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Current Issues in Spine

February 2-4, 2017

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August 2, 2017 OrthoSpineNews

August 02, 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 continues its strong revenue acceleration for the second quarter of 2017, driven by the increasing demand for the Company’s nanoLOCK® surface technology. 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

The company reports the following for the second quarter:

  • Surpassed 50,000 implantations of its Endoskeleton® interbody fusion devices since inception
  • nanoLOCK® sales volume has increased by 42% since the close of the first quarter
  • nanoLOCK® has been utilized to date by 150 surgeons in 98 hospitals
  • Achieved 2,500 implantations of nanoLOCK® since launch

Ted Bird, Chief Commercial Officer of Titan Spine, commented, “Following a record first quarter, we continued to exceed expectations during the second quarter for a strong close to the mid-2017 mark. The significant demand for nanoLOCK® is a direct reflection of our expanded sales team’s ability to reach more surgeons and surgeons’ recognition of the advantages our surface technology provides at the nano-cellular level for helping patients heal faster following spine fusion surgery. In fact, we have more than doubled the number of surgeon customers using nanoLOCK in the second quarter compared to the first. We are pleased that our second quarter achievements demonstrate a growing confidence and continued adoption of nanoLOCK®.”

Steve Cichy, Executive Vice President of Sales of Titan Spine, added, “The demand for nanoLOCK® has certainly fueled our significant sales growth over the first half of this year. We have recently invested significant capital to beef up our instrument set and implant inventory to meet this growing demand, which will start to pay dividends over the remainder of the year and beyond.”

Titan Spine offers a full line of Endoskeleton® titanium implants that feature its proprietary nanoLOCK® surface technology, which was launched in the U.S. in October 2016 following FDA clearance in late 2014. The nanoLOCK® surface technology consists 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.

nanoLOCK® named the winner of Back Pain Centers of America’s 2017 Awards of Excellence for the Technology Innovation Award

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.

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.

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


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August 1, 2017 OrthoSpineNews

July 31, 2017

LYON, France & NEW YORK–(BUSINESS WIRE)–The Medicrea Group (Euronext Growth Paris: FR0004178572 – ALMED), pioneering the convergence of healthcare IT and next-generation, outcome-centered device design and manufacturing with UNiD™ ASI technology, announced today that the world’s first minimally-invasive spine surgery using patient-specific implants was performed by Dr. C.J. Kleck at the University of Colorado Hospital using the company’s UNiD™ MIS Rod.

The limited visualization of the spine associated with Minimally-Invasive Spine (MIS) techniques poses unique challenges for surgeons whose goal is segmental sagittal balance, while offering known benefits to patients which include reduced muscle damage during surgery and improved recovery time post-operatively. Such advantages have led MIS solutions to be an area of particular growth in the spine market. Surgeons trained in MIS techniques are able to treat a growing number of spinal conditions due to recent advancements in imaging and device offerings. The UNiD™ MIS Rod is the first and only spinal implant in the world that is manufactured specially for the patient prior to minimally-invasive surgery. The UNiD™ MIS Rod is compatible with percutaneous and mini-open MIS applications, removing the need to modify implants intra-operatively.

“As one of the early adopters of UNiD™ ASI, I have seen firsthand the associated benefits of the technology in open deformity cases. I am pleased to extend it now to my MIS cases where I see the potential for increased utility in degenerative indications.” stated Dr. Kleck following the surgery. “With each patient-specific implant designed utilizing Medicrea’s support services, machine learning and predictive analytics, my colleagues and I have seen an improved efficiency in our pre-surgical as well as our surgical practice. I believe this scientific, data-driven model is the best approach available to optimize long-term patient results and represents the future of value-based spinal care.”

Denys Sournac, President and CEO of Medicrea, stated, “We are now able to respond to the growing demand for personalized UNiD™ ASI technology in minimally-invasive surgery by introducing the UNiD™ MIS Rod to our UNiD™ TEK line of FDA-cleared patient-specific implants. We are the only company in Spine able to generate Adaptive Spine Intelligence powered by proprietary data science and remain committed to driving improved outcomes and efficiencies for patients, surgeons, hospitals and payers with our platform of UNiD™ ASI implants, services and IT.”

Today, more than 1,500 UNiD™ Rod surgeries have been performed worldwide. The range of patient-specific implants available as UNiD™ TEK are fully compatible with Medicrea’s platform of innovative procedurally-integrated solutions.

