NuVasive First-to-Market With New Spine Innovations Featured at NASS 2016

Posted On October 25, 2016 By OrthoSpineNews In Spine /

SAN DIEGO, CA–(Marketwired – October 25, 2016) – NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced the introduction of new spine innovations at the North American Spine Society (NASS) 31st Annual Meeting held October 26-29, 2016 at the Boston Convention and Exhibition Center. NuVasive will showcase the Company’s expanded Integrated Global Alignment™ (iGA) platform, now supporting all spinal procedures, including cervical alignment. In addition, the Company will introduce proprietary image enhancement software that allows the surgical staff to significantly reduce exposure to surgical radiation in the operating room (OR), and directly addresses a known safety concern of surgeons and OR staff.

iGA Platform for Cervical

iGA is a proprietary, procedurally-integrated digital platform of specialized products designed to help surgeons achieve more precise spinal column alignment. The expanded platform makes NuVasive the first company to offer a solution to address spinal alignment for all spine procedures and provides surgeons an intuitive surgical workflow during pre-, intra- and post-operative that consists of software and hardware. NuVasive is committed to a global approach for assessing, preserving, and restoring spinal alignment in an effort to promote surgical efficiencies, lasting patient outcomes, and improved quality of life.

NuVasive’s differentiated technology helps surgeons:

Calculate the patient’s cervical alignment and preoperatively plan prior to surgery,
Correct and assess the cervical spine intraoperatively through integrated procedural solutions, and
Confirm postoperatively to reconcile the preoperative plan and the intraoperative assessment.

Part of the expanded platform includes the launch of Bendini® OCT, the innovative computer-assisted, rod bending system, which now has the ability to bend spinal rods for occipito-cervico-thoracic (OTC) cases. Bendini OCT is used in combination with NuvaPlanning™ software, integrated into surgical workflow for pre-, intra- and post-operative planning and confirmation, and NuvaMap™ O.R., the industry’s first and only real-time intraoperative assessment tool to assess the correction achieved prior to finishing the case. Also, as part of the cervical iGA platform, the Company will be launching the CoRoent® Small Interlock™ Hyperlordotic system, the first anterior cervical interfixated implant designed to treat cervical alignment deformities by offering multiple lordotic options to address patient-specific correction.

“Based on the identified clinical need and scientific foundation of driving improved clinical outcomes through optimized global sagittal alignment, we have expanded our iGA platform to now address cervical alignment. Building on the tremendous success the Company has seen with iGA, we are proud to offer the only available solution to address spinal alignment for all spine procedures,” said Jason Hannon, NuVasive’s president and chief operating officer. “This cutting-edge surgical planning technology enables surgeons to more completely plan for and achieve total sagittal alignment, including for patients suffering from cervical conditions. It represents another step forward in our mission to transform spine surgery.”

Improving OR Safety with LessRay® Technology

Physicians can exceed their lifetime Occupational Radiation Limit within the first decade of their career.

As surgery trends increasingly towards minimally invasive surgery (MIS) due to patient benefits, surgeon familiarity and superior clinical and economical outcomes, radiation exposure to surgeons and OR staff may increase.

To directly address this potential barrier to widespread adoption of MIS, NuVasive acquired the LessRay software technology suite from a private company called SafeRay Spine. The LessRay software is designed to be integrated into current surgeon workflow and utilizes an algorithm to drive image registration and enable management of radiation exposure, while maintaining high-quality, intra-operative images on existing C-Arm workflow without loss of visual accuracy.

“NuVasive has a strong history of delivering disruptive spine technology. From XLIF to iGA, we continually outpace our peers when addressing unmet clinical and market requirements. Radiation in the OR is a known issue, one that plagues the surgeon, the staff and the patient,” said Mr. Hannon. “This proprietary technology is aimed at supporting the surgeon and their staff, transforming their environment to be safer and more productive, while directly addressing one of the leading barriers to adopt MIS without any disruption to their familiar workflow. We see workflow familiarity as a key requirement for broad and rapid adoption of any successful technology platform.

“In addition, the technology fits our portfolio of differentiated solutions as a foundational element of our imaging, navigation and surgical automation development strategy. Our unmatched spine platform includes industry-leading hardware, software and services, transforming spine surgery through reproducible clinical and economic outcomes,” added Mr. Hannon.

