2017 – Page 24 – Selby Spine

Photo: ConforMIS 3D Printing and Additive Manufacturing Facility; Wilmington, MA

BILLERICA, Mass., Oct. 16, 2017 (GLOBE NEWSWIRE) — ConforMIS, Inc. (NASDAQ:CFMS), a medical technology company that offers joint replacement implants customized to fit each patient’s unique anatomy, today announced that, while the industry has begun to acknowledge the value of customized knee replacement implant systems compared to traditional off-the-shelf implant systems, it has obtained additional positive clinical data regarding the performance of its customized partial knee replacement implants.

A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/38f395f7-6e0c-415c-b971-eafda91979ec

Recently, Sam Onukuri, head of Johnson & Johnson’s 3D Printing Center of Excellence, acknowledged the advantages of customized knee implants and instruments that are developed based on a CT or MRI scan of a patient’s anatomy. In an interview generally discussing the advantages of additive manufacturing published in GE Reports by General Electric (GE) and in an “Employee Spotlight” article published by Johnson & Johnson, Onukuri noted the potential advantages of customized knee implants that may reduce both “pain and the recuperation time” compared to traditional off-the-shelf implant systems that come in a limited range of sizes. “Physicians make every effort to find the implant that fits best,” Onukuri says. “But it’s never a perfect match, and the same is true for the tools. As a result, the surgery takes longer — and so can healing and recovery — and the fit may not be perfect.” On the other hand, Onukuri noted that “customized solutions” based on patient CT or MRI scans “can achieve an exact fit for the joint.”

While the orthopedic industry researches potential customized alternatives to traditional off-the-shelf implant technology, ConforMIS continues to develop a growing body of positive clinical data regarding its existing customized knee implants. Most recently, in a study evaluating knee strength and mechanics that compared healthy control patients to those with either a modern off-the-shelf total knee replacement (TKR) or a customized bi-compartmental knee replacement (BKR), the authors concluded that the “study shows that BKR patients exhibit better strength and mechanics while performing activities of daily living.” According to the study results: the TKR group walked significantly slower when compared to both the BKR group and healthy controls (p < 0.05); the TKR knee had less peak extensor moment at stance than both the BKR and healthy control knees (p < 0.05); and both the BKR and healthy control knees displayed larger internal rotation at stance than that of the TKR knee (p < 0.05). The results of the study, for which ConforMIS provided financial support, were published online by International Orthopaedics on September 4, 2017.

“We are very pleased that the industry is now beginning to recognize the advantages and potentially transformative nature of customized knee implant and instrumentation solutions,” said Mark Augusti, Chief Executive Officer and President of ConforMIS. “ConforMIS has been a champion of customized implant technology for over a decade, and the body of clinical data demonstrating both the clinical and the economic advantages of customized total and partial knee implant systems continues to grow.”

About ConforMIS, Inc.

ConforMIS is a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants that are individually sized and shaped, or customized, to fit each patient’s unique anatomy. ConforMIS offers a broad line of customized knee implants and pre-sterilized, single-use instruments delivered in a single package to the hospital. In recent clinical studies, ConforMIS iTotal CR demonstrated superior clinical outcomes, including better function and greater patient satisfaction, compared to traditional, off-the-shelf implants. ConforMIS owns or exclusively in-licenses approximately 450 issued patents and pending patent applications that cover customized implants and patient-specific instrumentation for all major joints.

For more information, visit www.conformis.com.

Cautionary Statement Regarding Forward-Looking Statements

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

The photo is also available via AP PhotoExpress.

CONTACT:

Beth Best
beth.best@conformis.com
(781) 345-9032

Investor Contact:
Oksana Bradley
ir@conformis.com
(781) 374-5598

October 13, 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 received FDA 510(k) clearance for the Senhance™ Surgical Robotic System.

“The clearance of the Senhance System in the US is a milestone in the progress of robotics and is expected to deliver improvement in the efficacy, value and choices offered to patients, surgeons and hospitals,” said Todd M. Pope, President and Chief Executive Officer of TransEnterix. “Millions of surgical procedures in the US are performed each year laparoscopically with basic manual tools that limit surgeons’ capability, comfort and control. New choices are needed that enhance the senses, control and comfort of the surgeon, minimize the invasiveness of surgery for the patient, and maximize value for the hospital. Senhance is this new choice.”

