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Current Issues in Spine

February 2-4, 2017

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December 13, 2018 OrthoSpineNews

OVERLAND PARK, Kan.Dec 13, 2018 /PRNewswire/ — Overland Park Surgical Suites is a state of the art outpatient surgical center and is the first outpatient surgery center in the Midwest to offer patients a robotics-assisted alternative to traditional knee replacement surgery.

“We were eager to bring the NAVIO robotics-assisted surgery to the area,” said Scott Abraham, M.D., Orthopedic Surgeon and founder of Overland Park Surgical Suites, LLC. “This exacting technique is the preferred approach for most patients and we’ve seen dramatic surgical outcomes.”

The NAVIO Surgical System starts with an advanced computer system that gathers precise anatomic and alignment information about a damaged knee that a surgeon uses to create a specific surgical plan, according to Dr. Abraham.

“This extra layer of data collection is designed to ensure the knee procedure is performed as accurately as possible for the best long-term outcome,” he said.

Abraham has already performed more than 100 robotic-assisted partial and total knee replacements at Overland Park Surgical Suites and St. Joseph Medical Center, and draws patients to his practice from throughout KansasMissouri and Iowa. He said the NAVIO System is particularly well suited for active adults in their 40s and 50s who have developed knee problems, but have opted to put off surgery as a remedy.

“Knee replacement surgery has a controversial reputation,” Abraham added.

Unfortunately, this leads many patients to delay medical intervention because of concerns about invasive surgery, painful rehab and significant downtime. The NAVIO System helps offset these concerns with the improved accuracy and the potential for faster recovery, leading to the goal of improved surgical outcomes and increased patient satisfaction.

The first knee implant procedure was performed 50 years ago in 1968, according to the American Academy of Orthopaedic Surgeons. Now, more than 600,000 knee replacement surgeries are performed each year, making it one of the most in-demand surgical specialties in the country. Yet often, patients are dissatisfied with the outcome.

Not so for Beth Archer of Leawood, who in October was the first person in the state of Kansas to undergo a partial knee replacement using robotic surgical assistance at Overland Park Surgical Suites.

“I’d been living with knee pain for four years,” Archer said. “The quality of my life dramatically improved with my partial knee replacement done with the NAVIO Surgical System. I returned home immediately and was self-sufficient, had little pain and within a week I was walking without a cane or walker. I highly recommend this robotic surgery.”

Abraham added that the NAVIO benefits are many, yet robotic surgical-assist is still in its infancy.

“We’re proud that Overland Park Surgical Suites is the first outpatient surgery center in the region to offer this state of the art NAVIO knee replacement procedure,” Abraham said. “But we won’t be the last. In fact, we think this is the future of the surgical field. It puts the power of robotics in the skilled hand of the surgeon. And that means a better outcome for all our patients.”

For more information or to schedule a NAVIO consultation with Dr. Abraham, call APEX ORTHOPEDICS and Sports Medicine at 913-642-0200.

NOTE: Not all patients are candidates for surgery using the NAVIO Surgical System. Discuss your condition and implant options with your surgeon. Individual results of joint replacement vary. Implants may not produce the same feel or function as your original knee. There are potential risks with knee replacement surgery such as loosening, fracture, dislocation, wear and infection that may result in the need for additional surgery. NAVIO is not for everyone. Children, pregnant women, patients who have mental or neuromuscular disorders that do not allow control of the knee joint, and morbidly obese patients should not undergo a NAVIO procedure.

(www.OverlandParkSS.com
Overland Park Surgical Suites is a state-of-the-art, orthopedic outpatient surgical center in Overland Park, KS. It was established by clinical personnel to offer safe, high quality surgical care. It is one of the first surgery centers in the Kansas City area to perform outpatient total joint replacements and is licensed by the State of Kansas and accredited by The Joint Commission.

About Smith & Nephew: 
(www.RediscoverYourGo.com
Smith & Nephew is a global medical technology business dedicated to helping healthcare professionals improve people’s lives. With leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma & Extremities, Smith & Nephew has around 15,000 employees and a presence in more than 100 countries. Annual sales in 2017 were more than $4.8 billion. Smith & Nephew is a member of the FTSE100.

