NuVasive SpineTRACK Registry Named Qualified Clinical Data Registry By Centers Of Medicare And Medicaid Services

SAN DIEGOFeb. 20, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced that the Company’s SpineTRACK Registry has received the designation of Qualified Clinical Data Registry (QCDR) by the Centers of Medicare and Medicaid Services (CMS) for the 2018 Merit-based Incentive Payment System (MIPS) reporting year. As a result, SpineTRACK participants can now use the platform to earn Medicare payment incentives.

The SpineTRACK Registry is a NuVasive-sponsored prospective, multicenter, observational data collection quality improvement tool established in 2011. SpineTRACK serves as a comprehensive and collaborative data collection and quality improvement solution for spine practices, and is designed to allow surgeons to use real-time reports to make better treatment decisions, patients to track their progress to better understand treatment benefits and hospitals to evaluate outcome variations to aid in providing the highest value of care.

MIPS is one of two tracks under the Quality Payment Program, which moves Medicare Part B providers to a performance-based payment system. MIPS streamlines three historical Medicare programs—the Physician Quality Reporting System (PQRS), the Value-based Payment Modifier (VM) Program and the Medicare Electronic Health Record (EHR) Incentive Program (Meaningful Use)—into a single payment program.

Comprising four indicators—1) Quality (50%), 2) Improvement Activities (15%), 3) Advancing Care Information (25%) and 4) Cost (10%)—each category is weighted and factored into a final score which can impact Medicare payments by plus or minus 5% in 2020. As a QCDR, the SpineTRACK Registry is able to support the MIPS Quality reporting requirements on behalf of eligible providers.

“SpineTRACK is a unique differentiator for NuVasive and is the longest-running spine outcomes database sponsored by any spine company,” said Matt Link, executive vice president, strategy, technology and corporate development for NuVasive. “Since 2011, more than 9,500 patients have been enrolled in SpineTRACK and numerous peer-reviewed papers have been published using its data. The QCDR designation helps our customers meet quality reporting criteria to deliver optimal results and earn incentives that can grow their practices. This is truly a value-add that aligns with our focus on systems-based spine solutions.”

About NuVasive
NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally disruptive, 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

Nexxt Spine Marks 250th Implantation of the NEXXT MATRIXX® System Interbody

February 19, 2018

NOBLESVILLE, Ind.–(BUSINESS WIRE)–Nexxt Spine, LLC, a medical device company focused on designing, manufacturing, and distributing innovative spinal solutions, today announced the milestone of the 250th implantation of the NEXXT MATRIXX® System.

Launched in 2017 the NEXXT MATRIXX® System is a collection of 3D printed porous titanium interbodies that leverages Nexxt generation technology to create interbody and VBR devices with optimized open architectural porosity, residue-free surface technology, and robust radiographic imaging performance.

“It is exciting to review the images surgeons are submitting showing the level of bone formation 12 weeks post-operative,” stated Nexxt Spine President, Andy Elsbury. Mr. Elsbury continued, “Multiple surgeons are taking so much pride in the results they are achieving.”

One of the first implantations of the NEXXT MATRIXX System® was conducted by Dr. George Picetti, Orthopedic Surgeon with Sutter Medical Group in Sacramento, California. “I am particularly pleased with the bone formation and cage integration I have seen in my twelve-week follow-up appointments with the NEXXT MATRIXX® Interbody System,” remarked Dr. Picetti.

Mr. Elsbury also stated, “Another pleasantly surprising trend since launch is how quickly surgeons progressed from initial cervical usage to the lumbar interbodies. Surgeons have moved to the NEXXT MATRIXX® System being their standard of care now that they have seen the post-operative results.”

Dr. Michael McNamara, Orthopedic Surgeon with the Bone and Joint Institute of Tennessee, was also one of the first surgeons to implant the device. “The surgeries have gone extremely well. The instrumentation is intuitive and allows me to accurately place the implants,” said Dr. McNamara.

The first products to feature the NEXXT MATRIXX® technology are available for both cervical and lumbar indications in an assortment of height, length, width and lordotic angulation combinations to accommodate the unique anatomic and clinical circumstances of each patient. The NEXXT MATRIXX® System will launch additional product lines in 2018.

About Nexxt Spine

Nexxt Spine, LLC is a medical device company focused on designing, manufacturing, and distributing innovative spinal solutions. The company is dedicated to increasing efficiency and patient outcomes through the development of new and innovative products. Nexxt Spine manufactures on the most technologically advanced platforms in order to treat painful and debilitating spinal injuries. Nexxt Spine is located in Noblesville, Indiana where all spinal implants and 95% of surgical instruments are manufactured in a state of the art facility.