With this clearance, the Senhance becomes the first new market entrant into the field of abdominal surgical robotics since 2000. Using the system, a surgeon directs small surgical instruments and a camera with precise movements and comfort. The system builds on the foundation of laparoscopy and features the security of haptic feedback and eye-sensing camera control for the first time in a robotic surgery platform. Additionally, the Senhance utilizes an open architecture, which allows hospitals and surgeons to leverage existing technology investments within the operating room ecosystem. The system is specifically engineered to manage operative costs effectively, making robotic surgery cost-effective on a per-procedure basis through the use of fully reusable instruments.

“Surgeons are approaching the boundaries of minimally invasive care performed with handheld manual instruments and cameras, and are seeking new technologies that will allow us to advance beyond these boundaries,” said Dr. Steve Eubanks, a general surgeon and Executive Director of Academic Surgery at Florida Hospital. “The future will be driven by the appropriate use of robotics and information tools in the operating room. The Senhance platform grants laparoscopic surgeons robotic precision, control of our vision, and haptic feedback while minimizing procedural costs, and is a welcome revolution in our field.”

TransEnterix will host a conference call on Tuesday, October 17, 2017 at 8:00 AM ET to discuss the FDA clearance of the Senhance. To listen to the conference call on your telephone, please dial (844) 804-5261 for domestic callers or (612) 979-9885 for international callers, reference conference code 1546349. To access the live audio webcast or archived recording, use the following link http://ir.transenterix.com/events.cfm. The replay will be available on the Company’s website.

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 received FDA 510(k) clearance and has been granted a CE Mark. 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 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 and include whether the Senhance Surgical Robot will deliver improvement in the efficacy, value and choices offered to patients, surgeons and hospitals, whether the Senhance System will maximize value for hospitals and whether the Senhance platform grants laparoscopic surgeons robotic precision, control of surgeon’s vision and haptic feedback while minimizing procedural costs. 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 7, 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:
Mohan Nathan, +1-919-765-8400
media@transenterix.com

October 16, 2017

BEDFORD, Mass.–(BUSINESS WIRE)–Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated orthopedics medicines company specializing in therapeutics based on its proprietary hyaluronic acid (“HA”) technology, today announced that regulatory authorities in Australia granted approval to MONOVISC^®, Anika’s single injection viscosupplement for the treatment of pain associated with osteoarthritis of all synovial joints, including the hip and knee. MONOVISC is commercially available in over twenty countries, including the United States, Canada, and various European countries. MONOVISC also recently received approval in the Asia-Pacific countries of India and Taiwan. Anika intends to further expand MONOVISC into additional international markets in 2018.

“The Asia-Pacific region presents an important growth opportunity for our global orthobiologics franchise, and we’re excited to bring MONOVISC to patients in Australia and New Zealand,” said Charles H. Sherwood, Ph.D., Chief Executive Officer of Anika Therapeutics. “With this approval, MONOVISC is poised to become the most widely available single-injection viscosupplement in the world and will be a key driver in growing global market share.”

The global expansion of MONOVISC is an important international orthobiologics revenue driver for Anika, and Australia and New Zealand represent a large and growing market opportunity. Anika has a multi-year, exclusive distribution agreement with Surgical Specialties Pty. Ltd. to market MONOVISC in Australia and New Zealand. Established in 2006, Surgical Specialties is an independent distributor of innovative medical devices, with a team of over 70 people in sales offices throughout Australia and New Zealand. Surgical Specialties is an ideal partner for Anika with its established relationships with leading orthopaedic surgeons and sports physicians, a successful track record, and a highly skilled and dedicated national sales force.

About MONOVISC

MONOVISC is Anika’s next-generation HA-based therapy for treating osteoarthritis that features enhanced durability in a safe, easy-to-use, single injection regimen. MONOVISC is made from highly purified, non-animal, natural hyaluronan. Hyaluronan occurs naturally throughout the body, especially in articular cartilage, synovial fluid in joints and in the skin. For more information about MONOVISC, please visit www.monovisc.com.

About Anika Therapeutics, Inc.

