Nexxt Spine Announces Full Market Release of INERTIA CORTI-FIXX™ Cortical-Cancellous Pedicle Screw System

April 26, 2017

NOBLESVILLE, Ind.–(BUSINESS WIRE)–Nexxt Spine, LLC, a medical device company focused on designing, manufacturing and distributing innovative spinal solutions, today announced the full market release of the INERTIA CORTI-FIXX™ Cortical-Cancellous Pedicle Screw System. Corti-Fixx screws are designed to achieve greater cortical bone purchase with a smaller midline incision when utilized in a medial to lateral pedicle approach known as the Cortical Bone Trajectory (CBT).

Corti-Fixx implants and instruments are built upon the Inertia Pedicle Screw System’s foundation and offer an alternative to traditional pedicle screw fixation. The unique dual to quad lead threads double the number of screw-to-bone contact points within the pedicle thereby increasing resistance to pull out.

Andy Elsbury, President of Nexxt Spine, stated, “Trends within the spine market call for less invasive procedures that are simple, reliable and reproducible. The Corti-Fixx screw further differentiates the Inertia Pedicle Screw System and provides multiple solutions for fixation in diminished bone quality through an open or MIS approach.”

About Nexxt Spine

Nexxt Spine, LLC is a privately held medical device manufacturer dedicated to increasing procedural efficiency and patient outcomes through development of innovative products, manufactured on the most technologically advanced platforms, and utilizing irreproachable quality standards to treat painful and debilitating spinal pathologies.

Additional information can be found at www.nexxtspine.com.

Contacts

Nexxt Spine, LLC
Sarah Koch, 317-436-7801
SKoch@NexxtSpine.com

Sky Ridge Medical Center Acquires First Mazor X™ System in Ten-State Region

LONE TREE, Colo., April 25, 2017 /PRNewswire/ — Sky Ridge Medical Center acquired the first Mazor X system in Colorado and a ten-state region for spine surgery. The Sky Ridge Spine and Total Joint Center, a recipient of the Joint Commission Gold Seal of Approval, strives to improve patient outcomes with advanced technology and surgical techniques.

As part of its commitment to providing exceptional clinical care, Sky Ridge surgeons are now performing spine surgeries with the Mazor X system, which increases the efficiency and safety of spine surgery.

“The Mazor X system is setting a new standard of care. It is introducing technologies that link the knowledge and proficiency of our surgeons with digital data and analysis, enabling us to transform spine surgery, increasing its predictability for patients, surgeons and hospital teams,” said Susan Hicks, CEO, Sky Ridge Medical Center.

The Mazor X™ system creates a 3D model of the spinal cord that can be viewed from multiple angles. This 3D model helps surgeons identify potential challenges, better assess the patient’s anatomy to determine the best implants and develop a personalized care plan for each patient.

The system also includes tools that maximize stability during surgery. This, combined with imaging that increases the surgeon’s planning and visibility, results in increased precision with improved patient outcomes, including:

  • Fewer complications
  • Greater accuracy
  • Shorter surgeries
  • Faster recovery times

The Sky Ridge Spine & Total Joint Center offers:

  • Comprehensive team of specialists who provide personalized care before, during and after surgery.
  • Experienced physicians who perform more spine surgeries than any other hospital in Colorado.
  • Fellowship-trained neurosurgeons and orthopedic surgeons.
  • Best recovery environment in Colorado.
  • Most advanced technology, including minimally invasive surgery.
  • State-of-the-art, dedicated facility with private entrance.
  • Pre- and post-operative education.
  • Dedicated recovery floor with specialty-trained staff.

Media Contact:

Linda Watson
Director of Marketing & PR
720-979-7422
Linda.Watson@healthonecares.com

About Sky Ridge Medical Center

Sky Ridge Medical Center is a member of the HealthONE network. We work together to provide a higher level of care.

Visit www.skyridgemedcenter.com to learn more.

About Mazor Robotics

Mazor Robotics believes in healing through innovation by developing and introducing revolutionary technologies and products aimed at redefining the gold standard of quality care.

