North America Minimally Invasive Surgical Instruments Market Analysis & Forecasts To 2023 – ResearchAndMarkets.com

April 25, 2018

DUBLIN–(BUSINESS WIRE)–The “North America Minimally Invasive Surgical Instruments Market – Forecasts from 2018 to 2023”report has been added to ResearchAndMarkets.com’s offering.

North America minimally invasive surgical instruments market is projected to grow at a CAGR of 7.28% from a market size of US$6.954 billion in 2017 during the forecast period and reach a market size of US$10.601 billion in 2023.

Early adoption of advanced technologies coupled with the presence of major market players in the region contributes to the growth of North America minimally invasive surgical instruments market. Growing geriatric population and high demand for quality healthcare services in this region further supports the market growth of minimally invasive surgical instruments market in the region.

This research study examines the current market trends related to the demand, supply, and sales, in addition to the recent developments. Major drivers, restraints, and opportunities have been covered to provide an exhaustive picture of the market. The analysis presents in-depth information regarding the development, trends, and industry policies and regulations implemented in each of the geographical regions. Further, the overall regulatory framework of the market has been exhaustively covered to offer stakeholders a better understanding of the key factors affecting the overall market environment.

Companies Mentioned

  • Ethicon US, LLC
  • Aesculap, Inc.
  • Medtronic
  • Stryker
  • Zimmer Biomet
  • CONMED Corporation
  • Microline Surgical
  • Abbott Laboratories

Key Topics Covered:

1. Introduction

2. Research Methodology

3. Executive Summary

4. Market Dynamics

5. North America Minimally Invasive Surgical Instruments Market By Type

6. North America Minimally Invasive Surgical Instruments Market By Application

7. North America Minimally Invasive Surgical Instruments Market By Geography

8. Competitive Intelligence

9. Company Profiles

For more information about this report visit https://www.researchandmarkets.com/research/kh8zg4/north_america?w=4

Contacts

ResearchAndMarkets.com
Laura Wood, Senior Manager
press@researchandmarkets.com
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Related Topics: Surgical Devices

TransEnterix Schedules First Quarter 2018 Financial and Operating Results Conference Call for May 8, 2018

April 24, 2018

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–TransEnterix, Inc. (NYSE American:TRXC) announced today that it plans to release first quarter 2018 financial and operating results after the market closes on Tuesday, May 8, 2018. Todd M. Pope, President and Chief Executive Officer, and Joseph P. Slattery, Executive Vice President and Chief Financial Officer will host a conference call to discuss these results starting at 4:30 pm Eastern Time the same day. The call will be concurrently webcast.

To listen to the conference call on your telephone, please dial 844-804-5261 for domestic callers and 612-979-9885 for international callers, and reference conference ID 4854118 approximately ten minutes prior to the start time. To access the live audio webcast or archived recording, use the following link http://ir.transenterix.com/events.cfm. The replay will be available on the Company’s website.

About TransEnterix

TransEnterix is a medical device company that is 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.

Contacts

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

SeaSpine to Report First Quarter 2018 Financial Results on May 3, 2018

CARLSBAD, Calif., April 19, 2018 (GLOBE NEWSWIRE) — SeaSpine Holdings Corporation (NASDAQ:SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, announced today that it will release first quarter 2018 financial results after the close of trading on Thursday, May 3, 2018. The Company’s management team will host a conference call beginning at 1:30pm PT / 4:30pm ET to discuss the financial results and recent business developments.

Individuals interested in listening to the conference call may do so by dialing (877) 418-4766 for domestic callers or (614) 385-1253 for international callers, using Conference ID: 8167947. To listen to a live webcast, please visit the Investors section of the SeaSpine website at: www.seaspine.com.

The call will be archived until Thursday May 17, 2018. The audio archive can be accessed by calling (855) 859-2056 in the U.S. or (404) 537-3406 from outside the U.S. The passcode for the audio replay is 8167947.

About SeaSpine

SeaSpine 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. SeaSpine’s spinal implants portfolio consists of an extensive line of products to facilitate spinal fusion in minimally invasive surgery, complex spine, deformity and degenerative procedures. Expertise in both orthobiologic sciences and spinal implants product development allows SeaSpine to offer its surgeon customers a differentiated portfolio and a complete procedural solution to meet their fusion requirements. SeaSpine currently markets its products in the United States and in over 30 countries worldwide.

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

RTI Surgical Schedules First Quarter 2018 Earnings Call for May 3, 2018

April 19, 2018

ALACHUA, Fla.–(BUSINESS WIRE)–RTI Surgical, Inc. (Nasdaq: RTIX), a global surgical implant company, today announced that it plans to release financial results for the first quarter 2018 on Thursday, May 3, 2018 prior to the market open.

RTI will host a conference call and simultaneous audio webcast to discuss first quarter results at 9:00 a.m. ET the same day. The conference call can be accessed by dialing (877) 383-7419 (U.S.) or (760) 666-3754 (International). The webcast can be accessed through the investor section of RTI’s website at www.rtix.com. A replay of the conference call will be available on RTI’s website for one month following the call.

About RTI Surgical, Inc.

