Nexxt Spine Announces FDA Clearance for the NEXXT MATRIXX™ System

Posted On October 4, 2017 By OrthoSpineNews In Regulatory, Spine, Top Stories /

October 04, 2017

NOBLESVILLE, Ind.–(BUSINESS WIRE)–Nexxt Spine, LLC, a medical device company focused on designing, manufacturing, and distributing innovative spinal solutions, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the NEXXT MATRIXX™ System.

The NEXXT MATRIXX™ System of 3D printed porous titanium leverages Nexxt generation technology to create interbody and VBR devices with optimized open architectural porosity, residue-free surface technology, and robust radiographic imaging performance.

Several studies have shown that textured titanium alloy surfaces elicit a positive bone response including an increase in osteoblast differentiation and surface osteointegration as compared to classically smooth surfaces. With these studies in mind, Nexxt Spine has coupled their proprietary, residue-free, surface technology with an open, varied porosity, titanium architecture whereby the NEXXT MATRIXX™ implants exhibit up to 4X more surface area for bone apposition and up to 2X more open pore volume than conventional spinal implants.

Andy Elsbury, President of Nexxt Spine, stated, “The NEXXT MATRIXX™ System applies breakthrough technology to our company’s product portfolio and surgeon response has been overwhelmingly positive. We will continue to expand our NEXXT MATRIXX™ offering throughout 2017 and into 2018 to ensure this differentiated technology is available for all spinal fusion surgical approaches.”

The first products to feature the NEXXT MATRIXX™ technology are available in both interbody and VBR options in an assortment of height, length, width and lordotic angulation combinations to accommodate the unique anatomic and clinical circumstances of each patient.

For more information about NEXXT MATRIXX, visit www.nexxtspine.com.

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

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

Contacts

Nexxt Spine, LLC
Sarah Koch
Info@NexxtSpine.com

OrthAlign, Inc. Receives CE Mark Approval Expanding Global Product Portfolio to include Precision Technologies for DAA Total Hip and Unicompartmental Knee Arthroplasty

Posted On October 4, 2017 By OrthoSpineNews In Recon, Regulatory /

ALISO VIEJO, CA (PRWEB) OCTOBER 03, 2017

OrthAlign, Inc., a privately held U.S.-based medical device and technology company, received CE Mark Approval to market its advanced precision technologies for Direct Anterior Approach Total Hip (DAA HipAlign®) and Unicompartmental Knee Arthroplasty (UniAlign®) surgeries, in Europe and other countries.

“As OrthAlign has focused on expanding customer reach and its application pipeline in 2017, we are pleased that surgeons outside of the United States and Japan can now have access to our newest precision technologies DAA HipAlign and UniAlign,” said Eric B. Timko, OrthAlign’s Chief Executive Officer and Chairman. “We will continue providing orthopedic surgeons and healthcare facilities throughout the world our clinically beneficial portfolio of products, staying true to our core design principles of ease of use, precision, and cost effectiveness.”

Recent global statistics have shown that the direct anterior approach for total hip arthroplasty is growing, as it arguably leads to quicker recovery, less pain, and more normal function for patients after hip replacement. DAA HipAlign does not require any pre-operative imaging or intraoperative fluoroscopy, while providing more clinically relevant positioning for cup placement and leg length measurement. Early clinical data from the United States demonstrates that surgeons can expect to reduce fluoroscopy exposure time by about 45%. Early clinical data from Japan shows cup placement (for both inclination and anteversion) accuracy of ±10°, with at least 95.9% confidence.

Unicompartmental knee arthroplasty procedures are also growing in popularity, worldwide. UniAlign establishes the mechanical axis of the tibia, determining the varus/valgus angle and the posterior slope angle of the cutting block relative to the tibia, for the transverse resection. The system has been validated in simulated use testing to achieve resection accuracy of ±2.0° in the coronal plane, ±3.0° in the sagittal plane and ±2.0 mm in depth. This accuracy has been validated with at least 90% confidence.