About Medicrea (www.Medicrea.com)

Through the lens of predictive medicine, Medicrea leads the design, integrated manufacture, and distribution of 30+ FDA approved spinal implant technologies that have been utilized in over 100,000 spinal surgeries to date. By leveraging its proprietary software analysis tools with big data and machine learning technologies and supported by an expansive collection of clinical and scientific data, Medicrea is well-placed to streamline the efficiency of spinal care, reduce procedural complications and limit time spent in the operating room.

Operating in a $10 billion marketplace, Medicrea is a Small and Medium sized Enterprise (SME) with 175 employees worldwide, which includes 50 who are based in the U.S. The Company has an ultra-modern manufacturing facility in Lyon, France housing the development and production of 3D-printed titanium patient-specific implants.

For further information, please visit: Medicrea.com.

Connect with Medicrea:
FACEBOOK | INSTAGRAM | TWITTER | WEBSITE | YOUTUBE

Medicrea is listed on
EURONEXT Growth Paris
ISIN: FR 0004178572
Ticker: ALMED

Contacts

Medicrea
Denys Sournac
Founder, Chairman and CEO
dsournac@Medicrea.com
or
Fabrice Kilfiger,
Chief Financial Officer
fkilfiger@Medicrea.com
Tel: +33 (0)4 72 01 87 87


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July 31, 2017 OrthoSpineNews

TORONTOJuly 31, 2017 /PRNewswire/ — 7D Surgical, developer of ground breaking surgical navigation technologies, announced today that Spartan Medical has purchased the 7D Surgical System to support its strategic sales plan in MarylandWashington D.C. and Virginia.  7D Surgical has entered into an exclusive sales representative agreement with Spartan Medical for many of the premier medical facilities within those markets.

“Our new partnership with Spartan Medical is another important step in our rapid growth strategy in North America,” said Beau Standish, Chief Executive Officer of 7D Surgical.  “Their expertise and unique relationships with federal facilities will be critical in bringing the most advanced machine-vision based navigation technologies to DoD spine surgeons and the U.S. military personnel and veterans they serve.”

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 automatically registered using only visible light in just seconds with 7D Surgical’s Flash™ Registration 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.  Continuing to leverage the capabilities of machine-vision, 7D Surgical’s soon to be released Flash™ Fix technology can also update and correct the registration at any time during the procedure in just seconds.

“To me, this is similar to the invention of the X-ray,” said Vince Proffitt, President of Spartan Medical.  “Those of us that have been in surgeries supporting our implants know the real challenges of accurate and reproducible imaging and navigation.  We know how dependent the surgery may be on the equipment technicians’ skills and training, and we also know the incredible risks of daily radiation. The 7D Surgical System eliminates these critical concerns and creates a surgeon controlled, real-time, radiation-free, simple and accurate imaging and navigation system…truly a technological marvel!”

Live demonstrations of the 7D Surgical System are available at Spartan Medical Headquarters in Silver Spring, Maryland.  Contact Spartan Medical to schedule a time to experience the system in action at 1-888-240-8091, or email Spartan Medical at 170185@email4pr.com.

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

Flash™ Fix: http://7dsurgical.com/7d-surgical-system/flash-technology/

Contact:
Beau Standish, CEO
7D Surgical
+1 647 484-0078
www.7Dsurgical.com
170185@email4pr.com

About Spartan Medical

Spartan Medical Inc. was founded in 2008 by a former Air Force Intelligence Officer to provide an extensive armamentarium of advanced medical devices and technologies focused on the needs of the VA and DoD surgeon.  Spartan Medical is considered a top priority vendor in the VA as a certified Service-Disabled Veteran-Owned Small Business (SDVOSB), and has secured multi-year Blanket Purchase Agreements at 30 major military treatment facilities.  With a core staff possessing over 200 years of combined expertise and experience in the field, and numerous highly trained and skilled consultants across the nation, Spartan Medical assures no single points of failure.  Consistent with its mission to provide the best products and services to our nation’s wounded warriors and veterans, Spartan Medical has recently collaborated with 7D Surgical to provide the most innovative, state-of-the-art, image-guided spinal navigation system – with zero radiation –  to meet the incredible need to improve implant placement accuracy in real-time while eliminating radiation in the operating room.

Contact:
Vince Proffitt, President
Spartan Medical Inc.
+1 888 240 -8091
www.spartanmedspine.com
170185@email4pr.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.

