TransEnterix Announces Global SurgiBot System Agreement

Posted On December 18, 2017 By OrthoSpineNews In Robotics /

December 18, 2017

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–TransEnterix, Inc. (NYSE American: TRXC), a medical device company that is pioneering the use of robotics to improve minimally invasive surgery, today announced that the Company has entered into an agreement with Great Belief International Limited (GBIL), to advance the SurgiBot System towards global commercialization. The SurgiBot System is the single-port, robotically enhanced laparoscopic surgical platform developed by TransEnterix.

This agreement transfers ownership of the SurgiBot System assets, while the Company retains the option to distribute or co-distribute the SurgiBot System outside of China. Upon completion of the transfer of all SurgiBot System assets, GBIL will have the System manufactured in China and obtain Chinese regulatory clearance from the China Food and Drug Administration (“CFDA”), while entering into a nationwide distribution agreement with China National Scientific and Instruments and Materials Company (CSIMC) for the Chinese market. Being the largest medical device distribution company in China, CSIMC will help GBIL maximize the commercial potential of the SurgiBot System in the Chinese market, and optimize post-sale services to Chinese hospitals. The Company retains the right to commercialize the SurgiBot System outside of China after manufacturing has been established and the necessary regulatory approvals have been obtained.

The agreement provides the Company with proceeds of at least $29 million, of which $7.5 million is expected to be received by the end of December 2017 and $7.5 million is expected to be received by March 31, 2018, which includes a $3.0 million equity investment in TransEnterix common stock at $2.33 per share, a 10% premium to the closing price on the date which the agreement was executed. The remaining $14 million, representing minimum royalties, will be paid beginning on the earlier of receipt of Chinese regulatory approval or five years.

“The relationship announced today with GBIL will allow us to advance the SurgiBot System toward global commercialization while significantly reducing our required investment and simultaneously leveraging ‘in-country’ manufacturing in the world’s most populous country,” said Todd M. Pope, President and CEO at TransEnterix. “This is a strong validation of the value of the SurgiBot platform, the world’s only abdominal surgical robot that allows surgeons to remain in the sterile field. We believe this relationship provides us with a significant opportunity to expand our product offerings of robotic solutions for hospitals and patients around the world.”

“We see a tremendous commercial opportunity for the SurgiBot System in China and are extremely enthusiastic to work with TransEnterix to bring this product to China along with the rest of the world,” said Gary Wang, President of GBIL. “The SurgiBot is unique in so many ways; we believe it can be transformational for our healthcare system.”

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 in today’s value-based healthcare environment. 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 Senhance Surgical Robotic System is available for sale in the US, the EU and select other countries. The company has also developed the SurgiBot System, a single-port, robotically enhanced laparoscopic surgical platform that is the subject of this press release. For more information, visit the TransEnterix website at www.transenterix.com.

About China National Scientific and Instruments and Materials Company (CSIMC)

CSIMC (China National Scientific Instruments and Materials Co., Ltd.) is the core enterprise of China National Pharmaceutical Group Corporation (SINOPHARM), specializing in scientific instruments and medical equipment. Being the largest medical equipment and device distribution enterprise, CSIMC has an operational network of 95 subsidiaries and branches across China, covering 26 provinces (more than 90% of regions of the whole country), and having business relationships with hundreds of global medical companies. From 2010 to 2016, CSIMC achieved CAGR of company revenue of more than 50%, leading to a total revenue of more than 3.4 billion USD in 2016. For more information, visit the CSIMC website at http://www.csimc.com.cn.

About Great Belief International Limited (GBIL):

GBIL is a BVI based company dedicated in investment and asset management in the healthcare industry. Their main business revenues are from investment in the Chinese medical sector.