TM is a Trademark of Smith & Nephew

Contact:      

Betsy Donnelly

Phone:         

913 208 5400

Email:           

Betsy@TrailheadMarketingTeam.com

SOURCE Overland Park Surgical Suites

Related Links

http://www.overlandparkss.com


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December 12, 2018 OrthoSpineNews

Reston, Virginia, Dec. 12, 2018 (GLOBE NEWSWIRE) — The Virginia Institute of Robotic Surgery at Reston Hospital Center has acquired a second Mazor X System for their rapidly growing spine program, making it the first in the nation to have two of these robotic systems at one hospital location.

The Reston Hospital Center (RHC) Spine Team is comprised of nationally-recognized spine surgeons who excel in implementing the latest in surgical advancements for spinal procedures. One of the first in the country to acquire and use Mazor Technology in 2012, RHC, in collaboration with its surgeons, has been a pioneer in using advanced technology and procedures in the operating room.  In 2016, the facility was the first in the Mid-Atlantic to acquire and perform a procedure using the latest Mazor X platform. More than 1,500 spine surgeries are performed annually at RHC, with over 600 of these procedures utilizing the advanced technology of the Mazor X system, offering patients an advanced, minimally invasive surgical option for the spine.

“Providing our surgeons with the technology and resources they need to keep our surgical program at the forefront of innovation means that our patients receive the most advanced care in the safest environment,” said John Deardorff, CEO of Reston Hospital Center and President of HCA’s Northern Virginia Market. “As a leader in spine surgery we are committed to delivering exceptional care and the best possible outcomes for our patients.”

Reston Hospital Center is one of only eight Visiting Clinician Programs (VCP) in the United States where surgeons from around the world come to train on the latest in Mazor technology.  The VCP gives surgeons the opportunity to learn about the latest in robotic-assisted spine surgery capabilities from the proctoring surgeon, Dr. Christopher Good of the Virginia Spine Institute. In addition to the surgical training, surgeons also learn how a comprehensive robotic surgical program runs from an operational and administrative perspective.

About Reston Hospital Center

Part of HCA Virginia Health System, Reston Hospital Center is a 197-bed, acute-care medical and surgical facility that has garnered high honors for attentive patient care and nursing excellence.  Reston Hospital Center is home to the region’s newest Level II Trauma Center and the most comprehensive robotic surgery in the Mid-Atlantic. Statewide, HCA Virginia Health System operates 14 hospitals and more than 30 outpatient centers and is affiliated with 3,000 physicians. It is Virginia’s fourthlargest private employer, provides $190.8 million in charity and uncompensated care, and pays $72.6 million in taxes annually. For more information about Reston Hospital Center visit www.restonhospital.com

Erin Echelmeyer
Reston Hospital Center
703-689-9030
Erin.Echelmeyer@hcahealthcare.com

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December 7, 2018 OrthoSpineNews

AUDUBON, Pa., Dec. 06, 2018 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal solutions company, recently announced the entrance of ExcelsiusGPS®, a revolutionary robotic guidance and navigation system, to the international market with system installations completed in several European countries. This past October, the first European Excelsius GPS® procedure was performed at the Metropolitan Hospital in Neo Faliro, Athens, Greece by Mr. Panagiotis E. Zoumpoulis. Since then, numerous open and minimally invasive spine procedures have been performed at Bonifatius Hospital in Germany and at the Fornaca Clinic in Italy.

“Surgeons and hospital administrators in the United States have shown tremendous levels of interest in ExcelsiusGPS® since it first launched domestically at the end of 2017,” said Dave Demski, Chief Executive Officer at Globus Medical. “Users have realized the system’s ability to help advance patient care and provide tangible benefits for surgeons and their staff. As we begin to scale our efforts abroad, we have seen similar levels of enthusiasm within the international surgeon community and look forward to the continued adoption of ExcelsiusGPS® into these markets.”

Italy’s first surgeries were performed by Prof. Franco Benech, and Dr. Carlo Alberto Benech, from Benech Neurosurgery and Spine Specialists in Turin, Italy at the Fornaca Clinic. “With the addition of ExcelsiusGPS® we now offer patients seeking spine surgery a level of accuracy that was not possible without this technology,” said Prof. Benech. “Our team is committed to providing the highest level of care to our patients by offering the latest advancements in robotic-assisted spine surgery at our facilities.”

