LEESBURG, Va., Sept. 29, 2017 (GLOBE NEWSWIRE) -- K2M Group Holdings, Inc. (NASDAQ:KTWO) (the "Company" or "K2M"), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance™, today announced that it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its YUKON™ OCT Spinal System. YUKON OCT offers surgeons an advanced system aimed at facilitating fusion with posterior fixation in the occipito-cervico-thoracic regions of the spine with the goal of helping to achieve three-dimensional spinal balance.The YUKON OCT Spinal System features newly designed top-loading, high angulation, polyaxial screws that provide up to 105 degrees of polyaxial angulation. YUKON OCT screw heads accept both Ø3.5 & Ø4.0 mm rods in both cobalt chrome and titanium, and accommodate construct rigidity based on degenerative or deformity corrections. Square thread set screws facilitate screw introduction and minimize the potential for cross-threading, while an updated occipital plate features integrated lateral holes with the goal of enhancing occiput fixation. “The YUKON OCT System expands on K2M’s current offering while accounting for the challenging posterior cervical cases surgeons often treat,” said Chambliss Harrod, MD, a spine and orthopedic surgeon at the Bone & Joint Clinic of Baton Rouge. “Unlike systems that feature only highly favored angulation screw designs, YUKON OCT is a comprehensive system that offers surgeons the ability to treat a variety of spinal conditions—including routine degenerative cases, revisions, and complex cervical deformities.” YUKON OCT’s advanced, streamlined reduction instrumentation allows for intraoperative flexibility and ease of use. The pistol grip style Rod Reducer provides 20 mm of reduction, while the Sequential Reducers deliver 20 mm of controlled reduction and correction. “We are pleased to announce FDA clearance of the YUKON OCT Spinal System and the successful completion of its first surgical cases,” said K2M President and CEO Eric Major. “K2M is a global leader in spinal innovation and YUKON OCT is our new solution that deepens our expanding portfolio of spinal devices for the occipito-cervico-thoracic region of the spine. Accompanied by our comprehensive Balance ACS™ platform, YUKON OCT offers a competitive surgical solution with the goal of achieving Total Body Balance for patients.” Balance ACS (BACS™) provides solutions focused on achieving balance of the spine by addressing each anatomical vertebral segment with a 360-degree approach to the axial, coronal, and sagittal planes, emphasizing Total Body Balance as an important component of surgical success. For more information on the YUKON OCT Spinal System and K2M’s complete product portfolio, visit www.K2M.com. For more information on Balance ACS, visit www.BACS.com. About K2M K2M Group Holdings, Inc. is a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance. Since its inception, K2M has designed, developed, and commercialized innovative complex spine and minimally invasive spine technologies and techniques used by spine surgeons to treat some of the most complicated spinal pathologies. K2M has leveraged these core competencies into Balance ACS, a platform of products, services, and research to help surgeons achieve three-dimensional spinal balance across the axial, coronal, and sagittal planes, with the goal of supporting the full continuum of care to facilitate quality patient outcomes. The Balance ACS platform, in combination with the Company’s technologies, techniques, and leadership in the 3D-printing of spinal devices, enable K2M to compete favorably in the global spinal surgery market. For more information, visit www.K2M.com and connect with us on Facebook, Twitter, Instagram, LinkedIn, and YouTube. Forward-Looking Statements This press release contains forward-looking statements that reflect current views with respect to, among other things, operations and financial performance. Forward-looking statements include all statements that are not historical facts such as our statements about our expected financial results and guidance and our expectations for future business prospects. In some cases, you can identify these forward-looking statements by the use of words such as, “outlook,” “guidance,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “could,” “seeks,” “predicts,” “intends,” “plans,” “estimates,” “anticipates” or the negative version of these words or other comparable words. Such forward-looking statements are subject to various risks and uncertainties including, among other things: our ability to achieve or sustain profitability in the future; our ability to demonstrate to spine surgeons the merits of our products; pricing pressures and our ability to compete effectively generally; collaboration and consolidation in hospital purchasing; inadequate coverage and reimbursement for our products from third-party payors; lack of long-term clinical data supporting the safety and efficacy of our products; dependence on a limited number of third-party suppliers; our ability to maintain and expand our network of direct sales employees, independent sales agencies and international distributors and their level of sales or distribution activity with respect to our products; proliferation of physician-owned distributorships in the industry; decline in the sale of certain key products; loss of key personnel; our ability to enhance our product offerings through research and development; our ability to manage expected