News – Page 153 – Selby Spine

September 07, 2017

EOS imaging (Paris:EOSI)(Euronext, FR0011191766 – EOSI – Eligible PEA – SME), the pioneer in 2D/3D orthopedic medical imaging, today announced its consolidated results for the six months ended June 30, 2017, as stated by the Board of Directors on September 7, 2017.

First Half 2017 Financial Results

in millions euros	First Half 2017	First Half 2016
Sales	16,46	14,14
Other Income	0,82	1,17
Total Income	17,28	15,31
Direct COGS	(9,03)	(7,63)
Gross Margin as % of sales	8,25 45,1%	7,68 46,0%
Operating expenses	(10,91)	(9,41)
Operating Income	(2,66)	(1,73)
Financial Income	(1,06)	(0,67)
Net Income	(3,72)	(2,40)
	As of June 30, 2017	As of Dec. 31, 2016
Cash	17,6	14,9

Marie Meynadier, Chief Executive Officer of EOS imaging, commented: “Our performance in the first half of 2017 included strong revenue growth in the EMEA and APAC regions, partially offset by lower sales in North America where we were implementing a new, reinforced organizational structure. This impacted our operational and financial performance, despite the improvement in production and maintenance efficiency.

EOS imaging solutions are increasingly recognised as a standard of care, as evidenced by nearly one million patients each year that benefit from a low-dose EOS scan and comprehensive imaging results, along with the physicians and healthcare systems that benefit from the platform’s innovative and effective solutions. Given this positive position in the market, we decided to accelerate our growth initiatives in the United States, our most important market and a priority for our company.

We are confident in a rapid return to growth in North America, under the leadership of Mike Lobinsky, who we recently appointed as President of the region.

Our initiatives in North America, combined with the positive business dynamics in the rest of the world, and with our investments in our product offering, should strongly improve our performance in the short and medium terms.”

First Half 2017 Sales Growth: +16%

In the first half of 2017, the Company generated revenue of €16.5 million, up 16% compared to the first half of 2016. The Company sold 34 EOS® systems during the first half of the year, compared to 28 systems in the same period last year. Sales of maintenance contracts increased by 28% to €2.84 million, reflecting the continued growth of the installed base of EOS systems under contract.

The increase in revenues over the first half of 2017 was driven by strong sales in the EMEA and APAC regions, partially offset by lower sales in North America, related to an operational reorganization.

First Half 2017 Gross Margin: €8.3 million representing 45.1% of Revenues

Gross margin for the first half of 2017 was 45.1% of revenues, as compared to 46.0% during the same period last year. This reflects lower sales in North America, which represented approximately 35% of revenues in the period, as compared 54% of revenues in the first half of 2016. This was partially offset by improved manufacturing costs and maintenance in the first half of 2017 compared to the same period last year.

Controlled Increase of Operating Expenses

Operating expenses for the first half of 2017 totaled €10.9 million, up 16% compared to the same period last year and in-line with the Company’s revenue growth in the period. These expenses are slightly below their level in the second half of 2016.

Operating loss for the first half of 2017 was €2.7 million, compared with an operating loss of €1.7 million in the same period last year (and of €2.8 million in the second half of 2016). This reflects the decrease in gross margin and a one-time decline in other income (CIR and subsidies).

Net financial expense for the first half of 2017 totaled €1.1 million, compared to €0.7 million in the same period last year, reflecting interest expense on the Company’s €15 million debt financing, the last tranche of which was drawn in June 2016.

Net loss for the first half of 2016 was €3.7 million, compared with a net loss of €2.4 million in the same period last year (and €2.8 million in the second half of 2016).

The Company had 152 employees at June 30, 2017, compared with 132 at December 31, 2016.

Cash Position and Balance Sheet: Improving Equity and Cash Positions

The Company’s cash position at June 30, 2017 was €17.6 million, compared with €14.9 million at December 31, 2016. Equity at June 30, 2017 was €27.3 million, compared with €22.8 million at December 31, 2016. This includes 2,204,844 new shares issued primarily in a private placement completed in April 2017 but coming also from the Equity Line Société Générale and from the exercise of options.

First Half of 2017 Financial Report

EOS imaging’s first half of 2017 financial report can be downloaded from its web site at www.eos-imaging.com by selecting Documentation, then Financial reports from the Investors menu.

For more information, please visit www.eos-imaging.com.

EOS imaging has been chosen to be included in the new EnterNext© PEA-PME 150 index, composed of 150 French companies and listed on Euronext markets in Paris.

