provides superior patient outcomes and affirms that SCS is a clinically valuable treatment option.”

Based on data from cohorts of 70 and 55 subjects who chose sub-perception therapy for long-term follow-up, the WHISPER RCT demonstrated that:

  • If patients are able to choose between the SCS therapy that provides the most effective pain relief, the number of subjects whose pain was effectively controlled by SCS increased by 62 percent;
  • 57 percent of patients in a study cohort preferred having the option of both sub-perception and paresthesia-based therapy;
  • Subjects whose pain was managed by paresthesia-based therapy during the randomized phase had an average reduction in baseline pain scores from 7.2 to 2.5, if they were able to choose between the SCS therapy that provided the most effective relief; and
  • At 12 months, pain scores for subjects who preferred sub-perception therapy decreased on average from 7.1 to 3.8 and 89 percent rated their condition better or a great deal better; these subjects had an SCS implant for an average of five years.

The study expands on research from the PROCO RCT (Evaluation of Stimulation Pulse Rate on Clinical Outcomes in Patients Whose Pain is Controlled by 10 kHz Frequency) which established in de novo patients that similar pain relief and improvement in quality of life measures are experienced independent of the type of frequency (from 1 kHz up to 10 kHz) used in sub-perception SCS therapy when the proper target and dose are identified.

“This rigorous, carefully conducted trial underscores the importance of providing patients with multiple therapeutic options for the relief of chronic pain in one SCS system that can help address their complex needs,” said Maulik Nanavaty, president and senior vice president, Neuromodulation, Boston Scientific. “We are dedicated to improving the lives of patients with industry-leading neuromodulation technology designed for long-lasting relief.”

The WHISPER RCT results follow the recent launch of the Boston Scientific Spectra WaveWriterTM SCS System, which offers patients the ability to simultaneously use sub-perception and paresthesia-based therapies.

INVESTOR UPDATE
The company will also host an investor event and webcast on January 12 from 1:00-2:00 PM PST to provide a presentation and answer questions from investors about the Boston Scientific Neuromodulation portfolio. The event will be accessible via live webcast at www.bostonscientific.com/investors. A replay of the webcast will be accessible at http://www.bostonscientific.com/investors beginning approximately one hour following the completion of the event.

About Boston Scientific
Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 35 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, visit www.bostonscientific.com and connect on Twitter and Facebook.

Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements may be identified by words like “anticipate,” “expect,” “project,” “believe,” “plan,” “estimate,” “intend” and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, statements regarding our product launches and product performance and impact. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements.

Factors that may cause such differences include, among other things: future economic, competitive, reimbursement and regulatory conditions; new product introductions; demographic trends; the closing and integration of acquisitions; intellectual property; litigation; financial market conditions; and future business decisions made by us and our competitors. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A – Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A – Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file hereafter. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. This cautionary statement is applicable to all forward-looking statements contained in this document.

CONTACTS
Media:
Catherine Brady
Media Relations
508-683-4797
Catherine.Brady@bsci.com

Investors:
Susie Lisa, CFA
508-683-5565 (office)
Investor Relations
Boston Scientific Corporation
investor_relations@bsci.com

SOURCE Boston Scientific Corporation

Related Links

http://www.bostonscientific.com

4WEB Medical Announces Record Sales Growth in 2017

DALLASJan. 10, 2018 /PRNewswire/ — 4WEB Medical, the industry leader in 3D printed implant technology, announced today that the company posted 57% year-over-year growth for the 2017 fiscal year.  In addition, 4WEB’s fourth quarter results eclipsed the largest quarter in the company’s history for revenue, units sold, surgeon users, and case volume.  This achievement marks an impressive performance trend of seven quarters of consecutive growth.

“4WEB continues to drive growth with portfolio enhancements and new surgeon adoption of its truss implant technology.  In 2017 we achieved an 84% increase in surgeon users with over 300 surgeons having used our implants nationwide,” said Geoffrey Bigos, 4WEB Medical’s Vice President of Spine Sales.  “This accomplishment was attributed to an expansion of our sales management team, the growth of our existing product offering, and significant investments in new product development.”

