Globus Medical Acquires Surgimap®

Posted On September 14, 2018 By OrthoSpineNews In Spine, Top Stories /

AUDUBON, Pa., Sept. 13, 2018 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal solutions company, today announced the acquisition of Nemaris Inc., a privately held company that markets and develops Surgimap®, a leading surgical planning software platform. Surgimap® allows healthcare professionals to simulate potential surgical outcomes and share medical imaging globally to improve procedural workflow and patient care.

“The acquisition of Surgimap® bolsters Globus Medical’s efforts to advance the future of computer-assisted surgery with the goal of improving patient outcomes,” said Chief Executive Officer Dave Demski. “Software-enhanced solutions are critical components of the future of computer-assisted surgery, and Surgimap® is the leading surgical planning software technology in the spine market today. We are very excited about the strategic fit of this acquisition, which will allow us to further enhance the capability of our ExcelsiusGPS® navigation and robotic system to assist surgeons in planning complex spine procedures and placing screws more accurately and less invasively.”

Surgimap®’s intuitive, patient specific surgical planning and cloud-based infrastructure, with predictive algorithms and visual guides, is licensed to most of the leading spine implant manufacturers today to enable these customers to plan and simulate potential surgical outcomes in the course of treating complex deformities. The addition of Surgimap® will further strengthen Globus Medical’s ExcelsiusGPS® platform by streamlining workflow and enabling superior data analytics. These existing platform features, in addition to the deep software expertise of the Surgimap® team, are also expected to accelerate the launch of new products in Imaging, Navigation, and Robotics.

“The acquisition will enable Globus to combine Surgimap®’s best-in-class spine surgery planning technology with the best-in-class robotic and navigation technology of ExcelsiusGPS®,” said Dr. Frank Schwab, Chief of Spine, New York City, and co-founder of Nemaris. “We think the synergies bring enormous benefit to the entire spine community and particularly surgeons who are interested in less invasive robotic and navigation based procedures.”

About Globus Medical, Inc.
Globus Medical, Inc. is a leading musculoskeletal solutions company based in Audubon, PA. The company was founded in 2003 by an experienced team of professionals with a shared vision to create products that enable surgeons to promote healing in patients with musculoskeletal disorders. Additional information can be accessed at http://www.globusmedical.com.

Safe Harbor Statements
All statements included in this press release other than statements of historical fact are forward-looking statements and may be identified by their use of words such as “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan” and other similar terms. These forward-looking statements are based on our current assumptions, expectations and estimates of future events and trends. Forward-looking statements are only predictions and are subject to many risks, uncertainties and other factors that may affect our businesses and operations and could cause actual results to differ materially from those predicted. These risks and uncertainties include, but are not limited to, factors affecting our quarterly results, our ability to manage our growth, our ability to sustain our profitability, demand for our products, our ability to compete successfully (including without limitation our ability to convince surgeons to use our products and our ability to attract and retain sales and other personnel), our ability to rapidly develop and introduce new products, our ability to develop and execute on successful business strategies, our ability to successfully integrate the operations of Nemaris and retain key employees, our ability to comply with changing laws and regulations that are applicable to our businesses, our ability to safeguard our intellectual property, our success in defending legal proceedings brought against us, trends in the medical device industry, general economic conditions, and other risks. For a discussion of these and other risks, uncertainties and other factors that could affect our results, you should refer to the disclosure contained in our most recent annual report on Form 10-K filed with the Securities and Exchange Commission, including the sections labeled “Risk Factors” and “Cautionary Note Concerning Forward-Looking Statements,” and in our Forms 10-Q, Forms 8-K and other filings with the Securities and Exchange Commission. These documents are available at www.sec.gov. Moreover, we operate in an evolving environment. New risk factors and uncertainties emerge from time to time and it is not possible for us to predict all risk factors and uncertainties, nor can we assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Given these risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements. Forward-looking statements contained in this press release speak only as of the date of this press release. We undertake no obligation to update any forward-looking statements as a result of new information, events or circumstances or other factors arising or coming to our attention after the date hereof.

Contact:
Brian Kearns
Vice President, Business Development and Investor Relations
Phone: (610) 930-1800
Email: investors@globusmedical.com
www.globusmedical.com

Benvenue Medical Completes Divestiture of its Vertebral Augmentation Systems Portfolio

Posted On September 14, 2018 By OrthoSpineNews In Spine, Top Stories /

September 13, 2018

SANTA CLARA, Calif.–(BUSINESS WIRE)–Benvenue Medical, Inc., a developer of minimally invasive expandable implant solutions for lumbar fusion, today announced it has completed the divestiture of its vertebral augmentation systems portfolio for an undisclosed amount to IZI Medical Products, LLC. The completion of the sale of this business allows Benvenue Medical to devote its full resources to accelerating growth opportunities in the large market for its Luna 3D Interbody Fusion System.

