Globus Medical Reports Full Year and Fourth Quarter 2017 Results

AUDUBON, Pa., Feb. 21, 2018 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal solutions company, today announced its financial results for the fourth quarter and year ended December 31, 2017.

Fourth Quarter:

  • Worldwide sales increased 16.1% as reported to $176.0 million
  • Fourth quarter net income was $24.4 million, or 13.8% of sales, including a one-time tax reform expense of $11.0 million
  • Diluted earnings per share (EPS) were $0.25
  • Non-GAAP diluted EPS were $0.38
  • Non-GAAP adjusted EBITDA was 34.9% of sales

Full Year 2017:

  • Worldwide sales increased 12.8% as reported to $636.0 million
  • Net income for the year was $107.3 million, or 16.9% of sales, including a one-time tax reform expense of $11.0 million
  • Diluted EPS were $1.10
  • Non-GAAP diluted EPS were $1.31
  • Non-GAAP adjusted EBITDA was 35.6% of sales

“Fourth quarter sales were a record $176.0 million, a year-over-year increase of 16.1%,” said Dave Demski, CEO.  “We also delivered non-GAAP EPS of $0.38, despite increased investments to support our robotics and trauma launches.  Sales growth was strong across all parts of the business in the fourth quarter, with U.S. spine up 6.5%, international spine up 16.2% and Imaging, Navigation and Robotics posting revenue for the first time.”

“Full year 2017 sales were $636.0 million, a 12.8% increase over 2016 and non-GAAP EPS was $1.31.  In 2017, we not only recorded our first sales of the ExcelsiusGPS™ robotic and navigation system, we also launched 9 new products in spine, received FDA clearance for 10 systems in trauma, further expanded our in-house manufacturing capacity, recruited a record number of competitive sales reps into our U.S. spine sales force, made tremendous progress on the Alphatec International integration, and smoothly completed the CEO transition.”

Fourth quarter sales in the U.S. increased 16.1% compared to the fourth quarter of 2016 as a result of mid-single digit core spine growth plus a successful robotic launch.  International sales increased by 16.2% over the fourth quarter of 2016 on an as reported basis.

Fourth quarter GAAP net income was $24.4 million, flat compared to the same period last year including a one-time tax reform expense of $11.0 million.  Diluted EPS for the fourth quarter was $0.25, also flat compared to the same period last year.  Non-GAAP diluted EPS was $0.38 for the fourth quarter, an increase of 20.6%, compared to $0.31 in the fourth quarter of 2016.

The company generated operating cash flow of $44.8 million and non-GAAP free cash flow of $31.4 million in the fourth quarter of 2017.  Full year 2017 operating cash flow was $159.5 million and non-GAAP free cash flow was $107.8 million.  Cash, cash equivalents and marketable securities ended the quarter at $429.8 million.  The company remains debt free.

2018 Annual Guidance
The company confirms 2018 full year sales of $690 million and non-GAAP fully diluted earnings per share of $1.50.

Conference Call Information
Globus Medical will hold a teleconference to discuss its 2017 fourth quarter and full year results with the investment community at 4:30 p.m. Eastern Time today.  Globus invites all interested parties to join the call by dialing:

1-855-533-7141  United States Participants
1-720-545-0060   International Participants
There is no pass code for the teleconference.

For interested parties who do not wish to ask questions, the teleconference will be webcast live and may be accessed through a link on the Globus Medical website at

The call will be archived until Wednesday, February 28, 2018.  The audio archive can be accessed by calling 1-855-859-2056 in the U.S. or 1-404-537-3406 from outside the U.S. The passcode for the audio replay is 716-5819.

About Globus Medical, Inc.
Based in Audubon, Pennsylvania, Globus Medical, Inc. was founded in 2003 by an experienced team of professionals with a shared vision to create products that enable surgeons to promote healing in patients with musculoskeletal disorders. Additional information can be accessed at

Non-GAAP Financial Measures
To supplement our financial statements prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”), management uses certain non-GAAP financial measures.  For example, non-GAAP adjusted EBITDA, which represents net income before interest income, net and other non-operating expenses, provision for income taxes, depreciation and amortization, stock-based compensation, provisions for litigation, technology in-licensing fee, and acquisition related costs, is useful as an additional measure of operating performance, and particularly as a measure of comparative operating performance from period to period, as it is reflective of changes in pricing decisions, cost controls and other factors that affect operating performance, and it removes the effect of our capital structure, asset base, income taxes and interest income and expense.  Our management also uses non-GAAP adjusted EBITDA for planning purposes, including the preparation of our annual operating budget and financial projections.  Provision for litigation represents costs incurred for litigation settlements or unfavorable verdicts when the loss is known or considered probable and the amount can be reasonably estimated, or in the case of a favorable settlement, when income is realized.  Acquisition related costs/licensing represents the change in fair value of business acquisition related contingent consideration; costs related to integrating recently acquired businesses including but not limited to costs to exit or convert contractual obligations, severance, and information system conversion; and specific costs related to the consummation of the acquisition process such as banker fees, legal fees, and other acquisition related professional fees, as well as one time licensing fees.