“Flash,” as well as the “7D” logo, whether standing alone or in connection with the words “7D Surgical” are protected trademarks of 7D Surgical.

SOURCE 7D Surgical Inc.

Related Links

http://7dsurgical.com


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July 28, 2017 OrthoSpineNews
Shelton, CT, July 28, 2017 –(PR.com)– Orchid Design (Orchid), a leader in innovative surgical device design, development and regulatory services for the orthopedic and spine industry, is pleased to announce the appointment of a new Director of Engineering for its Shelton, Connecticut design center. Poised for continued growth, Orchid has added Brandon Beckendorf to oversee the development of orthopedic and spine products for Orchid’s customers.
Brandon comes to Orchid with strong product development experience in extremities, craniomaxillofacial, and sports medicine. Most recently, as the Director of Engineering at OsteoMed, he introduced lean product development, DFx, concurrent engineering, and a disciplined approach to project management to increase overall project performance. In his roles at both OsteoMed and Arthrex, Brandon developed a strong understanding of FDA regulations and product development know-how required for the global development of orthopedic implants and instruments. Brandon earned a ME and BS in Biomedical Engineering from Texas A&M University.
“We are pleased to have Brandon join our team to continue to build on our 14 years of helping our customers launch innovative new products to help surgeon and their patients. His demonstrated leadership and product development expertise will expand our capabilities to drive new products to market for our customers,” Steve Maguire, General Manager, Orchid Design.
About Orchid Design
Orchid Design, a division of Orchid Orthopedic Solutions, is the orthopedics industry leader in innovative surgical device design, development and regulatory submission services. Utilizing their ISO 13485 certified product development process, Orchid Design partners with device companies to help bring their ideas to life and streamline the pathway to commercial launch. The company has two design centers located in Shelton, CT and Memphis, TN, focused on the orthopedic medical device market. For more information about Orchid, visit the company’s website at www.orchid-ortho.com/about-orchid-design.
About Orchid
Orchid is a worldwide leader in design and manufacturing for the orthopedic and medical device markets. Orchid is able to do this by compressing time to market, providing new technologies and being the best total supply-chain value. Orchid provides expertise in design and development, quality and regulatory support, implant manufacture, advanced machining, plastics technology, instrument manufacturing, implant coatings, surface treatments, and packaging services. With 14 world-class facilities located around the globe, Orchid continues to provide others an opportunity to live a better life through the products, services and the way the company conducts business. For more information about Orchid, visit the company’s website at www.orchid-ortho.com.
Contact Information
Orchid
Abbie Woolston
517-694-2300
Contact
www.orchid-ortho.com

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July 27, 2017 OrthoSpineNews

SAN DIEGOJuly 27, 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced a new organizational structure to drive the Company’s growth and profitability goals, supporting its strategy to help deliver safer, more predictable spine surgery.

“As the innovation pioneer and largest, pure-play spine technology company, NuVasive continues to deliver significant value to its customers and shareholders,” said Gregory T. Lucier, NuVasive’s chairman and chief executive officer. “With incredible opportunities ahead, we are taking steps to refine the company’s operating structure to tightly align strategy, product development and marketing and integrate our global commercial channels, while scaling global operations to best address the growing needs of our partners and patients.”

Today the Company announced that Jason Hannon, president and chief operating officer, is stepping down from his position to pursue other interests. He will remain with NuVasive through the end of the year in an advisory capacity. During Mr. Hannon’s successful 12-year career at NuVasive, he has made countless important contributions to the Company. In connection with Mr. Hannon’s departure, the Company has accelerated its timeline to implement organizational changes that will position NuVasive to execute against the Company’s strategic goals. Effective August 1, the Company will:

  • Align strategy, technology and marketing to build a world-class product development and commercialization capability;
  • Integrate its U.S. Commercial and International sales functions into a scalable global commercial organization; and
  • Transform global operations to drive operational efficiencies through the combination of manufacturing, supply chain, information technology (IT), regulatory affairs and quality assurance (RA/QA).

Matt Link, president, U.S. Commercial is being promoted to a key leadership role as executive vice president, Strategy, Technology and Corporate Development, a newly created position to further drive the Company’s innovation agenda. Mr. Link is a long-tenured NuVasive executive with more than 15 years of industry experience, including extensive knowledge of the U.S. spine marketplace, as well as surgeon and hospital dynamics. In this role, he will lead product and systems development, global marketing, surgeon education, clinical research and corporate development. Mr. Link’s experience in surgeon requirements and commercial operations will be key as NuVasive continues to bring leading innovation to market.