EOS imaging is listed on Compartment C of Euronext Paris

ISIN: FR0011191766 – Ticker: EOSI

About EOS imaging

EOS imaging designs, develops, and markets EOS^®, an innovative medical imaging system dedicated to osteo-articular pathologies and orthopaedics, as well as associated solutions. The Company is authorized to market in 51 countries, including the United States (FDA), Japan and the European Union (EC). The Group posted 2016 revenues of €30.8 million and employed 132 people at December 2016, including an R&D team of 43 engineers. The Group is based in Paris and has five subsidiaries in Besançon (France), Cambridge (Massachusetts), Montreal (Canada), Frankfurt (Germany) and Singapore.

Contacts

EOS imaging
Pierre Schwich, CFO
Ph: +33 (0)1 55 25 60 60
investors@eos-imaging.com
or
NewCap
Financial communication and investor relations
Pierre Laurent
Ph: +33 (0)1 44 71 94 96
eosimaging@newcap.eu
or
The Ruth Group (US)
Press relations / Joanna Zimmerman
Ph: 646-536-7006
jzimmerman@theruthgroup.com

FT. LAUDERDALE, Fla., Sept. 7, 2017 /PRNewswire/ — Spinal Resources, Inc.^® (SRI) announced that it has received FDA 510(k) clearance for its Swedge™ Pedicle Screw System. This unique system offers multiple benefits, including CoCr and Titanium tulips; double lead and Cortical Cancellous Threads; Polyaxial, Monoaxial, Reduction, and Iliac screws; and MIS (minimally invasive spinal surgery) options. Currently, the Swedge system is cleared for a 5.5mm rod; 4.75mm and 5.0mm rods are pending clearance.

Since 2005, Spinal Resources, Inc. has been developing its groundbreaking technology, which accommodates multiple rods in a single-screw tulip with single-locking cap, and effectively locks the tulip’s angle without the presence of a rod. The FDA’s clearance of the Swedge™ Stabilization System marks the transition of Spinal Resources, Inc. from design and distribution experts into full manufacturers of innovative surgical enhancements. The Swedge system is the company’s first product development effort–and a seminal achievement: SRI’s system holds the tulip’s position while contouring rods in a multi-level scenario. The transition rod features a gradual taper between sections to minimize stress risers. Designed to improve efficiencies within the current and trending hospital environment by reducing inventory and increasing surgical procedure options, which may result in more affordable alternatives for patients, Spinal Resources, Inc.’s versatile, all-in-one Swedge implant system gives clinicians more surgical flexibility in degenerative, deformity, and midline approach surgeries, with a wider range of options to stabilize and conform to varying anatomies. Its MIS capabilities offer patients a smaller incision, with the added benefits of less tissue disturbance, reduced rehab/recovery time, and enhanced outcomes.

A report from GlobalData Healthcare, a UK-based company specializing in providing business data and analytics, indicated the 2017 global spinal fusion market is experiencing steady growth of about 3.4% CAGR (compound annual growth rate). The market is estimated to rise from $7.1 billion in 2016 to approximately $9 billion by 2023. The December 2016 report attributes the increase to degenerative spinal conditions caused by aging and the prevalence of technological advancements in surgeries. To learn more, see https://www.globaldata.com/spinal-fusion-market-approach-9-billion-2023-technology-improves-says-globaldata/.

According to President and Chief Executive Officer Bernard Bedor, no other screw on the market is quite like the Swedge System in capability. “We believe we’ve done something unique with our product,” he said. “We’ve taken three different rod sizes, put them into one effective tulip, and can lock them with a one-step locking cap. The Swedge System provides surgeons with greater versatility in the pre-planning and inter-operative stages, effectively reducing the surgical ‘fiddle factor’ thanks to its convenient standard and transition rods and screws in a variety of diameters and lengths. Our focus at SRI is to be problem-solvers for patients by supporting surgeons and hospitals in their important work with fewer instruments and a smarter system that shorten operating room time and lower costs.”

With the ownership of four (4) patents (and two more under consideration), this FDA clearance, and several other promising products in its pipeline, SRI is standing out as a strong contender in the design and manufacture of innovative solutions that enhance surgical procedures. The company is exploring full commercialization via strategic partnership, license, and/or private/corporate funding. For more information, contact our media and investors relations specialist: Ms. Melanie Raskin – melanie.raskin@aktaPD.com

Intended Use
The Swedge™ Pedicle Screw Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally-mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal tumor, pseudoarthrosis, and failed previous fusion.