Professor Peter Douglas Klassen with Bonifatius Hospital in Lingen, Germany echoes a similar sentiment, commenting, “ExcelsiusGPS® is truly a revolutionary technology designed to improve surgeon wellness and patient care. We are excited about the potential impact that robotic guidance and navigation may have in improving screw placement accuracy, MIS efficiency, and reducing radiation exposure.”

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. Additional information can be accessed at http://www.globusmedical.com.

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 comply with changing laws and regulations that are 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 its 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:
Brian Kearns
Vice President, Business Development and Investor Relations
Phone: (610) 930-1800
Email:  investors@globusmedical.com
www.globusmedical.com


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December 3, 2018 OrthoSpineNews

CENTER VALLEY, Pa.Dec. 3, 2018 /PRNewswire/ — Olympus, a global technology leader in designing and delivering innovative solutions for medical and surgical procedures, among other core businesses, announced today that it has been recognized with the Surgical Products’ 2018 Excellence in Surgical Products (ESP) Award, distinguishing ENDOEYE FLEX 3D and FlexDex® (3D/FlexDex) as the winner in the OR Equipment and Accessories category. This is the fifth time Olympus has been named an ESP award winner.

Olympus’ 3D imaging combined with FlexDex technology simplifies suturing in difficult-to-reach areas by precisely translating the surgeon’s hand, wrist and arm movements from outside the patient into corresponding movements of an end-effector inside the patient’s body. With a chip-on-tip and dual lens design, the ENDOEYE FLEX 3D video laparoscope restores natural 3D vision and depth perception during laparoscopic procedures and mimics what the human eye would see in open surgery. The 3D/FlexDex platform offers an alternative to high-cost robotics in minimal access surgery by providing the visualization and wristed instrumentation for suturing found in robotic technology, but at a fraction of the cost. Importantly, this technology can be used in any OR, at any time, on a laparoscopic platform already familiar to surgeons.

“Olympus is honored to receive this recognition from Surgical Products,” said Randy Clark, President of the Medical Systems Group at Olympus. “The Olympus 3D/FlexDex solution is an exciting addition to our portfolio. It provides both the patient and surgeon with more options compared to the alternative costs and limitations associated with robotic surgery. This allows us to stay true to our mission to drive increased quality of care, cost reductions and patient satisfaction.”

ESP Award winners are determined by magazine readers, commonly surgeons who have had hands-on experience or first-hand demonstration of the innovations being nominated. Readers voted for the companies and products they felt were most deserving by selecting those that contributed most to surgical performance, efficiency and safety.

Other Olympus products previously recognized as ESP award winners include:

  • 2017: PK AIM
  • 2016: VISERA 4K Ultra High Definition (UHD)
  • 2013: HD 3D Video Laparoscope
  • 2012: THUNDERBEAT

The Olympus 3D/FlexDex solution is showcased in the November/December issue of Surgical Products magazine as well as in the magazine eDaily newsletter.

About Surgical Products Magazine

Surgical Products is a publication for surgeons, anesthesiologists and department heads in charge of operating/emergency rooms, ICU/CCUs, infection control, OR materials management and other areas. Surgical Products has been published for 35 years, has a circulation of 55,000 and is published 10 times a year.

About Olympus Medical Systems Group

Olympus is a global technology leader, crafting innovative optical and digital solutions in medical technologies; life sciences; industrial solutions; and cameras and audio products. Throughout our nearly 100-year history, Olympus has focused on being true to society and making people’s lives healthier, safer and more fulfilling.

Our Medical Business works with health care professionals to combine our innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing with their skills to deliver diagnostic, therapeutic and minimally invasive procedures to improve clinical outcomes, reduce overall costs and enhance quality of life for patients. For more information, visit medical.olympusamerica.com.

About FlexDex

FlexDex is an innovative medical device company that has developed a platform technology to provide surgeons with high performance and cost effective minimally invasive surgical instruments. The Company’s focus is to enable advanced minimally invasive procedures with greater precision and efficiency bringing the benefits of minimally invasive surgery to patients throughout the world. FlexDex was developed at the University of Michigan by co-founders Shorya Awtar, Sc.D., James Geiger, MD and Greg Bowles. This platform technology enables highly intuitive, one-to-one mapping of the surgeon’s arm and hand motions to the articulating instrument inside the patient’s body. The patented “Virtual Center™” of the FlexDex platform is a simple mechanical design that, we believe, will greatly enhance the capabilities of all Minimally Invasive Surgical (MIS) instruments. The FlexDex Needle Driver, the first instrument of the FlexDex platform, has been granted the CE mark and is available for sale in the United States and internationally. For more information visit https://flexdex.com