Contacts

Nexxt Spine
Sarah Koch
Info@NexxtSpine.com

Medicrea Reports Directors’ Dealings Disclosure

February 16, 2018

LYON, France & NEW YORK–(BUSINESS WIRE)–The MEDICREA Group (Euronext Growth: FR0004178572 – ALMED), pioneering the convergence of healthcare IT and next-generation, outcome-centered device design and manufacturing with UNiD ASI™ technology, announces transactions on securities of the Company by its Chairman and Chief Executive Officer.

In accordance with Article 19 of Regulation (EU) No 596/2014 of April 16th, 2014, the Company has declared to the AMF the acquisition of 60,000 shares on February 13th, 2018 by its Chairman and Chief Executive Officer, Denys Sournac.

About Medicrea (www.Medicrea.com)

Operating in a $10 billion marketplace, Medicrea is a Small and Medium sized Enterprise (SME) with 175 employees worldwide, which includes 40 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.

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 150,000 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.

For further information, please visit: www.medicrea.com

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

Medicrea is listed on
EURONEXT Growth Paris
ISIN: FR 0004178572
Ticker: ALMED
LEI: 969500BR1CPTYMTJBA37

Contacts

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

TranS1® Announces Three New Patents

Denver, Feb. 13, 2018 (GLOBE NEWSWIRE) — TranS1®, a spinal device company focused on breakthrough solutions that minimize tissue trauma, today announced it has added three new patents to its portfolio. The patents relate to two new developments associated with presacral interbody fusion, including two new expandable cages designed to create lordosis at L5-S1, along with a new technique to perform sacroiliac (SI) fusion.

“TranS1’s patent portfolio remains one of the strongest in the industry,” said Jeffrey Schell, chief executive officer of TranS1, who is also a patent attorney. “Our strategy remains to advance the most innovative technologies to lessen tissue trauma during spine surgery and to vigorously guard those technological innovations through domestic and international patent protection.”

TranS1 offers a full complement of minimally invasive surgery (MIS) solutions for spinal pathologies, including the award-winning Pylon™ posterolateral decortication and bone graft placement system, the KeyLIF™ MIS Oblique Lateral Interbody Fusion system and the AxiaLIF® presacral interbody fusion system.The AxiaLIF procedure allows for minimally invasive spinal fusion at L5-S1 for patients with certain spinal pathologies. Presacral interbody fusion at L5-S1 was awarded a Category 1 CPT® Code (22586) in 2013 by the American Medical Association’s CPT Editorial Committee.  According to the CPT Editorial Panel, procedures recognized as Category 1 are widely performed throughout the United States, consistent with accepted medical practice and supported by relevant published research demonstrating the clinical efficacy of the procedure.

In addition to its full suite of MIS procedures and devices, TranS1 has also created and continues to develop a patent portfolio focused on spinal health technologies. The company remains committed to becoming the most innovative in the industry by developing new technologies, applying lessons learned from its development of related approaches, and by attracting the most experienced engineers and surgeons to its team. In all, TranS1 has more than 100 issued patents and has filed more than 50 new patent applications in the last three years.

About TranS1
Headquartered in Denver, TranS1 develops medical breakthroughs to solve spinal pathologies that minimize trauma to the tissues surrounding the spine. The company’s flagship product, AxiaLIF+, is a minimally invasive option for surgeons to accomplish spinal fusion at the L5-S1 joint. The company was named Denver’s Most Innovative Workplace by the 80/95 Awards, presented by the Denver Post. In 2017, the company won the “New Spine Technology” award from Orthopedics This Week for its Pylon™ MIS Posterolateral Decortication and Bone Graft Placement System. For more information, visit www.TranS1.com.

# # #

Doyle Albee
dalbee@mapr.agency

Simplify Medical Completes Enrollment in IDE Trial Studying Simplify Disc in One Level of Spine for Cervical Disc Replacement

February 14, 2018

SUNNYVALE, Calif.–(BUSINESS WIRE)–Simplify Medical Pty Ltd, maker of the Simplify® cervical artificial disc, today announced completion of enrollment in its U.S. IDE trial studying the Simplify Disc used for one-level cervical implantation of the device between C3 to C7 compared with a historical control group. The trial enrolled 166 patients at 16 U.S. sites.