Skip Kiil, executive vice president, International is named executive vice president, Global Commercial. Mr. Kiil joined NuVasive in June and has more than 15 years of experience as a global medical technologies and life sciences business leader. He was previously with Alcon, a division of Novartis Corporation, where he most recently served as surgical head, EuropeMiddle EastAfrica and Russia. He is a proven leader in managing and growing complex, global commercial enterprises internationally and domestically within the healthcare and spine technology industries. His strategic and operational expertise in market entry and development are critical as NuVasive seeks to double its International market share in the coming years and further expand the Company’s position in the U.S. marketplace.

Steve Rozow, vice president, Global Operations, assumes an elevated role as executive vice president, Global Process Transformation, including IT and RA/QA, in addition to his current Global Operations responsibilities. Since joining NuVasive in 2015, Mr. Rozow has led improvements in supply chain and fulfillment, as well as the successful development of the Company’s new manufacturing facility in West Carrollton, Ohio. Mr. Rozow is an experienced medical device leader including more than 20 years with Zimmer, where he served in various manufacturing and operational leadership roles. His position is critical as the Company focuses on scaling global operations and driving operational improvement initiatives.

Unrelated to the organizational updates announced today, the Company has accepted the resignation of its chief financial officer, Quentin Blackford, effective August 25, 2017. Mr. Blackford is pursuing another opportunity outside the spine industry and has agreed to remain with the company during this transition period. Mr. Blackford’s resignation is not the result of any dispute or disagreement with NuVasive, including any matters relating to the Company’s accounting practices or financial reporting. Vickie Capps, in her role as an independent member of NuVasive’s board of directors and a member of the audit committee, will provide guidance and support to the Company’s financial organization during the transition period. Ms. Capps is a well-respected financial executive, having served as CFO of DJO Global, as well as CFO of several public and private companies. Ms. Capps will also assist the Company in its search for a successor to Mr. Blackford.

“Since becoming CEO over two years ago, I have been working with our board to build a world-class leadership team to support our revenue growth and profitability goals. Together, we are executing against our 5-year strategic plan and building a deep bench of talent, positioning us well to execute against our short- and long-term initiatives. I remain more confident than ever in our Company’s position to take on the next $1 billion in growth,” said Lucier.

About NuVasive

NuVasive, Inc. (NASDAQ: NUVA) is transforming spine surgery and beyond with minimally invasive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With $962 million in revenues (2016), NuVasive has an approximate 2,300 person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.

Forward-Looking Statements

NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA® platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

SOURCE NuVasive, Inc.

Related Links

http://www.nuvasive.com


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July 27, 2017 OrthoSpineNews

WAYNE, Pa.July 27, 2017 /PRNewswire/ — Camber Spine Technologies, today announced that they have exceeded 150 implantations of the ENZA™ Zero-Profile ALIF device that was launched last July.

“We have been doing anterior spine reconstructions for over 20 years and have used a lot of different ALIF devices,” said Orthopedic Surgeon, Dr. Steven B. Wolf, M.D. of OIP in Camp Hill, PA. “I have extensive experience using the Globus Independence®, Zimmer-LDR ROI-A® and other ALIF devices from Renovis and Titan Spine.  The ENZA™ has been an indispensable alternative to all those implants. I can insert ENZA™ and deploy fixation with one instrument and I have the reassurance that I can easily remove it if needed. With the insertion of ENZA™ the patient’s spine feels immediate stabilization, especially if they need to be flipped for posterior instrumentation. Our access surgeon loves this implant, because it makes his job much easier. ENZA’s™ single instrument deployment, without extra retraction of the vessels, eliminates the need for passing multiple locking instrumentation required by other devices.”

ENZA™ was designed to increase patient safety by minimizing retraction necessary for implantation of the device, utilizing its integrated fixation. It is often described as “designed for the access surgeon” because of its completely inline instrumentation–which relieves the burden that other systems induce by requiring larger retraction to accommodate angled instrumentation.

“We are very excited to achieve this important milestone in the initial launch of the ENZA™ ALIF,” said Daniel Pontecorvo, Camber Spine’s CEO. The overwhelming interest and success of ENZA™ reaffirms our plan to make this the first of an entire platform of products utilizing our patented ENZA™ Duo Presa™ (Two Grips) Anchor Technology. Surgeons assert that it is a simpler, safer and more stable alternative to all other locking ALIF devices.”