NuVasive NASS Participation Details

NuVasive will showcase and demo its new technologies at NuVasive Booth #1315 on the NASS exhibit floor.

The Company will also feature the new BASE™ Interfixated Titanium system, a key addition to the iGA platform. BASE is designed to achieve fusion goals and spinal alignment objectives with precision, innovative functionality and a wide range of implant size and lordosis options. Titanium implants have a proven strength profile compared to that of other materials on the market. The new system offers versatile fixation options with a distinctive locking mechanism and anatomic implant design to help rebuild spinal foundation.

NuVasive’s participation at NASS includes a series of in-booth presentations and workshops. Visit the Company’s website for presentation details.

About NuVasive
NuVasive, Inc. (NASDAQ: NUVA) is a world leader in minimally invasive, procedurally-integrated spine solutions. From complex spinal deformity to degenerative spinal conditions, NuVasive is transforming spine surgery with innovative technologies designed to deliver reproducible and clinically proven surgical outcomes. NuVasive’s highly differentiated, procedurally-integrated solutions include access instruments, implantable hardware and software systems for surgical planning and reconciliation technology that centers on achieving the global alignment of the spine. With $811 million in revenues (2015), NuVasive has an approximate 2,200 person workforce in more than 40 countries around the world. 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.

CONTACT INFORMATION

Investor Contact:
Suzanne Hatcher
NuVasive, Inc.
858-458-2240
Email contact

Media Contact:
Michael Farrington
NuVasive, Inc.
858-909-1940
Email contact

Spinal Elements® Announces Expansion of Sales Team

Posted On October 25, 2016 By OrthoSpineNews In Spine /

October 25, 2016 – CARLSBAD, Calif.–(BUSINESS WIRE)

Spinal Elements, a spine technology company, announced the expansion of its Sales team with the addition of Steve Haayen. Mr. Haayen is taking the role of Area Vice President of Sales in the Western United States.

Haayen brings over 10 years of spine sales and management experience to Spinal Elements, having previously held roles with Stryker Spine, Globus Medical, Lanx, and Biomet. In his roles with each company, Haayen has led sales growth while achieving multiple President’s & Chairman’s Club Awards, and Sales Director of the Year along with leading the Representative and Distributor of the Year from his region. Furthermore, he has a depth of experience in minimally invasive (MIS) and lateral access spine systems, an area of focus for Spinal Elements.

“We are very fortunate to have someone with Steve’s depth of knowledge in the space of our new expanding technologies. Steve’s business acumen, procedural and industry knowledge will help us continue the strong sales growth we have seen in 2016,” added Paul Cory, Vice President of Sales at Spinal Elements.

Spinal Elements is introducing several new technologies over the coming months including a novel MIS lateral access system, expandable interbody devices that aid in the restoration of proper sagittal balance by expanding and lordosing, and an MIS interspinous process fixation device. The company expects strong demand for these new procedurally driven surgical solutions in addition to the robust growth seen in its current line of products. Additional Sales management positions will be filled to help address ongoing expansion.

Spinal Elements will be exhibiting (Exhibit 1341) October 26^th through the 28^th at the North American Spine Society meeting in Boston. The company has seen over 20% growth this year in its core technologies, fueled by demand for its advanced technologies including Ti-Bond titanium coated implants.

About Spinal Elements

Spinal Elements, headquartered in Carlsbad, CA, is a spine technology company for spine surgeons who demand innovative, extremely high quality surgical solutions. From the company’s early work which helped make PEEK commonplace throughout the spine industry to recent advancements in Ti-Bond® porous titanium coated PEEK interbody implants and controlled delivery technology, Spinal Elements has built a reputation for being trustworthy, innovative and different. The company is focused on the development and marketing of progressive spinal treatment options and markets a complete portfolio of advanced spinal implant technologies. Additionally, the company distributes Hero® Allograft, the net proceeds from which are donated to charities benefiting children with life-threatening medical conditions. The company recently launched a warranty program for its Ti-Bond technology based on the success of over 10,000 devices implanted. For more information, please visit www.spinalelements.com.