Anika Therapeutics, Inc. (NASDAQ: ANIK) is a global, integrated orthopedic medicines company based in Bedford, Massachusetts. Anika is committed to improving the lives of patients with degenerative orthopedic diseases and traumatic conditions with clinically meaningful therapies along the continuum of care, from palliative pain management to regenerative cartilage repair. The Company has over two decades of global expertise developing, manufacturing, and commercializing more than 20 products based on its proprietary hyaluronic acid (HA) technology. Anika’s orthopedic medicine portfolio includes ORTHOVISC^®, MONOVISC, and CINGAL^®, which alleviate pain and restore joint function by replenishing depleted HA, and HYALOFAST^®, a solid HA-based scaffold to aid cartilage repair and regeneration. For more information about Anika, please visit www.anikatherapeutics.com.

Forward-Looking Statements

The statements made in the last sentences of the first and second paragraphs and first sentence of the third paragraph of this press release, which are not statements of historical fact, are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include, but are not limited to, those relating to the Company’s international expansion plans for MONOVISC, the market for the Company’s products in foreign countries, including Australia and New Zealand, and the status of MONOVISC as a global revenue driver for the Company. These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks, uncertainties, and other factors. The Company’s actual results could differ materially from any anticipated future results, performance, or achievements described in the forward-looking statements as a result of a number of factors including, but not limited to, (i) the Company’s ability to successfully commence and/or complete clinical trials of its products on a timely basis or at all; (ii) the Company’s ability to obtain pre-clinical or clinical data to support domestic and international pre-market approval applications, 510(k) applications, or new drug applications, or to timely file and receive FDA or other regulatory approvals or clearances of its products; (iii) that such approvals will not be obtained in a timely manner or without the need for additional clinical trials, other testing or regulatory submissions, as applicable; (iv) the Company’s research and product development efforts and their relative success, including whether we have any meaningful sales of any new products resulting from such efforts; (v) the cost effectiveness and efficiency of the Company’s clinical studies, manufacturing operations, and production planning; (vi) the strength of the economies in which the Company operates or will be operating, as well as the political stability of any of those geographic areas; (vii) future determinations by the Company to allocate resources to products and in directions not presently contemplated; (viii) the Company’s ability to successfully commercialize its products, in the U.S. and abroad; (ix) the Company’s ability to provide an adequate and timely supply of its products to its customers; and (x) the Company’s ability to achieve its growth targets. Additional factors and risks are described in the Company’s periodic reports filed with the Securities and Exchange Commission, and they are available on the SEC’s website at www.sec.gov. Forward-looking statements are made based on information available to the Company on the date of this press release, and the Company assumes no obligation to update the information contained in this press release.

Contacts

For Investor Inquiries:
Anika Therapeutics, Inc.
Sylvia Cheung, 781-457-9000
Chief Financial Officer
or
For Media Inquiries:
Pure Communications
Sonal Vasudev, 917-523-1418
sonal@purecommunicationsinc.com

SAN DIEGO, Oct. 16, 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced an expanded U.S. Food and Drug Administration (FDA) 510(k) clearance of the Company’s TLX interbody system, used in the leading spinal fusion surgery. New clearance introduces an expandable 20 degree cage and broader indications for use, including use with allogeneic bone graft and use in additional levels of the spine.

The TLX interbody system is a market-leading solution that is inserted through a conventional transforaminal lumbar interbody fusion (TLIF) approach. NuVasive developed a minimally invasive approach for the TLIF procedure, the MAS® TLIF or Maximum Access Surgery (MAS) TLIF. Designed to be used with a minimally invasive spine surgery approach, TLX implants can be placed seamlessly into the disc space due to their low profile, bulleted design. A proprietary inserter allows the surgeon to insert, expand and rapidly post pack the implant through the same instrument, optimizing surgical efficiency. The TLX interbody system provides restoration of sagittal alignment with customizable degrees of lordosis and was designed to induce lordosis in an anatomical fashion, unique to what is currently on the market.

Prior to the expanded 510(k) clearance, TLX interbodies were available in 15 degree lordotic options and were only indicated for use with allograft. The recent clearance includes a 20 degree expandable interbody, and additional indications for use with allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The new indications also include use in the thoracic spine and at the thoracolumbar junction for treatment of disc degeneration disease or degenerative spondylolisthesis at one or two adjacent levels. Use of the TLX interbody system as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis was also cleared. The TLX system’s size offerings provide multiple options for varying patient size and anatomic considerations.

“With the additional clearance for our latest TLX system, we now provide the leading tools for TLIF procedures with our MAS TLIF solution, validating our commitment to improving spine solutions,” said Matt Link, executive vice president of strategy, technology and corporate development of NuVasive. “This clearance highlights our persistant investment in transforming spine outcomes by developing spine’s leading procedures, materials, expandables, systems and services.”