“As international expansion has been one of OrthAlign’s priorities, receiving CE Mark approvals for use of our technology in two rapidly growing segments is great news,” said James Young Kim, OrthAlign’s Vice President and General Manager of International. “Our international distributor network has been waiting for these approvals, as many of their local surgeons have been asking for the technology.”

DAA HipAlign and UniAlign will be included in OrthAlign Plus® handheld navigation devices, along with OrthAlign’s award-winning KneeAlign® technology. To date, OrthAlign technology has successfully been used in over 65,000 cases, in over 25 countries, with more than 15 published international clinical studies demonstrating its accuracy.

About OrthAlign, Inc.

OrthAlign is a privately held medical device and technology company, developing advanced technologies that deliver healthier and more pain-free lifestyles to joint replacement patients, globally. We provide healthcare professionals with cutting edge, computer-assisted surgical tools that seamlessly and cost-effectively deliver vital data and clinical results to optimize outcomes for our patients. For more information regarding OrthAlign, please visit http://www.orthalign.com.

“ORTHALIGN®, ORTHALIGN PLUS®, KNEEALIGN®, KNEEALIGN® 2, HIPALIGN®, and UNIALIGN™ are registered trademarks of OrthAlign, Inc.”

Court Sets the Trial Date for MiMedx Patent Infringement Lawsuit Against MTF, Medline and Liventa

Posted On October 3, 2017 By OrthoSpineNews In Biologics, Regulatory /

MARIETTA, Ga., Oct. 2, 2017 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts and patent-protected processes for multiple sectors of healthcare, announced today that the United States District Court for the Northern District of Georgia has set a trial date of January 22, 2018 for the Company’s patent infringement lawsuit against Musculoskeletal Transplant Foundation, Inc. (“MTF”), Medline Industries, Inc. (“Medline”) and Liventa Bioscience, Inc. (“Liventa”).

In the Company’s press release of September 18, 2017, MiMedx communicated that the efforts of MTF, Liventa and Medline to avoid a trial through summary judgment and other legal maneuvers had failed, and that the matter was finally at a stage where the court could set a trial date. In that press release, the Company committed that once the Court advised MiMedx of the specific trial date, the Company would issue a subsequent press release announcing the trial date.

Parker H. “Pete” Petit, Chairman and CEO, said, “We filed this lawsuit in April 2014, and are very pleased to finally have a hard date set for this trial. We are anxiously awaiting January 22^nd, and look forward to presenting our patent infringement allegations against these defendants during the five day period the court has allocated for this trial. The numerous legal maneuvers to avoid trial that were employed by MTF, Liventa and Medline have failed, and we are highly confident in our case against these defendants.”

About MiMedx

MiMedx® is the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. “Innovations in Regenerative Medicine” is the framework behind our mission to give physicians products and tissues to help the body heal itself. We process the human placental tissue utilizing our proprietary PURION® Process among other processes, to produce safe and effective allografts. MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization. MiMedx is the leading supplier of placental tissue, having supplied over 1,000,000 allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. For additional information, please visit www.mimedx.com.

Important Cautionary Statement

This press release includes forward-looking statements, including statements regarding the Company’s confidence in its case and expectations for results of a trial. These statements also may be identified by words such as “believe,” “except,” “may,” “plan,” “potential,” “will” and similar expressions, and are based on our current beliefs and expectations. Forward-looking statements are subject to significant risks and uncertainties, and we caution investors against placing undue reliance on such statements. Actual results may differ materially from those set forth in the forward-looking statements. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include the risk that different or additional facts may be discovered that change conclusions, and the risks of litigation. For more detailed information on the risks and uncertainties, please review the Risk Factors section of our most recent annual report or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statement.

SOURCE MiMedx Group, Inc.