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Innovative Product and Service Offering for the Future of Spinal Surgery To Be Introduced at NASS 2016

Posted On October 25, 2016 By OrthoSpineNews In Spine /

October 25, 2016 – ALLENDALE, N.J.–(BUSINESS WIRE)

Ascential, an innovative implant and delivery solution for lower acuity spinal procedures in the ambulatory surgery center (ASC) and hospital settings, will be introduced at the North American Spine Society (NASS) Annual Meeting in Boston, Oct. 26-29, 2016 (booth No. 1511).

Ascential offers a portfolio of newly designed sterile-packaged implants, customized service levels, and a streamlined distribution model. The innovative Ascential solution is intended to provide operational efficiencies, competitive pricing, and reduced operating costs so that staff can spend less time managing logistics and more time and resources on patient care.

Ascential implants are manufactured by Stryker in accordance with the company’s stringent quality standards. Products available with Ascential include:

The ACP 1 Anterior Cervical Plating System, offering a simple backout prevention mechanism, high degree of screw angulation, and streamlined instrumentation.
The IBD Peek^C Anterior Cervical Spacer System, featuring a chamfered leading edge, a large open graft window, and a collet-style inserter.
VBA Vitoss Foam Pack, the top-selling synthetic bone graft, a versatile material that is stable in a fluid environment, can soak and hold bone marrow, is compression-resistant, and can be mixed with local bone.

Ascential is enabled with optional end-to-end radio-frequency identification (RFID) inventory management using proprietary technology. As a result, it allows sales representatives and facility staff to easily monitor and manage inventory pre-, post- and intra-operatively to help reduce labor costs and ensure implant availability. The implants are also sterile-packaged to reduce the sterilization burden and chance of infection.^1,2 All implant packaging is UDI (Unique Device Identification) compliant and includes patient labels to promote traceability.

Unlike conventional inventory management methods, which generally require sales representatives to drop off equipment a few days prior to surgery, then come back to attend the surgery, and take the instruments back for reprocessing post-surgery, Ascential enables instruments to remain with the customer to be processed and sterilized on a schedule that makes sense for each facility. Dedicated and optimized instrument sets with sterile-packaged implants help ensure availability, reduce case scheduling activities, and enable more flexible sterilization workflows.

This new inventory management program can be customized for each facility based on an analysis of the number of spine cases, surgical days, number of surgeons, and other variables and priorities. “Ambulatory surgery centers are often focused on improving logistics, increasing efficiency, and reducing costs,” said Orrin Levine, Senior Director, Business Solutions at Stryker. “The new Ascential solution positively impacts all three—once it’s up and running, processes for spinal fusion procedures can become even more simplified, repeatable, and scalable.”

About Ascential

Ascential is a new approach to spine healthcare that offers high-quality products with increased efficiency and profitability for hospitals and outpatient surgery centers. Ascential is manufactured by Stryker, one of the world’s leading medical technology companies. For more information, please visit us at www.ascentialhealth.com.

References

1. Bible J, O’Neill K, Crosby C, Schoenecker J, McGirt M, Devin C. Implant contamination during spine surgery. Spine J.2013;13(6):637-640.

2. Menekse G, Kuscu F, Suntur B, et al. Evaluation of the time-dependent contamination of spinal implants: prospective randomized trial. Spine. 2015;40(16):1247-1251.

Content ID ACP1-PR-1_12074

View source version on businesswire.com: http://www.businesswire.com/news/home/20161025005388/en/

joimax® shows major presence at NASS 2016 with a User Meeting and Workshop at Harvard Medical School, a NASS CME Lab and an Expert Panel Forum at the exhibition booth

Posted On October 24, 2016 By OrthoSpineNews In Spine /

Irvine, CA and Karlsruhe, Germany – October 25, 2016 – joimax^®, the global acting German developer and marketer of technologies and training methods for endoscopic minimally-invasive spinal surgery, will again exhibit at the annual meeting of the North American Spine Society (NASS) 2016, taking place from October 26 – 29 in Boston, USA. Prior to the convention, on Monday, October 24, joimax^® will hold a User Meeting followed by a workshop at the Harvard Medical School Conference Center. On Tuesday, October 25, the NASS CME-Lab with a joimax^® station will take place. During the exhibition a group of internationally respected spine experts will also give presentations in a forum at the joimax^® booth.

