COLUMBIA, Md., Nov. 07, 2016 (GLOBE NEWSWIRE) — Osiris Therapeutics, Inc. (NASDAQ:OSIR), a leading regenerative medicine company focused on developing and marketing products for wound care, orthopaedics, and sports medicine, today announced its preliminary revenue estimates for 2014 and 2015 and its anticipated 2016 revenue.

As previously announced, the Company is working diligently to complete the restatement of its 2014 financial statements as soon as possible.  Once that process is complete, the Company expects to transition to a new independent registered accounting firm and begin work on the 2015 financial statements.  The Company has made substantial progress in its work on the restatement and as a result, the Company is now able to provide revenue estimates for these annual periods.

The Company currently estimates that the restatement will result in revenue of $46 to $50 million in 2014, which is less than the previously reported revenue of $58.8 million, and that it expects to report revenue of $85 to $90 million for 2015.   In addition, the Company also announced today that it expects to report revenue for 2016 of $100 to $110 million.

As a result of the ongoing process to complete the restatement, the revenue estimates in this press release are preliminary and subject to revision.  Due to this ongoing work, the Company is not yet able to estimate net income or earnings per share information.

About Osiris Therapeutics

Osiris Therapeutics, Inc., based in Columbia, Maryland, is a world leader in researching, developing, and marketing regenerative medicine products that improve health and lives of patients and lower overall healthcare costs. Having developed the world’s first approved stem cell drug, the Company continues to advance its research and development in biotechnology by focusing on innovation in regenerative medicine – including bioengineering, stem cell research and viable tissue based products.  Osiris has achieved commercial success with products in orthopaedics, sports medicine and wound care, including BIO^{4 ™}, Cartiform^®, Grafix^®, TruSkin^™ and Stravix^™.  Osiris, Grafix, Cartiform, TruSkin and Stravix are trademarks of Osiris Therapeutics, Inc., and BIO⁴ is a trademark of Howmedica Osteonics Corp. More information can be found on the Company’s website, www.Osiris.com. (OSIR-G)

Forward-Looking Statements

This press release contains forward-looking statements. Forward-looking statements include statements about our expectations, beliefs, plans, objectives, intentions, assumptions and other statements that are not historical facts. Words or phrases such as “anticipate,” “believe,” “continue,” “ongoing,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project” or similar words or phrases, or the negatives of those words or phrases, may identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. Such forward-looking statements include, without limitation, statements regarding the Company’s estimated range of revenues for 2014 and 2015 and its anticipated financial performance for the remainder of this calendar year.  Forward-looking statements are subject to known and unknown risks and uncertainties and could cause actual results to differ materially from those expressed or implied by the forward-looking statements. Several factors could cause actual results to differ materially from those expressed in or contemplated by the forward-looking statements. Such factors include, but are not limited to, the identification of additional errors in the restatement process, changes in the scope or focus of the accounting adjustments, the risk that additional information may arise prior to the expected filing with the SEC of the restated financial statements and the 2015 and 2016 financial statements or subsequent events that would require us to make adjustments. Other risk factors affecting the Company are discussed in detail in the Company’s filings with the SEC, including its Annual Reports on Form 10-K.  Accordingly, you should not unduly rely on these forward-looking statements. We undertake no obligation to publicly revise any forward-looking statement to reflect circumstances or events after the date of this press release or to reflect the occurrence of unanticipated events, except as required by law.

For additional information, please contact:



Diane Savoie

Osiris Therapeutics, Inc.

(443) 545-1834

OsirisPR@Osiris.com

Source: Osiris Therapeutics, Inc.

News Provided by Acquire Media

SALT LAKE CITY, UT–(Marketwired – Nov 10, 2016) – Amedica Corporation ( NASDAQ : AMDA ), a company that develops and commercializes silicon nitride ceramics as a biomaterial platform, today announced financial results for the third quarter ended September 30, 2016.