“We want to thank the surgeon investigators, their staffs and the patients participating in the Simplify trial for their time and tremendous support,” said David Hovda, chief executive officer of Simplify Medical. “Recognizing that most of the devices used in disc replacement today require patients to be exposed to substantial ionizing radiation from CT scans post-operatively, it’s important for patients and physicians to have an alternative that minimizes that risk.”

The trial’s national co-primary investigator Domagoj Coric, MD, with Carolina Neurosurgery and Spine Associates, said, “The Simplify Disc is straightforward to implant, with materials designed to optimize biocompatibility and lower disc heights to better match cervical anatomy. We are pleased with the positive early clinical outcomes and look forward to seeing the longer-term study results, anticipating that they will validate the promise seen to date.”

Richard Guyer, MD, chairman of the Texas Back Institute Foundation and national co-primary investigator for the study, said, “The Simplify Disc is made of materials designed to optimize MRI imaging of the disc space and adjacent spinal canal without artifact. This can minimize or eliminate the use of post-operative CT scans and their risk of radiation to patients, and we look forward to having this capability as an option for treating our patients with cervical disc disease.”

While magnetic resonance imaging (MRI) is widely used pre-operatively for surgical planning, spine surgeons often switch to CT scans post-operatively in order to accommodate metal components, which can make it difficult to view the devices, as well as the facets and adjacent disc levels. However, CT scans have been shown to expose patients to ionizing radiation that equates to 400 to 550 chest X-rays per scan.

Composed of primarily non-metal materials (PEEK-on-ceramic), the Simplify Disc is designed to be viewed on MRI in order to minimize patient exposure to radiation. With no metal in its articulating components, the disc is also designed for low levels of wear to optimize long-term durability. Implantation of the Simplify Disc is accomplished in a straightforward, three-step procedure. The Simplify Disc is also anatomically designed with low height implant options to accommodate patients with smaller cervical disc spaces, making it ideal for women and certain regional populations. The device is considered MRI-conditional, posing no known hazard in an MRI environment within prescribed conditions of use.

The Simplify Disc used in two levels of the spine is being studied in a second IDE trial in the U.S., which is approximately 40 percent enrolled and enrollment is expected to be completed by the end of 2018. The prospective pivotal trial will encompass up to 200 patients at up to 18 centers, comparing cervical implantation of the device in two contiguous discs from C3 to C7 with two-level cervical fusion surgery. For information about eligibility or enrollment in the two-level clinical trial, please visit http://www.simplifytrial.com/.

The Simplify Disc has received the CE Mark and is commercially available in select European markets. Early clinical data has shown substantial improvement in patient pain scores and functional improvement after treatment.

ABOUT SIMPLIFY MEDICAL

Simplify Medical is focused on cervical spinal disc arthroplasty, using innovative, MRI-friendly materials designed to decrease the need for ionizing radiation and enhance patient options. Simplify Medical is located in Sunnyvale, California. To learn more, visit http://www.simplifymedical.com/.

Caution: The Simplify Disc is an investigational device in the United States and is limited by law to investigational use.

Contacts

Chronic Communications Inc.
Michelle McAdam, (949) 545-6654
michelle@chronic-comm.com

Spineology Completes Enrollment in IDE Trial for Mesh Fusion Implant

February 14, 2018

ST. PAUL, Minn.–(BUSINESS WIRE)–Spineology Inc., an innovator in anatomy-conserving spine surgery, is excited to announce that enrollment is now complete in the Company’s SCOUT clinical trial. The SCOUT (Spineology Clinical Outcomes Trial) IDE, conducted under an FDA-approved protocol, is a prospective multicenter non-randomized performance goal investigation, designed to evaluate safety and effectiveness outcomes in instrumented lumbar interbody fusion procedures for the treatment of degenerative disc disease (DDD).

Spineology’s deployable graft containment mesh implant is a uniquely porous device that deploys within the disc space as it is filled, permitting the contained bone graft to conform to the prepared vertebral body endplates. The system’s design allows for disc space preparation and implant placement through a small cannula.

Spineology’s OptiMesh® deployable graft containment implant received 510(k) clearance from FDA in 2003 for graft containment within the vertebral body. The SCOUT trial is designed to provide clinical data to support a regulatory submission for expanded indications, allowing the implant to be used with bone graft and supplemental posterior fixation in support of lumbar interbody fusion for treating painful DDD.

