Intuitive Surgical Announces Third Quarter Earnings

SUNNYVALE, Calif., Oct. 18, 2018 (GLOBE NEWSWIRE) — Intuitive Surgical, Inc. (“Intuitive”) (Nasdaq: ISRG), a global technology leader in robotic-assisted, minimally invasive surgery, today announced financial results for the quarter ended September 30, 2018.

Q3 Highlights

  • Worldwide da Vinci procedures grew approximately 20% compared with the third quarter of 2017, driven primarily by growth in U.S. general surgery procedures and worldwide urologic procedures.
  • The Company shipped 231 da Vinci Surgical Systems compared with 169 in the third quarter of 2017.
  • Third quarter 2018 revenue of $921 million grew approximately 14% compared with $808 million for the third quarter of 2017. Third quarter 2017 revenue included $21 million that had previously been deferred in connection with a customer trade-out program that the Company had offered certain first quarter 2017 customers.
  • Third quarter 2018 GAAP net income was $293 million, or $2.45 per diluted share, compared with $299 million, or $2.56 per diluted share, for the third quarter of 2017.
  • Third quarter 2018 non-GAAP* net income was $337 million, or $2.83 per diluted share, compared with $325 million, or $2.78 per diluted share, for the third quarter of 2017. The customer trade-out program mentioned above increased third quarter 2017 GAAP and non-GAAP* net income per diluted share by approximately $0.09. Third quarter 2017 GAAP and non-GAAP* net income benefited from $68 million, or $0.59 per diluted share, related to certain tax benefits.
  • The Company shipped the first three da Vinci SP® Surgical Systems in the third quarter of 2018. The da Vinci SP system is the Company’s latest surgical system platform which delivers the surgical instruments and camera through a single port for narrow access surgery.
  • In August 2018, the Company submitted a premarket notification to the U.S. Food and Drug Administration (“FDA”) for the Ion™ endoluminal system, the Company’s new flexible robotic-assisted, catheter-based platform, designed to navigate through very small lung airways to reach peripheral nodules for biopsies.

Q3 Financial Summary

Gross profit, income from operations, net income, net income per diluted share, and diluted shares are reported on a GAAP and non-GAAP* basis. The non-GAAP* measures are described below and are reconciled to the corresponding GAAP measures at the end of this release.

Third quarter 2018 revenue was $921 million, an increase of approximately 14% compared with $808 million in the third quarter of 2017. Third quarter 2017 revenue included $21 million of revenue that had previously been deferred in connection with a customer trade-out program that the Company had offered certain first quarter 2017 customers.

Third quarter 2018 instrument and accessory revenue increased by approximately 21% to $486 million, compared with $401 million for the third quarter of 2017, primarily driven by approximately 20% growth in da Vinci procedure volume.

Third quarter 2018 systems revenue increased by approximately 5% to $275 million, compared with $262 million for the third quarter of 2017. The Company shipped 231 da Vinci Surgical Systems in the third quarter of 2018, compared with 169 in the third quarter of 2017. The third quarter 2018 system shipments included 58 systems shipped under operating lease arrangements, compared with 20 during the third quarter of 2017. Third quarter 2017 systems revenue included revenue related to the customer trade-out program mentioned above.

Third quarter 2018 GAAP income from operations increased to $313 million, compared with $281 million in the third quarter of 2017. Third quarter 2018 non-GAAP* income from operations increased to $391 million, compared with $349 million in the third quarter of 2017.

Third quarter 2018 GAAP net income was $293 million, or $2.45 per diluted share, compared with $299 million, or $2.56 per diluted share, for the third quarter of 2017.

Third quarter 2018 non-GAAP* net income was $337 million, or $2.83 per diluted share, compared with $325 million, or $2.78 per diluted share, for the third quarter of 2017. The customer trade-out program mentioned above, including the associated deferral of product costs and income tax effect, increased GAAP and non-GAAP* net income per diluted share by approximately $0.09. Third quarter 2017 GAAP and non-GAAP* net income benefited from $68 million, or $0.59 per diluted share, related to certain tax benefits.

The Company ended the third quarter of 2018 with $4.6 billion in cash, cash equivalents, and investments, an increase of $311 million during the quarter, primarily driven by cash generated from operations.

Commenting on the announcement, Gary Guthart, President and CEO of Intuitive, said, “We are pleased with our strong third quarter procedure growth, da Vinci system placements, and the financial results that follow. With our customers, we remain dedicated to the pursuit of our shared mission to improve the availability and quality of minimally invasive surgery.”

