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.

READ THE REST HERE

(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

October 17, 2018

SANTA CLARA, Calif., Oct. 16, 2018 /PRNewswire/ — SI-BONE, Inc. (Nasdaq: SIBN) (“SI-BONE”), a medical device company that pioneered the minimally invasive surgical treatment of the sacroiliac joint with the iFuse Implant System®, today announced the pricing of its initial public offering of 7,200,000 shares of common stock at a price to the public of $15.00 per share. In addition, SI-BONE has granted the underwriters a 30-day option to purchase up to an additional 1,080,000 shares of common stock, at the initial public offering price less underwriting discounts and commissions. The shares are expected to begin trading on The Nasdaq Global Market under the ticker symbol “SIBN” on October 17, 2018.

Morgan Stanley and BofA Merrill Lynch are acting as joint book-running managers. Canaccord Genuity LLC and JMP Securities LLC are acting as co-managers.

The offering is being made only by means of a prospectus.  When available, a copy of the final prospectus may be obtained from Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014 or from BofA Merrill Lynch, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte NC  28255-0001, Attn: Prospectus Department, or email at dg.prospectus_requests@baml.com.

A registration statement relating to these securities has been filed with, and declared effective by, the Securities and Exchange Commission. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

SOURCE SI-BONE, Inc.

Related Links

http://www.si-bone.com

DUBLIN, Oct. 17, 2018 /PRNewswire/ —

The “Pedicle Screw System Market by Product Type (Monoaxial & Polyaxial Pedicle Screw), Surgery (Open, Minimal Invasive), Indication (Spinal Deformities, Spinal Trauma), Application (Thoracolumbar, Cervical Fusion) – Global Forecast to 2023” report has been added to ResearchAndMarkets.com’s offering.

The global pedicle screw systems market is expected to reach USD 724.23 million by 2023 from USD 538.64 million in 2018, at a CAGR of 6.1%.

The major factors driving the growth of this market are the increasing incidence of spinal cord injuries, the growing preference for minimally invasive surgeries, and a rising geriatric population.

By product type, the pedicle screw systems market is segmented into monoaxial, polyaxial, and other pedicle screw systems. In 2018, the polyaxial pedicle screw systems segment is estimated to command the largest share of the pedicle screw systems market. The large share of this segment can be attributed to the increasing incidences and prevalence of spinal cord injuries.

On the basis of surgery type, the pedicle screw systems market has been segmented into open surgery and minimally invasive surgery. The open surgery segment is expected to account for the largest share of the pedicle screw systems market in 2018. The large share of this segment can be attributed to the rising geriatric population and increasing incidence of spinal deformities.

Based on indication, the pedicle screw systems market has been segmented into spinal degeneration, spinal trauma, spine deformities, and other indications. In 2018, the spinal degeneration segment is projected to account for the largest share of the pedicle screw systems market. The increasing incidence of degenerative spinal disorders is the major driving factor for this market.

By application, the market is categorized into thoracolumbar fusion and cervical fusion. In 2018, thoracolumbar fusion is expected to command the largest share of this market. The increasing incidences of lumbar degenerative disc diseases and the launch of new products are key factors driving the growth of the thoracolumbar fusion segment.

The market is dominated by North America, followed by Europe. North America will continue to dominate the market during the forecast period. The rising geriatric population and increasing incidence of spinal disorders in this region are the major factors supporting the growth of the pedicle screw systems market in North America.

Stringent regulatory frameworks and time-consuming product approval processes may hinder the growth of the pedicle screw systems market to a certain extent.

The major players in the pedicle screw systems market include Globus Medical (US), DePuy Synthes (US), Zimmer Biomet (US), B. Braun (US), Stryker (US), and Medtronic (Ireland).