The TLX interbody system, coupled with the Company’s Integrated Global Alignment® (iGA) suite of software that allows surgeons to calculate, correct and confirm a patient’s pathology, has the ability to improve TLIF procedures overall. The software can calculate alignment parameters with the preoperative planning tools NuvaLine® and NuvaMap® and can intraoperatively correct using real-time intraoperative assessment with NuvaMap O.R. software. Surgeons can then confirm the restoration and preservation of global sagittal alignment postoperatively.

“The procedurally-integrated TLIF platform from NuVasive has allowed me to become much more efficient in my TLIF procedures,” said William Hunter, MD, neurosurgeon at The Spine Clinic at Neuroscience and Spine Center of the Carolinas. “The platform also allows me to confirm restoration of my patients’ lordosis intra-operatively using NuvaMap O.R. These tools have made my procedures more predictable, providing optimal treatment for my patients.”

NuVasive will showcase its market-leading, procedurally-integrated technologies, including the new TLX interbody system in NuVasive Booth #713 at the North American Spine Society Annual Meeting held October 25-28, 2017 in Orlando, Fla.

About NuVasive
NuVasive, Inc. (NASDAQ: NUVA) is transforming spine surgery and beyond with minimally invasive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With $962 million in revenues (2016), NuVasive has an approximate 2,300 person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.

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

SOURCE NuVasive, Inc.

Related Links

http://www.stryker.com

With an estimated market value of $350M, posterior cervical fusion is still an attractive growing market. Common indications for Posterior cervical fixation are pain caused by excessive motion, sagittal balance correction and instability from a traumatic event. Cervical posterior systems are often described as smaller lumbar versions, grossly discounting the often unpredictable challenges of the cervical anatomy.

A comprehensive implant range is your best bet to overcome unforeseen intraoperative struggles. For example, the C7 vertebra is often skipped due to its location, yet a very low profile screw head with extreme angulation can overcome the challenge. Crosslinks fixed to screw heads help avoid spinal cord compression while transition rods and a wide variety of domino connectors allow effortless constructs.

When the Perla® system was designed, focus was placed on creating an extensive implant range, combined with a single compact instrument set. Dr Vittorio Morreale, Henry Ford Hospital (MI), has described Perla® as ‘truly efficient and complete’. In conjunction with surgical power for screw insertion, Perla® has become his system of choice for posterior cervical fixation. “I prefer inserting the screws with the aid of a power tool. I have observed over the years increasing reproducibility, control and precision that I couldn’t quite achieve with manual placing.”

For additional information on Perla, click here.

Discover the advantages of partnering with Spineart

Spineart will be at NASS, booth #316.

SAN ANTONIO, TEXAS (PRWEB) OCTOBER 13, 2017

Zeshan Hyder, DO, of Bone & Joint Specialists in Merrillville, Ind.; Frank K. Kuwamura, III, MD, of Innovative Spine in San Antonio, Texas; and Larry M. Kjeldgaard, DO, of Cervical Spine Specialist in Fort Worth, Texas are the first surgeons to implant medical devices from Nvision Biomedical Technologies with Structural Encoding® technology. The Structural Encoding technology advances patient care by providing permanent marking embedded within the device that is accessible through an x-ray image.

“We are always looking for the best technologies available to improve the results for our patients and get them back to their productive and pain-free activity as quickly as possible. Having a clear knowledge of their history helps us create the best plan of care. Structural encoding provides transparency for surgeons and patients that creates a new level of knowledge from patient research to implant integrity, all of which equals better patient care,” said Dr. Hyder.

Dr. Kuwamura agrees, “As surgeons, we take care to understand our patients’ lifestyles and activity level. The more knowledge we have, the better decisions we can make for their care. Patients move, physicians retire, and when we see patients that have had previous procedures with other surgeons, it can be almost impossible to get their records. We spend significant time trying to track that information down, but sometimes we don’t know what has previously been implanted until we are in surgery. Structural Encoding changes all of that. We now have a way to know everything about a device and previous surgeries simply by taking an x-ray.”

Structural Encoding, a patented technology platform developed by Watershed Idea Foundry, is the industry’s most innovative solution for medical device identification with permanent direct part marking. Manufacturers can license the technology for use in their medical devices to meet the U.S. Food and Drug Administration’s (FDA) regulation around permanent marking of the device itself, called Unique Device Identification (UDI). Nvision Biomedical Technologies, a San Antonio-based medical device and biologics manufacturer, is the first company to launch devices with the Structural Encoding technology.