In addition, for the period ended December 31, 2017 and for other comparative periods, we are presenting non-GAAP net income and non-GAAP diluted earnings per share, which represents net income and diluted earnings per share excluding the provision for litigation, amortization of intangibles, acquisition related costs/licensing, prior period adjustment and the tax effects of such adjustments.  Prior period adjustments represent the cumulative impact of prior year adjustments related to depreciation, scrap and provision for excess and obsolete inventory, none of which were individually material to the related year’s financial position or results of operations.  We believe these non-GAAP measures are also useful indicators of our operating performance, and particularly as additional measures of comparative operating performance from period to period as they remove the effects of litigation, amortization of intangibles, acquisition related costs/licensing, prior period adjustments and the tax effects of such adjustments, which we believe are not reflective of underlying business trends.  Additionally, for the periods ended December 31, 2017 and for other comparative periods, we also define the non-GAAP measure of free cash flow as the net cash provided by operating activities, adjusted for the impact of restricted cash, less the cash impact of purchases of property and equipment.  We believe that this financial measure provides meaningful information for evaluating our overall financial performance for comparative periods as it facilitates an assessment of funds available to satisfy current and future obligations and fund acquisitions.  Furthermore, the non-GAAP measure of constant currency sales growth is calculated by translating current year sales at the same average exchange rates in effect during the applicable prior year period.  We believe constant currency sales growth provides insight to the comparative increase or decrease in period sales, in dollar and percentage terms, excluding the effects of fluctuations in foreign currency exchange rates.

Non-GAAP adjusted EBITDA, non-GAAP net income, non-GAAP diluted earnings per share, free cash flow and constant currency sales growth are not calculated in conformity with U.S. GAAP.  Non-GAAP financial measures have limitations as analytical tools and should not be considered in isolation or as a substitute for financial measures prepared in accordance with U.S. GAAP.  These measures do not include certain expenses that may be necessary to evaluate our liquidity or operating results.  Our definitions of non-GAAP adjusted EBITDA, non-GAAP net income, non-GAAP diluted earnings per share, free cash flow and constant currency sales growth may differ from that of other companies and therefore may not be comparable.  Additionally, we have recast prior periods for non-GAAP net income and non-GAAP diluted earnings per share.

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

Three Months Ended Year Ended
(In thousands, except per share amounts) December 31,
December 31,
December 31,
December 31,
Sales $ 176,034 $ 151,590 $ 635,977 $ 563,994
Cost of goods sold 40,856 39,002 150,453 134,705
Gross profit 135,178 112,588 485,524 429,289
Operating expenses:
Research and development 11,413 13,643 43,679 44,532
Selling, general and administrative 72,958 60,839 267,817 222,156
Provision for litigation (112 ) 100 2,668 3,156
Amortization of intangibles 2,238 1,805 7,909 3,478
Acquisition related costs 321 479 1,611 1,826
Total operating expenses 86,818 76,866 323,684 275,148
Operating income 48,360 35,722 161,840 154,141
Other income, net 2,240 755 8,088 3,138
Income before income taxes 50,600 36,477 169,928 157,279
Income tax provision 26,224 12,179 62,580 52,938
Net income $ 24,376 $ 24,298 $ 107,348 $ 104,341
Earnings per share:
Basic $ 0.25 $ 0.25 $ 1.12 $ 1.09
Diluted $ 0.25 $ 0.25 $ 1.10 $ 1.08
Weighted average shares outstanding:
Basic 96,489 95,862 96,243 95,647
Diluted 98,726 96,513 97,887 96,432





EOS imaging Announces First System Installation within Asklepios Private Hospital Group in Germany

February 21, 2018

PARIS–(BUSINESS WIRE)–Regulatory News:

EOS imaging (Paris:EOSI) (Euronext, FR0011191766 – EOSI – Eligible PEA – PME), the pioneer of 2D/3D imaging and data solutions for orthopedics, today announced the first installation of an EOS® system within the Asklepios Hospital Group, the second largest private hospital network in Germany. The EOS system is available at the Asklepios Paulinen Hospital, enabling 3D full-body imaging at a low-dose of radiation, and reinforcing the hospital’s mission as a “Center of Excellence” for back disorders and treatment. The Asklepios Paulinen Hospital hosted a ceremony to celebrate the installation and introduce the community to the EOS system on February 21, 3:00 – 5:00 pm CET.

The Asklepios Paulinen Hospital is a general hospital with 316 beds located in Wiesbaden, Germany that specializes in state-of-the-art methods for improved patient care. In order to diagnose and treat patients in an interdisciplinary manner, it established several specialized medical centers including spinal surgery and orthopedics. With the installation of the EOS system, the spine and orthopedic team has taken another step towards an integrative “Center of Excellence” for the diagnosis and treatment of back disorders. The new device represents a major advance in diagnostics, the subsequent treatment planning and the treatment control of malpositions and deformities of the musculoskeletal system.

“I am thrilled with the new system, which opens up a whole new range of diagnostic options, including more than 100 3D clinical parameters that provide information on the spine’s angular and axial relationships with unprecedented precision. Particularly for patients with deformities like scoliosis, the Micro Dose option is a clear advantage, allowing us to take pictures with minimal radiation while maintaining excellent image quality,” commented Professor Dr. Thomas Niemeyer, Head of the Spine Surgery Department.