SOURCE Olympus Medical Systems Group

Related Links

http://medical.olympusamerica.com


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October 18, 2018 OrthoSpineNews

October 18, 2018

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–TransEnterix, Inc. (NYSE American:TRXC), a medical device company that is digitizing the interface between surgeons and patients to improve minimally invasive surgery, congratulates its President and Chief Executive Officer, Todd M. Pope, for being named to TIME Magazine’s 50 Most Influential People in Health Care for 2018. In this inaugural list, Pope is highlighted for his role as one of those leaders whose work right now is transforming health care.

“Being named one of TIME Magazine’s 50 Most Influential People in Health Care for 2018 is a tremendous honor,” said Todd M. Pope, TransEnterix president and CEO. “It’s humbling to be recognized alongside other talented, boundary-pushing individuals across the spectrum of health care. This recognition reflects the efforts of our global team at TransEnterix who work every day to deliver innovative solutions that help surgeons achieve better outcomes for their patients.”

As Chief Executive Officer, Mr. Pope sets the company’s strategic vision and oversees its continuing growth. Mr. Pope has spent more than 25 years working in key leadership positions within the medical-device industry. Prior to joining TransEnterix, Mr. Pope served as worldwide president of Cordis, a multi-billion-dollar division within Johnson & Johnson’s medical-device sector. He previously held a number of senior leadership positions within Johnson & Johnson and Boston Scientific.

About TransEnterix

TransEnterix is a medical device company that is digitizing the interface between the surgeon and the patient to improve minimally invasive surgery by addressing the clinical and economic challenges associated with current laparoscopic and robotic options in today’s value-based healthcare environment. The Company is focused on the commercialization of the Senhance Surgical System, which digitizes laparoscopic minimally invasive surgery. The system allows for robotic precision, haptic feedback, surgeon camera control via eye sensing and improved ergonomics while offering responsible economics. The Senhance Surgical System is available for sale in the US, the EU and select other countries. For more information, visit www.transenterix.com.

Forward-Looking Statements

This press release includes statements relating to the Senhance Surgical 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 delivery of TransEnterix’s innovative solutions help surgeons achieve better outcomes for their patients. 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 8, 2018, 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

TransEnterix, Inc.
Investor Contact:
Mark Klausner, 443-213-0501
transenterix@westwicke.com
or
Media Contact:
Joanna Rice, 951-751-1858
joanna@greymattermarketing.com


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October 16, 2018 OrthoSpineNews

October 16, 2018

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–TransEnterix, Inc. (NYSE American: TRXC), a medical device company that is digitizing the interface between surgeons and patients to improve minimally invasive surgery, today announced demonstrations of its Senhance™ Surgical System at the American College of Surgeons (ACS) Clinical Congress 2018 at the Boston Convention & Visitors Center in Boston, MA, October 21 – 25.

Surgeons, Hospital Administrators and related staff are invited to experience Senhance Surgery during the Company’s daily demonstrations located at the TransEnterix booth #577, from Monday, October 22 – Wednesday, October 24 from 10:30 a.m. – 11:30 a.m. ET. Participants will witness how digital laparoscopy is redefining minimally invasive surgery through meaningful technology, designed to compete in today’s value-based healthcare landscape. To schedule a demonstration in advance, visit transenterix.com/events.

“Digital laparoscopy with the Senhance System provides a digitized interface between the surgeon and patient, giving surgeons improved control, comfort, clinical intelligence and confidence when performing a wide variety of procedures with the goal of delivering superior value to more patients,” said TransEnterix Chief Commercial Officer, Eric Smith. “We look forward to attending ACS and demonstrating how digital laparoscopy with the Senhance is ushering in a new era of minimally invasive surgery.”

The Senhance Surgical System received U.S. FDA clearance in October 2017 and represents the first robotic surgery platform to enter the U.S. market since 2000. It is the only digital laparoscopic platform available that offers reusable instruments to help keep costs down, as well as haptic feedback, which allows surgeons to experience and sense pressure/tension with alerts if pressure threshold is reached – an added layer of security. The System combines much-needed technological advances with economic advantages and represents a fundamental change in the approach to minimally invasive surgery.

