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InVivo Therapeutics to Present at 55th International Spinal Cord Society Annual Scientific Meeting

Posted On September 7, 2016 By OrthoSpineNews In Biologics, Neuro /

September 07, 2016

CAMBRIDGE, Mass.–(BUSINESS WIRE)–InVivo Therapeutics Holdings Corp. (NVIV) today announced that Kristin Neff, Vice President of Clinical Operations & Project Management, is scheduled to present at the 55^th International Spinal Cord Society (ISCoS) Annual Scientific Meeting to be held September 14-16, 2016 in Vienna, Austria. Ms. Neff was invited to present along with several other leaders in the field of spinal cord injury clinical research on September 14 during the symposium titled “Clinical Trials Update for 2016.” The symposium, organized by the Spinal Cord Outcomes Partnership Endeavor (SCOPE), is intended to provide an update on current clinical research to foster communication between researchers and clinicians on advancements and challenges in clinical research.

“I am excited to share our encouraging progress to date and partake in the discussion on the challenges of conducting clinical studies in the spinal cord injury patient population,” Ms. Neff said.

For more information regarding the meeting, visit:https://www.iscosmeetings.org/

About the Neuro-Spinal Scaffold™ Implant

Following acute spinal cord injury, surgical implantation of the biodegradable Neuro-Spinal Scaffold within the decompressed and debrided injury epicenter is intended to support appositional healing, thereby reducing post-traumatic cavity formation, sparing white matter, and allowing neural regeneration across the healed wound epicenter. The Neuro-Spinal Scaffold, an investigational device, has received a Humanitarian Use Device (HUD) designation and currently is being evaluated in the INSPIRE pivotal probable benefit study for the treatment of patients with complete (AIS A) traumatic acute spinal cord injury.

About InVivo Therapeutics

InVivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who then was at Boston Children’s Hospital and who now is affiliated with Massachusetts General Hospital. In 2011, the company earned the David S. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. In 2015, the company’s investigational Neuro-Spinal Scaffoldreceived the 2015 Becker’s Healthcare Spine Device Award. The publicly-traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com.

Contacts

InVivo Therapeutics Holdings Corp.
Brian Luque, 617-863-5535
Investor Relations
bluque@invivotherapeutics.com

TransEnterix, Inc. Unveils New Brand Identity for Robotic Surgical System

Posted On September 7, 2016 By OrthoSpineNews In Robotics /

September 07, 2016

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–TransEnterix, Inc. (NYSE MKT: TRXC), a medical device company that is pioneering the use of robotics to improve minimally invasive surgery, today announced the launch of a new brand identity for the ALF-X Robotic Surgical System, which henceforth will be known as The Senhance™ Surgical Robotic System (“Senhance”).

“We are pleased to announce the new brand identity for our multiport surgical robotic system,” said Todd M. Pope, President and CEO of TransEnterix. “This is a pivotal point in our growth strategy and we believe Senhance speaks directly to the benefits experienced with our system.”

Mr. Pope continued: “Our goal is to advance minimally invasive surgery and the tools surgeons have at their disposal to provide patients with the best possible care while also providing a more attractive value proposition to the hospital. Senhance is designed to enhance laparoscopic surgery and specifically empowers the senses of the surgeon in ways that were never previously possible. The security of haptics and the convenience of eye sensing camera control are meaningful ways that technology can provide a further extension of the surgeon’s skill.”

The new logo, evocative of a thumb-print combined with circuitry, is a representation of the strong connection that Senhance provides between the surgeon and technology.

Senhance carries the CE Mark for use in general surgery, gynecology, urology and thoracic surgery. TransEnterix is actively preparing a submission for U.S. FDA Clearance for Senhance.

About TransEnterix

TransEnterix is a medical device company that is pioneering the use of robotics to improve minimally invasive surgery by addressing the clinical and economic challenges associated with current laparoscopic and robotic options. The company is focused on the commercialization of the Senhance Surgical Robotic System, a multi-port robotic system that brings the advantages of robotic surgery to patients while enabling surgeons with innovative technology such as haptic feedback and eye sensing camera control. The company is also developing the SurgiBot™ System, a single-port, robotically enhanced laparoscopic surgical platform. The Senhance Surgical Robotic System has been granted a CE Mark but is not currently available for sale in the United States. For more information, visit the TransEnterix website at www.transenterix.com.