It is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally-mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: DDD (degenerative disc disease), trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

About Spinal Resources, Inc.^® (SRI)
Founded in 2005, Spinal Resources, Inc.^®is a Ft. Lauderdale, Florida-based spinal medical device company that supports cost-effective patient care with innovative mechanical and biomechanical products to alleviate pain, shorten recovery time, restore health, and extend quality of life. SRI has engineered a unique line of patented spinal and cervical fixation systems with stem growth factors for the surgical repair and reconstruction of debilitating spinal conditions. For more information, visit spinalresourcesinc.com.

Media Contact:
Melanie Raskin
175102@email4pr.com

SOURCE Spinal Resources, Inc.(R)

NEW YORK, NY (PRWEB) SEPTEMBER 06, 2017

Orthopedic spine surgeon Dr. Alexios Apazidis completed a successful C3-4 anterior cervical discectomy and fusion at Fifth Avenue Surgery Center in New York City in August. As a result of a herniated disc, the female patient was experiencing radiculopathy symptoms and neck pain. After failing conservative treatment options including physical therapy, pain medications and epidural injections – she opted for a surgical approach.

Preferring a zero profile implant option as a result of existing hardware at the adjacent level, Dr. Apazidis chose to utilize the spinal device company’s Less Exposure Surgery Technology, A-CIFT SoloFuse – designed to leverage the familiarity of existing techniques while providing an alternative to cumbersome plating for one-level procedures.

Dr. Apazidis attested to the advantages of using the A-CIFT SoloFuse technology during this procedure. “The system is very easy to use. The instrumentation is low profile and well thought out, allowing you to expedite the procedure,” said Dr. Apazidis.

“This was a perfect case for A-CIFT SoloFuse because it was adjacent to a two-level fusion with a plate that was extremely proximal to the adjacent level and likely led to the degeneration of that level,” he explained. “The ability to have a low profile implant around a bulky plate allowed us to avoid the need to extend the dissection and spend time removing the plate. The trajectory of the screws allows us to achieve excellent fixation and maintain the position of the implant as it was placed intraoperatively.”

The simplicity of the A-CIFT SoloFuse design makes for a straightforward implantation that minimizes tissue disruption. This was SpineFrontier technology’s debut at the Fifth Avenue Surgery Center.

About Dr. Apazidis

Dr. Apazidis is affiliated with multiple hospitals in the New York area, including NYU Winthrop Hospital and Nassau University Medical Center. He received his medical degree from Boston University School of Medicine and is a member of the American Academy of Orthopedic Surgeons, North American Spine Society, Medical Society of the State of New York and Suffolk County Medical Society. He is certified board eligible by the American Board of Orthopedic Surgeons.

About SpineFrontier® Inc.
SpineFrontier Inc. is a growing medical technology company that designs, develops and markets both implants and instruments for spine surgery based on the Less Exposure Surgery (LES®) Philosophy. These technologies are designed to allow for outpatient surgery due to minimal disruption of normal tissues. SpineFrontier is headquartered in Malden, Mass. It is a KICVentures portfolio company and the leader in LES® technologies and instruments.

About Less Exposure Surgery
Less Exposure Surgery (LES®) is based on a new philosophy of performing surgery. LES® is less invasive than MIS. By developing improved technologies and techniques tailored for pinpointing a problem and fixing it without collateral damage, LES® minimizes tissue disruption.

About A-CIFT SoloFuse
A-CIFT SoloFuse-P Standalone Less Exposure Surgery System was intentionally designed to leverage the familiarity of existing techniques while providing an alternative to cumbersome plating for one-level procedures. Its simplicity of design makes for a straightforward implantation that minimizes tissue disruption.

SAN DIEGO, Sept. 7, 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced the acquisition of Vertera Spine, a privately-held medical device company developing and commercializing highly innovative interbody implants for spinal fusion using patented porous polyetheretherketone (PEEK) technology. Terms of the acquisition were not disclosed.

The acquisition of Vertera Spine reflects NuVasive’s continued commitment to pursue strategic opportunities as it builds out its advanced materials science portfolio to complement the Company’s position as the innovation leader in spine. As a result of this acquisition, NuVasive is now the only medical device company to offer porous interbody technology across both PEEK and titanium materials, thereby addressing the spectrum of surgeons’ needs and preferences for interbody implants. Vertera Spine’s technology provides a unique three-dimensional porous PEEK architecture to help elicit and encourage bone ingrowth based on pre-clinical studies, a key factor in improved patient outcomes in spinal fusion procedures, using a proprietary processing method that retains strength and durability.