K2M Receives FDA Clearance for Next-Generation YUKON™ OCT Spinal System

Posted On September 29, 2017 By OrthoSpineNews In Regulatory, Spine, Top Stories /

LEESBURG, Va., Sept. 29, 2017 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (NASDAQ:KTWO) (the “Company” or “K2M”), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance^™, today announced that it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its YUKON^™ OCT Spinal System. YUKON OCT offers surgeons an advanced system aimed at facilitating fusion with posterior fixation in the occipito-cervico-thoracic regions of the spine with the goal of helping to achieve three-dimensional spinal balance.

The YUKON OCT Spinal System features newly designed top-loading, high angulation, polyaxial screws that provide up to 105 degrees of polyaxial angulation. YUKON OCT screw heads accept both Ø3.5 & Ø4.0 mm rods in both cobalt chrome and titanium, and accommodate construct rigidity based on degenerative or deformity corrections. Square thread set screws facilitate screw introduction and minimize the potential for cross-threading, while an updated occipital plate features integrated lateral holes with the goal of enhancing occiput fixation.

“The YUKON OCT System expands on K2M’s current offering while accounting for the challenging posterior cervical cases surgeons often treat,” said Chambliss Harrod, MD, a spine and orthopedic surgeon at the Bone & Joint Clinic of Baton Rouge. “Unlike systems that feature only highly favored angulation screw designs, YUKON OCT is a comprehensive system that offers surgeons the ability to treat a variety of spinal conditions—including routine degenerative cases, revisions, and complex cervical deformities.”

YUKON OCT’s advanced, streamlined reduction instrumentation allows for intraoperative flexibility and ease of use. The pistol grip style Rod Reducer provides 20 mm of reduction, while the Sequential Reducers deliver 20 mm of controlled reduction and correction.

“We are pleased to announce FDA clearance of the YUKON OCT Spinal System and the successful completion of its first surgical cases,” said K2M President and CEO Eric Major. “K2M is a global leader in spinal innovation and YUKON OCT is our new solution that deepens our expanding portfolio of spinal devices for the occipito-cervico-thoracic region of the spine. Accompanied by our comprehensive Balance ACS^™ platform, YUKON OCT offers a competitive surgical solution with the goal of achieving Total Body Balance for patients.”

Balance ACS (BACS^™) provides solutions focused on achieving balance of the spine by addressing each anatomical vertebral segment with a 360-degree approach to the axial, coronal, and sagittal planes, emphasizing Total Body Balance as an important component of surgical success.

For more information on the YUKON OCT Spinal System and K2M’s complete product portfolio, visit www.K2M.com. For more information on Balance ACS, visit www.BACS.com.

About K2M

K2M Group Holdings, Inc. is a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance. Since its inception, K2M has designed, developed, and commercialized innovative complex spine and minimally invasive spine technologies and techniques used by spine surgeons to treat some of the most complicated spinal pathologies. K2M has leveraged these core competencies into Balance ACS, a platform of products, services, and research to help surgeons achieve three-dimensional spinal balance across the axial, coronal, and sagittal planes, with the goal of supporting the full continuum of care to facilitate quality patient outcomes. The Balance ACS platform, in combination with the Company’s technologies, techniques, and leadership in the 3D-printing of spinal devices, enable K2M to compete favorably in the global spinal surgery market. For more information, visit www.K2M.com and connect with us on Facebook, Twitter, Instagram, LinkedIn, and YouTube.