Recent Company Highlights

• Decreased year-to-date operational cash burn by 25%
• Received FDA clearance for Valeo® II Lateral Lumbar interbody fusion device
• Submitted 510(k) to FDA for new Taurus metals system with first implantation expected by end of the year
• The first stage of testing of silicon nitride by the CFDA (chinese FDA) has begun and is expected to be completed by January 2017.
• Submitted materials testing data and clinical data to the Japan PMDA
• Reduced headcount by 38% which will reduce operating cash burn by about $2 million per year
• Submitted response to FDA clarifying 510(k) application for composite silicon nitride spacer (C+CSC)

“Despite the decrease in commercial sales this quarter, we are confident with our commercial sales strategy targeted at adding new surgeons and distributors and expanding our sales into new territories,” said Dr. Sonny Bal, Chairman and Chief Executive Officer. “Later this month, we will announce a new sales leader; a seasoned, proven individual with credibility in the spine field.”

“We believe that our silicon nitride ceramic is the best-characterized biomaterial available, and offers a compelling set of advantages, especially for use in spine surgery. Even as we explore strategic development opportunities with external partners, we will remain focused on driving our spine sales,” added Dr. Bal.

Third Quarter 2016 Financial Results

Total product revenue was $3.4 million in the third quarter of 2016 as compared to $4.8 million in the same period of 2015, a decrease of $1.4 million, or 29%. This decrease was due to lower private label sales during the quarter and weaker than expected commercial sales during the final stages of the implementation of the Company’s commercial sales expansion strategy. We expect that our commercial sales expansion strategy will be substantially completed during the fourth quarter with benefits expected to begin during the first quarter of 2017. The decrease in revenue for the third quarter 2016 was also attributable, in part, to continued market pricing pressure and hospital vendor consolidation.

Cost of revenue decreased $0.9 million, or 53%, as compared to the same period in 2015. The decrease in cost of revenue was primarily due to the decline in product sales. Excluding the impact of excess or obsolete inventory for both periods, third quarter 2016 gross margins ended at 82% of total sales, as compared to 73% during the prior year period. The increase in gross margins as a percentage of sales is primarily attributable to lower private label sales, which have lower gross margins, and to a lesser extent, the impact of the medical device excise tax moratorium.

Operating expenses decreased $0.2 million, or 3%, as compared to the same period in 2015. This decline in operating expenses is primarily due to a decrease of $0.5 million in commissions as a result of decreased sales and a $0.3 million decrease in personnel related expenses. This improvements were offset by an increase of $0.6 million in legal expenses.

Net loss for the third quarter 2016 was $4.3 million, compared to a net loss of $10.1 million in the prior-year period. The reduction in net loss was primarily the result of improved gross profit, decreases in operating costs, and improvements in other income (expense).

Adjusted EBITDA, which is defined as earnings before deductions for interest, taxes, depreciation, amortization, non-cash stock compensation expense, change in fair value of derivative liabilities, offering costs, loss on extinguishment of derivative liabilities and loss on extinguishment of debt for the third quarter 2016 was a loss of $2.7 million, compared to a loss of $2.2 million for the third quarter 2015.

Cash and cash equivalents totaled $10.6 million as of September, 2016. Operating cash burn decreased to $5.3 million for the nine months ended September 30, 2016 as compared to $7.1 million the prior year period, or 25%. Total principal debt obligations were $9.0 million as of September 30, 2016, a decrease of $1.8 million from September 30, 2015.

Conference Call

The Company will hold an investor conference call to discuss the financial results on Thursday November 10, 2016 at 5:00 PM Eastern Time. The Company invites all interested parties to join the call by dialing Toll Free 877-524-8416, any time after 4:50 p.m. Eastern Time on November 10^th. The Conference ID number is 13649236. International callers should dial 412-902-1028. For those who are not available to listen to the live webcast, a digital replay will be archived on the investor relations section of the Amedica website under News/Events.

LEESBURG, Va., Nov. 10, 2016 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (Nasdaq:KTWO) (“K2M” or the “Company”), a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine and minimally invasive spine technologies and techniques, today announced an offering of 4,500,000 shares of its common stock by affiliates of Welsh, Carson, Anderson & Stowe XI, L.P. (the “selling stockholders”). The offering is expected to close on or about November 17, 2016, subject to customary closing conditions. In addition, the underwriter has a 30-day option to purchase up to 675,000 additional shares of common stock from the selling stockholders on a pro rata basis.

