Exactech Welcomes Orthopaedic Sales Veteran Stuart Kleopfer as Senior VP of Global Sales

October 02, 2018

GAINESVILLE, Fla.–(BUSINESS WIRE)–Exactech, a developer and producer of innovative implants, instrumentation and computer-assisted technologies for joint replacement surgery announced today the appointment of Stuart Kleopfer as Senior Vice President of Global Sales, effective Oct. 1, 2018.

Kleopfer will provide leadership for Exactech’s global sales functions with responsibility for the United States sales organization and the company’s current international team. Kleopfer is a veteran of the orthopaedics industry with 30 years experience in sales and marketing. He had a distinguished career at Biomet that included serving as president, U.S. Commercialization, and then with ZimmerBiomet where he served as president, Americas, until 2017.

“I am excited to be back in orthopaedics and look forward to re-engaging with surgeons and sales representatives,” Kleopfer said. “Exactech has a great product offering and with what we have in the research and development pipeline, I am confident we will be able to strengthen our global sales channel, generate top line revenue and grow market share.”

According to Exactech CEO David Petty, “Stuart is a great addition to Exactech and an excellent fit for our surgeon-focused culture. It’s an exciting time of growth for the company and we are eager to leverage Stuart’s expertise,” he said.

Exactech Co-Executive Chairman Jeff Binder also commented, “We are excited to add Stuart, with his proven track record of success, to the Exactech team and I am looking forward to working with him again.”

About Exactech

Based in Gainesville, Fla., Exactech develops and markets orthopaedic implant devices, related surgical instruments, and biologic materials, as well as computer assistance and other Augmented OrthopaedicTM technologies to hospitals and physicians. The company manufactures many of its orthopaedic devices at its Gainesville facility. Exactech’s orthopaedic products are used in the restoration of bones and joints that have deteriorated as a result of injury or diseases such as arthritis. Exactech markets its products throughout the United States and in more than 30 markets in Europe, Latin America, Asia and the Pacific. Additional information about Exactech can be found at www.exac.com.

Contacts

Exactech Inc.
Media Contact
Priscilla Bennett, 352-377-1140
Vice President, Corporate & Marketing Communication
media@exac.com

Bioventus Receives ANVISA Approval to Market DUROLANE® in Brazil and Selects Pfizer as Exclusive Distribution Partner

October 02, 2018

HOOFDDORP, Netherlands–(BUSINESS WIRE)–Bioventus, a global leader in orthobiologic solutions, has received approval from Agência Nacional de Vigilância Sanitária (ANVISA) to market DUROLANE, its single-injection joint-fluid osteoarthritis (OA) treatment, in Brazil. ANVISA has approved DUROLANE for the symptomatic treatment of mild to moderate knee and hip OA. In addition, Bioventus has selected Pfizer as its exclusive distribution partner for the market.

OA involves the breakdown, or degeneration, of cartilage and the synovial fluid that cushions and lubricates joint tissuesHyaluronic acid (HA)-based products like DUROLANE, help manage pain in the knees and hips of patients with OA.

Pfizer has more than 100 sales representatives throughout Brazil and will offer DUROLANE as part of its arthritis pain management portfolio which also includes CELEBRA®, a COX-2 selective nonsteroidal anti-inflammatory drug (NSAID).

“Brazil is the largest market for patients seeking osteoarthritis pain solutions in Latin America and one of the larger markets worldwide,” said Tony Bihl, CEO of Bioventus. “Introducing DUROLANE here gives patients and physicians access to a proven pain reliever for knee OA, expands the footprint of Bioventus and underscores our continuing efforts to bring orthobiologic solutions to patients around the world.”

“We are very pleased Pfizer is adding DUROLANE to its pain management portfolio for OA patients in Brazil,” said John Nosenzo, Chief Commercial Officer, Bioventus. “The company’s sales representatives have tremendous knowledge regarding osteoarthritis pain solutions. In addition, they have deep relationships with physicians and hospitals, making this a natural fit for Bioventus.”

