Captiva Spine Announces TowerLOX-EXT® MIS Extended Tab Pedicle Screw Receives Clearance

Posted On September 11, 2018 By OrthoSpineNews In Regulatory, Spine, Top Stories /

Jupiter, FL, September 2018 – Captiva Spine, Inc., which designs, manufactures and distributes elegant and intuitive spine fusion solutions announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market TowerLOX-EXT® MIS Extended Tab Pedicle Screw complementing its TowerLOX® MIS Pedicle Screw System.

TowerLOX-EXT MIS Extended Tab Pedicle Screw

TowerLOX-EXT MIS Extended Tab Pedicle Screws provide the narrow insertion of an extended tab pedicle screw and the versatility, reliability, and security of a tower-based MIS pedicle screw. TowerLOX-EXT’s narrow insertion path coupled with TowerLOX’s patented articulating rod delivery/reduction options expand the capabilities of the system. Most notably, TowerLOX-EXT allows percutaneous tower attachment after the extended tabs have been removed, establishing a new standard for MIS pedicle screw systems. This is especially important intraoperatively, or for use when extending the fusion at a later date.

Dale Mitchell, President of Captiva Spine, stated “The design rationale and goals developed with our surgeon collaborators guided the creation of TowerLOX-EXT Extended Tab Pedicle Screw. Our intent was to reduce insertion pathway, eliminate counter-torque wound expansion, and retain the versatility provided by TowerLOX’s unique instrumentation for rod delivery, rod reduction, and spondylolisthesis reduction.”

TowerLOX® MIS Pedicle Screw System already supports MIS, mini-open, and open cases with simple and less invasive rod insertion (using patented Pivotec® Technology) and efficient internal/external rod reduction. TowerLOX-EXT screws provide 15mm of controlled built-in rod reduction above the break-off and in-situ tower attachment capabilities provide a MIS rescue/revision option not available with other extended tab systems.

Captiva Spine’s TowerLOX-EXT MIS Extended Tab Pedicle Screw is one of five new product launches that will be featured at Booth 1649 during the North American Spine Society (NASS) Annual Meeting held in Los Angeles, September 26-28, 2018.

Inquiries from tenured distribution professionals looking to partner with a company to build a relationship for the long run are always welcome.

For sales, contact:
Chip Jones, Director of Sales and Marketing
chip.jones@captivaspine.com or 561-277-9480 ext. 725
or via their website www.captivaspine.com/contact-us.

About Captiva Spine, Inc.

As a privately owned medical device organization founded in 2007, Captiva Spine supports spine surgeons, tenured spine distributors, and healthcare facilities in providing patients with progressive spinal care and an obsessive focus on quality. They strive to create and maintain sincere, honest, collaborative relationships. By valuing their relationships above all else, it fosters the mutual trust and openness needed for Captiva Spine to be a conduit of high quality, smart, elegant, and intuitive patient solutions. As a family of industry professionals, Captiva Spine takes pride in delivering these solutions responsibly and ethically while never losing sight of what they refer to as the Human Factor: Finding the joy in their daily lives and serving the needs of their customers with sincere, professional enthusiasm.

SEE MORE ABOUT TOWERLOX-EXT

This Press Release can be found at PRWeb.com and is also featured on other industry sites.

Amedica Corporation to Host Conference Call to Discuss Recent Sale of Spine Implant Business and Transition to Biomaterials Company

Posted On September 11, 2018 By OrthoSpineNews In Spine /

SALT LAKE CITY, Sept. 11, 2018 (GLOBE NEWSWIRE) — Amedica Corporation (NASDAQ: AMDA), a company that develops and commercializes silicon nitride for biomedical applications, announced today that it will host a conference call with Dr. Sonny Bal, Chairman and CEO of Amedica Corporation, to discuss the recently announced sale of its spine implant business to CTL Medical and its transition to a biomaterials company.