“We work with our patients to determine the best outcomes for getting them back to their quality of life and sometimes that means surgery,” said Dr. Kjeldgaard. “If we do determine surgery is the best course of action, the knowledge we have and the more information we can provide our patients, the better. Structural Encoding gives us an advantage in patient care and gives the patient peace of mind for a lifetime.”

Nvision initially launched three devices in the nv line with Structural Encoding. nv(c)® is an anterior cervical interbody fusion system; nv(p)® is a posterior lumbar interbody fusion system; and nv(a)® is an anterior lumbar interbody fusion system. The initial surgeries were anterior cervical discectomy with fusion at one and two levels, with a structurally encoded nv(c) PEEK interbody implant.

“The entire medical device industry is looking to provide UDI compliant devices, but none are as seamless or as user-friendly as those with Structural Encoding,” said Dr. Hyder. “Structural Encoding is self-contained and doesn’t cause any extra steps or paperwork for the surgeon or the hospital, and that alone is good for our patients.”

About Nvision Biomedical Technologies
Nvision is a San Antonio-based medical device and biologics manufacturing company focused on providing surgeons implants that are paired with instrumentation and biologics to simplify and improve surgery procedures that help patients get back to their quality of life.

Nvision is committed to developing and manufacturing thoughtfully designed products combined with exceptional service that keep the patients, surgeons, healthcare providers and distribution partners in mind. Nvision is aligned with surgeon thought leaders, key researchers, and development engineers from prestigious institutions to design, test, and bring to market the most innovative concepts.

About Dr. Zeshan Hyder
Dr. Zeshan Hyder is partner with Bone & Joint Specialists in Merrillville, Ind. He is a board-certified orthopedic surgeon, who has been voted Best of the Region for Spine Care by The Times for three straight years.

He graduated Cum Laude from the University of Illinois and throughout his medical education has published articles on various subjects related to arthroplasty and spinal surgery. During his fellowship and residency programs he gained valuable expertise in sports medicine, orthopedics and trauma as well as conservative and surgical management of all orthopedic spinal disorders.

About Dr. Frank Kuwamura
Dr. Frank K. Kuwamura, the founder and chief surgeon at Innovative Spine in San Antonio, Texas, is a board-certified orthopedic surgeon who specializes in emerging technology for spinal care.

A graduate of Boston University Medical School, Kuwamura completed his internship in general surgery and residency in orthopedic surgery at the National Naval Medical Center in Bethesda, Maryland where he earned the rank of Commander in the 3rd Marine Division. He is a member of the American Academy of Orthopedic Surgeons and the Bexar County Medical Society. He has held the title of Diplomat of the National Board of Medical Examiners and served on the American Board of Orthopedic Surgeons, Board Certification.

About Dr. Larry Kjeldgaard
Dr. Larry M. Kjeldgaard, founder and owner of Cervical Spine Center in Fort Worth and Hurst, Texas is a board-certified orthopedic surgeon who specializes in the treatment of the spine, neck and back.

A graduate from the Philadelphia College of Osteopathic Medicine, Dr. Kjeldgaard completed his residency at the Community General Osteopathic Hospital in Harrisburg, PA, and his orthopedic surgery residency training in Pontiac, Michigan. He’s a member of American Osteopathic Board of Orthopedic Surgeons, American Medical Association, the American Osteopathic Academy of Orthopedics and Texas Osteopathic Medical Association.

Dublin, Ireland – 11 October 2017 –Today, DePuy Synthes, part of the Johnson & Johnson Family of Companies, unveiled the VIPER PRIME™ System, an innovative Minimally Invasive Surgery (MIS) pedicle screw designed to simplify MIS spinal fusion surgery. VIPER PRIME reduces the number of instruments needed, the number of instrument passes and the number of steps required to insert a percutaneous screw utilizing a minimally invasive technique. The product was shown for the first time during this week’s EUROSPINE 2017 congress taking place in Dublin, Ireland.

Minimally invasive spinal fusion surgery is gaining popularity thanks to evidence that it may help improve outcomes when performing surgery through a smaller skin incision, which leads to less trauma to surrounding soft tissue, reduced blood loss during operation, and potentially a faster recovery for patients^(3,4). However, as MIS fusion becomes more common, there is a need to simplify these procedures and overcome clinical challenges associated with the current technology.