DUROLANE is based on a natural, safe and proven technology process called NASHA®. This process yields stabilized (HA) which is a naturally occurring molecule that provides the lubrication and cushioning in a normal jointIt has been proven to provide greater reduction in OA knee pain versus Synvisc-One®1* and longer lasting pain relief versus a steroid injection2. DUROLANE is also safe for repeated courses of therapy. Repeated use of DUROLANE does not increase the incidence of adverse events.2,3

About Bioventus

Bioventus is an orthobiologics company that delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The orthobiologic products from Bioventus include offerings for osteoarthritis, surgical and non-surgical bone healing. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. For more information, visit www.BioventusGlobal.com and follow the company on Twitter @Bioventusglobal.

Bioventus, the Bioventus logo, and DUROLANE are registered trademarks of Bioventus LLC. NASHA is a registered trademark of Nestle Skin Health s.a. CELEBRA is a registered trademark of Pfizer. Synvisc-One and Synvisc are registered trademarks of Genzyme Corporation.

Summary of Indication for Use: Symptomatic treatment of mild to moderate knee or hip osteoarthritis. There are no known contraindications. You should not use DUROLANE if you have infections or skin disease at the injection site. DUROLANE has not been tested in pregnant or lactating women, or children. Risks can include transient pain, swelling and/or stiffness at the injection site.,Indications presented are those approved in Brazil; indications and product offerings vary by country. Consult with your local Bioventus representative for approved use within your region of interest. Full prescribing information can be found in product labeling, at www.DUROLANE.com.

References: 1. McGrath AF, McGrath AM, Jessop ZM, et al. A comparison of intra-articular hyaluronic acid competitors in the treatment of mild to moderate knee osteoarthritis. J Arthritis. 2013; 2(1):108. doi:10.4172/2167-7921.1000108. 2. Leighton R, Åkermark C, Therrien R, et. al. NASHA hyaluronic acid vs methylprednisolone for knee osteoarthritis: a prospective, multi-centre, randomized, non-inferiority trial. Osteoarthritis Cartilage. 2014; 22(1):17-25. 3. DUROLANE [package insert]. Durham, NC: Bioventus LLC; 2017.

Contacts

Bioventus LLC
Thomas Hill, 919-474-6715
thomas.hill@bioventusglobal.com

Lambda Technologies Extends the Life of Orthopedic Implants

Lambda Technologies has developed a surface treatment for modular orthopedic implants that eliminates the chance of failure from fretting fatigue. Low plasticity burnishing (LPB®) applies a deep, beneficial surface layer of designed residual compression to mitigate fretting fatigue in titanium implants. By putting the edge of contact region in high residual compression much deeper than the shallow shear cracks formed by fretting, the cracks cannot propagate and the chance of fracture from fretting is eliminated.

Millions of people have regained their mobility because of hip or knee implant technology. Day- to-day activities of the implant recipient, particularly those who are active, can lead to repeated metal-to-metal sliding contact in the joint, leaving the implant vulnerable to fretting induced fatigue cracks and, potentially, failure in the edge-of-contact region. If failure does occur, revision surgeries are required, significantly affecting the quality of life of patients. Fatigue testing of the modular hip and knee prosthesis systems by original manufacturers showed that LPB treatment improves the baseline fatigue strength by nominally 40%, and completely eliminated the occurrence of fretting induced failure.

The FDA has approved Lambda’s LPB process for extending the life of modular prostheses. During the twelve-plus years that orthopedic surgeons have been using LPB treated hip implants, and approximately three years of LPB treated knee implants, no LPB processed implant has failed from fretting fatigue. Dr. N. Jayaraman, Director of Materials Research for Lambda Technologies noted that, “The cost savings and improvement in the quality of life for patients is immeasurable. And as an added bonus, the ease of implementation of LPB into existing production environments in CNC mills or lathes has made it very cost-effective for the manufacturers.“

Lambda Technologies is an innovative company incorporating a premier materials research laboratory with a world-class engineering and production enterprise dedicated to the development and optimization of surface treatments to improve component performance. For additional information on Lambda Technologies or the LPB process, contact Julie Prevéy at (513) 561-0883 or visit http://www.lambdatechs.com.

