ConforMIS Announces Clinical Study iTotal CR Customized Implants better approximate knee motion compared to Off-the-Shelf Total Knee Implant

Posted On October 17, 2016 By OrthoSpineNews In Recon /

BEDFORD, Mass., October 17, 2016 (GLOBE NEWSWIRE) – ConforMIS, Inc. (NASDAQ:CFMS), a medical technology company that develops, manufactures and sells joint replacement implants that are customized to fit each patient’s unique anatomy, today announced that The Journal of Arthroplasty has accepted for printed publication, and published online, the results of an in vivo clinical study comparing the motion patterns of patients with a ConforMIS iTotal® CR implant versus patients with a traditional off-the-shelf total knee implant. The study demonstrated that ConforMIS iTotal CR patients exhibited motion patterns that were more consistent with the normal knee than the patients that had received traditional off-the-shelf implants.

“I have been using ConforMIS customized knee replacements for over five years and this study reinforces the results that I have observed in my patients that have received a ConforMIS iTotal CR implant,” said William Kurtz, MD, a fellowship-trained surgeon at Saint Thomas Midtown Hospital in Nashville, TN. “In my experience, the ConforMIS knee system typically gives my patients a better outcome than a standard off-the-shelf knee and a better opportunity to get back to doing the activities they love.”

In this study, researchers at the University of Tennessee’s Center for Musculoskeletal Research assessed the kinematics of 38 patients (24 patients with a ConforMIS iTotal CR implant and 14 patients with a leading off-the-shelf implant) all implanted by the same surgeon. Using state-of-the-art mobile fluoroscopy, researchers were able to analyze tibiofemoral kinematics, or motion patterns of the knee, and to evaluate each patient for weight-bearing range-of-motion, femorotibial translation, femorotibial axial rotation, and condylar liftoff during a weight bearing deep knee bend and a rise from a seated position.

When a healthy knee bends, the lateral condyle, or outer portion of the end of the thigh bone (femur), rolls back on the shin bone (tibia) and rotates externally towards the outside of the knee. Patients who received a ConforMIS iTotal CR demonstrated greater lateral femoral rollback (4.0mm vs. 1.2mm) and better axial rotation (6.3° vs. 4.4°) during deep knee bend, which is closer to normal knee motion. These differences were statistically significant.

During a deep knee bend, 35% of patients with the off-the-shelf knee replacement experienced implant lift-off in early flexion (prior to 60°), while none (0%) of the patients with iTotal CR experienced implant lift-off in early flexion. According to the researchers, this demonstrates that the iTotal CR had improved mid-flexion stability compared to the standard off-the-shelf implant. The researchers hypothesized that one reason iTotal CR patients exhibited less lift-off could be because the customized nature of the iTotal CR implant’s shape facilitates improved translation and rotation properties when compared to the traditional off-the-shelf implant, leading to a higher likelihood of a stable knee in mid-flexion. ConforMIS provided financial support for this study.

“This study is one of many examples of how ConforMIS challenges conventional wisdom in joint replacement and is leading the way in how patient outcomes are measured,” said Philipp Lang, MD, MBA, Chief Executive Officer and President of ConforMIS. “As a company, we are continuing to support head-to-head, direct comparative studies against many implant designs, and we are supporting multiple studies in progress that are assessing various patient outcomes measures. Just as we are constantly innovating our product line, we are also looking to new and innovative ways to better measure patient outcomes as exemplified by the mobile fluoroscopy used in this study.”

About ConforMIS, Inc.

ConforMIS is a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants that are individually sized and shaped, or customized, to fit each patient’s unique anatomy. ConforMIS offers a broad line of customized knee implants and pre-sterilized, single-use instruments delivered in a single package to the hospital. In recent clinical studies, ConforMIS iTotal CR demonstrated superior clinical outcomes, including better function and greater patient satisfaction, compared to traditional, off-the-shelf implants. ConforMIS owns or exclusively in-licenses approximately 500 issued patents and pending patent applications that cover customized implants and patient-specific instrumentation for all major joints.

For more information, visit www.conformis.com. To receive future releases in e-mail alerts, sign up at http://ir.conformis.com/.