Key Topics Covered:

1 Introduction

2 Research Methodology

3 Executive Summary

4 Premium Insights
4.1 Pedicle Screw Systems Market Overview
4.2 Asia Pacific: Pedicle Screw Systems Market, By Product Type (2018)
4.3 Pedicle Screw Systems Market, By Region (2018)
4.4 Geographical Snapshot of the Pedicle Screw Systems Market

5 Market Overview
5.1 Introduction
5.2 Market Dynamics
5.2.1 Drivers
5.2.1.1 Increasing Incidence of Spinal Injuries
5.2.1.2 Rising Geriatric Population
5.2.1.3 Technological Advancements
5.2.1.4 Growing Preference for Minimally Invasive Surgeries
5.2.2 Opportunities
5.2.2.1 Emerging Economies Present Significant Growth Opportunities
5.2.3 Challenges
5.2.3.1 Stringent Regulatory Framework and Time-Consuming Approval Process
5.2.3.2 Product Failures and Recalls

6 Pedicle Screw Systems Market, By Product Type
6.1 Introduction
6.2 Polyaxial Pedicle Screw Systems
6.3 Monoaxial Pedicle Screw Systems
6.4 Other Pedicle Screw Systems

7 Pedicle Screw Systems Market, By Surgery Type
7.1 Introduction
7.2 Open Surgery
7.3 Minimally Invasive Surgery

8 Pedicle Screw Systems Market, By Indication
8.1 Introduction
8.2 Spinal Degeneration
8.3 Spinal Trauma
8.4 Spinal Deformities
8.5 Other Indications

9 Pedicle Screw Systems Market, By Application
9.1 Introduction
9.1.1 Thoracolumbar Fusion
9.1.2 Cervical Fusion

10 Pedicle Screw System Market, By Region
10.1 Introduction
10.2 North America
10.2.1 US
10.2.2 Canada
10.3 Europe
10.4 Asia Pacific
10.4.1 China
10.4.2 India
10.4.3 Japan
10.4.4 Rest of Asia Pacific
10.5 Rest of the World

11 Competitive Landscape
11.1 Overview
11.2 Market Ranking Analysis, 2017
11.3 Competitive Scenario
11.3.1 Product Launches and Approvals
11.3.2 Acquisitions
11.3.3 Expansions

12 Company Profiles

• Alphatec Spine, Inc. (A Subsidiary of Alphatec Holdings, Inc.)
• B. Braun Melsungen AG
• Depuy Synthes (A Subsidiary of Johnson & Johnson)
• Globus Medical, Inc.
• KM Group Holdings, Inc.
• Medtronic PLC
• Orthofix International N.V.
• RTI Surgical, Inc.
• Stryker Corporation
• Zimmer Biomet Holdings, Inc.

For more information about this report visit https://www.researchandmarkets.com/research/krbcqv/pedicle_screw?w=5

Did you know that we also offer Custom Research? Visit our Custom Research page to learn more and schedule a meeting with our Custom Research Manager.

Media Contact:

Research and Markets 
Laura Wood, Senior Manager 
press@researchandmarkets.com 

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SOURCE Research and Markets

Related Links

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October 16, 2018

CARLSBAD, Calif., Oct. 11, 2018 (GLOBE NEWSWIRE) — SeaSpine Holdings Corporation (NASDAQ: SPNE) (“SeaSpine” or the “Company”), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced the pricing of its previously announced underwritten public offering of 3,250,000 shares of its common stock at a public offering price of $15.50 per share. The gross proceeds to SeaSpine, before deducting the underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $50.4 million. The offering is expected to close on or about October 15, 2018, subject to customary closing conditions.

Wells Fargo Securities, LLC, Piper Jaffray & Co. and Cantor Fitzgerald & Co. are acting as joint book-running managers and BTIG, LLC is acting as lead manager for the offering. SeaSpine has granted the underwriters a 30-day option to purchase up to an additional 487,500 shares at the public offering price, less underwriting discounts and commissions.

SeaSpine intends to use the net proceeds from this offering to repay all of its outstanding borrowings under the Company’s credit facility with Wells Fargo Bank, National Association, and for general corporate purposes, including general and administrative expenses, capital expenditures and general working capital purposes.

A shelf registration statement on Form S-3 relating to the public offering of the shares of common stock described above was filed with the Securities and Exchange Commission (the “SEC”) and became effective on August 24, 2016. A preliminary prospectus supplement relating to the offering has been filed with the SEC and a final prospectus supplement relating to the offering will be filed with the SEC. Copies of the final prospectus supplement and accompanying prospectus, when available, may be obtained from Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 375 Park Avenue, New York, New York, 10152, by telephone at (800) 326-5897 or by email: cmclientsupport@wellsfargo.com; or Piper Jaffray & Co., 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, Attn: Prospectus Department, by telephone at (800) 747-3924 or by email: prospectus@pjc.com; or Cantor Fitzgerald & Co., 499 Park Ave., 6^th Floor, New York, New York 10012, Attn: Capital Markets, or by email: prospectus@cantor.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