Key topics of the joimax^® User Meeting will be centered around the endoscopic treatment of degenerative spinal diseases on the basis of the joimax^® portfolio products with TESSYS^®, CESSYS^®, iLESSYS^® Delta systems as well as EndoLIF^® and Percusys^®. A group of spine experts will share their expertise and extensive knowledge on the treatment of spinal diseases. The meeting will be completed with a cadaver lab with 3-4 stations at the Conference Center of the Harvard Medical School to train attendees on the whole range of endoscopic minimally-invasive spine surgery applications based on the joimax^® techniques.

Tuesday’s NASS CME-Lab will be chaired by Professor Michael Y. Wang, M.D. FACS, University of Miami Miller School of Medicine, Miami, Florida, another pioneering spine surgeon and joimax^® faculty member, who recently published a special edition in theJournal of Neurosurgery called Neurosurgical Focus, focused on Endoscopic Spine Surgery.

Additionally, joimax^® will host a “Meet the Expert Forum” with presentations at its booth given by Dr. Ralf Wagner and Dr. Erik Traupe, both from Germany, and also Dr. Menno Iprenburg from the Netherlands. Topics discussed will include the benefits of spinal endoscopic transforminal and interlaminar decompression methods over traditional ones. joimaxs’^® novel treatment options for advanced indications enjoy a fast growing adoption rate of its endoscopic technologies worldwide will also be discussed.

“In the context of the annual NASS meetings’ we aim to share the latest information, innovative techniques and best practices with renowned spine care professionals from around the world. These joimax^® activities will satisfy the requirements of spine specialists to take advantage of the latest innovations and technologies in endoscopic minimally-invasive spine surgery,” says Wolfgang Ries, CEO and founder of joimax^®.

“With our existing product range as well as with our newly launched products – the MultiZYTE^® SI endoscopic sacroiliac joint therapy set, MultiZYTE^® RT for endoscopic minimally-invasive treatment of the facet joint and the new Intracs^® Intraoperative Navigation Tracking & Control System, joimax^® uniquely enhances its endoscopic minimally-invasive product portfolio to fully meet users’ needs,” he continues.

About joimax^®

Founded in Karlsruhe, Germany, in 2001, joimax^® is the leading developer and marketer of complete systems for endoscopic minimally invasive spinal surgery. With TESSYS^® (transforaminal), iLESSYS^® (interlaminar) and CESSYS^® (cervical) for decompression procedures, MultiZYTE^® RT (e.g. for rhizotomy) and with MultiZYTE^® SI for SI-Joint therapy or with EndoLIF^® and Percusys^® for endoscopic minimally-invasive assisted stabilizations, proven endoscopic systems are provided that, together, cover a whole variety of indications.

In procedures for herniated disc, stenosis, pain therapy or spinal stabilization treatment, surgeons utilize joimax^® technologies to operate through small incisions – under local or full anesthetic – via tissue and muscle-sparing corridors through natural openings into the spinal canal (e.g. intervertebral foramen, the “Kambin triangle”).

Press Contact Germany

joimax^® GmbH
Sabine Jarosch
sabine.jarosch@joimax.com
Phone +49 721 25514 0

Press Contact USA

joimax^® Inc.
Melissa Brumley
Melissa.brumley@joimaxusa.com
001 949 859 3472

DeGen Medical Launches Latitude-C™ Porous Ti Cervical Interbody Spacer

Posted On October 24, 2016 By OrthoSpineNews In Spine /

FLORENCE, SC–(Marketwired – October 24, 2016) – DeGen Medical introduces Latitude-C™ Porous Ti Cervical Interbody Spacer, an extension of our popular and effective Latitude-C™ product line, is designed to consider the uncinate process of the cervical vertebra. The lateral angled shape is a shift from traditional rectangular shape and mimics patient anatomy. The variety of profiles and angles provided allows a perfect fit at every fusion level and match individual patient anatomy. The Latitude-C™ Porous Ti Spacers with porous titanium coated surfaces are designed to provide an effective surface for bone implant contact.

The first anterior cervical fusion surgery using DeGen Medical’s Porous Ti technology was performed by Dr. Bauerle. “The right roughness developed by DeGen Medical allows better bone apposition increasing fusion rates,” exclaims Dr. Bauerle, “The remarkable increase in graft volume benefit early union and wide surface area support is very beneficial to decrease micro-motion between vertebral bodies and subsidence.”