growth; our ability to successfully acquire or invest in new or complementary businesses, products or technologies; our ability to educate surgeons on the safe and appropriate use of our products; costs associated with high levels of inventory; impairment of our goodwill and intangible assets; disruptions in our main facility or information technology systems; our ability to ship a sufficient number of our products to meet demand; our ability to strengthen our brand; fluctuations in insurance cost and availability; our ability to comply with extensive governmental regulation within the United States and foreign jurisdictions; our ability to maintain or obtain regulatory approvals and clearances within the United States and foreign jurisdictions; voluntary corrective actions by us or our distribution or other business partners or agency enforcement actions; recalls or serious safety issues with our products; enforcement actions by regulatory agencies for improper marketing or promotion; misuse or off-label use of our products; delays or failures in clinical trials and results of clinical trials; legal restrictions on our procurement, use, processing, manufacturing or distribution of allograft bone tissue; negative publicity concerning methods of tissue recovery and screening of donor tissue; costs and liabilities relating to environmental laws and regulations; our failure or the failure of our agents to comply with fraud and abuse laws; U.S. legislative or Food and Drug Administration regulatory reforms; adverse effects of medical device tax provisions; potential tax changes in jurisdictions in which we conduct business; our ability to generate significant sales; potential fluctuations in sales volumes and our results of operations over the course of the year; uncertainty in future capital needs and availability of capital to meet our needs; our level of indebtedness and the availability of borrowings under our credit facility; restrictive covenants and the impact of other provisions in the indenture governing our convertible senior notes and our credit facility; continuing worldwide economic instability; our ability to protect our intellectual property rights; patent litigation and product liability lawsuits; damages relating to trade secrets or non-competition or non-solicitation agreements; risks associated with operating internationally; fluctuations in foreign currency exchange rates; our ability to comply with the Foreign Corrupt Practices Act and similar laws; our ability to implement and maintain effective internal control over financial reporting; potential volatility in our stock due; our lack of current plans to pay cash dividends; our ability to take advantage of certain reduced disclosure requirements and exemptions as a result of being an emerging growth company; increased costs and additional regulations and requirements as a result of no longer qualifying as an emerging growth company as of December 31, 2017; potential dilution by the future issuances of additional common stock in connection with our incentive plans, acquisitions or otherwise; anti-takeover provisions in our organizational documents and our ability to issue preferred stock without shareholder approval; potential limits on our ability to use our net operating loss carryforwards; and other risks and uncertainties, including those described under the section entitled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the SEC and our Quarterly Report filed with the SEC on August 2, 2017, as such factors may be updated from time to time in our periodic filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements. These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this release and our filings with the SEC. We operate in a very competitive and challenging environment. New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this release. We cannot assure you that the results, events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results, events or circumstances could differ materially from those described in the forward-looking statements. The forward-looking statements made in this press release relate only to events as of the date on which the statements are made. We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Unless specifically stated otherwise, our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, investments or other strategic transactions we may make. Media Contact: Zeno Group on behalf of K2M Group Holdings, Inc. Christian Emering, 212-299-8985 Christian.Emering@ZenoGroup.com Investor Contact: Westwicke Partners on behalf of K2M Group Holdings, Inc. Mike Piccinino, CFA, 443-213-0500 K2M@westwicke.com Read More