For more information, please visit www.mazorrobotics.com.

This content was issued through the press release distribution service at Newswire.com. For more info visit: http://www.newswire.com

SOURCE Sky Ridge Medical Center

Related Links

http://www.skyridgemedcenter.com

Amendia Partnership with Global Spine Outreach Strengthens

Marietta, GA (PRWEB) April 25, 2017

Amendia, Inc., designer, developer, and manufacturer of spinal implant and instrument solutions, announces the continuation of its strategic partnership with and platinum sponsorship of Global Spine Outreach (“GSO”), a charitable organization dedicated to training surgeons in developing nations in the safe and effective management of complex spine deformity cases, particularly in children.

GSO’s focus is to provide hands-on surgical education and training to in-country surgeons. Through graduated, long-term educational models, GSO empowers local surgeons to safely treat the most severe spine conditions in their own communities. Over time, the organization helps to create sustainable spine centers that serve local communities year-round.

As a strategic supporter of GSO’s designated surgical mission sites, Amendia enables on-going interaction between the U.S. team and local surgeons. The bi-annual missions allow surgeons to perform multiple surgeries on children with complex spine deformities.

“The physician education and training GSO provides is invaluable to the spine industry’s success and advancement in first-rate treatment of the most severe spinal deformities,” said Chris Fair, Amendia’s CEO. “Through our partnership, we empower young U.S. surgeons to participate in mission trips with established surgeons, and then bring that experience back to their hospitals and patients.”

“Amendia’s support streamlines GSO’s mission to provide children around the world access to life-transforming surgical care,” said Dr. Anthony S. Rinella, orthopaedic spine surgeon, GSO Board President, and founder of the Illinois Spine and Scoliosis Center. “Together, we advocate for the nearly 200 million people afflicted with scoliosis and educate those who can make a difference in their lives.”

The continued sponsorship supports the annual Spinal Deformity Symposium for surgeons, to be held October 29, 2017 in Mexico City, which unites industry experts, U.S. faculty, and over 100 Mexican surgeons in a combination of case presentations and workshops designed to improve and expand care to spine deformity patients. In addition, the support provides for a robust databasing program that results in the continued improvementof spinal deformity management.

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. To learn more about Global Spine Outreach, please visit http://www.globalspineoutreach.org.

About Amendia

Headquartered in a state-of-the-art manufacturing facility in Marietta, Georgia, Amendia is a leading designer, developer, and manufacturer of medical devices used in spinal surgical procedures. Amendia’s vertically-integrated strategy focuses on improving surgical outcomes with innovative implant solutions. For more information, please visit http://www.amendia.com.

Amedica Announces Regulatory Clearance to Market and Sell Valeo® Silicon Nitride Spinal Implants in Australia

SALT LAKE CITY, UT–(Marketwired – Apr 24, 2017) – Amedica Corporation (NASDAQ: AMDA), an innovative medical device company that develops and commercializes silicon nitride, is pleased to announce it has been granted marketing clearance for its Valeo interbody fusion devices in Australia.

The Valeo product line is made entirely of Amedica’s proprietary medical grade silicon nitride ceramic — an ideal material for fusion because of its nanostructured surface, osteoconductivity, osteoinductivity, anti-microbial properties, and ease of radiographic imaging.

“The Australian clearance is a tremendous opportunity for Amedica. Interestingly, during 1986-1988, Australian surgeons and engineers were the first to synthesize reaction-bonded silicon nitride, and implant the material in lumbar spine fusion patients. Favorable outcomes in terms of pain relief and successful fusion were reported at the 15-year follow-up time interval. Thus, the pioneering clinical use of silicon nitride in spine fusion originated in Australia, and we are excited to see the material return to its place of birth,” said Dr. Sonny Bal, CEO. “The successful outcomes from Australia are now validated by 45 scientific papers published by Amedica in top-tier peer journals, and clinical data that will be published throughout this year. We look forward to working with Australian surgeons, and providing them with improved options for spinal fusion surgery.”