The Latitude-C™ Porous Ti Cervical Interbody Spacer comes in a variety of shapes and sizes:

Five different footprints from 12x12mm to 20x15mm, with each footprint having 13 different heights ranging from 5mm to 14mm
Three different shape options to choose from — Anatomic, Lordotic and Parallel

The Latitude-C PEEK Interbody Spacer has been available since February 2016.

Come see us at NASS 2016, Booth #1159!

About DeGen Medical, Inc.

DeGen Medical, Inc. is a medical-device development company dedicated to providing surgeons with innovative products designed to improve quality of life for patients with complex spinal disorders. World-class implants, coupled with intuitively-designed instrumentation, provide a complete package to promote superior surgical outcomes. Our passion to advance spine-care solutions is driven by clinical insights, sound research, and science-based design. DeGen Medical maintains the highest quality standards to provide reliable products and safeguard patient health.

Image Available:http://www.marketwire.com/library/MwGo/2016/10/24/11G119230/Images/Coated_PEEK-8840b4993c1e9de2afbc9fe43e0d3b30.jpg

CONTACT INFORMATION

For more information, please contact:
Jessica Clark
DeGen Medical, Inc.
Phone: 877-240-7838
www.DeGenmedical.com

Spinal Elements® Announces Initial Procedures with Katana™ MIS Lateral System

Posted On October 24, 2016 By OrthoSpineNews In Spine /

October 24, 2016

CARLSBAD, Calif.–(BUSINESS WIRE)–Spinal Elements, a spine technology company, announced that the first procedures with its minimally invasive (MIS) Katana Lateral System were successfully completed.

The Katana Lateral System is a muscle-splitting system that is designed to overcome some of the inherent challenges in MIS lateral surgery. Traditionally, spine surgery has been performed from the back (posterior) or the front (anterior). Recent MIS advancements allow for accessing the spine from the side (lateral). Currently-marketed systems can intrap tissue as the access is created. Furthermore, the nature of how these systems create the surgical corridor can compress neural structures near the spine.

The Katana System was designed to address both of these challenges. Surgical access with Katana is gently created in the plane of the muscle, preventing the muscle intrapment that can plague earlier technology based system. The posterior-forward design philosophy of the Katana system further helps prevent the nerve compression problems that other systems can create. Both of these design enhancements are proprietary to Spinal Elements’ next generation system.

The implants used with the Katana Lateral System take advanatage of Spinal Elements’ Ti-Bond® titanium surface technology. The application of Ti-Bond allows the spinal implants to maintain their radioulucent properties that permit intraoperative montoring of implant position while allowing postoperative assessment of fusion progress. These implants also maintain their load-sharing strength profile that has been clinically proven important to the bone healing process. These properties are further enhanced by the additional stability of Ti-Bond’s roughened surface and longer-term benefits of its hydrophilic titanium structure.

Burak Ozgur, MD, a leading MIS spine surgeon based in Newport Beach, California, had this to say about his experience with the Katana System: “The system far exceeded my expectations. The Katana System’s design allows for efficient access to the spine without the drawbacks of the other systems available. The lack of muscle intrapment and encroachment into my surgical corridor allows for a more fluid procedure. I believe this could be a game changing technology that surgeons could easily adopt into their practice.”

About Spinal Elements

Contacts

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

Spine Wave Announces the Commercial Launch of the Velocity® P Expandable Interbody Device

Posted On October 24, 2016 By OrthoSpineNews In Spine /

October 24, 2016

SHELTON, CT–(Marketwired – October 24, 2016) – Spine Wave, Inc. is committed to the commercialization of high-quality, innovative medical devices for the treatment of spinal disorders. Spine Wave is pleased to announce that it will be fully launching the Velocity^® P Expandable Interbody Device system in mid-November with the arrival of commercial-scale inventory quantities. The company has been a pioneer in the field of expandable spacers since 2008, and surgeons have subsequently implanted over 50,000 Spine Wave expandable devices.

The Velocity^® P Expandable Interbody Device is the latest iteration in a long line of expandable devices from Spine Wave and will be prominently featured at NASS. The implant’s low profile allows for a less invasive surgical approach that may result in less nerve root retraction and bone resection. The load-bearing core is made from PEEK, a material well known for its favorable modulus. A unique titanium shell encompasses the implant and enhances its strength, while a plasma-sprayed titanium coating provides the surface texture and endplate interface many surgeons prefer. The controlled incremental expansion with an integrated trial feature is designed to allow surgeons to restore disc height and optimize the implant-to-patient fit. The device has a spacious graft chamber that can be easily filled post expansion utilizing the company’s proprietary guided funnel system. Post-expansion grafting allows for both maximum graft volume and graft-to-endplate contact within the device.