Details related to this call are as follows:

Date: Thursday, September 13, 2018

Time: 11:00 a.m., Eastern Time

Dial-in: Toll-free 877-524-8416
International 412-902-1028

Questions: Questions will not be taken during the call. Investors may submit questions prior to the call via email to IR@amedica.com. Questions will be accepted through 10:00 p.m. Mountain time on Tuesday, September 11, 2018.

For those who are not available to listen to the call, a digital replay will be archived on the investor relations section of the Amedica website under Events & Presentations.

About Amedica Corporation

Amedica is an innovative biomaterials and OEM company that develops and commercializes silicon nitride for various biomedical applications including orthopedic, dental and arthroplasty.

Contacts:
Amedica IR 
801-839-3502
IR@amedica.com

Genesys Spine releases AIS-C Stand-Alone System

Posted On September 10, 2018 By OrthoSpineNews In Spine, Top Stories /

AUSTIN, Texas, Sept. 10, 2018 /PRNewswire/ — Genesys Spine is pleased to announce the FDA clearance of our latest product line, the AIS-C Stand-Alone System.

The AIS-C Stand-Alone system is a first of its kind, non-screw based, zero-profile, direct-anterior stand-alone interbody system for the cervical spine. It was designed to provide the greatest ease of use to the surgeon at every step of the procedure.

Advantages of the AIS-C Stand-Alone System include:

Direct anterior approach – Allows for a smaller, mid-line incision.
Non-screw-based fixation.
Quick, simple, non-impacting anchor insertion – Does not need an awl or drill.
Zero-step locking mechanism – Contains a locking feature that provides visual confirmation of engagement, but allows for anchor removal when desired.
Easily revised or removed – Use of the removal instruments allows the locking mechanism to be defeated so the anchor can be extracted. No drilling is required.

Dr. Matthew Philips, board-certified neurosurgeon and Director of the Brain and Spine Center at SouthCoast Health in Massachusetts says, “The ease of application of the AIS-C Stand-Alone will reduce both my surgical times and the morbidity associated with plate and screw constructs. This advantageous technique has made this my implant of choice for ACDFs.”

“The most significant aspect of the AIS-C design is its simplicity to implant. From a surgeon’s perspective, there’s only one extra step compared to a standard cervical fusion. Once everything is loaded, they simply squeeze the trigger of the inserter and detach from the implant.” -J. Landon Gilkey, Senior Principal Design Engineer, Genesys Spine.

“The AIS-C Stand-Alone system works great from insertion to removal and I think it will remain one of Genesys’ flagship products for years to come.” –Benjamin Keller, Product Development Engineer, Genesys Spine.

Media inquiries please contact:

marketing@genesysspine.com

www.genesysspine.com

About Genesys Spine:

Founded in 2009, Genesys Spine is a privately held company focused on the design, development and marketing of an array of medical implants and instruments with novel characteristics. These devices, with their award winning proprietary features, all remain within existing parameters for today’s current reimbursement codes.

SOURCE Genesys Spine

Carevature Medical’s Dreal™ Decompression System is Safer for Patients, Says Recent Article

Posted On September 10, 2018 By OrthoSpineNews In Spine /

TEL AVIV, Israel, Sept. 5, 2018 /PRNewswire/ — According to a recent article in the International Journal of Spine Surgery, advanced decompression innovator Carevature’s Dreal™ device yields significantly better results in incidental dural tears, with 87% improvement compared to high-speed drills and Kerrison Rongeurs (0.4% vs. 2.91%; p<0.01); and 80% improvement compared to ultrasonic bone cutters (0.4% vs. 1.95%; p<0.01).

This data demonstrates the Dreal™’s marked advantages in reducing natural risk of neural element injury. The results are attributed to the device’s unique curved and shielded tip design, which requires only a very limited number of passes to remove the target pathology.^[1]

“This confirms what my colleagues and I have been experiencing in our surgical practice,” says Dr. Ely Ashkenazi, MD, neurosurgeon and senior spine surgeon at Tel Aviv’s Israel Spine Center, where he and his team have used the Dreal™ in over 200 cervical, thoracic, and lumbar spine procedures.