Forward Looking Statements

This press release includes statements relating to the SurgiBot System and our agreement with GBIL 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 parties to the agreements successfully complete all of the anticipated activities and milestones, whether TransEnterix will receive at least $29 million (including minimum royalties) from GBIL, whether GBIL will be able to obtain the necessary clearances to sell the SurgiBot System in China, whether the agreement with GBIL will provide TransEnterix a significant opportunity to expand its product offerings, whether TransEnterix will be able to successfully distribute or co-distribute the SurgiBot System in other jurisdictions, and realize revenues beyond the initial consideration and minimum royalties and whether the SurgiBot System can become a transformational device in the healthcare system. 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.
Investors:
Mark Klausner, +1 443-213-0501
invest@transenterix.com
or
Media:
Joanna Rice, + 1 951-751-1858
joanna@greymattermarketing.com

THINK Surgical, Inc. Receives CE Mark Approval for the TSolution One® Surgical System for Total Knee Arthroplasty

Posted On December 13, 2017 By OrthoSpineNews In Recon, Regulatory, Robotics /

FREMONT, Calif., Dec. 11, 2017 /PRNewswire/ — THINK Surgical Inc., a global medical device manufacturer of the only active robotic surgical system for orthopaedic surgery, announces that it has received CE Mark approval for the TSolution One® Surgical System, bringing active robotic precision to Total Knee Arthroplasty (TKA).

The TSolution One Surgical System first entered the European market in 2015 when it received CE Mark approval for Total Hip Arthroplasty (THA). Currently, the system has 510(k) clearance for THA in the United States and four centers are enrolling patients for an IDE clinical study for TKA. Earlier in the year, the TSolution One Surgical System received Korean-FDA clearance for both THA and TKA. It also received approval for sale in Israel by the Ministry of Health for THA.

“We are pleased to offer one of the most advanced technologies in Total Knee Replacement through the TSolution One Surgical System to the European market and other countries that rely on the CE Mark,” said John Hahn, CEO of THINK Surgical, Inc. “Obtaining the CE Mark represents a key milestone towards continuing the global commercialization of our differentiated robotic technology and our commitment to improving patients’ lives and partnering with surgeons to transform orthopedic surgery.”

TSolution One is a robotic system that enables surgeons to create the patient’s personalized pre-surgical joint replacement plan, using CT-based 3D planning and the system’s open implant library to achieve an optimized surgical plan. During surgery, the robot precisely executes the patient’s individual surgical plan by removing diseased bone and preparing the bone cavity and joint surface with sub-millimeter dimensional accuracy.¹THINK’s active robotic technology has been shown to improve joint replacement implant fit and alignment as compared to conventional joint replacement surgery.² Accurate implant fit and alignment may be responsible for reduced postoperative pain, complications, and improved patient function.^3,4

¹Paul HA, Bargar WL, Mittlestadt B, Musits B, Taylor RH, Kazanzides P, et al. Development of a Surgical Robot for Cementless Total Hip Arthroplasty. Clin Orthop Relat Res 1992;285:57–66

²Netravali, Nathan et al., “A Perspective on Robotic Assistance for Knee Arthroplasty” Advances in Orthopedics (2013): DOI http://dx.doi.org/10.1155/2013/970703

³P. F. Choong, M. M. Dowsey, and J. D. Stoney, “Does accurate anatomical alignment result in better function and quality of life? Comparing conventional and computer-assisted total knee arthroplasty,” Journal of Arthroplasty, vol. 24, no. 4, pp. 560–569, 2009.

⁴Barrack RL. Dislocation after total hip arthroplasty: Implant design and orientation. J Am Acad Orthop Surg. 2003;11(2):89-99.

About THINK Surgical, Inc.
THINK Surgical, Inc. is committed to the future of orthopaedic surgery and to improving patient care through the development of leading-edge precision technology. THINK Surgical develops, manufactures, and markets the only active robotic surgical system for orthopaedic surgery.

For more information, visit www.THINKSurgical.com.
TSolution One® is a registered trademark of THINK Surgical, Inc.

Contact: Nancy Heinzer
510-249-2318
info@thinksurgical.com

Related Links
THINK Surgical website

SOURCE THINK Surgical, Inc.

TransEnterix Announces Senhance US Sale Agreement With Florida Hospital

Posted On November 13, 2017 By OrthoSpineNews In Robotics /

November 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 that Florida Hospital entered into an agreement to purchase the Company’s Senhance™ Surgical Robotic System.

The Florida Hospital Orlando campus will be home to the first commercial unit of the Senhance Surgical System to be installed in the United States.