Cautionary Statement Regarding Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for ConforMIS, including statements about future clinical studies, future results of clinical studies, the potential clinical, economic or other impacts and advantages of using customized implants, as well as other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” and similar expressions, constitute forward-looking statements within the meaning of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995. 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. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of a variety of risks and uncertainties, including risks related to results seen in ongoing and future clinical and economic studies of our products, risks related to our estimates regarding the potential market opportunity for our current and future products, our expectations regarding our sales and other results of operations, and the other risks and uncertainties described in the “Risk Factors” sections of our public filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent ConforMIS’s views as of the date hereof. ConforMIS anticipates that subsequent events and developments may cause ConforMIS’s views to change. However, while ConforMIS may elect to update these forward-looking statements at some point in the future, ConforMIS specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing ConforMIS’s views as of any date subsequent to the date hereof.

Lynn Granito

Berry & Company Public Relations, LLC

345 7^th Avenue

Suite 402

New York, NY 10001

T: 212 253-8881 F: 212 253-8241

lgranito@berrypr.com

www.berrypr.com

Zyga Releases 12-month Fusion and Clinical Results of Sacroiliac Joint Fusion with Decortication

Posted On October 17, 2016 By OrthoSpineNews In Spine /

MINNETONKA, Minn., Oct. 17, 2016 /PRNewswire/ — Zyga Technology, Inc., a medical device company focused on the design, development and commercialization of minimally invasive devices to treat underserved conditions of the lumbar spine, today released 12-month fusion and clinical results for patients receiving SImmetry® Sacroiliac (SI) Joint Fusion with decortication. Study results were presented on Saturday morning at the 2016 Society for Minimally Invasive Spine Surgery (SMISS) Annual Meeting by Dr. William Cross, an orthopedic trauma surgeon at the Mayo Clinic in Rochester, Minn.

“Minimally Invasive SI joint fusion has been established as an effective treatment for certain patients suffering from SI joint disorders, but many technologies available today don’t follow the accepted orthopedic principles that lead to successful long-term fusion,” said Dr. Cross, the lead author and presenter at the SMISS scientific meeting. “For me, it’s common sense that SI joint fusion should include decortication and bone grafting to achieve long-term success. The results of this study provide compelling evidence that decortication and bone grafting may contribute to earlier fusion, and that the procedure provides significant pain relief at one year post-op.”

This prospective, multi-center study enrolled 19 patients at three institutions, who underwent a CT scan 12 and 24 months after receiving minimally invasive SI joint fusion with decortication and bone grafting. CT images were reviewed by a non-biased, independent radiology core laboratory to assess fusion in relation to the joint and the area of decortication. At 12 months, fusion was reported in 74% of patients, and back pain decreased from 7.9 to 2.2 (72%). Of patients in whom fusion was reported, 86% showed fusion in the area of decortication. Freedom from device- or procedure-related adverse events through 12 months was 100%. 24-month results for the study are expected in early 2017.

The SImmetry Sacroiliac Joint Fusion System is a minimally invasive procedure intended for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. The Company will next exhibit at the 2016 North American Spine Society (NASS) meeting inBoston, Mass., October 26 – 28.

The Centers for Disease Control and Prevention lists back problems as the second most common cause of disability in U.S. adultsⁱ. It has been reported that approximately 20 percent of all chronic low back pain derives from the sacroiliac jointⁱⁱ.

About Zyga Technology, Inc.

Zyga Technology, Inc. is dedicated to the research, development and commercialization of solutions that provide empirical clinical and economic value in the treatment of underserved conditions of the spine. In addition to marketing the SImmetry System, the company is conducting a U.S. multicenter clinical study of the Glyder Facet Restoration Device, an investigational, non-fusion, minimally invasive technology intended to provide relief from lumbar facet pain. For more information, visit zyga.com.

ⁱ Centers for Disease Control and Prevention. Prevalence of disabilities and associated health conditions among adults—United States, 1999. JAMA. 2001; 285(12):1571-1572.
ⁱⁱ Cohen SP et al. Sacroiliac Joint Pain: A Comprehensive Review of Epidemiology, Diagnosis and Treatment. Expert Rev Neurother. 2013; 13(1):99-116

CONTACT:
Erin Morrison
Tel 952 698 9956
emorrison@zyga.com

Photo – http://photos.prnewswire.com/prnh/20150323/183902
Logo – http://photos.prnewswire.com/prnh/20110118/CG30384LOGO

SOURCE Zyga Technology, Inc.