“I’ve been deeply impressed with the design and function of these devices,” adds Scott C. Kutz, MD, neurosurgeon at the Texas Back Institute (Plano, TX). “I don’t believe any other device on the market can provide these results. Furthermore, it increases the efficiency and safety with which I can perform multiple, dissimilar spinal procedures. In particular, these devices are extremely helpful in minimally invasive spine surgery – a market segment that’s expanding relative to standard spine surgery. I expect that use of the Dreal™ system will grow exponentially over the next few years, in step with the demand for minimally invasive spinal techniques.”

Says Charlie Harrison, President of Carevature Medical, Inc. (Marietta, GA): “We’ve all been waiting for the new line of bayoneted designs, which truly raises the bar for decompression systems. Feedback from surgeons has been superb, and we’re confident that this overwhelmingly positive response will be a major step towards the Dreal™’s rapid expansion in US markets and beyond.”

ABOUT CAREVATURE

Carevature Medical Ltd., a privately-held medical device company headquartered in Rehovot, Israel, is dedicated to developing advanced orthopedic surgery solutions. Carevature is currently marketing its flagship line of products for spinal indications, Dreal™: the first and only curved device powerful enough to efficiently cut bone, and small enough for use in all sections of the spine. Over 800 patients worldwide have been treated with the Dreal™, with outstanding safety and recovery results.

www.carevature.com

^[1]Suitability of Administrative Databases for Durotomy Incidence Assessment: Comparison to the Incidence Associated With Bone-Removal Devices, Calculated Using a Systemic Literature Review and Clinical Data. Robert Pflugmacher, Angelo Franzini, Shaked Horovitz, Richard Guyer, Ely Ashkenazi. International Journal of Spine Surgery Aug 2018, 12 (4) 498-509; DOI: 10.14444/5061

Media contact:

Robert W. Cook, VP Marketing & Sales

Carevature Medical, Inc.

M: +1-260-417-1643

E: bob@carevature.com

SOURCE Carevature Medical Ltd.

St. Mary’s Medical Center Selected to Study Use of TOPS™ System

Posted On September 6, 2018 By OrthoSpineNews In Spine /

SAN FRANCISCO, Sept. 5, 2018 /PRNewswire/ — The Spine Center at Dignity Health St. Mary’s Medical Center, has been selected to participate in a FDA/IDE pivotal study, sponsored by Premia Spine, Ltd., studying the use of the TOPS™ System. St. Mary’s Medical Center is one of 30 spine centers throughout the U.S. taking part in the study to evaluate the efficacy and safety of the TOPS™ System compared to traditional lumbar fusion.

The TOPS™ System is a mechanical device designed to restore motion of the spine in all directions. Instead of permanently locking the two vertebrae with a fusion, the device allows the two vertebrae to continue moving. If approved, TOPS™ would potentially be the first posterior arthroplasty device for the treatment of degenerative Grade I spondylolisthesis and spinal stenosis.

“We are very excited to be selected as investigators in the TOPS™ System study because it offers a unique opportunity for patients who meet the study’s criteria to potentially receive a motion preserving device for the surgical treatment of degenerative spondylolisthesis and spinal stenosis,” said Dr. James Zucherman, orthopedic surgeon and medical director of the St. Mary’s Spine Center.

Patients participating in the study will either undergo surgery with the TOPS™ System or lumbar spinal fusion. Patients are randomly placed into one group or the other with a 67 percent likelihood of undergoing surgery with the Premia device.

“There are countless people suffering from debilitating back pain caused by a slipped disc or narrowing of the spine who must either manage the pain through physical therapy and injections or undergo surgery,” added Dr. Zucherman. “We believe that this study will provide us the scientific data needed to support the continued use of technologies that aim to correct underlying spinal conditions while helping to restore range of motion.”

Study participants must be experiencing:

radiating leg pain,
greater leg or buttock pain than back pain,
severe pain after walking as little as 100 yards or 2 minutes,
and/or pain that reduces when sitting, bending forward, or leaning over a shopping cart.

These symptoms could be signs of degenerative spondylolisthesis, spinal stenosis and additional spinal conditions. Patients can learn more about the TOPS™ System study by calling (415-750-5836) or visiting http://www.ClinicalTrials.gov, search NCT03012776.