Dr. Stéphane Lavoie of DeLand, Florida enrolled the first SCOUT subject. As one of the top enrolling sites, Dr. Lavoie also enrolled the final study subject. “The Spineology interbody fusion system allows me to efficiently prepare the disc space for fusion through a very small access, reducing surgical time and trauma to the surrounding tissues. It has been exciting to participate in the clinical trial for this unique fusion system and I have been pleased with my patient outcomes.”

“The unique deployable mesh allows me to create a confirming bone graft pack to support new bone growth,” added Dr. Martin Krag, Professor of Orthopaedics at the University of Vermont Larner College of Medicine. “Importantly, patient satisfaction is very good. At our institution we have observed rapid and substantial improvements in pain and function scores for study subjects post-surgery.”

Early results in the SCOUT trial have been encouraging. Dr. John Chi will be formally presenting interim SCOUT results at the upcoming meeting of the International Society for the Advancement of Spine Surgery (ISASS) to be held this April in Toronto, Canada. Dr. Chi is an Associate Professor of Neurosurgery at Harvard Medical School and the Director of Neurosurgical Spinal Oncology at Brigham and Women’s Hospital, the top enrolling site in the SCOUT IDE trial.

The SCOUT trial includes 102 patients who were experiencing painful lumbar degenerative disc disease of at least six months’ duration. Patients will be followed for 24 months minimum and the company is gathering data on hospital parameters, pain and function, patient satisfaction, safety and radiographic fusion. The list of nationwide study sites participating in the SCOUT IDE includes Brigham and Women’s Hospital, University of Vermont, the Spine Institute of Louisiana, Florida Orthopaedic Associates, and Georgetown University, among others. Details of the study may be found at the NIH clinical trials website, https://clinicaltrials.gov/ct2/show/NCT02347410?spons=spineology&rank=1.

Subsequent to appropriate follow-up, the clinical outcomes data collected will allow Spineology to submit a De Novo application to the FDA to seek marketing clearance for interbody mesh fusion indications in the U.S.

About Spineology Inc.
Spineology Inc. provides innovative, anatomy-conserving spinal technologies for surgeons and their patients. Spineology surgical techniques conserve spinal bone, ligament and muscle tissue. Spineology is committed to increasing procedural efficiency, reducing surgical morbidity and accelerating patient recovery. Learn more at spineology.com.

Contacts

Spineology Inc.
John Booth, 651-256-8511
jbooth@spineology.com

Medovex Corporation Presents Initial Data on the DenerveX® System During NSpine 2nd Platinum Course in Arosa, Switzerland

ATLANTA, Feb. 13, 2018 (GLOBE NEWSWIRE) — Medovex Corp. (OTCQB:MDVX) (“Medovex” or the “Company”), the developer of the DenerveX® System, a new and novel device designed for enduring relief of Facet Joint Syndrome related to chronic back pain, a non-addictive, non-opioid drug alternative capable of restoring a patient to a more normal and active lifestyle, today announced that the Company participated at the NSpine Platinum Small Group Educational Event in Arosa, Switzerland, held January 29th through February 3rd, 2018.

Medovex medical advisory board member Vik Kapoor MD, from Manchester, U.K. presented on two separate days at the N-Spine Platinum Small Group Educational Event. Dr. Kapoor presented initial data on his first 20 cases using the DenerveX System, which he considers very positive. The presentation was well received by approximately 50 European neuro, spinal, and orthopedic surgeons. Attending surgeons were granted 30 European CME credits (6 ECMEC® per day) by the European Accreditation Council for Continuing Medical Education (EACCME).

A third day marketing presentation focused on the DenerveX System including discussion related to reimbursement opportunities specific to individual countries, leading to expressed interest from many attendees to start performing DenerveX cases in their respective countries.

In an effort to enhance the value of the meeting, the third day of the event consisted of novel technologies identified by NSpine as improving the field of spine care. The Medovex team was pleased to have been selected.

The value of the Arosa meeting lies in its educational content – to gain a greater understanding of current trends and decision making in spinal surgery – and in the networking with senior decision makers in the world of spinal surgery.

Manfred Sablowski, Medovex Senior Vice President of Global Sales & Marketing stated, “We are pleased to have been selected for participation at The NSpine Platinum Small Group Educational Event. The professional networks built through these events are as valuable as the educational content itself. During this master’s course, Medovex had the privilege of meeting many of the world’s preeminent surgeons who we continue to draw on for advice in managing unusually complex cases.”