Global Medical Ceramics Market Growth at CAGR of 7.06%, 2016-2020: Challenges, Trends & Drivers – Key Vendors are 3M ESPE, CoorsTek Medical, Straumann & Stryker – Research and Markets

Posted On October 17, 2016 By OrthoSpineNews In Financial /

October 17, 2016

DUBLIN–(BUSINESS WIRE)–Research and Markets has announced the addition of the “Global Medical Ceramics Market 2016-2020”report to their offering.

The global medical ceramics market to grow at a CAGR of 7.06% during the period 2016-2020.

The report covers the present scenario and the growth prospects of the global medical ceramics market for 2016-2020. To calculate the market size, the report considers the revenue generated through the sales of medical ceramic products in applications such as orthopedic, implantable devices, dental application, surgical and diagnostic instrument, and therapeutic treatment of cancer by considering 2015 as the base year. The report also includes a discussion of the key vendors operating in this market.

Original equipment manufacturers (OEMs) in some industries prefer customized ceramics for their components. The production of customized components is not always feasible as customization increases the production cost and time.

Market players, instead of mass-producing simple shapes, prefer to manufacture ceramics according to the buyers (OEM) requirement. Such customized production of technical ceramics requires additional efforts during the stages of molding and formulation of components. Specific customization needs for different applications such as bone void fillers, spinal fusion, bone augmentation, osteoconductive scaffold for bone regeneration and spine cage inserts are acting as a trend for the growth of the ceramic medical market.

Key questions answered in this report

What will the market size be in 2020 and what will the growth rate be?
What are the key market trends?
What is driving this market?
What are the challenges to market growth?
Who are the key vendors in this market space?
What are the market opportunities and threats faced by the key vendors?
What are the strengths and weaknesses of the key vendors?

Key vendors

3M ESPE
CoorsTek Medical
Straumann
Stryker

Other prominent vendors

Amedica
APC International
BCE Special Ceramics
CeraRoot

Key Topics Covered:

Part 01: Executive summary

Part 02: Scope of the report

Part 03: Market research methodology

Part 04: Introduction

Part 05: Market landscape

Part 06: Market segmentation by type

Part 07: Market segmentation by applications

Part 08: Geographical segmentation

Part 09: Market drivers

Part 10: Impact of drivers

Part 11: Market challenges

Part 12: Impact of drivers and challenges

Part 13: Market trends

Part 14: Vendor landscape

Part 15: Key vendor analysis

Part 16: Appendix

For more information about this report visit http://www.researchandmarkets.com/research/bb8frx/global_medical

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Related Topics: Ceramics

Intuitive Surgical Reports New Employee Option Grants for October 2016

Posted On October 17, 2016 By OrthoSpineNews In Financial /

SUNNYVALE, Calif., Oct. 14, 2016 (GLOBE NEWSWIRE) — Intuitive Surgical, Inc. (ISRG) today reported that equity awards approved by the Compensation Committee of the Board of Directors, which consists entirely of Independent Directors, were made to 66 new employees. Pursuant to NASDAQ Marketplace Rule 5635(c)(4), the equity awards were granted under the Intuitive Surgical, Inc. 2009 Commencement Incentive Plan, which the Board of Directors of Intuitive Surgical, Inc. adopted for the granting of equity awards to new employees. In accordance with NASDAQ rules, these grants were made under an equity incentive plan without shareholder approval. NASDAQ rules require a public announcement of equity awards to be made under this type of plan. 66 employees were granted a combination of Restricted Stock Units (RSUs) and Stock Options to purchase an aggregate of 10,221 shares of the Company’s common stock; 5,072 of the shares granted were Stock Options and 5,149 of the shares granted were RSUs. Both the RSUs and Stock Options vest over four years. The Stock Options expire in 10 years assuming continued employment. No officers received any award under this plan. The exercise price for the Stock Options granted is $718.04 which was the closing price of Intuitive Surgical, Inc.’s common stock on the NASDAQ Global Market as such price was reported by NASDAQ on October 7, 2016. The Company’s policy is to issue RSUs and Stock Option grants to new employees, where equity makes sense, on the fifth business day of every calendar month.

About Intuitive Surgical, Inc.