ABOUT SEASPINE

SeaSpine (www.seaspine.com) is a global medical technology company focused on the design, development and commercialization of surgical solutions for the treatment of patients suffering from spinal disorders. SeaSpine has a comprehensive portfolio of orthobiologics and spinal implants solutions to meet the varying combinations of products that neurosurgeons and orthopedic spine surgeons need to perform fusion procedures on the lumbar, thoracic and cervical spine. SeaSpine’s orthobiologics products consist of a broad range of advanced and traditional bone graft substitutes that are designed to improve bone fusion rates following a wide range of orthopedic surgeries, including spine, hip, and extremities procedures.

FORWARD-LOOKING STATEMENTS

This press release contains certain forward-looking information about SeaSpine that is intended to be covered by the safe harbor for “forward-looking statements” provided by the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. Words such as “expect(s),” “feel(s),” “believe(s),” “will,” “may,” “anticipate(s)” and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements about the Company’s expectations regarding its capital raising efforts, including the closing of the public offering, the underwriters’ exercise of their option to purchase additional shares and the Company’s intended use of proceeds. All such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond the control of the Company, which could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include, but are not limited to, surgeons’ willingness to continue to use the Company’s existing products and to adopt its newly launched products, including the risk that the Company’s products do not demonstrate adequate safety or efficacy, independently or relative to competitive products, to support expected levels of demand or pricing; the ability of newly launched products to perform as designed and intended and to meet the needs of surgeons and patients, including as a result of the lack of clinical validation of products in limited commercial (or “alpha”) launch; the Company’s ability to attract new, high-quality distributors, whether as a result of inability to reach agreement on financial or other contractual terms or otherwise, disruption to the Company’s existing distribution network as new distributors are added, and the ability of new distributors to generate growth or offset disruption to existing distributors; continued pricing pressure, whether as a result of consolidation in hospital systems, competitors or others, as well as exclusion from major healthcare systems, whether as a result of unwillingness to provide required pricing or otherwise; the risk of supply shortages and the associated, potentially long-term disruption to product sales, including as a result of the Company’s dependence on a limited number of third-party suppliers for components and raw materials, or otherwise; unexpected expense and delay, including as a result of developing and supporting the launch of new products, the fact that newly launched products may require substantial additional development activities, which could introduce further expense and delay, or as a result of obtaining regulatory clearances; the Company’s ability to continue to invest in product development and sales and marketing initiatives at levels sufficient to drive future revenue growth, including as a result of its inability to obtain funding on a timely basis on acceptable terms, or at all; general economic and business conditions in the markets in which the Company does business, both in the U.S. and abroad, as well as other risks and uncertainties described under the “Risk Factors” contained in the Company’s periodic and interim SEC reports, including but not limited to, its Annual Report on Form 10-K for the fiscal year ended December 31, 2017, its Quarterly Reports on Form 10-Q for the quarters ended March 31, 2018 and June 30, 2018 and its Current Reports on Form 8-K filed from time to time with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof, and the Company does not undertake any obligation to revise and disseminate forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of or non-occurrence of any events.

Investor Relations Contact
Lynn Pieper Lewis
(415) 937-5402
ir@seaspine.com

October 11, 2018

October 11, 2018

AMSTERDAM, The Netherlands, Oct. 10, 2018 (GLOBE NEWSWIRE) — Wright Medical Group N.V. (NASDAQ:WMGI) today announced it has completed its acquisition of Cartiva, Inc. (Cartiva), an orthopaedic medical device company focused on treatment of osteoarthritis of the great toe.  The transaction adds a differentiated PMA-approved technology for a high-volume foot and ankle procedure and further accelerates growth opportunities in Wright’s global Extremities business.

Wright previously announced on August 27, 2018 that it had entered into a definitive agreement to acquire 100% of Cartiva’s outstanding equity on a fully diluted basis for a total price of $435 million in cash.

Wright will provide updated full-year 2018 guidance, including the impact of the Cartiva acquisition, on its third quarter 2018 earnings call, which is scheduled for November 7, 2018.

