RTI Surgical® Continues to Augment Leadership Team to Accelerate its Strategic Direction

Posted On September 19, 2017 By OrthoSpineNews In Biologics /

September 18, 2017/Roxane Wergin, Director, Corporate Communications

ALACHUA, Fla. (September 18, 2017) – RTI Surgical Inc. (RTI) (Nasdaq: RTIX), a leading global surgical implant company, announced today three new appointments to its senior leadership team to accelerate the Company’s strategic growth initiatives. They include Jonathon Singer, a member of RTI’s board of directors, as Chief Financial and Administrative Officer, effective October 2, 2017. Outgoing CFO Robert Jordheim will leave the company to pursue new endeavors following a successful transition. RTI also appointed Olivier Visa, formerly Vice President of Global Compounding for Baxter, and Julius Aviza, past Vice President of Global Quality at American Medical Systems, to lead its OEM, Donor Services, Sports business and quality assurance function, respectively.

The new management additions demonstrate another important step toward positioning RTI for continued progress in executing its strategic transformation plan. The augmented leadership team has decades of highly specialized functional and industry expertise, along with a diverse skill set that is aligned to build on RTI’s recent strong performance and to advance its progress toward returning RTI to long-term sustainable growth and profitability. Each leader will play a critical role in further developing their respective functional excellence, streamlining RTI’s businesses, upgrading its processes and reinforcing a culture that is laser focused on the customer.

New Chief Financial and Administrative Officer

Mr. Singer, an RTI board member since May 2016, will resign from the board to focus on his new role, which includes managing the company’s financial operations and overseeing RTI’s information technology, legal and business development functions. He will report to RTI Chief Executive Officer Camille Farhat.

“As we continue to implement our long-term growth strategy, we need the right team to accelerate and solidify our progress,” said Mr. Farhat. “I am particularly proud to welcome Jonathon who already has been a valuable contributor to RTI’s progress as one of our board members. His intricate knowledge of RTI combined with his broad business experience and deep background in strategic planning, finance, operations, IT, investor communications and business development will bring a new dimension to his role and help us accomplish the significant work ahead of us.”

Mr. Singer has more than 30 years of leadership experience at publicly-traded health care and pharmaceutical organizations. Previously, he was Executive Vice President and Chief Financial Officer at Sagent Pharmaceuticals, a producer of generic injectable products that won numerous awards for growth and innovation during his tenure. Mr. Singer also served as CFO of Landauer, a radiation safety products and services provider, and as Vice President for Global Finance and CFO of the Medical Segment at specialty medical device company, Teleflex. A certified public accountant, he has held finance, accounting and operations roles at Cardinal Health, R.R. Donnelley & Sons and KPMG.

“I would like to extend my appreciation and gratitude to Rob Jordheim for his service as CFO and interim CEO,” said Mr. Farhat. “His commitment to RTI’s mission has contributed to putting us back on the path toward growth. We all wish Rob the best in his future endeavors.”

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Medtronic Announces FDA Approval and U.S. Launch of Next Generation Spinal Cord Stimulator for Chronic Pain Management

Posted On September 19, 2017 By OrthoSpineNews In Regulatory /

DUBLIN – September 18, 2017 – Medtronic plc (NYSE:MDT) today announced FDA approval and U.S. launch of the Intellis(TM) platform for the management of certain types of chronic intractable pain. The Intellis platform was designed to overcome limitations with current spinal cord stimulation (SCS) systems, such as battery performance, and can power the Evolve^SM workflow^*, which standardizes guidance and balances high-dose (HD) and low-dose (LD) therapy settings. The Intellis platform can record and track patient activity 24/7 and is managed on the Samsung Galaxy Tab S2 tablet interface, enabling physicians to address the subjective and personal nature of chronic pain by monitoring progress and making modifications to better suit their patients’ therapy needs.

Duke University Medical Center in Durham, N.C. implanted one of the first patients in the U.S. with the Intellis device.

“Chronic pain is challenging to manage. Having real-time data can provide more information about patients’ quality of life changes,” said Dr. Lance Roy, pain medicine specialist at Duke University Medical Center. “This platform represents a welcome new option for managing some kinds of chronic pain. New non-opioid treatment options are important given the national crisis related to opioid abuse.”

Back problems are one of the top 10 most expensive medical conditions, with an estimated 30 percent of the 300,000 patients annually that undergo lumbosacral spine procedures developing chronic intractable pain.¹ Chronic pain can negatively impact all aspects of a person’s life – relationships, work productivity and activities of daily living, yet it remains under-recognized and undertreated.¹ Neurostimulation has been proven to provide effective long-term pain relief and improve quality of life, in addition to being a treatment option for patients interested in trying a non-drug alternative.^2-6

“Drawing upon our 40-year legacy in SCS, the launch of the Intellis platform isn’t just about a new device, but about combining cutting edge hardware with optimal therapy through the Evolve workflow to enable personalized, long-term pain relief,” said Marshall Stanton, M.D., senior vice president and president of Medtronic’s Pain Therapies division, which is part of the Restorative Therapies Group. “Medtronic is committed to addressing patient needs, so the Intellis platform was designed based on what is most important to patients and physicians. We considered the entire patient journey – starting with the primary goal of optimal pain relief and access to important diagnostic tools, like MRI, to ease of use with simplified programming, faster recharge and a smaller implant.”