“We are pleased to expand our presence in Germany with this installation,” commented Marie Meynadier, Chief Executive Officer of EOS imaging. “The Asklepios Hospital Group is committed to advancing the orthopedic standard of care, as evidenced by building a Center of Excellence for the diagnosis and treatment of back disorders at the Asklepios Paulinen Hospital. We look forward to our technology contributing to this commitment.”

About EOS imaging

EOS imaging designs, develops, and markets EOS®, an innovative medical imaging system dedicated to osteoarticular pathologies and orthopaedics, as well as associated solutions. The Company is authorized to market in 51 countries, including the United States (FDA), Japan and the European Union (EC). The Group posted 2017 sales of €37.1 million and employs 152 people at December 2017. The Group is based in Paris and has five subsidiaries in Besançon (France), Cambridge (Massachusetts), Montreal (Canada), Frankfurt (Germany) and Singapore.

EOS imaging has been selected to integrate the EnterNext © PEA – PME 150 index, composed of 150 French, listed companies on the Euronext markets in Paris.

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


EOS imaging
Pierre Schwich, +33 (0)1 55 25 61 24
The Ruth Group (US)
Press relations
Joanna Zimmerman, 646-536-7006

Anika Reports Fourth Quarter and Full Year 2017 Financial Results

February 21, 2018

BEDFORD, Mass.–(BUSINESS WIRE)–Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated orthopedic medicines company specializing in therapeutics based on its proprietary hyaluronic acid (“HA”) technology, today reported financial results for the fourth quarter and full year ended December 31, 2017, along with business progress in the periods.

“2017 was a year of significant achievement for Anika, highlighted by double-digit revenue growth, expansion of MONOVISC® and CINGAL® into new international markets, completion of the CINGAL Phase III trial enrollment ahead of schedule, and the strengthening of our executive team,” said Charles H. Sherwood, Ph.D., Chief Executive Officer. “As we look to 2018, we are poised to complete the CINGAL Phase III trial and submit a New Drug Application to the FDA. Our strategic objectives are focused on global commercial expansion, pipeline advancement, and the development of a direct commercialization capability in the U.S. to accelerate our revenue and earnings growth in the years ahead and to create sustained value for our shareholders.”

Fourth Quarter and Full Year Financial Results

  • Total revenue for the fourth quarter of 2017 was $29.4 million, compared to $28.7 million for the fourth quarter of 2016. Total revenue for the full year of 2017 grew 10% to $113.4 million, compared to $103.4 million for the full year of 2016. Total revenue for the full year of 2017 included $5.0 million in milestone revenue earned in the second quarter as a result of MONOVISC achieving $100 million in U.S. end-user sales within a consecutive 12-month period ending in June 2017.
  • Product revenue increased 2% year-over-year in the fourth quarter of 2017. MONOVISC revenue grew 21% year-over-year in the fourth quarter of 2017, which was partially offset by the decline in ORTHOVISC® revenue in the same period, following the industry shift from multiple to single injection therapies. For the full year of 2017, product revenue increased 5% and MONOVISC global revenue grew 29%, which was the primary overall revenue growth driver.
  • International Orthobiologics revenue increased 22% for the full year of 2017, due primarily to the global expansion of MONOVISC, as well as the growth of CINGAL in international markets. Domestically, ORTHOVISC and MONOVISC continued to maintain a combined market-leading position.
  • Total operating expenses for the fourth quarter of 2017 were $19.7 million, compared to $16.0 million for the fourth quarter of 2016. The increase in total operating expenses was due primarily to higher research and development investments required to advance the Company’s growing pipeline towards regulatory approvals and to expand the commercial team in anticipation of those product launches. Total operating expenses for the full year of 2017 were $67.7 million, compared to $52.8 million for the full year of 2016.
  • Net income for the fourth quarter of 2017 was $8.1 million, or $0.53 per diluted share, compared to $8.1 million, or $0.54 per diluted share, for the fourth quarter of 2016. Net income for the fourth quarter of 2017 included a one-time tax benefit of $2.3 million, or $0.15 per diluted share, resulting from the recently enacted U.S. tax reform legislation. Net income for the full year of 2017 was $31.8 million, or $2.11 per diluted share, compared to $32.5 million, or $2.15 per diluted share, for the full year of 2016.

Recent Business Highlights
The Company made key commercial, operational, pipeline, and financial advancements, including:

  • Expanding CINGAL and MONOVISC international presence, with MONOVISC product approvals and related commercial launches in India, Australia, and Taiwan.
  • Advancing its product pipeline with completion of patient enrollment in the CINGAL Phase III clinical study, and continued progress on enrolling patients in the FastTRACK Phase III HYALOFAST® Study for cartilage repair.
  • Expanding Anika’s regenerative medicine portfolio with 510(k) clearance from the FDA for its injectable HA-based bone repair treatment.
  • Expanding its strategic collaboration with the Institute for Applied Life Sciences at the University of Massachusetts Amherst to continue the development of an innovative therapy for the treatment of rheumatoid arthritis, and with the Institute of Integrative Biology at the University of Liverpool to collaborate on research to develop an injectable mesenchymal stem cell therapy for the treatment of osteoarthritis.
  • Completed all planned activities related to the consolidation of the Company’s global manufacturing operations at Anika’s Bedford, Massachusetts corporate headquarters.