Now available in the United States, the recently FDA-cleared Senhance Surgical System represents an innovative technology designed to assist surgeons in performing minimally invasive surgery. The system features multiple robotic arms that are controlled by a surgeon seated comfortably at a console. The surgeon controls small surgical instruments with robotic precision while at the same time moving a small scope that tracks the eye movement of the surgeon. The Senhance is the first surgical robotic system to offer the security of haptic force feedback that allows surgeons to feel the forces the instruments generate when handling delicate tissue. The Senhance represents a new era of digital laparoscopy designed to support responsible economics for the hospital, patient and today’s value-based healthcare system.

“We are pleased to announce our first US sale of the Senhance Surgical System,” said Todd M. Pope, President and CEO at TransEnterix. “Florida Hospital is a global leader in the application of next generation technologies to care for patients. It’s fitting that Florida Hospital will be the first in the United States to adopt this technology for patient care.”

“The digital operating room of the future has arrived, and our surgeons will continue to be leaders in applying robotic technology, like the Senhance, to benefit our patients across a full range of procedures and specialties,” said Dr. Steve Eubanks, surgeon and Executive Medical Director for the Institute for Surgical Advancement at Florida Hospital. “Our team of clinicians selected the Senhance Surgical System to further our minimally invasive offerings. We believe this robotic system will support our surgeons in maximizing their precision and control during procedures while minimizing costs.”

About Florida Hospital

Florida Hospital is a member of Adventist Health System, which operates 45 hospitals in 9 states, making it one of the largest not-for-profit healthcare systems in the United States, caring for more than 5 million patients annually. Florida Hospital continues to be at the forefront of health-care innovation. In addition to the Florida Hospital Institute for Surgical Advancement, it’s also home to the Florida Hospital Nicholson Center, a facility specializing in training surgeons from around the globe on the latest surgical technology and techniques, and the Global Robotics Institute, a world leader in the robotic-assisted treatment of prostate cancer.

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 in today’s value-based healthcare environment. The company is focused on the commercialization of the Senhance™ Surgical Robotic System, a multi-port robotic system that brings the advantages of robotic surgery to patients while enabling surgeons with innovative technology such as haptic feedback and eye sensing camera control. The company is also developing the SurgiBot™ System, a single-port, robotically enhanced laparoscopic surgical platform. The Senhance Surgical Robotic System is available for sale in the US, the EU and select other countries. 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 Robotic System will benefit Florida Hospital’s patients and whether the Senhance Surgical Robotic System will support Florida Hospital’s surgeons in maximizing their precision and control during procedures while minimizing 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:
Joanna Rice, + 1 951-751-1858
joanna@greymattermarketing.com

Smith & Nephew’s NAVIO™ Surgical System launches the first robotics-assisted bi-cruciate retaining total knee replacement

Posted On November 13, 2017 By OrthoSpineNews In Recon, Robotics, Top Stories /

13 November 2017

Smith & Nephew (NYSE:SNN; LSE:SN), the global medical technology business, today announces completion of the world’s first robotics-assisted bi-cruciate retaining total knee replacement procedures.

The NAVIO robotics-assisted surgical system aids in implanting the JOURNEY™ II XR (bi-cruciate retaining total knee system) which is one of the only total knee designs allowing retention of the ACL, and is designed to improve patient satisfaction. ¹

With this launch, NAVIO now offers both partial and total knee options that include the first and only robotics-assisted bi-cruciate retaining knee procedure, commercially available today.

Drs. Vivek Neginhal (WV), David Rovinsky(HI), and David Fabi (CA) recently performed the first cases. “I believe that the NAVIO is able to provide critical elements of success for the JOURNEY II XR, such as accuracy of tibia component placement and a streamlined surgical technique.” Dr. Neginhal further commented: “I was amazed at how fluid the knee motion was on the first postop day. My patients have expressed great satisfaction so far. I believe that NAVIO’s accuracy and flexibility of use combined with JOURNEY II XR’s retention of the patient’s cruciate ligaments and physiological design will truly increase patients’ function and satisfaction.”