The divested portfolio includes the Kiva^®VCF Treatment System, Kiva^®Pilot and Blazer^® Vertebral Augmentation System devices.

“IZI Medical’s acquisition of the Kiva and associated VCF product franchise allows us to singularly focus on our minimally invasive spinal implant and procedure product line,” said Robert K. Weigle, CEO of Benvenue Medical. “Our best-in-class Luna 3D Expandable Interbody System is an ideal minimally invasive expandable spinal implant and platform technology, enabling Nitinol, PEEK and Titanium materials to be combined in a procedural solution for degenerative disc disease that can be treated in either the hospital or the ASC setting.”

Benvenue Medical also announced the addition of its new Orbit Discectomy Instrumentation that facilitates a circumferential and comprehensive discectomy and endplate preparation to achieve a fusion. This novel new tool kit can be used in open and minimally invasive surgery with the Luna 3D implants, including compatibility with a variety of surgical fusion approaches.

Benvenue Medical will continue its spine surgeon-focused product development and U.S. operations at its Santa Clara, Calif., facility.

About the Luna 3D Interbody Fusion System

The Luna 3D Interbody Fusion System is one of the largest footprint yet least invasive devices for posterior lumbar interbody spinal fusion. The Luna 3D System is comprised of a PEEK implant designed to expand in multiple dimensions within the disc space, first in footprint, second in height and third in lordosis, allowing surgeons to effectively restore sagittal balance and height via a MIS posterior approach while providing the stability of a larger construct more often associated with an anterior approach. After a discectomy is performed, the Luna 3D Implant is delivered through a small diameter cannula into the disc space. After expanding its footprint, it is then expanded in height, diameter and lordosis with the insertion of a middle section. When the cannula is removed, a large volume of bone graft is placed in the middle of the implant to facilitate stabilization and an interbody fusion.

About Benvenue Medical, Inc.

Benvenue Medical, Inc. provides next-generation minimally invasive systems for lumbar fusion that combine expandable implants with novel delivery instruments to provide enduring functional benefits for patients. The company is privately held and funded by CRG. Its first products are designed for the treatment of degenerative disc disease and instability of the lumbar spine. For more information, visit www.benvenuemedical.com.

Contacts

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

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.

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

Amedica Announces Filing of Key Patent Application Relating to the Anti-Viral Effect of its Silicon Nitride

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

SALT LAKE CITY, Sept. 10, 2018 (GLOBE NEWSWIRE) — Amedica Corporation (NASDAQ: AMDA), a company that develops and commercializes silicon nitride for biomedical applications, today announced the filing of a U.S. patent application for breakthrough research findings that have identified a new property of its proprietary silicon nitride.

Amedica investigators led by Dr. Giuseppe Pezzotti, a professor at the Kyoto Institute of Technology (Japan) and consultant to Amedica Corporation, have developed micromeritic silicon nitride powders as well as bulk surfaces that are effective against several strains of commonly prevalent viruses – including Influenza A virus (H1N1), the virus responsible for the 2009 flu pandemic. The research has also identified the surface chemical properties of silicon nitride that contribute to the observed virucidal effect.

The mechanism, known as alkaline transesterification, is known to cause genomic cleavage in active viruses leading to their inactivation and lysis. The investigation employed a commonly accepted assay of measuring mammalian cell viability in the presence of high concentrations of virus particles. In the case of Influenza A virus, a 5-minute exposure to Amedica’s silicon nitride either at room temperature or at 4^oC was enough to result in complete virus lysis and inactivation such that 100% of the exposed cells survived. In an identical parallel test conducted without silicon nitride, the virus remained intact and was able to infect and destroy exposed cells. Silicon nitride proved to be an effective disinfectant of the virus thus providing a protective effect to cells exposed to the virus.

“These unexpected results are of course entirely welcome, and the remarkable discovery opens new frontiers in our evolving understanding of silicon nitride as a biomaterial and in practical applications of it,” said Dr. B. Sonny Bal, Chairman and CEO of Amedica Corporation. “The discovery is particularly timely given our recent divestment of the retail spine business to CTL Medical and our transition to an OEM manufacturer and biomaterials company.”