Intuitive Surgical, Inc. (ISRG), headquartered in Sunnyvale, California, is the global technology leader in robotic-assisted, minimally invasive surgery. Intuitive Surgical develops, manufactures and markets robotic technologies designed to improve clinical outcomes and help patients return more quickly to active and productive lives. The Company’s mission is to extend the benefits of minimally invasive surgery to the broadest possible base of patients. Intuitive Surgical – Taking surgery beyond the limits of the human hand™.

About the da Vinci® Surgical System

The da Vinci® System is a breakthrough surgical platform designed to enable complex surgery using a minimally invasive approach. The da Vinci® System consists of an ergonomic surgeon console, a patient-side cart with four interactive robotic arms, a high-performance vision system and proprietary EndoWrist® instruments. Powered by state-of-the-art robotic and computer technology, the da Vinci® System is designed to scale, filter and seamlessly translate the surgeon’s hand movements into more precise movements of the EndoWrist® instruments. The net result is an intuitive interface with breakthrough surgical capabilities. By providing surgeons with superior visualization, enhanced dexterity, greater precision and ergonomic comfort, the da Vinci Surgical System makes it possible for more surgeons to perform minimally invasive procedures involving complex dissection or reconstruction. This ultimately has the potential to raise the standard of care for complex surgeries, translating into numerous potential patient benefits, including less pain, a shorter recovery and quicker return to normal daily activities.

Intuitive®, da Vinci®, da Vinci S®, da Vinci® Si™, InSite® and EndoWrist® are trademarks or registered trademarks of Intuitive Surgical, Inc.

For more information, please visit the company’s web site at www.intuitivesurgical.com.

Ohio judge dismisses hundreds of off-label Medtronic Infuse patient lawsuits

Posted On October 14, 2016 By OrthoSpineNews In Regulatory /

October 14, 2016

US district court judge, Timothy S Black (Southern Ohio, USA) has dismissed the accusation of several hundred plaintiffs that they have been treated off-label with Medtronic’s Infuse.

The plaintiffs were all former patients of Atiq Durrani (Cincinnati, USA), an orthopaedic surgeon indicted in 2013 for providing “medically unnecessary” spinal surgeries. Durrani’s hospital, West Chester Hospital, and its parent company, UC Health, settled allegations of violation of the False Claims Act with a payment of US$4.1 million. The hospital was accused of charging federal healthcare programmes for the “unnecessary” surgeries performed by Durrani. The surgeon now resides in Pakistan, following his indictment.

Medtronic received pre-market approval for the use of Infuse in single-level L4-S1 fusions using an anterior lumbar interbody fusion procedure in combination with the LT-cage. It was indicated as a treatment for degenerative disc disease. MedPageToday, however, reported that up to 80% of the product’s usage was likely to be off-label.

In this case, a number of plaintiffs had been treated without the use of LT-cage, while some had been treated posteriorly. Infuse had been used by Durrani in the cervical and thoracic spine, as well as across multiple levels.

In 2015, the bone morphogenetic protein received approval for three new indications; use in OLIF51 procedures with certain sizes of the Medtronic PEEK Perimeter Implant at a single level from L5-S1, use in OLIF25 procedures with certain sizes of the company’s PEEK Clydesdale Implant at a single level from L2-L5, and use in ALIF procedures with certain sizes of Medtronic’s PEEK Perimeter Implant at a single level from L2-S1.

According to Black, these off-label uses are not necessarily illegal. The plaintiffs had failed to provide sufficient evidence in court as to the harm caused by problems with the Infuse product.

The plaintiffs in this case attempted to argue both that Durrani had committed fraud, acting as an agent of Medtronic, because of his continued use of the Infuse product, in spite of his knowledge of its risks. The patients also argued, however, that Medtronic had itself committed fraud by failing to inform Durrani of the risks associated with the product, according to Black.

“Several courts throughout the country have examined this exact issue and have held that ‘the FDA established specific federal requirements for the Infuse device, even when the Infuse Protein is used alone,’” Black wrote, commenting that the FDA is not required by federal law to publish the adverse event data provided by Medtronic.