About Amedica Corporation
Amedica is the only manufacturer of medical grade silicon nitride — an innovative biomaterial technology ideal for use in spinal fusion and across a variety of medical applications. The Company’s products are manufactured in its ISO 13485 certified manufacturing facility located in Salt Lake City, Utah. Amedica’s FDA-cleared and CE-marked spine products are currently marketed in the U.S. and select markets in Europe and South America through its distributor network.

For more information on Amedica or its silicon nitride material platform, please visit www.amedica.com.

Forward-Looking Statements
This press release contains statements that constitute forward-looking statements within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. Forward-looking statements contained in this press release include, but are not limited to, the Company’s opportunities for global expansion, and the Company’s future commercialization plans. Such statements are subject to risks and uncertainties such as whether the FDA approves the Company’s submission, the timing of such approval and the Company’s success in commercializing its products. Additional factors that could cause actual results to differ materially from those contemplated within this press release can also be found in Amedica’s Risk Factors disclosure in its Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on March 23, 2016, and in Amedica’s other filings with the SEC. Amedica disclaims any obligation to update any forward-looking statements.

CONTACT INFORMATION

Titan Spine Record Sales in Q1 2017 and Reaches 1,000 Implantations nanoLOCK® Endoskeleton® Interbody Fusion Devices

April 24, 2017

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 achieved record sales revenue for the first quarter of 2017. Additionally, the company recently exceeded 1,000 implantations of its Endoskeleton® titanium interbody fusion devices featuring nanoLOCK® surface technology since its launch in the fourth quarter of 2016. nanoLOCK® is the company’s next-generation surface technology featuring enhanced micro and nano-scaled architecture, proven to significantly improve the osteogenic response it creates.1 Titan Spine will be showcasing nanoLOCK® at booth #2249 during the American Association of Neurological Surgeons (AANS) Annual Scientific Meeting, taking place April 22-26 in Los Angeles.

The company reports the following:

  • Record quarterly sales for Q1 2017 that are significantly greater than prior year
  • nanoLOCK® has been utilized to date by 74 surgeons in 52 hospitals across 26 states
  • nanoLOCK® sales volume has increased by 270% since December 2016

Ted Bird, Chief Commercial Officer of Titan Spine, commented, “Achieving record sales growth in the first quarter this year speaks to the accelerating demand for our surface-enhanced titanium interbody devices and an increasing appreciation of the importance of our proprietary nano-architecture in its ability to drive rapid osteogenesis. The attainment of the 1,000-unit threshold of our nanoLOCK®device in just six months of its commercial availability underscores the market demand for devices that benefit patients in the early post-op timeframe as spine surgeons are now under the microscope for improved early results more than ever before. Our rapid nanoLOCK®adoption has certainly been aided by its sole access to the CMS new technology ICD-10 code for nanotextured interbody fusion devices, which has placed nanoLOCK® in a category all its own and has resulted in a dramatic increase in the number of hospitals and surgeons that have access to it. We could not be more pleased with our sales results to date and the continued successful launch of nanoLOCK®.”

Steve Cichy, Executive Vice President of Sales of Titan Spine, added, “Our Q1 achievements reflect the growing demand from our current surgeon base plus new relationships we have made with surgeon adopters that are beginning to embrace the benefits of nanotechnology for their patients. As a result, we have significantly invested in our field sales management team by tripling the number of Area Vice Presidents and Regional Managers we employ in just under a year. We are uniquely positioned to continue to take market share throughout the rest of 2017 and beyond.”

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.2,3,4 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 textured surface 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.

1 Olivares-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.

2 Olivares-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.

3 Olivares-Navarrete, R., Gittens, R.A., Schneider, J.M., Hyzy, S.L., Haithcock, D.A., Ullrich, P.F., Schwartz, Z., Boyan, B.D. (2012). Osteoblasts exhibit a more differentiated phenotype and increased bone morphogenetic production on titanium alloy substrates than poly-ether-ether-ketone. The Spine Journal, 12, 265-272.