“From the standpoint of spine surgery, the antiviral properties of silicon nitride implants probably have little consequence since viral infections of implanted biomaterials are not a practical problem. On the other hand, systemic viral infections and their spread through contaminated surfaces are a global concern. Drug treatments of established Influenza A infections, such as Tamiflu, are effective only in controlling symptoms by reducing viral load and the virus can still mutate to newly resistant, dangerous strains. The control of viral propagation by surface sanitization is therefore of worldwide interest; witness the hand sanitizers and other protections used commonly during the flu season. Surface sanitization destroys the virus itself, and commonly-used methods rely on ammonia, alcohol, silicon nanoparticles, and certain pH conditions to inactivate virus particles.”

“The latest findings show the above-surface conditions for viral disinfection are already manifest on Amedica’s silicon nitride whether the material is studied in bulk form or as a micron-layer coating on other surfaces. This property is a powerful advantage toward safe and reliable methods for viral inactivation and elimination. This fortuitous, intrinsic anti-viral effect of Amedica’s silicon nitride has broad applications in health care, from medical therapies to various medical devices and equipment such as examination tables, clothing, filters, masks, gloves, catheters, endoscopic instruments, and well beyond.”

“Previous data, supported by clinical studies, have established that Amedica’s silicon nitride enhances osteogenesis while resisting bacterial adhesion; both highly desirable properties in spinal fusion implants. Now, the material appears to be equally effective against the world’s most common pathogens, i.e., viruses that are responsible for a number of diseases and their global spread. Going forward, we will seek commercial applications and partnerships that can leverage the unique antiviral behavior of silicon nitride, a property that, to our knowledge, is not present in any other biomaterial known in the world today.”

Further to today’s announcement, Amedica will 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.

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

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (“PSLRA”) that are subject to a number of risks and uncertainties, including without limitation the risks associated with generating data to support the patent application for the technology and of obtaining a patent that provides commercially significant protection for this technology; the risk that the technology may infringe the proprietary rights of third parties. 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. A discussion of those risks and uncertainties can 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 29, 2018, and in Amedica’s other filings with the SEC. Amedica disclaims any obligation to update any forward-looking statements. 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

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.

tirbolox-l-tlif-plif-cage-3d-printed-implant-captiva-spine-pr-12bto.jpg

Captiva Spines’s TirboLOX-L™ Dual Layer Organic Lattice Structure 3D Printed Titanium Lumbar Cages Receive Clearance

Posted On September 5, 2018 By OrthoSpineNews In Regulatory, Spine, Top Stories /

Jupiter, FL, August 2018 – Captiva Spine is a medical device organization located in Jupiter, Florida, dedicated to delivering smart, elegant and intuitive spinal fusion solutions. Today, Captiva Spine is announcing it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its TirboLOX-L 3D Printed Titanium Lumbar Cages.

TirboLOX-L Titanium Lumbar Cages

TirboLOX-L Titanium Lumbar Cages are created using advanced 3D printing technologies to form titanium alloy interbody fusion devices with a dual layer organic lattice structure. This lattice structure features a micro-rough surface topography, interconnected dual porosity, and open architecture. Titanium alloy implants with micro-rough surface topographies and dual porosity have been shown to promote direct bony ongrowth, ingrowth and vascularization. TirboLOX-L’s open architecture is designed to reduce radiographic presence for clear imaging. TirboLOX-L’s high coefficient of friction creates immediate bidirectional fixation.

Dennis Ty, Director of R&D of Captiva Spine declared, “With the advanced capabilities of 3D Additive Manufacturing we were able to create a unique lattice structure similar to trabecular bone incorporating a micro-rough surface for clot retention and early osteogenic cell migration, including a dual layer of porosity with pore sizes specifically designed to promote bone ingrowth and vascularization. Through substantial surgeon design input we are able to deliver TirboLOX-L’s unique dual layer organic lattice structure with numerous geometries and sizes that appeal to a wide range of surgeon preferences.”

Dale Mitchell, President and Founder of Captiva Spine said, “I am pleased our development team was able to incorporate our proprietary Pivotec® Pivoting TLIF Cage into TirboLOX. Pivotec technology has been used in thousands of surgeries to address the challenges of controlling cage insertion and angle manipulation during surgery and is now available in a wide range of porous Titanium 3D printed, sterile packaged implants. This is especially important during minimally invasive (MIS) applications where time and safety is always of the essence.”

Captiva Spine’s TirboLOX-L Lumbar Cages are 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 Angles, 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.