The Company will not receive any proceeds from the sale of shares of common stock in the offering, including from any exercise by the underwriter of its option to purchase additional shares from the selling stockholders.

Wells Fargo Securities, LLC will act as the sole book-running manager and underwriter for the offering.  Wells Fargo Securities, LLC proposes to offer the shares of common stock from time to time to purchasers directly or through agents, or through brokers in brokerage transactions on the Nasdaq Global Select Market, or to dealers in negotiated transactions or in a combination of such methods of sale, at a fixed price or prices, which may be changed, or at market prices prevailing at the time of sale, at prices related to such prevailing market prices or at negotiated prices.

Following the offering, the selling stockholders will continue to beneficially own 9,486,263 shares, or approximately 22.5%, of K2M’s outstanding common stock after giving effect to the offering (or 8,811,263 shares, or approximately 20.9%, if the underwriter fully exercises its option to purchase additional shares from the selling stockholders).

A registration statement (including a prospectus) relating to these securities has been filed with the U.S. Securities and Exchange Commission (the “SEC”) and has become effective.  Before you invest, you should read the prospectus in that registration statement and other documents filed with the SEC for more information about the Company and this offering.  You may obtain these documents free of charge by visiting the SEC’s website at www.sec.gov. A copy of the prospectus supplement and the accompanying prospectus related to the offering may be obtained from Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 375 Park Avenue New York, New York 10152 or by telephone at: 800-326-5897 or email at: cmclientsupport@wellsfargo.com.

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

About K2M Group Holdings, Inc.

K2M Group Holdings, Inc. is a global medical device company focused on designing, developing and commercializing innovative complex spine and minimally invasive spine technologies and techniques used by spine surgeons to treat some of the most difficult and challenging spinal pathologies. K2M has leveraged these core competencies to bring to market an increasing number of products for patients suffering from degenerative spinal conditions. These technologies and techniques, in combination with a robust product pipeline, enable the company to favorably compete in the global spinal surgery market.

Forward-Looking Statements

This press release contains forward-looking statements that reflect our current views with respect to, among other things, our operations and financial performance. Forward-looking statements include all statements that are not historical facts such as our statements about our expected financial results and guidance and our expectations for future business prospects, including with respect to our international distribution partners in Australia and Japan. In some cases, you can identify these forward-looking statements by the use of words such as “outlook,” “guidance,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “could,” “seeks,” “predicts,” “intends,” “plans,” “estimates,” “anticipates” or the negative version of these words or other comparable words. Such forward-looking statements are subject to various risks and uncertainties including, among other things: our ability to achieve or sustain profitability; our ability to successfully demonstrate the merits of our technologies; pricing pressure from our competitors, hospitals and changes in third-party coverage and reimbursement; competition and our ability to develop and commercialize new products; aggregation of hospital purchasing from collaboration and consolidation; hospitals and other healthcare providers may be unable to obtain adequate coverage and reimbursement for procedures performed using our products; the safety and efficacy of our products is not yet supported by long-term clinical data; our dependence on a limited number of third-party suppliers; our ability to maintain and expand our network of direct sales employees, independent sales agencies and international distributors and their level of sales or distribution activity with respect to our products; the proliferation of physician-owned distributorships; concentration of sales from a limited number of spinal systems or products that incorporate these technologies; loss of the services of key members of our senior management, consultants or personnel; ability to enhance our product offerings through our research and development efforts; failure to properly manage our anticipated growth; acquisitions of or investments in new or complementary businesses, products or technologies; ability to train surgeons on the safe and appropriate use of our products; requirements to maintain high levels of inventory; impairment of our goodwill or intangible assets; disruptions in our information technology systems; any disruption or delays in operations at our facilities, including our new headquarter facility; or an ability to ship a sufficient number of our products to meet demand; ability to strengthen our brand; fluctuations in insurance cost and availability; extensive governmental regulation in the United States and foreign jurisdictions; failure to obtain or maintain regulatory approvals and clearances; requirements for new 510(k) clearances, premarket approvals or new or amended CE Certificates of Conformity; medical device reporting regulations in the United States and foreign jurisdictions; voluntary corrective actions by us or our distribution or other business partners or agency enforcement actions; a recall of our products; withdrawal or restrictions on our products or the discovery of serious safety issues with our products; possible enforcement action if we engage in improper marketing or promotion of our products; the misuse or off-label use of our products; delays or failures in any future clinical trials; the results of clinical trials; procurement and use of allograft bone tissue; environmental laws and regulations; compliance by us or our sales representatives with FDA regulations or fraud and abuse laws; U.S. legislative or regulatory healthcare reforms; medical device tax provisions in the healthcare reform laws; our need to generate significant sales to become profitable; potential fluctuations in sales volumes and our results of operations may fluctuate over the course of the year; uncertainty in our future capital needs; failure to comply with the restrictions in our revolving credit facility; continuing worldwide economic instability; our inability to protect our intellectual property rights; our reliance on patent rights that we either license from others or have obtained through assignments; our patent litigation; the outcome of potential claims that we, our employees, our independent sales agencies or our distributors have wrongfully used or disclosed alleged trade secrets or are in breach of non-competition or non-solicitation agreements with our competitors; potential product liability lawsuits; operating risks relating to our international operations; foreign currency fluctuations; our ability to comply with the Foreign Corrupt Practices Act and similar laws associated with our activities outside the United States; possible conflicts of interest with our large shareholders; increased costs and additional regulations and requirements as a result of becoming a public company; our ability to implement and maintain effective internal control over financial reporting in the future; the potential impact of any future acquisitions, mergers, dispositions, joint ventures, investments or other strategic transactions we may make; and other risks and uncertainties, including those described under the section entitled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the SEC, as such factors may be updated from time to time in our periodic filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements. These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this release and our filings with the SEC.