Forward-Looking Statements

This press release contains forward-looking statements that reflect current views with respect to, among other things, operations and financial performance. Forward-looking statements include all statements that are not historical facts such as our statements about our expected financial results and guidance and our expectations for future business prospects. In some cases, you can identify these forward-looking statements by the use of words such as, “outlook,” “guidance,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “could,” “seeks,” “predicts,” “intends,” “plans,” “estimates,” “anticipates” or the negative version of these words or other comparable words. Such forward-looking statements are subject to various risks and uncertainties including, among other things: our ability to achieve or sustain profitability in the future; our ability to demonstrate to spine surgeons the merits of our products; pricing pressures and our ability to compete effectively generally; collaboration and consolidation in hospital purchasing; inadequate coverage and reimbursement for our products from third-party payors; lack of long-term clinical data supporting the safety and efficacy of our products; dependence on a limited number of third-party suppliers; our ability to maintain and expand our network of direct sales employees, independent sales agencies and international distributors and their level of sales or distribution activity with respect to our products; proliferation of physician-owned distributorships in the industry; decline in the sale of certain key products; loss of key personnel; our ability to enhance our product offerings through research and development; our ability to manage expected growth; our ability to successfully acquire or invest in new or complementary businesses, products or technologies; our ability to educate surgeons on the safe and appropriate use of our products; costs associated with high levels of inventory; impairment of our goodwill and intangible assets; disruptions in our main facility or information technology systems; our ability to ship a sufficient number of our products to meet demand; our ability to strengthen our brand; fluctuations in insurance cost and availability; our ability to comply with extensive governmental regulation within the United States and foreign jurisdictions; our ability to maintain or obtain regulatory approvals and clearances within the United States and foreign jurisdictions; voluntary corrective actions by us or our distribution or other business partners or agency enforcement actions; recalls or serious safety issues with our products; enforcement actions by regulatory agencies for improper marketing or promotion; misuse or off-label use of our products; delays or failures in clinical trials and results of clinical trials; legal restrictions on our procurement, use, processing, manufacturing or distribution of allograft bone tissue; negative publicity concerning methods of tissue recovery and screening of donor tissue; costs and liabilities relating to environmental laws and regulations; our failure or the failure of our agents to comply with fraud and abuse laws; U.S. legislative or Food and Drug Administration regulatory reforms; adverse effects of medical device tax provisions; potential tax changes in jurisdictions in which we conduct business; our ability to generate significant sales; potential fluctuations in sales volumes and our results of operations over the course of the year; uncertainty in future capital needs and availability of capital to meet our needs; our level of indebtedness and the availability of borrowings under our credit facility; restrictive covenants and the impact of other provisions in the indenture governing our convertible senior notes and our credit facility; continuing worldwide economic instability; our ability to protect our intellectual property rights; patent litigation and product liability lawsuits; damages relating to trade secrets or non-competition or non-solicitation agreements; risks associated with operating internationally; fluctuations in foreign currency exchange rates; our ability to comply with the Foreign Corrupt Practices Act and similar laws; our ability to implement and maintain effective internal control over financial reporting; potential volatility in our stock due; our lack of current plans to pay cash dividends; our ability to take advantage of certain reduced disclosure requirements and exemptions as a result of being an emerging growth company; increased costs and additional regulations and requirements as a result of no longer qualifying as an emerging growth company as of December 31, 2017; potential dilution by the future issuances of additional common stock in connection with our incentive plans, acquisitions or otherwise; anti-takeover provisions in our organizational documents and our ability to issue preferred stock without shareholder approval; potential limits on our ability to use our net operating loss carryforwards; and other risks and uncertainties, including those described under the section entitled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the SEC and our Quarterly Report filed with the SEC on August 2, 2017, as such factors may be updated from time to time in our periodic filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements. These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this release and our filings with the SEC.

We operate in a very competitive and challenging environment. New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this release. We cannot assure you that the results, events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results, events or circumstances could differ materially from those described in the forward-looking statements.

The forward-looking statements made in this press release relate only to events as of the date on which the statements are made. We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Unless specifically stated otherwise, our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, investments or other strategic transactions we may make.