SEE MORE ABOUT TIRBOLOX-L

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

Orthopaedic Surgeon Dr. Jeffrey Carlson Completes Milestone Case With SpineFrontier’s Invue Technology

Posted On September 4, 2018 By OrthoSpineNews In Spine, Top Stories /

NEWPORT NEWS, VA. (PRWEB) SEPTEMBER 04, 2018

SpineFrontier announced today that Dr. Jeffrey R. Carlson completed his 500th case using SpineFrontier’s Invue plate and screws, with no recorded screw backouts. The operation took place on Aug. 21 at Mary Immaculate Hospital in Newport News, Va. Dr. Carlson performed a one-level anterior cervical discectomy and fusion. Prior to undergoing surgery, the patient’s neck pain was constant along with left upper extremity pain and numbness in the right forearm. She failed conservative treatments including physical therapy, chiropractics, pain management and an epidural steroidal injection. Cervical X-rays revealed degenerative disc disease and kyphosis and her MRI showed spinal stenosis and a herniated disc at C5-6. This surgery was performed as an outpatient Less Exposure Surgery (LES) procedure and the patient was discharged just two hours post operatively.

The Invue screw’s connected tab feature provides enhanced feedback for secure final screw locking, a close design collaboration between Dr. Carlson and SpineFrontier.

“The Invue anterior plating system has a twofold screw locking mechanism. The first is a thread-through feature, where both the major and minor diameters of the screw are timed with the plate’s screw hole. The second is the connected ‘hurricane tabs’ (also referred to as locking arms) which snap and lock into place underneath the plate’s lip. The dual locking mechanism provides a robust plate-to-screw interface to prevent screw backout, while the connected tab feature provides the user with tactile, visual and audible confirmation of the lock,” said SpineFrontier Lead Product Manager Mike Bache.

Dr. Carlson’s case represents an evolution in the performance of cervical plating screws. Moreover, this surgical milestone proves an achievement for the innovative LES approach, which results in smaller incisions, minimizes tissue disruption, and reduces blood loss and surgery time. The LES approach provides a potentially speedier recovery.

Dr. Carlson noted, “We haven’t had a single Invue screw back out since we began utilizing the product. Prior to using SpineFrontier technology, we generally saw one to two patients annually with a backout issue, which became our expectation regarding results. With the Invue screw, we’ve fortunately reversed that presumption of patient return.”

Dr. Jeffrey Carlson serves as President and Managing Partner of the Orthopaedic & Spine Center in Newport News, Va. He is a board-certified, fellowship-trained spine specialist who focuses on the treatment of injuries and disorders of the spine. He is a thought leader and pioneer in the development and implementation of outpatient spinal surgery procedures and techniques, including Less Exposure Surgery, which is minimally invasive and less traumatic for the patient.

Dr. Carlson received his Bachelor of Science from the University of Maryland and promptly began medical school at George Washington University. Post-graduate training included his residency at Harvard University, and two fellowships.

About SpineFrontier Inc.
SpineFrontier’s mission is to advance the standard of spine surgery through innovative technology. SpineFrontier believes less is more: less time in treatment and recovery is more time in action for patients and surgeons. Headquartered in Malden, Ma., SpineFrontier is a KICVentures portfolio company and the leader in LES technologies and instruments.

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FDA Grants Eden Spine 510(K) Clearance for Its Thoraco Lumbar Spine Locking Plate – SPHYNX™

Posted On August 30, 2018 By OrthoSpineNews In Regulatory, Spine, Top Stories /

GENEVA, SWITZERLAND (PRWEB) AUGUST 30, 2018

The SPHYNX™ is the ideal complement to Eden Spine proprietary, expandable titanium vertebral body replacement implant with rotatable endplates, the GIZA™ which provides multiple angulation options by simple endplates rotation. The GIZA™ is intended to replace and fuse a collapsed, damaged, or unstable vertebral body due to a tumor or a fracture.

Made of titanium, the low profile SPHYNX™ is to be implanted via the antero-lateral approach for the treatment of thoraco-lumbar instabilities. Indications include spinal fractures, vertebral tumors, secondary instabilities of the thoracic and thoraco-lumbar spine, and any other indication requiring an anterior stabilization low profile.

“The SPHYNX™ is the latest innovation coming from our R&D department in Geneva, Switzerland,” says Ben Mokhtar, President of Eden Spine Europe, SA. “Our goal was to develop a technology that was simple to use, intuitive, and worked with the anatomy. To achieve that goal we have developed a cutting edge integrated locking system, minimized the thickness of the implant in an effort to respect the surrounding tissues, and maximized the range of precurved plates, to provide optimal adaptation to patient’s anatomy.”
The SPHYNX™ was granted CE Mark approval in 2016.
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About Eden Spine Europe SA:
Eden Spine is a privately held, technology driven spinal organization based in Switzerland since 2005. The company distributes a range of innovative spinal technologies in the United States and abroad. Eden Spine patented portfolio is composed of a mix of fusion and non-fusion technologies.

For distribution opportunities, please contact us at
Customer.service(at)edenspine(dot)com or visit http://www.edenspine.com

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