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

The forward-looking statements made in this press release relate only to events as of the date on which the statements are made. We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements.

Investor Contact:
Westwicke Partners on behalf of K2M Group Holdings, Inc.
Mike Piccinino, CFA
443-213-0500

CARLSBAD, Calif., Nov. 09, 2016 (GLOBE NEWSWIRE) — Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a provider of spinal fusion technologies, announced today financial results for the third quarter ended September 30, 2016. Today the Company also announced that Donald Williams, the Chairman of the Company’s Audit Committee, has been named Lead Independent Director, effective immediately.

• Third quarter total net revenues of $26.7 million; revenue from the Company’s U.S. commercial business of $25.2 million.
• Cash totaled $25.6 million at the end of the third quarter.

Highlights of the Third quarter 2016 and Recent Activities

Operational Activities

• Closed sale of international business to Globus Medical on September 1, 2016 for $80 million in cash and $30 million, 5-year term loan.
• New capital structure established — reduced overall Company debt to $40.9 million at September 30, 2016.
• CEO search actively underway with a nationally recognized executive search firm.

Products and Portfolio

• Actively developing and commercializing products in the minimally invasive (MIS) and complex spine markets — two of the fastest growth segments for spine.
• Arsenal™ Deformity  — limited launch underway, including the addition of the Adolescent Idiopathic Scoliosis (AIS) module in Q4 2016.
• Battalion™ Lateral Spacer System and Squadron™ Lateral Retractor — received FDA 510(k) market clearance; preparing for limited market release in Q1 2017.
• XYcor® Expandable Spinal Spacer System — received FDA 510(k) market clearance; introduced to surgeons at NASS; limited market release anticipated in Q4 2016.

Supply Chain Operations

• Completed transition of international business to Globus Medical; successfully operating supply chain model to support ongoing supply agreement for international products.
• Completed corporate restructuring to align with the Company’s targeted focus on the U.S. markets and reduced workforce by 20%.
• Suppliers are engaged and actively collaborating with the Company to ensure the continuous flow of new and existing products through the supply chain.

“We are in the process of building an exciting new company, a new Alphatec, with a simplified operating model, new senior leadership and a positive new culture for our employees and our customers — all of which are supported by a broad portfolio of innovative products,” said Leslie Cross, Chairman and Chief Executive Officer of Alphatec Spine.  “Strategically, our focus for the new Alphatec is simple.  We must excel at managing our supply chain and we need to reinvigorate our sales performance and grow our U.S. business.  Today, we are actively working on both initiatives with a collective passion and sense of urgency.  This journey will take time and we anticipate both challenges and opportunities along the way.  I am confident that the leadership team has the skills and experience to drive the change needed to improve our performance and deliver enduring, profitable growth.   We look forward to sharing more details about our plans early in the new year.”