Forward Looking Statements

This press release includes statements relating to The Senhance™ Surgical Robotic System and the SurgiBot™ System and our current regulatory and commercialization plans for these products. These statements and other statements regarding our future plans and goals constitute “forward looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control and which may cause results to differ materially from expectations, including whether Senhance speaks directly to the benefits both surgeons and patients experience with our Senhance system; whether Senhance is designed to enhance laparoscopic surgery and specifically empower the senses of the surgeon in ways never before provided. For a discussion of the risks and uncertainties associated with TransEnterix’s business, please review our filings with the Securities and Exchange Commission (SEC), including our Annual Report on Form 10-K filed on March 3, 2016 and our other filings we make with the SEC. You are cautioned not to place undue reliance on these forward looking statements, which are based on our expectations as of the date of this press release and speak only as of the origination date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Contacts

For TransEnterix, Inc.
Investor Contact:
Mark Klausner, +1 443-213-0501
invest@transenterix.com
or
Media Contact:
(For EU) Conrad Harrington, +44 (0)20 3178 8914
(For US) Hannah Dunning, +1 415-618-8750
TransEnterix-SVC@sardverb.com

Sports Medicine Oregon Performs First Meniscus Replacements in Oregon with NUsurface® Implant

Posted On September 7, 2016 By OrthoSpineNews In Sports Medicine /

September 07, 2016

PORTLAND, Ore.–(BUSINESS WIRE)–Sports Medicine Oregon, a comprehensive orthopaedic clinic treating a wide variety of injuries and illnesses, and Active Implants, a company that develops orthopedic implant solutions, today announced that the first meniscus replacement procedures in Oregon have been performed by orthopaedic surgeons Drs. Richard Edelson and Jonathan Greenleaf. Sports Medicine Oregon and its affiliate Oregon Outpatient Surgery Center is the only site in Oregon – and one of just 10 sites nationwide – enrolling patients with persistent knee pain caused by injured or deteriorating meniscus cartilage in the SUN (Safety Using NUsurface®) clinical trial, which is designed to assess the safety and effectiveness of the NUsurface® Meniscus Implant (pronounced “new surface”) in restoring function similar to that of a natural, healthy meniscus.

The first patient to receive the implant in Oregon was 59-year-old Philomath resident Don Bennett. Bennett grew up playing basketball and initially tore his meniscus in his left knee while playing basketball 30 years ago, only to suffer another tear eight years later. He underwent two meniscectomy surgeries to treat the meniscus tears, but the pain in his knee gradually returned and increased in severity. Over the past five years, the physical demands of his daily job function as a water system maintenance specialist and even daily walking activity aggravated his knee to the point of constant pain.

“There are limited options for patients like Don, who experience persistent knee pain following meniscus injury and surgery,” Dr. Edelson said. “He had exhausted his non-surgical options. Even though his pain had increased in severity over the last five years, he was not a candidate for total knee replacement.”

The meniscus is a tissue pad between the thigh and shin bones. Once it is damaged, the meniscus has a very limited ability to heal. Over 1 million partial meniscectomies (to remove the torn portion of the meniscus) are performed in the U.S. every year, more than the total number of hip and knee replacement surgeries combined. However, many patients still experience persistent knee pain following meniscus partial excision surgery.

“Meniscus injuries can be a very painful and debilitating problem, even leading to potential joint replacement at a young age,” Dr. Greenleaf said. “It is our belief that the NUsurface implant may allow patients to delay or avoid knee replacement and return to an improved level of activity without pain.”

It has been nearly two months since Bennett received the implant on July 13 through a small incision in his knee and completed a six-week rehabilitation program, and he has returned to his daily leisure and sports activities. With only a month left until his retirement from a 35-year career working for the city of Corvallis, he is most looking forward to salmon fishing, spending more time going on walks with his wife, attending his daughter’s Pac 12 volleyball games and coaching his son ahead of his basketball games.

“Prior to receiving the implant, I was living with constant pain and the fear that a total knee replacement was my only option,” Bennett said. “The NUsurface Meniscus Implant is giving me back my mobility. I’m looking forward to supporting my kids’ athletic endeavors, taking hikes with my wife and walking painlessly.”

The NUsurface Meniscus Implant has been used in Europe under CE Mark since 2008 and Israel since 2011.

About the Clinical Trial

The SUN study (Safety Using NUsurface®) will enroll approximately 120 patients as part of regulatory process to gain approval from FDA to sell the device in the U.S. All patients who meet study requirements and agree to enter the trial are offered the NUsurface Meniscus Implant as treatment. Treatment with NUsurface in the SUN trial is eligible for coverage by Medicare and some private insurance companies. To be eligible for the study, participants must be between the ages of 30 and 75 and have pain after medial meniscus surgery that was performed at least six months ago. To learn more about the SUN study, please visit http://sun-trial.com or call (844) 680-8951.

