Providence Medical Technology Announces Appointment of US Sales Executive and Publication of Two Additional Clinical Studies

PLEASANTON, Calif.Jan. 8, 2018 /PRNewswire/ — Providence Medical Technology, an innovator in cervical spine fusion, today announced the appointment of Jeremy Laynor as Vice President of US sales. The company also announced the publication of two new studies in the Journal of Craniovertebral Junction and Spine further demonstrating the clinical benefits of its unique cervical fusion technology.

Jeremy is an accomplished sales executive who has successfully built high-growth sales teams launching disruptive medical technology. Jeremy most recently served as Vice President of Sales at Paradigm Spine where he led a team of direct and independent distributors selling novel spinal technology. He has also held sales leadership positions at Medtronic and Cardinal Health.

“Jeremy is an excellent fit for this critical leadership position,” commented Jeff Smith, CEO of Providence Medical Technology. “He understands the challenges of selling unique devices in the spine market and brings a strong network of spine surgeons and distributor partners to Providence. Jeremy completes the buildout of our executive team that will elevate our company to new levels as we further commercialize our differentiated posterior cervical fusion technology.”

Additionally, the December issue of the Journal of Craniovertebral Junction and Spine features two studies both authored by Dr. Krzysztof Siemionow et al., that demonstrate the clinical performance of posterior fusion utilizing the company’s DTRAX® Spinal System and CAVUX® cervical cages. One study reviewed the safety profile of 89 consecutive patients diagnosed with cervical radiculopathy and surgically treated with posterior cervical fusion and bilateral cages. The study reports a median hospital stay of 29 hours and overall complication rate related to the posterior cervical fusion of only 3.4%.

A complete copy of this study can be found at http://bit.ly/2E1fKuY

The second study publishes for the first time a case series of posteriorly placed cervical cages as an adjunct to fusion in place of lateral mass screws. The study concludes that posterior cervical cages may be an alternative option to traditional lateral mass screws. These two new publications add to the growing body of evidence supporting the company’s posterior cervical fusion technology of 13 total peer-reviewed scientific publications.

A complete copy of this study can be found at http://bit.ly/2CB3vsg

“The DTRAX Spinal System has greatly increased my procedural efficiency during posterior cervical fusion surgeries,” commented Dr. Kris Siemionow, MD, PhD Orthopedic Spine Surgeon at the University of Illinois at Chicago. “The instruments allow me to perform all the steps of a cervical fusion in a controlled fashion with an intuitive workflow while the cages offer a safe alternative to traditional lateral mass screws.”

DTRAX Spinal System is a set of sterile packaged, single-use instruments designed to perform posterior cervical fusion and has been used in over 9,000 cases worldwide. The CAVUX Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-C7) with accompanying radicular symptoms at one disc level.

About Providence Medical Technology, Inc.
Providence Medical Technology, Inc. is a privately-held medical device company focused on innovative solutions for cervical spinal conditions. The company has pioneered a proprietary approach to posterior cervical fusion and has developed surgical instrumentation and implants that offer unique benefits to the $2 billion worldwide cervical spine market. The Providence family of products includes the DTRAX® Spinal Instrumentation System, CAVUX® intervertebral implants, ALLY® line of bone, facet and cervical pedicle screws, and BIOLOGIX™ allograft cervical cages. All products are shipped-sterile and single-use to maximize perioperative efficiency and ensure consistent quality and performance. For more information, visit www.providencemt.com

 

SOURCE Providence Medical Technology

Related Links

http://www.providencemt.com

Implanet Announces Its Annual Report on the Liquidity Contract with Tradition Securities and Futures (TSAF)

January 08, 2018

BORDEAUX, France & BOSTON–(BUSINESS WIRE)–Regulatory News:

IMPLANET (Paris:ALIMP) (OTCQX:IMPZY) (Euronext Growth : ALIMP, FR0010458729, PEA-PME eligible ; OTCQX : IMPZY), a medical technology company specializing in vertebral and knee-surgery implants, today is announcing its annual report on its liquidity contract with TSAF as of December 31, 2017.

Pursuant to the liquidity contract entrusted by the IMPLANET group to TSAF, the following assets appeared on the liquidity account as of December 31, 2017:

• 156,000 shares

• Cash balance of the liquidity account: €35,509.25

As a reminder, at the time of the half-year statement of the liquidity contract as of June 30, 2017, the following resources were booked to the liquidity account, which was then entrusted to ODDO Corporate Finance:

• 134,950 shares

• Cash balance of the liquidity account: €46,060.29

About IMPLANET
Founded in 2007, IMPLANET is a medical technology company that manufactures high-quality implants for orthopedic surgery. Its flagship product, the JAZZ® latest-generation implant, aims to treat spinal pathologies requiring vertebral fusion surgery. Protected by four families of international patents, JAZZ® has obtained 510(k) regulatory clearance from the Food and Drug Administration (FDA) in the United States and the CE mark. IMPLANET employs 48 staff and recorded 2016 sales of €7.8 million. For further information, please visit www.implanet.com.
Based near Bordeaux in France, IMPLANET established a US subsidiary in Boston in 2013.
IMPLANET is listed on Euronext™ Growth market in Paris. The Company would like to remind that the table for monitoring the BEOCABSA, OCA, BSA and the number of shares outstanding, is available on its website: http://www.implanet-invest.com/suivi-des-actions-80