“With the addition of porous PEEK technology, NuVasive takes the next step in building out its advanced materials science technology focused on delivering the highest level of scientifically driven properties for best spinal fusion rates, including porosity, visualization, surface and structure. This in turn helps to create more predictable, improved outcomes for patients undergoing spine surgery,” said Gregory T. Lucier, chairman and chief executive officer of NuVasive. “Our go-to-market plans include adding Vertera Spine’s FDA-cleared products to NuVasive’s commercial offerings, as well as applying the porous PEEK technology to our innovation roadmap as we further build out our pipeline of highly differentiated products to increase our market penetration.”

Chris Lee, chief executive officer of Vertera Spine, said, “Vertera Spine is excited to join NuVasive to further proliferate our game-changing material technology, as they bring to bear the industry’s leading product innovation capability as well as the scale and resources necessary to realize our full potential. Since founding the company in 2013, our goal has been to help reach more surgeon customers and their patients with this disruptive technology. Together, we will now be able to better serve the market and change the lives of patients around the world.”

Ken Gall, chair of Mechanical Engineering and Materials Science at Duke University, said, “The development of porous PEEK was a breakthrough discovery based on nearly ten years of scientific research. The end result of this fundamental materials work was the first load bearing porous polymer scaffold used in the human body that is both high-strength and finely tuned to promote bony attachment.”

Vertera Spine’s existing interbody product lines will be added to NuVasive’s portfolio for U.S. commercial sale and distribution including:

COHERE^® Cervical Interbody Fusion Device: COHERE is FDA-cleared and recently received a new ICD-10 code, issued by the Center of Medicare & Medicaid Services (CMS), effective October 1. COHERE is the only product approved for use with the new code, signifying CMS’ recognition of the innovation and potential clinical and tracking benefits of using porous PEEK.
COALESCE^TM Lumbar Interbody Fusion Device: COALESCE recently received FDA 510(k) clearance for use in anterior, transforaminal, posterior, and lateral lumbar interbody fusion procedures. Additional extensions for the device are planned for TLIF and PLIF procedures in multiple footprint, height, and lordotic angle configurations.

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 the integration of Vertera Spine into the Company’s business, 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.

September 05, 2017

HUNTLEY, Ill.–(BUSINESS WIRE)–Centric Medical, a division of Life Spine^®, Inc., which focuses on developing surgical implants for the treatment of lower distal extremity pathology, announced today record revenue growth of their TARSA-LINK^™ Stand-Alone Wedge Fixation System and ROGUE^™ Hammertoe Correction System within their Foot & Ankle division, plus OSTEO-LINK^® 100% Demineralized Bone Matrix and MARROW CELLUTION^™ Bone Marrow Harvesting System within their Biologics division.

“The groundbreaking TARSA-LINK Stand-Alone Wedge Fixation System, which was the market’s first stand-alone osteotomy wedge with built-in fixation, along with the TARSA-LINK Bunion Correction System designed as the first stand-alone opening base wedge with built-in fixation on the market, have provided us with a leading foot and ankle portfolio offering,” said Mariusz Knap, Vice President of Marketing and Business Development for Life Spine. “We then introduced the ROGUE Hammertoe Correction System to the market, amongst other products. The revenue gained within Centric Medical in the past eight months alone is over 112% compared to the full year prior. These innovative systems are just a small part of a successfully growing foot and ankle portfolio.”

“Within the Osteobiologics product division, revenue growth of 105% has already been seen in the past eight months when compared to the prior full year,” continued Mr. Knap. According to in-vivo test results, OSTEO-LINK has been engineered and processed to deliver the highest level of osteoinductivity characteristic with 100% DBM by weight. “We are excited to include our new offering called OSTEO-LINK Hydratable ICM (Inductive Carrier Matrix), which is an osteoinductive bone matrix that may be hydrated with saline, blood, BMA, or PRP. We can also offer surgeons the ability to capture BMA with our MARROW CELLUTION Bone Marrow Harvesting System. It is designed to overcome the limitations of a traditional bone marrow needle and results in a bone marrow harvest that is so rich in key stem and progenitor cells that the aspirate may no longer require manipulation through centrifugation prior to application. This allows the surgeon to complete a true bone healing triad for the greatest possible clinical outcomes.”