Media Contact:

Zeno Group on behalf of K2M Group Holdings, Inc.
Christian Emering, 212-299-8985
Christian.Emering@ZenoGroup.com

Investor Contact:
Westwicke Partners on behalf of K2M Group Holdings, Inc.
Mike Piccinino, CFA, 443-213-0500
K2M@westwicke.com

EOI Announces FDA Clearance for the FLXfit15, the Only 3D Articulated Expandable Cage With 15 degrees of Lordosis Correction

Posted On September 28, 2017 By OrthoSpineNews In Regulatory, Spine /

OR AKIVA, Israel, September 28, 2017 /PRNewswire/ —

Expanding Orthopedics Inc. (EOI), a privately-held medical device company focused on developing and commercializing innovative expandable devices for spine surgery, today announced FDA 510(k) clearance for the FLXfit™15, enhancing the already successful FLXfit™ 3D Expandable Cage System. The FLXfit™15 will expand the surgeon’s flexibility and capability by offering a family of products in different length options with infinitely adjustable expansion and lordosis correction of upto 4mm and 15⁰.

Dale Binke, EOI’s VP of US Sales, notes that, “One of the major trends in fusion surgeries is progression towards MIS style procedures, inpatient or outpatient.” However, Dale explains, “There is an inherent challenge in inserting a large interbody cage that restores lumbar lordosis while controlling sagittal and coronal alignment.” He adds, “The FLXfit expandable cage is already providing the ultimate expandable TLIF solution, combining the best-in-class footprint that can be delivered through a MIS window and a unique expansion mechanism that restores lordosis.” Dale summarizes, “With the FLXfit15™, EOI’s engineering team has pushed the envelope a step further by combining an articulating cage with optimal footprint which can be easily delivered and expanded in a controlled manner up to 4mm and 15⁰ of lordotic restoration.”

Expandable cages are gaining market momentum and play a key role in successful fusion procedures. Ofer Bokobza, CEO of Expanding Orthopedics, comments, “The FLXfit™ System has already trail blazed the way for anatomical fit, expandable cages by providing great clinical promise so far.” Ofer says, “The FLXfit15™ will further enhance the anatomical fit with its 15⁰ lordosis and the shorter footprint version (32mm) will offer great flexibility in treating patients with smaller anatomies.” He concludes, “We are thrilled with the release of the FLXfit™15 in the US and certain that the enhanced versatility of the new FLXfit™ family will help gain a greater share in the fusion surgery market, both in MIS and open approaches.”

About Expanding Orthopedics Inc.

Expanding Orthopedics Inc. is medical device company developing and marketing innovative products designed to address unmet clinical needs for spine care and improve long-term patients’ outcome. The Company is spearheaded by a seasoned management team, and is advised by a prominent team of spine surgeons. EOI owns a broad patent portfolio around anatomically fit, expandable devices for enhanced stability through a minimally invasive approach.

Contact info:
David Elkaim,
VP Marketing and Sales
E-mail: david@xortho.com
Phone: (347)-3219683

Providence Medical Technology Expands Offering of Posterior Cervical Fusion Solutions

Posted On September 27, 2017 By OrthoSpineNews In Regulatory, Spine, Top Stories /

WALNUT CREEK, Calif., Sept. 27, 2017 /PRNewswire/ — Providence Medical Technology, an innovator in cervical spine fusion, today announced FDA 510K clearance for its ALLY™ Posterior Fixation System. The system is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for acute and chronic instabilities of the cervical spine (C1 to C7) and is compatible with the company’s flagship DTRAX® Spinal System.

DTRAX Spinal System is a set of sterile packaged, single-use instruments designed to perform posterior cervical fusion and has been used in over 7,000 cases worldwide. Posterior cervical fusion is indicated for patients with symptomatic nerve root involvement and/or mechanical instability. Spinal implants are typically used as an adjunct to posterior cervical fusion cases, and the newly cleared ALLY Posterior Fixation System is the latest addition to the family of spinal fusion implants offered by Providence. Providence also offers CAVUX® Cervical Cages, ALLY Bone Screws, and ALLY Facet Screws as options for spinal instrumentation during cervical fusion procedures.