Contacts

IMPLANET
Ludovic Lastennet, Tel. : +33 (0)5 57 99 55 55
CEO
investors@implanet.com
or
NewCap
Investor Relations
Julie Coulot, Tel. : +33 (0)1 44 71 20 40
implanet@newcap.eu
or
NewCap
Media Relations
Nicolas Merigeau, Tel. : +33 (0)1 44 71 94 98
implanet@newcap.eu
or
AlphaBronze
US-Investor Relations
Pascal Nigen, Tel.: +1 917 385 21 60
implanet@alphabronze.net

Mazor Robotics Received 27 System Orders During Q4 2017; Expects to Report Record Full Year and Quarterly Revenue

CAESAREA, Israel, Jan.  8, 2018 /PRNewswire/ — Mazor Robotics Ltd. (TASE: MZOR) (NASDAQGM: MZOR), a pioneer and a leader in the field of surgical robotic systems, expects to report record revenue of approximately $65 million for the full year ended December 31, 2017.  In addition, the Company expects to report record revenue of approximately $19 million for the fourth quarter, which is the Company’s strongest quarter for system orders and revenue.

In the fourth quarter of 2017, the Company received purchase orders for 27 robotic guidance systems. This is the first full quarter since Medtronic assumed exclusive worldwide distribution of the Mazor X™ system for spine surgeries, as as part of the second phase of the commercial agreement between the companies.

The 27 orders are comprised of:

  • 24 Mazor X systems, of which 23 were ordered by Medtronic.
  • Three Renaissance system purchase orders from a U.S. customer and distribution partners in Germany and Thailand.

The Company’s system backlog on December 31, 2017 was 16 systems (14 Mazor X and two Renaissance systems).

“The fourth quarter results demonstrate the successful and smooth transition of the Mazor X sales and marketing activities to Medtronic,” commented Ori Hadomi, Chief Executive Officer.  “In addition, the co-development of innovative robotic spine solutions with Medtronic continues to make progress. At the same time, we are maximizing the market opportunities for Renaissance and evaluating potential new indications for our technologies.”

For the 2017 full year, the Company received purchase orders for 73 systems, of which 64 were for the Mazor X system.  The Company anticipates that Medtronic’s assumption of global commercial responsibility for the Mazor X will lead to increased market penetration and an accelerated number of Mazor X system installations during the coming years. As previously reported, from a financial results perspective, the anticipated revenue from Mazor X capital systems and disposables will be affected by the distribution model pricing with Medtronic. Therefore, the Company is currently anticipating modest revenue growth for 2018 compared to the preliminary 2017 record revenue of $65 million. As previously disclosed, the distribution agreement with Medtronic is expected to reduce the Company’s full year 2018 sales and marketing expenses and deliver significant savings. Beyond 2018, revenue growth is expected to accelerate and be driven primarily by the expanding installed base and increased recurring revenues.

Effective with the first quarter of 2018, due to the commencement of the exclusive worldwide distribution agreement with Medtronic and consistent with industry practice, the Company will no longer provide preliminary results for revenue, orders received and backlog. This information will be reported in full, as part of the quarterly and annual financial results releases.

The Company intends to report its financial results for the fourth quarter and full year ended December 31, 2017 in mid-February and will issue a press release with the specific time, dial-in credentials and webcast details.  The full year results are expected to include an adjusted increase in 2017 third quarter revenue from $17.2 million to $18.6 million due to system deliveries to Medtronic which had been incorrectly recorded as delivered after the third quarter ended on September 30, 2017.  Amended financial results for three and nine months ended September 30, 2017 are available through the Company’s website at https://www.mazorrobotics.com/index.php/investors-relations/financial-reports.

About Mazor

Mazor Robotics (TASE: MZOR; NASDAQGM: MZOR) believes in healing through innovation by developing and introducing revolutionary robotic technologies and products aimed at redefining the gold standard of quality care. Mazor Robotics Guidance Systems enable surgeons to conduct spine and brain procedures in an accurate and secure manner. For more information, please visit www.MazorRobotics.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other securities laws. Any statements in this release about future expectations, plans or prospects for Mazor, including without limitation, statements regarding the expected revenue for the full year and fourth quarter of 2017, the evaluation of new indications for its technologies, the increased market penetration and accelerated number of Mazor X installation during the coming years, the effect of the distribution model pricing with Medtronic on the anticipated  revenue from Mazor X capital systems and disposables, the expected adjustment in third quarter 2017 revenues, the timing of reporting of full year and fourth quarter financial results, the expected reduction in sales and marketing expense in 2018, the expected modest revenue growth for 2018 compared to preliminary 2017 record revenue, the expected growth beyond 2018, and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “will” and similar expressions are forward-looking statements.  These statements are only predictions based on Mazor’s current expectations and projections about future events. There are important factors that could cause Mazor’s actual results, level of activity, performance or achievements to differ materially from the results, level of activity, performance or achievements expressed or implied by the forward-looking statements. Those factors include, but are not limited to, the impact of general economic conditions, competitive products, product demand and market acceptance risks, reliance on key strategic alliances, fluctuations in operating results, and other factors indicated in Mazor’s filings with the Securities and Exchange Commission (SEC) including those discussed under the heading “Risk Factors” in Mazor’s annual report on Form 20-F filed with the SEC on May 1, 2017 and in subsequent filings with the SEC. For more details, refer to Mazor’s SEC filings.  Mazor undertakes no obligation to update forward-looking statements to reflect subsequent occurring events or circumstances, or to changes in our expectations, except as may be required by law.

U.S. Contacts: EVC Group

Michael Polyviou/Doug Sherk – Investors
mpolyviou@evcgroup.comdsherk@evcgroup.com
732-232-6914; 646-445-4800

SOURCE Mazor Robotics Ltd.