About the Intellis(TM) Platform
The Intellis platform can help optimize treatment and improve patient-physician communication by tracking and sharing daily activities, body positions and therapy usage and by giving physicians an objective look at mobility and progress. The Intellis platform also addresses a common patient complaint: battery recharge issues. With Medtronic’s proprietary Overdrive(TM) battery technology, the Intellis battery can be fully recharged from empty to full in approximately one hour and physicians can now estimate recharge intervals based on therapy settings.

Additional advances in the Intellis platform include secure wireless Samsung Galaxy Tab S2 programmers for physicians that enable faster delivery of evolving workflows and software upgrades. The Intellis implantable neurostimulator was designed for improved patient comfort and is the world’s smallest fully implantable SCS neurostimulator. The Intellis platform also includes both Medtronic’s proprietary SureScan(TM) MRI technology for the broadest access available to MRI diagnostic imaging and simple eligibility determination, which allows MRI scans anywhere on the body under certain conditions, as well as AdaptiveStim(TM) technology for automatic adjustments to deliver the right therapy dose to the right location, as the pain target shifts based on body position.

“We are excited to partner with Medtronic in their aim to simplify programming, and streamline therapy management with the Intellis platform,” said Dr. Dave Rhew, chief medical officer and head of Healthcare and Fitness for Samsung Electronics America. “Samsung’s Galaxy tablets-secured by the HIPAA-ready Samsung Knox mobile security platform-will support future Medtronic therapies and over the air (OTA) software upgrades to ensure clinicians using Intellis have access to the most up-to-date solutions.”

About Spinal Cord Stimulation
Medtronic neurostimulation therapy for chronic intractable pain uses a medical device placed under a patient’s skin to deliver mild electrical impulses through a lead implanted in the epidural space to block pain signals from going to the brain. SCS is a non-opioid therapy that is clinically proven and cost-effective for treating chronic pain. Multiple randomized controlled trials have demonstrated that SCS provides more effective pain relief than both re-operation and conventional medical management.^{2-4, 7}


Medtonic’s Intellis(TM) Spinal Cord Stimulation Platform
Click the thumbnail above for a larger image.

About Medtronic Pain Therapies
Medtronic has the broadest portfolio of pain therapies, which have been in use for over 40 years and have benefited hundreds of thousands of patients worldwide. Medtronic developed and leads the field of neuromodulation, the targeted and regulated delivery of electrical pulses and pharmaceuticals to specific sites in the nervous system, and continues to innovate and bring patient-centric advances.

About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world’s largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 84,000 people worldwide, serving physicians, hospitals and patients in approximately 160 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

*A workflow is guidance only and physicians should use their medical judgement and product labeling to optimize therapy for individual patients, which may require discontinuation or modification of a workflow.

References:
1.   Mekhail N, Wentzel DL, Freeman R, Quadri H. Counting the costs: case management implications of spinal cord stimulation treatment for failed back surgery syndrome. Prof Case Manag. 2011;16(1):27-36.
2.   North RB., Kidd DH., Farrokhi F, et al. Spinal cord stimulation versus repeated lumbosacral spine surgery for chronic pain: a randomized, controlled trial. Neurosurg; 56: 98-106 (2005).
3.   Kumar K., Taylor RS., Jacques L, et al., Spinal cord stimulation versus conventional medical management for neuropathic pain: a multicenter randomised controlled trial in patients with failed back surgery syndrome. Pain; 132: 179-188. (2007).
4.   Kemler MA., De Vet HCW., Barendse GAM et al., The effect of spinal cord stimulation in patients with chronic reflex sympathetic dystrophy: two years’ follow-up of the randomized controlled trial. Ann Neurol; 55: 13-18 (2004).
5.   Taylor RS, Spinal cord stimulation in Complex Regional Pain Syndrome and Refractory Neuropathic Back and Leg Pain/Failed Back Surgery Syndrome: results of a systematic review and meta-analysis. J Pain Symptom Manage; 31: S13-S19 (2006).
6.   Cameron T, Safety and efficacy of spinal cord stimulation for the treatment of chronic pain – a 20 year literature review. J Neurosurg Spine; 100: 254-267 (2004).
7.   Kumar K, Taylor RS, Jacques L, Eldabe S, Meglio M, Molet J, et al. The effects of spinal cord stimulation in neuropathic pain are sustained: a 24-month follow-up of the prospective randomized controlled multicenter trial of the effectiveness of spinal cord stimulation. Neurosurgery. 2008;63(4):762-70.