Robert Palmisano, president and chief executive officer, commented, “We are delighted to welcome Cartiva as a member of the Wright family.  With approximately 120,000 procedures for great toe arthritis performed each year in the U.S., we believe that this technology provides a proven alternative to fusion that reduces joint pain without sacrificing the foot’s natural movement and retains mobility and range of motion.”

Cartiva’s Synthetic Cartilage Implant (SCI) is indicated for treating arthritis at the base of the great toe and received U.S. Premarket Approval in July 2016.  The SCI is composed of a biocompatible, durable, low-friction organic polymer that functions similarly to natural cartilage and can be implanted in about 35 minutes.  Unlike fusion, Cartiva reduces joint pain without sacrificing the foot’s natural movement and retains mobility and range of motion.  Due to a less restrictive rehabilitation protocol, Cartiva patients typically return to function and activities of daily living faster than patients who undergo a fusion procedure.  Additional regulatory approvals have been obtained in Canada, EU, Brazil, Chile and Australia.

About Wright Medical Group N.V.

Wright Medical Group N.V. is a global medical device company focused on extremities and biologics products. The company is committed to delivering innovative, value-added solutions improving the quality of life for patients worldwide.  Wright is a recognized leader of surgical solutions for the upper extremities (shoulder, elbow, wrist and hand), lower extremities (foot and ankle) and biologics markets, three of the fastest growing segments in orthopaedics.

™ and ® denote trademarks and registered trademarks of Wright Medical Group N.V. or its affiliates, registered as indicated in the United States, and in other countries.  All other trademarks and trade names referred to in this release are the property of their respective owners.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS    

This release includes forward-looking statements under the Private Securities Litigation Reform Act of 1995. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “could,” “may,” “will,” “believe,” “estimate,” “continue,” “guidance,” “future,” other words of similar meaning and the use of future dates. Forward looking statements in this release include, but are not limited to, statements about the anticipated clinical and financial performance of Cartiva’s products.  Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Each forward-looking statement contained in this release is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, failure to achieve the anticipated financial benefits of the Cartiva acquisition, unanticipated clinical performance issues with Cartiva products or the introduction of competitive products with clinical performance attributes that are superior to Cartiva products, failure to achieve wide market acceptance of the Cartiva products due to clinical, regulatory, cost, reimbursement or other issues, failure to achieve anticipated financial results for 2018, the failure of Wright’s 2017 U.S. sales force additions to achieve expected results, delay or failure to drive U.S. lower extremities or biologics sales to anticipated levels; continued supply constraints; failure to integrate the legacy Wright and Tornier businesses and realize net sales synergies and cost savings from the merger with Tornier or delay in realization thereof; operating costs and business disruption as a result of that merger, including adverse effects on employee retention and sales force productivity and on business relationships with third parties; integration costs; actual or contingent liabilities; adverse effects of diverting resources and attention to providing transition services to the purchaser of the large joints business; the adequacy of Wright’s capital resources and need for additional financing; the timing of regulatory approvals and introduction of new products; physician acceptance, endorsement, and use of new products; failure to achieve the anticipated commercial sales of our AUGMENT^® Bone Graft and other new products; the effect of regulatory actions, changes in and adoption of reimbursement rates; product liability claims and product recalls; pending and threatened litigation; risks associated with the metal-on-metal master settlement agreement and the settlement agreement with the three settling insurers; risks associated with the subsequent metal-on-metal settlement agreements and ability to obtain the additional new insurance proceeds contingent thereon; risks associated with international operations and expansion; fluctuations in foreign currency exchange rates; other business effects, including the effects of industry, economic or political conditions outside of the company’s control; reliance on independent distributors and sales agencies; competitor activities; changes in tax and other legislation; and the risks identified under the heading “Risk Factors” in Wright’s Annual Report on Form 10-K for the year ended December 31, 2017 filed by Wright with the SEC on February 28, 2018 and subsequent SEC filings by Wright, including without limitation its Quarterly Reports on Form 10-Q for the quarters ended April 1, 2018 and July 1, 2018. Investors should not place considerable reliance on the forward-looking statements contained in this release. Investors are encouraged to read Wright’s filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this release speak only as of the date of this release, and Wright undertakes no obligation to update or revise any of these statements. Wright’s business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

Investors & Media:

Julie D. Dewey
Sr. Vice President, Chief Communications Officer
Wright Medical Group N.V.
(901) 290-5817
julie.dewey@wright.com