9/27/2017 Aliso Viejo, CA, Sept. 27, 2017 (GLOBE NEWSWIRE) -- OrthAlign, Inc., a leading provider of orthopedic surgical navigation solutions, announced today that the company has raised $10 million in a series D financing round. The investment will be used to fuel product development as the company expands from a solution provider for total knee surgery to a platform technology provider for total knee, partial knee, and total hip replacement surgeries. The funds will additionally be used to support continued commercial expansion through investments in hiring and key programs both in the U.S. and International markets. OrthAlign manufactures and distributes its core technology, KneeAlign®, which is a computer-assisted navigation application for total knee replacement surgery. KneeAlign has powered more than 65,000 surgeries worldwide, and is clinically-supported by more than 15 peer-reviewed published studies. KneeAlign is well positioned as a perfect solution for the future of orthopedic surgery, delivering the accuracy and consistency that users demand while avoiding the unnecessary capital and recurring costs that large-console navigation and robotics bring to the healthcare market. Reducing instrumentation trays and delivering information directly into the surgeon’s hands, the KneeAlign technology is the only computer navigation platform that exists 100% within the sterile field. These same fundamental benefits continue to resonate with expansion into Uni and Hip applications. “We are pleased to have completed our latest financing round to support our operational goals of strong revenue growth and application expansion,” said Eric B. Timko, Chairman and CEO of OrthAlign. “We continue to invest in developing KneeAlign because we see it as a key component of the total knee replacement technology landscape moving forward, especially considering the importance of delivering solutions in the ambulatory surgery center environment. But we are no longer a single-solution provider, and have rapidly expanded our commercial platform technology to include solutions for partial knee replacement with our UniAlign™ application. Our solution for total hip replacement, HipAlign®, supports both posterior- and direct anterior approaches and is currently in a limited user release with full-commercialization slated for 2018.” “We are truly excited for the next phase of OrthAlign,” said Gary Henley, board member. “With a new management team in place, the company’s focus on expanding commercial footprint domestically and in key markets around the world, coupled with a focus on research and development, position the business for long-term success in this competitive marketplace.” This latest financing round was led by existing investors River Cities Capital Funds, California Technology Ventures, Research Corporation Technologies and Mutual Capital Partners who show continued support for the company. ORTHALIGN, INC. OrthAlign, Inc. is a privately held medical device and technology company, developing advanced technologies that deliver healthier and more pain-free lifestyles to joint replacement patients, globally. We provide healthcare professionals with cutting edge, computer-assisted surgical tools that seamlessly and cost-effectively deliver vital data and clinical results to optimize outcomes for our patients. For more information regarding OrthAlign, please visit www.orthalign.com or contact Adam Simone (firstname.lastname@example.org). Adam Simone OrthAlign, Inc. email@example.comRead More
09-29-2017/Persistence Market Research Spinal stenosis is a condition which usually occurs in the elderly patients. Stenosis mean abnormal narrowing of a body channel. This mean spinal stenosis is narrowing of the spinal canal. The narrowing of spinal canal occurs due to degeneration of intervertebral disk and facet joint. This condition mainly affects people above 50 years but can also affect younger people who are born with abnormal spinal canal. If the narrowing is minimal symptoms will not occur but too much narrowing can lead to compression of nerves and can be problematic. Spinal stenosis symptoms include lower back pain, numbness in legs and balance problem. It can occur anywhere along the spine. A sample of this report is available upon request @ www.persistencemarketresearch.com/samples/15376 Spinal Stenosis Implant Market: Drivers and Restraints Increasing prevalence of spinal stenosis is one of the major factor driving the growth of spinal stenosis implant market. Other factors contributing to the growth of the market are increasing older population and rise in the obesity cases which can lead to spinal injury or stenosis. Increasing demand and adoption of the minimally invasive surgeries and better relief over the medication are also factors driving growth in this market. Spinal Stenosis Implant Market: Segmentation The global spinal stenosis implant market can be segmented on the basis of product type, material type, end user, and region. On the basis of the product type global spinal stenosis implant market can be segmented into: Spacing Devices Fusion Devices On the basis of the material type global spinal stenosis implant market can be segmented into: Stainless Steel Titanium On the basis of end user global spinal stenosis implant market can be segmented as: Hospitals Clinics Ambulatory Surgical Units Spinal Stenosis Implant Market: Overview Spinal stenosis implant market is expected to show significant growth over the forecast period. Increasing case of arthritis and ageing of the population is expected to be the factor facilitating the growth of spinal stenosis implant market. Spacing is devices are expected to be highest revenue generating and fastest growing product segment due to increasing demand for minimally invasive treatments as this procedure has lesser risks involved and also it allows easy movement in comparison to fusion or fixation devices which involves long surgical process and higher blood loss. Along with this spacing devices provide faster and lasting symptoms relief and has lesser hospital stay. Titanium spinal stenosis implants are expected to be fastest growing, and highest selling as titanium is strong and light in weight when compared to the stainless