TransEnterix Provides Corporate Update

October 01, 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 provided a corporate update, including preliminary unaudited revenue for the third quarter ended September 30, 2018.

“We made significant progress during the third quarter, including the continued adoption of Senhance, driven by the advancement of our sales and marketing strategy, the announcement of the MST acquisition agreement and the expansion of our instrument portfolio,” said Todd M. Pope, President and CEO at TransEnterix. “As we look towards the remainder of 2018 and into 2019, we are focused on increasing the applicability of Senhance to more patients, surgeons, and hospitals and growing on a global basis.”

Third Quarter 2018 Revenue Outlook

For the third quarter ended September 30, 2018, the Company expects to report revenue of approximately $5.4 million. This revenue is primarily driven by the sale of four Senhance systems, as follows:

  • In the US, UPMC purchased a Senhance Surgical System to be utilized at its Magee-Womens Hospital in Pittsburgh. Magee combines a wealth of specialty services with a focus on gynecologic and obstetric services. UPMC is a $19 billion world-renowned health care provider and insurer, which is focused on new models of accountable, cost-effective, and patient-centered care.
  • In EMEA (Europe, Middle East, Africa), three systems were sold:
    • A system was sold to Maxima Medical Center, in Veldhoven, the Netherlands, which is a member of a cooperative association of the 20 largest Dutch teaching hospitals that work together in areas of education and quality control, to guarantee the best level of healthcare.
    • Two systems were sold to distributors, one of which was a demonstration system purchased to support territory marketing and regulatory initiatives.

Balance Sheet

Preliminary unaudited cash and cash equivalents as of September 30, 2018 totaled approximately $82 million. The Company anticipates that it has sufficient cash to fund the business through 2020, assuming the funding of the $20 million in potential future debt tranches available under the Company’s existing debt financing agreements.

Acquisition Agreement with MST

On September 23, 2018, the Company announced that it had entered into an agreement to acquire substantially all of the assets of MST Medical Surgery Technologies Ltd. (“MST”), an Israel medical technology company. MST is a leader in the field of surgical technology, having developed a software-based image analytics platform powered by advanced visualization, scene recognition, artificial intelligence, machine learning and data analytics.

The addition of MST’s technology, IP portfolio, and R&D team will support and accelerate TransEnterix’s vision to leverage its Senhance Surgical System to deliver digital laparoscopy, thereby increasing control in the surgical environment and reducing surgical variability. In addition, the acquisition will provide immediate access to an established R&D center in Israel with a core team of experienced engineers. The acquisition is expected to close in the fourth quarter of 2018, and is subject to customary closing conditions.

Instrument Portfolio Expansion

Ultrasonic Instrument System

  • On September 6, 2018, the Company announced that it had filed its application for FDA 510(k) clearance for its Senhance Ultrasonic Instrument System, ahead of expectations. The Company expects to achieve an FDA 510(k) clearance in the first quarter of 2019.
  • As announced on October 1, 2018, the Company received a CE Mark for its Senhance Ultrasonic Instrument System. The Company continues to expect to commercially launch the Ultrasonic Instrument System in CE Mark countries in the fourth quarter of 2018.

3mm Diameter Instrument Set

  • The Company continues to anticipate receiving FDA 510(k) clearance for its expanded instrument set, including 3mm diameter instruments, by the end of 2018.

Articulating Instruments

  • The Company continues to expect to submit its application for FDA 510(k) clearance for its 5mm diameter articulating instruments during the fourth quarter of 2018.
  • The Company continues to expect to receive CE Mark for its 5mm diameter articulating instruments during the fourth quarter of 2018.

