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

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

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.

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

WARSAW, Ind., Jan. 05, 2018 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (“OrthoPediatrics”) (NASDAQ:KIDS), a company exclusively focused on advancing the field of pediatric orthopedics, announced today its preliminary unaudited revenue for the fourth quarter and full year ended December 31, 2017.

Preliminary unaudited fourth quarter revenue is expected to be in the range of $11.5 million to $11.7 million, up 22% to 24%, when compared to $9.4 million in the fourth quarter of 2016. OrthoPediatrics’ preliminary unaudited full year 2017 revenue is expected to be in the range of $45.4 million to $45.6 million, representing annual growth of 22%.

The company plans to release its fourth quarter and full year 2017 financial results in early March 2018. The quarterly and annual preliminary revenue estimates for 2017 included in this press release are prior to the completion of review and audit procedures by the company’s independent registered public accounting firm and are therefore subject to adjustment.

About OrthoPediatrics Corp.
Founded in 2006, OrthoPediatrics is an orthopedic company focused exclusively on providing a comprehensive product offering to the pediatric orthopedic market to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets 24 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This offering spans trauma & deformity, complex spine and ACL reconstruction procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and 35 countries outside the United States.

Forward-Looking Statements
Any forward-looking statements are subject to risks and uncertainties such as those described in OrthoPediatrics’ most recently filed Quarterly Report on Form 10-Q for the period ended September 30, 2017 which OrthoPediatrics filed with the Securities and Exchange Commission on November 13, 2017.  Actual results may differ materially from anticipated results.

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

January 04, 2018

DUBLIN, Dec. 28, 2017 /PRNewswire/ —

The “Middle East Medical Device Market by Product (In Vitro Diagnostics (IVD), Cardiology, Orthopedics), by FDA classification (Class I, II, III), by End-user, by Region and Segment Forecasts, 2014 – 2025” report has been added to Research and Markets’ offering.

The Middle East medical devices market is expected to reach USD 31.6 billion by 2025. This growth is anticipated to be a result of increasing geriatric population, and increasing incidences of conventional diseases such as diabetes and obesity. Other major drivers include technological innovations and increasing demand and acceptance of such technologies in Middle Eastern countries majorly in UAE, Saudi Arabia and Qatar.

Furthermore, rising competitive pressure is witnessed in the Middle East medical device market as a result of high demand and low supply ratio. Hence, it can be predicted that the Middle East medical device market may witness lucrative growth over the forecast period.

Another factor responsible for this propelling growth is the supportive reimbursement pathways adapted by the Middle Eastern countries majorly to ensure quality healthcare provisions for every civilian. Major developments are witnessed in terms of regulatory structures as well, with an agenda to provide monetary benefits to the civilians and improve overall lifestyle of the people.

Further Key Findings From The Study Suggest:

Based on product type, In-Vitro Diagnostics(IVD) is expected to dominate the market as of 2016. Furthermore, neurology device segment is anticipated to grow at the fastest CAGR owing to the factors such as growing incidence of conventional diseases, augmenting research and technological advancement offered by key industry players to meet the current unmet needs.

The medical devices are also analyzed depending upon the U.S. FDA classification, with Class II being the dominant as well as the fastest growing segment during the forecast period. The Class II device segment is anticipated to capture over 60.0% of the market share by 2025.

Geographic expansion into Qatar, U.A.E. and Iraq by well-established players is anticipated to promote the fastest growth for the region.

Few of the industry players for the Middle East medical devices market include Medtronic, Johnson & Johnson, Siemens, Roche, Becton Dickinson and Abbott Laboratories.

Entry of various new players coupled with collaborative efforts by existing players is expected to be witnessed over the forecast period.

Key Topics Covered:

Chapter 1. Methodology and Scope

Chapter 2. Executive Summary

Chapter 3. Middle East Medical Device Market Variables, Trends & Scope

Chapter 4. Middle East Medical Device Market: Product Estimates & Trend Analysis

Chapter 5. Middle East Medical Device Market: FDA Classification Estimates & Trend Analysis

Chapter 6. Middle East Medical Device Market: End-use Estimates & Trend Analysis

Chapter 7. Middle East Medical Device Market: Regional Estimates & Trend Analysis

Chapter 8. Competitive Landscape

Medtronic
Johnson & Johnson
Siemens
Roche
Becton Dickinson
Abbott Laboratories
Novartis
Olympus Corporation
General Electric
Biomerica
Baxter International
Smith and Nephew
BioMrieux
Philips
Zimmer Biomet
For more information about this report visit https://www.researchandmarkets.com/research/vh9c5x/middle_east

Media Contact:

Laura Wood, Senior Manager
press@researchandmarkets.com

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SOURCE Research and Markets

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