RTI Surgical is a leading global surgical implant company providing surgeons with safe biologic, metal and synthetic implants. Committed to delivering a higher standard, RTI’s implants are used in sports medicine, general surgery, spine, orthopedic and trauma procedures and are distributed in nearly 50 countries. RTI has four manufacturing facilities throughout the U.S. and Europe. RTI is accredited in the U.S. by the American Association of Tissue Banks and is a member of AdvaMed. For more information, please visit www.rtix.com.

Forward-Looking Statements

This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management’s current expectations, estimates and projections about our industry, our management’s beliefs and certain assumptions made by our management. Words such as “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” variations of such words and similar expressions are intended to identify such forward-looking statements. In addition, except for historical information, any statements made in this communication about anticipated financial results, growth rates, new product introductions, future operational improvements, gaining market share and results or regulatory actions or approvals or changes to agreements with distributors also are forward-looking statements. These statements are not guarantees of future performance and are subject to risks and uncertainties, including the risks described in public filings with the U.S. Securities and Exchange Commission (SEC). Our actual results may differ materially from the anticipated results reflected in these forward-looking statements. Copies of the company’s SEC filings may be obtained by contacting the company or the SEC or by visiting RTI’s website at www.rtix.com or the SEC’s website at www.sec.gov.

Contacts

RTI Surgical, Inc.
Media Contact:
Molly Poarch, +1-224-287-2661
mpoarch@rtix.com
or
Investor Contact:
Nathan Elwell, +1-847-530-0249
nelwell@lincolnchurchilladvisors.com

 

Johnson & Johnson Reports 2018 First-Quarter Results

NEW BRUNSWICK, N.J.April 17, 2018 /PRNewswire/ — Johnson & Johnson (NYSE: JNJ) today announced sales of $20.0 billion for the first quarter of 2018, an increase of 12.6% as compared to the first quarter of 2017. Operational sales results increased 8.4% and the positive impact of currency was 4.2%. Domestic sales increased 6.1%. International sales increased 19.9%, reflecting operational growth of 10.9% and a positive currency impact of 9.0%. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales increased 4.3%, domestic sales increased 1.3% and international sales increased 7.6%.*

Net earnings and diluted earnings per share for the first quarter of 2018 were $4.4 billion and $1.60, respectively. First-quarter 2018 net earnings included after-tax intangible amortization expense of approximately $1.0 billion and a charge for after-tax special items of approximately $0.3 billion. First-quarter 2017 net earnings included after-tax intangible amortization expense of approximately $0.2 billion and a charge for after-tax special items of approximately $0.4 billion. Excluding after-tax intangible amortization expense and special items, adjusted net earnings for the current quarter were $5.6 billion and adjusted diluted earnings per share were $2.06, representing increases of 11.8% and 12.6%, respectively, as compared to the same period in 2017.* On an operational basis, adjusted diluted earnings per share also increased 5.5%.A reconciliation of non-GAAP financial measures is included as an accompanying schedule.

“We are pleased with the strong and consistent performance delivered by our colleagues around the world, demonstrated by our sales and EPS growth in the first quarter,” said Alex Gorsky, Chairman and Chief Executive Officer. “Our Pharmaceutical business continues to deliver robust growth and we are pleased with the improvement in our Consumer business. In our Medical Devices businesses, we have areas of leadership and continue to make investments and portfolio choices to improve performance.”

Mr. Gorsky continued, “The U.S. tax legislation passed late last year is creating the opportunity for us to invest more than $30 billion in R&D and capital investments in the U.S. over the next four years, which is an increase of 15%.”

The Company increased its sales guidance for the full-year 2018 to a range of $81.0 to $81.8 billion, reflecting expected operational growth in the range of 4.0% to 5.0%. Additionally, the Company reaffirmed its adjusted earnings guidance for full-year 2018 to a range of $8.00 to $8.20 per share, reflecting expected operational growth in the range of 6.8% to 9.6%.

Segment Sales Performance
Worldwide Consumer sales of $3.4 billion for the first quarter 2018 represented an increase of 5.3% versus the prior year, consisting of an operational increase of 1.3% and a positive impact from currency of 4.0%. Domestic sales increased 1.6%, international sales increased 8.2%, which reflected an operational increase of 1.2% and a positive currency impact of 7.0%. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales increased 2.0%, domestic sales increased 1.6% and international sales increased 2.3%*.

Worldwide operational results, excluding the net impact of acquisitions and divestitures, were driven by beauty products primarily NEUTROGENA, AVEENO, and Dr. Ci Labo, and international analgesics in over-the-counter products, partially offset by the negative impact of domestic baby care products.