Full Year 2018 Corporate Outlook
Looking forward to 2018, the Company expects total revenue growth to be around the mid-single digit percentage range for the full year of 2018. Licensing, milestone and contract revenue is expected to be $5 million for the year. The Company also anticipates continued headway on several key initiatives including:

  • Completion of the Phase III clinical trial of CINGAL, and the submission of a New Drug Application to the FDA for CINGAL;
  • International expansion of MONOVISC and CINGAL;
  • Continued progress toward the development of a direct commercialization capability in the U.S.; and
  • Expanding Anika’s regenerative medicine pipeline with a new product candidate for rotator cuff repair.

Conference Call Information
Anika’s management will hold a conference call and webcast to discuss its financial results and business highlights tomorrow, Thursday, February 22 at 9:00 am ET. The conference call can be accessed by dialing 1-855-468-0611 (toll-free domestic) or 1-484-756-4332 (international). A live audio webcast will be available in the “Investor Relations” section of Anika’s website, An accompanying slide presentation may also be accessed via the Anika website. A replay of the webcast will be available on Anika’s website approximately two hours after the completion of the event.

About Anika Therapeutics, Inc.
Anika Therapeutics, Inc. (NASDAQ: ANIK) is a global, integrated orthopedic medicines company based in Bedford, Massachusetts. Anika is committed to improving the lives of patients with degenerative orthopedic diseases and traumatic conditions with clinically meaningful therapies along the continuum of care, from palliative pain management to regenerative cartilage repair. The Company has over two decades of global expertise developing, manufacturing, and commercializing more than 20 products based on its proprietary hyaluronic acid (HA) technology. Anika’s orthopedic medicine portfolio includes ORTHOVISCMONOVISC, and CINGAL, which alleviate pain and restore joint function by replenishing depleted HA, and HYALOFAST, a solid HA-based scaffold to aid cartilage repair and regeneration. For more information about Anika, please visit

Forward-Looking Statements
The statements made in the last sentence of the second paragraph and those made in the section titled “Full Year 2018 Corporate Outlook” of this press release, which are not statements of historical fact, are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include, but are not limited to, those relating to the completion of the Company’s CINGAL clinical trial and associated regulatory submission, the Company’s development of, and goals associated with, its direct commercial capability, the Company’s expectations regarding its 2018 financial performance, the international expansion of the Company’s viscosupplementation product lines, and the expansion of the Company’s regenerative medicine portfolio. These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks, uncertainties, and other factors. The Company’s actual results could differ materially from any anticipated future results, performance, or achievements described in the forward-looking statements as a result of a number of factors including, but not limited to, (i) the Company’s ability to successfully commence and/or complete clinical trials of its products on a timely basis or at all; (ii) the Company’s ability to obtain pre-clinical or clinical data to support domestic and international pre-market approval applications, 510(k) applications, or new drug applications, or to timely file and receive FDA or other regulatory approvals or clearances of its products; (iii) that such approvals will not be obtained in a timely manner or without the need for additional clinical trials, other testing or regulatory submissions, as applicable; (iv) the Company’s research and product development efforts and their relative success, including whether we have any meaningful sales of any new products resulting from such efforts; (v) the cost effectiveness and efficiency of the Company’s clinical studies, manufacturing operations, and production planning; (vi) the strength of the economies in which the Company operates or will be operating, as well as the political stability of any of those geographic areas; (vii) future determinations by the Company to allocate resources to products and in directions not presently contemplated; (viii) the Company’s ability to successfully commercialize its products, in the U.S. and abroad; (ix) the Company’s ability to provide an adequate and timely supply of its products to its customers; and (x) the Company’s ability to achieve its growth targets. Additional factors and risks are described in the Company’s periodic reports filed with the Securities and Exchange Commission, and they are available on the SEC’s website at Forward-looking statements are made based on information available to the Company on the date of this press release, and the Company assumes no obligation to update the information contained in this press release.

Anika Therapeutics, Inc. and Subsidiaries
Consolidated Statements of Operations
(in thousands, except per share data)
For the Three Months Ended December 31,

For the Twelve Months Ended December 31,

2017 2016 2017 2016
Product revenue $ 28,884 $ 28,296 $ 107,783 $ 102,932
Licensing, milestone and contract revenue 504 430 5,637 447
Total revenue 29,388 28,726 113,420 103,379
Operating expenses:
Cost of product revenue 8,716 7,539 27,364 24,027
Research and development 4,266 2,959 18,787 10,732
Selling, general and administrative 6,678 5,488 21,540 18,013
Total operating expenses 19,660 15,986 67,691 52,772
Income from operations 9,728 12,740 45,729 50,607
Interest income, net 138 49 473 263
Income before income taxes 9,866 12,789 46,202 50,870
Provision for income taxes 1,799 4,704 14,386 18,323
Net income $ 8,067 $ 8,085 $ 31,816 $ 32,547
Basic net income per share:
Net income $ 0.55 $ 0.56 $ 2.18 $ 2.22
Basic weighted average common shares outstanding 14,596 14,538 14,575 14,682
Diluted net income per share:
Net income $ 0.53 $ 0.54 $ 2.11 $ 2.15
Diluted weighted average common shares outstanding 15,141 14,979 15,068 15,116






The biomaterial of next-gen spinal implants

19 February 2018 – Medical Plastics News

A wealth of research and clinical experience is confirming that the use of PEEK-Optima polymer-based spinal implants confers advantages that can, potentially, enhance the efficacy of spinal implants and improve patient outcomes. Combined data from three clinical studies that directly compared PEEK-Optima with titanium devices for cervical fusion showed fusion rates between 88-100% for PEEK-Optima versus 47-93% for titanium devices.1-3 The high-performing polymer was the first implantable PEEK and introduced by Invibio Biomaterial Solutions (Invibio) in 1999. Since that time the company has pioneered further innovations and supported its partner companies with pre-clinical study results and clinical outcome data to achieve regulatory clearances and to help educate the medical community.