Sablowski continued, “Events like these are important milestones for Medovex, as well as a key inflection point gaining us leverage for our Company’s growth strategy focused in Europe, South America, and Australia. Importantly, it provides potential future customers the opportunity to experience firsthand the intuitive DenerveX System.”

Please also follow us on Facebook at https://www.facebook.com/medovex/.

About Medovex

Medovex was formed to acquire and develop a diversified portfolio of potentially ground breaking medical technology products. Criteria for selection include those products with potential for significant improvement in the quality of patient care combined with cost effectiveness. The Company’s first pipeline product, the DenerveX System, is intended to provide long lasting relief from pain associated with facet joint syndrome at significantly less cost than currently available options. To learn more about Medovex Corp., visit www.medovex.com.

Safe Harbor Statement                                                     

Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Company’s filings with the Securities and Exchange Commission (the “SEC”), not limited to Risk Factors relating to its business contained therein. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.

Contact Information

 

EIT Emerging Implant Technologies Announces CE Mark and First Cases for the World’s First Fully 3D Printed Adjustable Cage.

Emerging Implant Technologies GmbH (EIT), a German medical device manufacturer exclusively focused on creating innovative technologies for spinal application by utilizing additive manufacturing, announces that it has received CE mark and performed the first surgeries in Germany with the first fully 3D printed adjustable interbody fusion cage worldwide.

The adjustable EIT PLIF cage is printed as one piece with no assembly needed in the production process. This reduces cost significantly compared to regular expandable cages that are manufactured with traditional machining processes.

The adjustable PLIF allows for restoration of lordosis angles up to 18° and supports minimally invasive insertion techniques. The goal is to reduce intraoperative trauma, optimize size adaptation and improve restoration of sagittal balance to improve fusion rates, reduce subsidence and adjacent segment disease (ASD) related to insufficient sagittal balance restoration. The bone contact areas consist of EIT Cellular Titanium® porous structure to enhance primary stability and bony integration.

“Adjustable cage technology has the potential to change the interbody fusion cage market as it can be offered at reasonable pricing that copes with existing pressures and reimbursement systems all over the globe. Additive manufacturing allows us to bring down cost tremendously. We are thrilled to be the first that have accomplished this platform technology and can now offer this technology to the European spine community” says Guntmar Eisen, founder and CEO of EIT.

Nancy Lamerigts, MD, PhD and VP of Marketing and Research says “with the new devices we now start the launch of our 2nd generation product line combining EIT Cellular Titanium® technology with functionality. So now we can really combine faster fusion and better alignment, respecting the economic environment that has prevented the breakthrough of expandable cage technology for years.”

Dr. Marcus Eif, head of neurosurgery at the Klinikum Görlitz in Germany, who has performed the first case with the new system, experienced that the EIT adjustable PLIF implant allowed for a minimal invasive approach while still being able to restore the required lordosis. “The intuitive instrumentation and the functionality of the implant enabled a straightforward procedure and an excellent postoperative result”.

About EIT

EIT is the first medical device manufacturer to exclusively focus on spinal implants, that are designed according to latest science on optimal bone ingrowth in porous titanium scaffolds and produced with additive manufacturing methods. EIT was founded in 2014. Implants and Instruments are made in Germany.

The EIT implants are made of EIT Cellular Titanium®, that addresses the clinical shortcomings of the current cage designs and materials (non-fusion, biocompatibility, subsidence, migration and imaging distortion), thereby obtaining very promising fusion results and improved clinical outcome due to the qualities of the porous 3-D printing of titanium. The highly porous titanium scaffold ensures extensive bone ingrowth as a result of its specific design and elasticity close to the cancellous bone. Due to its unique design with a porosity of 80% the EIT implants ensure uncompromised imaging on X-ray and MRI and enabling excellent follow up on defining bone ingrowth and fusion with CT.

A complete portfolio of EIT Smart Spinal Implants™ based on EIT Cellular Titanium® is available for the cervical and lumbar spine, with an extensive choice in footprint sizes, heights and lordosis angles to support the recreation of sagittal balance and alignment. Since 2014 over 15.000 EIT cases have been performed in over 15 markets globally. EIT received various FDA approvals and began introducing products in the US in Q4 of 2017.

K2M Group Holdings, Inc. to Participate in the 2018 RBC Capital Markets Global Healthcare Conference

LEESBURG, Va., Feb. 12, 2018 (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 its participation in the 2018 RBC Capital Markets Global Healthcare Conference at the Lotte New York Palace Hotel in New York, New York. Management will participate in a fireside chat on Thursday, February 22 at 2:05 p.m. Eastern Time.