4WEB expects sustained growth in 2018 through continued adoption of its most recent product launches – a line of Hyperlordotic ALIF Implants and the Lateral Spine Truss System.  The company plans to further accelerate its commercial expansion strategy with two additional product launches this year, building upon the most comprehensive 3D printed implant portfolio on the market today. These high-impact product launches will include cervical and anterior lumbar implants with integrated fixation.

4WEB’s proprietary truss implant technology is an open architecture scaffold that uses the mechanics of the design to stimulate an osteogenic response in adjacent cellular material. The additive manufacturing process used to produce the proprietary implant line creates a hierarchical surface roughness that improves initial fixation, provides a stable environment for bone growth, and contributes to the osteogenic nature of the implant design.

Jim Bruty, 4WEB Medical’s Senior Vice President of Sales & Marketing added, “It is imperative to innovate products that solve clinical problems for surgeons and patients.  The advantages that the company’s truss implants provide, compared to the antiquated annular implant designs offered by our competitors, has been a driving factor in increased surgeon adoption and 4WEB’s 2017 growth.”

4WEB Medical is an implant device company founded in 2008 in Dallas, Texas. Thirty years of research in topological dimension theory led to the discovery of a novel geometry, the 4WEB, that can be used as a building block to create high-strength, lightweight web structures. The company leveraged this breakthrough along with cutting-edge 3D printing technology to develop 4WEB Medical’s proprietary truss implant platform. The 4WEB Medical product portfolio for spine includes the Cervical Spine Truss System, the Anterior Spine Truss System, the Posterior Spine Truss System, and the Lateral Spine Truss System. 4WEB is actively developing truss implant designs for knee, hip, trauma and patient specific orthopedic procedures.

For more information about 4WEB Medical, 4WEB’s Truss Implant Technology, and the Spine Truss Systems, please visit www.4WEBMedical.com.

SOURCE 4WEB Medical

Related Links

http://www.4webmedical.com

New Kleiner Spine Graft Delivery Tool Improves Outcomes for Patients, Surgeons, Hospitals and Payers

DENVERJan. 10, 2018 /PRNewswire/ — Kleiner Device Labs today announced full commercial availability of a new spinal bone graft delivery tool, the KG® 1, featuring a patented design that facilitates less-invasive procedures and has been proven in clinical testing to reduce spinal fusion failure rates by 68%1.

“In my own surgical practice, I was frustrated by unacceptable failure rates in spinal fusions and bad outcomes for my patients that were driven by existing graft delivery tools that jam, don’t distribute graft material to the right locations or quantity, or required excessive manipulation that creates soft tissue inflammation or damage. The round, end dispensing tools left me frustrated and with ‘am I done yet?’ questions,” said Jeff Kleiner, M.D., founder and CEO of Kleiner Device Labs.

“In testing, we found that the KG 1’s design solves all these problems, and use of the new tool, alone, improved my spinal arthrodesis rate from 75% to 92%1,” added Kleiner.

The benefits for patients include higher success rates and far fewer remedial second surgeries, less post-operative pain and infection risk, and less use of bone morphogenetic protein (BMP).

For surgeons, the KG 1 facilitates less-invasive procedures, faster surgeries, and reduces frustrations and guesswork in the OR.

Michael J. Rauzzino, M.D., of Front Range Spine and Neurosurgery in Denver, added, “I have found that I have been able to get a great deal more graft material into the disc space in a much more quantifiable and rapid fashion.  The delivery device has been very simple and easy to use and I have used it for both minimally invasive as well as in open applications.  It has been particularly helpful for me in the minimally invasive fusions we do, greatly increasing the amount of bone graft material that I have been able to get into the interspace.  I have also found it extremely helpful for our minimally invasive lateral approaches to the spine where due to the depth of the wound and the anatomy, it was difficult to get a good deal of bone graft into the interspace.”

Srdjan Mirkovic, M.D. of NorthShore Orthopaedic Institute in Chicago added, “Over the last five months in my T-lif and L-Lif operations, I have been able to expedite bone graft insertion for these procedures and avoid the problems that I encountered with round, end-dispensing bone funnels including cannula tip visualization, jamming, injury to the bony end plates of the disk space and failure to distribute bone graft in the disk space. I found that I was able to introduce more scaffold and cells and still have room for my fusion cage.  It has decreased my operating time, eliminated the frustration and challenge of interbody grafting and improved my early fusion results without using BMP.  It has worked well with all of the flowable graft extender and ground autograft that I have used.”