Additional supplemental financial and procedure information has been posted to the Investor Relations section of the Intuitive website at: https://isrg.gcs-web.com/.

Webcast and Conference Call Information

Intuitive will hold a teleconference at 1:30 p.m. PDT today to discuss the third quarter 2018 financial results. The call is being webcast by Nasdaq OMX and can be accessed at Intuitive’s website at www.intuitive.com or by dialing (800) 230-1096 or (612) 234-9960.

About Intuitive Surgical, Inc.

Intuitive Surgical, Inc. (Nasdaq: ISRG), headquartered in Sunnyvale, California, is a global technology leader in robotic-assisted, minimally invasive surgery. Intuitive Surgical develops, manufactures, and markets robotic technologies designed to improve clinical outcomes and help patients return more quickly to active and productive lives. The Company’s mission is to extend the benefits of minimally invasive surgery to the broadest possible base of patients. Intuitive Surgical – Taking surgery beyond the limits of the human hand™.

About the da Vinci Surgical System

There are several models of the da Vinci surgical system. The da Vinci surgical systems are designed to help surgeons perform minimally invasive surgery. Da Vinci systems offer surgeons high-definition 3D vision, a magnified view, and robotic and computer assistance. They use specialized instrumentation, including a miniaturized surgical camera and wristed instruments (i.e., scissors, scalpels and forceps) that are designed to help with precise dissection and reconstruction deep inside the body.

Da Vinci®, da Vinci SP®, and Ion™ are trademarks or registered trademarks of Intuitive Surgical, Inc.

For more information, please visit the Company’s website at www.intuitive.com.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding the Company’s dedication to the pursuit of a shared mission to improve the availability and quality of minimally invasive surgery. These forward-looking statements are necessarily estimates reflecting the best judgment of the Company’s management and involve a number of risks and uncertainties that could cause actual results to differ materially from those suggested by the forward-looking statements. These forward-looking statements should, therefore, be considered in light of various important factors, including, but not limited to, the following: the impact of global and regional economic and credit market conditions on healthcare spending; healthcare reform legislation in the United States and its impact on hospital spending, reimbursement and fees levied on certain medical device revenues; changes in hospital admissions and actions by payers to limit or manage surgical procedures; the timing and success of product development and market acceptance of developed products, including, but not limited to, the recently launched SP surgical system and 3rd generation stapling platform; the results of any collaborations, in-licensing arrangements, joint ventures, strategic alliances or partnerships; procedure counts; regulatory approvals, clearances and restrictions or any dispute that may occur with any regulatory body, including, but not limited to, the recently submitted premarket notification to the FDA for the Ion™ endoluminal system; guidelines and recommendations in the healthcare and patient communities; intellectual property positions and litigation; competition in the medical device industry and in the specific markets of surgery in which the Company operates; unanticipated manufacturing disruptions or the inability to meet demand for products; the results of legal proceedings to which the Company is or may become a party; product liability and other litigation claims; adverse publicity regarding the Company and the safety of the Company’s products and adequacy of training; the Company’s ability to expand into foreign markets; the impact of changes to tax legislation, guidance, and interpretations; changes in tariffs, trade barriers, and regulatory requirements; and other risk factors under the heading “Risk Factors” in the Company’s report on Form 10-K for the year ended December 31, 2017, as updated by the Company’s other filings with the Securities and Exchange Commission. Statements using words such as “estimates,” “projects,” “believes,” “anticipates,” “plans,” “expects,” “intends,” “may,” “will,” “could,” “should,” “would,” “targeted” and similar words and expressions are intended to identify forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update or release any revisions to these forward-looking statements, except as required by law.

*About Non-GAAP Financial Measures

To supplement its consolidated financial statements, which are prepared and presented in accordance with accounting principles generally accepted in the United States (“GAAP”), the Company uses the following non-GAAP financial measures: non-GAAP gross profit, non-GAAP income from operations, non-GAAP net income, non-GAAP net income per diluted share (“EPS”), and non-GAAP diluted shares. The presentation of this financial information is not intended to be considered in isolation or as a substitute for, or superior to, the financial information prepared and presented in accordance with GAAP.