A live audio webcast of the presentation will be provided under the ‘Events & Presentations’ section of the Company’s investor relations website at http://Investors.K2M.com/. It is recommended that listeners log on 15 minutes early in order to register and download any necessary software. An archive of the webcast will be available for replay following the conference.

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 FacebookTwitterInstagramLinkedIn 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 and retain their use of our products; pricing pressures and our ability to compete effectively generally in our industry; collaboration and consolidation in hospital purchasing; inadequate coverage and reimbursement for our products from third-party payers; 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 to our corporate headquarters and operations facilities or critical information technology systems, distributors or surgeon users; 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 price; our lack of current plans to pay cash dividends; 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 November 1, 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.



Camber Spine Technologies Announces First Implantations Of SPIRA™-C Open Matrix Cervical Interbody

WAYNE, Pa.Feb. 12, 2018 /PRNewswire/ — Camber Spine, a leading innovator in spine and medical technologies, today announced the first surgeries using the company’s proprietary SPIRA™-C Open Matrix Cervical Interbody device, a unique, interbody fusion implant consisting of spiral support arches and Surface by Design™ technology. The first cases were performed successfully this past week with several surgeons across the country performing multilevel ACDF procedures.

Dr. Michael Dorsi, M.D. of Ventura Neurosurgery was one of the first surgeon design team members to perform a multilevel procedure using SPIRA™-C this past week. According to Dr. Dorsi: “I really appreciate the design of this implant. Upon insertion, I feel as though the cage has immediate stability because of the roughened surface which provides significant friction. The arched design has large openings which allows for significant graft packing and creates a snowshoe-like effect of distributed load sharing which should decrease the risk of subsidence. The open matrix architecture eliminates the need for the central lumen in traditional cervical cages, potentially speeding up the mechanical fusion process, optimizing clinical and fusion outcomes.”

Dr. Michael Dorsi, M.D., is a board-certified, fellowship trained neurosurgeon who has been providing state-of-the-art care to the greater Ventura County area since 2012. Dr. Dorsi attended The Johns Hopkins University, graduated Phi Beta Kappa with Highest Honors and a degree in Neuroscience and subsequently completed his residency training in neurosurgery. He was awarded the Cloward Award from the American Association of Neurological Surgeons for Fellowship Training in Minimally and Invasive Spine Surgery at UCLA.

SPIRA™-C was designed to address surgeon frustrations associated with traditional cervical interbody devices such as the need for immediate stability. SPIRA™-C was developed for Camber Spine under a collaborative agreement with the Institute for Musculoskeletal Science & Education (IMSE), an independent, full-service product development and engineering services company. With an extensive faculty of dedicated physicians, IMSE leverages the collaborative balance between engineering and surgeon ingenuity to create next-level medical devices. The SPIRA™-C design team included several John Hopkins trained Neurosurgeons, all with extensive backgrounds treating complicated cervical pathologies.

“Surgeon design team members are a key component to our success. The insight they provide helps us create smarter solutions, maximizing technological advances and ultimately driving innovation in minimally invasive spine surgery. We are fortunate to have an esteemed surgeon such as Dr. Dorsi on our team helping us turn surgeon frustrations into innovationsThere is a lot of excitement around the SPIRA™ technology platform and we expect products like SPIRA™-C and SPIRA™ALIF to fuel our continued sales growth.”

– Seth Anderson, Founding Partner and Vice President, Surgeon Relations

SPIRA™-C is the second in the SPIRA™ family to employ a novel arched design as well as Surface by Design™ technology specifically designed to increase fusion rates and stabilization. The spiral support arches decrease subsidence by load sharing over the entire endplate, while also maximizing bone graft capacity. The Surface by Design™ technology is a deliberately designed roughened surface that facilitates bone growth through an optimized pore diameter, strut thickness and trabecular pattern.

About Camber Spine

Camber Spine Technologies, LLP, is a medical device company focused on the design, development and commercialization of innovative and proprietary musculoskeletal implant systems. The company is committed to delivering surgeon inspired new technologies to the spine market. Camber Spine, located in Wayne, Pennsylvania, markets a line of proprietary musculoskeletal products nationwide through its exclusive distributor, S1 Spine.

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

SOURCE Camber Spine Technologies

Related Links

http://cambermedtech.com