For hospitals and payers, facilitating surgeons’ use of the KG 1 can reduce the costs of spinal fusion surgery through reducing the number of remedial procedures, higher OR throughput and reduced use of BMP.

The patented KG 1 graft delivery tool includes a cannula, plunger and detachable funnel, which facilitates easier loading of graft material.  The KG 1’s unique shape allows easier entry into the disk interspace, minimizing soft tissue damage or irritation.  The bi-portal design ejects graft material to fill both sides of the disk space while leaving a central void for insertion of a fusion cage.  The KG 1 is disposable, guaranteeing sterility of the instrument and eliminating the system costs of cleaning and restocking.  Made of Lexan®, the KG 1 has been strength tested and proven beyond normal surgical applications.

The KG 1 is available commercially from the company and through authorized distributors, as well as to Veterans Administration and military healthcare facilities on the GSA schedule through Government Marketing & Procurement.

For KG 1 technical specifications, instructions for use, or clinical efficacy information, please go to the company’s web site.

Images of the KG 1 are available on Flikr,  here.

About Kleiner Device Labs
Kleiner Device Labs is creating new tools and devices to advance minimally invasive spine surgery and improve outcomes and costs for patients, surgeons, hospitals and payers.  Kleiner Device Labs is headquartered in Incline Village, California.  More information is available on the company’s web site at http://www.kleinerlabs.com/.

Lexan is a registered trademark of Sabic Global Technologies B.V.
KG is a registered trademark of Kleiner Device Labs/Spinal Surgical Strategies

1Kleiner, et. al., Med Devices and Tech, 2016

Media and Investor Contact:
Brad Samson
Kleiner Device Labs
brad.samson@kleinerlabs.com                                 
714.955.3951

 

SOURCE Kleiner Device Labs

Related Links

http://www.kleinerlabs.com/

Spine Industry Veteran Paul Graveline Joins Spinal Elements

January 10, 2018

CARLSBAD, Calif.–(BUSINESS WIRE)–Leading spinal solutions provider Spinal Elements today announced that Paul Graveline has joined the company as its Executive Vice President and Chief Commercial Officer. In his new role, Mr. Graveline will have responsibility for all of the commercial efforts of Spinal Elements.

“Paul is very well known in our industry and has a tremendous depth of experience in building and leading organizations,” said Jason Blain, President and CEO of Spinal Elements. “His leadership and experience will be an invaluable addition to our efforts as Spinal Elements continues to grow both in the United States and abroad. We are all very excited to have Paul on the Spinal Elements team.”

Mr. Graveline brings more than 20 years of experience in surgical spine technology. His past positions include Global Vice President of Sales for Zimmer Biomet Spine, Chief Operating Officer for Zimmer Spine, and Vice President of Sales for Stryker Spine.

“This is a talented group of people and the quality of the products is tremendous. With new expandable technologies, an interspinous process device, and a differentiated lateral access platform all launching this year, this is an exciting time to join Spinal Elements,” said Graveline, adding, “The technology we have available today combined with what is in our development pipeline makes this an amazing opportunity to create something special in our industry.”

About Spinal Elements

Spinal Elements is an outcomes-driven spinal surgical solutions company with locations in Carlsbad, CA and Marietta, GA. A leading designer, developer, manufacturer and marketer of innovative medical devices used in spinal surgical procedures, our mission is to combine leading medical device technologies, biologics and instrumentation to create positive surgical outcomes that exceed surgeon and patient expectations. For more information, please visit www.amendia.com or www.spinalelements.com.

Contacts

for Spinal Elements
Laura Charlton (formerly Johnson)
(760) 450-7749 cell
laurajohnsonpr@yahoo.com

 

(Photo: Business Wire)

 

Spine Surgery Products Market to Reach USD $16.7 Billion by 2025, Globally: Transparency Market Research

ALBANY, New YorkJanuary 9, 2018 /PRNewswire/ —

The global Market for Spine Surgery Product was valued at USD 10.2 billion in 2016 and is estimated to reach USD 16.7 billion by 2025 at a CAGR of 5.8% from 2017 to 2025.