About Centric Medical

Centric Medical is dedicated to improving the quality of life for patients with distal extremity symptomatology, increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Centric Medical, which is privately held, is based in Huntley, Illinois. For more information, please visit: http://www.centricmedical.com.

Contacts

Centric Medical
Mr. Omar Faruqi
Chief Financial Officer
ofaruqi@lifespine.com
847-884-6117

ALPHARETTA, Ga., Sept. 6, 2017 /PRNewswire/ — Halyard Health (NYSE: HYH), a medical technology company focused on eliminating pain, speeding recovery and preventing infection, today announced the introduction of five new COOLIEF* Multi-Cooled RF Kits for use in performing COOLIEF Cooled Radiofrequency (RF) treatments. The new kits expand upon the four existing COOLIEF Multi-Cooled RF Kits by offering different component lengths and active tip sizes to treat additional modalities with our multi-probe kits. These kits allow physicians to ablate up to three nerves at once, saving time and the inconvenience of having to open multiple kits and components.

The new COOLIEF Multi-Cooled RF Kits have been developed to target nerves within the spine and knee. Each kit is equipped with all the components necessary to conduct a multi-probe COOLIEF Cooled RF treatment including the new COOLIEF* Fluid Delivery Introducer (FDI). The FDI enables fluids to be instilled through the port so that the physician can maintain probe placement and reduce instances of repositioning. The five new configurations of COOLIEF Multi-Cooled RF Kits include:

MCK2-17-50-2 (Cervical): 2 Probes, 4 Introducers, 2 Tube Kits
MCK2-17-50-4 (Knee): 2 Probes, 4 Introducers, 2 Tube Kits
MCK2-17-75-2 (Cervical): 2 Probes, 4 Introducers, 2 Tube Kits
MCK2-17-75-5.5 (Thoracic): 2 Probes, 4 Introducers, 2 Tube Kits
MCK3-17-50-4 (Knee): 3 Probes, 6 Introducers, 2 Tube Kits

“The addition of these five new multi-probe kits more than doubles the number of COOLIEF Multi-Cooled RF Kits available to pain physicians,” said Phil Cranmer, associate marketing director, Interventional Pain Management, Halyard Health. “Rather than having to piece together multiple kits and components, the COOLIEF Multi-Cooled RF Kit provides everything they need to perform multiple lesions simultaneously in one cost-effective package based on the type of procedure required.”

COOLIEF Cooled RF is the first and only treatment to receive clearance from the U.S. Food and Drug Administration (FDA) for the relief of chronic moderate to severe knee pain caused by osteoarthritis (OA). COOLIEF Cooled RF is a minimally-invasive and non-surgical outpatient procedure to target and treat the nerves causing chronic pain. This advanced thermal radiofrequency pain management system uses water-cooled technology to safely deactivate pain-causing sensory nerves. COOLIEF Cooled RF has been shown to provide up to 24 months of pain relief, improved physical functionality, and reduced drug utilization.

To learn more about COOLIEF Cooled RF, please visit http://www.halyardhealth.com/chronicpain.

About Halyard Health

Halyard Health Inc. (NYSE: HYH) is a medical technology company focused on eliminating pain, speeding recovery and preventing infection for healthcare providers and their patients. Headquartered in Alpharetta, Georgia, Halyard is committed to addressing some of today’s most important healthcare needs, such as reducing the use of opioids while helping patients move from surgery to recovery and preventing healthcare-associated infections. Halyard’s business segments – Medical Devices and Surgical and Infection Prevention (S&IP) – develop, manufacture and market clinically superior solutions that improve medical outcomes and business performance in more than 100 countries. For more information, visit www.halyardhealth.com.

*Registered Trademarks or Trademarks of Halyard Health, Inc. or its affiliates.

SOURCE Halyard Health, Inc.

LEESBURG, Va., Sept. 06, 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 will serve as a Double Diamond Sponsor for the 52^nd Annual Meeting & Course of the Scoliosis Research Society (SRS), taking place September 6–9 in Philadelphia, PA. The Company will offer product demonstrations of its newest surgical solutions, industry-leading 3D-printed portfolio, and Balance ACS^™ platform in meeting room #403.

“K2M is a proud Double Diamond Sponsor of this year’s SRS meeting, a keynote forum for advancing new surgical solutions that improve the lives of patients living with spinal deformities,” said John P. Kostuik, MD, Chief Medical Officer, Co-founder, and Member of the Board of Directors at K2M, and Past President of the SRS. “We remain committed to the highest level of excellence in developing new technologies that facilitate spinal deformity correction in both adolescents and adults, while emphasizing Total Body Balance as a critical component for improving quality outcomes in patients.”