Medtronic Photo

Contacts:
Sara Thatcher
Public Relations
+1-901-399-2098

Ryan Weispfenning
Investor Relations
+1-763-505-4626

Zip Surgical Skin Closure Reduces Post-Discharge Costs, Clinic Calls and Antibiotics in First Economic Study of Device

Posted On September 19, 2017 By OrthoSpineNews In Recon, Top Stories /

September 18, 2017

CAMPBELL, Calif. & COLUMBUS, Ohio–(BUSINESS WIRE)–ZipLine Medical, Inc. today announced results from an economic study that showed that Zip Surgical Skin Closure reduced post-discharge costs for total knee arthroplasty (TKA) when compared to staples. Results were presented Friday at the Knee Society Members Meeting by Roger Emerson, MD, of the Texas Center for Joint Replacement, Plano, Texas.

“In the study, we saw that staples and the Zip are both fast to apply in the operating room, but in the post-discharge environment, staple-related issues, such as patient phone calls, emergency department visits, infection concerns and removal create extra work and extra cost in the long run,” said Dr. Emerson. “In addition, patients were apprehensive about staple removal and concerned when they saw redness around their staples, which in some cases triggered antibiotic prescriptions to avoid possible infection.”

The study encompassed 130 consecutive TKA patients, with half of subjects closed with staples and half closed with Zip Surgical Skin Closure. All surgeries were performed at the Texas Center for Joint Replacement by the same surgeon using the same approach and implant, and were closed by the same surgical physician’s assistant. Patients were followed from surgery to first clinic post-operative visit (day 21-28) for assessment.

The study findings showed that the Zip reduced all of the following measures when compared to staples:

46 percent reduction in incision-related actual clinic costs
60 percent reduction in incision-related phone calls
60 percent reduction in incision-related clinic visits
75 percent reduction in incision-related antibiotics prescribed

In addition, patients found the resulting scar from the Zip to be cosmetically more appealing, and the Zip device less painful to remove, than staples.

”In addition to actual emergency room, clinic and wound-related care costs, which can be considered ‘bundle-busters’ in a bundled care setting, there are opportunity costs to consider, where unreimbursed time responding to patient calls, concerns and staple removal results in less time spent on billable activities,” said Omar Alnachoukati, director of clinical research at the Texas Center for Joint Replacement. “In the study, we found a five times higher opportunity cost in the staple group.”

He continued, “Total joint arthroplasty is the largest expense for a single condition among Medicare beneficiaries, totaling $7 billion annually. With staples currently one of the primary methods currently used for TKA closure, this study suggests that replacing staples with the non-invasive Zip device has the potential to offer significant savings to the healthcare system.”

The Zip is a non-invasive and easy to use skin closure device that replaces sutures, staples, and glue for surgical incisions and lacerations. Clinical studies have demonstrated significant time savings, fewer wound complications and the ability to reduce post discharge healthcare costs. A patented force distribution design results in secure wound closure, excellent scar quality and high patient satisfaction. Unlike staples or sutures, there are no skin punctures with the Zip that can create pathways for bacteria. Benefits of the Zip have been demonstrated in clinical studies in orthopedic total joint arthroplasty, foot and ankle, pediatric cardiothoracic, electrophysiology, dermatology, and plastic and reconstructive surgery.

ABOUT ZIPLINE MEDICAL

ZipLine Medical is an innovator in cost-effective, non-invasive surgical skin closure devices that deliver high patient satisfaction and surgeon efficiency. Zip Surgical Skin Closure devices have been used in more than 100,000 cases and in over 30 countries worldwide. ZipLine Medical was founded by Amir Belson, M.D. and is headquartered in Campbell, CA. For more information, visit www.ziplinemedical.com.

Zip® Surgical Skin Closure devices are classified by the U.S. FDA as ‘Class I, 510(k) Exempt’ and have received the CE Mark and CFDA approval.

Contacts

Chronic Communications, Inc.
Michelle McAdam, 310.902.1274
michelle@chronic-comm.com

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First Lumbar AxioMed Viscoelastic Total Disc Replacement Implanted in Australia

Posted On September 18, 2017 By OrthoSpineNews In Spine /

BRISBANE, AUSTRALIA (PRWEB) SEPTEMBER 14, 2017

AxioMed is pleased to announce the success of the first viscoelastic Freedom Lumbar Disc case in Australia. Dr. Steven Yang completed the procedure on a 35-year-old female patient suffering from degenerative disc disease with radiating pain as a result of a degenerative lumbar disc at level L5-S1. The patient failed conservative treatments prior to undergoing surgery.

Dr. Yang spoke to the advantages of the AxioMed Disc after the operation, stating, “The Freedom Lumbar Disc is a great implant. It’s a very easy system to use and the compressible viscoelastic core restores the natural motion in the lumbar spine. My patient was pain free and out of the hospital in two days.”