steel implants and it has better elasticity which allows easy movement. Ambulatory surgical units are expected to have the highest number of such surgeries as these units are being used for performing the minimally invasive surgeries and patients don't need to stay overnight. Spinal Stenosis Implant Market: Region Wise Outlook Geographically, spinal stenosis implant market can be segmented as North America, Latin America, Europe, Asia-Pacific and Middle East & Africa. North America is the highest revenue generating market for the spinal stenosis implants due to reimbursement policies and better healthcare infrastructures followed by Europe. Higher adoption rate of non-medicated treatment options and focus of major players to aware people is driving growth in this region. Asia Pacific is also expected to show significant growth due to presence of large population pool, ageing population and increasing case of spinal injuries. Japan is expected to be biggest Asia Pacific market for spinal stenosis implants due to increasing geriatric population. To view TOC of this report is available upon request @ www.persistencemarketresearch.com/toc/15376 Spinal Stenosis Implant Market: Key Players Some of the market participants in the spinal stenosis implant market are Stryker, Paradigm Spine LLC, Vertiflex, Inc., Orthofix Holdings, Inc., Medtronic Public Limited Company, Kyphon, Inc., Abbott and Zimmer Spine. Focus of the companies is changing over the past few years from fixation devices to spacing devices. The research report presents a comprehensive assessment of the market and contains thoughtful insights, facts, historical data, and statistically supported and industry-validated market data. It also contains projections using a suitable set of assumptions and methodologies. The research report provides analysis and information according to categories such as market segments, geographies, types, technology and applications. About Us Persistence Market Research (PMR) is a third-platform research firm. Our research model is a unique collaboration of data analytics and market research methodology to help businesses achieve optimal performance. To support companies in overcoming complex business challenges, we follow a multi-disciplinary approach. At PMR, we unite various data streams from multi-dimensional sources. By deploying real-time data collection, big data, and customer experience analytics, we deliver business intelligence for organizations of all sizes. Contact Us Persistence Market Research 305 Broadway 7th Floor, New York City, NY 10007, United States, USA – Canada Toll Free: 800-961-0353 Email: firstname.lastname@example.org Web: www.persistencemarketresearch.com This release was published on openPR.Read More
Green Sun Medical awarded $50K for scoliosis brace at prestigious pediatric medical device competition
Fort Collins, CO – (September 28, 2017) – Fort Collins based start-up Green Sun Medical was awarded the top cash prize of $50,000 during the FDA-sponsored pediatric medical device competition at the Fifth Annual Pediatric Device Innovation Symposium in San Jose, Calif. organized by the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Health System. Green Sun Medical is developing a dynamic scoliosis brace that will allow physicians to remotely monitor the performance on the patients. “We are honored to have our scoliosis brace recognized with these other pediatric device innovations,” said Jamie Haggard, CEO of Green Sun Medical. He also said that current treatments include braces developed over 40 years ago and spinal fusion surgeries. Green Sun Medical was awarded the top cash prize of $50,000 in grant money an the pitch competition sponsored by the National Capital Consortium for Pediatric Device Innovation (NCC-PDI), an FDA-funded consortium led by Children’s National and the A. James Clark School of Engineering at the University of Maryland. The competition was part of the annual symposium to foster innovation that will advance pediatric healthcare and address the unmet surgical and medical device needs for children. “Our heartfelt congratulations to Green Sun Medical who was selected from a highly competitive field of worthy devices," said Kolaleh Eskandanian, Ph.D., executive director of the Sheikh Zayed Institute and NCC-PDI. "In our role as a catalyst for pediatric innovation, we see this as the beginning of our relationship with Green Sun Medical. She adds that in addition to financial support, the awardees will have access to consultation services for all phases of pediatric device development – from ideation through marketing – to help them get their devices to market faster. During the competition, 12 finalists had five minutes to present their proposal to the judging panel, which included Susan Alpert, M.D., of SFA Consulting, a former director of the FDA Office of Device Evaluation and former senior vice president and chief regulatory officer of Medtronic; Charles Berul, M.D., of Children’s National; Andrew Elbardissi, M.D., of Deerfield Management; Rick Greenwald, Ph.D., of the New England Pediatric Device Consortium (NEPDC); James Love, J.D., of Oblon; Josh Makower, M.D., of NEA; Jennifer McCaney, Ph.D., of MedTech Innovator; Jackie Phillips, M.D., of Johnson & Johnson; and Tracy Warren of Astarte Ventures. This competition was created to foster innovation in the pediatric device sector, which continues to lag behind adult device development and creates a host of challenges for doctors when treating children. Since inception in 2013, NCC-PDI has supported 67 pediatric devices and the companies and research labs owning these devices have collectively raised $55 million in additional funding. To learn more about Green Sun Medical visit http://www.greensunmedical.com # # # Green Sun Medical was founded to transform the treatment to address Adolescent Idiopathic Scoliosis. We are developing a dynamic brace that applies continuous corrective pressure and allows the physicians to remotely monitor their patients.Read More