Related Links

http://www.mazorrobotics.com/

SeaSpine Announces Preliminary Results for Fourth Quarter and Full-Year 2017

CARLSBAD, Calif., Jan. 08, 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 preliminary financial results for fourth quarter and full-year 2017.

Preliminary and unaudited revenue for fourth quarter 2017 is expected to be in the range of $34.2 million to $34.4 million, reflecting approximately 6% growth compared to the prior year period.  Compared to fourth quarter 2016, total U.S. revenue is expected to increase 6% to approximately $31.5 million, with U.S. orthobiologics revenue expected to increase approximately 12% to $16.9 million and U.S. spinal implants revenue expected to be essentially flat at $14.6 million.

Preliminary and unaudited full-year 2017 revenue is expected to be in the range of $132.0 million to $132.2 million, reflecting growth of approximately 2.5% over full-year 2016.

Cash and cash equivalents at December 31, 2017 are expected to be approximately $10.8 million and the Company had no outstanding borrowings under its $30 million credit facility.  The Company did not sell any shares of its common stock under its “at the market” equity offering program during fourth quarter 2017.

“We are encouraged by our revenue growth in the fourth quarter and, in particular, the strong performance of our U.S. orthobiologics franchise,” said Keith Valentine, President and Chief Executive Officer of SeaSpine.  “As we continue to launch innovative products and gain traction with our distributor base, we expect our spinal implants franchise to deliver top line growth in 2018. We are confident that focused execution of our commercial strategy, investments in new products, and our growing distribution network position SeaSpine for sustained and accelerating revenue growth beginning in the second half of 2018.”

2018 Financial Outlook
SeaSpine expects full-year 2018 revenue to be in the range of $135 million to $139 million.

About SeaSpine
SeaSpine (www.seaspine.com) is a global medical technology company focused on the design, development and commercialization of surgical solutions for the treatment of patients suffering from spinal disorders. SeaSpine has a comprehensive portfolio of orthobiologics and spinal implants solutions to meet the varying combinations of products that neurosurgeons and orthopedic spine surgeons need to perform fusion procedures on the lumbar, thoracic and cervical spine. SeaSpine’s orthobiologics products consist of a broad range of advanced and traditional bone graft substitutes that are designed to improve bone fusion rates following a wide range of orthopedic surgeries, including spine, hip, and extremities procedures. SeaSpine’s spinal implants portfolio consists of an extensive line of products to facilitate spinal fusion in minimally invasive surgery (MIS), complex spine, deformity and degenerative procedures. Expertise in both orthobiologic sciences and spinal instrumentation product development allows SeaSpine to offer its surgeon customers a differentiated portfolio and a complete solution to meet their fusion requirements. SeaSpine currently markets its products in the United States and in over 30 countries worldwide.

Forward-Looking Statements
SeaSpine cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that are based on the Company’s current expectations and assumptions. Such forward-looking statements include, but are not limited to, statements relating to: the spinal implants franchise delivering top line growth in 2018; the Company’s ability to generate sustained and accelerating revenue growth beginning in the second half of 2018; and the Company’s expectations for full-year 2018 revenue.  In addition, this release contains preliminary financial results for fourth quarter and full-year 2017.  Preliminary results for 2017 are provided prior to completion of all internal and external review and audit procedures and therefore are subject to adjustment.  Among the factors that could cause or contribute to material differences between the Company’s actual results and the expectations indicated by the forward-looking statements are risks and uncertainties that include, but are not limited to: surgeons’ willingness to continue to use the Company’s existing products and to adopt its newly launched products, including the risk that the Company’s products do not demonstrate adequate safety or efficacy, independently or relative to competitive products, to support expected levels of demand or pricing; the ability of newly launched products to perform as designed and intended and to meet the needs of surgeons and patients, including as a result of the lack of clinical validation of products in limited commercial (or “alpha”) launch; the Company’s ability to attract new, high-quality distributors, whether as a result of inability to reach agreement on financial or other contractual terms or otherwise, disruption to the Company’s existing distribution network as new distributors are added, and the ability of new distributors to generate growth or offset disruption to existing distributors; continued pricing pressure, whether as a result of consolidation in hospital systems, competitors or others, as well as exclusion from major healthcare systems, whether as a result of unwillingness to provide required pricing or otherwise; the risk of supply shortages and the associated, potentially long-term disruption to product sales, including as a result of the Company’s dependence on a limited number of third-party suppliers for components and raw materials, or otherwise; unexpected expense and delay, including as a result of developing and supporting the launch of new products, the fact that newly launched products may require substantial additional development activities, which could introduce further expense and delay, or as a result of obtaining regulatory clearances; the Company’s ability to continue to invest in product development and sales and marketing initiatives at levels sufficient to drive future revenue growth, including as a result of its inability to obtain funding on a timely basis on acceptable terms, or at all; general economic and business conditions in the markets in which the Company does business, both in the U.S. and abroad; and other risks and uncertainties more fully described in the Company’s news releases and periodic filings with the Securities and Exchange Commission. The Company’s public filings with the Securities and Exchange Commission are available at www.sec.gov.

You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date when made. SeaSpine does not intend to revise or update any forward-looking statement set forth in this news release to reflect events or circumstances arising after the date hereof, except as may be required by law.