The Company uses these non-GAAP financial measures for financial and operational decision-making and as a means to evaluate period-to-period comparisons. The Company believes that these non-GAAP financial measures provide meaningful supplemental information regarding its performance and liquidity by excluding items such as intangible asset charges, share-based compensation (“SBC”) expenses, and other special items. Intangible asset charges consist of non-cash charges, such as the amortization of intangible assets, as well as in-process R&D charges. The Company believes that both management and investors benefit from referring to these non-GAAP financial measures in assessing its performance and when planning, forecasting, and analyzing future periods. These non-GAAP financial measures also facilitate management’s internal comparisons to its historical performance and liquidity. The Company believes these non-GAAP financial measures are useful to investors because (1) they allow for greater transparency with respect to key metrics used by management in its financial and operational decision-making and (2) they are used by institutional investors and the analyst community to help them analyze the performance of the Company’s business.

Non-GAAP gross profit. The Company defines non-GAAP gross profit as gross profit excluding intangible asset charges, expenses related to SBC, and litigation charges.

Non-GAAP income from operations. The Company defines non-GAAP income from operations as income from operations excluding intangible asset charges, expenses related to SBC, and litigation charges and recoveries.

Non-GAAP net income and EPS. The Company defines non-GAAP net income as net income excluding intangible asset charges; expenses related to SBC; litigation charges and recoveries, net of the related tax effects; and tax adjustments including the excess tax benefits or deficiencies associated with share-based compensation arrangements, the provisional income tax expense related to the Tax Cuts and Jobs Act (“2017 Tax Act”), and the net tax effects related to intra-entity transfers of non-inventory assets. The Company excludes income tax expense related to the 2017 Tax Act because of its one-time nature as well as the excess tax benefits or deficiencies associated with share-based compensation arrangements and the tax effects associated with non-cash amortization of deferred tax assets related to intra-entity non-inventory transfers as the Company does not believe these items correlate with the on-going results of its core operations. The tax effects of the non-GAAP items are determined by applying a calculated non-GAAP effective tax rate, which is commonly referred to as the with-and-without method. Without excluding these tax effects, investors would only see the gross effect that these non-GAAP adjustments had on the Company’s operating results. The Company’s calculated non-GAAP effective tax rate is generally higher than its GAAP effective tax rate. The Company defines non-GAAP EPS as non-GAAP net income divided by non-GAAP diluted shares which are calculated as GAAP weighted average outstanding shares plus dilutive potential shares outstanding during the period.

There are a number of limitations related to the use of non-GAAP measures versus measures calculated in accordance with GAAP. Non-GAAP gross profit, non-GAAP income from operations, non-GAAP net income, and non-GAAP EPS exclude items such as intangible asset charges, SBC, excess tax benefits or deficiencies associated with share-based compensation arrangements, and non-cash amortization of deferred tax assets related to intra-entity transfer of non-inventory assets, which are primarily recurring items. SBC has been and will continue to be for the foreseeable future a significant recurring expense in the Company’s business. In addition, the components of the costs that the Company excludes in its calculation of non-GAAP net income and non-GAAP EPS may differ from the components that its peer companies exclude when they report their results of operations. Management addresses these limitations by providing specific information regarding the GAAP amounts excluded from non-GAAP net income and non-GAAP EPS and evaluating non-GAAP net income and non-GAAP EPS together with net income and net income per share calculated in accordance with GAAP.

INTUITIVE SURGICAL, INC.
UNAUDITED QUARTERLY CONDENSED CONSOLIDATED STATEMENTS OF INCOME
(IN MILLIONS, EXCEPT PER SHARE DATA)
Three months ended
In millions (except per share data) September 30,
2018
June 30,
2018
September 30,
2017
Revenue:
Instruments and accessories $ 486.3 $ 476.1 $ 401.2
Systems 274.6 277.4 262.0
Services 160.0 155.8 144.6
Total revenue 920.9 909.3 807.8
Cost of revenue:
Product 225.1 228.1 195.4
Service 53.5 48.9 44.3
Total cost of revenue 278.6 277.0 239.7
Gross profit 642.3 632.3 568.1
Operating expenses:
Selling, general and administrative (1) 221.4 259.8 204.1
Research and development 107.6 95.1 83.4
Total operating expenses 329.0 354.9 287.5
Income from operations 313.3 277.4 280.6
Interest and other income, net 21.9 18.2 10.8
Income before taxes 335.2 295.6 291.4
Income tax expense (benefit) (2) 43.4 41.0 (7.2 )
Net income 291.8 254.6 298.6
Less: net loss attributable to non-controlling interest in joint venture (0.7 ) (0.7 )
Net income attributable to Intuitive Surgical, Inc. $ 292.5 $ 255.3 $ 298.6
Net income per share attributable to Intuitive Surgical, Inc.:
Basic $ 2.57 $ 2.25 $ 2.67
Diluted (3) $ 2.45 $ 2.15 $ 2.56
Weighted average shares outstanding:
Basic 114.0 113.5 111.8
Diluted 119.2 118.5 116.8
(1) Selling, general and administrative includes the effect of the following item:
Litigation charges (recoveries) $ (1.8 ) $ 42.5 $ 9.7
(2) Income tax expense (benefit) includes the effect of the following items:
Certain one-time tax benefit $ (4.6 ) $ $ (68.4 )
Excess tax benefits related to share-based compensation arrangements $ (24.1 ) $ (21.6 ) $ (19.7 )
(3) Diluted net income per share includes the effect of the following items:
Litigation recoveries (charges), net of tax $ 0.01 $ (0.27 ) $ (0.05 )
Certain one-time tax benefit $ 0.04 $ $ 0.59
Excess tax benefits related to share-based compensation arrangements $ 0.20 $ 0.18 $ 0.17