The NAVIO is a next generation handheld robotics platform designed to aid surgeons with implant alignment, ligament balancing and bone preparation – key factors that can drive implant survivorship.^2,3 The small footprint of NAVIO allows for set up and portability. Furthermore, the NAVIO robotics-assisted system does not require a preoperative image, such as a CT scan. This allows patients to receive the benefits of robotics-assistance without the extra steps, costs, and radiation associated with additional preoperative imaging.⁴

“The JOURNEY II XR bi-cruciate retaining knee has the potential to deliver the best possible outcome for the surgeon and patient through the preservation of important anatomical structures such as the ACL. The NAVIO robotics-assisted surgical system enables accurate tibial implant placement to deliver a more reproducible surgical technique. We are proud to be the only company to offer the unique combination of NAVIO robotics-assistance and the JOURNEY II XR Knee System,” said Mike Donoghue, Senior Vice President of Global Marketing, Orthopaedics at Smith & Nephew.

References

Moro-Oka, Taka-Aki, Marc Muenchinger, Jean Pierre Canciani, and Scott A. Banks.“Comparing in Vivo
Kinematics of Anterior Cruciate-retaining and Posterior Cruciate-retaining Total Knee Arthroplasty.” Knee
Surgery, Sports Traumatology, Arthroscopy 15.1 (200&): 93:99. Web.
Sharkey, P., et al. “Why Are Total Knee Arthroplasties Failing Today?” Clinical Orthopaedics and Related Research. 2002 Nov;404:7-13.
Siddique, N., Ahmad, Z. “Revision of Unicondylar to Total Knee Arthroplasty: A Systematic Review” The Open Orthopaedics Journal 2012;6; (Suppl 2: M2) 268-275
Sg2 Healthcare Intelligence. Technology Guide: Orthopedic Surgical Robotics. 2014.25. Readmissions Reduction Program (HRRP). CMS.gov. Page last Modified: 04/18/2016 5:08 PM.

Enquiries

Media
Charles Reynolds	+44 (0) 1923 477314
Smith & Nephew

Dave Snyder	+1 (978) 749-1440
Smith & Nephew

Simon Conway / Debbie Scott	+44 (0) 20 3727 1000
FTI Consulting

Investors
Ingeborg Øie	+44 (0) 20 7960 2285
Smith & Nephew

About Smith & Nephew

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 2016 were almost $4.7 billion. Smith & Nephew is a member of the FTSE100 (LSE:SN, NYSE:SNN).

For more information about Smith & Nephew, please visit our website www.smith-nephew.com, follow @SmithNephewplc on Twitter or visit SmithNephewplc on Facebook.com.

^{Forward-looking Statements}

^{This document may contain forward-looking statements that may or may not prove accurate. For example, statements regarding expected revenue growth and trading margins, market trends and our product pipeline are forward-looking statements. Phrases such as “aim”, “plan”, “intend”, “anticipate”, “well-placed”, “believe”, “estimate”, “expect”, “target”, “consider” and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from what is expressed or implied by the statements. For Smith & Nephew, these factors include: economic and financial conditions in the markets we serve, especially those affecting health care providers, payers and customers; price levels for established and innovative medical devices; developments in medical technology; regulatory approvals, reimbursement decisions or other government actions; product defects or recalls or other problems with quality management systems or failure to comply with related regulations; litigation relating to patent or other claims; legal compliance risks and related investigative, remedial or enforcement actions; disruption to our supply chain or operations or those of our suppliers; competition for qualified personnel; strategic actions, including acquisitions and dispositions, our success in performing due diligence, valuing and integrating acquired businesses; disruption that may result from transactions or other changes we make in our business plans or organisation to adapt to market developments; and numerous other matters that affect us or our markets, including those of a political, economic, business, competitive or reputational nature. Please refer to the documents that Smith & Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith & Nephew’s most recent annual report on Form 20-F, for a discussion of certain of these factors. Any forward-looking statement is based on information available to Smith & Nephew as of the date of the statement. All written or oral forward-looking statements attributable to Smith & Nephew are qualified by this caution. Smith & Nephew does not undertake any obligation to update or revise any forward-looking statement to reflect any change in circumstances or in Smith & Nephew’s expectations.}