Spinal fusion products are used in spinal fusion surgery. The products are involved in removing the damaged disc and replacing it with any fusion products. Non-fusion products are used during spine surgery, which are implanted to treat spine conditions. This also allows the patient to retain its movement and flexibility. The non-fusion products are becoming the treatment of choice, especially for the younger, more active patient. Increase in number of spine surgeries, rise in use of bone grafts and bone morphogenetic proteins in spinal fusion surgery, growing number of spinal surgeries using electrical stimulation devices such as inductive coupling devices, captive coupling devices and other implants drives the market growth rate by 2025.

View Report Preview at https://www.transparencymarketresearch.com/spine-surgery-products-market.html

The global spine surgery product market is categorized based on product, application, and by end user. Based on product, the markets are further classified into fusion products {cervical fusion, interbody fusion, spinal fixation, minimally invasive surgical (MIS) devices, spine biologics (demineralized bone matrix, synthetic bone graft substitutes)}; non fusion products (motion preservation, spine stimulators, and vertebral compression fracture (VCF) devices). Fusion product was a major product of segment in the spine surgery product market, which is attributed to treatment in cervical and lumbar surgery. Increase in production of regenerative healing products by companies expands its presence in spinal surgery, orthopedic trauma and dental treatments which is likely to boost the segment growth during forecast period. Commercialization of minimal invasive surgery devices in Asia Pacific countries is likely to boost the fusion product segment growth in the near future. Minimally invasive surgery devices is widely used for spine surgeries as the devices are less expensive and factors such as quicker recovery after surgery, less post-operative pain, and smaller incisions makes minimally invasive surgery as an attractive option among patients and is likely to boost the growth rate of the segment by 2025.

Request to View Sample of Report – https://www.transparencymarketresearch.com/sample/sample.php?flag=S&rep_id=37748

Based on application, the market is segmented into vertebral fracture repair, spinal fusion, and others. Vertebral fracture repair segment is accounted to hold the largest market share in 2016, due to increase in number of spine surgeries, number of incidence of vertebral fractures, spondylitis, motor vehicle collisions, etc. is expected to drive the segment growth. Demand for spinal fusion in emerging markets such as Asia Pacific and Latin America is projected to propel the segment growth rate between 2017 and 2025. The spinal fusion segment is likely to account for second highest share by 2025 due to rise in spinal surgeries for tumors, disc degenerative problems, scoliosis, fractures, etc. According to Journal of Spine, 2017, about 75% of cases of spinal stenosis occur in the low back (lumbar spine). This causes pressure on the spinal cord and nerves; however, increasing adoption of spine biologics products, fixation devices and other use of MIS devices are likely to expand the segment growth rate and market attractiveness from 2017 to 2025. By end user, the market are further segmented into hospitals, ambulatory surgical centers, and others. The hospitals segment dominated the spine surgery product market in 2016, and is expected to continue to dominate the market by 2025.

Download PDF Brochure of Report: https://www.transparencymarketresearch.com/sample/sample.php?flag=B&rep_id=37748

Increasing investments of manufacturers on the development of new spine products for spine surgery and demands for physicians for robotic system, are the drivers responsible for the remarkable market growth of the segment. Furthermore, product availability, storage capability, reimbursement of treatment cost, and increase in the number of hospitals are expected to propel the segment during the forecast period.

The major players in the spine surgery product are – Stryker, Medtronic, Zimmer Biomet, Globus Medical, K2M, NuVasive, Aesculap Implant Systems, LLC (B. Braun Company), RTI Surgical, Inc., Alphatec Holdings, Inc., Orthofix International N.V., DePuy Synthes, and others

Buy Spine Surgery Products Market Research Report: https://www.transparencymarketresearch.com/checkout.php?rep_id=37748&ltype=S

About TMR

Transparency Market Research (TMR) is a global market intelligence company providing business information reports and services. The company’s exclusive blend of quantitative forecasting and trend analysis provides forward-looking insight for thousands of decision makers. TMR’s experienced team of analysts, researchers, and consultants use proprietary data sources and various tools and techniques to gather and analyze information.