About the NUsurface® Meniscus Implant

The NUsurface® Meniscus Implant, from Active Implants LLC, is an investigational treatment for patients with persistent knee pain following medial meniscus surgery. It is made from medical grade plastic and, as a result of its unique materials, composite structure and design, does not require fixation to bone or soft tissues. The NUsurface Meniscus Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint. Clinical trials are underway in the U.S., Europe and Israel to verify the safety and effectiveness of the NUsurface Meniscus Implant.

About Sports Medicine Oregon

The goal of Sports Medicine Oregon is the restoration of active lifestyles to injured athletes of all ages. The team of specialty-trained physicians takes pride in providing the community with the highest quality orthopedic care. Whether it is the professional athlete or the weekend warrior, it strives to provide timely and comprehensive care at the state-of-the-art facility which includes full service X-ray, outpatient physical therapy, and the adjoining surgery center. For more information, please visit http://sportsmedicineoregon.com/.

About Oregon Outpatient Surgery Center

Oregon Outpatient Surgery Center is a multispecialty surgical center, which includes joint replacements. Oregon Outpatient Surgery Center provides caring, friendly, highly-skilled and trained professional staff, delivering the personal attention every patient deserves in a comfortable, professional atmosphere, a cost effect alternative to traditional surgical care.

About Active Implants

Active Implants, LLC develops orthopedic implant solutions that complement the natural biomechanics of the musculoskeletal system, allowing patients to maintain or return to an active lifestyle. Active Implants is privately held with headquarters in Memphis, Tennessee. European offices are in Driebergen, The Netherlands, with R&D facilities in Netanya, Israel. For more information, visitwww.activeimplants.com.

CAUTION Investigational device. Limited by United States law to investigational use.

Note to Editors: Photos of Don Bennett and Drs. Richard Edelson and Jonathan Greenleaf are available upon request.

Contacts

Merryman Communications
Joni Ramirez, 323-532-0746
joni@merrymancommunications.com

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Rotation Medical Bioinductive Implant Induces New Tissue Formation in Patients with Partial-Thickness Rotator Cuff Tears

Posted On September 7, 2016 By OrthoSpineNews In Biologics, Sports Medicine /

September 07, 2016

PLYMOUTH, Minn.–(BUSINESS WIRE)–Rotation Medical Inc., a medical device company focused on developing new technologies to treat rotator cuff disease, today announced that study results published in the current issue of Muscle, Ligaments and Tendons Journal showed that the company’s collagen-based bioinductive implant induced new tissue formation in all study patients with rotator cuff tears. The Rotation Medical rotator cuff system is a novel, implant-based solution for rotator cuff repair and a new alternative to traditional surgical repair.

The study assessed the ability of Rotation Medical’s bioinductive implant to induce new tissue formation and limit tear progression when placed on the bursal surface of partial thickness cuff tears. The implant induced significant new tissue formation in all 13 patients by three months (mean increase in tendon thickness 2.2 ± 0.26 mm), and the tissue matured over time and became radiologically indistinguishable from the underlying tendon. No tear progression was observed on MRI in any of the patients during the 24-month post-operative period. All patients’ Constant and American Shoulder and Elbow Society clinical scores improved significantly over time.¹

“Partial-thickness rotator cuff tears frequently enlarge due to increased local strain and often progress to full-thickness tears,” said Dr. Desmond John Bokor, lead study investigator and associate professor in the Department of Orthopaedic Surgery at Macquarie University in Australia. “The results of this study demonstrate the ability of the bioinductive implant to induce new tendon-like tissue, enabling partial-thickness rotator cuff tears to decrease in size and in most cases disappear. The ability to heal partial-thickness rotator cuff defects, and thus prevent tear propagation and progressive tendon degeneration, represents a novel interventional treatment paradigm for these lesions.”

Rotator cuff damage is the most common source of shoulder pain, affecting more than 4 million people annually in the U.S. Traditional approaches to treating degenerate or torn rotator cuffs often do not address the poor quality of the underlying tendon tissue, and a significant number of these tendons, after standard treatment, either degenerate further and/or re-tear. Cleared by the U.S. Food and Drug Administration in March 2014, the Rotation Medical bioinductive implant is designed to address this limitation by inducing new tissue growth at the site of implantation, resulting in increased tendon thickness and healing of tendon defects with new tissue growth. The collagen-based implant is about the size of a postage stamp and it is part of the Rotation Medical rotator cuff system, which also includes disposable instruments that allow the arthroscopic procedure to be performed easily and quickly.