During the meeting, K2M President and CEO Eric Major and members of the Company’s executive team will be onsite to showcase new and differentiated technologies for spinal deformity correction, including its industry-leading, 3D-printed Lamellar 3D Titanium Technology^™portfolio of products. In addition to the company’s comprehensive adolescent and adult deformity portfolio, K2M will highlight several of its latest offerings:

MESA^® 2 Deformity Spinal System & Next-Generation Cricket^® Technology: A next-generation MESA screw system with top-loading, low-profile, and Zero-Torque Technology^®. New MESA 2 Crickets provide surgeons with the ability to perform challenging correction maneuvers in all three anatomical planes.
NILE^® Proximal Fixation Spinal System: A spinal system specifically designed for proximal construct augmentation with a versatile application in complex procedures, from scoliosis to adult degenerative.
MOJAVE^™ PL 3D Expandable Interbody System: A first-to-market, FDA-cleared, 3D-printed expandable posterior-lumbar (PL) interbody system that features K2M’s Lamellar 3D Titanium Technology and is designed to allow for independent adjustment of the anterior and posterior height.
SAHARA^® AL Expandable Stabilization System: The only lordotic expandable interbody device with integrated screw fixation on the market.

The Company will feature its Balance ACS (BACS™) platform, which provides solutions to balance 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. K2M will demo the BACS System—which includes BACS Preauthorization, BACS Surgical Planner, BACS Anatomical Models, and BACS Data Management—and the BACS app, a convenient portal for surgeons to access the BACS System.

Further, Major will accept an honorary plaque acknowledging K2M’s Double Diamond sponsorship of the SRS meeting. The presentation will occur on September 6 from 6:25–6:35 p.m. at the Philadelphia Marriott Downtown in Ballroom–Salon A-F.

For more information on K2M’s 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

September 06, 2017

CASTEL SAN PIETRO, Switzerland–(BUSINESS WIRE)–The number of surgeons adopting the anterior approach to hip replacement is on the rise, with an estimated 20 percent of hip surgeons now performing the procedure. Medacta International, the family-owned global leader in the design of innovative joint replacement and spine surgery products, is leading the charge in training and supporting surgeons transitioning to this muscle-sparing technique. Today, the company and the Medacta Orthopaedic Research and Education (M.O.R.E.) Institute announced the execution of the 250^th M.O.R.E. AMIS^® Learning Center, where surgeons from all over the world will come to learn Medacta’s Anterior Minimally Invasive Surgery (AMIS) technique, complete with a system of tools and educational resources designed to support surgeons practicing the anterior approach for hip replacement.

“The promotion of patient well-being through AMIS is a cornerstone of Medacta’s mission, as it exemplifies our belief that only with a strong focus on medical education can surgical innovation truly move the industry forward,” said Francesco Siccardi, Executive Vice President of Medacta International. “The patient-centric technique is also ideal for the outpatient or same-day surgery setting, providing more options for both surgeons and patients in today’s changing healthcare landscape.”

The AMIS technique, informed by decades of clinical experience, is a muscle-sparing approach to total hip replacement that is associated with potential positive patient outcomes like shorter hospitalization and rehabilitation time, as well as a faster return to daily activities.

Offered as part of the M.O.R.E. Institute, the M.O.R.E. AMIS Education Program is a comprehensive offering for surgeons seeking to become proficient in the technique, including ongoing medical education and dedicated implants and instruments. To date, more than 5,500 surgeons across 31 countries have received training through the program. At the end of 2016, that translated to more than 80,000 hours of proctoring and surgeon-to-surgeon mentoring. In the field, surgeons have performed more than 250,000 total hip replacements utilizing the AMIS platform so far.

“The anterior approach to hip replacement has also been gaining traction among patients who are attracted to the possibility of a faster recovery and return to their daily lives,” said Frédéric Laude, M.D., a pioneer of the technique from Paris, France. “There is a learning curve associated with the approach though, so both hands-on and technical support are crucial to success. The level of attention and support Medacta provides through its M.O.R.E. AMIS Education Program is unparalleled.”

The 250^th M.O.R.E. AMIS Learning Center will be held September 15-16, 2017 in Chicago, IL, followed by a European installment September 25-26, 2017 in Basel, Switzerland. More information on the AMIS platform can be found at https://www.medacta.com/EN/amis.