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

Alphatec Announces Preliminary Fourth Quarter and Full Year 2017 Revenue and Corporate Updates

CARLSBAD, Calif., Jan. 08, 2018 (GLOBE NEWSWIRE) — Alphatec Holdings, Inc. (“Alphatec” or the “Company”) (Nasdaq:ATEC), a provider of innovative spine surgery solutions with a mission to improve patient lives through the relentless pursuit of superior outcomes, today announced preliminary estimates of revenue for the fourth quarter and full year ended December 31, 2017.  The Company also provided several corporate updates.

Preliminary, Unaudited Revenue

Quarter Ended
 December 31, 2017
  Year Ended 
December 31, 2017
Total revenue $25.9 million to $26.3 million $101.4 million to $101.8 million
U.S. commercial revenue $20.8 million to $21.0 million $86.8 million to $87.0 million

During the fourth quarter, preliminary U.S. commercial sales generated by dedicated agents and distributors expanded to more than 40%, in line with expectations, and up significantly from about 5% at the start of the year.

The Company ended the year with a cash balance of approximately $22.5 million. Operating cash burn improved for the fourth consecutive quarter.

“The fourth quarter marked continued execution of our strategy to build top line predictability and sustainability by strengthening the ATEC distribution channel,” said Terry Rich, Chief Executive Officer of Alphatec.  “Our team has substantial work ahead of us as we transform Alphatec, but I am confident that our unmatched organizational spine expertise and relentless dedication to better surgical outcomes will drive continued progress in this new year.”

Closing of Equity Investments in Alphatec Common Shares

In December 2017, the Company generated cash proceeds of $4.0 million as the result of personal financial commitments made by Patrick Miles and Quentin Blackford pursuant to common stock purchase agreements granted in conjunction with their appointments on October 2, 2017. Per the agreements, Mr. Miles purchased 1.3 million shares of common stock and Mr. Blackford purchased 0.4 million shares of common stock, all at a purchase price of $2.26 per share (the consolidated closing bid price of Alphatec common shares on September 29, 2017).

Additional Spine-Experienced Talent Joins Leadership Team

Lance DeNardin Named Area Vice President, West

DeNardin strengthens Alphatec’s distribution channel in the West, contributing his 30 years of expertise in the spine and medical device industry to the sales and distribution transformation that is well underway.  DeNardin has held marketing and sales leadership roles in spine since the mid-1980s, with Stryker, Medtronic and Lanx, Inc., where he was Senior Vice President, responsible for converting the company’s distribution channel to dedicated representation. Most recently, DeNardin was Co-Founder of CareCycle Solutions, an operating room fluid management reprocessing company, and a Partner at Genesis Medical Solutions, LLC, a medical management consulting company.

Michael Dendinger Named Vice President of Operations

Dendinger brings over 20 years of finance, supply chain, and operations experience to the Alphatec operational functions.  He joins the Company from NuVasive, Inc., where he served most recently as Director of Global Operations, following roles as NuVasive’s Ireland Managing Director and Supply Chain Director.  Prior to joining NuVasive, Dendinger held various supply chain and financial management roles at Cymer, Inc. and Intel Corporation.

Scott Lish Named Vice President of Development

With over ten years of experience designing and developing spine and orthopedic solutions, Lish will drive continued advancement of Alphatec’s surgical outcome-focused innovation.  Lish joins Alphatec from NuVasive, Inc., where he was most recently the Director of Development, after advancing through various development and engineering roles during his eight-year tenure.  Prior to joining NuVasive, Lish held engineering roles with Zimmer Dental and Toppan Optical Products, Inc.

Inducement Awards Granted

As an inducement to entering into employment with the Company, the Compensation Committee of the Board of Directors of Alphatec approved the following inducement grants under under Alphatec’s 2016 Employment Inducement Award Plan (the “Plan”):

  • Mr. DeNardin: 25,000 restricted stock units (“RSUs”) and an option to purchase 25,000 shares of common stock at a strike price of $2.49 per share, the fair market value on the grant date.
  • Mr. Dendinger: 25,000 RSUs and an option to purchase 25,000 shares of common stock at a strike price of $3.63 per share, the fair market value on the grant date.
  • Mr. Lish: 25,000 RSUs and an option to purchase 25,000 shares of common stock at a strike price of $3.63 per share, the fair market value on the grant date.

The Compensation Committee approved the grants to Messrs. Dendinger and Lish on November 7, 2017, and the grant to Mr. DeNardin on December 11, 2017.  Under the Plan, the RSUs will vest in equal installments annually over four years, assuming in each case the employee remains continuously employed by Alphatec as of such vesting date. In addition, the RSUs will fully vest upon a change in control of Alphatec. The stock options will vest over four years, with 25% of the options vesting on the first anniversary of the date of grant and the remainder of the options vesting monthly over the subsequent three years, assuming in each case the employee remains continuously employed by Alphatec as of such vesting date. In addition, the options will fully vest upon a change in control of Alphatec.

Alphatec is providing this information in accordance with NASDAQ Listing Rule 5635(c)(4).

About Alphatec Holdings, Inc.

Alphatec Holdings, Inc., through its wholly owned subsidiary Alphatec Spine, Inc., is a medical device company that designs, develops, and markets spinal fusion technology products and solutions for the treatment of spinal disorders associated with disease and degeneration, congenital deformities, and trauma. The Company’s mission is to improve lives by providing innovative spine surgery solutions through the relentless pursuit of superior outcomes. The Company markets its products in the U.S. via independent sales agents and a direct sales force.

Additional information can be found at www. atecspine.com.