“This study is further evidence that the Rotation Medical rotator cuff system has the potential to transform the treatment of rotator cuff disease,” said Martha Shadan, president and CEO of Rotation Medical. “Our bioinductive implant addresses both the biomechanics and biology required to heal a rotator cuff tendon tear, preventing rotator cuff tears from becoming larger over time, reducing the incidence of re-tears and, in some cases, shortening patient recovery time.”

The study, “Evidence of healing of partial-thickness rotator cuff tears following arthroscopic augmentation with a collagen implant: a 2-year MRI follow-up,” adds to the growing body of literature supporting the use of the bioinductive implant as a novel treatment for rotator cuff partial thickness tears. Additional publications and information about the Rotation Medical rotator cuff system are available on the company’s website.

About the Study

The implant was inserted via arthroscopic surgery. A total of 13 patients with intermediate (3-6 mm) to high-grade (>6 mm) partial thickness cuff tears completed two years of follow-up. At three, six, 12, and 24 months postoperatively, tendon thickness, defect size and quality were evaluated using magnetic resonance imaging (MRI), and clinical outcomes were assessed using the Constant and American Shoulder and Elbow Society scores. The partial-thickness cuff tears showed consistent filling of the defects, with complete healing in seven patients at 12 months, and a progressive improvement in tendon quality in the remaining patients. No tear progression was observed by MRI in any of the patients at 24 months. All clinical scores improved significantly over time. At 24 months, 12 of 13 patients (92 percent) had satisfactory or better results.

About Rotation Medical

Rotation Medical Inc. was founded in 2009 and is committed to improving the treatment of rotator cuff disease with the Rotation Medical rotator cuff system, a breakthrough technology that has the potential to prevent rotator cuff disease progression and reduce re-tears by inducing the growth of new tendinous tissue. The company is privately held and funded by New Enterprise Associates (NEA), Life Sciences Partners (LSP) and Pappas Ventures. For more information, visit www.rotationmedical.com.

________________________
¹ Bokor DJ, Sonnabend D, Deady L, Cass B, Young A, Van Kampen C, Arnoczky S. Evidence of healing of partial-thickness rotator cuff tears following arthroscopic augmentation with a collagen implant: a 2-year MRI follow-up. Muscle Ligaments Tendons J. 2016 May 19;6(1):16-25. doi: 10.11138/mltj/2016.6.1.016.

Contacts

Merryman Communications
Joni Ramirez, 323-532-0746
joni@merrymancommunications.com

Exactech Announces Investor Presentation at Baird Global Healthcare Conference

Posted On September 6, 2016 By OrthoSpineNews In Extremities, Recon /

September 06, 2016

GAINESVILLE, Fla.–(BUSINESS WIRE)–Exactech, Inc. (Nasdaq: EXAC), a developer and producer of bone and joint restoration products for extremities, knee, hip, spine and biologics, will present to investors at the Baird 2016 Global Healthcare Conference in New York on Wednesday, September 7, 2016. The company will also host one-on-one meetings with institutional investors.

The presentation by Exactech CEO David Petty and Executive Vice President of Finance & CFO Jody Phillips will begin at 4:20 p.m. ET, and will be available via live and archived webcast at http://wsw.com/webcast/baird46/exac. The replay will be available for 90 days.

About Exactech

Based in Gainesville, Fla., Exactech develops and markets orthopaedic implant devices, related surgical instruments and biologic materials and services to hospitals and physicians. The company manufactures many of its orthopaedic devices at its Gainesville facility. Exactech’s orthopaedic products are used in the restoration of bones and joints that have deteriorated as a result of injury or diseases such as arthritis. Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Additional information about Exactech, Inc. can be found at http://www.exac.com. Copies of Exactech’s press releases, SEC filings, current price quotes and other valuable information for investors may be found at http://www.exac.com andhttp://www.hawkassociates.com.

An investment profile on Exactech may be found at http://www.hawkassociates.com/profile/exac.cfm. To receive future releases in e-mail alerts, sign up at http://www.hawkassociates.com/about/alert.

This release contains various forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which represent the company’s expectations or beliefs concerning future events of the company’s financial performance. These forward-looking statements are further qualified by important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include the effect of competitive pricing, the company’s dependence on the ability of third party manufacturers to produce components on a basis which is cost-effective to the company, market acceptance of the company’s products and the effects of government regulation. Results actually achieved may differ materially from expected results included in these statements.