One such recent PEEK-based innovation was Invibio´s PEEK-Optima HA Enhanced polymer. It combines PEEK-Optima polymer with hydroxyapatite (HA) for medical applications where bone on-growth is required.  Hydroxyapatite, a well-known osteoconductive material that enhances bone apposition and a constituent of human bone, is fully integrated, not coated, into the PEEK matrix, making it available on all surfaces of a finished device, which also eliminates the time and expense of applying coatings to the manufactured implant.

Invibio´s enhanced biomaterial offers all the clinical advantages of PEEK-Optima Natural, including a modulus close to that of human bone, reduced stress shielding, and artifact-free imaging, whether by X-ray, MRI or CT scanning, allowing clear visual assessment of the fusion mass.

Pre-clinical studies demonstrate the potential benefits of PEEK-Optima HA Enhanced

The performance of PEEK-Optima HA Enhanced has been studied in pre-clinical studies, and has demonstrated a greater amount of new bone formation and a higher quality of new bone bridging, within early stages of treatment, compared with the results obtained when using PEEK-Optima Natural.

Invibio commissioned an independent cervical fusion study in sheep, to compare outcomes between interbody fusion devices composed of PEEK- Optima HA Enhanced, PEEK- Optima Natural and allograft bone. Results indicate that PEEK- Optima HA Enhanced may provide several advantages4:

  • Greater new bone formation. PEEK- Optima HA Enhanced resulted in greater new bone formation at six weeks, compared with PEEK- Optima Natural.
  • Higher quality new bone bridging. PEEK- Optima HA Enhanced provided a more favorable environment, with higher quality local bone at six and 12 weeks compared with PEEK-OPTIMA Natural.
  • Enhanced mechanical performance. PEEK- Optima HA Enhanced devices outperformed allograft, with fracture of the allograft devices in 6/13 (46%) instances.

A previous study had evaluated and compared the bone ongrowth that resulted from the use of the two implantable polymers in a bone defect model in sheep, and revealed that PEEK- Optima HA Enhanced resulted in approximately 75% direct bone apposition as early as four weeks following implantation compared with PEEK- Optima Natural.5




Spine Wave Launches Proficient® Posterior Cervical Spine System Implants for Complex Posterior Cervical-Thoracic Procedures

SHELTON, Conn., Feb. 21, 2018 (GLOBE NEWSWIRE) — Spine Wave is increasing the Proficient®Posterior Cervical Spine System’s product offering to further serve the posterior cervical spine market.  The system is gaining rapid adoption by spine surgeons, primarily due to its patented tri-lobe polyaxial screw design which offers a best in class 120 degrees of angulation.  Now, the Proficient® Posterior Cervical Spine System is expanded to include a range of new implants that make the system even more versatile for complex posterior cervical-thoracic procedures.

The Proficient® Posterior Cervical Spine System is now offered with a unique translation screw that provides medial-to-lateral translation to facilitate improved rod placement in posterior cervical-thoracic fixation procedures.  Other new Proficient® Posterior Cervical Spine System implants include screw-to-rod lateral connectors, rod-to-rod connectors, and smooth-shank screws as an alternative for fixation of the uppermost cervical spine levels.  Taken together, these new implants make the Proficient® Posterior Cervical Spine System even more appealing for complex posterior cervical-thoracic procedures.

“The Proficient® Posterior Cervical Spine System is an excellent alternative for spine surgeons treating complex posterior cervical-thoracic pathology,” said Peter G. Passias, M.D., FACS, Associate Professor of Orthopaedic and Neurological Surgery, NYU Health, New York, NY.  “The anatomy of the cervical-thoracic junction can make posterior cervical fixation procedures crossing that junction very challenging.  The Proficient® Posterior Cervical Spine System is versatile by design and these new implants make it even more so.”  “In particular,” Dr. Passias continued, “the system’s new translational screw makes rod placement in these procedures faster and easier in my practice because of the unique medial-to-lateral translation capability that it offers.”

“We have been very pleased with how well the Proficient® System has been received in the marketplace. The 120 degrees of angulation has been the biggest selling point and now the system is even more versatile with the advent of the translational screws,” said Mark LoGuidice, Spine Wave CEO. “Historically, Spine Wave has focused on thoraco-lumbar technologies. The Proficient® System is our first internally developed cervical offering and our engineers and surgeon designers have done a phenomenal job with this system.  In addition, we plan to launch a unique anterior cervical technology in the middle of this year. This important anterior system is currently in a limited market release and based on the early feedback, we have high expectations for this system as well.”