This achievement comes at an inflexion point for Camber Spine, as they continue to expand sales into new territories of the U.S with new hires.

The Camber Spine Technologies ENZA™ MIS Zero-Profile Anterior Interbody Fusion is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These implants may be implanted via a laparoscopic or an open anterior approach. The Camber Spine Technologies’ ENZA™ MIS Zero-Profile ALIF is intended to be used with additional FDA-cleared supplementary fixation systems.

About Camber Spine

Camber Spine Technologies, LLP, is a fast-growing musculoskeletal implant company founded in 2010 bringing innovative, best-in-class products to the market, providing surgeons and their patients with better treatment options. The company is committed to delivering surgeon inspired new technologies to the spine market. Camber is an ISO 13485 certified medical device company. Camber Spine Technologies, located in Wayne, Pennsylvania, markets a line of proprietary musculoskeletal products nationwide through its exclusive distributor, S1 Spine. For further information please visit www.cambermedtech.com . For inquiries about ENZA® or distribution opportunities please call 484.427.7060.

All of Camber Spine Technologies’ products are proudly MADE IN THE USA.

SOURCE Camber Spine Technologies


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July 27, 2017 OrthoSpineNews

NEW YORKJuly 27, 2017 /PRNewswire/ — 4WEB Medical, the industry leader in 3D printed implant technology, announced today the first surgeries utilizing the company’s Lateral Spine Truss System were recently performed in several notable hospitals in the United States. The company’s lateral interbody fusion device was designed to solve known surgical problems associated with legacy annular implant designs and represents a significant advancement in lateral access surgery.

“4WEB’s spine truss implants have proven to be very effective in providing excellent surgical outcomes for my patients,” said Frank Cammisa, MD, Hospital for Special Surgery, New York, NY. “In contrast to older ring-shaped implants with hollow cores, 4WEB’s truss implant web structure spans the entire endplate providing strong initial fixation and minimizing subsidence.”

The Lateral Spine Truss System is designed with a unique bi-convex dome that distributes load across a larger surface area and has three times more textured surface topography when compared to other competitive spine implants. The key differentiator for the product, though, is its proprietary truss design and the performance it lends to driving successful spine fusion results.

“A recent study comparing 4WEB’s lateral truss implant to a ring implant design demonstrated that the truss design had superior resistance to subsidence,” said John Peloza, MD, Center for Spine Care, Dallas, Texas.  “In fact, the 40mm length truss implant displayed 61% greater resistance to subsidence than the 60mm length ring implant1. These results are indicative of the optimized load distribution inherent to 4WEB’s truss implant technology that maximizes endplate contact while providing an open architecture for bone formation and fusion.”

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 includes the Cervical Spine Truss System, the ALIF Spine Truss System, the Posterior Spine Truss System, the Lateral Spine Truss System, and the Osteotomy 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.

  1. Kiapour, A.  Evaluation and Comparison of Subsidence Properties of 4WEB Lateral Device versus an Annular Lateral Device.

SOURCE 4WEB Medical

Related Links

http://www.4webmedical.com


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July 27, 2017 OrthoSpineNews

Back Pain Centers of America (BPC), which connects people searching for solutions to their neck and back pain with a reputable physician in their area, announces that Titan Spine’s nanoLOCK® Surface Technology is the winner of the 2017 Awards of Excellence for the Technology Innovation Award. This award is one of three categories of awards being presented in our 2017 series. The technology innovation award recognizes the top innovations advancing the field of orthopedic medicine.

The nanoLOCK® surface technology is a proprietary combination of textures at the macro, micro, and nano scales (MMN™) that has been shown to upregulate a significantly greater amount of bone growth factors necessary for fusion as compared to polyetheretherketone (PEEK), smooth titanium, and the company’s current titanium roughened surface. It is the next generation of the company’s current surface technology that has been implanted in patients since 2006.

“We are delighted to receive this award from Back Pain Centers of America,” said Andrew Shepherd, vice-president of marketing for Titan Spine. “Our nanoLOCK surface technology was developed with the goal of helping patients heal faster following back fusion surgery by interfacing with the patient’s cells at the nano level. We are pleased for the recognition it has generated.”

“We created this award category to recognize innovation and advances in medicine and technology,” said Brent Wheeler, president of Back Pain Centers of America. “We applaud Titan Spine for their innovation in taking spinal fusion procedures to the next level.”