Contacts

Exactech, Inc.
Investor contacts:
Jody Phillips, 352-377-1140
Executive Vice President of Finance &
Chief Financial Officer
or
Hawk Associates
Julie Marshall or Frank Hawkins, 305-451-1888
EXAC@hawkassociates.com
or
Media contact:
Priscilla Bennett, 352-377-1140
Vice President, Corporate & Marketing Communication

DJO Global Announces Appointment of Mike Eklund as Chief Operating Officer and Chief Financial Officer

Posted On September 6, 2016 By OrthoSpineNews In Recon /

Sept. 6, 2016

SAN DIEGO–(BUSINESS WIRE)– DJO Global, Inc., a global provider of medical device solutions for musculoskeletal health, vascular health and pain management, today announced the appointment of Mike Eklund as Chief Operating Officer and Chief Financial Officer, effective September 12, 2016.

“We are pleased to announce the appointment of Mike Eklund as Chief Operating Officer and Chief Financial Officer,” said Mike Mogul, DJO’s President and Chief Executive Officer. “The Chief Operating Officer role is a new position at DJO Global, which we have created to partner in leading day to day execution and to build a laser focus on end-to-end productivity.”

Mr. Eklund joins DJO Global from Dell where he last served as the Senior Vice President, Dell / EMC Value Creation and Integration Management Office. In this role, he led the Value Creation and Integration function for the $67 Billion combination of Dell and EMC. Prior to his latest role, he served as Chief Financial Officer of Dell’s $40 Billion Client Solutions Business Unit and Global Operations organization. In this role, he was also responsible for leading Dell’s Global Productivity Transformation Office, where he developed an affordability framework to define the core business model, identifying $3 Billion of productivity improvements and executing structural and quality savings of over $300 Million.

Previously, Mr. Eklund served as Vice President of Strategy, Business Planning and Operations for Dell’s $10 Billion Enterprise Solutions Group. He brings a wealth of global experience over a 20 year career with Dell, including finance and operating and treasury roles. In addition, he completed a 3 year international assignment based in the UK, as Finance Director for Dell’s Emerging Markets business which grew significantly during his tenure.

Mr. Eklund began his career in public accounting as a staff accountant in tax and audit, followed by a two year stint in the oil and gas industry in a variety of staff accounting and finance roles. He has a bachelor’s degree in accounting and a master’s degree in business administration (MBA).

About DJO Global

DJO Global is a leading global developer, manufacturer and distributor of high-quality medical devices that provide solutions for musculoskeletal health, vascular health and pain management. The Company’s products address the continuum of patient care from injury prevention to rehabilitation after surgery, injury or from degenerative disease, enabling people to regain or maintain their natural motion. Its products are used by orthopedic specialists, spine surgeons, primary care physicians, pain management specialists, physical therapists, podiatrists, chiropractors, athletic trainers and other healthcare professionals. In addition, many of the Company’s medical devices and related accessories are used by athletes and patients for injury prevention and at-home physical therapy treatment. The Company’s product lines include rigid and soft orthopedic bracing, hot and cold therapy, bone growth stimulators, vascular therapy systems and compression garments, therapeutic shoes and inserts, electrical stimulators used for pain management and physical therapy products. The Company’s surgical division offers a comprehensive suite of reconstructive joint products for the hip, knee and shoulder. DJO Global’s products are marketed under a portfolio of brands including Aircast®, Chattanooga, CMF™, Compex®, DonJoy®, Empi®, ProCare®, DJO® Surgical, Dr. Comfort®, Bell-Horn® and Exos^TM. For additional information on the Company, please visit www.DJOglobal.com.

View source version on businesswire.com: http://www.businesswire.com/news/home/20160906006532/en/

Contacts

DJO Investor/Media Contact:
DJO Global, Inc.
Matt Simons
SVP Business Development and Investor Relations
760.734.5548
matt.simons@DJOglobal.com

Source: DJO Global, Inc.

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NuVasive’s MAGEC System Featured in Live Surgery Event at the Spine Hospital at NewYork-Presbyterian

Posted On September 6, 2016 By OrthoSpineNews In Spine /

SAN DIEGO, CA–(Marketwired – September 06, 2016) – NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced a key event in the Company’s advancement in the treatment of patients with deformity spinal conditions.