AxioMed President Jake Lubinski personally met with Dr. Yang months before the surgery. “Dr. Yang’s disc replacement expertise led him to deciding the AxioMed Disc is the best treatment for his patients because it restores natural motion in the spine which ball-and-socket disc replacement cannot do.” Lubinski added, “With the addition of the viscoelastic lateral lumbar technique, we expect AxioMed to be the worldwide leader in disc replacement surgery.”

Dr. Yang is an orthopedic spinal surgeon specializing in complex spine reconstruction and vertebral tumor surgery, as well as all aspects of adult and pediatric spine surgery. Prior to joining his current practice – BrizBrain & Spine – in 2013, Dr. Yang was director of orthopedic surgery and director of spine surgery fellowship at the Royal Brisbane and Women’s Hospital.

View motion footage of the AxioMed Freedom Lumbar Disc here.

About AxioMed
Founded in 2001, AxioMed began its journey of exhaustively proving the Freedom® Disc through clinical studies in the U.S. and Europe, research, development and testing. In 2014, KICVentures recognized the disc’s enormous potential and acquired the company into their healthcare portfolio. AxioMed owns an exclusive viscoelastic material license on its proprietary Freedom Disc technology.

New surgeries allow upper extremity amputee patients optimal function

Posted On September 18, 2017 By OrthoSpineNews In Extremities, Top Stories /

CHARLOTTE, N.C., Sept. 18, 2017 (GLOBE NEWSWIRE) — Two Charlotte, N.C.-based orthopedic hand surgeons are pioneering new amputee surgeries that are offering patients unparalleled use of their upper extremities. OrthoCarolina hand surgeons Glenn Gaston and Bryan Loeffler are performing and developing multiple new surgical techniques for upper extremity amputees, including Targeted Muscle Reinnervation (TMR), which transplants nerves and allows them to reinnervate, or grow into, another muscle. TMR surgery enables nerve signals that have been transferred into a new muscle to control prostheses as a normal human arm would, using nerve impulses sent directly from the brain.

One of Dr. Gaston and Loeffler’s most recent and notable TMR patients is 32-year old mother of three Tiffany Johnson who lost her right arm when she was bitten by a shark while snorkeling off the coast of the Bahamas in June. The surgeons amputated Johnson’s arm just below the elbow joint. With badly damaged muscles and skin, the surgeons’ challenge was to keep the amputation below the elbow to ensure functional and sustained use of the limb. They transferred nerves that controlled the hand from the severed limb to another part of the arm, reinserting those nerves into another muscle. In their new location Johnson’s nerves can function as they would have previously. She is in the process of learning to use her new myoelectric hand, which is controlled by signals from her brain.

“Reassigning nerves to another part of the limb allows a patient easier control of their prosthesis and can also significantly reduce the phantom pain often felt by amputees,” said Dr. Gaston. “Even when a limb is gone, nerves are still available for the body to use.”

Drs. Loeffler and Gaston are developing other innovative forms of TMR by adapting the principles to other parts of the body including the forearms and legs. They also completed the first surgery for the prosthetic hand with individual finger control in 2016.

Beyond TMR, the doctors are leading experts in other advanced nerve reconstruction surgeries for adults and children with spinal cord injuries as well as brachial plexus injuries. They lead the the OrthoCarolina Reconstructive Center for Lost Limbs, a multidisciplinary clinic intended to help upper extremity amputees by offering patients the latest surgical innovations and technology to help them restore maximum limb performance and live life to the fullest. Cutting-edge techniques and surgeries include targeted muscle reinnervation, the STARFISH procedure (developed by the OrthoCarolina Hand Center), and flexion osteotomies to improve prosthetic fit and control. The Clinic coordinates with local and regional prosthetists and utilizes the most advanced myoelectric prostheses available.

“By coming to the clinic individuals who have amputations can meet with multiple healthcare providers and address variety of daily challenges that affect their lives, including general health and wellness, mobility, independence and more,“ said Dr. Loeffler. “It is also a chance for patients to meet others who have their same injuries or who have had similar surgeries, which goes a long way in dealing with the emotional part of their injury.”

Drs. Gaston and Loeffler have recently received awards from the American Academy of Orthopaedic Surgeons (AAOS) and have spoken at numerous international meetings about their work in the field of upper extremity reconstruction for amputees. Read more at orthocarolina.com.

About OrthoCarolina
With expert physicians and care providers in locations throughout our region, OrthoCarolina is one of the nation’s leading orthopedic practices and your destination for comprehensive orthopedic care. Our expertise in the areas of foot and ankle, hand, hip and knee, shoulder and elbow, spine, sports medicine and pediatrics to offer a continuum of care unmatched in our region — and throughout the country.

OrthoCarolina. You. Improved.

Connect with OrthoCarolina at orthocarolina.com or on Facebook, Twitter and YouTube.