 

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OrthoPediatrics Corp. Receives FDA 510(k) Clearance for Small Stature Scoliosis System with 26th Surgical System

WARSAW, Ind., Oct. 19, 2018 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (NASDAQ: KIDS), a company exclusively focused on advancing the field of pediatric orthopedics, announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new RESPONSE 4.5/5.0mm System for treating smaller stature younger patients with complex scoliosis.  The system represents the Company’s 26th surgical system and is expected to launch in the fourth quarter of 2018.

The RESPONSE 4.5/5.0mm System was designed in collaboration with pediatric orthopedic surgeons focused on additional solutions for treating complex pediatric scoliosis patients. It expands the Company’s RESPONSE platform to treat smaller stature children and builds upon the successful implant and instrument technology of the RESPONSE 5.5/6.0mm System. The RESPONSE 4.5/5.0mm System offers a hybrid implant technology allowing the option of either a 4.5mm rod in CoCr or 5.0mm rod in titanium or cobalt chromium/chrome material, multiple implant connector options, and innovative, new instrumentation.

OrthoPediatrics’ Executive Vice President, David Bailey, stated, “We are pleased with the FDA 510(k) clearance for our 4.5/5.0mm system, which allows physicians to better treat smaller statures and patients at a younger age. Our engineering teams have been diligently working with a prominent group of surgeons, and we are excited to bring their innovative vision to life with another surgical solution for treating complex pediatric scoliosis.  The addition of the new system to our scoliosis platform continues to demonstrate OrthoPediatrics’ focus and commitment to providing solutions for children with complex spinal disorders.”

Scott Luhmann, M.D., Chief of Staff at Shriners Hospital for Children-St. Louis and Associate Professor in the Department of Orthopedic Surgery and Fellowship Director of Pediatric Orthopedic Surgery at Washington University School of Medicine, commented, “The new Response 4.5/5.0mm System brings OrthoPediatrics’ expertise and passion for musculoskeletal care of pediatric patients to the area of spinal deformity. This surgeon-centric system is focused on surgical efficacy and efficiency with an elegant rod reduction tool that significantly cuts down laborious task time in the effort to provide optimal patient outcome.”

Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of U.S. federal securities laws. You can identify forward-looking statements by the use of words such as “may,” “might,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “believe,” “estimate,” “project,” “target,” “predict,” “intend,” “future,” “goals,” “potential,” “objective,” “would” and other similar expressions. Forward-looking statements involve risks and uncertainties, many of which are beyond OrthoPediatrics’ control. Important factors could cause actual results to differ materially from those in the forward-looking statements, including, among others, the risks, uncertainties and factors set forth under “Risk Factors” in OrthoPediatrics’ Annual Report on Form 10-K filed with the SEC on March 15, 2018. Forward-looking statements speak only as of the date they are made. OrthoPediatrics assumes no obligation to update forward-looking statements to reflect actual results, subsequent events, or circumstances or other changes affecting such statements except to the extent required by applicable securities laws.

RESPONSE™ Spine System
Designed with a complete focus on children, the RESPONSE system offers a simple, technologically advanced system of instruments and implants to treat the distinct needs of pediatric patients with spinal deformities. The system features advanced instrument & implant technology including 1) innovative, low profile screw design including a proprietary set screw thread design for improved fixation and reduced potential for cross threading, and 2) unique pedicle screw head accepts a 5.5mm or 6.0mm rod in both cobalt chrome and titanium. Additionally, the system has versatile reduction & de-rotation capabilities with rod reducer instrument designed for easy snap on and off 2-in-1 rod reduction instrument enables each surgeon to perform reduction and de-rotation technique of choice and serves as a rod reducer and de-rotator in one.