About the M.O.R.E. AMIS Education Program

Education is the most crucial tool to drive clinical proficiency and innovation, as well as patient outcomes across the globe. To support positive outcomes in the operating room, Medacta created the AMIS Education Program, a comprehensive multistep training process within its M.O.R.E. Institute. The Program involves visiting a Reference Center to watch live surgery, attending a M.O.R.E. AMIS Learning Center, and ultimately performing surgery with support from an AMIS certified surgeon proctor. Throughout, product specialists and surgeons are available to provide mentorship and support. Approximately 85 percent of surgeons trained via the M.O.R.E. AMIS Education Program continue to use the approach once their training is complete.

About the M.O.R.E. Institute – “Where the surgeon is never alone”

Strongly aware of its role to provide continuing education as products and techniques evolve, Medacta International founded the Medacta Orthopaedic Research and Education (M.O.R.E.) Institute to highlight this commitment. Built on the ideal of sharing experience within the international medical community, the mission of the M.O.R.E. Institute is to provide ongoing support to Medacta partners worldwide as they strive to make an impact by learning about and adopting emerging technologies, surgical techniques and orthopaedic products. The Institute includes the M.O.R.E. AMIS Education Program for total hip arthroplasty, which has revolutionized the teaching of the anterior approach to hip replacement throughout the world, as well as platforms to impact the specialties of partial and total knee arthroplasty, total and reverse shoulder arthroplasty, sports medicine and spine surgery. The Institute relies on Medacta consultants and the healthcare provider community to create networking opportunities and hundreds of educational events, including courses, wet labs, scientific evenings, surgeon-to-surgeon visits, international symposia, guesting and hosting thousands of participants from all over the world. With a strong focus on young and promising surgeons, the M.O.R.E. Institute also supports fellowship programs worldwide.

About Medacta

Medacta^® International is a world leading manufacturer of orthopedic implants, neurosurgical systems, and instrumentation. Medacta’s revolutionary approach and responsible innovation have resulted in standard of care breakthroughs in hip replacement with the AMIS^®system and total knee replacement with MyKnee^® patient matched technology. Over the last 10 years, Medacta has grown dramatically by taking a holistic approach and placing value on all aspects of the care experience from design to training to sustainability. Medacta is headquartered in Castel San Pietro, Switzerland, and operates in over 30 countries. To learn more about Medacta International, please visit www.medacta.com or follow @Medacta on Twitter.

Contacts

for Medacta International, Inc.
Jill Bongiorni, 516-729-2250
Jill@torchcomllc.com

AYNHAM, Mass., Sept. 6, 2017 /PRNewswire/ — OMNIlife science, Inc. (“OMNI™”), a privately-held, established medical technology company targeting the $15 billion global hip and knee replacement device market, announced today that the FDA has issued 510(k) clearance for its proprietary robotic tissue balancing device which is used with OMNI’s market-leading OMNIBotics® robotic-assisted total knee replacement technology platform.

This new technology, in clinical use since March in Australia, provides the surgeon with a quantitative tool to actively manage the soft tissue envelope with dynamic real-time feedback. When combined with the accuracy of alignment and bone cuts provided by the OMNIBotics system, the result is a completely customized procedure from both a skeletal perspective as well as a soft tissue perspective.

“Our proprietary Active Spacer technology represents a unique and significant step in the development of our OMNIBotics robotic platform. We have been convinced that a perfect knee alignment is not enough to enable good outcomes for our surgeons and their patients,” said Guy Mayer, Executive Chairman of OMNI’s Board of Directors. “We believe that our surgeons can now perform the perfect total knee replacement with our innovative robotic soft tissue balancing technology coupled with the optimum knee alignment provided by our OMNIBotics technology.”

The OMNIBotics system enables optimized knee implant placement using robotics driven by OMNI’s proprietary ART™ software. With more than 16,000 OMNIBotics procedures performed to date worldwide, it eliminates the need for preoperative CT scans or x-rays. Intraoperative adjustments are easily made, and the precise alignment of the implant may lead to a more rapid recovery and a more natural feeling total knee replacement.^1,2

“This is a major milestone for both OMNI and for the orthopedic market,” stated Christian Joly, Vice President of Robotics at OMNI. “We are now the only company in the world to provide a robotic technology to quantitatively drive the total knee replacement surgical procedure with both alignment and ligament balancing.”