About TransEnterix

TransEnterix is a medical device company that is digitizing the interface between the surgeon and the patient to improve minimally invasive surgery by addressing the clinical and economic challenges associated with current laparoscopic and robotic options in today’s value-based healthcare environment. The Company is focused on the commercialization of the Senhance Surgical System, which digitizes laparoscopic minimally invasive surgery. The system allows for robotic precision, haptic feedback, surgeon camera control via eye sensing and improved ergonomics while offering responsible economics. The Senhance Surgical System is available for sale in the US, the EU and select other countries. For more information, visit www.transenterix.com.

Forward Looking Statements

This press release includes statements relating to the Senhance Surgical 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 System will usher in a new era of minimally invasive surgery. 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 8, 2018, 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

TransEnterix, Inc.
Investor Contact:
Mark Klausner, 443-213-0501
transenterix@westwicke.com
or
Media Contact:
Joanna Rice, 951-751-1858
joanna@greymattermarketing.com


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October 11, 2018 OrthoSpineNews

October 11, 2018

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–TransEnterix, Inc. (NYSE American:TRXC), a medical device company that is digitizing the interface between the surgeon and the patient to improve minimally invasive surgery, today announced that the Company received FDA 510(k) clearance for 3 millimeter diameter instruments, as well as additional 5 millimeter Senhance System instruments.

The clearance of the 3 millimeter diameter instruments will allow the Senhance to be used for microlaparoscopic surgeries, enabling surgeons to operate through tiny incisions considered virtually scarless for patients.

“The ability to perform microlaparoscopic procedures using 3 millimeter instruments represents an unparalleled shift in the world of robotic surgery and a capability exclusive to the Senhance system,” said Todd M. Pope, TransEnterix CEO. “The addition of 3 millimeter instruments will allow many high volume surgeries to be performed with smaller incisions, which supports our mission of advancing minimally invasive surgical capabilities within digital laparoscopy.

“Utilizing 3 millimeter micro instruments on a robotic system represents a new advancement in reducing the invasiveness of many surgeries,” said Dr. Steven D. McCarus, MD, FACOG, Chief of Gynecologic Surgery at Florida Hospital Celebration Health. “Patients find such small incisions to be virtually scarless and cosmetically desirable. Surgeons may find that using such tiny instruments with the precision and control of a digital interface makes microlaparoscopy a preferred option to treat more conditions.”

About TransEnterix

TransEnterix is a medical device company that is digitizing the interface between the surgeon and the patient to improve minimally invasive surgery by addressing the clinical and economic challenges associated with current laparoscopic and robotic options in today’s value-based healthcare environment. The Company is focused on the commercialization of the Senhance™ Surgical System, which digitizes laparoscopic minimally invasive surgery. The system allows for robotic precision, haptic feedback, surgeon camera control via eye sensing and improved ergonomics while offering responsible economics. The Senhance Surgical System is available for sale in the US, the EU and select other countries. For more information, visit www.transenterix.com.

Forward Looking Statements

This press release includes statements relating to the Senhance Surgical System and related instruments 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 ability to perform microlaparoscopic procedures using 3 millimeter instruments represents an unparalleled shift in the world of robotic surgery; whether the addition of 3 millimeter instruments will allow many high volume surgeries to be performed with smaller incisions and whether surgeons may find that using tiny instruments with the precision and control of a digital interface makes microlaparoscopy a preferred option to treat more conditions. 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 8, 2018, 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

TransEnterix, Inc.
Investor Relations:
Mark Klausner, 443-213-0501
transenterix@westwicke.com
or
Media Relations:
Joanna Rice, 951-751-1858
joanna@greymattermarketing.com


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October 3, 2018 OrthoSpineNews

RAYNHAM, Mass.Oct. 3, 2018 /PRNewswire/ — OMNIlife science, Inc. (“OMNI”), a privately-held, medical technology company targeting the $15 billion global hip and knee replacement device market, reported today that the positive clinical benefits of the OMNIBotics® Robotic Active Spacer continue to be reinforced by more than 1,000 successful procedures performed to date. Orthopaedic surgeons have been evaluating this revolutionary system that utilizes a miniature robot to ensure the ligaments will be “balanced” after the knee replacement.