About OrthoPediatrics Corp.
Founded in 2006, OrthoPediatrics is an orthopedic company focused exclusively on providing a comprehensive product offering to the pediatric orthopedic market to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets 25 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This offering spans trauma & deformity, scoliosis, and sports medicine/other procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and 38 countries outside the United States.

Investor Contacts
The Ruth Group
Tram Bui / Emma Poalillo
(646) 536-7035 / 7024
tbui@theruthgroup.com / epoalillo@theruthgroup.com

NuVasive Names J. Christopher Barry To Succeed Gregory T. Lucier As Chief Executive Officer; Lucier To Remain Chairman Of The Board

SAN DIEGOOct. 19, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced its Board of Directors has named J. Christopher Barry to succeed Gregory T. Lucier as chief executive officer (CEO) effective November 5, 2018. Mr. Barry will join the NuVasive Board of Directors; Mr. Lucier will continue to serve as chairman of the Board.

“On behalf of the Board of Directors, I want to thank Greg for his many contributions to NuVasive—first as a member of the Board, and then as our chairman and CEO. Greg quickly shaped NuVasive into a global spine systems innovator, delivering highly differentiated technologies and procedurally integrated solutions to the market, improving patient outcomes by enabling better clinical decision-making and execution. We look forward to continuing to work with Greg, leveraging his business leadership and industry expertise as chairman of the Board,” said Don Rosenberg, lead independent director of the NuVasive Board. “Succession planning is one of the most important responsibilities for a Board of Directors of a publicly traded company, and we take those responsibilities seriously. Through our comprehensive recruitment efforts, we were impressed with Chris’s expertise in the medical device industry, and feel his strong reputation as a skilled and strategic operator, along with his innate passion and business know-how, will enable him to continue NuVasive’s transformation of spine surgery, adding tremendous value as he leads NuVasive into the future.”

Mr. Barry brings to NuVasive extensive experience as an innovative global leader in the healthcare and medical device industry. Currently, he serves as senior vice president and president of Surgical Innovations, the second-largest business unit at Medtronic with $5.5 billion in annual revenue. In this role, Mr. Barry leads and provides strategic direction to more than 14,000 employees working in 78 countries, including 10 manufacturing sites and multiple R&D centers around the globe. He also is responsible for driving the core growth in Surgical Innovations while diversifying the business through acquisitions in near adjacencies and overseeing the development of Medtronic’s surgical robotics development initiative. He previously held commercial and leadership roles at Covidien.

“Chris has successfully led teams globally, managed complex R&D programs, driven commercial initiatives and executed strategic acquisitions. He has built a stellar reputation for driving employee engagement and operational excellence,” said Gregory T. Lucier, chairman and CEO of NuVasive. “Through my personal and professional interactions with Chris, it is clear to me his leadership will benefit our surgeon partners, employees and shareholders. As a Board member and shareholder, I have every confidence in Chris’s ability to take NuVasive to its next level of growth.”

NuVasive also announced today that Matt Link, currently executive vice president, Strategy, Technology and Corporate Development, is promoted to president. Since joining NuVasive in 2006, Mr. Link has held various roles with increasing scope within the organization, particularly around building the U.S. Commercial organization and most recently bringing his spine and leadership expertise to the product and systems engineering, surgeon education and corporate development functions.

Mr. Lucier commented, “The combination of Chris and Matt at the helm of NuVasive creates the most dynamic leadership team in the industry.”

Mr. Lucier will remain involved with the strategic direction of the company as the chairman of the Board. His focus will also be on supporting Mr. Barry and Mr. Link in this leadership transition. Mr. Lucier has been with NuVasive since December 2013, first joining as a member of the Board of Directors, and then stepping in as chairman and CEO in May 2015.

The Company will further discuss the management transition plan on its third quarter 2018 earnings call scheduled for October 30, 2018, at 4:30 p.m. ET/1:30 p.m. PT.

About NuVasive
NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally disruptive, procedurally integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With over $1 billion in revenues, NuVasive has an approximate 2,400 person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.

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

SOURCE NuVasive, Inc.