Contact
Transparency Market Research
State Tower
90 State Street,
Suite 700,
Albany NY – 12207
United States
Tel: +1-518-618-1030
USA – Canada Toll Free: 866-552-3453
Email: sales@transparencymarketresearch.com

Website: http://www.transparencymarketresearch.com
TMR Blog: http://www.tmrblog.com/

SOURCE Transparency Market Research

Providence Medical Technology Announces Appointment of US Sales Executive and Publication of Two Additional Clinical Studies

PLEASANTON, Calif.Jan. 8, 2018 /PRNewswire/ — Providence Medical Technology, an innovator in cervical spine fusion, today announced the appointment of Jeremy Laynor as Vice President of US sales. The company also announced the publication of two new studies in the Journal of Craniovertebral Junction and Spine further demonstrating the clinical benefits of its unique cervical fusion technology.

Jeremy is an accomplished sales executive who has successfully built high-growth sales teams launching disruptive medical technology. Jeremy most recently served as Vice President of Sales at Paradigm Spine where he led a team of direct and independent distributors selling novel spinal technology. He has also held sales leadership positions at Medtronic and Cardinal Health.

“Jeremy is an excellent fit for this critical leadership position,” commented Jeff Smith, CEO of Providence Medical Technology. “He understands the challenges of selling unique devices in the spine market and brings a strong network of spine surgeons and distributor partners to Providence. Jeremy completes the buildout of our executive team that will elevate our company to new levels as we further commercialize our differentiated posterior cervical fusion technology.”

Additionally, the December issue of the Journal of Craniovertebral Junction and Spine features two studies both authored by Dr. Krzysztof Siemionow et al., that demonstrate the clinical performance of posterior fusion utilizing the company’s DTRAX® Spinal System and CAVUX® cervical cages. One study reviewed the safety profile of 89 consecutive patients diagnosed with cervical radiculopathy and surgically treated with posterior cervical fusion and bilateral cages. The study reports a median hospital stay of 29 hours and overall complication rate related to the posterior cervical fusion of only 3.4%.

A complete copy of this study can be found at http://bit.ly/2E1fKuY

The second study publishes for the first time a case series of posteriorly placed cervical cages as an adjunct to fusion in place of lateral mass screws. The study concludes that posterior cervical cages may be an alternative option to traditional lateral mass screws. These two new publications add to the growing body of evidence supporting the company’s posterior cervical fusion technology of 13 total peer-reviewed scientific publications.

A complete copy of this study can be found at http://bit.ly/2CB3vsg

“The DTRAX Spinal System has greatly increased my procedural efficiency during posterior cervical fusion surgeries,” commented Dr. Kris Siemionow, MD, PhD Orthopedic Spine Surgeon at the University of Illinois at Chicago. “The instruments allow me to perform all the steps of a cervical fusion in a controlled fashion with an intuitive workflow while the cages offer a safe alternative to traditional lateral mass screws.”

DTRAX Spinal System is a set of sterile packaged, single-use instruments designed to perform posterior cervical fusion and has been used in over 9,000 cases worldwide. The CAVUX Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-C7) with accompanying radicular symptoms at one disc level.

About Providence Medical Technology, Inc.
Providence Medical Technology, Inc. is a privately-held medical device company focused on innovative solutions for cervical spinal conditions. The company has pioneered a proprietary approach to posterior cervical fusion and has developed surgical instrumentation and implants that offer unique benefits to the $2 billion worldwide cervical spine market. The Providence family of products includes the DTRAX® Spinal Instrumentation System, CAVUX® intervertebral implants, ALLY® line of bone, facet and cervical pedicle screws, and BIOLOGIX™ allograft cervical cages. All products are shipped-sterile and single-use to maximize perioperative efficiency and ensure consistent quality and performance. For more information, visit www.providencemt.com

 

SOURCE Providence Medical Technology

Related Links

http://www.providencemt.com

Stryker announces nomination of two new Directors, Sheri S. McCoy and Rajeev Suri

By GlobeNewswire,  January 08, 2018

Kalamazoo, Michigan – January 8, 2018 – Stryker Corporation (NYSE:SYK) announced that Sherilyn (Sheri) S. McCoy and Rajeev Suri have been nominated for election to the Company’s Board of Directors at Stryker’s 2018 Annual Meeting of Shareholders, which is expected to be held on May 2, 2018.  Their successful elections would bring the total size of the Company’s Board to ten members.