A basic tenet of knee replacement is to balance the tension of the ligaments to ensure smoother knee function and better alignment. However, balancing frequently involves making small incisions in tighter ligaments to create equal ligament tension. The Active Spacer helps the surgeon position implants in anatomic alignment while maintaining ligament balance without having to incise ligaments. Early data on the use of the Active Spacer is showing a much higher rate of patient satisfaction at both three and six months’ post-surgery than what has been typically reported in the literature.

“We are pleased the benefits of OMNIBotics Active Spacer technology continue to be validated by multiple surgeons,” said Rick Epstein, CEO of OMNI. “Our OMNIBotics robotic-assisted technology guides the surgeon to the optimal implant position to achieve both mechanical alignment and balance, and each of the cuts are made with robotic precision. We believe a properly aligned and carefully balanced knee will result in optimized patient outcomes and it is exciting to be working with surgeons to advance the field of knee replacement with robotics.”

OMNIBotics with Active Spacer is the first and only robotic system to integrate ligament tension with bone alignment.

“I’ve been doing knee surgery for 25 years,” stated Jeffrey H. DeClaire, M.D. (DeClaire LaMacchia Orthopedic Institute, Rochester Hills, MI), “and I’ve always been very focused on balancing the knee, but there’s never been any way to measure and validate ligament balance and ligament tension in knee arthroplasty until the OMNIBotics Active Spacer.  This is a real breakthrough because now I know that each total knee arthroplasty I perform is precisely balanced with consistency and reproducibility that significantly improves the accuracy of the procedure, in addition to facilitating improved patient outcomes and patient satisfaction.”

ABOUT OMNI

OMNI is a privately held company with a proprietary robotic platform, OMNIBotics®, which allows surgeons to conduct patient-specific total knee surgery designed to enhance patient satisfaction and reduce hospital costs. In addition, OMNI designs, engineers, manufactures and distributes a wide range of proprietary hip and knee implants and is focused on providing cutting edge technologies to transform outcomes in joint replacement surgery and enhance a surgeon’s ability to help patients live active and pain-free lives. For more information about OMNI, please visit www.omnils.com.

FORWARD LOOKING STATEMENTS

Statements in this press release concerning the future business, operations and prospects of OMNIlife science, Inc., including its plans specific to OMNIBotics systems, as well as statements using the terms “plans,” “believes” or similar expressions are “forward-looking” statements as defined in the Private Securities Litigation Reform Act of 1995. These statements are based upon management’s current expectations and are subject to a number of factors and uncertainties. Information contained in these forward-looking statements is inherently uncertain, and actual performance and results may differ materially due to many important factors. Such factors include, among others, changes in competitive conditions and pricing in OMNI’s markets, decrease in the demand for OMNI’s products, delays in OMNI’s product research and development cycles, decreases in the use of OMNI’s principal product lines or in procedure volume, unanticipated issues in complying with domestic or foreign regulatory requirements related to OMNI’s current products or securing regulatory clearance or approvals for new products or upgrades or changes to OMNI’s current products, the impact of the United States healthcare reform legislation on hospital spending and reimbursement, any unanticipated impact arising out of the securities class action or any other litigation, inquiry, or investigation brought against OMNI, increases in costs of OMNI’s sales force and distributors, and unanticipated intellectual property expenditures required to develop, market, and defend OMNI’s products. OMNI cannot guarantee any future results, levels of activity, performance or achievement. OMNI undertakes no obligation to update any of its forward-looking statements after the date of this press release.

CONTACT

Cindy Holloway, Director of Marketing Communications Phone: (508) 824-2444  
cholloway@omnils.com

SOURCE OMNIlife science, Inc.

Related Links

http://www.omnils.com


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September 21, 2018 OrthoSpineNews

DUBLIN and CAESAREA, Israel – September 20, 2018 – Medtronic plc (NYSE:MDT), a global leader in medical technology, and Mazor Robotics (NASDAQ:MZOR, TASE:MZOR.TZ), a pioneer in the field of robotic guidance systems, today announced the companies have entered into a definitive merger agreement under which Medtronic will acquire all outstanding ordinary shares of Mazor for $58.50 per American Depository Share, or $29.25 (104.80 ILS) per ordinary share, in cash, for a total of approximately $1.64 billion, or $1.34 billion net of Medtronic’s existing stake in Mazor and cash acquired. The boards of directors of both companies have unanimously approved the transaction.