On Monday September 12, Dr. Michael G. Vitale, MD, MPH, Director of Pediatric Orthopedics at Columbia Orthopedics, will use the MAGEC^® system to treat a seven-year-old Early Onset Scoliosis (EOS) patient with a progressive 45 degree curve and multiple cardiac comorbidities. The case will be featured in a live surgery event, in partnership with BroadWater’s Total Spine Series 2016, hosted by The Spine Hospital at NewYork-Presbyterian.

Dr. Michael Vitale commented, “I am honored to take part in this event to demonstrate the success of the MAGEC system in transforming the lives of pediatric patients requiring surgical treatment for EOS. The live surgery event will demonstrate that the surgical technique is no different from what surgeons have historically done. However, with the elimination of additional planned distraction surgeries, the MAGEC system helps simplify care for this patient population like no other technology.”

“NuVasive’s technology platform is quickly becoming the standard of care in pediatric deformity. The MAGEC rod can be extended non-invasively with a magnet, significantly reducing the number of planned distraction surgeries from up to 15 surgeries over several years, to a single surgery. By transforming the experience for these young patients, NuVasive is able to help minimize the risks associated with multiple surgeries, while also reducing the total cost of care. We will continue to partner with surgeons like Dr. Vitale to revolutionize deformity surgery with a comprehensive offering for pediatric, adolescent and adult deformity patients,” said Gregory T. Lucier, NuVasive’s Chairman and Chief Executive Officer.

The simultaneous live surgery broadcast will allow surgeons to observe a live feed, ask real-time Q&A with operating surgeons and take part in afternoon case discussions and lectures. In addition, the live surgery has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education (AACME) through the joint sponsorship of Medical Education Resources (MER) and BroadWater, providing a maximum of up to 7 AMA PRA Category 1 credit(s)™. For more information and to register for the event, visit www.broad-water.com.

The MAGEC System

MAGEC is comprised of a sterile, single use spinal rod that is surgically implanted to brace the spine during growth and includes a small internal magnet that is controlled by an external remote controller. Periodic lengthening of the rod is performed externally to distract the spine in an office setting, eliminating distraction surgeries and helping to simplify care.

Earlier this month, the U.S. Centers for Medicare and Medicaid Services (CMS) granted a new technology add-on payment (NTAP) for magnetically controlled growth rods. For a technology to qualify for an NTAP in the inpatient setting, the solution must demonstrate a substantial clinical improvement relative to available alternatives.

About NuVasive

NuVasive, Inc. (NASDAQ: NUVA) is a world leader in minimally invasive, procedurally-integrated spine solutions. From complex spinal deformity to degenerative spinal conditions, NuVasive is transforming spine surgery with innovative technologies designed to deliver reproducible and clinically proven surgical outcomes. NuVasive’s highly differentiated, procedurally-integrated solutions include access instruments, implantable hardware and software systems for surgical planning and reconciliation technology that centers on achieving the global alignment of the spine. With $811 million in revenues (2015), NuVasive has an approximate 1,900 person workforce in more than 40 countries around the world. For more information, please visit nuvasive.com.

Forward-Looking Statements

NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA™ platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

Contact Information

Investor Contact:
Suzanne Hatcher
NuVasive, Inc.
858-458-2240
Email contact

Media Contact:
Michael Farrington
NuVasive, Inc.
858-909-1940
Email contact

VEXIM Announces the Registration of Its Products SpineJack® and Masterflow™ For the Treatment of Vertebral Fractures in Australia

Posted On September 6, 2016 By OrthoSpineNews In Regulatory /

September 06, 2016

TOULOUSE, France–(BUSINESS WIRE)–Regulatory News

VEXIM (Paris:ALVXM) (FR0011072602 – ALVXM / PEA‐PME), a medical device company specializing in the minimally invasive treatment of vertebral fractures, today announces it has received the regulatory approval from the Therapeutic Goods Administration (TGA) in order to commercialize the SpineJack® and the cement delivery system Masterflow^TMin Australia.

This success opens a new market opportunity for VEXIM in Australia which represents a potential market of €30 million in the treatment of vertebral compression fractures according to VEXIM’s estimations.

The company keeps expanding its international presence whilst preparing new products’ development.

Vincent Gardès, VEXIM’s CEO, concludes: “This registration will enable us to have a substantial increase of our global activities. The company considers launching the exportation in Australia by the end of 2016.”