About Dignity Health St. Mary’s Medical Center

Dignity Health St. Mary’s Medical Center is an accredited, not-for-profit community hospital that has been caring for the people of San Francisco since 1857. Located across from Golden Gate Park, it is the longest continually running hospital in San Francisco. For three consecutive years, from 2014 to 2016, St. Mary’s received the Distinguished Hospital Award for Clinical Excellence from Healthgrades. St. Mary’s also was recognized as one of the Top 100 Orthopedic Programs nationally by Becker’s Hospital Review and is a Certified Stroke Center by the Joint Commission. St. Mary’s state-of-the-art Cancer Center offers the full-range of oncology, radiation, and imaging services. Offering the most comprehensive breast imaging services in San Francisco, St. Mary’s has been designated as a Center of Excellence by the American College of Radiology, a recognition that represents the national gold standard. For more information, call 855.970.2938.

Join Our Community

facebook.com/StMarysSF

twitter.com/StMarys_SF

SOURCE Dignity Health St. Mary’s Medical Center

Positive Commercial Payor Policy Covering coflex® For The Surgical Treatment Of Lumbar Spinal Stenosis

Posted On September 6, 2018 By OrthoSpineNews In Spine /

NEW YORK, Sept. 6, 2018 /PRNewswire/ — Paradigm Spine, LLC, a leader in providing solutions for the treatment of lumbar spinal stenosis, announces issuance of a BlueCross BlueShield of South Carolina Medical Policy, entitled “Interspinous and Interlaminar Stabilization/Distraction Devices (Spacers)” dated August 2018.

Lumbar spinal stenosis (“LSS”), affecting 1.6 million patients annually, is a debilitating and degenerative disease in older patients (>50 years) often associated with significant leg and back pain, leg numbness and weakness, causing a significant reduction in an active lifestyle. Traditional surgical treatment options for LSS includes a decompression that removes bone and soft tissue and may also require a fusion to stabilize the spine. The coflex^® device is a non-fusion, motion-preserving stabilization implant, that is FDA PMA approved for the treatment of lumbar spinal stenosis and is used in conjunction with a decompression, or used in lieu of a spinal fusion.

To learn more about coflex^® Interlaminar Stabilization^®, please visit www.coflexsolution.com.

Marc Viscogliosi, Chairman & CEO – “With more than 90 peer-reviewed published articles, including landmark long-term follow-up clinical studies, spine medical society guidelines, and now with additional commercial insurance coverage, it is wonderful to be able to expand patient access to the coflex^® technology.”

About Paradigm Spine, LLC

Paradigm Spine, LLC, founded in 2004, is a privately held company and remains focused on the design and development of solutions for the disease management of spinal stenosis. The Company’s signature product is the coflex^® Interlaminar Stabilization^® device, which is currently used in over 60 countries worldwide. coflex^® is the only lumbar spinal device that has produced Level I evidence in two separate prospective, randomized, controlled studies against two different control groups, changing the standard of care for lumbar spinal stenosis treatment. For additional information visit www.paradigmspine.com or www.coflexsolution.com.

SOURCE Paradigm Spine, LLC

(PRNewsfoto/Paradigm Spine, LLC)

The coverage policy may be found here: http://www.cam-policies.com/internet/cmpd/cmp/mdclplcy.nsf/DispContent/A50CA6ABF1D50CAF8525811E0062FC38?opendocument

Reston Hospital Center Launches Training Program for Robotic Guided Spine Surgery

Posted On September 6, 2018 By OrthoSpineNews In Robotics, Spine /

Reston, Virginia, Sept. 06, 2018 (GLOBE NEWSWIRE) — The Virginia Institute of Robotic Surgery at Reston Hospital Center has announced the launch of its Visiting Clinician Program (VCP) for robotic assisted spine surgery using the Mazor X Robotic system, a partnered program with Medtronic. The VCP at Reston Hospital Center will be led by Dr. Christopher Good, spinal surgeon at the Virginia Spine Institute (VSI). As the Director of Scoliosis & Spinal Deformity Surgery at VSI, Dr. Good is at the forefront of spine surgery and has performed the Mid-Atlantic’s first and most advanced procedures using robotic assisted technology at Reston Hospital Center.