“The Velocity^® P Device is the most complex and challenging development project we have ever undertaken, and, based on surgeon feedback received during the limited market release, we could not be more pleased with the results. The Velocity^® P Device, when combined with the original StaXx^® platform and the more recently launched Leva^® Interbody Device, provides us with a market-leading portfolio of expandable implants in what we believe is one of the fastest growing and most strategically important segments of spine,” said Mark LoGuidice, Spine Wave’s Chief Executive Officer.

“I have been a vocal proponent of expandable implants since 2008 and have had an opportunity to use many of the more popular devices available,” said Domagoj Coric, M.D., Chief of Neurosurgery at Carolinas Medical Center. “The Velocity^® P device encompasses all the key features surgeons are looking for in an expandable implant. This powerful device has ideal material properties, and it is easy and intuitive to use. When using an expandable device, surgeons understand the importance of being able to pack additional graft material post expansion, and the guided grafting system on the Velocity^® is easily the best I have seen.”

About Spine Wave

In addition to the products mentioned above, Spine Wave’s product portfolio features many highly differentiated technologies including the StaXx^® family of products, which has a seven year proven track record in posterior surgery. The Leva^® Interbody Device is an expandable titanium implant that is optimized for ease of insertion and for maximum post expansion bone graft capability. The True Position^® Pivoting Spacer System is a pivoting “crescent-style” interbody fusion device that is implanted with the widely used TLIF technique and features Center Pivot Point Technology. The Velocity^® L Expandable Interbody Device, which is the Velocity^® Expandable Interbody Device designed for lateral interbody fusion procedures, was launched earlier this year alongside Spine Wave’s enhanced lateral system. The Sniper^® Spine System has developed a reputation as a leading MIS screw system and is now complemented with its Sniper^® Spine System XT extended tab screws and the the Annex^® Adjacent Level System. Spine Wave provides the simple yet versatile CapSure^® PS3 Spine System, which is proving to be a high quality, user friendly, traditional screw system. Spine Wave is dedicated to continuously delivering a robust and highly differentiated product pipeline, with a strong emphasis on minimally invasive solutions that will meet and exceed the expectations of our spine surgeon customers.

The Company is growing rapidly and continues to recruit new sales managers and independent distributors to fuel the growth. For further information on all of the Spine Wave products please visit the Company’s website at www.SpineWave.com.

CONTACT INFORMATION

Contact:
Terry Brennan
Chief Financial Officer
Email contact

203-712-1810

SIGNUS Medizintechnik receives 510(k) clearance for posterior pedicle screw system DIPLOMAT®

Posted On October 24, 2016 By OrthoSpineNews In Spine /

Alzenau, October 24, 2016.

In august SIGNUS announced the 510(k) clearance from the United States Food and Drug Administration (FDA) for their new DIPLOMAT pedicle screw system.

The DIPLOMAT has been developed in cooperation with international spine experts. As a posterior fixation system it provides user-friendly and reliable instrumentation for all spine treatments.

“The main focus of DIPLOMAT is the optimized balance between clinical perfor- mance and user-friendliness,” says SIGNUS Managing Director, Uwe Siedler. The system combines maximal clinical efficiency with all the important properties required for optimal patient treatment.

The pedicle screws are a modular two-piece implant: depending on the indication and surgical application, the pedicle screws can be assembled as required with the appropriate tulips. If necessary, the tulips can be removed and replaced in situ during surgery. A very low tulip profile of only 14.9 millimeters guarantees optimal anatomical alignment and prevents any protrusion of the tulip even in slim or young patients. The patented ELASTOLOK^® locking mechanism ensures the highest strength for the screw/tulip connection. The DIPLOMAT system provides optimal flexibility and efficiency thanks to these features.