4 Olivares-Navarrete, R., Hyzy, S.L., Gittens, R.A., Schneider, J.M., Haithcock, D.A., Ullrich, P.F., Slosar, P. J., Schwartz, Z., Boyan, B.D. (2013). Rough titanium alloys regulate osteoblast production of angiogenic factors. The Spine Journal, 13, 1563-1570.

Contacts

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

Pascale Davis, an internationally renowned expert on the spine market, joins Safe Orthopaedics as Global Head of Marketing

April 24, 2017

ERAGNY-SUR-OISE, France–(BUSINESS WIRE)–Regulatory News:

SAFE ORTHOPAEDICS (Paris:SAFOR) (FR0012452746 – SAFOR), a company offering an innovative range of sterile implants combined with their single-use instruments for spinal surgery, is today announcing the appointment of Pascale Davis, an internationally renowned expert on the spine market, as Global Head of Marketing.

Pascale is a seasoned veteran with over 18 years’ experience in marketing and scientific affairs. She worked for industry leaders including Zimmer Biomet, Synthes and SpineArt, where she acquired both marketing and scientific knowledge in Europe and in the United States.

Before joining Safe Orthopaedics, Pascale was Marketing Director for Europe, Middle East and Africa (EMEA) at Zimmer Biomet Spine, since 2012 where initially her role was EMEA Scientific Affairs Director. Previously, she held various positions of responsibility at Synthes Spine and SpineArt in Switzerland and then in the United States. Concurrently, Pascale was also Director of Education and Marketing for the International Society for Advancement of Spinal Surgery (ISASS) from 2001 until 2006.

“It gives us great pleasure to welcome Pascale to Safe Orthopaedics. Her arrival illustrates the Company’s ability to attract well-known international talents and the growing interest in its technology, as was recently demonstrated by AP-HP’s decision to list our products,commented Pierre Dumouchel, Co-Founder and Chief Executive Officer of Safe Orthopaedics. “Pascale’s arrival will provide a significant boost to our marketing capabilities and training programs that we provide to surgeons to foster the take-up of our products and to give them more information about the benefits of Safe Orthopaedics’ sterile single-use products for both minimally-invasive and trauma surgery.”

Pascale Davis, Safe Orthopaedics’ Head of Global Marketing, added: “I’m delighted to be joining Safe Orthopaedics. Their innovative technology is highly acclaimed and respected and gaining more and more traction in France and internationally. I will be applying my market knowledge together with the experience I gained in the scientific community to accelerate adoption of our products by surgeons and centers of excellence for spinal surgery — in France, Germany and also in other European and emerging markets.”

Next report: Full-year 2016 results on Friday, April 28, 2017

About Safe Orthopaedics

Founded in 2010, Safe Orthopaedics is a French medical technology company that aims to make spinal surgeries safer by using sterile implants and associated single-use instruments. Through this approach, these products eliminate all risk of contamination, reduce infection risks and facilitate a minimally-invasive approach for trauma and degenerative pathologies—benefiting patients. Protected by 17 patent families, the SteriSpineTM kits are CE-marked and FDA approved. The company is based at Eragny-sur-Oise (Val d’Oise department), and has 30 employees.

For more information, visit: www.SafeOrtho.com

Contacts

Safe Orthopaedics
Thierry Lambert, +33 (0)1 34 21 50 00
CFO
investors@safeorthopaedics.com
or
NewCap
Julien Perez / Valentine Brouchot
Investor Relations
Nicolas Merigeau
Media Relations
+33 (0)1 44 71 94 94
SafeOrtho@newcap.eu

SI-BONE, Inc. Announces Publication of 6-year Clinical Results Demonstrating Long-Term Positive Outcomes of iFuse Implant System®

SAN JOSE, Calif., April 24, 2017 /PRNewswire/ — SI-BONE, Inc., an innovative medical device company that pioneered the use of the iFuse Implant System® (“iFuse”), a triangular shaped minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced the publication of a 6-year study comparing the iFuse ImplantTM to both conservative management and radiofrequency denervation.  The long-term study titled Minimally Invasive Sacroiliac Joint Fusion, Radiofrequency Denervation and Conservative Management for Sacroiliac Joint Pain: Six Year Comparative Study, was published in the journal Neurosurgery.