^{◊ Trademark of Smith & Nephew. Certain marks registered US Patent and Trademark Office.}

OMNIlife science™, Inc. Announces First Clinical Evaluations of Revolutionary OMNIBotics® Active Spacer Robotic Tissue Balancing Device

Posted On October 31, 2017 By OrthoSpineNews In Recon, Robotics, Top Stories /

RAYNHAM, Mass., Oct. 31, 2017 /PRNewswire/ — OMNIlife science, Inc. (“OMNI™”), a privately-held, established medical technology company targeting the $15 billion global hip and knee replacement device market, announced today that they have begun clinical evaluations of their exclusive OMNIBotics Active Spacer robotic tissue balancing device at three U.S. sites. This technology received 510(k) clearance from the FDA on September 1, 2017.

The OMNIBotics Active Spacer, in clinical use since March in Australia, provides the surgeon with a quantitative tool to actively manage the soft tissue envelope with dynamic real-time feedback. When combined with the accuracy of alignment and bone cuts provided by the OMNIBotics system, the result is a completely customized procedure from both a skeletal and a soft tissue perspective.

“I believe that the active spacer technology is the tool we have been looking for to create even better predictability and reproducibility for knee replacement surgery,“ said Jeffrey M. Lawrence, M.D. Viroqua, WI. “I’m very excited to offer this system to my patients.”

Of his early experience, John M. Keggi, MD, Middlebury, CT said, “The active spacer technology is a great step forward that brings the most advanced measurement and analysis tools directly to each patient and surgeon right in the operating room. It’s an unprecedented, real-time evaluation of the knee that optimizes each step of the procedure.”

Studies indicate that a significant percentage of knee replacement patients do not achieve full satisfaction even with well-placed implants. One potential contributing factor is sub-optimal soft tissue balancing.

“The active spacer is an amazing new technology for knee replacement. It actually shows your surgeon, in real time, how tight or loose your knee is on each side as it bends. This information is then fed into a robot, which plans how your knee is replaced on an individual basis for optimum results,” said Amber Randall, MD an orthopedic surgeon in Arizona.

OMNI, a pioneer in robotic-assisted total knee replacement, now offers the only robotic technology that quantitatively drives the total knee replacement surgical procedure with both alignment and ligament balancing. Dr. Randall continues, “I believe that this revolutionary, never before seen technology will get us not one–but several–steps closer to the Holy Grail of knee replacement: the freely moving, perfectly stable and pain free knee.”

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.

TransEnterix Announces US 510(k) FDA Clearance for Senhance Surgical Robotic System

Posted On October 16, 2017 By OrthoSpineNews In Regulatory, Robotics, Top Stories /

October 13, 2017

“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

Stryker Receives FDA Clearance for Cementless Mako Total Knee with Triathlon® Tritanium®

Posted On October 16, 2017 By OrthoSpineNews In Recon, Regulatory, Robotics, Top Stories /

MAHWAH, N.J., Oct. 16, 2017 /PRNewswire/ — Stryker’s Joint Replacement division today announced that its cementless Mako Total Knee with Triathlon Tritanium has received 510(k) market clearance by the U.S. Food and Drug Administration.

Triathlon Tritanium combines the kinematics of Stryker’s market leading Triathlon knee implant with the latest in highly porous biologic fixation technology for a knee system like no other. The innovation of Tritanium’s tibial baseplate and metal-backed patella components are enabled by Stryker’s proprietary AMagine additive manufacturing technology and are SOMA-designed.

With cementless procedures rising in popularity and becoming a fast-growing trend¹, Mako Total Knee with Triathlon Tritanium expands the current robotics offering to provide a cementless solution for orthopaedic surgeons seeking a more predictable surgical experience combined with increased operating room efficiency, biologic fixation and an alternative to bone cement.

“With the rise in demand for cementless knee technology, we believe this new offering can have a positive impact on procedural efficiency and patient outcomes,” said Stuart Simpson, President, Stryker’s Joint Replacement division. “We’re excited to continue to lead in robotic technology and combine two of our most advanced and differentiated products to provide surgeons with the ability to transform orthopaedic surgery.”

About Stryker
Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com.