By combining all the pedicle preparation instruments into one single tool, the VIPER PRIME System eliminates the need for guidewires, Jamshidi needles and additional pedicle preparation instruments. In one bench study, the VIPER PRIME System demonstrated a 33 percent reduction in the time required to insert a pedicle screw compared to traditional MIS techniques⁽²⁾.

“I find the VIPER PRIME System easy and straightforward and I look forward to using it again for my future spinal fusion cases,” said Dr Kavakebi, an early user of the system from University Hospital Innsbruck, Austria.

Dr. Bordon from Hospital Manises, Valencia, Spain, who conducted the first surgery with the system in Europe concludes, “My OR team were very positive about the ease of assembly and the low footprint of the new system, that led to a more organized operating room.”

The VIPER PRIME System requires only two instrument trays, which may result in a more organized back table with fewer instruments, enhancing surgical workflow. The streamlined instrument set means a smaller procedural footprint that can also help reduce waste and processing costs.

“As a leader in pedicle screw technology, we have a responsibility to continue to innovate ways to make spinal fusion surgery less invasive for patients and less complicated for surgeons,” said Nadav Tomer, Global Platform Leader, DePuy Synthes Spine.

“The VIPER^® System has more than ten years of clinical heritage and this introduction of VIPER PRIME is our latest example of how we are providing differentiated technologies that simplify spine surgery, making it more reproducible for every surgeon while improving patient outcomes,” concluded Jordy Winters, DePuy Synthes Spine EMEA Lead.

About DePuy Synthes Companies
DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopaedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com .

Notes to editors
The VIPER PRIME System is currently being introduced to health care professionals in the Europe, Middle East and Africa (EMEA) region during educational and industry events. Full EMEA commercial availability of this tool is expected in early 2018.

The third-party trademarks used herein are the trademarks of their respective owners.

Registered Office: Johnson & Johnson Medical Limited, PO BOX 1988, Simpson Parkway, Livingston, West Lothian, EH54 0AB, United Kingdom. Incorporated and registered in Scotland under company number SC132162

References

VIPER PRIME^TM System Overview – DSEM/SPN/0617/0698
Internal data on file: ADAPTIV test report 103327910. Note: Bench tests results may not necessarily be indicative of clinical performance.
Jhala, Amit, et al. Minimally invasive transforaminal lumbar interbody fusion. Indian Journal of Orthopaedics 48(6) (2014 Nov-Dec); 562-567
Peng, Chan Weam Benedict, et al. Clinical and Radiological Outcomes of Minimally Invasive Versus Open Transforaminal Lumbar Interbody Fusion. SPINE Vol. 34, Number 13 (2009); 1385-1389.

DSEM/SPN/1017/0761

October 12, 2017

LYON, France & NEW YORK–(BUSINESS WIRE)–The Medicrea Group (Euronext Growth Paris: FR0004178572 – ALMED), pioneering the convergence of healthcare IT and next-generation, outcome-centered device design and manufacturing with UNiD™ ASI technology, publishes its sales for the 3^rd quarter ended September 30, 2017.


€ millions	2016	2017	Change
Q3	6.8	6.4	-5%
9 months to September 30	21.6	21.1	-2%

Changes in foreign exchange rates had no material impact on sales for the period

Sales totaled €6.4 million over the 3^rd quarter, down 5% compared to the same period of 2016, adversely affected since the start of the fiscal year by the complete lack of commercial activity in Brazil (the leading export market up to that point, excluding the distribution subsidiaries) since the beginning of the year.

The regulatory certifications required to deliver the Medicrea implants, now fully manufactured in the new ultra-modern Lyon facilities, to the Brazilian market have been definitively obtained since the ANVISA audit, which confirmed the compliance of the equipment and soundness of the Company’s quality system. This inability to deliver to the Brazilian market since the beginning of 2017 will generate a sales shortfall of almost €2 million over the full year 2017. Sales in Brazil will return to a normative level in 2018. In the United States, the momentum for adoption of UNiD™ ASI technology continues with the implantation of patient-specific UNiD™ Rods posting growth in excess of 42% over the 9 months to September 30, 2017 compared to the same period of 2016.