/EIN News/ — About Spine Wave

Spine Wave is a leader in expandable fusion technologies and is committed to continually delivering highly differentiated products to enable more efficient and less invasive solutions for spine surgeons and their patients. In addition to the Proficient® Posterior Cervical Spine System, Spine Wave also offers a broad portfolio of expandable devices marketed under the StaXx®, Velocity® and Leva® brand names.  The expandable technologies can be utilized in posterior, anterior and lateral surgical approaches.  To complement the expandable spacers, Spine Wave offers a comprehensive line of pedicle screws for both minimally invasive and traditional open approaches. Additionally, Spine Wave recently launched the GraftMag® Graft Delivery System which is being very well received because it is designed to make interbody bone grafting procedures faster and easier for surgeons.  The company is expanding rapidly and continues to recruit sales managers and independent distributors to fuel growth.  For more information on Spine Wave and its products, please visit


Terry Brennan, Chief Financial Officer
(203) 712-1810

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Centrexion Therapeutics Announces First Patient Dosed in Phase 3 Trial of CNTX-4975 for the Treatment of Moderate to Severe Knee Osteoarthritis Pain

February 21, 2018

BOSTON–(BUSINESS WIRE)–Centrexion Therapeutics Corporation, a company focused on developing non-opioid, non-steroidal therapeutics for the treatment of chronic pain, today announced that the first patient has been dosed in its Phase 3 VICTORY-1 clinical trial of CNTX-4975, a synthetic, ultra-pure injection of trans-capsaicin, for the treatment of chronic moderate to severe pain due to knee osteoarthritis (OA). CNTX-4975 is a highly differentiated, novel, non-opioid therapy that is designed to be injected directly into the painful joint to potentially provide fast-acting and long-lasting pain relief without the risk of abuse and addiction. CNTX-4975 was recently granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe pain associated with knee OA.

In the Phase 2b TRIUMPH clinical trial, treatment with a single injection of CNTX-4975 resulted in one of the largest reductions of pain associated with knee OA reported in any placebo-controlled clinical trial. The data showed statistically significant reduction in pain with walking, compared to placebo, beginning at Week 1, and continuing through six months.

“Chronic osteoarthritis pain is an important and rapidly growing public health issue. To improve the quality of life for the millions of people suffering from this condition, we must continue to explore novel approaches that lead to effective and safe therapeutic alternatives,” said Jeffrey B. Kindler, chief executive officer, Centrexion Therapeutics. “The initiation of our Phase 3 development program, with the dosing of the first patient, is a major milestone for both Centrexion and patients with chronic moderate to severe knee OA pain who are seeking better treatment options. We believe that CNTX-4975, which provided substantial, rapid onset pain reduction in patients with moderate to severe OA pain in previous clinical studies, has the potential to be a highly effective therapy that avoids the significant challenges, side effects and potential risks associated with currently available therapies.”

About the Phase 3 VICTORY-1 Trial

The Phase 3 trial is a randomized, double-blind, placebo-controlled, 52-week study to evaluate the safety and efficacy of a single injection of CNTX-4975 in people with chronic moderate to severe OA knee pain. The study will enroll approximately 325 patients aged 40 to 95 years of age. The primary endpoint of the study is the change in pain with walking measured at Week 12, using the Numeric Pain Rating Scale (NPRS). Secondary endpoints include change in pain with walking (Area Under the Curve [AUC]) and change in average knee stiffness and function (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC B, stiffness and WOMAC C, functional scale]) measured at Week 12. Additional secondary endpoints will be measured out to week 52, including change in knee pain (WOMAC A), knee stiffness and function (WOMAC B and C, respectively), patient global impression of change (PGIC) for the treated knee and quality of life measures.

More information about VICTORY-1 can be found at or under trial identifier NCT03429049.

About Osteoarthritis

Osteoarthritis (OA) is the most common form of arthritis, affecting approximately 14 million people in the United States.1 OA occurs when the protective cartilage on the ends of the bones wears down over time, and the bone around the joints harden and form edges. These changes cause pain, swelling and problems moving the joint. OA also causes an inflammatory process to occur in the affected joint, further damaging the cartilage. Although OA can damage the majority of joints in the body, it most commonly affects joints in the knees, hips, hands and spine. OA can cause pain severe enough that patients experience difficulty walking, climbing stairs or even rising from a chair. Despite currently available therapies, many patients opt for total joint replacement to manage the painful condition.

About CNTX-4975

CNTX-4975 is based on Centrexion’s proprietary STRATI™ technology (Synthetic TRans cApsaicin ulTra-pure Injection), a highly potent, ultra-pure, synthetic form of trans-capsaicin. CNTX-4975 is designed to be injected directly into the site of pain to provide rapid onset, large reduction and long duration of relief from moderate to severe joint pain without affecting touch sensibility or position sense. CNTX-4975 works by targeting the capsaicin receptor (TRPV1) to selectively and rapidly inactivate the local pain fibers transmitting signals to the brain. With a short half-life, CNTX-4975 is cleared from the body within 24 hours. This approach is designed to provide pain relief that can last for months until the ends of the local pain fibers regenerate, while maintaining normal sensation, such as touch, pressure and position, and without the risks of toxicities of NSAIDs and injected corticosteroids, or the side effects, including abuse and addiction, associated with opioid treatments. In January 2018, CNTX-4975 was granted Fast Track designation by the U.S. Food and Drug Administration for the treatment of pain associated with knee osteoarthritis.