Medtronic’s Infuse product has been dogged by controversy since a number of employees failed to report over a thousand adverse events associated with use of the product to the FDA between 2006 and 2008. The adverse events—which included four deaths—were discovered in a retrospective chart review of the product. According to a Star Tribune report, staff failed to notify the FDA about the adverse events, shutting the study down in 2008. By the time news emerged of these unreported adverse events in 2013, most of the Medtronic staff involved in the scandal had left the company, causing confusion within the company itself.

Medtronic attempted to provide more adequate information regarding adverse events in a study run by Yale University, but this, too, has been the subject of some controversy.

Final MACRA Regulations Bump More Than Half of Clinicians Out of MIPS

Posted On October 14, 2016 By OrthoSpineNews In Regulatory /

October 14, 2016 – Robert Lowes

The federal government today issued final regulations for the Medicare Accountability and CHIP Reauthorization Act (MACRA), which now exclude or exempt between 53% and 57% of physicians and other clinicians from a possible 2019 penalty in the new reimbursement system.

The Centers for Medicare & Medicaid Services (CMS) gave roughly 200,000 more clinicians this break mostly by redefining practices that would not have to participate in the new system because their involvement with Medicare is minimal. In its proposed MACRA regulations, CMS defined such low-volume providers as having less than $10,000 in Medicare-allowable charges and fewer than 100 Medicare patients. By raising the dollar threshold to $30,000 in the final regulations, the agency bumped up the number of low-volume providers from 226,000 to 384,000.

Of these 384,000 low-volume providers, 46% work in practices with fewer than 10 physicians, according to CMS. Organized medicine had complained that many small practices lacked the time, money, and expertise to master the new payment program by the time it goes into effect in 2017. The agency has repeatedly said that it’s heard those complaints and is trying to make the new system more physician-friendly.

MACRA shifts Medicare reimbursement from fee-for-service (FFS) to pay-for-value through a new framework called the Quality Payment Program (QPP). There are two tracks in QPP. The default track, which initially will encompass the most physicians, is the Merit-Based Incentive Payment System (MIPS). It combines three existing incentive programs: meaningful use of electronic health records (EHRs), the Value-Based Payment Modifier, and the Physician Quality Reporting System (PQRS). Physicians will receive a bonus or penalty based on their composite score across the performance categories of quality of care, cost of care, clinical practice improvement, and meaningful use of EHRs, now called advancing care information.

READ THE REST HERE

Regeneration of spinal nerve cells boosted

Posted On October 14, 2016 By OrthoSpineNews In Biologics /

UT Southwestern Medical Center – October 12, 2016

Researchers successfully boosted the regeneration of mature nerve cells in the spinal cords of adult mammals – an achievement that could one day translate into improved therapies for patients with spinal cord injuries.

“This research lays the groundwork for regenerative medicine for spinal cord injuries. We have uncovered critical molecular and cellular checkpoints in a pathway involved in the regeneration process that may be manipulated to boost nerve cell regeneration after a spinal injury,” said senior author Dr. Chun-Li Zhang, Associate Professor of Molecular Biology at UT Southwestern. Dr. Zhang cautioned that this research in mice, published today by Cell Reports, is still in the early experimental stage and is not ready for clinical translation.

“Spinal cord injuries can be fatal or cause severe disability. Many survivors experience paralysis, reduced quality of life, and enormous financial and emotional burdens,” said lead author Dr. Lei-Lei Wang, a postdoctoral researcher in Dr. Zhang’s lab whose series of in vivo (in a living animal) screens led to the findings.

Spinal cord injuries can lead to irreversible neural network damage that, combined with scarring, can ultimately impair motor and sensory functions. These outcomes arise because adult spinal cords have very limited ability to regenerate damaged neurons to aid in healing, said Dr. Zhang, a W.W. Caruth, Jr. Scholar in Biomedical Research and member of the Hamon Center for Regenerative Science and Medicine.

Dr. Zhang’s lab focuses on glial cells, the most abundant non-neuronal type of cells in the central nervous system. Glial cells support nerve cells in the spinal cord and form scar tissue in response to injury. In 2013 and 2014, the Zhang laboratory created new nerve cells in the brains and spinal cords of mice by introducing transcription factors that promoted the transition of adult glial cells into more primitive, stem cell-like states, and then coaxed them to mature into adult nerve cells.