About VEXIM, the innovative back microsurgery specialist
Based in Balma, near Toulouse (France), VEXIM is a medical device company created in February 2006. The company has specialized in the creation and marketing of minimally-invasive solutions for treating traumatic spinal pathologies. Benefitting from the financial support of it longstanding shareholder, Truffle Capital¹ and from BPI public subsidies, VEXIM has designed and developed the SpineJack®, a unique implant capable of repairing a fractured vertebra and restoring the balance of the spinal column. The company also developed the Masterflow^TM, an innovative solution for mixing and injecting orthopedic cement that enhances the accuracy of the injection and optimizes the overall surgical procedure. The company counts 62 employees, including its own sales teams in Europe and a network of international distributors.
VEXIM has been listed on Alternext Paris since May 2012. For further information, please visit www.vexim.com

SpineJack® ², a revolutionary implant for treating Vertebral Fractures
The revolutionary aspect of the SpineJack® lies in its ability to restore a fractured vertebra to its original shape, restore the spinal column’s optimal anatomy and thus remove pain and enable the patient to recover their functional capabilities. Thanks to a specialized range of instruments, inserting the implants into the vertebra is carried out by minimally-invasive surgery, guided by X-ray, in approximately 30 minutes, enabling the patient to be discharged shortly after surgery. The SpineJack® range consists of 3 titanium implants with 3 different diameters, thus covering 95% of vertebral fractures and all patient morphologies. SpineJack® technology benefits from the support of international scientific experts in the field of spinal surgery and worldwide patent protection through to 2029.

Masterflow^TM ², a high-performance orthopedic cement delivery system
The Masterflow^TM is an innovative solution for mixing and injecting orthopedic cement that enhances the accuracy of the injection and optimizes the overall surgical procedure for treating vertebral compression fractures. The device provides a better control of the injection of biomaterials into the spine. A complement of the SpineJack®, the Masterflow^TM stands out for being both easy to use and precise, particularly in its ability to stop the cement delivery instantly without inertia. The Masterflow^TM contributes to reducing pain in patients. Its first sales were recorded in the U.S. in February 2015, and the system has also received the CE marking in February 2015, a mandatory conformity mark for products marketed in Europe.

¹ Founded in 2001 in Paris, Truffle Capital is a leading independent European private equity firm. It is dedicated to investing in and building technology leaders in the IT, life sciences and energy sectors. Truffle Capital manages €550m via FCPRs and FCPIs, the latter offering tax rebates (funds are blocked during 7 to 10 years). For further information, please visit www.truffle.fr and www.fcpi.fr.

² This medical device is a regulated health product that, with regard to these regulations, bears the CE mark. Please refer to the Instructions for Use.

Contacts

VEXIM
Vincent Gardès, Tél. : +33 5 61 48 48 38
CEO
investisseur@vexim.com
or
PRESS
ALIZE RP
Caroline Carmagnol / Wendy Rigal
Tél. : +33 1 44 54 36 66
Tél. : +33 6 48 82 18 94
vexim@alizerp.com

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More than a third of adult spinal deformity patients experience at least one psychological disorder

Posted On September 6, 2016 By OrthoSpineNews In Spine /

6th September 2016

According to new research from the Hospital for Special Surgery in New York City, USA, 36.5% of patients undergoing surgical treatment for adult spinal deformity in the US Nationwide Inpatient Sample (NIS) has been coded with at least one psychological disorder catalogued in the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders: 5th Edition (DSM-V). Adult spinal deformity patients displayed the highest prevalence of psychological impairment, when compared with three other disabling chronic diseases.

The research—which was presented at the International Meeting for Advanced Spine Techniques (IMAST; 13-16 July, Washington, DC, USA) by Bassel Diebo (Brooklyn, USA)—aimed to “investigate incidences of psychological disorders in adult spinal deformity patients undergoing surgical treatment.” The condition is a growing problem in the USA, according to the researchers, who attribute its increasing prevalence to the country’s ageing population. The disability associated with adult spinal deformity has been noted as “concerning” in the literature, “when compared to other self-reported chronic conditions.” Diebo explained that the psychological burden of the condition—a major factor in disability—“remains unclear” in comparison to many disabling diseases.

Diebo et al performed a retrospective review of NIS data from 2002 to 2012, using International Classification of Diseases, Ninth Revision coding to identify patients with adult spinal deformity undergoing more than four levels of fusion (n=17,536). The research team also searched for patients with cardiac diseases (n=2,675,767), type one and/or two diabetes (n=1,137,435), and lung cancer (n=363, 334). The total population included from the NIS database during this period was 4,194,073.
Using the DSM-5 manual, Diebo and colleagues identified incidences of depressive, anxiety, obsessive-compulsive, stress, somatic symptom, sexual dysfunction, substance abuse, delirium and personality disorders in patients within each chronic disease group.