Ms. McCoy brings a wealth of healthcare and consumer experience gained during a 30-year career at Johnson & Johnson that included leadership of large medical device, pharmaceutical and consumer businesses.  She is currently Chief Executive Officer of Avon Products, a personal care products company. She has held her current position for five years, and has announced that she will be retiring on March 31, 2018. She is also a member of the Board of Directors of AstraZeneca, a global, science-led biopharmaceutical company.

Mr. Suri is President and Chief Executive Officer of Nokia, a leading global technology company. Mr. Suri has deep technology experience spanning nearly 30 years, most of which have been in leadership roles at Nokia. He has served in his current role at Nokia since 2014 and has engineered a transformation of the company through significant portfolio adjustments, such as the acquisition of Alcatel-Lucent.

“We are excited about the potential to add Sheri and Rajeev to our Board,” said Kevin A. Lobo, Chairman and Chief Executive Officer. “They will bring new perspectives and complementary skills, in addition to rich experiences leading large organizations.  They also both share a passion for healthcare and helping Stryker achieve its mission.”

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com.

Important Additional Information and Where You Can Find It

The Company, its directors and certain of its executive officers may be deemed to be participants in a solicitation of proxies from the Company’s shareholders at its 2018 Annual Meeting of Shareholders in connection with the director nominations disclosed above. Information regarding the Company’s directors and executive officers and their respective interests in the Company, by security holdings or otherwise, is set forth in the Company’s Definitive Proxy Statement for its 2017 Annual Meeting of Shareholders, filed with the Securities and Exchange Commission (the “SEC”) on March 20, 2017, and reports filed by the Company and ownership forms filed by the directors and executive officers with the SEC. The Company will furnish its Definitive Proxy Statement for its 2018 Annual Meeting of Shareholders to shareholders entitled to vote at the meeting and will file a copy with the SEC. The Company urges its shareholders to carefully read the Definitive Proxy Statement for its 2018 Annual Meeting of Shareholders, and any other relevant documents filed by the Company with the SEC, when available because they will contain important information. Shareholders may obtain free copies of the materials referenced above at www.sec.gov or www.stryker.com.

Contacts

For investor inquiries please contact:

Katherine A. Owen, Stryker Corporation, 269-385-2600 or katherine.owen@stryker.com

For media inquiries please contact:

Yin Becker, Stryker Corporation, 269-385-2600 or yin.becker@stryker.com

This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.

The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.

Source: Stryker Corporation via Globenewswire

This article appears in: News Headlines

Referenced Stocks: SYK

Spineology Completes First Lateral Post-Market Study Cases Using Novel Implant Design

January 08, 2018

ST. PAUL, Minn.–(BUSINESS WIRE)–Spineology Inc., an innovator in anatomy-conserving spine surgery, is excited to announce the completion of the first post-market study cases using its recently FDA-cleared Duo Lumbar Interbody Fusion System. In October, the company announced the initiation of this prospective, post-market lateral interbody fusion study designed to evaluate patient outcomes. To date, study cases have been completed by Dr. Craig Kuhns, Austin, Texas; Dr. Sandeep Kunwar, Fremont, California; and Dr. Jason Huffman, Napa, California.

The Duo System implant is the first to combine PEEK, titanium and graft containment mesh elements. This design dramatically reduces the access required to implant a device compared to traditional lateral systems. By significantly minimizing the nerve and soft tissue retraction typically required in these surgeries, the company believes the Duo System will reduce the post-operative thigh pain and other complications commonly associated with the lateral approach. In addition to reducing the exposure required for placement, the Duo implant, once filled, creates a large, load-sharing, endplate-conforming graft pack that expands up to 30mm in width to help maintain spinal correction and support fusion.