Contact:
Logan Stewart
704.323.2486
logan.stewart@orthocarolina.com

TransEnterix, Inc. Reports Progress on Senhance FDA Submission

Posted On September 18, 2017 By OrthoSpineNews In Regulatory, Robotics /

September 18, 2017

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–TransEnterix, Inc. (NYSE American: TRXC), a medical device company that is pioneering the use of robotics to improve minimally invasive surgery, today announced the Company has filed its response to the Food and Drug Administration’s (“FDA”) Additional Information (“AI”) request related to the Company’s Senhance Surgical Robotic System 510(k) submission.

“We are very pleased to have submitted our AI response ahead of schedule, demonstrating our team’s effectiveness and our ongoing collaboration with the FDA,” said Todd M. Pope, President and Chief Executive Officer of TransEnterix. “The submission of our response is a key step towards achieving 510(k) clearance for the Senhance, which we continue to expect in 2017.”

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 also developed 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 our second quarter 2017 results, the Senhance™ Surgical Robotic System and our current regulatory and commercialization plans for this product. 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 the Senhance 510(k) will achieve clearance in 2017, if at all. 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 for the year ended December 31, 2016, which was filed on March 6, 2017, 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
or
(For US) Hannah Dunning, +1-415-618-8750
TransEnterix-SVC@sardverb.com

HSS’ USE OF ROBOTICS IN SURGERY

Posted On September 18, 2017 By OrthoSpineNews In Robotics /

Elizabeth Hofheinz, M.P.H., M.Ed. / 9-18-2017

Todd Albert, M.D. is surgeon-in-chief and medical director and Korein-Wilson Professor of Orthopaedic Surgery at Hospital for Special Surgery (HSS) in New York. Dr. Albert, president-elect of the Scoliosis Research Society (SRS), knows that as a surgeon, it’s good to control what you can control. One way of doing this that incorporates the value of listening to patients is by using a technology they are asking for—robotics.

“A full 1% of all joint replacements in the entire country are performed at HSS,” says Dr. Albert to OTW. “People seek out what is new and if we can give them that in a safe manner, then we are being responsive to our patients. In addition, we have a responsibility to orthopedic surgeons to define what is best. And while I am not saying robotics are necessarily the best option, we have an obligation to invest in them given their proven track record in some procedures.”

“HSS invests in robotics research because our surgeons—who drive innovation—are interested in it and want to take the lead in stellar patient care. Many total joint surgeons do not use robotics, however, if the data show improved results then they will end up adopting robotics.”

At present, HSS has three Stryker Mako machines, which are primarily being utilized in knee and hip surgery. One lucky HSS physician who pioneered the use of these sophisticated machines is Andrew Pearle, M.D. He told OTW, “We do approximately 500 partial knee replacements a year, 85% of which are done using a robot; we perform over 100 total knee surgeries a year using a robot. In all, we do more robotic cases worldwide of any facility.”

READ THE REST HERE

Mazor Robotics Announces Closing of the Third Tranche Equity Investment

Posted On September 15, 2017 By OrthoSpineNews In Financial, Top Stories /

September 15, 2017

CAESAREA, Israel–(BUSINESS WIRE)–Mazor Robotics Ltd. (TASE:MZOR) (NASDAQGM:MZOR), a pioneer and a leader in the field of surgical guidance systems, today announced the closing of the third tranche equity investment by Medtronic pursuant to the executed agreement between the parties, as previously disclosed on August 30, 2017. Mazor issued 1.04 million American Depositary Shares (ADSs) at $38.46 per ADS, which is equal to the weighted average price of the ADSs for the trailing 20-day period ending on and including August 29, 2017, for an aggregate purchase price of $40 million. In addition, Mazor issued to Medtronic warrants to purchase an additional 1.21 million ADSs at an exercise price of $44.23 per ADS, which represents a 15% premium over the per share price for the $40 million equity investment. Medtronic has the right to exercise the warrants immediately in whole or in part, for cash, and they expire after 18 months from the issuance date.

Medtronic’s total investment in Mazor to date totals $72 million.

About Mazor
Mazor Robotics (TASE: MZOR; NASDAQGM: MZOR) believes in healing through innovation by developing and introducing revolutionary technologies and products aimed at redefining the gold standard of quality care. Mazor Robotics Guidance System enables surgeons to conduct spine and brain procedures in an accurate and secure manner. For more information, please visit www.MazorRobotics.com.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other securities laws. Any statements in this release about future expectations, plans or prospects for the Company, including without limitation, statements containing the words “believes,” “anticipates,” “plans,” “expects,” “will” and similar expressions are forward-looking statements. These statements are only predictions based on Mazor’s current expectations and projections about future events. There are important factors that could cause Mazor’s actual results, level of activity, performance or achievements to differ materially from the results, level of activity, performance or achievements expressed or implied by the forward-looking statements. Those factors include, but are not limited to, the impact of general economic conditions, competitive products, product demand and market acceptance risks, reliance on key strategic alliances, fluctuations in operating results, and other factors indicated in Mazor’s filings with the Securities and Exchange Commission (SEC) including those discussed under the heading “Risk Factors” in Mazor’s annual report on Form 20-F filed with the SEC on May 1, 2017 and in subsequent filings with the SEC. For more details, refer to Mazor’s SEC filings. Mazor undertakes no obligation to update forward-looking statements to reflect subsequent occurring events or circumstances, or to changes in our expectations, except as may be required by law.