READ THE REST HERE

Titan Medical and Ximedica Resume Development of the Sport Surgical System

Posted On October 14, 2016 By OrthoSpineNews In Robotics /

TORONTO, ON–(Marketwired – October 13, 2016) – Titan Medical Inc. (TMD.TO) (TITXF) today reported that the Company and its principal development partner, Ximedica LLC have reached agreement on the initiation of an acceptable development plan for the SPORT™ Surgical System. The agreement is effective immediately and is focused on Titan’s previously announced Human Factors and Usability Trials milestones for the SPORT system.

“Ximedica is a valued partner and this agreement enables us to resume the development of the SPORT Surgical System,” commented John Barker, Interim CEO of Titan Medical Inc. “This agreement and the decisions by the Board of Directors earlier this week demonstrate the committed effort of our company to advance the SPORT Surgical System.”

“We believe the SPORT Surgical System represents a significant technology and everyone at Ximedica is proud to be associated with its continued development,” commented Randall Barko, President and CEO of Ximedica. “Our development team is re-engaging and our objective is to deliver on Titan’s milestones.”

As the new development plan proceeds the Company will report on its progress.

About Titan Medical Inc.

Titan Medical Inc. is a Canadian public company focused on the design and development of a robotic surgical system for application in minimally invasive surgery (“MIS”). The Company’s SPORT™ Surgical System, currently under development, includes a surgeon-controlled robotic platform that incorporates a 3D high-definition vision system and multi-articulating instruments for performing MIS procedures through a single incision. The surgical system also includes a surgeon workstation that provides a surgeon with an advanced ergonomic interface to the robotic platform for controlling the instruments and provides a 3D high-definition endoscopic view of inside a patient’s body. The SPORT Surgical System is designed to enable surgeons to perform a broad set of surgical procedures for general abdominal, gynecologic, and urologic indications. For more information, visit the Company’s website at www.titanmedicalinc.com.

Forward-Looking Statements

This news release contains “forward-looking statements” which reflect the current expectations of management of the Company’s future growth, results of operations, performance and business prospects and opportunities. Wherever possible, words such as “may”, “would”, “could”, “will”, “anticipate”, “believe”, “plan”, “expect”, “intend”, “estimate”, “potential for” and similar expressions have been used to identify these forward-looking statements. These statements reflect management’s current beliefs with respect to future events and are based on information currently available to management. Forward-looking statements involve significant risks, uncertainties and assumptions. Many factors could cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements, including, without limitation, those listed in the “Risk Factors” section of the Company’s Annual Information Form dated March 30, 2016 (which may be viewed at www.sedar.com). Should one or more of these risks or uncertainties materialize, or should assumptions underlying the forward looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in the news release are based upon what management currently believes to be reasonable assumptions, the Company cannot assure prospective investors that actual results, performance or achievements will be consistent with these forward-looking statements.

EOI Announces that Dr. Roybal will Present his Experience with the FLXfit™ 3D Expandable Cage at SMISS

Posted On October 13, 2016 By OrthoSpineNews In Spine /

OR AKIVA, Israel, October 13, 2016 /PRNewswire/ —

Expanding Orthopedics Inc. (EOI), a privately held medical device company focused on developing and commercializing innovative expandable devices for spine surgery, is proud to announce that Dr. Raphael Roybal from The Spine Institute at Chatham Orthopaedics, Savannah, GA., will present his clinical experience with the FLXfit™, the world’s only articulated and expandable cage with in-situ lordosis restoration, at the SMISS, Las Vegas (Oct 13-16, 2016).

Dr. Roybal, who has already implanted tens of FLXfit™ cages, “I wanted to compare lordosis correction between fixed and expandable lordotic cages using MIS TLIF approach”. And indeed, he says that “The results of an initial series with 6 months follow-up show that the use of the FLXfit™ expandable cage demonstrated increased correction of the sagittal alignment post-operatively compared to a fixed angle banana cage.” In Dr. Roybal’s eyes, “This is clearly understood by the configuration of the cage covering a wider footprint area with a more controlled expansion of the lordosis angle conforming to the unique patient’s anatomy. Additionally, the procedure is faster, easier and gentler to the patient due to the expansion mechanism.”