Worldwide Pharmaceutical sales of $9.8 billion for the first quarter 2018 represented an increase of 19.4% versus the prior year with an operational increase of 15.1% and a positive impact from currency of 4.3%. Domestic sales increased 9.9%; international sales increased 33.1%, which reflected an operational increase of 22.5% and a positive currency impact of 10.6%. Sales included the impact of Actelion Ltd which contributed 7.6%, to worldwide operational sales growth. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales increased 7.5%, domestic sales increased 2.2% and international sales increased 15.3%.*

Worldwide operational results, excluding the net impact of acquisitions and divestitures, were driven by new products and the strength of core products. Strong growth in new products include DARZALEX (daratumumab), for the treatment of patients with multiple myeloma, IMBRUVICA (ibrutinib), an oral, once-daily therapy approved for use in treating certain B-cell malignancies, a type of blood or lymph node cancer and TREMFYA (guselkumab), for the treatment of adults living with moderate to severe plaque psoriasis.  Additional contributors to operational sales growth included ZYTIGA  (abiraterone acetate), an oral, once-daily medication for use in combination with prednisone for the treatment of metastatic, castration-resistant prostate cancer, STELARA (ustekinumab) and international SIMPONI/SIMPONI ARIA (golimumab), biologics for the treatment of  a number of immune-mediated inflammatory diseases, XARELTO (rivaroxaban), an oral anticoagulant, and INVEGA SUSTENNA/XEPLION/TRINZA/TREVICTA (paliperidone palmitate), long-acting, injectable atypical antipsychotics for the treatment of schizophrenia in adults.

During the quarter, the U.S. Food and Drug Administration (FDA) approved an additional indication for ZYTIGA (abiraterone acetate), in combination with prednisone for the treatment of patients with metastatic high-risk castration-sensitive prostate cancer and ERLEADA (apalutamide) an oral androgen receptor inhibitor for the treatment of patients with non-metastatic castration-resistant prostate cancer. In addition, the Committee for Medicinal Products for Human Use issued a positive opinion recommending marketing authorization for JULUCA (rilpivirine and dolutegravir), the first, single-pill, two-drug regimen for the treatment of human immunodeficiency virus type 1 infection.

Also in the quarter, a marketing authorization application was submitted to the European Medicines Agency for apalutamide, an oral androgen receptor inhibitor for the treatment of patients with high-risk non-metastatic castration-resistant prostate cancer.

Worldwide Medical Devices sales of $6.8 billion for the first quarter 2018 represented an increase of 7.5% versus the prior year consisting of an operational increase of 3.2% and a positive currency impact of 4.3%. Domestic sales increased 2.2%; international sales increased 12.7%, which reflected an operational increase of 4.2% and a positive currency impact of 8.5%. Sales included the partial quarter impact of the recently acquired surgical vision business  which contributed 3.1%, to worldwide operational sales growth. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales increased 1.1%, domestic sales decreased 0.2% and international sales increased 2.4%.*

Worldwide operational results, excluding the net impact of acquisitions and divestitures, were driven by ACUVUE contact lenses in the Vision Care business; electrophysiology products in the Interventional Solutions business; endocutters in the Advanced Surgery business; and trauma products in the Orthopaedics business, partially offset by declines in the Diabetes Care business and spine products in the Orthopaedics business.

During the quarter, the acquisition of Orthotaxy S.A.S., a privately-held developer of software-enabled surgery technologies, including a differentiated robotic-assisted surgery was completed. In addition, the Company announced a binding offer from Platinum Equity, a private investment firm, to acquire its LifeScan business for approximately $2.1 billion, subject to customary adjustments.

Subsequent to the quarter, ACUVUE OASYS with Transitions received 510(k) clearance from the FDA and is indicated for vision correction and the attenuation of bright light.

Additionally, Johnson & Johnson plans to implement actions across its global supply chain that are intended to enable the company to focus resources and increase investments in critical capabilities, technologies and solutions necessary to manufacture and supply its product portfolio of the future, enhance agility and drive growth. The Company expects these supply chain actions will include expanding our use of strategic collaborations, and bolstering our initiatives to reduce complexity, improving cost-competitiveness, enhancing capabilities and optimizing our network.  Discussions regarding specific future actions are ongoing and are subject to all relevant consultation requirements before they are finalized.

In total, the Company expects these actions to generate approximately $0.6 to $0.8 billion in annual pre-tax cost savings that will be substantially delivered by 2022. The Company expects to record pre-tax restructuring charges of approximately $1.9 to $2.3 billion, which will be treated as a special item.

About Johnson & Johnson
At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s largest and most broadly-based health care company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. We are blending our heart, science and ingenuity to profoundly change the trajectory of health for humanity.

* Operational sales growth excluding the net impact of acquisitions and divestitures, as well as adjusted net earnings, adjusted diluted earnings per share and operational adjusted diluted earnings per share excluding after-tax intangible amortization expense and special items, are non-GAAP financial measures and should not be considered replacements for, and should be read together with, the most comparable GAAP financial measures. Except for guidance measures, reconciliations of these non-GAAP financial measures to the most directly comparable GAAP financial measures can be found in the accompanying financial schedules of the earnings release and the Investor Relations section of the company’s website at www.investor.jnj.com. Johnson & Johnson does not provide GAAP financial measures on a forward-looking basis because the company is unable to predict with reasonable certainty the ultimate outcome of legal proceedings, unusual gains and losses, acquisition-related expenses and purchase accounting fair value adjustments without unreasonable effort. These items are uncertain, depend on various factors, and could be material to Johnson & Johnson’s results computed in accordance with GAAP.