DIPLOMAT impresses users not only with its high level of safety but also with its ease of handling during surgery. All the pedicle screws are cannulated, as well as being fenestrated from a diameter of 5.5 millimeters. The comfortable screw-cannula diameter of 1.9 millimeters also allows the use of stronger guide wires, which noticeably stabilizes the insertion of the pedicle screw during MIS procedures. The DIPLOMAT pedicle screws have a self-tapping double thread that provides the best possible fixation and perfect anchoring in the bone. The high thread pitch enables faster insertion which considerably shortens surgery time.

More information about DIPLOMAT

Download press release as PDF

Vertera Spine Reports Successful Early Outcomes with the Porous PEEK COHERE Fusion Device

Posted On October 24, 2016 By OrthoSpineNews In Spine /

SOURCE Vertera Spine

ATLANTA, Oct. 24, 2016 /PRNewswire/ — Vertera Spine, a developer of medical devices using advanced biomaterial technologies, today announced the first early successful outcomes using the COHERE® Cervical Interbody Fusion Device. COHERE is Vertera Spine’s first device featuring the company’s patented porous PEEK (polyetherether ketone) Scoria® biomaterial technology. Scoria’s porous architecture seamlessly integrates with the bulk PEEK implant providing an environment for bony tissue ingrowth while retaining the mechanical and imaging properties of traditional PEEK implants. Vertera Spine will be showcasing COHERE and its Scoria technology at the upcoming NASS meeting October 26-28^th in Boston, MA.

Since its initial soft launch in May 2016, over 400 COHERE devices have been implanted in anterior cervical fusion surgeries by a select number of surgeons across the United States. Dr. Robert McGuire, Past Chairman of AO Spine North America and from the University of Mississippi Medical Center in Jackson, Miss., was one of the first surgeons to use the COHERE implant.

“I have been very pleased with the early outcomes I am seeing with the COHERE device,” said Dr. McGuire. “There has been a clinical need for a porous PEEK fusion device that addresses the limited integration capabilities of traditional PEEK devices. I am excited to adopt COHERE into my practice.”

Studies have demonstrated that porous implants are able to generate a stronger osteogenic cellular response and better osseointegrate over implants with micro- and nano-roughness.^1,2While porous metal or porous metal-coated PEEK implants have found their way into spinal fusion applications, COHERE is the first device in clinical use to be manufactured entirely out of PEEK and contain porosity. Because there is no metal, COHERE also provides the additional advantage of not producing any medical imaging artifacts, allowing accurate visualization of the fusion site.

Dr. Clint Hill (The Orthopaedic Institute in Paducah, Kentucky), another soft launch COHERE user, has several several patients at 5 months post-surgery.

“COHERE with its porous PEEK architecture is the first of its kind to offer an osteoconductive environment without the use of metal. With all my patients who have received a COHERE device, I am observing early signs of fusion with significant bony bridging,” said Dr. Hill.

Likewise, Dr. Brandon Strenge, also from the Orthopaedic Institute in Kentucky, has implanted several COHERE devices and is observing similar outcomes at almost 5-months post-surgery.

“The hydrophilic nature and ingrowth capability of COHERE’s porous architecture gives me the confidence that fusion can be achieved even in more challenging multi-level cases,” said Dr. Strenge. “Porous PEEK Scoria is a game-changing technology that will make all other PEEK devices obsolete and could lend itself to many future applications.”

Vertera Spine’s porous PEEK Scoria technology is backed by extensive academic research at Duke University and the Parker H. Petit Institute for Bioengineering and Bioscience at Georgia Institute of Technology. Professor Ken Gall, Chair of the Department of Mechanical Engineering and Materials Science at Duke, will be sharing some of the latest research in a presentation entitled, “Biomechanical Performance of a Novel Porous PEEK for Interbody Fusion Devices” at the NASS meeting on Wednesday October 26^th.

About Vertera Spine:

Vertera Spine is a privately-held medical device company that develops and commercializes multifunctional implants that use or complement its patented porous technology to address critical clinical needs in spine surgery. The company has received funding from the National Science Foundation, Georgia Research Alliance, and Duke Angel Network to translate its growing technology portfolio into commercial products. For more information, visit www.verteraspine.com or call 678.705.9039.

COHERE and Scoria are registered trademarks of Vertera Spine. All other trademarks and trade names are the property of their respective holders.

¹Svehla M, Walsh MR et al. Morphometric and mechanical evaluation of titanium implant integration: Comparison of five surface structures. Journal of Biomedical Materials Research, 2000.