Medtronic’s acquisition of Mazor strengthens Medtronic’s position as a global leader in enabling technologies for spine surgery, and drives Mazor Robotics’ vision to bring its core technology to the forefront of the global market. Mazor’s proprietary core platform technology, including the Mazor X(TM) Robotic Guidance System (Mazor X), and the Renaissance® Surgical-Guidance System (Renaissance), are transforming spinal surgery from freehand procedures to accurate, state-of-the-art, guided procedures. By combining Medtronic’s market-leading spine implants, navigation, and intra-operative imaging technology with Mazor’s robotic-assisted surgery (RAS) systems, Medtronic intends to offer a fully-integrated procedural solution for surgical planning, execution and confirmation. The companies plan to showcase this technology integration at the upcoming NASS (North American Spine Society) 2018 Annual Meeting in Los Angeles.

“We believe robotic-assisted procedures are the future of spine surgery, enhancing surgeons’ abilities to perform complex procedures with greater precision, consistency and control. Medtronic is committed to accelerating the adoption of robotic-assisted surgery and transforming spine care through procedural solutions that integrate implants, biologics and enabling technologies,” said Geoff Martha, executive vice president and president of the Restorative Therapies Group at Medtronic. “The acquisition of Mazor adds robotic-assisted guidance systems to our expanding portfolio of enabling technologies, and we intend to further cultivate Mazor’s legacy of innovation in surgical robotics with the site and team in Israel as a base for future growth.”

This transaction builds on a relationship originated in May 2016 under a multi-phased strategic and equity investment agreement between Medtronic and Mazor. In August 2017, Medtronic expanded the partnership to become the exclusive worldwide distributor of the Mazor X system, leading to the successful installation of more than 80 Mazor X systems since launch. With today’s announcement bringing the two companies together, Medtronic aims to accelerate the advancement and adoption of RAS in spine to the benefit of patients, providers, and the healthcare system more broadly.

“Today is a historic day for spine surgery and a defining event in the market’s evolution, and I want to acknowledge and thank all of those whose contribution and faith have been so critical and impactful to our success,” said Ori Hadomi, CEO of Mazor Robotics. “The Mazor team and product portfolio’s full integration into Medtronic will maximize our impact globally through Medtronic’s channels, advance our systems’ leadership position in the marketplace, and drive the realization of our vision to heal through innovation.”

Financial Highlights
The acquisition is expected to close during Medtronic’s third fiscal quarter ending January 25, 2019, subject to the satisfaction of customary closing conditions including receipt of regulatory clearances and approval by Mazor’s shareholders. The transaction is expected to be modestly dilutive to Medtronic’s fiscal 2019 adjusted earnings per share, but given the current strength of Medtronic’s business, the company expects to absorb the dilution.

Consistent with its long-term financial objectives, Medtronic projects the acquisition to generate a double-digit return on invested capital (ROIC) by year four, with an increasing contribution thereafter.

Medtronic’s financial advisors for the transaction are Perella Weinberg Partners LP and Goldman Sachs & Co. LLC, with Meitar Liquornik Geva Leshem Tal and Ropes & Gray LLP acting as legal advisors. Mazor’s financial advisor is J.P. Morgan Securities LLC, Duff & Phelps LLC, with Kirkland & Ellis LLP and Luchtenstein Levy Wiseman Law office acting as legal advisor.

About Mazor Robotics
Mazor, founded in 2001, pioneered the application of robotics technology and guidance for use during spinal procedures, and is the market segment’s leader. In 2011, the Company introduced the Renaissance system and in 2016 launched the next generation Mazor X system. To date, more than 200 Mazor systems are in clinical use on four continents and have guided the placement of more than 250,000 implants during some 40,000 procedures, enabling minimally-invasive spine surgery to become standard procedure in many hospitals. Mazor’s core technology has received more than 15 U.S. Food and Drug Administration clearances and has been the subject of more than 60 publications, leading the spine robotics market on the evidence front. Mazor is the holder of more than fifty patents worldwide.