Contacts

U.S. Contacts:
EVC Group
Michael Polyviou, 212.850.6020
mpolyviou@evcgroup.com
or
Doug Sherk, 646.445.4800
dsherk@evcgroup.com

Globus Medical (GMED) Announces First Case In Orthopedic Trauma

Posted On September 15, 2017 By OrthoSpineNews In Extremities /

9/15/2017

AUDUBON, Pa., Sept. 14, 2017 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal solutions company, today announced it completed its first orthopedic trauma surgical case. Globus Medical’s new ANTHEM™ Distal Radius Fracture System was used by Dr. Asif Ilyas, Hand Surgeon and Trauma Surgeon with The Rothman Institute at Thomas Jefferson University in Philadelphia PA, to successfully treat a distal radius fracture.

The ANTHEM™ Distal Radius Fracture System is a comprehensive fixation system designed to treat a variety of traumatic wrist fractures with anatomically contoured plates for intraoperative versatility. “This is the first orthopedic trauma surgery performed using a plating system designed, manufactured and sold by Globus Medical,” said Barclay Davis, Vice President, Orthopedic Trauma. “We are very proud to continue Globus’ reputation for innovation, speed to market, and listening to our surgeon customers, by bringing this philosophy to the orthopedic trauma market. This introduction is the culmination of a significant effort between Globus Medical’s outstanding product development team and leading orthopedic trauma surgeons. And there are many more to come.”

The innovative ANTHEM™ plate design allows a clear view of the fracture line for improved diagnosis and care. “This plate features a positioning slot and screw that allows multidirectional fine tuning of plate position to provide surgeons maximum flexibility during surgery. I am impressed by how intuitive the tray and system are and how natural the instrumentation feels. The implant was seamless in its placement and fixation,” said Dr. Asif Ilyas. “Trauma is a large, busy, and complex space. That space is ready for a company like Globus to take our current designs and technology and advance them to the next level.”

Globus Medical is planning to introduce its new orthopedic trauma product line at the Orthopaedic Trauma Association’s 33rd Annual Meeting to be held October 11-14, 2017 in Vancouver, Canada.

Indications
The ANTHEM™ Fracture System is indicated for fixation of fractures, osteotomies, arthrodesis and reconstruction of bones for the appropriate size of the device to be used in adult patients, including the clavicle, scapula, humerus, radius, ulna, small bones (metacarpals, metatarsals, phalanges), wrist, pelvis, femur, tibia, fibula, ankle, and foot. Small fragment and distal fibula plates may be used in all pediatric subgroups (except neonates) and small stature adults. Distal radius plates may be used in adolescents (12-21 years of age).

About Globus Medical, Inc.
Globus Medical, Inc. is a leading musculoskeletal solutions company based in Audubon, PA. The company was founded in 2003 by an experienced team of professionals with a shared vision to create products that enable surgeons to promote healing in patients with musculoskeletal disorders.

Safe Harbor Statements
All statements included in this press release other than statements of historical fact are forward-looking statements and may be identified by their use of words such as “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan” and other similar terms. These forward-looking statements are based on our current assumptions, expectations and estimates of future events and trends. Forward-looking statements are only predictions and are subject to many risks, uncertainties and other factors that may affect our businesses and operations and could cause actual results to differ materially from those predicted. These risks and uncertainties include, but are not limited to, factors affecting our quarterly results, our ability to manage our growth, our ability to sustain our profitability, demand for our products, our ability to compete successfully (including without limitation our ability to convince surgeons to use our products and our ability to attract and retain sales and other personnel), our ability to rapidly develop and introduce new products, our ability to develop and execute on successful business strategies, our ability to successfully integrate the international operations acquired from Alphatec, both in general and on our anticipated timeline, our ability to transition Alphatec’s international customers to Globus Medical products, our ability to realize the expected benefits to our results from the Alphatec acquisition, our ability to comply with laws and regulations that are or may become applicable to our businesses, our ability to safeguard our intellectual property, our success in defending legal proceedings brought against us, trends in the medical device industry, general economic conditions, and other risks. For a discussion of these and other risks, uncertainties and other factors that could affect our results, you should refer to the disclosure contained in our most recent annual report on Form 10-K filed with the Securities and Exchange Commission, including the sections labeled “Risk Factors” and “Cautionary Note Concerning Forward-Looking Statements,” and in our Forms 10-Q, Forms 8-K and other filings with the Securities and Exchange Commission. These documents are available at www.sec.gov. Moreover, we operate in an evolving environment. New risk factors and uncertainties emerge from time to time and it is not possible for us to predict all risk factors and uncertainties, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Given these risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements. Forward-looking statements contained in this press release speak only as of the date of this press release. We undertake no obligation to update any forward-looking statements as a result of new information, events or circumstances or other factors arising or coming to our attention after the date hereof.