Johnson & Johnson will conduct a conference call with investors to discuss this news release today at 8:30 a.m., Eastern Time. A simultaneous webcast of the call for investors and other interested parties may be accessed by visiting the Johnson & Johnson website at www.investor.jnj.com. A replay and podcast will be available approximately two hours after the live webcast by visiting www.investor.jnj.com.

Copies of the financial schedules accompanying this press release are available at www.investor.jnj.com/historical-sales.cfm. These schedules include supplementary sales data, a condensed consolidated statement of earnings, reconciliations of non-GAAP financial measures, and sales of key products/franchises. Additional information on Johnson & Johnson, including adjusted income before tax by segment, a pharmaceutical pipeline of selected compounds in late stage development and a copy of today’s earnings call presentation can be found on the company’s website at www.investor.jnj.com.

NOTE TO INVESTORS CONCERNING FORWARD-LOOKING STATEMENTS

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things: future operating and financial performance, product development, market position and business strategy. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: economic factors, such as interest rate and currency exchange rate fluctuations; competition, including technological advances, new products and patents attained by competitors; challenges inherent in new product research and development, including uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success for new and existing products; challenges to patents; the impact of patent expirations; the ability of the company to successfully execute strategic plans, including restructuring plans; the impact of business combinations and divestitures; manufacturing difficulties or delays, internally or within the supply chain; product efficacy or safety concerns resulting in product recalls or regulatory action; significant adverse litigation or government action, including related to product liability claims; changes to applicable laws and regulations, including tax laws and global health care reforms; trends toward health care cost containment; changes in behavior and spending patterns of purchasers of health care products and services; financial instability of international economies and legal systems and sovereign risk; increased scrutiny of the health care industry by government agencies. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 31, 2017, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.govwww.jnj.com or on request from Johnson & Johnson. Any forward-looking statement made in this release speaks only as of the date of this release. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.

 

Johnson & Johnson and Subsidiaries

Supplementary Sales Data

(Unaudited; Dollars in Millions)

FIRST QUARTER

Percent Change

2018

2017

Total

Operations

Currency

Sales to customers by

segment of business

Consumer

    U.S.

$       1,436

1,414

1.6

%

1.6

    International

1,962

1,814

8.2

1.2

7.0

3,398

3,228

5.3

1.3

4.0

Pharmaceutical

    U.S.

5,354

4,872

9.9

9.9

    International

4,490

3,373

33.1

22.5

10.6

9,844

8,245

19.4

15.1

4.3

Medical Devices

    U.S.

3,161

3,092

2.2

2.2

    International

3,606

3,201

12.7

4.2

8.5

6,767

6,293

7.5

3.2

4.3

U.S.

9,951

9,378

6.1

6.1

International

10,058

8,388

19.9

10.9

9.0

Worldwide

$     20,009

17,766

12.6

%

8.4

4.2

 

 

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K2M Group Holdings, Inc. to Release First Quarter of Fiscal Year 2018 Financial Results on May 1, 2018

LEESBURG, Va., April 13, 2018 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (NASDAQ:KTWO) (the “Company” or “K2M”), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance, today announced that first quarter of fiscal year 2018 financial results will be released after the market close on May 1, 2018.

Management will host a conference call at 5:30 p.m. Eastern Time on May 1, 2018 to discuss the results of the first quarter, and to host a question and answer session. Those who would like to participate may dial 866-393-4306 (734-385-2616 for international callers) and provide access code 8395568 approximately 10 minutes prior to the start of the call. A live webcast of the call will also be provided on the investor relations section of the Company’s website at http://Investors.K2M.com/.

For those unable to participate, a replay of the call will be available for two weeks at 855-859-2056 (404-537-3406 for international callers); access code 8395568. The webcast will be archived on the investor relations section of the Company’s website.

About K2M

K2M Group Holdings, Inc. is a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance. Since its inception, K2M has designed, developed, and commercialized innovative complex spine and minimally invasive spine technologies and techniques used by spine surgeons to treat some of the most complicated spinal pathologies. K2M has leveraged these core competencies into Balance ACS®, a platform of products, services, and research to help surgeons achieve three-dimensional spinal balance across the axial, coronal, and sagittal planes, with the goal of supporting the full continuum of care to facilitate quality patient outcomes. The Balance ACS platform, in combination with the Company’s technologies, techniques and leadership in the 3D-printing of spinal devices, enable K2M to compete favorably in the global spinal surgery market. For more information, visit www.K2M.com and connect with us on FacebookTwitterInstagramLinkedIn and YouTube.

Forward-Looking Statements

This press release contains forward-looking statements that reflect current views with respect to, among other things, operations and financial performance.  Forward-looking statements include all statements that are not historical facts such as our statements about our expected financial results and guidance and our expectations for future business prospects.  In some cases, you can identify these forward-looking statements by the use of words such as, “outlook,” “guidance,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “could,” “seeks,” “predicts,” “intends,” “plans,” “estimates,” “anticipates” or the negative version of these words or other comparable words. 