“Our team has been leading the way in implementing the latest in surgical innovations for years,” said John Deardorff, President and CEO of HCA’s Northern Virginia Market and Reston Hospital Center. “Consistently providing excellent patient care and superior results, Reston Hospital Center has become recognized as a destination that surgeons from around the world come to train.”

The VCP at Reston Hospital Center is designed to enable spine surgeons from around the world to see the technology while learning best practices for implementation in another facility or surgical program.

A visit to the program includes a case observation, as well as an opportunity to complete a training curriculum and to spend time with Dr. Good, learning the technology and how its best applied in complex cases. Visiting surgeons will also be exposed to the daily operations of running a comprehensive robotic surgery program from the administrative perspective, while having the opportunity to speak with leadership from the surgical services area.

“Our research is showing that this robotic technology can decrease radiation to patients in the operating room, as well as improve the safety for patients having spine surgery,” said Dr. Christopher Good. “The launch of this Visiting Clinician Program at Reston Hospital Center is just one more step toward ensuring that our patients have the safest and most advanced treatment available to them; and, now, I have the pleasure of giving the same opportunity to surgeons around the world.”

The robotic assisted technology is used for pre-planning minimally invasive as well as complex spinal reconstruction procedures. It allows spine surgeons to precisely plan out the desired surgery and to carry out the procedure with a high degree of confidence and accuracy.

About Reston Hospital Center

Part of HCA Virginia Health System, Reston Hospital Center is a 187-bed, acute-care medical and surgical facility that has garnered high honors for attentive patient care and nursing excellence. Reston Hospital Center is home to the region’s newest Level II Trauma Center and the most comprehensive robotic surgery in the Mid-Atlantic. Statewide, HCA Virginia Health System operates 14 hospitals and more than 30 outpatient centers and is affiliated with 3,000 physicians. It is Virginia’s fourth‐largest private employer, provides $190.8 million in charity and uncompensated care, and pays $72.6 million in taxes annually. For more information about Reston Hospital Center visit www.restonhospital.com.

Erin Echelmeyer
Reston Hospital Center
703-689-9030
Erin.Echelmeyer@hcahealthcare.com

4WEB Medical Announces Substantial Growth of its Lateral Product Offering

Posted On September 6, 2018 By OrthoSpineNews In Spine /

DALLAS, Sept. 5, 2018 /PRNewswire/ — 4WEB Medical, the industry leader in 3D printed implant technology, announced today substantial growth driven by its Lateral Spine Truss System™.

“We are extremely pleased with the adoption of our Lateral Spine Truss System™. 4WEB has achieved double digit growth YTD 2018 compared to 2017 in revenue, users, cases and units sold. Most impressive is the 73% increase in surgeon users,” said Jim Bruty, 4WEB Medical’s Senior Vice President. “We expect this trend to continue as demand for our lateral offering will be strengthened by the launch of 4WEB’s Total Lateral Solution at NASS 2018 in Los Angeles.”

4WEB’s proprietary Truss Implant Technology™ consists of a web structure at the bone interface that resists subsidence by distributing load across the entire vertebral endplate. Subsidence is a concern in lateral fusion with literature showing that cages with narrower widths and shorter lengths correlate to increased subsidence rates. A subsidence study performed by The University of Toledo compared the performance of the 4WEB Lateral Truss Implant to a competitive ring shaped implant. The study showed that the smallest footprint 4WEB Truss Implant outperformed the largest footprint ring shaped implant across all bone density models, including osteoporotic bone models, further demonstrating the importance of the maximizing endplate contact.