Contact :
Daniel Scavilla
Senior Vice President, Chief Financial Officer
Phone: (610) 930-1800
Email: investors@globusmedical.com
www.globusmedical.com

VEXIM: Strong First Half 2017 Results, in Line with Expectations

Posted On September 15, 2017 By OrthoSpineNews In Financial /

September 14, 2017

TOULOUSE, France–(BUSINESS WIRE)–Regulatory News:

VEXIM (FR0011072602 – ALVXM / PEA‐PME) (Paris:ALVXM), a medical device company specializing in the minimally-invasive treatment of vertebral fractures, announces its consolidated results for the first half of 2017² in line with guidance³.

“Our sales performance and controlled expenses for the first half of 2017 are in line with our expectations. This trend should be reinforced in the second half of 2017 allowing us to remain confident in reaching profitability for 2017. On the U.S. development, we are excited to announce we will hold an investors meeting at the upcoming 2017 NASS Congress in Orlando where we will share information on our on-going FDA clinical trial comparing SpineJack® to balloon kyphoplasty and also the go-to-market strategy that will support the launch of SpineJack® in the U.S., subject to 510(k) clearance. These various milestones further position our company to become a global leader in the spine-trauma market,” said Vincent Gardès, VEXIM’s CEO.

+21% increase in sales, gross margin of 72.6% and significant net loss reduction

VEXIM’s sales reached €10.4 million in the first half of 2017, up 21% compared to the same period of 2016. This significant revenue growth shows the effectiveness of the direct sales strategy implemented for SpineJack® in Europe, combined with a network of specialized distributors at the international level (see press release on VEXIM’s sales in the first half of 2017⁴).

The gross profit increased 19% compared to the first half of 2016, up to €7.5 million, representing a 72.6% gross margin (as percentage of sales) vs. 73.8% on the same period last year and 72.2% for the full year 2016. Given the implementation of the direct sales strategy, VEXIM maintained a high level of gross margin, in a context of stable prices.

Compared to the 21% increase in revenue, operating expenses decreased 1%, to €9.0 million, compared with the first half of 2016. The effective control of operating expenses resulted in a saving of €1.3 million in the net operating loss, down to €1.5 million. Net loss for the period was €1.6 million.


Consolidated statement as of June 30, 2017

in € millions	First Half 2017	First Half 2016	YoY (%)
Sales	10.4	8.6	21%
Gross profit (gross margin)	7.5 (72.6%)	6.3 (73.8%)	19%
Operating expenses	9.0	9.1	-1%
Net operating income (loss)	-1.5	-2.8	-46%
Net income (loss)	-1.6	-2.8	-43%

Solid cash position at €5.7 million

As of June 30, 2017, VEXIM had €5.7 million in cash, allowing the company to secure its future development. The company’s current cash position and future cash flows should allow VEXIM to continue to grow in-line with its ambitions.

Other business achievements over the first half of 2017

Finalized recruitment of all patients for the FDA study supporting the 510(k) filing for SpineJack® in the U.S.;
Launch of a dedicated and specific product for the German market: Masterflow™ Plus;
Regulatory approval of SpineJack® in Brazil.

Full-year 2017 guidance confirmed

Given the Company’s solid results for the first half of 2017, VEXIM is on track to reach its full-year 2017 objectives:

Maintain strong revenue growth and reach 30% growth over the full year 2017;
Achieve profitability for the full year 2017 and generate operational positive cash-flows;
Further expand internationally through upcoming distribution agreements in Brazil by the end of 2017;
Share information on the on-going 510(k) clinical trial and subsequent go-to-market strategy in the U.S. at the upcoming NASS meeting in Orlando;
Continue innovating in the treatment of high energy vertebral fractures through product development projects, leveraging the SpineJack® platform;
Continue to develop and penetrate the German market;
Regarding the transfer of VEXIM shares to the regulated market of Euronext Paris, which was authorized by the Board of Directors on 21 March 2017, the company is still reviewing all necessary requirements and changes needed to pursue this project. VEXIM aims at completing this review shortly and will complete the transfer by the end of 2017 or beginning of 2018.

Financial reporting schedule:
3^rdquarter sales results: Wednesday, October 25^th, 2017⁵ (after market close)

NASS 2017: Vexim Investor & Analyst Lunch Meeting & Webcast

U.S. FDA clinical trial update and go-to-market strategy

(in English)

Wednesday, October 25^th, 2017 at 12:00 PM ET (Orlando) / 6:00 PM CEST (Paris time)

To join please contact:

For U.S.: The Ruth Group at epoalillo@theruthgroup.com or Tel : +1 646 536 7024

For EU & Intl: Alize RP at vexim@alizerp.com or Tel. : +33 1 44 54 36 66

A replay of the webcast will be available on VEXIM’s website within 48 hours at:

http://www.vexim.com/us/ (U.S. section of the website) > shareholder area

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 long-standing shareholder, Truffle Capital⁶ 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 67 employees, including its own sales teams in Europe and a network of international distributors.