²Cheng A, Boyan BD, et al. Enhanced Osteoblast Response to Porosity and Resolution of Additively Manufactured Ti-6Al-4V Constructs with Trabeculae-Inspired Porosity. 3D Printing and Additive Manufacturing, 2016.

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/vertera-spine-reports-successful-early-outcomes-with-the-porous-peek-cohere-fusion-device-300349600.html

Orthofix Announces NASS Coverage Policy Recommendations for Electrical Bone Growth Stimulators

Posted On October 24, 2016 By OrthoSpineNews In Spine /

October 24, 2016

LEWISVILLE, Texas–(BUSINESS WIRE)–Orthofix International N.V. (NASDAQ:OFIX), a diversified, global medical device company, is pleased to announce the North American Spine Society (NASS) has issued first-of-its-kind coverage recommendations for electrical bone growth stimulators. These evidence-based coverage policy recommendations support the use of pulsed electromagnetic field (PEMF) stimulation devices as an adjunct to spinal fusion surgery.

Dr. Richard Guyer, orthopedic spine surgeon, co-founder and director at the Texas Back Institute in Dallas said, “Bone growth stimulation devices are an important option for patients with risk factors that might inhibit the success of their spinal fusion procedures. By stimulating bone growth, we can often avoid the need for revision surgery.”

The just-issued NASS coverage policy recommends the use of electrical stimulation for spinal fusion healing in all regions of the spine including cervical and lumbar regions. Orthofix is the only company with a bone growth (osteogenesis) stimulator approved by the U.S. Food and Drug Administration (FDA) as a noninvasive, adjunctive treatment option for cervical fusion.

“We are pleased that NASS has chosen to proactively examine the medical evidence and recommend electrical bone growth stimulation devices in order to assist payors, surgeons and patients by defining appropriate use and coverage positions,” said Brad Niemann, President of the Orthofix BioStim strategic business unit. “This policy is important as it further validates the use of bone growth stimulators like the Orthofix CervicalStim and SpinalStim systems, for improving spinal fusion outcomes in patients at risk of a failed fusion.”

The Orthofix CervicalStim^™ and SpinalStim^™ devices use a low-level pulsed electromagnetic field that helps activate and augment the body’s natural healing process. These devices provide patients with a safe, noninvasive treatment option for promoting spinal fusion.

Orthofix invites those attending NASS 2016 to visit Booth #615 to learn more about the Company’s BioStim devices and the coverage recommendations.

About NASS

The North American Spine Society (NASS) is comprised of more than 8,000 members from several disciplines, including orthopedic surgery, neurosurgery, physiatry, neurology, radiology, anesthesiology, research and physical therapy. As part of its mission to foster the highest quality, evidence-based and ethical spine care, NASS develops credible and reasonable coverage recommendations to assist payors, providers, and patients in defining appropriate and fair coverage decisions. NASS evidence-based coverage recommendations are developed to advocate for NASS’ positions on various clinical and practice issues to ensure continued provision of quality spine care.

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, TX, 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 subsidiaries. In addition, Orthofix is collaborating on research and development activities with leading clinical organizations such as Brown University, Sinai Hospital of Baltimore, Cleveland Clinic, Texas Scottish Rite Hospital for Children and the Musculoskeletal Transplant Foundation. For more information, please visit www.orthofix.com.

Forward-Looking Statements

This communication contains certain forward-looking statements under the Private Securities Litigation Reform Act of 1995. These forward-looking statements, which may include, but are not limited to, statements concerning the projections, financial condition, results of operations and businesses of Orthofix and its subsidiaries, are based on management’s current expectations and estimates and involve risks and uncertainties that could cause actual results or outcomes to differ materially from those contemplated by the forward-looking statements. The forward-looking statements in this release do not constitute guarantees or promises of future performance. Factors that could cause or contribute to such differences may include, but are not limited to, risks relating to: practices of health insurance companies and other third-party payors with respect to reimbursement for our PEMF devices; any future changes to the coverage determinations of NASS for electrical bone growth stimulators; and other risks described in the “Risk Factors” section of our Annual Report on Form 10-K for the fiscal year ended December 31, 2015, as well as in other reports that we file in the future. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to update or revise the information contained in this press release.

Contacts

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