Results showed that adult spinal deformity patients had “the highest prevalence of any psychological disorder” amongst the groups (p<0.001). Thirty-six point five per cent of these patients experienced at least one psychological disorder, followed by cardiac disease patients (33.3%), diabetic patients (28.3%) and lung cancer patients (24%).

When stratified according to age, researchers found that, amongst adult spinal deformity patients with psychological disorders, “61.7% were between 55 and 74 years old”. Six point two per cent were between 25 and 40 years old, with 12.2% over seventy-five years of age.

Amongst the patients, the most common disorders for 55-74 year olds were depressive, anxiety and sleep disorders. Amongst the younger age bracket of 41-54 years, however, the most common psychological disorders were substance abuse-based. Of the four most common psychological disorders amongst the population—depressive, sleep, anxiety and substance abuse—adult spinal deformity patients exhibited the highest percentage of the former three.

In conclusion, Diebo highlighted the prevalence of psychological disorders amongst this group, emphasising that “one in every three adult spinal deformity patients” was coded with at least one psychological disorder. Diebo recommended that “proper psychological screening, patient counselling and appropriate support” should be a part of adult spinal deformity treatment.

St. Teresa Medical, Inc. Announces Appointment of Richard Guyer, M.D. to Scientific Advisory Board

Posted On September 6, 2016 By OrthoSpineNews In Spine /

ST. PAUL, Minn., Sept. 6, 2016 /PRNewswire-USNewswire/ — St. Teresa Medical, Inc. today announced the appointment of Richard Guyer M.D. to its scientific advisory board. Dr. Guyer is a board certified orthopedic spine surgeon and one of the founders of Texas Back Institute and serves as its President. He also serves as the Chairman of the Board of Directors for the Texas Back Institute Research Foundation and has been Director of the Spine Surgery Fellowship program since its inception in 1986.

Dr. Guyer did his medical school and residency training at the University of Pennsylvania School of Medicine and completed two spine fellowships, one at Case Western Reserve University with Henry Bohlman, M.D. in Cleveland, Ohio and the other with Leon Wiltse, M.D. in Long Beach, California. He holds many patents in spine surgery and has published over 100 peer-reviewed articles and 45 chapters presenting his research at national and international spine conferences. While the majority of the research work has dealt with the diagnosis and treatment of painful degenerative spinal conditions, he is also one of the pioneers in minimally invasive surgery and lumbar and cervical disc replacement. In the early 1980s he worked with his former mentor Parviz Kambin who pioneered endoscopic discectomy. In 2000 he performed one of the first disc lumbar disc replacements in the USA and has been an investigator in nearly a dozen U.S. IDE studies of both cervical and lumbar disc replacements. He continues to research and publish in this area as well as in motion preservation and minimally invasive treatments.

Dr. Guyer has been very active with various spine societies including North American Spine Society (NASS), Cervical Spine Research Society (SSRS), International Society for the Study of the Lumbar Spine (ISSLS), and International Society for the Advancement of Spine Surgery (ISASS) serving as President of NASS during the 2006-2007 year and various committees of the ISASS. He was recently appointed to the board of directors of the American Board of Spinal Surgery.

Philip Messina, President and CEO said, “We are very pleased to welcome Dr. Guyer to our Scientific Advisory Board. He is considered to be among the top spine surgeons in the world. We could not be more pleased to have him on board. “

Timothy Floyd, MD, Chief Scientific Officer and Chair of the Scientific Advisory Board said, “Dr. Guyer is a world leader in cutting edge spine surgery and techniques. His counsel, as we move into our global clinical trial on SURGICLOT will be important.”

About St. Teresa

St. Teresa Medical, Inc.^®, based in St. Paul, MN., is a medical-device company developing SURGICLOT^®, a new unique dissolvable hemostatic dressing for use during orthopedic surgery. SURGICLOT^® is uniquely fabricated from nanoscale electro-spun dextran fibers infused with fibrinogen and thrombin. SURGICLOT^® works by supplementing and enhancing the body’s natural clotting mechanism. SURGICLOT^® utilizes thrombin and fibrinogen obtained from human sources.

For more information, see www.StTeresaMedical.com.

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/st-teresa-medical-inc-announces-appointment-of-richard-guyer-md-to-scientific-advisory-board-300322887.html

SOURCE St. Teresa Medical, Inc.

Month: September 2016

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