Expansion of Geographic Regulatory Approvals

The Company continues to expect to receive Taiwanese FDA approval for the Senhance Surgical System instruments by the end of 2018. In the second quarter of 2018, the Company received approval in Taiwan for the Senhance Surgical System.

Appointment of Chief Commercial Officer

On September 4, 2018, the Company announced that Eric Smith has been named Chief Commercial Officer, effective August 31, 2018. In this newly created role, which reports directly to the Chief Executive Officer, Mr. Smith leads the company’s global commercialization efforts, with a focus on both strategic and tactical execution efforts in sales, upstream and downstream marketing, field clinical support and training with a focus on adoption and clinical excellence.

About TransEnterix, Inc.

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 anticipated third quarter 2018 financial results, the acquisition agreement with MST, the Senhance Surgical System, the Senhance Ultrasonic Instrument System and our current regulatory and commercialization plans for these and our other products. These statements and other statements regarding our future plans and goals constitute “forward looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control and which may cause results to differ materially from expectations and include whether the preliminary unaudited 2018 third quarter revenue will be approximately $5.4 million, whether preliminary cash and cash equivalents will be $82 million as of September 30, 2018, whether, for the remainder of 2018 and into 2019, we will be able to increase the applicability of Senhance to more patients, surgeons and hospitals and growing on a global basis, whether the MST transaction will be able to close in the 2018 fourth quarter, whether we will achieve an FDA clearance of the Senhance Ultrasonic Instrument System in the 2019 first quarter, whether we will commercially launch the Ultrasonic Instrument System in CE Mark countries in the 2018 fourth quarter, whether we will receive FDA 510(k) clearance for our expanded instrument set, including 3mm diameter instruments, by the end of 2018, whether we will submit our FDA 510(k) clearance for our 5mm diameter articulating instruments during the 2018 fourth quarter, whether we will receive CE Mark for our 5mm diameter articulating instruments during the 2018 fourth quarter, whether we will receive Taiwanese FDA approval for the Senhance Surgical System instruments by the end of 2018 and whether we will have sufficient cash to fund the business through 2020, assuming the funding of the $20 million in potential future debt tranches available under our existing debt financing agreements. 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

For TransEnterix, Inc.
Investors:
Mark Klausner, +1-443-213-0501
invest@transenterix.com
or
Media:
Joanna Rice, + 1-951-751-1858
joanna@greymattermarketing.com

Spineology U.S. Clinical Trial for Interbody Fusion

October 01, 2018

ST. PAUL, Minn.–(BUSINESS WIRE)–Spineology Inc., an innovator in anatomy-conserving spine surgery, is excited to announce that John Chi, M.D., M.P.H., Associate Professor of Neurosurgery at Harvard Medical School and the Director of Neurosurgical Spinal Oncology at Brigham and Women’s Hospital in Boston, Massachusetts, presented 12-month outcomes data from Spineology’s SCOUT clinical trial at the recent annual meeting of the North American Spine Society (NASS) in Los Angeles, California.

The SCOUT study (Spineology Clinical Outcomes Trial), conducted under an FDA-approved IDE protocol, is a prospective multicenter non-randomized performance goal investigation, designed to evaluate safety and effectiveness outcomes in instrumented lumbar interbody fusion procedures for the treatment of degenerative disc disease (DDD).

The fusion implant used in the SCOUT Study is Spineology’s porous graft containment mesh that deploys within the disc space as it is filled, permitting the packed bone graft to conform to the prepared vertebral body endplates. The system’s design allows for disc space preparation and implant placement through a small cannula.

The SCOUT trial includes 102 patients who were experiencing painful lumbar degenerative disc disease of at least six months’ duration. Patients are skeletally mature adults with single-level symptomatic lumbar DDD requiring interbody fusion. Patients have been enrolled at ten participating study sites, and study enrollment is complete. Dr. Chi and his co-authors reported on 102 treated subjects, of whom 80 have completed 12-month postoperative follow-up and 27 have completed 24-month follow-up.