About Centrexion Therapeutics

Centrexion Therapeutics Corp. is focused on advancing the treatment of chronic moderate to severe pain with one of the largest, exclusively pain-focused pipelines of non-opioid, non-addictive therapies in active development. Centrexion Therapeutics recognizes the needs of over a quarter of a billion people living with chronic pain worldwide, and aims to develop new, safer and more effective therapies that overcome the limitations and challenges associated with current pain treatments. Founded by world-renowned leaders in drug development and well-funded by key investors, Centrexion Therapeutics is building a pain treatment powerhouse to address the substantial and growing global chronic pain epidemic. For more information about Centrexion Therapeutics, visit

1. Deshpande, B., et al. Number of Persons With Symptomatic Knee Osteoarthritis in the US: Impact of Race and Ethnicity, Age, Sex, and Obesity. Arthritis Care & Research. Published online November 3, 2016


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NuVasive SpineTRACK Registry Named Qualified Clinical Data Registry By Centers Of Medicare And Medicaid Services

SAN DIEGOFeb. 20, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced that the Company’s SpineTRACK Registry has received the designation of Qualified Clinical Data Registry (QCDR) by the Centers of Medicare and Medicaid Services (CMS) for the 2018 Merit-based Incentive Payment System (MIPS) reporting year. As a result, SpineTRACK participants can now use the platform to earn Medicare payment incentives.

The SpineTRACK Registry is a NuVasive-sponsored prospective, multicenter, observational data collection quality improvement tool established in 2011. SpineTRACK serves as a comprehensive and collaborative data collection and quality improvement solution for spine practices, and is designed to allow surgeons to use real-time reports to make better treatment decisions, patients to track their progress to better understand treatment benefits and hospitals to evaluate outcome variations to aid in providing the highest value of care.

MIPS is one of two tracks under the Quality Payment Program, which moves Medicare Part B providers to a performance-based payment system. MIPS streamlines three historical Medicare programs—the Physician Quality Reporting System (PQRS), the Value-based Payment Modifier (VM) Program and the Medicare Electronic Health Record (EHR) Incentive Program (Meaningful Use)—into a single payment program.

Comprising four indicators—1) Quality (50%), 2) Improvement Activities (15%), 3) Advancing Care Information (25%) and 4) Cost (10%)—each category is weighted and factored into a final score which can impact Medicare payments by plus or minus 5% in 2020. As a QCDR, the SpineTRACK Registry is able to support the MIPS Quality reporting requirements on behalf of eligible providers.

“SpineTRACK is a unique differentiator for NuVasive and is the longest-running spine outcomes database sponsored by any spine company,” said Matt Link, executive vice president, strategy, technology and corporate development for NuVasive. “Since 2011, more than 9,500 patients have been enrolled in SpineTRACK and numerous peer-reviewed papers have been published using its data. The QCDR designation helps our customers meet quality reporting criteria to deliver optimal results and earn incentives that can grow their practices. This is truly a value-add that aligns with our focus on systems-based spine solutions.”

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 $962 million in revenues (2016), NuVasive has an approximate 2,300 person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit

Forward-Looking Statements
NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA® platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at 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.

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Opening of FX Shoulder USA: the French Shoulder Arthroplasty Specialist

DALLASFebruary 20, 2018 /PRNewswire/ —

FX Solutions, French number two in shoulder arthroplasty, has established an US subsidiary named FX Shoulder USA, Inc. to further expand directly into the US markets and to provide its current and future United State clients with an unique, large and innovative offer of shoulder implants.

FX Shoulder USA, based in Dallas, TX, was formed to proudly be the exclusive distributor for FX Solutions products effective January 1, 2018.

Created in 2011, FX Solutions has generated an annual growth of its turnover of more than 60% since its creation and plans to keep the same growth in 2018, particularly in the United States.

Its products have been approved in the USA since 2016 with the Humelock II, its only lockable shoulder trauma prosthesis available in the US. In January 2017, FX Solutions further expanded its portfolio with the introduction of the Humelock Reversed, a 145° reverse angle (available since 2011 in Europe). Additionally, in June 2017 it’s short stem Humeris was released as its primary platform.

FX Shoulder USA has quickly built a strong network of surgeons and distributors in FloridaPennsylvaniaRhode IslandMarylandGeorgia and Texas and looks to further expand its distribution across the Midwest and West Coast. The group has strong growth ambitions and aims to develop rapidly in North America, the world’s largest market for shoulder prostheses.

FX Shoulder USA is the only company worldwide, and especially in the United States, to focus exclusively on shoulder arthroplasty. With a very technical and customer service-oriented approach, the company offers the best choice in shoulders replacement, adapted to any procedure the surgeon would require.

FX Shoulder USA will exhibit at the American Academy of Orthopedic Surgeons (AAOS) March 6-10, 2018 in New Orleans at booth n°3158 and at the American Shoulder and Elbow Surgeons (ASES) in Chicago in October 2018.

Histogenics Corporation to Present at Upcoming Investor Conferences

WALTHAM, Mass., Feb. 20, 2018 (GLOBE NEWSWIRE) — Histogenics Corporation (Histogenics) (Nasdaq:HSGX), a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function, announced that Company Management will be presenting at two upcoming healthcare investor conferences.