The study evaluated 137 patients seen in an outpatient neurosurgery clinic who received either conservative management (63 patients), SI joint denervation (47) or SI joint fusion with the iFuse Implant (27) for SI joint pain due to either osteoarthritic degenerative sacroiliitis or SI joint disruption.  Outcomes were based on SI joint pain ratings using a 0-10 visual analog scale (VAS), functional status using Oswestry Disability Index (ODI), pain medication use and work status.  Patients treated with conservative management as well as those treated with radiofrequency denervation had no long-term improvement in pain or function, and in fact got worse, whereas the iFuse Implant group had markedly superior improvements in pain (See Figure 1) and function.

At last follow-up, 80% of the patients in both the conservative management and radiofrequency denervation groups were using opioids, compared to only 7% of the patients in the iFuse Implant group.  At last follow-up, 70% of patients treated with the iFuse Implant had returned to work, compared to 34% of those treated with radiofrequency denervation and 19% of those treated with  conservative management.

Figure 1  VAS SI joint pain score

Publication of results of this long-term study extends the duration of follow-up out to 6 years with the iFuse Implant.  iFuse is specifically designed for SI joint fusion with a unique triangular shape that prevents rotational motion and a porous surface that promotes bony ongrowth and ingrowth1.  The iFuse Implant is the only SI joint fusion device with prospective peer-reviewed publications demonstrating safety, effectiveness and durable positive outcomes, and the only SI joint fusion device with a FDA-cleared claim that clinical studies demonstrate improvements in pain, patient function and quality of life.

“An interesting observation from our study was that over one-third of patients seen in our clinic and initially treated with conservative management failed to achieve adequate pain relief and required additional treatments.  Of the treatments available, only SI joint fusion with the iFuse Implant provided sustained, long term pain relief,” said Vicente Vanaclocha-Vanaclocha MD, PhD, primary author of the study.  “Furthermore, the fact that the treatment option provided was often decided by external factors enhanced the comparability of groups.  This study offers solid evidence that the iFuse Implant is an effective long-term treatment for those patients with chronic pain resulting from certain types of SI joint pathologies who fail to respond to initial conservative management.”

Jeffrey Dunn, President and CEO of SI-BONE commented: “This study is remarkable in that it highlights the profound positive impact on patients with SI joint pain who have access to SI joint fusion.  The opioid epidemic is a challenging public health problem in the U.S. and coverage policies that provide access to technologies like the iFuse Implant can have a meaningful impact on reducing dependence on opioids.”

About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is a leading innovative medical device company dedicated to the development, manufacture and commercialization of minimally invasive surgical devices for the treatment of patients with low back symptoms related to certain sacroiliac (SI) joint disorders.  SI-BONE, Inc. first received 510(k) clearance to market its iFuse Implant System (“iFuse”) from the Food and Drug Administration (FDA) in November 2008. The CE mark for European commercialization was obtained in November 2010.

The iFuse Implant System provides a minimally invasive surgical solution to fuse the SI joint using patented triangular titanium implants that create an interference fit within the ilium and sacrum.  The triangular implant shape, combined with the press fit insertion, is designed to provide immediate fixation by minimizing rotational motion.  The implants have a porous surface that provide an ideal environment for bone ongrowth and ingrowth1, facilitating long-term fusion of the joint.  The iFuse Implant is the only commercially available SI joint fusion device in the United States with significant published prospective clinical evidence that demonstrates safety, effectiveness and economic benefits, including three large multicenter studies, two of which are randomized controlled trials.  Currently, there are more than 50 peer-reviewed publications supporting positive clinical outcomes, safety, biomechanics, and the economic benefits of the iFuse Implant (www.si-bone.com/results).

The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis.  This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.  There are potential risks associated with the iFuse Implant System.  It may not be appropriate for all patients and all patients may not benefit.  For information about the risks, visit: www.si-bone.com/risks

SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2017 SI-BONE, Inc. All Rights Reserved. 9761.041017

  1. MacBarb RF, Lindsey DP, Woods SA, Lalor PA, Gundanna MI, Yerby SA. Fortifying the Bone-Implant Interface Part II: An In Vivo Evaluation of 3D-Printed and TPS-Coated Triangular Implants. Int J Spine Surg. 2017;11. [Accepted, publication pending]

 

SOURCE SI-BONE, Inc.