WARSAW, Ind., Sept. 11, 2017 /PRNewswire/ -- Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced the launch of the Persona® Partial Knee System, the latest addition to its portfolio of personalized and anatomically designed knee implant systems. The launch of the Persona Partial Knee System is the first significant jointly developed new product for the Company since the Zimmer Biomet combination, and reinforces the Company's leadership position in partial knee replacement. "The global introduction of the Persona Partial Knee System is the combined Company's first major product launch and fills a significant gap in our knee portfolio," said Daniel Florin, Interim Chief Executive Officer, Senior Vice President and Chief Financial Officer. "The partial knee market continues to expand as patients demand alternatives to traditional knee replacement. The addition of the fixed-bearing Persona Partial Knee System complements the Company's mobile-bearing Oxford® Partial Knee, further strengthening our leadership position in this growing market." The Persona Partial Knee System represents the next era in personalization, equipping surgeons with a comprehensive system of implants and instruments that are designed to offer an uncompromising fit and efficiency in the operating room. The development team leveraged global experts in partial knee replacement and utilized the ZiBRA™ Anatomical Modeling System to analyze thousands of bones, both male and female, representing a diverse global population. "The new Persona Partial Knee System has made me a better partial knee surgeon," said Craig Della Valle, MD, a developing surgeon from Rush University Medical Center in Chicago, Illinois. "Its combination of compartment-specific implants that fit better to ergonomic instruments has made me both more accurate and efficient. The system is definitely a move forward in the right direction," said Dr. Della Valle. Rocci Trumper, MD, at Poudre Valley Hospital in Fort Collins, Colorado successfully performed the first surgery of the Persona Partial Knee System since the full global commercial launch on August 31, 2017. "The instruments were thoughtfully designed and the tibial component fit well," said Dr. Trumper. There have been more than 1,000 cases to date across centers in the U.S., EMEA and Japan, and more than 260 patients have been enrolled in a 10-year global multi-center study. "The introduction of the Persona Partial Knee System comes at a significant time as we continue to see an increase in the demand for knee replacements," said Dan Williamson, Zimmer Biomet's Group President, Joint Reconstruction. "This innovative technology furthers our commitment to restore mobility, alleviate pain and improve the quality of life for patients around the world." About Zimmer Biomet Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products. We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives. We have operations in more than 25 countries around the world and sell products in more than 100 countries. For more information, visit www.zimmerbiomet.com, or follow Zimmer Biomet on Twitter at www.twitter.com/zimmerbiomet. Cautionary Statement Regarding Forward-Looking Statements This release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning Zimmer Biomet's expectations, plans, prospects, and product and service offerings, including new product launches and potential clinical successes. Such statements are based upon the current beliefs and expectations of management and are subject to significant risks, uncertainties and changes in circumstances that could cause actual outcomes and results to differ materially. For a list and description of some of such risks and uncertainties, see Zimmer Biomet's periodic reports filed with the U.S. Securities and Exchange Commission (SEC). These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in Zimmer Biomet's filings with the SEC. Forward-looking statements speak only as of the date they are made, and Zimmer Biomet disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Readers of this release are cautioned not to rely on these forward-looking statements, since there can be no assurance that these forward-looking statements will prove to be accurate. This cautionary statement is applicable to all forward-looking statements contained in this release. ZBH-Corp SOURCE Zimmer Biomet Holdings, Inc. Image courtesy of Zimmer Biomet.Read More
Resurgens Spine Center welcomes three fellowship-trained surgeons to Georgia’s largest spine practice
- Education: He received his medical degree from Indiana University and completed his residency at Madigan Army Medical Center in Tacoma, Wash. He completed his Spine Fellowship at Augusta University Health in Augusta, Ga.and is board certified.
- Locations: 105 Regency Park Drive, McDonough. 770-506-4119. 665 South 8th St., Griffin. 770-227-7050. 6635 Lake Drive, Morrow. 770-968-1323.