“The Duo System allows me to efficiently place the implant through a very small access, which reduces trauma to the muscle and neural elements,” said Dr. Sandeep Kunwar. “During placement, the implant can immediately correct spinal deformity. Once in place, the implant is filled with allograft and provides a very large footprint, resulting in excellent stabilization of the segment and a large area for fusion.”

“Thigh-related post-operative complications associated with the lateral approach have been well documented,” said Dr. Craig Kuhns. “Based on my experience, the Duo System has the ability to significantly reduce these complications, which makes for a much easier postoperative course for my patients.”

“The Duo System is intuitively designed,” added Dr. Jason Huffman. “The small, 18mm tubular access portal reduces trauma to soft tissues and neural structures while significantly minimizing tissue creep. It also eliminates the need to position blades, saving me time during the procedure. The instrumentation allows for an efficient, radical discectomy and timely placement of the implant. The reduced access requirements and efficiency of the system both play a role in the reduction of post-operative thigh pain and weakness, and the overall success of the surgery.”

Additional sites nationwide are participating in the Duo System post-market study and are currently completing training or screening 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

RTI Surgical Announces Acquisition of Zyga Technology, Inc.

January 04, 2018

ALACHUA, Fla.–(BUSINESS WIRE)–RTI Surgical, Inc. (Nasdaq: RTIX), a global surgical implant company, today signed an agreement to acquire Zyga Technology, Inc., with closing subject to filing with the state of Delaware. Zyga Technology is a leading spine-focused medical device company that develops and produces innovative minimally invasive devices to treat underserved conditions of the lumbar spine. Zyga Technology’s primary product is the SImmetry® Sacroiliac Joint Fusion System.

“Acquiring Zyga Technology further advances our strategic transformation focused on reducing complexity, driving operational excellence and accelerating growth,” said Camille Farhat, President and CEO. “We are increasing our focus on both internal development and external investment, and acquiring Zyga Technology’s innovative minimally invasive treatment both accentuates our robust spine portfolio and opens significant opportunities to accelerate growth.”

Farhat added, “The acquisition provides access to a procedure that has been growing in excess of 20% in recent years and leverages the core competencies of our Spine franchise. We believe it is perfectly aligned with our Spine-focused expansion strategy to pursue niche differentiated products, to gain scale and customer retention and support portfolio pull-through along the way. As part of the RTI team, we believe Zyga has the potential to produce significant growth by gaining market share, growing procedure volume and driving increased adoption. SImmetry® is a differentiated product designed to drive fusion and supported by clinical data and, with access to RTI’s larger, sophisticated sales force, we will introduce the system to a much wider surgeon audience.”

The sacroiliac joint fusion (SIJF) market has seen significant growth in recent years and is estimated currently to be a $100 million market in the United States. By 2024, the SIJF market in the US is expected to exceed $200 million, anticipated to be driven mainly by an increase in procedure volumes and adoption by new surgeons.

Zyga Technology is a private company with approximately 30 employees and approximately $4 million in annual revenue. Upon closing, RTI Surgical will fund the acquisition through a combination of cash and borrowing under its existing credit facility. Terms of the deal were not disclosed. The agreement has been executed as of today, January 4, 2018, by both parties. Closing will occur following the re-opening of the Delaware Department of State, which is presently closed due to inclement weather.

About RTI Surgical, Inc.

RTI Surgical is a leading global surgical implant company providing surgeons with safe biologic, metal and synthetic implants. Committed to delivering a higher standard, RTI’s implants are used in sports medicine, general surgery, spine, orthopedic, trauma and cardiothoracic procedures and are distributed in nearly 50 countries. RTI has four manufacturing facilities throughout the U.S. and Europe. RTI is accredited in the U.S. by the American Association of Tissue Banks and is a member of AdvaMed. For more information, please visit www.rtix.com.

About Zyga Technology, Inc.

Zyga Technology markets the SImmetry® Sacroiliac Joint Fusion System, a minimally invasive procedure intended for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. The SImmetry® System is known for its ability to create a true SI joint arthrodesis, including decortication, bone grafting and fixation with a threaded implant. For more information, please visit www.zyga.com.