Statistically significant improvements were seen at six months, twelve months and 24 months in scores for low back pain and functional limitations, as recorded by Visual Analog Scale (VAS) and Oswestry Disability Index (ODI) respectively. At the primary fusion endpoint of 12-months 65 of 70 (93%) with available films were fused, as read on CT by two independent radiologists. Eighty nine percent (89%) of subjects reported “Excellent” or “Good” patient satisfaction at 12 months (71 of 80) and 24 months (24 of 27). Safety was excellent. There were no unanticipated adverse events and no interbody device-related serious adverse events.

“We have found this innovative minimally invasive graft containment device to be a safe and effective option for lumbar interbody fusion procedures,” said Dr. Chi. “Patient- reported outcomes are very favorable, including improved function, reduced pain, and high satisfaction rates. Combined with excellent safety and radiographic fusion, the SCOUT study is demonstrating very favorable results.”

The list of nationwide study sites participating in the SCOUT IDE includes Brigham and Women’s Hospital, University of Vermont, the Spine Institute of Louisiana, Florida Orthopaedic Associates, and Georgetown University, among others. Details of the study may be found at the NIH clinical trials website, https://clinicaltrials.gov/ct2/show/NCT02347410?spons=spineology&rank=1.

Spineology’s OptiMesh® deployable implant received 510(k) clearance from FDA in 2003 for graft containment within the vertebral body. The SCOUT trial is designed to provide clinical data in support of a regulatory submission to FDA for expanded indications, allowing the company to market the implant to be used with bone graft and supplemental posterior fixation in support of lumbar interbody fusion for treating painful DDD.

Spineology CEO John Booth said, “We are very pleased to know that SCOUT patients have reported these high satisfaction rates and good clinical improvements with their fusion success. We look forward to continuing patient follow-up and gaining the market clearance that will allow us to market this unique fusion device. We are grateful to Dr. Chi and all the SCOUT investigators for their commitment to this important clinical trial.”

About Spineology Inc.
Spineology Inc. provides innovative, anatomy-conserving spinal technologies for surgeons and their patients. Spineology surgical techniques conserve spinal bone, ligament and muscle tissue. Spineology is committed to increasing procedural efficiency, reducing surgical morbidity and accelerating patient recovery. Learn more at spineology.com.

Contacts

Spineology Inc.
John Booth, 651-256-8511
jbooth@spineology.com
or
Risdall
Dave Folkens, 651-286-6713
dave@risdall.com

Medacta International Appoints Francesco Siccardi its Next Chief Executive Officer

October 01, 2018

CASTEL SAN PIETRO, Switzerland–(BUSINESS WIRE)–Medacta® International, the privately held, family-owned global leader in the design of innovative joint replacement and spinal surgery products, today announced that Francesco Siccardi, a noted biomedical engineer and current Executive Vice President of Medacta International, will become the company’s next chief executive officer on November 1, 2018. After nearly twenty years at the helm of the company, Medacta’s founder, Dr. Alberto Siccardi, will transition from his current CEO role and remain President of the company’s Board of Directors.

“It has been tremendously gratifying to see Medacta’s focus on medical education and sustainability resonate with surgeons and healthcare organizations around the world and to know that, together, we have changed orthopedics for tens of thousands of patients and their families,” said Dr. Alberto Siccardi, who founded Medacta following his own experience as a hip replacement surgery patient. “Medacta’s continued growth and prosperity make this an opportune time to transition to the next generation of the company’s leadership. With a deep understanding of both the technical and commercial sides of our business, Francesco is the right person to lead Medacta into the next phase of its evolution.”