Stryker’s Spine Division to Feature Comprehensive Product Portfolio at AANS 2017 Conference

April 21, 2017

ALLENDALE, N.J.–(BUSINESS WIRE)–Stryker’s Spine division will exhibit its comprehensive suite of spinal products at the American Association of Neurological Surgeons (AANS) Annual Scientific Meeting, April 22–26, 2017, at the Los Angeles Convention Center (booth No. 1301). This exhibition includes a number of advanced spinal products and technologies that Stryker’s Spine division has introduced in the past year. The company also will offer a Lunch-and-Learn educational program for AANS members attending the meeting.

“This is an exciting time, both for the field of spinal surgery and for Stryker’s Spine division,” said Bradley Paddock, President of the company’s Spine division. “Our expanding portfolio of spinal procedural innovations and differentiated technologies demonstrates our commitment to bringing state-of-the-art products to physicians and their patients. We will continue to increase and strengthen our leadership position in this segment and are thrilled to showcase our latest technology advances at the AANS conference.”

Stryker’s Spine division’s products offer advancements for both traditional and minimally invasive surgical techniques. Recently introduced technologies that will be highlighted at the meeting include:

  • The Tritanium Posterior Lumbar (PL) Cage, a 3D-printed 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. It is manufactured using Stryker’s proprietary Tritanium Technology, which allows for the creation of porous structures that are designed to mimic cancellous bone in pore size, level of porosity, and interconnectivity of the pores.1 The cage is now offered in a variety of new sizes, which were introduced at the 2017 AAOS conference in March.
  • Aero-C Cervical Stability System (Aero-C), the only StraightForward anterior cervical discectomy and fusion (ACDF) device that offers uniform compression across the interbody space.2 Using Aerofoil™ Compression Technology, Aero-C is designed to pull the vertebral bodies toward the implant as it is inserted, creating compressive forces at the implant-to-endplate interface.2
  • Xia CT (Xia 4.5 Cortical Trajectory), which includes implants and instruments used in less invasive LITe LIF posterior lumbar interbody fusion procedures for patients with degenerative disc disease, spondylolisthesis, and trauma. The cortical trajectory procedure facilitates a smaller midline incision to help achieve decompression, fixation, and fusion.3 It also is intended to be more muscle sparing than standard open procedures that require lateral dissection, and its reduced incision may allow for more efficient exposure and closure time.3
  • The LITe BIO Delivery System, a hand-held device used to facilitate delivery of bone graft material to spinal surgery sites, simplifies graft delivery, accommodates a surgeon’s preferred graft materials,4 and allows for direct visualization of graft placement. The unique design of the LITe BIO Delivery System provides surgeons with a single-handed method to deliver any type of autograft, allograft, or synthetic bone graft material without obstructing visibility. The innovative delivery tool provides tactile, visual, and audible confirmation of bone graft delivery, and the mallet-free system eliminates the impaction of bone graft.

Stryker’s Spine division will host the Lunch-and-Learn seminar, “Tritanium: A Novel Highly Porous Titanium Alloy for Interbody Fusion Procedures,” Monday, April 24 from 1:10–1:55 p.m. The seminar will be presented by Matthew J. McGirt, M.D., from the Department of Neurosurgery at the University of North Carolina.

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.

References

1. Karageorgiou V, Kaplan D. (2005) Porosity of 3D biomaterial scaffolds and osteogenesis. Biomaterials, 26, 5474-5491.
2. PROJ0000050417 Aero-C Anchor Induced Compression Testing Design Iteration Memo
3. Lee GW, Son JH, Ahn MW, Kim HJ, Yeom JS. (2015) The comparison of pedicle screw and cortical screw in posterior lumbar interbody fusion: a prospective randomized noninferiority trial. The Spine Journal 15, 1519-1526.
4. FDA Cleared Indications for Use: The LITe BIO Delivery System is intended to deliver autograft, allograft or synthetic bone graft materials to all orthopaedic surgical sites.

Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademarks or service marks: Aero, Aerofoil, LITe, StraightForward, Stryker, Tritanium, and Xia. All other trademarks are trademarks of their respective owners or holders.

Content ID TRITA-PR-7_13958

Contacts

Sullivan & Associates
Barbara Sullivan, 714/374–6174
bsullivan@sullivanpr.com

7D Surgical Enters Into Key Distribution Agreements in the United States for Its Breakthrough Image Guidance System for Spine Surgery

TORONTO, April 20, 2017 /PRNewswire/ — 7D Surgical, developer of ground breaking surgical navigation technologies, announced today that it has entered into exclusive sales representative agreements with two premier American medical device distributors covering key strategic geographies in the United States.  Surgical One Inc. will represent 7D Surgical in several states from the Midwest to the Gulf Coast, while DB Surgical will cover the southeast U.S., including the important medical device markets in Florida.

“Proven distribution partners, such as Surgical One and DB Surgical, will complement our direct sales force in the commercialization of the MvIGS technology for the execution of our rapid growth strategy,” said Beau Standish, Chief Executive Officer of 7D Surgical.  “Both companies have the infrastructure, footprint and existing relationships that are required to effectively promote the benefits of 7D Surgical’s fast, cost effective and radiation-free image guided spine surgery to a large and underserved market.”

The 7D Surgical System is the first and only Machine-Vision Image Guided Surgery (MvIGS) platform. For the first-time spine surgery patients can be quickly, easily and automatically registered using only visible light and 7D Surgical’s Flash RegistrationTM technology. Unlike time-consuming conventional image guided surgery (IGS) systems that depend on intraoperative radiation, this new MvIGS platform can achieve an incredibly fast surgical workflow for spine procedures. 7D Surgical anticipates adding additional qualified distribution partners in coming months.

“When Surgical One learned about the new MvIGS system, we recognized immediately that the 7D Surgical technology had erased the traditional barriers to spinal image guidance adoption and the low utilization of existing alternatives,” said Al Ludvigsen, President of Surgical One Inc. “We are thrilled to exclusively represent this fast, radiation-free solution for spinal image guidance to the clinicians and patients we support.”

“While spinal image guidance had been shown in studies to reduce surgical complications, we have yet to see widespread adoption of existing technologies among spinal surgeons,” said Debbie Burg, President of DB Surgical.  “We see the introduction of the 7D Surgical System MvIGS technology as a game-changer with the potential to finally expand the use of IGS in spine surgery.”

About 7D Surgical

7D Surgical is a privately owned Toronto-based company that develops advanced optical technologies and machine vision-based registration algorithms to improve surgical workflow and patient care. 7D Surgical’s flagship FDA 510(k)-cleared and Health Canada-approved MvIGS system delivers profound improvement to surgical workflows in spine surgery, providing the promise of similar future advancements in other surgical specialties.  www.7Dsurgical.com

Contact:
Beau Standish, CEO
7D Surgical
+1 647 484-0078
www.7Dsurgical.com
155698@email4pr.com

About Surgical One, Inc.

SurgicalOne, Inc. is the premier surgical specialty distribution company in the Midwest to Midsouth. Our 30 direct employees cover 10 total states, with sales representatives and service repair technicians in each major market. We represent the top tier, finest microsurgical, neurosurgical and spinal product manufacturers in the world. Since our founding in 2000, we have maintained a relentless, singular focus on patients, surgical clinicians and medical facility administrators. Our ultimate goal is improved patient outcomes, combined with the highest level of clinician satisfaction. www.surgicalone.com

About DB Surgical

DB Surgical is dedicated to bringing transformational surgical technologies to hospitals and surgery centers. The company focuses on introducing tools that enable surgeons to advance patient outcomes beyond those available today. Since 1997, DB Surgical has worked with industry-leading surgeons to understand and meet the evolving needs of healthcare providers. The company is based in Coral Springs, FL and has 18 professionals located throughout Florida, Georgia, and Alabama focusing on the Neuro, Spine, ENT, Cardiovascular, Ophthalmic, and Plastic Reconstructive surgical disciplines. In addition to providing cutting-edge technologies, DB Surgical also offers a complete line of specialty surgical products designed to create value within the healthcare supply chain. www.DBSurgical.com.