Forward-Looking Statements

This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management’s current expectations, estimates and projections about our industry, our management’s beliefs and certain assumptions made by our management. Words such as “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” variations of such words and similar expressions are intended to identify such forward-looking statements. In addition, except for historical information, any statements made in this communication about anticipated financial results, growth rates, new product introductions, future operational improvements, gaining market share and results or regulatory actions or approvals or changes to agreements with distributors also are forward-looking statements. Additionally, the statement relating to the expected size of the SIJF market in the United States in 2024 is a forward-looking statement. These statements are not guarantees of future performance and are subject to risks and uncertainties, including the risks described in public filings with the U.S. Securities and Exchange Commission (SEC). Our actual results may differ materially from the anticipated results reflected in these forward-looking statements. Copies of the company’s SEC filings may be obtained by contacting the company or the SEC or by visiting RTI’s website at www.rtix.com or the SEC’s website at www.sec.gov.

Contacts

RTI Surgical, Inc.
MEDIA CONTACT:
Molly Poarch, +1-224-287-2661
mpoarch@rtix.com
or
INVESTOR CONTACT:
Nathan Elwell, +1-847-530-0249
nelwell@lincolnchurchilladvisors.com

NuVasive Extends First-Of-Its-Kind Porous PEEK Interbody To TLIF And PLIF Procedures

SAN DIEGOJan. 4, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, announced today the launch of the Company’s COALESCETM Thoracolumbar Interbody Fusion Device as well as FDA 510(k) clearance for expanded indications of its COHERE® Cervical Interbody Fusion Device. The launch and updated claims follow the NuVasive September 2017 acquisition of Vertera Spine, developers of highly innovative interbody implants for spinal fusion using patented porous polyetheretherketone (PEEK) technology.

The NuVasive Advanced Materials Science (AMS) Portfolio includes Porous PEEK™ and Modulus® Titanium interbody implants that are engineered for enhanced osseointegration and biomechanical properties when compared to solid implants with smooth or rough surfaces. Based on animal studies, COALESCE and COHERE provide a unique three-dimensional Porous PEEK architecture to help elicit and encourage bone ingrowth. The technology used to develop these devices utilizes a proprietary processing method that introduces porous structure without compromising implant strength.

“Our strategy in building our AMS portfolio is to provide unprecedented, innovative technologies that enhance the surface, structure and visualization properties of these implants,” said Gregory T. Lucier, chairman and chief executive officer of NuVasive. “Our launch of COALESCE and the expanded clearance of COHERE and COALESCE are all part of our continued commitment to bring disruptive technology to market and investment into our comprehensive AMS portfolio, which converge to provide a better surgical experience and improve patient quality of life.”

COALESCE is now commercially available for TLIF and PLIF procedures in multiple footprint, height and lordotic options, and is magnetic resonance compatible. Following its recently cleared 510(k), COALESCE indications have been expanded to include use for one or two adjacent levels in the thoracolumbar spine (T1– S1) with both autograft and allograft for treatment of degenerative disc disease and degenerative spondylolisthesis as well as multi-level degenerative scoliosis. The device previously received FDA 510(k) clearance for use in anterior, transforaminal, posterior and lateral lumbar interbody fusion procedures.

The expanded FDA 510(k) indications for COHERE allow it to be used at multiple levels in the cervical spine (C2 – T1) with both autograft and allograft. In addition, COHERE received a new ICD code from the Center of Medicare & Medicaid Services (CMS) in October. COHERE is the only product approved for use with the new code, signifying CMS’ recognition of the innovation and potential clinical and tracking benefits of using Porous PEEK technology.

“Patients can gain significant pain relief and improved functional outcomes through the stabilization and fusion of the degenerated spinal motion segment,” said Dr. Kenneth Burkus, orthopaedic surgeon at The Hughston Clinic. “COHERE and COALESCE contribute to these outcomes by retaining the biomechanical properties necessary for intradiscal spinal applications, while helping facilitate osseointegration and bone growth. The use of these new Porous PEEK implants may enhance fusion and limit the risk of stress-shielding, subsidence and implant failure.”

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 $962 million in revenues (2016), NuVasive has an approximate 2,300 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