“We are encouraged by the continued adoption of our posterior cervical fusion technology. Surgeons are increasingly considering posterior cervical fusion with intervertebral cages and supplemental screw fixation when treating patients with cervical spine disorders,” said Providence CEO, Jeff Smith. “The regulatory clearance of ALLY Posterior Fixation System is an important milestone and reflects our commitment to continued innovation and expansion of our differentiated product offering.”

Providence recently announced multiple independent clinical studies supporting the safety, efficacy, and cost-efficiency of its posterior cervical fusion technology. The company will be exhibiting at the annual meeting of the North American Spine Society (NASS) in Orlando, Florida, on October 25-28, booth #1140.

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 approach to posterior cervical fusion and has developed surgical instrumentation and implants that offer unique benefits to the $2 billion worldwide 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

Implanet Strengthens JAZZ Intellectual Property Portfolio

Posted On September 26, 2017 By OrthoSpineNews In Regulatory /

September 26, 2017

BORDEAUX, France & BOSTON–(BUSINESS WIRE)–Regulatory News:

IMPLANET (Paris:IMPL) (OTCQX:IMPZY) (Euronext Growth: ALIMP, FR0010458729, PEA-PME eligible), a medical technology company specializing in vertebral and knee-surgery implants, today announces that the US Patent and Trademark Office (USPTO) has granted two new patents for the JAZZ™ platform.

These two new patents further strengthen the portfolio of 22 patents covering all the aspects of the JAZZ™ platform. It is the result of an extremely proactive and rigorous policy that is one of the strategic keys to commercial development and value creation.

Régis Le Couedic, Implanet’s Product Development & Manufacturing Director, says: “These two new U.S. patents expand our protection on this highly competitive market. Intellectual Property is essential to Implanet’s formula, we meticulously manage our portfolio. Clinical results support the fact that we possess the band market’s most advanced implants and instrumentation. We will continue to expand the scope of protection covering our JAZZ™ platform and future innovations.”

Ludovic Lastennet, CEO of Implanet, adds: “Obtaining these patents is an integral part of our value-creation strategy, we aim to put solid barriers in place in an addressable spine market estimated at $2.1 billion. The systematic growth of our IP protection enables us to reinforce our current commercial partnerships and look towards future strategic alliances.”

Next financial press release: revenue for the 3^rd quarter of 2017, on October 10, 2017, before market opens.

About IMPLANET

Founded in 2007, IMPLANET is a medical technology company that manufactures high-quality implants for orthopedic surgery. Its flagship product, the JAZZ™ latest-generation implant, aims to treat spinal pathologies requiring vertebral fusion surgery. Protected by four families of international patents, JAZZ™ has obtained 510(k) regulatory clearance from the Food and Drug Administration (FDA) in the United States and the CE mark. IMPLANET employs 48 staff and recorded 2016 sales of €7.8 million. For further information, please visit www.implanet.com. Based near Bordeaux in France, IMPLANET established a US subsidiary in Boston in 2013. IMPLANET is listed on Euronext™ Growth market in Paris.

Disclaimer

This press release contains forward-looking statements concerning Implanet and its activities. Such forward looking statements are based on assumptions that Implanet considers to be reasonable. However, there can be no assurance that the anticipated events contained in such forward-looking statements will occur. Forward- looking statements are subject to numerous risks and uncertainties including the risks set forth in the registration document of Implanet registered by the French Financial Markets Authority (Autorité des marchés financiers (AMF)) on April 26, 2016 under number R.16-035 and available on the Company’s website (www.implanet-invest.com), and to the development of economic situation, financial markets, and the markets in which Implanet operates. The forward-looking statements contained in this release are also subject to risks unknown to Implanet or that Implanet does not consider material at this time. The realization of all or part of these risks could lead to actual results, financial conditions, performances or achievements by Implanet that differ significantly from the results, financial conditions, performances or achievements expressed in such forward-looking statements. This press release and the information it contains do not constitute an offer to sell or to subscribe for, or a solicitation of an order to purchase or subscribe for Implanet shares in any country.