  • Canaccord Genuity 2018 Musculoskeletal Conference – New Orleans (March 6, 2018)

    Adam Gridley, Histogenics’ CEO, will present a corporate overview on Tuesday, March 6, 2018 at 8:00 a.m. CT / 9:00 a.m. ET.  The conference immediately precedes the American Academy of Orthopaedic Surgeons (AAOS) Annual Meeting and explores the current state of orthopedics, biologics, imaging, robotic surgery, tissue sculpting, and regenerative tissue companies.
  • Cowen and Company 38th Annual Health Care Conference – Boston, MA (March 12-14, 2018)

    Mr. Gridley will present a corporate overview on Wednesday, March 14, 2018 at 8:40 a.m. ET.

To access a live audio webcast of the presentations on the “Investor Relations” page of the Histogenics website, please click here.  The webcasts will be available for approximately 45 days following the respective conferences.

About Histogenics Corporation

Histogenics (Nasdaq:HSGX) is a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function.  Histogenics’ lead investigational product, NeoCart®, is designed to rebuild a patient’s own knee cartilage to treat pain at the source and may prevent a patient’s progression to osteoarthritis.  NeoCart is one of the most rigorously studied restorative cell therapies for orthopedic use.  Histogenics recently completed enrollment of its NeoCart Phase 3 clinical trial and expects to report top-line, one-year superiority data in the third quarter of 2018.  NeoCart is designed to perform like articular hyaline cartilage at the time of treatment, and as a result, may provide patients with more rapid pain relief and accelerated recovery as compared to the current standard of care. Histogenics’ technology platform has the potential to be used for a broad range of additional restorative cell therapy indications.  For more information on Histogenics and NeoCart, please visit

Johnson & Johnson Medical Devices Companies Acquire Orthotaxy to Develop Next-Generation Robotic-Assisted Surgery Platform in Orthopaedics

PARISFeb. 20, 2018 /PRNewswire/ — Johnson & Johnson Medical Devices Companies, through French affiliate Apsis S.A.S., announced today the acquisition of Orthotaxy, a privately-held developer of software-enabled surgery technologies, including a differentiated robotic-assisted surgery solution. This proprietary technology is currently in early-stage development for total and partial knee replacement, and the Johnson & Johnson Medical Devices Companies plan to broaden its application for a range of orthopaedic surgery procedures.

The goal is to build a next-generation robotic-assisted orthopaedic surgery solution that is cost-effective, time-efficient, and user-friendly in a variety of care settings. Orthotaxy’s technology will be a critical part of a complete orthopaedic solution that uses enabling technologies to personalize procedures, optimize surgery and bring value to customers and patients. Founded by Stéphane Lavallée, a robotics entrepreneur, Orthotaxy designs and develops computer-assisted platforms.

“Our goal is to bring to market a robotic-assisted surgery technology that is an integral part of a comprehensive orthopaedics platform, delivering value to patients, physicians and healthcare providers across the episode of care,” said Ciro Rӧmer, Company Group Chairman of DePuy Synthes, the orthopaedics business of Johnson & Johnson. “The team at Orthotaxy has significant expertise and passion in developing this platform, and we aspire to bring to market a differentiated technology that helps improve clinical outcomes and increases patient satisfaction.”

This acquisition underscores the companies’ commitment in building an innovative and comprehensive digital surgery platform that brings value to customers and improves the standard of care for as many patients as possible. Moving forward, Johnson & Johnson Medical Devices Companies will focus on digital technology solutions that expand beyond providing best-in-class products to transformative solutions across the full continuum of care.

Financial terms of the transaction will not be disclosed.

About DePuy Synthes

DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopaedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit

About the Johnson & Johnson Medical Devices Companies

The Johnson & Johnson Medical Devices Companies’ purpose is to reach more patients and restore more lives. Having advanced patient care for more than a century, these companies represent an unparalleled breadth of products, services, programs, and research and development capabilities in surgical technology, orthopedics, cardiovascular, and specialty solutions with an offering directed at delivering clinical and economic value to healthcare systems worldwide.

Cautions Concerning Forward-Looking Statements

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding the acquisition of Orthotaxy. 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 Apsis, DePuy Synthes, the Johnson & Johnson Medical Devices Companies, and Johnson & Johnson. Risks and uncertainties include, but are not limited to: the potential that the expected benefits and opportunities of the acquisition may not be realized or may take longer to realize than expected; challenges inherent in product research and development, especially at an early stage of the development program, including uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success for new products; competition, including technological advances, new products and patents attained by competitors; challenges to patents; and changes to applicable laws and regulations, including tax laws and global health care reforms. In addition, there are risks and uncertainties related to the ability of the Johnson & Johnson family of companies to successfully integrate the technology, operations and employees of Orthotaxy, as well as the ability to ensure continued development of Orthotaxy’s products. 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 January 1, 2017, including under “Item 1A. Risk Factors,” its most recently filed Quarterly Report on Form 10-Q, including under the caption “Cautionary Note Regarding Forward-Looking Statements,” and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at or on request from Johnson & Johnson. Neither the Johnson & Johnson Medical Devices Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.


SOURCE Johnson & Johnson Medical Devices Companies