- Education: After receiving his medical degree from Philadelphia College of Osteopathic Medicine in Suwanee, Georgia, he completed his residency at Doctors Hospital in Columbus, Ohio. He completed his Spine Fellowship at Duke University Medical Center in Durham, N.C.
- Location: 4150 Deputy Bill Cantrell Memorial Road, Suite 300, Cumming. 770-886-8111.
- Education: He received his medical degree from the Perelman School of Medicine at the University of Pennsylvaniain Philadelphia, Penn. and completed his residency at St. Luke's University Hospital in Bethlehem, Penn. He completed his Spine Fellowship at the Cleveland Clinic Foundation in Cleveland, Ohio.
- Location: 5671 Peachtree Dunwoody Road, Suite 900, Atlanta, Ga. 404-847-9999.
September 28, 2017
Safe Orthopaedics’ half-year report will be available in the Investors > Documentation > Regulated Information section of the Company’s website (www.SafeOrtho.com) from September 29, 2017.
|€ thousands – IFRS||30/06/2017||30/06/2016|
|Revenues - France||803||599|
|Revenues - Rest of the world||841||605|
Adjusted total revenues1
|Revenues from discontinued activities||0||99|
|Purchases used and change in inventories||(839)||(981)|
|Other operating expenses||(406)||(351)|
|Operating income/(loss) before non-recurring items||(2,481)||(3,402)|
|Other operational income and expenses||(49)||(10)|
ContactsSafe Orthopaedics Pierre Dumouchel, Tél.: +33 (0)1 34 21 50 00 CEO email@example.com or NewCap Julien Perez / Valentine Brouchot Investor Relations Nicolas Merigeau Media Relations Tél.: +33 (0)1 44 71 94 94 SafeOrtho@newcap.eu
EOI Announces FDA Clearance for the FLXfit15, the Only 3D Articulated Expandable Cage With 15 degrees of Lordosis Correction
OR AKIVA, Israel, September 28, 2017 /PRNewswire/ --
Expanding Orthopedics Inc. (EOI), a privately-held medical device company focused on developing and commercializing innovative expandable devices for spine surgery, today announced FDA 510(k) clearance for the FLXfit™15, enhancing the already successful FLXfit™ 3D Expandable Cage System. The FLXfit™15 will expand the surgeon's flexibility and capability by offering a family of products in different length options with infinitely adjustable expansion and lordosis correction of upto 4mm and 15⁰.
Dale Binke, EOI's VP of US Sales, notes that, "One of the major trends in fusion surgeries is progression towards MIS style procedures, inpatient or outpatient." However, Dale explains, "There is an inherent challenge in inserting a large interbody cage that restores lumbar lordosis while controlling sagittal and coronal alignment." He adds, "The FLXfit expandable cage is already providing the ultimate expandable TLIF solution, combining the best-in-class footprint that can be delivered through a MIS window and a unique expansion mechanism that restores lordosis." Dale summarizes, "With the FLXfit15™, EOI's engineering team has pushed the envelope a step further by combining an articulating cage with optimal footprint which can be easily delivered and expanded in a controlled manner up to 4mm and 15⁰ of lordotic restoration."
Expandable cages are gaining market momentum and play a key role in successful fusion procedures. Ofer Bokobza, CEO of Expanding Orthopedics, comments, "The FLXfit™ System has already trail blazed the way for anatomical fit, expandable cages by providing great clinical promise so far." Ofer says, "The FLXfit15™ will further enhance the anatomical fit with its 15⁰ lordosis and the shorter footprint version (32mm) will offer great flexibility in treating patients with smaller anatomies." He concludes, "We are thrilled with the release of the FLXfit™15 in the US and certain that the enhanced versatility of the new FLXfit™ family will help gain a greater share in the fusion surgery market, both in MIS and open approaches."
About Expanding Orthopedics Inc.
Expanding Orthopedics Inc. is medical device company developing and marketing innovative products designed to address unmet clinical needs for spine care and improve long-term patients' outcome. The Company is spearheaded by a seasoned management team, and is advised by a prominent team of spine surgeons. EOI owns a broad patent portfolio around anatomically fit, expandable devices for enhanced stability through a minimally invasive approach.
Contact info: David Elkaim, VP Marketing and Sales E-mail: firstname.lastname@example.org Phone: (347)-3219683Read More