Disclosure Regarding Preliminary Unaudited Results

The preliminary financial results presented above reflect Alphatec’s estimates based solely upon information available to it as of the date hereof, is not a comprehensive statement of its financial results or position as of or for the three months and full year ended December 31, 2017, and has not been audited, reviewed or compiled by its independent registered public accounting firm, Mayer Hoffman McCann P.C. (“MHM”). Accordingly, MHM does not express an opinion or any other form of assurance with respect thereto. Alphatec’s actual fourth quarter and full year results may differ materially from these estimates. Accordingly, investors should not place undue reliance upon these estimates.

Forward Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainty. Such statements are based on management’s current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The Company cautions investors that there can be no assurance that actual results or business conditions will not differ materially from those projected or suggested in such forward-looking statements as a result of various factors. Forward-looking statements include the references to the Company’s strategy in significantly repositioning the Alphatec brand and turning the Company into a growth organization.  The important factors that could cause actual operating results to differ significantly from those expressed or implied by such forward-looking statements include, but are not limited to:  the uncertainty of success in developing new products or products currently in the Company’s pipeline; the uncertainties in the Company’s ability to execute upon its strategic operating plan; the uncertainties regarding the ability to successfully license or acquire new products, and the commercial success of such products; failure to achieve acceptance of the Company’s products by the surgeon community, including Battalion and Arsenal Deformity; failure to obtain FDA or other regulatory clearance or approval for new products, or unexpected or prolonged delays in the process; continuation of favorable third party reimbursement for procedures performed using the Company’s products; unanticipated expenses or liabilities or other adverse events affecting cash flow or the Company’s ability to successfully control its costs or achieve profitability; uncertainty of additional funding; the Company’s ability to compete with other competing products and with emerging new technologies; product liability exposure; an unsuccessful outcome in any litigation in which the Company is a defendant; patent infringement claims; claims related to the Company’s intellectual property and the Company’s ability to meet its financial obligations under its credit agreements and the Orthotec settlement agreement. The words “believe,” “will,” “should,” “expect,” “intend,” “estimate” and “anticipate,” variations of such words and similar expressions identify forward-looking statements, but their absence does not mean that a statement is not a forward-looking statement.  A further list and description of these and other factors, risks and uncertainties can be found in the Company’s most recent annual report, and any subsequent quarterly and current reports, filed with the  Securities and Exchange Commission. Alphatec disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law.

Investor/Media Contact:

Lee Roth / Emma Poalillo
The Ruth Group
(646) 536-7000


Company Contact:

Jeff Black
Executive Vice President and Chief Financial Officer
Alphatec Holdings, Inc.

ConforMIS Reports Preliminary Fourth Quarter and Year-End 2017 Revenue Results; Provides 2018 Financial Guidance

BILLERICA, Mass., Jan. 08, 2018 (GLOBE NEWSWIRE) — ConforMIS, Inc. (NASDAQ:CFMS), a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants that are customized to fit each patient’s unique anatomy, announced today preliminary, unaudited, revenue results for the fourth quarter and the year ended December 31, 2017.

Expected Q4 Summary:

  • Total revenue of approximately $20.8 million, down 4% year-over-year on a reported basis and 5% on a constant currency basis
  • Product revenue of approximately $20.5 million, down 4% year-over-year on a reported basis and 5% on a constant currency basis
    – U.S. product revenue of approximately $17.7 million, consistent year-over-year
    – Rest of World product revenue of approximately $2.8 million, down 24% year-over-year on a reported basis and 29% year-over-year on a constant currency basis

Expected 2017 Summary:

  • Total revenue of approximately $78.1 million, down 2% year-over-year on a reported and constant currency basis
  • Product revenue of approximately $77.1 million, down 2% year-over-year on a reported and constant currency basis
    – U.S. product revenue of approximately $64.4 million, up 3% year-over-year
    – Rest of World product revenue of approximately $12.7 million, down 23% year-over-year on a reported basis and 22% year-over-year on a constant currency basis

These preliminary results are being provided in advance of the Company’s presentation at the 36th Annual J.P. Morgan Healthcare Conference at the Westin St. Francis Hotel in San Francisco. Mark Augusti, the Company’s President and Chief Executive Officer, will present at the conference at 2:00 p.m. PT on Wednesday, January 10, 2018.

“We expect to achieve the high end of our revenue guidance and are pleased with the Company’s performance to close out our fiscal year,” said Mr. Augusti.

The preliminary unaudited revenue results described in this press release are estimates only and are subject to revision. The Company will report its full financial results, including gross margin, for the fourth quarter and the year ended 2017 on February 7, 2018.

2018 Financial Guidance

For the full year 2018, the Company expects total revenue in a range of $79.6 million to $83.6 million. The Company’s 2018 revenue guidance assumes the following:

  • Product revenue in a range of $79 million to $83 million, representing year-over-year growth of 2% to 8% on a reported basis and 2% to 7% on a constant currency basis.
  • Royalty revenue of approximately $0.6 million related to ongoing patent license royalty payments.

For the full year 2018, the Company expects total gross margin in a range of 44% to 46%.

Note on Non-GAAP Financial Measures

In addition to disclosing financial measures prepared in accordance with U.S. generally accepted accounting principles (GAAP), the Company provides certain information regarding the Company’s financial results or projected financial results on a non-GAAP “constant currency basis.” This information estimates the impact of changes in foreign currency rates on the translation of the Company’s current or projected future period financial results as compared to the applicable comparable period. This impact is derived by taking the adjusted current or projected local currency results and translating them into U.S. Dollars based upon the foreign currency exchange rates for the applicable comparable period. It does not include any other effect of changes in foreign currency rates on the Company’s results or business. Non-GAAP information is not a substitute for, and is not superior to, information presented on a GAAP basis.