Related Links

http://www.nuvasive.com

SYNOSTE Ltd raises €5.1 million to launch its smart skeletal deformation correction technology

(Helsinki, October 18, 2018) – SYNOSTE Ltd, a Finnish medical device company creates smart solutions for patient-friendly bone-lengthening and bone-deformation correction. The company has raised over five million euros to start clinical investigations and to develop new clinical applications. SYNOSTE’s patented technology platform provides the basis for further disruptive changes in the treatment of congenital, trauma- and tumor-related limb discrepancies, adult and pediatric deformities, and craniomaxillofacial deformations.

The new funding was provided by Lifeline Ventures, a specialist early investor in game-changing technologies and AO Invest, an investment fund backed by the AO Foundation, the world’s largest community and network of musculoskeletal surgeons and scientists.

“We are excited to gain funding from two complimentary groups – Lifeline’s forward-thinking mindset and strong entrepreneurial experience combined with AO’s expertise and access to a global network of our target surgeons will empower our development of an expanded portfolio of cutting-edge solutions and enable us to transition them into clinical practice faster”, says SYNOSTE’s Managing Director and co-founder Harri Hallila.

 “SYNOSTE is exactly the type of company that interests AO Invest; they have created not just a product but a platform that will enable various intelligent solutions from traditional intramedullary nails to flat plates that can be used in the treatment of extremely painful and psychologically debilitating conditions” comments Michel Orsinger, Chairman of AO Invest.

The €5.1M Lifeline and AO investment raises the total equity invested in SYNOSTE to ten million euros. SYNOSTE’s other investors include strategic and financial investors: Evonik Venture Capital, a German materials company; High-Tech Gründerfonds, Germany’s largest seed investor; Innovestor Ventures, with the largest portfolio of venture backed companies in Finland; and Mectalent, a partner company that provides SYNOSTE component manufacturing and precision mechanics.

For further information about SYNOSTE, this investment, and our market opportunities, please contact Harri Hallila (hallila@synoste.com).
About AO Invest
AO Invest is a newly established investment fund focused on start-ups active in the field of musculoskeletal disorders. The fund is backed by the AO Foundation, a 60-year old non-profit organization, which boasts the world’s largest network of more than 19’000 surgeons and scientists in orthopedics and trauma. The goal of AO Invest is to invest in start-ups related to the AO Foundation’s core expertise, and use the Foundation’s unique reach and expertise to help their companies achieve their full potential.

About Lifeline Ventures
Lifeline Ventures is a team of serial entrepreneurs who invest in the sectors where they have explicit and comprehensive knowledge, know how, and experiences. As start-up specialists the team at Lifeline start working with a fledgling companies before they have launched their first products. The company credo is to be “FIRST” in the heart and mind of the partnering entrepreneur to support them in both times of trouble and joy. Lifeline’s notable investments include e.g. Supercell (acquired by Softbank), Moves (acquired by Facebook), Oncos Therapeutics, ZenRobotics and Applifier (acquired by Unity). For more information, please visit http://www.lifelineventures.com

Centric Medical™ Announces 510(k) Clearance of the SATURN™ External Fixation System

October 18, 2018

HUNTLEY, Ill.–(BUSINESS WIRE)–Centric Medical, a division of Life Spine®, Inc., which focuses on developing surgical implants for the treatment of lower distal extremity pathology, announced today That the U.S. Food and Drug Administration (FDA) has given 510(k) marketing clearance to the SATURN External Fixation System which consists of rings, struts, threaded rods, pins, wires and connectors intended to be used as a means to stabilize the foot, ankle and long bone segments.

“I am excited to continue the expansion of our foot and ankle portfolio with more complex solutions like the SATURN External Fixation System. The system has a wide variety of components to allow for a unique anatomical construct for each patient. The key features were designed with the intention to reduce operating time and provide greater ease of use for the surgical team,” said Mariusz Knap, Vice President of Marketing and Business Development for Life Spine and Centric Medical, “because the procedure involves so many moving pieces, it is crucial for the design to be simple, efficient and user-friendly.”

The external fixation system is the tenth 510(k) clearance for Life Spine in the last year and can be utilized for fusions, fractures, deformity reconstructions, tumors and Charcot Reconstructions.

About Centric Medical

Centric Medical is dedicated to improving the quality of life for patients with distal extremity symptomatology, increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Centric Medical, which is privately held, is based in Huntley, Illinois. For more information, please visit: http://www.centricmedical.com.