Such forward-looking statements are subject to various risks and uncertainties including, among other things: our ability to achieve or sustain profitability in the future; our ability to demonstrate to spine surgeons and hospital customers the merits of our products and to retain their use of our products; pricing pressures and our ability to compete effectively generally; collaboration and consolidation in hospital purchasing; inadequate coverage and reimbursement for our products from third-party payers; lack of long-term clinical data supporting the safety and efficacy of our products; dependence on a limited number of third-party suppliers; our ability to maintain and expand our network of direct sales employees, independent sales agencies and international distributors and their level of sales or distribution activity with respect to our products; proliferation of physician-owned distributorships in the industry; decline in the sale of certain key products; loss of key personnel; our ability to enhance our product offerings through research and development; our ability to maintain adequate working relationships with healthcare professionals; our ability to manage expected growth; our ability to successfully acquire or invest in new or complementary businesses, products or technologies; our ability to educate surgeons on the safe and appropriate use of our products; costs associated with high levels of inventory; impairment of our goodwill and intangible assets; disruptions to our corporate headquarters and operations facilities or critical information technology systems or those of our suppliers, distributors or surgeon users; our ability to ship a sufficient number of our products to meet demand; our ability to strengthen our brand; fluctuations in insurance cost and availability; our ability to remediate the material weaknesses in our IT general controls; our ability to comply with extensive governmental regulation within the United States and foreign jurisdictions; our ability to maintain or obtain regulatory approvals and clearances within the United States and foreign jurisdictions; voluntary corrective actions by us or our distribution or other business partners or agency enforcement actions; recalls or serious safety issues with our products; enforcement actions by regulatory agencies for improper marketing or promotion; misuse or off-label use of our products; delays or failures in clinical trials and results of clinical trials; legal restrictions on our procurement, use, processing, manufacturing or distribution of allograft bone tissue; negative publicity concerning methods of tissue recovery and screening of donor tissue; costs and liabilities relating to environmental laws and regulations; our failure or the failure of our agents to comply with fraud and abuse laws; U.S. legislative or Food and Drug Administration regulatory reforms; adverse effects associated with the exit of the United Kingdom from the European Union; adverse effects of medical device tax provisions; potential tax changes in jurisdictions in which we conduct business; our ability to generate significant sales; potential fluctuations in sales volumes and our results of operations over the course of a fiscal year; uncertainty in future capital needs and availability of capital to meet our needs; our level of indebtedness and the availability of borrowings under our credit facility; restrictive covenants and the impact of other provisions in the indenture governing our convertible senior notes and our credit facility; worldwide economic instability; our ability to protect our intellectual property rights; patent litigation and product liability lawsuits; damages relating to trade secrets or non-competition or non-solicitation agreements; risks associated with operating internationally; fluctuations in foreign currency exchange rates; our ability to comply with the Foreign Corrupt Practices Act and similar laws; increased costs and additional regulations and requirements as a result of being a public company; our ability to implement and maintain effective internal control over financial reporting; potential volatility in our stock price; our lack of current plans to pay cash dividends; potential dilution by the future issuances of additional common stock in connection with our incentive plans, acquisitions or otherwise; anti-takeover provisions in our organizational documents and our ability to issue preferred stock without shareholder approval; potential limits on our ability to use our net operating loss carryforwards; and other risks and uncertainties, including those described under the section entitled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the SEC, as such factors may be updated from time to time in our periodic filings with the SEC, which are accessible on the SEC’s website at www.sec.gov.  Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements.  These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this release and our filings with the SEC.

We operate in a very competitive and challenging environment. New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this release. We cannot assure you that the results, events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results, events or circumstances could differ materially from those described in the forward-looking statements.

The forward-looking statements made in this press release relate only to events as of the date on which the statements are made. We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Unless specifically stated otherwise, our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, investments or other strategic transactions we may make.

EOS imaging Reports 1st Quarter 2018 Revenue Growth of 34% and Full Year 2017 Results

April 11, 2018

PARIS–(BUSINESS WIRE)–Regulatory News:

EOS imaging (Paris:EOSI) (Euronext, FR0011191766 – EOSI), the pioneer of orthopedic medical imaging 2D / 3D, today announces its first quarter 2018 consolidated sales revenue and consolidated results for the full year ended December 31, 2017, as adopted by the Board of Directors on April 11, 2018.

FIRST QUARTER 2018 & FULL YEAR 2017 HIGHLIGHTS

  • Q1 2018 sales increased 34% to €9.5 million, driven by 54% growth in the North American region
    (76% exluding forex impact) coupled with an increase in average selling price (ASP) despite an unfavorable forex effect
  • 2017 revenue up 21% to €37.1 million taking the 5-year CAGR to 32% (2012-2017)
  • Gross margin temporarily impacted during the reorganization in North America during 2017
  • Robust control of operating expenses
  • Cash position of €6.9 million as of December 31, 2017, strengthened in January 2018 by drawing a fourth tranche of €4.9 million on the bond issue

Marie Meynadier, CEO of EOS imaging, commented: “2017 was a year rich in corporate achievements for EOS imaging. We successfully completed an in-depth remodeling of our North American operations in record time to support our development in this key market, while maintaining strong growth of 54% on the combination of the EMEA and APAC markets. The strong momentum in North America evidenced by Q1 2018 sales growth supports our confidence about the effectiveness of this new organization.

Sales growth, driven by the contribution of the North American zone and significant improvement in selling prices, will contribute positively to the increase in the gross margin in 2018. This combined with continued cost control of operating expenses will allow to significantly reduce operating losses over the coming year.