VEXIM has been listed on Euronext Growth since May 2012. For further information, please visit www.vexim.com

SpineJack® ⁷, 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.

Name: VEXIM
ISIN code: FR0011072602
Ticker: ALVXM

Appendixes


Condensed consolidated interim financial statements

In thousands of Euros	Six-month period ended
	June 30, 2016	June 30, 2017

Revenue	8 564	10 365
Cost of sales	(2 246)	(2 843)

Gross profit	6 318	7 522

Selling and marketing expenses	(4 927)	(5 001)
Operational expenses	(1 619)	(1 572)
General and administrative expenses	(2 773)	(2 714)
Other gains / (losses), net	240	284

Operating loss	(2 761)	(1 481)

Finance income / (loss), net	(9)	(53)

Loss before income tax	(2 770)	(1 534)
Income tax expense	(36)	(54)

Loss for the year	(2 806)	(1 588)

Attributable to:
Equity holders of the Company	(2 806)	(1 588)
	–	–

Earnings per share attributable to the equity holders of the Company during the period

Basic earnings per share	(0,37)	(0,21)


Diluted earnings per share	(0,37)	(0,21)


Interim consolidated balance sheet – Assets

In thousands of Euros	December 31, 2016	June 30, 2017

Intangible assets	2 229	3 226
Property and equipment	1 382	1 649
Other receivables	171	226
Deferred tax assets	522	500

Non-current assets	4 304	5 601

Inventories	3 675	4 684
Trade receivables	4 670	5 508
Other receivables	2 255	2 112
Cash and cash equivalents	9 765	5 734

Current assets	20 365	18 038

Total assets	24 669	23 639


Interim consolidated balance sheet – Equity and liabilities

In thousands of Euros	December 31, 2016	June 30, 2017

Ordinary shares	762	764
Share premium	61 109	61 296
Other reserves	1 204	1 724
Retained earnings	(45 383)	(46 970)
Equity attributable to equity holders of the Company	17 693	16 813

Non-controlling interests	–	–

Total equity	17 693	16 813

Repayable advances	427	43
Retirement benefit obligations	111	125
Non-current liabilities	538	168

Repayable advances	314	400
Trade payables	2 365	3 603
Other payables	3 541	2 437
Provisions for other liabilities and charges	218	218
Current liabilities	6 438	6 658

Total liabilities	6 976	6 826

Total equity and liabilities	24 669	23 639


Interim consolidated statement of cash-flow

In thousands of Euros	Six-month period ended
	June 30, 2016	June 30, 2017

Loss for the period	(2 806)	(1 588)
Adjustments for:
Depreciation of tangible assets, amortization of intangible assets	136	162
Impairment of receivables	83	(22)
Impairment of inventories	20	7
Share-based payments	277	496
Change in retirement benefit obligation	27	14
Variation in provisions for risks	167	–
Income tax	35	54

Cash used in operations before changes in working capital	(2 061)	(877)

Changes in working capital
Inventories	(12)	(1 016)
Trade receivables	(693)	(816)
Other receivables	(436)	178
Trade payables	(518)	1 238
Other payables	158	(1 284)
Cash used in changes in working capital	(1 501)	(1 700)


Net cash used in operating activities	(3 562)	(2 577)

Cash flows from investing activities
Purchases of property and equipment	(595)	(356)
Purchases of intangible assets	(443)	(1 070)
Disposal of assets	–	–

Net cash used in investing activities	(1 038)	(1 426)

Cash flows from financing activities
Proceeds from issuance of ordinary shares, net of issuance costs	10 453	189
Direct costs paid related to capital increase	(421)	–
Repayable advance	(210)	(314)
Treasury shares	–	69

Net cash generated by / (used) in financing activities	9 822	(56)

Net increase / (decrease) in cash and cash equivalents	5 222	(4 059)

Cash and cash equivalents at beginning of the period	4 208	9 765
Effect of exchange rate fluctuations	(12)	29

Cash, cash equivalents at end of the period	9 418	5 734

¹ NASS : North American Spine Society : https://www.spine.org/
² The results, which were subject to a limited review, have been approved by the Board of Directors of VEXIM at its meeting held on September 13^th, 2017.
³ Consolidated financial statements presented in Appendix.
⁴ Press release published on July 11^th, 2017: http://us.vexim.com/press/continued-growth-adoption-spinejack-q2-2017/
⁵ indicative date, subject to change.
⁶ 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.
⁷ 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, CEO
José Da Gloria, Chief Financial Officer
Tél. : +33 5 61 48 48 38
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

Month: September 2017

New Chief Financial and Administrative Officer

Contacts

Contacts

Elizabeth Hofheinz, M.P.H., M.Ed. / 9-18-2017

Contacts

Contacts