Dr. Roybal added, “A statistically significant improvement was noted in the group treated with the FLXfit cage vs. the fixed banana cage in all heights and lordosis measurements (p ≤0.02) and that maintenance of correction without subsidence in both groups was noted at 6 months.” He concludes that “The major advantage of the FLXfit™ over existing solutions is its ability to combine a big footprint, optimal anterior column support and significant bone graft volume while preserving the patient’s anatomy through a posterior, MIS, TLIF approach.”

Ofer Bokobza, CEO of Expanding Orthopedics, said that “We are very proud of Dr. Roybal’s achievement and honored by the selection to present at the renowned SMISS meeting.” He explains that “Dr. Roybal’s clinical results demonstrate the FLXfit™ ability to restore lordosis while maintaining it over time.” Ofer concludes that “We see a great momentum in the US market with more surgeons adopting the FLXfit™ as their preferred treatment option for their patients.”

About Expanding Orthopedics Inc.

Expanding Orthopedics Inc. (EOI) is a 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 backed by prominent spine surgeons. EOI owns a broad patent portfolio around anatomically fit, expandable devices for enhanced stability through a minimally invasive approach.

Contact info

David Elkaïm, VP Marketing and Sales
E-mail: david@xortho.com
Phone: +1-(347)321-96-83

SOURCE Expanding Orthopedics Inc. (EOI)

Medovex Corporation Reports Successful Demonstration of Expanding EMEA Business at EuroSpine 2016, Berlin, Germany

Posted On October 13, 2016 By OrthoSpineNews In Spine /

ATLANTA, GA–(Marketwired – Oct 13, 2016) – Medovex Corp. (NASDAQ: MDVX), a developer of medical technology products, today announced that the Company successfully exhibited its’ DenerveX™ System during EuroSpine 2016 Tradeshow last week in Berlin, Germany.

As part of the product exhibition, Medovex highlighted its innovative DenerveX™ System, a minimally invasive surgical (MIS) procedure pioneered by Medovex that was built around the denervation of the posterior capsulectomy of the Facet Joint using our patented Rotablation™ technology which is “A significant paradigm shift in the treatment of Facet Joint pain.”

Patrick Kullmann, President and COO for Medovex, stated, “We consider EuroSpine 2016 in Berlin our ‘pre-launch’ meeting leading up to what is expected to be an eventual formal CE Marking. In particular, we were very pleased to see visiting surgeons and distributors from more than 25 countries, and from all continents, at our booth, along with existing and new potential distributors visiting with us.”

Kullmann continued, “Importantly, we conducted meetings and demonstrations with at least six potentially strategic companies that could open the door to future collaboration for distribution, investment, co-future development of future generations of the technology or even potential acquisition. Many of the spine surgeons and pain relief physicians visiting the booth stated that the DenerveX Design is very elegant, and represents a very new and creative approach in treating pain associated with the Facet Joint Syndrome. Their clear appreciation for our different approach in performing a new procedure by way of a posterior capsulectomy of the facet joint, compared to the less effective standard radio frequency ablation (Rhizotomy), gives us cause for continued cautious optimism going forward.”

During EuroSpine 2016, Medovex also announced the official opening of the Company’s European Distribution Center in Berlin.

The Center will serve as Medovex’s European distribution service headquarters and function as the commercial hub for all European distributors, as well as other customer and technical support functions. The international operations center in Atlanta, GA (USA) will remain the Company’s global operational headquarters.

Manfred Sablowski, Senior Vice President of Global Sales & Marketing, added, “The opening of the European distribution service center is an important milestone for Medovex and a key inflection point for our Company’s strategy to grow our business in Europe, Middle Eastern and Africa regions. In the past months, we have additionally expanded our footprint to include all of Scandinavia and Israel. Our future goal is to increase our world-class EMEA distribution in other key countries. With the recent appointment of Juan Davila as Director Sales & Marketing for Latin America, having extensive experience in this market, we expect to continue to execute our go to market strategy.”

The DenerveX System consists of the DenerveX device, a single use medical device and the DenerveX Pro-40 Power Generator, both designed to be less invasive with faster recovery time than current surgical treatment options. It consists of two procedures combined into one device and is expected to provide for a longer lasting treatment solution while offering potential savings to the health care system. DenerveX is not yet commercially available.

DenerveX system is not yet CE marked or FDA cleared and is not yet commercially available.

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 device, 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 patent 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.

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Medovex Corp.
Jason Assad
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