The company is further strengthened and well-positioned to respond effectively to the strong acceleration of the adoption of the EOS® system and continue to provide healthcare professionals and patients with innovative solutions tailored to their needs.”

REVENUE UP 34% IN FIRST QUARTER 2018, DRIVEN BY NORTH AMERICA

€ millions Q1 2018 Q1 2017 Var
Equipment sales 7.56 5.47 38%
As a % of total revenues 79% 77%
Sales of maintenance 1.73 1.40 24%
As a % of total revenues 18% 19%
Sales of consumables and services 0.26 0.26 0%
As a % of total revenues 3% 4%
Total revenues 9.54 7.13 34%
NB. Unaudited data

Equipment sales increased 38% compared to the first quarter of 2017 to €7.56 million, following the sales of 19 EOS® systems, compared to the 14 systems sold in first quarter 2017. Average selling price reached €398 thousand, including currency effects, compared with €391 thousand in 2017.

Sales of maintenance contracts increased 24% to €1.7 million. This reflects the continued increase in the installed base of EOS® systems and an associated high contract subscription rate after warranty.

Sales of consumables and services were stable at €0.3 million.

€ millions Q1 2018 Q1 2017 Var
EMEA 3.53 3.21 10%
North America 3.81 2.48 54%
Asia-Pacific 2.21 1.44 53%
Total revenues 9.54 7.13 34%
NB. Unaudited data

Sales in the North American market grew at a historic level of 54% to €3.8 million (76% growth at constant exchange rate). The strong dynamics observed in the first quarter in the region confirms the trend observed in the fourth quarter of 2017 and abodes for solid growth in coming quarters. ASP in USD in North America was 10% above that of the first quarter of 2017.

Sales rose 54% in the Asia-Pacific region to €2.2 million, boosted by a strong Australian market and new milestones in China.

In the EMEA region, the company observed continued momentum on all key markets, with sales growth of 10% at €3.5 million.

A FULL YEAR OF STRONG ACHIEVEMENTS IN 2017

  • Revenue growth of 21% to €37.1 million

EOS imaging reported full year 2017 revenue of €37.1 million, an increase of 21% compared to the prior year.

Equipment sales grew by 20% to €30.0 million. Recurring revenues were €7.1 million, up 24% compared to 2016. Recurring revenues included sales of maintenance of €5.9 million and sales of consumables and services of €1.2 million.

In addition, EOS imaging received €1.7 million in public grants in 2017 to support ongoing innovation, including a research tax credit recognized in “Other income”.

  • Gross margin temporarily impacted at 45.3%

Gross margin for the full year 2017 was 45.3%, a decrease compared to the prior year mainly due to a reduction in average selling price which was partially compensated by reductions in average cost of sales.

Average selling price was impacted by (1) the remodeling of the US organization, leading to a lower North American contribution to global revenue as well as a decrease in ASP in the first half of the year, and (2) a forex effect.

  • Solid control of operating expenses

Operating expenses excluding cost of share-based payments for the full year 2017 totaled €23.4 million, up 11% compared to the prior year. Global operating expenses were 24.3 million and included a €0.4 million increase in the cost of share-based payments.

Operating loss for the full year 2017 was €5.8 million compared with an operating loss of €4.6 million in 2016.

Net financial expense for the full year 2017 totaled €2.0 million, compared to €1.6 million in 2016, reflecting interest expense on the Company’s €15.0 million debt financing

Net loss for the full year 2016 was €7.8 million compared with a net loss of €6.2 million in the previous year.

  • Summarized Income statement
In millions of euros 2017 2016
Revenue 37.09 30.77
Other income 1.72 2.33
Total income 38.81 33.10
Direct cost of sales (20.29) (16.20)
Gross margin 16.81 14.58
as a % of revenue 45.3% 47.4%
Indirect cost of production and services (4.12) (3.83)
Research & development (4.10) (3.89)
Sales & marketing (9.81) (8.66)
Regulatory expenses (0.74) (0.70)
Administrative costs (4.61) (3.91)
Total operating expenses excluding cost of goods and share-based payments (23.38) (20.99)
Share-based payments (0.91) (0.48)
Total operating expenses (24.29) (21.46)
Operating income/(loss) (5.77) (4.56)
Net financial income/(expense) (2.01) (1.61)
Net income/(loss) (7.78) (6.17)
NB. Unaudited data
  • Net cash at December 31, 2017: €6.9 million

As of December 31, 2017, EOS imaging’s net cash totaled €6.9 million, compared with €14.9 million at December 31, 2016. A fraction of the first tranche of the IPF debt was reimbursed in 2017, and a rescheduling and drafting of a €4.9 million fourth tranche concluded in early 2018.

Consolidated equity stood at €23.2 million at December 31, 2017, compared with €22.8 million at December 31, 2016.

ABOUT EOS imaging

EOS imaging designs, develops and markets EOS®, a major innovative medical imaging solution dedicated to osteoarticular pathologies and orthopaedics combining equipment and services targeting a $2M per year market opportunity. EOS imaging is currently present in 27 countries, including the United States under FDA agreement, Japan, China and the European Union under CE labelling, through approximately 250 EOS® installed representing around one million patient exams every year. Revenues were €37.1M in 2017, e.g. a +32% CAGR over 2012-2017.