Contacts

IMPLANET
Ludovic Lastennet
CEO
Tel. : +33 (0)5 57 99 55 55
investors@implanet.com
or
NewCap
Investor Relations
Florent Alba
Tel. : +33 (0)1 44 71 94 94
implanet@newcap.eu
or
NewCap
Media Relations
Nicolas Merigeau
Tel. : +33 (0)1 44 71 94 98
implanet@newcap.eu
or
AlphaBronze
US-Investor Relations
Pascal Nigen
Tel.: +1 917 385 21 60
implanet@alphabronze.net

SpinalCyte, LLC Announces New Australian Patent

Posted On September 21, 2017 By OrthoSpineNews In Regulatory /

September 20, 2017

HOUSTON–(BUSINESS WIRE)–SpinalCyte, LLC, a Texas-based tissue engineering technology company focused on regrowth of the spinal disc nucleus using human dermal fibroblasts, announced today the issuance of Australian Patent No. 2015202319, “Methods And Compositions For Repair of Cartilage Using An In Vivo Bioreactor.”

The technology described in the patent involves producing chondrocytes or chondrocyte-like cells using fibroblasts in vivo with mechanical stress and low oxygen tension.

“This Australian patent covers our core technology and provides the foundation for our intellectual property protection internationally. It solidifies our scientific basis and protects our technology in an extremely important market,” said Pete O’Heeron, Chief Executive Officer, SpinalCyte.

With this addition, SpinalCyte’s portfolio now includes 24 U.S. and foreign patents issued and directly owned by the company, along with 45 patents pending.

About SpinalCyte, LLC

Based in Houston, Texas, SpinalCyte, LLC is a tissue engineering technology company developing an innovative solution for spinal nucleus replacement using human dermal fibroblasts. Currently, SpinalCyte holds 24 U.S. and international issued patents and has filed for an additional 45 patents pending. Funded entirely by angel investors, SpinalCyte represents the next generation of medical advancement.

Contacts

SpinalCyte, LLC
Investor Contact:
Pete O’Heeron, 281-461-6211
CEO
info@spinalcyte.com

Mazor Robotics Announces CE Mark Approval for the Mazor X Surgical Assurance Platform

Posted On September 20, 2017 By OrthoSpineNews In Regulatory, Robotics, Top Stories /

September 20, 2017

CAESAREA, Israel–(BUSINESS WIRE)–Mazor Robotics Ltd. (TASE: MZOR; NASDAQGM: MZOR), a pioneer and a leader in the field of surgical robotic systems, announced today CE Mark approval for its Mazor X Surgical Assurance Platform. The CE Mark allows Mazor and its commercial partner, Medtronic, to market the Mazor X in the European Union, as well as other countries that recognize the CE Mark.

“Receipt of the CE Mark is an important step in our plan to expand the patient, surgeon and hospital benefits of the Mazor X Surgical Assurance Platform to the European market,” said Ori Hadomi, Mazor’s Chief Executive Officer. “Our commercial partner for the Mazor X, Medtronic, will be responsible for marketing and selling the system in Europe and we look forward to working with them to ensure a successful launch.”

The Mazor X will be displayed in Medtronic’s booth (F10) at EUROSPINE, which is being held from October 11-13, 2017 in Dublin, Ireland.

About Mazor

Mazor Robotics (TASE: MZOR; NASDAQGM: MZOR) believes in healing through innovation by developing and introducing revolutionary robotic technologies and products aimed at redefining the gold standard of quality care. Mazor Robotics Guidance Systems enable surgeons to conduct spine and brain procedures in an accurate and secure manner. For more information, please visit www.MazorRobotics.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other securities laws. Any statements in this release about future expectations, plans or prospects for the Company, including without limitation, statements regarding the benefits of CE Mark approval, statements regarding the marketing and selling of the system in Europe, and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “will” and similar expressions are forward-looking statements. These statements are only predictions based on Mazor’s current expectations and projections about future events. There are important factors that could cause Mazor’s actual results, level of activity, performance or achievements to differ materially from the results, level of activity, performance or achievements expressed or implied by the forward-looking statements. Those factors include, but are not limited to, the impact of general economic conditions, competitive products, product demand and market acceptance risks, reliance on key strategic alliances, fluctuations in operating results, and other factors indicated in Mazor’s filings with the Securities and Exchange Commission (SEC) including those discussed under the heading “Risk Factors” in Mazor’s annual report on Form 20-F filed with the SEC on May 1, 2017 and in subsequent filings with the SEC. For more details, refer to Mazor’s SEC filings. Mazor undertakes no obligation to update forward-looking statements to reflect subsequent occurring events or circumstances, or to changes in our expectations, except as may be required by law.