“Our development model is transforming, with the gradual integration of a unique and comprehensive digital healthcare platform that no other traditional spinal implant manufacturer is able to offer today. In the United States, this transformation was accompanied by organizational changes and a necessary adaptation of the sales force, more accustomed to selling surgical implants than offering sophisticated planning services and personalized solutions with high added value for each patient and adapted to the technique of each surgeon. The overall growth of our activity in this priority market is temporarily affected by these changes, but I am confident that with the two major recruitments we have just achieved, which we will be announcing in the near future, and especially with the very promising clinical results recently released with the publication of our White Paper on rod fracture rates, the use of our UNID™ ASI technology by surgeons and hospitals should accelerate significantly,” stated Denys Sournac, President and CEO of Medicrea.

Next publication: 2017 Annual Sales on January 11, 2018 after market.

About Medicrea (www.Medicrea.com)

Through the lens of predictive medicine, Medicrea leads the design, integrated manufacture, and distribution of 30+ FDA approved spinal implant technologies that have been utilized in over 150,000 spinal surgeries to date. By leveraging its proprietary software analysis tools with big data and machine learning technologies and supported by an expansive collection of clinical and scientific data, Medicrea is well-placed to streamline the efficiency of spinal care, reduce procedural complications and limit time spent in the operating room.

Operating in a $10 billion marketplace, Medicrea is a Small and Medium sized Enterprise (SME) with 175 employees worldwide, which includes 50 who are based in the U.S. The Company has an ultra-modern manufacturing facility in Lyon, France housing the development and production of patient-specific implants 3D-printed from powdered Titanium.

For further information, please visit: Medicrea.com.

Connect with Medicrea:
FACEBOOK | INSTAGRAM | TWITTER | WEBSITE | YOUTUBE

Medicrea is listed on
EURONEXT Growth Paris
ISIN: FR 0004178572
Ticker: ALMED
LEI: 969500BR1CPTYMTJBA37

Contacts

Medicrea
Denys Sournac
Founder, Chairman and CEO
dsournac@Medicrea.com
or
Fabrice Kilfiger, +33 (0)4 72 01 87 87
Chief Financial Officer
fkilfiger@Medicrea.com

October 13, 2017

CAESAREA, Israel–(BUSINESS WIRE)–Mazor Robotics Ltd. (TASE: MZOR; NASDAQGM: MZOR), a pioneer and a leader in the field of surgical robotic guidance systems, announced the appointment of Ron A. Tavlin as Vice President, Business Development. In this newly created role, Mr. Tavlin will report directly to Ori Hadomi, Mazor’s Chief Executive Officer.

“Last year, we began an effort to expand the use of Mazor’s core proprietary technology beyond our current indications to further develop our business with the focus on continued growth and innovation. This effort has progressed to the point where a proven business development leader will move our initiatives forward and maximize our opportunities to heal through innovation. Ron Tavlin brings to Mazor an impressive business development track record. He will lead the implementation of our strategies to develop Mazor’s business beyond our current spine focus as we pursue our goal of being the leader in image based medical robotics,” commented Mr. Hadomi.

Mr. Tavlin has more than 25 years of experience with public and private companies. Prior to joining Mazor, he was a consultant supporting the Medtronic Ventures and Corporate Development teams, with an emphasis on supporting the business development activities in Europe, Middle East and Africa (EMEA) and AsiaPacific (APAC). Prior to Medtronic, he was the Chief Operating Officer of BlueWind Medical, and the Co-founder and Managing Partner of Omega Capital, a private equity fund focused on early stage, middle market, and turnaround opportunities, including medical devices. Mr. Tavlin received a Bachelor of Science in Electrical Engineering from the City University of New York, and a Masters of Business Administration degree from Stern School of Business New York University.

About Mazor

Mazor Robotics (TASE: MZOR; NASDAQGM: MZOR) believes in healing through innovation by developing and introducing revolutionary robotic technologies and products aimed at redefining the gold standard of quality care. Mazor Robotics Guidance Systems enable surgeons to conduct spine and brain procedures in a precise manner. For more information, please visit http://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 regarding the benefits of Mr. Tavlin’s appointment, and other 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

EVC Group
Investors
Michael Polyviou, 212-850-6020
mpolyviou@evcgroup.com
or
Doug Sherk, 646-445-4800
dsherk@evcgroup.com

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1.	Table 54: Primary TKA Implant Market. US Markets for Large-Joint Reconstructive Implants 2013. Millennium Research Group. March 2013. Pg. 84