For more information, please visit www.eos-imaging.com.

EOS imaging has been chosen to be included in the new EnterNext© PEA-PME 150 index, composed of 150 French companies and listed on Euronext and Alternext markets in Paris.

EOS imaging is listed on Compartment C of Euronext Paris
ISIN: FR0011191766 – Ticker: EOSI

Next press release: Release of Q2 2018 sales in July 17, 2018

Contacts

EOS imaging
Marie Meynadier, CEO, +33 1 55256060
investors@eos-imaging.com
or
Press Relations (US)
The Ruth Group
Joanna Zimmerman, +1 646-536-7006
jzimmerman@theruthgroup.com
or
Investor Relations (US)
The Ruth Group
Matt Picciano / Emma Poalillo
Ph: +1 646-536-7008 / 7024
eos-imaging@theruthgroup.com

NuVasive Announces Conference Call And Webcast Of First Quarter 2018 Results

SAN DIEGOApril 10, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, announced today that its first quarter 2018 earnings announcement will take place on Tuesday, May 1, 2018, after the close of the market.

NuVasive will hold a conference call on Tuesday, May 1, 2018, at 4:30 p.m. ET / 1:30 p.m. PT to discuss the results of its financial performance for the first quarter 2018. The dial-in numbers are 1-877-407-9712 for domestic callers and 1-201-689-8323 for international callers. A live webcast of the conference call will be available online from the Investor Relations page of the Company’s website at www.nuvasive.com.

After the live webcast, the call will remain available on NuVasive’s website through June 1, 2018. In addition, a telephone replay of the call will be available until May 8, 2018. The replay dial-in numbers are 1-844-512-2921 for domestic callers and 1-412-317-6671 for international callers. Please use pin number: 13678607.

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, but are not limited to, the risk that NuVasive’s revenue or earnings projections may turn out to be inaccurate because of the preliminary nature of the forecasts; the risk of further adjustment to financial results or future financial expectations; unanticipated difficulty in selling products, generating revenue or producing expected profitability; and those other risks and uncertainties more fully 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

InVivo Therapeutics Provides Business Update

April 09, 2018

CAMBRIDGE, Mass.–(BUSINESS WIRE)–InVivo Therapeutics Holdings Corp. (Nasdaq:NVIV) today provided a general business update. The company is announcing a 1-for-25 reverse stock split of its common stock and a proportionate reduction in its authorized common stock. The company anticipates the reverse stock split will become effective at 5:00 p.m. Eastern Time on April 16, 2018, and shares of InVivo Therapeutics common stock will trade on a post-split basis under the Company’s existing trading symbol, “NVIV,” at the market open on April 17, 2018. The new CUSIP number for the Company’s common stock following the reverse stock split will be 46186M 407.

At the effective time of the reverse stock split, every 25 shares of InVivo Therapeutics common stock will be combined into 1 share of InVivo Therapeutics common stock. In connection with the reverse stock split, the authorized shares will be reduced from 100 million shares to four million shares. The reverse stock split is anticipated to reduce the company’s issued and outstanding shares of common stock from approximately 38.1 million to approximately 1.52 million. In addition, proportionate adjustments will be made to the exercise prices of the company’s outstanding stock options and warrants and to the number of shares issued and issuable under the company’s existing stock incentive plans.

The company also announced that it is in the process of finalizing a lease assignment, expected to result in lease-related savings of approximately $3M through 2019. In addition to the lease assignment, InVivo is undertaking other key initiatives to align its core competencies and business strategy in the most cost-efficient manner. Based on these initiatives, InVivo projects its average cash burn over the last three quarters of 2018 to be approximately $1M per month, compared to an average cash burn of approximately $1.5M per month during the last three quarters of 2017 and the first quarter of 2018.

“InVivo remains committed to executing on its near-term goals while building momentum to create shareholder value. Cost-saving initiatives, including the proposed assignment of our lease, will allow us to continue to chart our new path forward,” said Richard Toselli, M.D., President and Chief Executive Officer of InVivo Therapeutics. “In light of this strategy and after careful consideration, we further determined that a reverse stock split will best allow us to achieve future financing goals on favorable terms for the company and its shareholders. We have received the support of our Board of Directors in taking these actions, and we look forward to providing further updates as we explore financing options.”

About InVivo Therapeutics

InVivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who then was at Boston Children’s Hospital and who now is affiliated with Massachusetts General Hospital. In January 2018, the company announced updated clinical evidence, including improvements in patients with acute spinal cord injury (SCI), from its INSPIRE study of the Neuro-Spinal Scaffold™. The publicly traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com.