Contact:
Phone: 954-340-2727
Fax: 954-340-1221
Email: sales@dbsurgical.com

Forward-looking Statements

This press release contains forward-looking statements regarding, among other things, statements pertaining to expectations, goals, plans, objectives, and future events. 7D Surgical intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934, and the Private Securities Reform Act of 1995. In some cases, forward-looking statements can be identified by the following words: “may,” “can,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “promise,” “continue,” “ongoing,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements are based on the current estimates and assumptions of our management as of the date of this press release and are subject to risks, uncertainties, changes in circumstances, assumptions, and other factors that may cause actual results to differ materially from those indicated by forward-looking statements, many of which are beyond 7D Surgical’s ability to control or predict. Given these uncertainties, undue reliance should not be placed on these forward-looking statements. 7D Surgical does not undertake any obligation to release publicly any updates or revisions to these forward-looking statements to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events.

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SOURCE 7D Surgical

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NuVasive Launches New Spinal Trauma Portfolio

SAN DIEGO, April 19, 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced the launch of the new RELINE® Trauma portfolio, which will serve as the Company’s foundation to address the estimated $100 million U.S. spine trauma fixation market, currently growing 5.6 percent annually.

Spine trauma cases are performed approximately 90 percent open and only 10 percent minimally-invasive. RELINE Trauma is the first trauma system designed to provide surgeons the flexibility to customize their approach intra-operatively, including traditional open, MAS® (Maximum Access Surgery) or hybrid procedures, depending on the pathology and patient needs. Developed by the leader in minimally disruptive spine technology, the Company’s new trauma system supports surgeons in the increasing transition from open to MAS spine procedures.

The system offers surgeons the ability to customize implant types and supports a multitude of techniques, depending on surgeon preference. Also, RELINE Trauma enhances the surgeon’s ability to dial-in fracture correction through a dual rack system achieving independent lordosis restoration and parallel compression/distraction for ligamentotaxis. This enables procedures to be completed by one surgeon rather than two, helping reduce the total cost of the procedure.

“The versatility of the new RELINE Trauma system allows me to address trauma surgery circumferentially,” said Juan Uribe, M.D., Associate Professor, Department of Neurosurgery, University of South Florida College of Medicine, Tampa, Florida. “NuVasive has removed the need for a second surgeon and eliminated hours in comparison to the alternative technique. RELINE Trauma is a game-changer in spine.”

In addition, the RELINE Trauma Fracture Frame instrumentation allows for controlled fracture correction throughout the procedure, with or without a rod present in the construct. The systems also allows surgeons the ability to place various rod diameters and/or materials before or after fracture correction, greatly improving the ability to reduce fractures more easily and reproducibly.

“The launch of RELINE Trauma is a key milestone in our continued commitment to industry-leading innovation that delivers untapped clinical and economic value for our surgeon partners,” said Jason Hannon, president and chief operating officer of NuVasive. “RELINE Trauma will help define the standard of trauma care for spine, with its ability to dramatically reduce time and provide complete versatility intra-operatively. The system will be the foundation of our trauma portfolio as we invest further in this key market.”

RELINE Trauma is further integrated with proprietary NuVasive Computer Assisted Technologies such as NVM5®, NuvaLine™, NuvaMap® and NuvaMap® O.R., all within the Integrated Global Alignment® (iGA) platform. iGA allows surgeons to calculate, correct and confirm spinal alignment through preoperative planning, intraoperative assessment, and postoperative confirmation for their trauma cases. Additionally, constructs are further enhanced with the integration of the Bendini® system which expedites manual rod manipulation via computer-assisted bend instructions.

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

 

SOURCE NuVasive, Inc.

Related Links

http://www.nuvasive.com