Contacts

EVC Group
Investors
Michael Polyviou, 212-850-6020
mpolyviou@evcgroup.com
or
Doug Sherk, 646-445-4800
dsherk@evcgroup.com

Stryker’s Spine Division Receives FDA Clearance for 3D-Printed Tritanium® C Anterior Cervical Cage

Posted On September 20, 2017 By OrthoSpineNews In Regulatory, Spine, Top Stories /

September 20, 2017

ALLENDALE, N.J.–(BUSINESS WIRE)–Stryker’s Spine division today announced that its Tritanium^® C Anterior Cervical Cage, a 3D-printed interbody fusion cage intended for use in the cervical spine, has received 510(k) clearance from the U.S. Food and Drug Administration.

The Tritanium C Anterior Cervical Cage is constructed from Stryker’s proprietary Tritanium In-Growth Technology,¹ a novel, highly porous titanium material designed for bone in-growth and biological fixation.¹ Tritanium material may be able to wick or retain fluid, in contrast to traditional titanium material.²

“We are excited to introduce the Tritanium C Anterior Cervical Cage following the successful launch last year of our Tritanium Posterior Lumbar Cage,” said Bradley Paddock, President of Stryker’s Spine division. “The benefits of additive manufacturing to create highly porous spinal implants that are ‘engineered for bone’ are becoming increasingly clear. Additive manufacturing allows us to push beyond conventional manufacturing techniques to address design complexity and achieve previously unmanufacturable geometries, while delivering the performance, reproducibility, and quality our customers have come to expect.”

The unique porous structure of the Tritanium material is designed to create a favorable environment for cell attachment and proliferation, as demonstrated in an in-vitro study.³* It is inspired by the microstructure of cancellous bone⁴ and enabled by AMagine™, Stryker’s proprietary approach to implant creation using additive manufacturing, also known as 3D printing.

The Tritanium C Anterior Cervical Cage features an open central graft window and lateral windows to help reduce stiffness of the cage and minimize subsidence. In addition, the large graft window allows for bone graft containment. Engineered for stability,⁵ the cage has serrations on the superior and inferior surfaces designed for bidirectional fixation and to maximize surface area for endplate contact with the cage. Its smooth posterior edges help to facilitate insertion and protect soft tissue and anatomy. The Tritanium C Anterior Cervical Cage is offered in a number of footprints, heights, and lordotic angles to adapt to a variety of patient anatomies. It will be available to surgeons in Q4 2017.

Intended Use (US)

The Tritanium C Anterior Cervical Cage is indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels from the C2 to T1 disc. The cage is to be used with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and is to be implanted via an open, anterior approach. For the full indications for use, please refer to the Tritanium C Anterior Cervical Cage Instructions for Use.

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com.

References

PROJ43909: Tritanium technology claim support memo
RD0000050927: Tritanium material capillary evaluation
RD0000053710: Tritanium cell infiltration and attachment experiment
*No correlation to human clinical outcomes has been demonstrated or established
Karageorgiou V, Kaplan D. Porosity of 3D biomaterial scaffolds and osteogenesis. Biomaterials, 26, 5475-5491
PROJ44960: Coefficient of friction memo

Content ID TRICC-PR-1_15507

Contacts

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