¹Koenig JA, Suero EM, Plaskos C: Surgical Accuracy and Efficiency of Computer-Navigated TKA with a Robotic Cutting Guide – Report on First 100 Cases. J Bone Joint Surg Br 2012 vol 94-B no. SUPP XLIV 103.
²Revenga C, et al, Computer-Assisted Navigation Versus Conventional Total Knee Arthroplasty In A Spanish Multicenter Study. 16th EFORT Congress. London. 2014.

ABOUT OMNI

OMNI is a privately held company with a proprietary robotic platform, OMNIBotics®, which allows surgeons to conduct patient-specific total knee surgery designed to enhance patient satisfaction and reduce hospital costs. In addition, OMNI designs, engineers, manufactures and distributes a wide range of proprietary hip and knee implants and is focused on providing cutting edge technologies to transform outcomes in joint replacement surgery and enhance a surgeon’s ability to help patients live active and pain-free lives. For more information about OMNI, please visit www.omnils.com.

FORWARD LOOKING STATEMENTS

Statements in this press release concerning the future business, operations and prospects of OMNIlife science, Inc., including its plans specific to OMNIBotics systems, as well as statements using the terms “plans,” “believes” or similar expressions are “forward-looking” statements as defined in the Private Securities Litigation Reform Act of 1995. These statements are based upon management’s current expectations and are subject to a number of factors and uncertainties. Information contained in these forward-looking statements is inherently uncertain, and actual performance and results may differ materially due to many important factors. Such factors include, among others, changes in competitive conditions and pricing in OMNI’s markets, decrease in the demand for OMNI’s products, delays in OMNI’s product research and development cycles, decreases in the use of OMNI’s principal product lines or in procedure volume, unanticipated issues in complying with domestic or foreign regulatory requirements related to OMNI’s current products or securing regulatory clearance or approvals for new products or upgrades or changes to OMNI’s current products, the impact of the United States healthcare reform legislation on hospital spending and reimbursement, any unanticipated impact arising out of the securities class action or any other litigation, inquiry, or investigation brought against OMNI, increases in costs of OMNI’s sales force and distributors, and unanticipated intellectual property expenditures required to develop, market, and defend OMNI’s products. OMNI cannot guarantee any future results, levels of activity, performance or achievement. OMNI undertakes no obligation to update any of its forward-looking statements after the date of this press release.

CONTACT

Cindy Holloway, Director of Marketing Communications
Phone: (508) 824-2444
cholloway@omnils.com

SOURCE OMNIlife science, Inc.

SAN DIEGO, Sept. 6 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use of the Company’s redesigned MAGEC® system with its RELINE® Small Stature system. NuVasive will feature these new product offerings at the Scoliosis Research Society (SRS) 52nd Annual Meeting & Course to be held September 6-9, 2017 in Philadelphia.

The MAGEC system uses innovative magnetic technology within adjustable growing rods to treat early-onset scoliosis in a less invasive manner. The latest advancements to the MAGEC system include redesigned components to help provide ease-of-use for the surgeon and help make surgical outcomes more reproducible. In addition, the MAGEC system is introducing a new 5.0 millimeter rod diameter offering, that when paired with the low-profile RELINE Small Stature system, is designed to provide optimal strength to growing-rod constructs to help improve clinical outcomes.

RELINE Small Stature is a comprehensive pediatric deformity fixation system allowing to achieve optimal construct strength with a reduced implant profile. RELINE Small Stature is the only small stature system that is compatible with the new 5.0 millimeter MAGEC rod.

“As a low-profile pediatric fixation system, RELINE Small Stature is the first-of-its-kind system to offer competitively-sized pediatric implants that accept up to a 5.0mm rod,” said Matt Link, executive vice president of strategy, technology and corporate development at NuVasive. “The clearance for our redesigned MAGEC system with RELINE Small Stature highlights our speed to market and our further commitment to bringing procedural solutions that transform care to the pediatric deformity market.”

NuVasive has reached meaningful gains in both the adult and pediatric deformity markets, a $2.5 billion opportunity over the last two years and is a leading sponsor of SRS. The Company’s ‘Embracing the Journey Together’ initiative includes pediatric spinal deformity research, education and spinal deformity event support, assisting leading surgeons as they educate other surgeons around the world.

NuVasive will showcase its market-leading, procedurally-integrated technologies in Meeting Room #406 at the Philadelphia Marriot Downtown. Visit here for more details.

About NuVasive

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.

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