Tasha White, 4WEB Medical’s Marketing Director commented, “Lateral access procedures are the fastest growing segment in spine fusion surgery. We are committed to this market and offering surgeons the best solution for their patients. 4WEB’s proprietary bone interface web structure provides superior resistance to subsidence which is imperative in lateral spine surgery. The results of the University of Toledo study prove our innovative implant design outperforms ring shaped designs and demonstrates the superiority of 4WEB’s technology. Improved clinical outcomes have a tremendous appeal to surgeons and will be the driving force in the growth of our lateral product line.”

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

Photo: (PRNewsfoto/4WEB Medical)

Amedica Announces Agreement To Sell Spine Business To CTL Medical

Posted On September 6, 2018 By OrthoSpineNews In Spine, Top Stories /

SALT LAKE CITY, Sept. 06, 2018 (GLOBE NEWSWIRE) — Amedica Corporation (NASDAQ:AMDA) today announced that it has entered into an asset purchase agreement with CTL Medical, a Dallas, TX-based privately held medical device manufacturer that focuses on the spine implant and instrument market, whereby CTL Medical will acquire all of Amedica’s commercial spine business for total consideration of up to $10 million. The transaction is expected to close in the third quarter of 2018, and is subject to usual and customary due diligence and closing conditions.

The agreement will make CTL Medical the exclusive owner of Amedica’s portfolio of metal and silicon nitride spine products, with access to future silicon nitride spine technologies. As part of the transaction, CTL Medical will acquire Amedica’s entire existing inventory of spine products, including US and OUS regulatory clearances and intellectual property related to such. Amedica’s products, which are presently sold under the brand names of Taurus, Preference, and Valeo will be transferred to CTL Medical, while manufacturing, R&D, and all intellectual property related to the core biomaterial technology of silicon nitride will remain with Amedica in Salt Lake City. Amedica will serve as CTL’s exclusive OEM provider of silicon nitride products.

Following the purchase, CTL Medical will change its name to CTL Amedica. Amedica will re-position under a new name that is reflective of the breadth of its technology and potential applications.

“The transaction makes strategic sense, by monetizing our commercial spine sales organization and allowing Amedica to focus on its core biomaterials and OEM business,” said Dr. Sonny Bal, Chairman of the Board of Directors of Amedica. “Combining the mutually complementary products, customers, and sales regions of the two companies will offer significant accretive value to our shareholders. The addition of a highly-differentiated silicon nitride and metal product line to CTL Medical’s complete offering of spine surgery implants and instruments will benefit both companies, as well as our surgeon customers. Amedica’s products and scientific data have established that silicon nitride resists bacteria, promotes bone healing, and has superior clinical outcomes. CTL Medical is best positioned to profitably leverage these advantages in the retail spine market.”

“Going forward, Amedica will actively support spine sales by CTL Medical, specifically through surgeon education, peer-forums, publications, and research related to silicon nitride. Divesting the sales organization will drive down costs, while allowing Amedica to focus on additional OEM revenue opportunities outside of spine, such as in the dental and arthroplasty markets. As additional downstream opportunities with CTL Medical become apparent in the future, they will be explored as well.” added Dr. Bal.

“CTL Medical is a fast-growing, profitable company, with a complete line of FDA 510k cleared, market-tested spine products, in-house manufacturing facilities and an experienced sales team. Adding the credibility of Amedica’s products and technology, to which over 70 peer-reviewed publications already attest, to our product portfolio will generate new opportunities both in the U.S. and overseas” said Daniel Chon, President and CEO of CTL Medical. “Our team was deeply impressed at how far Amedica has taken its technology, in terms of breadth of application, as well as the quality, discipline, and depth of Amedica’s scientific inquiry. Onward, our goal is to apply the attributes of silicon nitride across our entire product line. CTL Medical will be the only company worldwide to offer such technology, further strengthening our position as an industry leader” added Mr. Chon.

Amedica is an innovative biomaterials and OEM company that develops and commercializes silicon nitride for various biomedical applications including orthopedic, dental and arthroplasty. CTL Medical is a forward thinking medical device design, development and manufacturing company that produces a full line of cervical, thoracic, and lumbar products (hence “CTL”) at its manufacturing headquarters in Dallas, Texas.