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 86,000 people worldwide, serving physicians, hospitals and patients in more than 150 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

Any forward-looking statements, including, but not limited to, statements regarding the proposed transaction between Medtronic and Mazor, the expected timetable for completing the transaction, strategic and other potential benefits of the transaction, including meeting Medtronic’s long-term financial metrics for acquisitions, Mazor’s products and product candidates, and other statements about Medtronic or Mazor managements’ future expectations, beliefs, goals, plans or prospects, are subject to risks and uncertainties including, but not limited to, the ability and timing to satisfy conditions to closing including shareholder and regulatory approvals, the impact of the announcement of the transaction on the business, and other risks and uncertainties such as those described in Medtronic’s and Mazor’s reports and other filings with the Securities and Exchange Commission. Actual results may differ materially from anticipated results. Medtronic and Mazor caution investors not to place considerable reliance on the forward-looking statements contained in this press release. These forward-looking statements speak only as of the date of this document, and Medtronic and Mazor undertake no obligation to update or revise any of these statements except to the extent required by law.

ADDITIONAL INFORMATION

In connection with the proposed transaction, Mazor intends to mail a proxy statement to its shareholders and furnish a copy of the proxy statement with the SEC on Form 6-K. Shareholders of Mazor are urged to read the proxy statement and the other relevant material when they become available because they will contain important information about Mazor, Medtronic, the proposed transaction and related matters. Shareholders are urged to carefully read the proxy statement and other relevant materials when they become available before making any voting or investment decision with respect to the proposed transaction. The proxy statement (when available) may be obtained for free at the SEC’s website at www.sec.gov. In addition, the proxy statement will be available, without charge, at Mazor’s website at www.mazorrobotics.com.

-end-

Medtronic Contacts:
David T. Young
Public Relations
+1-774-284-2746

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

Mazor Contacts:
Eran Gabay – Gelbart Kahana
Israel Public Relations
+972-54-246378

Michael Polyviou – EVC Group
U.S. Public Relations
+1-732-232-6914


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September 6, 2018 OrthoSpineNews

Reston, Virginia, Sept. 06, 2018 (GLOBE NEWSWIRE) — The Virginia Institute of Robotic Surgery at Reston Hospital Center has announced the launch of its Visiting Clinician Program (VCP) for robotic assisted spine surgery using the Mazor X Robotic system, a partnered program with Medtronic. The VCP at Reston Hospital Center will be led by Dr. Christopher Good, spinal surgeon at the Virginia Spine Institute (VSI). As the Director of Scoliosis & Spinal Deformity Surgery at VSI, Dr. Good is at the forefront of spine surgery and has performed the Mid-Atlantic’s first and most advanced procedures using robotic assisted technology at Reston Hospital Center.

“Our team has been leading the way in implementing the latest in surgical innovations for years,” said John Deardorff, President and CEO of HCA’s Northern Virginia Market and Reston Hospital Center. “Consistently providing excellent patient care and superior results, Reston Hospital Center has become recognized as a destination that surgeons from around the world come to train.”

The VCP at Reston Hospital Center is designed to enable spine surgeons from around the world to see the technology while learning best practices for implementation in another facility or surgical program.

A visit to the program includes a case observation, as well as an opportunity to complete a training curriculum and to spend time with Dr. Good, learning the technology and how its best applied in complex cases. Visiting surgeons will also be exposed to the daily operations of running a comprehensive robotic surgery program from the administrative perspective, while having the opportunity to speak with leadership from the surgical services area.

Our research is showing that this robotic technology can decrease radiation to patients in the operating room, as well as improve the safety for patients having spine surgery,” said Dr. Christopher Good. “The launch of this Visiting Clinician Program at Reston Hospital Center is just one more step toward ensuring that our patients have the safest and most advanced treatment available to them; and, now, I have the pleasure of giving the same opportunity to surgeons around the world.”

The robotic assisted technology is used for pre-planning minimally invasive as well as complex spinal reconstruction procedures. It allows spine surgeons to precisely plan out the desired surgery and to carry out the procedure with a high degree of confidence and accuracy.

About Reston Hospital Center

Part of HCA Virginia Health System, Reston Hospital Center is a 187-bed, acute-care medical and surgical facility that has garnered high honors for attentive patient care and nursing excellence.  Reston Hospital Center is home to the region’s newest Level II Trauma Center and the most comprehensive robotic surgery in the Mid-Atlantic. Statewide, HCA Virginia Health System operates 14 hospitals and more than 30 outpatient centers and is affiliated with 3,000 physicians. It is Virginia’s fourthlargest private employer, provides $190.8 million in charity and uncompensated care, and pays $72.6 million in taxes annually. For more information about Reston Hospital Center visit www.restonhospital.com

Erin Echelmeyer
Reston Hospital Center
703-689-9030
Erin.Echelmeyer@hcahealthcare.com