Earnings Conference Call Details

The Company will release full results for the fourth quarter and the year ended December 31, 2017 via conference call on Wednesday, February 7, 2018 at 4:30 p.m. Eastern Time.

The conference call releasing full quarterly and year end results will be hosted by Mark Augusti, President and Chief Executive Officer and Paul Weiner, Chief Financial Officer.

To participate in the conference call, please call 877-809-6331 (or 615-247-0224 for international) and use conference ID number 4065099 or listen to the webcast in the investor relations section of the Company’s website at ir.conformis.com. The online archive of the webcast will be available on the Company’s website for 30 days.

About ConforMIS, Inc.

ConforMIS is a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants that are individually sized and shaped, or customized, to fit each patient’s unique anatomy. ConforMIS offers a broad line of customized knee implants and pre-sterilized, single-use instruments delivered in a single package to the hospital. In clinical studies, ConforMIS iTotal CR demonstrated superior clinical outcomes, including better function and greater patient satisfaction, compared to traditional, off-the-shelf implants. ConforMIS owns or exclusively in-licenses approximately 420 issued patents and pending patent applications that cover customized implants and patient-specific instrumentation for all major joints.

For more information, visit www.conformis.com. To receive future releases in e-mail alerts, sign up at ir.conformis.com.

Cautionary Statement Regarding Forward-Looking Statements

Statements in this press release about our future expectations, plans and prospects, including statements about our financial position and results, total revenue, product revenue, gross margin, as well as other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” and similar expressions, constitute forward-looking statements within the meaning of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995. We may not actually achieve the forecasts disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual financial results could differ materially from the projections disclosed in the forward-looking statements we make as a result of a variety of risks and uncertainties, including risks related to our estimates and expectations regarding our revenue, gross margin, expenses, revenue growth and other results of operations, and the other risks and uncertainties described in the “Risk Factors” sections of our public filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent our views as of the date hereof. We anticipate that subsequent events and developments may cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date hereof.

Investor contact
Oksana Bradley
ir@conformis.com
(781) 374-5598

Stryker announces nomination of two new Directors, Sheri S. McCoy and Rajeev Suri

By GlobeNewswire,  January 08, 2018

Kalamazoo, Michigan – January 8, 2018 – Stryker Corporation (NYSE:SYK) announced that Sherilyn (Sheri) S. McCoy and Rajeev Suri have been nominated for election to the Company’s Board of Directors at Stryker’s 2018 Annual Meeting of Shareholders, which is expected to be held on May 2, 2018.  Their successful elections would bring the total size of the Company’s Board to ten members.

Ms. McCoy brings a wealth of healthcare and consumer experience gained during a 30-year career at Johnson & Johnson that included leadership of large medical device, pharmaceutical and consumer businesses.  She is currently Chief Executive Officer of Avon Products, a personal care products company. She has held her current position for five years, and has announced that she will be retiring on March 31, 2018. She is also a member of the Board of Directors of AstraZeneca, a global, science-led biopharmaceutical company.

Mr. Suri is President and Chief Executive Officer of Nokia, a leading global technology company. Mr. Suri has deep technology experience spanning nearly 30 years, most of which have been in leadership roles at Nokia. He has served in his current role at Nokia since 2014 and has engineered a transformation of the company through significant portfolio adjustments, such as the acquisition of Alcatel-Lucent.

“We are excited about the potential to add Sheri and Rajeev to our Board,” said Kevin A. Lobo, Chairman and Chief Executive Officer. “They will bring new perspectives and complementary skills, in addition to rich experiences leading large organizations.  They also both share a passion for healthcare and helping Stryker achieve its mission.”

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com.

Important Additional Information and Where You Can Find It

The Company, its directors and certain of its executive officers may be deemed to be participants in a solicitation of proxies from the Company’s shareholders at its 2018 Annual Meeting of Shareholders in connection with the director nominations disclosed above. Information regarding the Company’s directors and executive officers and their respective interests in the Company, by security holdings or otherwise, is set forth in the Company’s Definitive Proxy Statement for its 2017 Annual Meeting of Shareholders, filed with the Securities and Exchange Commission (the “SEC”) on March 20, 2017, and reports filed by the Company and ownership forms filed by the directors and executive officers with the SEC. The Company will furnish its Definitive Proxy Statement for its 2018 Annual Meeting of Shareholders to shareholders entitled to vote at the meeting and will file a copy with the SEC. The Company urges its shareholders to carefully read the Definitive Proxy Statement for its 2018 Annual Meeting of Shareholders, and any other relevant documents filed by the Company with the SEC, when available because they will contain important information. Shareholders may obtain free copies of the materials referenced above at www.sec.gov or www.stryker.com.

Contacts

For investor inquiries please contact:

Katherine A. Owen, Stryker Corporation, 269-385-2600 or katherine.owen@stryker.com

For media inquiries please contact:

Yin Becker, Stryker Corporation, 269-385-2600 or yin.becker@stryker.com

This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.

The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.

Source: Stryker Corporation via Globenewswire

This article appears in: News Headlines

Referenced Stocks: SYK

NuVasive Announces Preliminary Unaudited Full Year 2017 Revenue Results And Preliminary 2018 Outlook

SAN DIEGOJan. 8, 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 preliminary unaudited revenue results for the fourth quarter and full year 2017.  The Company expects fourth quarter 2017 revenue to be approximately $272 million and full year 2017 revenue to be approximately $1,030 million and in line with the guidance provided on Oct 24, 2017.