Maxim Group LLC is serving as Amedica’s strategic advisor. Amedica intends to host a conference call on September 13, 2018 to discuss the agreement with CTL Medical, and to provide a business update. Details related to this call will be provided at a later date.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (“PSLRA”). Such forward-looking statements include but are not limited to statements about the consummation of the transaction, the benefits of the transaction, including future accretive value to CTL and Amedica’s future financial results, operating plans, objectives, expectations and intentions, and other statements that are not historical facts. These forward-looking statements are subject to risks and uncertainties that may cause actual results or events to differ materially from those projected, including but not limited to the risks that the transaction does not close when expected or at all because required regulatory, shareholder or other approvals and other conditions to closing are not received or satisfied on a timely basis or at all; the risk that the benefits from the transaction may not be fully realized or may take longer to realize than expected, including as a result of changes in general economic and market conditions, interest and exchange rates, monetary policy, laws and regulations and their enforcement, and the degree of competition in the geographic and business areas in which Amedica and CTL operate; the ability of CTL to promptly and effectively integrate Amedica’s commercial spine business; the reaction to the transaction of the companies’ customers, employees, and counterparties; and the diversion of management time on transaction-related issues. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management’s current estimates, projections, expectations and beliefs. Amedica undertakes no obligation to publicly revise or update the forward-looking statements to reflect events or circumstances that arise after the date of this report.

Contacts:
Amedica IR
801-839-3502
IR@amedica.com

Source: Amedica Corporation

This article appears in: News Headlines

Referenced Stocks: AMDA

Innovasis Announces Successful Launch of TxHA™

Posted On September 6, 2018 By OrthoSpineNews In Spine, Top Stories /

SALT LAKE CITY, September 6, 2018 – Innovasis is pleased to announce the commercial launch of TxHA, ™ a TLIF interbody fusion device offering PEEK Optima HA Enhanced polymer.

Designed for use in spinal fusion procedures, the TxHA interbody device contains osteoconductive hydroxyapatite (HA) fully integrated into the polymer and exposed on all surfaces of the implant. This product follows the successful launch of Px HA (PLIF interbody) and Ax (Stand-alone ALIF) last year.

The first surgery was completed by Dr. Lavelle in Syracuse, NY. “The case went extremely well! The interbody and instrumentation is well designed and allowed for an easy and straightforward implantation. With this material technology you can expect better fusion rates.” said Dr. Lavelle. “HA PEEK is the future of PEEK interbodies.”

The Innovasis TxHA™ Transforaminal Lumbar IBF System is an intervertebral fusion device for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine (L2-S1). The implant is used to facilitate fusion in the lumbar spine and placed via a transforaminal approach. The TxHA implant also features a tapered leading edge to ease insertion, a convex profile to match anatomy, tantalum markers for improved visualization, and pyramidal teeth for migration resistance.

About Innovasis

Innovasis is a groundbreaking company engaged in the research, development, manufacturing, and marketing of spinal implant devices and related products. Innovasis offers a spinal product line with implants and instruments that address the major pathologies and focus areas of traditional spinal surgery.

Spine

Captiva Spine Announces TowerLOX-EXT® MIS Extended Tab Pedicle Screw Receives Clearance

TowerLOX-EXT MIS Extended Tab Pedicle Screw

About Captiva Spine, Inc.

Amedica Corporation to Host Conference Call to Discuss Recent Sale of Spine Implant Business and Transition to Biomaterials Company

Genesys Spine releases AIS-C Stand-Alone System

Related Links

Carevature Medical’s Dreal™ Decompression System is Safer for Patients, Says Recent Article

Related Links

St. Mary’s Medical Center Selected to Study Use of TOPS™ System

Positive Commercial Payor Policy Covering coflex® For The Surgical Treatment Of Lumbar Spinal Stenosis

Related Links

Reston Hospital Center Launches Training Program for Robotic Guided Spine Surgery

4WEB Medical Announces Substantial Growth of its Lateral Product Offering

Related Links

Amedica Announces Agreement To Sell Spine Business To CTL Medical

Innovasis Announces Successful Launch of TxHA™