Francesco Siccardi has served as Executive Vice President of Medacta International since 2010. A biomechanical engineer by training, he has been instrumental in the conception, development, and manufacture of many of Medacta’s leading products, including the AMIS® (Anterior Minimally Invasive Surgery) product line for total hip replacement, GMK® Sphere Total Knee System, MyKnee® Patient-Matched Technology, Efficiency Single Use Instruments, and the recently launched Medacta Shoulder System. Additionally, he was the driving force behind the creation of the Medacta Spine and Sports Medicine divisions. Francesco Siccardi joined Medacta in 2002 after studying Biomedical Engineering at the Politecnico of Milan.

“Medacta was borne out of my father’s experience as a patient, when he realized that orthopedic care should and could be better for both patient and surgeon alike. The company’s success is testament to that initial vision, and to the hard work behind it,” said Francesco Siccardi. “Over the past twenty years, Medacta has opened hundreds of surgeon learning centers, expanded into several new surgical disciplines, supported research efforts around the world, and changed the face of orthopedics in the process. The future is bright, and I am ecstatic to lead our talented Medacta team toward it.”

With Francesco Siccardi, the next generation of the Siccardi family will take over the operational responsibility of Medacta International. Francesco will be supported by the other two children of Dr. Alberto Siccardi: Alessandro Siccardi, a Board Member and head of the company’s supply chain, and Maria Luisa Siccardi, who also serves as a member of the company’s Board. Together with Medacta’s talented team of 930 employees, the organization strives to realize its mission to improve the patient experience emphasizing medical education, healthcare sustainability and responsible innovation.

About Medacta International

Medacta® International is a world leading company, developer and supplier, specializing in joint replacement, spine surgery, and sports medicine solutions. Medacta’s revolutionary approach and responsible innovation, focusing on Minimally Invasive Solutions and Personalized Medicine, have resulted in standard of care breakthroughs in hip replacement with the AMIS® system and total knee replacement with MyKnee® patient matched technology. Medacta has grown dramatically by taking a different approach and placing value on all aspects of the care experience from design to training to sustainability. Medacta is headquartered in Castel San Pietro, Switzerland, operates in over 30 countries around the globe, and employs more than 930 people. To learn more about Medacta International, please visit www.medacta.com or follow @Medacta on Twitter and LinkedIn.

Contacts

For Medacta International
Jill Bongiorni, 516-729-2250
Jill@torchcomllc.com

TransEnterix Receives CE Mark Approval for Senhance Ultrasonic Instrument System

October 01, 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 CE Mark approval for its Senhance Ultrasonic Instrument System.

Advanced energy devices, including ultrasonic devices, represent some of the most versatile and critical tools for surgeons in minimally invasive surgery. These instruments deliver controlled energy to effectively ligate and divide tissue, and minimize thermal injury to surrounding structures.

“Advanced energy devices are an important tool for laparoscopic surgeons because of their applicability within a wide range of procedures,” said Todd M. Pope, TransEnterix CEO. “We believe the addition of the Senhance Ultrasonic will help drive broader penetration of Senhance and help advance digital laparoscopy in Europe and other countries that accept CE Mark around the world.”

“Ultrasonic energy devices are critical tools in managing complex surgeries while minimizing bleeding and trauma to surrounding tissue,” said Prof. Dietmar Stephan, M.D., Head of Minimally Invasive and Robotic Surgery at St. Marien Hospital in Siegen, Germany. “In certain procedures, use of such advanced energy has become standard of care. The addition of this capability to the Senhance Digital Laparoscopic platform is a significant expansion of clinical applicability.”

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 the Senhance Ultrasonic Instrument 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™ Ultrasonic advanced energy capability will broaden the potential applicability of Senhance surgery in CE Mark countries, whether the Senhance Ultrasonic will help drive broader penetration of Senhance and help advance digital laparoscopy in Europe and other countries around the world that accept CE Mark, and whether the addition of the ultrasonic energy device to the Senhance Digital Laparoscopic platform is a significant expansion of Senhance’s clinical applicability. 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