NuVasive preliminary revenue results for full year 2017 reflect approximately 7% growth on a reported and constant currency basis, compared to revenue of $962 million for 2016. When NuVasive updated its full year 2017 financial guidance on Oct. 24 to reflect third-quarter 2017 results, the Company assumed international revenue growth of over 20 percent, a lingering impact of Hurricane Maria in Puerto Rico in the fourth quarter and softer U.S. procedural volumes continuing into the fourth quarter. Those assumptions have remained unchanged.

The Company will report full year 2017 financial results and provide its full financial outlook for 2018 during its earnings announcement planned for mid-February.

“NuVasive launched a record number of new technologies in 2017 and accelerated growth across the globe delivering more than a 20 percent sales increase outside the United States for the fifth sequential quarter,” said Gregory T. Lucier, chairman and chief executive officer of NuVasive. “What’s impressive is this success has occurred in a year when the overall U.S. spine market has softened. Whether through game-changing product introductions or strategic acquisitions, we intend to deliver the most innovative and comprehensive spine solutions to our customers so they can best serve their patients. We will continue this momentum in 2018.”

2018 Preliminary Outlook
The Company’s preliminary outlook for 2018 includes full year revenue growth in the mid-single digits over 2017 revenue results, at least 100 basis points of expansion in non-GAAP operating margin, adjusted EBITDA now in a range of approximately $290 to $300 million, and a substantial tax savings resulting from the tax reform legislation passed late in 2017.

When the Company provides its full financial outlook for 2018, it will include the expected financial impact of the Company’s acquisition of SafePassage. In Dec. 2017, NuVasive announced it had entered into an agreement to acquire SafePassage to bolster its NuVasive Clinical Services™ business and solidify its leadership position as the largest provider of outsourced intraoperative neuromonitoring (IONM) services.  This joining of forces will strengthen the NuVasive IONM business line with more than 550 neurophysiologists and oversight physicians in the U.S.—allowing for the delivery of services to over 1,000 customers and 3,000 surgeons. The acquisition of SafePassage remains on track and is anticipated to close in Jan. 2018, subject to customary closing conditions.

The Company will also provide additional commentary on the expected impact of U.S. tax reform.  NuVasive expects to realize substantial tax savings as a result of the recent passage of the tax bill, An Act to provide for reconciliation pursuant to titles II and V of the concurrent resolution on the budget for fiscal year 2018, which provides for a reduction of the U.S. corporate tax rate from 35 percent to approximately 21 percent. The legislation is poised to significantly reduce the future corporate tax rate for NuVasive, which prior to the enactment of the tax overhaul was expected to be approximately 33 percent on a non-GAAP basis in 2018.

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 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.  Forward-looking statements include, but are not limited to, statements regarding the Company’s expected revenue results for the fourth quarter and full year 2017, financial projections and goals for 2018, the timing of the anticipated acquisition of SafePassage, including the potential benefits of the acquisition, and the anticipated impact of the new tax law.  The forward-looking statements contained herein are based on the current expectations and assumptions of NuVasive and not on historical facts.  The Company’s expectations for fourth quarter and full year 2017 revenue results are preliminary and unaudited and are subject to adjustment in the ongoing review and audit procedures by the Company’s external auditors.  The following important factors, among others, could cause actual results to differ materially from those set forth in the forward-looking statements:  the completion of the audit of the Company’s 2017 financial results, including the risk of adjustment to its preliminary fourth quarter and full year revenue results; the satisfaction of conditions to closing the agreement to acquire SafePassage, including the risk that any required conditions are not satisfied, are delayed or are subject to unanticipated conditions that could adversely affect the combined company or the expected benefits of the acquisition; the risk that NuVasive’s estimates and projections related to financial and operating goals for 2018 and future tax and financial and operating results may turn out to be inaccurate because of the preliminary nature of the Company’s forecasts; the risk of further adjustment to future financial expectations; unanticipated difficulty in selling products, generating revenue or producing expected profitability; and those other risks and uncertainties more fully described in the Company’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

TransEnterix Provides 2017 Year End Corporate Update

January 08, 2018

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–TransEnterix, Inc. (NYSE American:TRXC), a medical device company that is pioneering the use of robotics to improve minimally invasive surgery, today provided a year-end corporate update.

“2017 was a transformational year for TransEnterix that included the commencement of U.S. Senhance commercialization and progression towards the global commercialization of SurgiBot,” said Todd M. Pope, President and CEO at TransEnterix. “We are very excited about the opportunity that lies ahead in 2018 as we look to build upon our momentum and drive the global adoption of the Senhance.”

Senhance System Revenue

During the quarter ending December 31, 2017, the Company sold two Senhance Systems for total revenue of approximately $3.3 million. Total 2017 revenue is approximately $7.0 million, a 360% increase over 2016, representing a total of five Senhance Systems: Europe (two), Asia (two, including one sale for which the revenue was not recognized in 2017) and the United States (one).

The company currently has received one European Senhance System order that it expects to deliver and recognize revenue for in the quarter ending March 31, 2018.

Product Portfolio

During 2017, the company completed the following product portfolio initiatives:

  • Obtained Senhance System FDA 510(k) clearance for use in colorectal and gynecologic laparoscopic surgery
  • Obtained CE mark and began commercializing the world’s first robotic micro-laparoscopic (3 millimeter) instruments
  • Expanded list of compatible visualization and fluorescence systems to include systems from Stryker, Novadaq (Stryker), Conmed and Richard Wolf
  • Filed approximately 40 new US patent applications. The Company’s patent portfolio now includes approximately 93 issued patents, 25 of which are US Patents, as well as approximately 92 pending applications, 54 of which are US applications.