Contacts

For Centric Medical
Mr. Omar Faruqi
Chief Financial Officer
ofaruqi@lifespine.com
847-884-6117

The Orthopaedic Implant Company Launches Semi-Extended Tibial Nail Platform

VISEON, Inc. Announces FDA Clearance of the Voyant System for Minimally Invasive Spine Surgery Access, Visualization, and Illumination

October 18, 2018

IRVINE, Calif.–(BUSINESS WIRE)–Viseon, Inc. today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for their Voyant System for Minimally Invasive Spine Surgery, featuring proprietary HD imaging sensor and illumination technology. The Voyant System is composed of a sterile single-use, disposable retractor device with integrated state-of-the-art visualization technology, and a reusable controller enabling digital intraoperative manipulation of the surgical site image, displayed on existing operating room HD flat-panel display monitors. The sterile device also allows the surgeon to adjust intraoperative depth of focus.

Viseon President and CEO Jeffrey Valko stated, “We believe the primary factor contributing to spine surgeons’ slow adoption of minimally invasive spine surgery has been inconsistent outcomes driven by the limited or lack of direct access to and visibility of the surgical anatomy. Traditional capital-intensive surgical microscopes and loupes have been in use for many years, and Viseon is offering state-of-the-art technology as a simple alternative.”

John Liu, MD, professor of clinical neurological surgery at the Keck School of Medicine of USC commented, “This system offers an alternative to surgical microscope and surgical loupes visualization for many minimally invasive spine surgery procedures, eliminating ergonomic consequences and multiple scope repositioning maneuvers and refocusing. It also is useful teaching in the OR, since everyone can see and learn from the procedure.”

About Viseon, Inc.

Viseon has developed a platform technology that has multiple opportunities for technological expansion, including wireless, neuro-monitoring and navigation, fluorescence, sensor integration and complementary robotic applications. The company has demonstrated clinical utility in posterior lumbar decompression and interbody fusion procedures and is expanding into lumbar lateral access and anterior cervical decompression fusion applications. The privately held medical device company is located in Irvine, California, founded in 2017, and recently completed an oversubscribed follow-on financing in October 2018.

For further information, please visit www.viseon-spine.com.

Contacts

Viseon, Inc.
Jeffrey J. Valko, (949) 662-3959

Kuros Biosciences Advances its Fibrin-PTH (KUR-113) Spinal Fusion Product Candidate Program

SCHLIEREN (ZURICH), Switzerland, Oct. 18, 2018 (GLOBE NEWSWIRE) — Kuros Biosciences AG (SIX: KURN) announced today that the Company has reached a key milestone in its Fibrin-PTH (KUR-113) spinal fusion product candidate development program with the submission of a 510(k) regulatory package for its enabling lumbar intervertebral body fusion device to the U.S. Food and Drug Administration (FDA).

Kuros Biosciences will include this news in its program update to the North American Association of Spinal Surgeons (NASS) orthobiologics course ‘2018 Biologic Interventions for Spinal Pathologies: Stem Cells, Growth Factors & Novel Therapeutics’ being held in Chicago on Friday October 19.

“The submission of this US FDA 510(k) regulatory package keeps our KUR-113 spinal fusion product candidate development on track. Completion of the lumbar intervertebral body fusion device development is an important corporate milestone as the device will be used in the upcoming clinical trials in combination with Kuros’ spinal fusion product candidate KUR-113,” said Joost de Bruijn, CEO of Kuros.  “Coupled with the invitation to present an update at such a highly focused spine meeting of acknowledged experts in orthobiologics science marks the successful progress of our Company.”

About KUR-113
KUR-113 consists of a natural fibrin-based healing matrix with an immobilized targeted bone growth factor (truncated human parathyroid hormone (PTH) analog). KUR-113 is designed to be applied directly into and around an intervertebral body fusion device as a gel, where it polymerizes in situ. KUR-113 will be combined with the interbody spacer device in the upcoming clinical trial for interbody spinal fusion.

About the NASS ‘2018 Biologic Interventions for Spinal Pathologies’ Meeting
The field of spinal biologics is rapidly evolving as patients, researchers, and clinicians are recognizing its potential to treat challenging painful conditions. While the roles of both nonoperative and surgical treatment are relatively well-defined in the spine care treatment landscape, the indications, risks, and concerns regarding biologics for a variety of spinal conditions have not been agreed upon. Because of the differences in regulatory pathways for many of these products, the availability of data is variable making administrative decision-making difficult. This meeting will bring together exciting minds from academia and industry to discuss pertinent technologies and relevant issues in biologics use for spinal conditions.