More information about Titan Spine’s nanoLOCK® Surface Technology can be found at this link.

About Back Pain Centers of America
Back Pain Centers of America (BPC) has helped people find safe, reliable relief for chronic pain since 2009. The call centers match patients searching for relief for neck and back pain to reputable, board-certified healthcare practices in their geographic area. BPC has the largest network of minimally-invasive spine centers in America. This service is free to patients. For more information, please visit http://www.backpaincenters.com. Also follow BPC on LinkedIn, Facebook, or Twitter.


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July 26, 2017 OrthoSpineNews

DALLAS, TX – 07/25/2017 (PRESS RELEASE JET) — CTL Medical Corporation, a Dallas-based medical device manufacturing and service company, has secured FDA clearance to market its new MATISSE™ Titanium ACIF Cage implant with TiCro™ surface, used in the practice of spine fusion surgery.

The MATISSE™ Titanium ACIF Cage with CTL Medical’s proprietary TiCro™ surface technology offers 200 percent greater endplate contact surface area, as well as bone conforming geometry for increased mechanical locking at the cage and bone interface. The implant includes a tapered leading edge for easy insertion and a large graft area to further promote bony fusion. The device is available in a variety of sizes and configurations to accommodate variations in vertebral levels and patient anatomy.

“Countless engineering hours and R&D resources went in to developing CTL Medical’s patent pending TiCro™ surface technology, which was designed to expand our current portfolio, advance fusion technologies, and offer spine surgeons numerous surgical advantages,” stated Danny Chon, president & CEO of CTL Medical Corporation. “The Matisse™ system includes streamlined instrumentation and a variety of footprints, heights and lordotic profiles to accommodate variations in patient anatomy.”

MATISSE™ Titanium ACIF Cage with TiCro™ is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one-disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. MATISSE Anterior Cervical Interbody Fusion Cage system is used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. MATISSE™ Titanium ACIF Cage with TiCro™ is to be used with supplemental fixation, such as CTL Medical’s VAN GOGH™ Anterior cervical plating system, which has been cleared for use in the cervical spine.

The use of cage devices in spinal surgery began with clinical trials in 1989, and since then, multiple implant improvements have debuted – leading to easier procedures, benefitting both spine surgeons and overall patient success and recovery times.

For more information on CTL Medical Corporation, visit www.ctlmed.com.

About CTL Medical Corporation
CTL Medical Corporation is a fully integrated, industry-leading, global medical device design, development and manufacturing company. CTL has assembled a world-class executive team, bringing together some of the industry’s most exceptional talent, positioning it to be a leader in medical device design and manufacturing. For more information, visit www.ctlmed.com.

Jeff Cheatham
TrizCom PR
O: 972-247-1369
C: 972-961-6171
jeffc@trizcom.com

Media Contacts:

Company Name: TrizCom PR
Full Name: Jeff Cheatham
Phone: (972) 247-1369
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Website: www.trizcom.com


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July 26, 2017 OrthoSpineNews

WALNUT CREEK, Calif.July 25, 2017 /PRNewswire/ — Providence Medical Technology, Inc., a developer of innovative cervical spine technology today announced regulatory approval from the Australian Therapeutic Goods Administration (TGA) for its DTRAX line of instruments and implants used in tissue-sparing posterior cervical fusion. The TGA approval covers GL-DTRAX Spinal System, GL-DTRAX Cervical Cage-T System, GL-DTRAX Cervical Cage-B, GL-DTRAX Expandable Cage, and GL-DTRAX Bone Screw. Providence plans to submit products to the Prostheses List in August 2017 for inclusion in early 2018.

“We are excited to deliver our innovative spinal technology to the Australian market and provide patients with less disruptive options for cervical spine surgery,” said Michael Scott, VP of International with Providence. “Australiarepresents an important, strategic market as it boasts a robust healthcare system, offers established reimbursement, and has a history of embracing innovative treatments for spine surgery.”

Providence’s DTRAX line of devices and instruments are designed to increase procedural efficiency, improve clinical outcomes, minimize complications, and reduce recovery times. Tissue-sparing posterior cervical fusion with intervertebral cages offers distinct advantages over traditional posterior fusion techniques. The products have seen continued, rapid adoption by spine surgeons, hospitals, and ambulatory surgery centers since their introduction and, to date, over 7,000 procedures have been performed worldwide.

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

 

SOURCE Providence Medical Technology, Inc.