The Company expects to complete the following product portfolio initiatives in 2018:

  • Expand the Senhance System US FDA clinical indications to include hernia and gallbladder, doubling the total addressable market
  • Launch new ultrasonic energy device
  • Launch new five-millimeter articulating instrument platform

SurgiBot Global System Agreement

On December 18, 2017, the Company announced that it had entered into an agreement with Great Belief International Limited (GBIL) to advance the SurgiBot System towards global commercialization.

The agreement provides the Company with proceeds of at least $29 million, of which $7.5 million was received in December of 2017. An additional $7.5 million is expected to be received by March 31, 2018, including a $3.0 million equity investment at $2.33 per share. The remaining $14 million, representing minimum royalties, will be paid beginning at the earlier of receipt of Chinese regulatory approval or five years.

This agreement transfers ownership of the SurgiBot System assets, while the Company retains the option to distribute or co-distribute the SurgiBot system outside of China. Upon completion of the transfer of all SurgiBot system assets, GBIL will have the SurgiBot system manufactured in China and obtain Chinese regulatory clearance from the China Food and Drug Administration (“CFDA”), while entering into a nationwide distribution agreement with China National Scientific and Instruments and Materials Company (CSIMC) for the Chinese market.

Balance Sheet

As of December 31, 2017, the Company’s cash and restricted cash balance was approximately $97 million. The Company believes that this capital is sufficient to fund operations through the year 2019.

As of December 31, 2017, there were approximately 199 million shares of common stock outstanding.

About TransEnterix, Inc.

TransEnterix is a medical device company that is pioneering the use of robotics 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 Robotic System, a multi-port robotic system that brings the advantages of robotic surgery to patients while enabling surgeons with innovative technology such as haptic feedback and eye sensing camera control. The Senhance Surgical Robotic System is available for sale in the US, the EU and select other countries. For more information, visit the TransEnterix website at www.transenterix.com.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control and which may cause results to differ materially from expectations, including whether we will be able to build upon our momentum and drive the global adoption of the Senhance in 2018; whether we will deliver and recognize revenue from the sale of a European Senhance System in the 2018 first quarter; whether we will expand the Senhance System US FDA clinical indications to include hernia and gallbladder; whether we will launch a new ultrasonic energy device, whether we will launch a new five-millimeter instrument platform; whether TransEnterix will receive at least $29 million (including minimum royalties) from GBIL; whether GBIL will be able to obtain the necessary clearances to sell the SurgiBot System in China; whether TransEnterix will be able to successfully distribute or co-distribute the SurgiBot System outside of China, and realize revenues beyond the initial consideration and minimum royalties; and whether our cash through December 31, 2017 will be sufficient capital to fund operations through the year 2019. We cannot assure you that our expectations will be realized. For a discussion of the risks and uncertainties associated with TransEnterix’s business, please review our filings with the Securities and Exchange Commission (SEC), including our Annual Report on Form 10-K filed on March 6, 2017 and our other filings we make with the SEC. You are cautioned not to place undue reliance on these forward looking statements, which are based on our expectations as of the date of this press release and speak only as of the origination date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Contacts

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

Spineology Completes First Lateral Post-Market Study Cases Using Novel Implant Design

January 08, 2018

ST. PAUL, Minn.–(BUSINESS WIRE)–Spineology Inc., an innovator in anatomy-conserving spine surgery, is excited to announce the completion of the first post-market study cases using its recently FDA-cleared Duo Lumbar Interbody Fusion System. In October, the company announced the initiation of this prospective, post-market lateral interbody fusion study designed to evaluate patient outcomes. To date, study cases have been completed by Dr. Craig Kuhns, Austin, Texas; Dr. Sandeep Kunwar, Fremont, California; and Dr. Jason Huffman, Napa, California.

The Duo System implant is the first to combine PEEK, titanium and graft containment mesh elements. This design dramatically reduces the access required to implant a device compared to traditional lateral systems. By significantly minimizing the nerve and soft tissue retraction typically required in these surgeries, the company believes the Duo System will reduce the post-operative thigh pain and other complications commonly associated with the lateral approach. In addition to reducing the exposure required for placement, the Duo implant, once filled, creates a large, load-sharing, endplate-conforming graft pack that expands up to 30mm in width to help maintain spinal correction and support fusion.

“The Duo System allows me to efficiently place the implant through a very small access, which reduces trauma to the muscle and neural elements,” said Dr. Sandeep Kunwar. “During placement, the implant can immediately correct spinal deformity. Once in place, the implant is filled with allograft and provides a very large footprint, resulting in excellent stabilization of the segment and a large area for fusion.”

“Thigh-related post-operative complications associated with the lateral approach have been well documented,” said Dr. Craig Kuhns. “Based on my experience, the Duo System has the ability to significantly reduce these complications, which makes for a much easier postoperative course for my patients.”

“The Duo System is intuitively designed,” added Dr. Jason Huffman. “The small, 18mm tubular access portal reduces trauma to soft tissues and neural structures while significantly minimizing tissue creep. It also eliminates the need to position blades, saving me time during the procedure. The instrumentation allows for an efficient, radical discectomy and timely placement of the implant. The reduced access requirements and efficiency of the system both play a role in the reduction of post-operative thigh pain and weakness, and the overall success of the surgery.”

Additional sites nationwide are participating in the Duo System post-market study and are currently completing training or screening patients.

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

Contacts

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