Safe Harbor Statement

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as “believe,” “anticipate,” “intend,” “estimate,” “will,” “may,” “should,” “expect” and similar expressions, and include statements regarding the company’s planned reverse stock split and planned cost savings initiatives, including the proposed assignment of its lease. Any forward-looking statements contained herein are based on current expectations, and are subject to a number of risks and uncertainties. Factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to: the company’s ability to effect the 1-for-25 reverse stock split and the administrative process related thereto, to successfully identify financing alternatives and raise the capital necessary to undertake the second pivotal trial, to successfully decrease costs and spend and to successfully open additional clinical sites for enrollment and to enroll additional patients if such trial is initiated; the timing of the Institutional Review Board process; the company’s ability to obtain FDA approval to commercialize its products; the company’s ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the company’s products and technology in connection with spinal cord injuries; the availability of substantial additional funding for the company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and other risks associated with the company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies identified and described in more detail in the company’s Annual Report on Form 10-K for the year ended December 31, 2017 and its other filings with the SEC, including the company’s quarterly reports on Form 10-Q and current reports on Form 8-K. The company does not undertake to update these forward-looking statements.

Contacts

InVivo Therapeutics
Heather Hamel, 617-863-5530
Investor Relations
Investor-relations@invivotherapeutics.com

SpineGuard Reports Q1 2018 Revenue

April 05, 2018

PARIS & SAN FRANCISCO–(BUSINESS WIRE)–Regulatory News:

SpineGuard (Paris:ALSGD) (FR0011464452 – ALSGD), an innovative company that develops and markets instruments designed to secure the placement of surgical implants by bringing real-time digital technology into the operating room, reported today its first-quarter 2018 revenue of €1.95m decreasing 7.9% in constant currency (-2.9% in the USA) and of €1.8m at actual exchange rate.

Stéphane Bette, CEO and co-founder of SpineGuard, said: “The sales result in the first quarter was impacted by a base effect as well as an unfavorable dollar-euro exchange rate. This trimester also includes the preparation work for deploying the “Smart Screw” embedded with DSG™ sensing technology in the USA, where we signed with Zavation an additional distribution agreement allowing us to directly serve our customers and contribute from now on to significantly increase our revenue per surgery. Our teams are mobilized to reach our goal of operational profitability by year-end thanks to expense control discipline as well as geographic focus on the USA, France and China where we just delivered a second order.

Global revenue in the first quarter of 2018 was €1,769k vs. €2,169k in Q1 2017 strongly impacted by the decrease of the US Dollar relative to the Euro, i.e. -18.4%. The decrease was 7.9% cc.

SpineGuard sold 2,351 DSG™ units in the first quarter of 2018 vs. 2,397 units in Q1 2017. 1,306 units (56%) were sold in the USA where the revenue decreased 2.9% in constant currency (-15.9% at actual exchange rate) at USD 1,846k vs. USD 1,901k.

Recent events:

February 2018

SpineGuard S.A (Paris) passed successfully the three-year cycle CE mark
renewal audit by the TÜV SÜD.

March 2018

“SmartScrew Technology Reduces Radiation Exposure and OR Time in MIS
Lumbar Surgery” Article published in Becker’s Spine Review.

Here.

March 2018

SpineGuard S.A (Paris) underwent an inspection by the U.S. Food and Drug
Administration without any inspectional observations.

March 2018

Publication of a German study recognizing PediGuard as a safety tool for
securing cervical screw placement in the peer-reviewed scientific journal
European Spine Journal. Find the abstract Here.

Next financial press release: 2018 Half-year revenue: July 11, 2018

About SpineGuard®
Founded in 2009 in France and the USA by Pierre Jérôme and Stéphane Bette, SpineGuard’s mission is to make spine surgery safer by bringing real-time digital technology into the operating room. Its primary objective is to establish its proprietary DSG™ (Dynamic Surgical Guidance) technology as the global standard of surgical care, starting with safer screw placement in spine surgery and then in other surgeries. PediGuard®, the first device designed using DSG, was co-invented by Maurice Bourlion, Ph.D., Ciaran Bolger, M.D., Ph.D., and Alain Vanquaethem, Biomedical Engineer. It is the world’s first and only handheld device capable of alerting surgeons to potential pedicular or vertebral breaches. Over 60,000 surgical procedures have been performed worldwide with DSG™ enabled devices. Numerous studies published in peer-reviewed medical and scientific journals have demonstrated the multiple benefits that PediGuard® delivers to patients, surgical staff and hospitals. SpineGuard is expanding the scope of its DSG™ platform through strategic partnerships with innovative medical device companies and the development of smart instruments and implants. SpineGuard has offices in San Francisco and Paris. For further information, visit www.spineguard.com.

Disclaimer

The SpineGuard securities may not be offered or sold in the United States as they have not been and will not be registered under the Securities Act or any United States state securities laws, and SpineGuard does not intend to make a public offer of its securities in the United States. This is an announcement and not a prospectus, and the information contained herein does and shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the securities referred to herein in the United States in which such offer, solicitation or sale would be unlawful prior to registration or exemption from registration.

Contacts

SpineGuard
Stéphane Bette, Tel: +33 (0)1 45 18 45 19
Chief Executive Officer
s.bette@spineguard.com
or
Manuel Lanfossi
Chief Financial Officer
m.lanfossi@spineguard.com
or
Europe / NewCap
Investor Relations & Financial Communication
Mathilde Bohin / Pierre Laurent
Tel: +33 (0)1 44 71 94 94
spineguard@newcap.eu