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

SOURCE Stryker

Mazor Robotics Appoints Medical Device Industry Veteran Ron Tavlin as Vice President- Business Development

Posted On October 13, 2017 By OrthoSpineNews In Robotics, Top Stories /

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

Globus Medical Announces First Spine Surgeries Using ExcelsiusGPS™

Posted On October 10, 2017 By OrthoSpineNews In Robotics, Spine, Top Stories /

AUDUBON, Pa., Oct. 10, 2017 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal solutions company, today announced the first spine surgeries using ExcelsiusGPS™, a revolutionary robotic guidance and navigation system. Surgeries using ExcelsiusGPS™ were performed last week at The Johns Hopkins Hospital in Baltimore, Maryland and St. Mark’s Hospital in Salt Lake City, Utah. The surgical team at Johns Hopkins was led by neurosurgeons Dr. Nick Theodore and Dr. Ali Bydon, while orthopedic spine surgeon Dr. Kade Huntsman performed the surgeries at St. Marks.

“ExcelsiusGPS™ is the only robotic system that combines surgical navigation and robotic guidance for spinal surgery, which offers significant advantages to spine surgeons,” said Dr. Huntsman, “The system has been designed to take into account the typical surgical workflow to facilitate procedural efficiency.”

“ExcelsiusGPS™ is the culmination of years of research and development efforts and demonstrates Globus Medical’s superior product development capabilities,” said Norbert Johnson, Vice President of Robotics, Imaging, & Navigation. “We believe the ExcelsiusGPS™ System will advance patient care and provide tangible benefits for surgeons and hospitals in terms of time, accuracy and reduced radiation exposure through the application of robotic and navigation technology in spine and orthopedic surgery.”

ExcelsiusGPS™ supports minimally invasive and open screw placement procedures. It seamlessly integrates Globus Medical implants and instruments and is compatible with pre-operative CT, intra-operative CT and fluoroscopic imaging modalities. The system is designed to minimize radiation exposure, streamline workflow, and reproducibly assist in implant placement.

Globus Medical expects its first revenues from the sale of ExcelsiusGPS™ systems to occur in the fourth quarter 2017, in alignment with current company guidance.

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

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

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

Mazor Robotics Received 22 System Orders During Q3 2017; Expects to Report Record Quarterly Revenue

Posted On October 9, 2017 By OrthoSpineNews In Financial, Robotics /

October 09, 2017

CAESAREA, Israel–(BUSINESS WIRE)–Mazor Robotics Ltd. (TASE: MZOR; NASDAQGM: MZOR), a pioneer and a leader in the field of surgical robotic systems, expects to report record revenue of approximately $17.2 million for the third quarter ended September 30, 2017. During the third quarter of 2017, the Company received a total of 22 system purchase orders from customers in the U.S., Asia and Israel. The 22 orders are comprised of:

19 purchase orders for the Mazor X™ system, of which 11 were ordered by Medtronic. As of September 18, 2017, Medtronic assumed full responsibility for the distribution of the Mazor X system, as part of the second phase of the commercial agreement between the companies. Five of the Medtronic ordered systems were delivered in Q3.
A purchase order for three Renaissance systems from the Company’s distribution partner in China, one of which was delivered in Q3.

“This quarter we transferred to Medtronic members of our talented capital sales team along with a solid sales pipeline. This transition was performed in a smooth and effective manner and we maintained robust sales activity during the transition period,” commented Ori Hadomi, Chief Executive Officer. “The continued strong performance in the third quarter of 2017 reflects the increased demand and interest in Mazor’s robotic platforms.”

Mazor’s system backlog at the end of the third quarter was 17 systems (15 Mazor X and two Renaissance systems). The Company intends to report its financial results for the third quarter ended September 30, 2017 on or about November 7, 2017 and will issue a press release with the specific time, dial-in credentials and webcast details.

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 an accurate and secure manner. For more information, please visit www.MazorRobotics.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other securities laws. Any statements in this release about future expectations, plans or prospects for the Company, including without limitation, statements regarding the expected revenue for the third quarter of 2017, the amount of recording of additional revenue from backlog, the timing of reporting of third quarter financial results, 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