For further information, please contact:
Kuros Biosciences AG Media & Investors
Michael Grau Hans Herklots
Chief Financial Officer LifeSci Advisors
Tel +41 44 733 47 47 +41 79 598 7149

About Kuros Biosciences AG 
Kuros Biosciences is focused on the development of innovative products for tissue repair and regeneration and is located in Schlieren (Zurich), Switzerland and Bilthoven, The Netherlands. The Company is listed according to the International Financial Reporting Standard on the SIX Swiss Exchange under the symbol KURN. Visit www.kurosbio.com for additional information on Kuros, its science and product pipeline.

Forward Looking Statements 
This media release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. You are urged to consider statements that include the words “will” or “expect” or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include scientific, business, economic and financial factors, Against the background of these uncertainties, readers should not rely on forward-looking statements. The Company assumes no responsibility for updating forward-looking statements or adapting them to future events or developments.

Simplify Medical Appoints IP Attorney Veteran to VP, General Counsel

SUNNYVALE, Calif., Oct. 18, 2018 (GLOBE NEWSWIRE) — Simplify Medical Pty Ltd, maker of the Simplify® cervical artificial disc, today announced that it has appointed Cindy Lynch to Vice President, General Counsel. Ms. Lynch has nearly 15 years of experience providing strategic legal and intellectual property advice to medical device startups.

Ms. Lynch’s appointment comes at a time when Simplify is expanding commercial efforts in Europe and nearing completion of its two-level U.S. IDE clinical trial for the implantation of its cervical artificial disc. The Company completed enrollment of its one-level trial in February 2018 with 166 patients enrolled at 16 U.S. sites and anticipates complete enrollment of 200 patients at 18 centers in its two-level study by the end of 2018.

David Hovda, Chief Executive Officer of Simplify Medical, commented, “Cindy has led our intellectual property program for years, and we are very excited she has joined our team as General Counsel.  While continuing to lead our IP program, which we believe is the largest and most impactful portfolio in cervical spine motion preservation, she will lead our overall legal strategy and continue to ensure our technology remains fully protected.”

Ms. Lynch specializes in intellectual property law and business venture advising. Prior to consulting for companies including Simplify Medical as in-house Counsel, she worked as the VP of Intellectual Property at Elixir Medical Corporation, Moximed, Inc., SpinalMotion, Inc., Conor Medsystems, Inc., and as a partner at Burns, Doane, Swecker & Mathis, LLP. Lynch will complete her M.B.A. from San Francisco State University in 2018 and earned her J.D. from George Mason University School of Law in 1995.

“I am thrilled to be part of the Simplify Medical team,” Cindy Lynch, J.D., said. “This is an exciting time to be working with Simplify as we near completion of the two-level Simplify Disc IDE trial enrollment and work toward the highly-anticipated commercial launch of the Simplify Disc, which will provide patients an innovative option for cervical disc replacement. As we continue to expand our commercial efforts, the protection of Simplify’s legal and IP interests is critical, and I look forward to working closely with the management team in these efforts.”

About Simplify Disc
Simplify® Disc is a motion preserving cervical artificial disc designed to allow for advanced imaging capability of MRI, and better match patients’ anatomies and kinematics. It is composed of advanced, primarily non-metal materials (PEEK-on-ceramic) to permit the full diagnostic imaging capability of MRI and may eliminate the need for CT/Myelogram and CT imaging in order to minimize patient exposure to radiation. The Simplify Disc is anatomically designed, offering a broader range of disc heights including low height implant options to better fit patients’ anatomies. With no metal in its articulating components, the disc is also designed for low levels of wear to optimize long-term durability. Implantation of the Simplify Disc is accomplished in a straightforward, three-step procedure.

About Simplify Medical
Simplify Medical is a medical device company focused on cervical spinal disc arthroplasty, using innovative, MRI-compatible materials designed to decrease the need for ionizing radiation and enhance patient options. Simplify Medical is located in Sunnyvale, California. To learn more, visit http://www.simplifymedical.com/.

Caution: The Simplify Disc is an investigational device in the United States and is limited by law to investigational use.

Simplify Medical Contacts:

Investor Contact:
Brian Johnston, The Ruth Group
Tel: +1 646-536-7028
Email: bjohnston@theruthgroup.com

Media Contact:
Kirsten Thomas, The Ruth Group
Tel: +1 508-280-6592
Email: kthomas@theruthgroup.com

TransEnterix CEO, Todd Pope Named One of TIME Magazine’s 50 Most Influential People in Health Care 2018

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