Mr. Cross added, “In addition, I am pleased to announce that Don Williams has accepted to serve as the Company’s Lead Independent Director.  Don has been an Alphatec board member since May 2015 and the Chairman of the Audit Committee since October 2015.  His experience in the public accounting industry and his contributions as a director on our board have been invaluable and we appreciate his continuing commitment to Alphatec.”

Discontinued and Continuing Operations
On September 1, 2016, the Company completed the sale of the Company’s international operations and distribution channel to Globus Medical.   Consequently, the Company’s financial results from the international business, excluding revenue and cost of sales with wholly owned subsidiaries, are reflected within discontinued operations for all periods presented. Going forward, the financial results from continuing operations will consist of net product revenue for the U.S. commercial business and the revenue associated with the supply agreement with Globus Medical. For more information on the details related to discontinued operations, please see the Company’s Form 10-Q filed with the Securities and Exchange Commission on November 9, 2016.

Quarter Ended September 30, 2016

U.S. commercial revenues for the third quarter of 2016 were $25.2 million, down 8%, compared to $27.4 million reported for the third quarter of 2015.   Within the Company’s direct hospital business, implant unit volume has increased over the prior year, however, this growth has been offset by mid-single digit price decline consistent with the pricing trends the Company has experienced for the past several years.  Revenue from the Company’s stocking business is down approximately 50% from the prior year.  The third quarter of 2016 was a difficult quarter for the Company given the distraction related to the sale of the international business, which contributed to a sequential decline in hospital implant unit volumes from the second quarter of 2016.  Today, with the successful sale and transition of the international business complete and an improved balance sheet, the Company is actively engaging with surgeon and distributor customers and building a plan to regain sales momentum and improve U.S. sales.

U.S. gross profit and gross margin for the third quarter of 2016 were $15.2 million and 60.4%, respectively, compared to $19.5 million and 71.3%, respectively, for the third quarter of 2015.

Gross margin declined 10.9 percentage points from the third quarter of 2016 primarily as a result of increased inventory costs due to lower than anticipated purchase volume and obsolete inventory reserve adjustments related to optimizing the Company’s product portfolio through active product lifecycle management.

Total operating expenses for the third quarter of 2016, excluding charges for restructuring and intangible asset impairment, were $17.1 million, reflecting a decrease of $4.6 million compared to the third quarter of 2015.  The Company has been actively monitoring its expenses and reducing costs across the general and administrative (G&A), research and development (R&D) and marketing and selling areas of the business, which contributed to this 21% overall reduction in total operating expenses.  The Company is making steady progress on its goal of reducing its operating expenses by $20 million and continues to look for additional opportunities to improve its cost structure to better align with its focus on the U.S. market going forward.

GAAP net loss for the third quarter of 2016 was $13.7 million or ($1.18) per share (basic and diluted), compared to a net loss of $160.3 million, or ($18.96) per share basic and diluted for the third quarter of 2015.  GAAP net loss for the third quarter of 2015 was unfavorably impacted by $164.3 million of non-cash impairment charges, as well as favorable $6.3 million of warrant fair-value adjustments attributable to the Company’s underlying stock price.

Adjusted EBITDA in the third quarter of 2016 was $709 thousand, or 2.7% of revenues, compared to $3.5 million, or 11.0% of revenues reported in the third quarter of 2015.  Third quarter 2016 adjusted EBITDA represents net income excluding effects of interest, taxes, depreciation, amortization, stock-based compensation and restructuring expenses.

Cash and cash equivalents were $25.6 million at September 30, 2016, compared to $9.5 million reported at June 30, 2016.  The increase is primarily the result of the proceeds from the sale of the international business and the associated borrowing under the debt facility with Globus Medical.

Total Current and Long-term Debt, which includes both MidCap Financial and Globus Medical, was $40.9 million at September 30, 2016.  This represents a decrease of $34.7 million from June 30, 2016 as a result of the Company applying a significant portion of the net proceeds from the sale of the international business to reduce the Company’s total debt and the addition of the $25 million initial draw down from the credit facility with Globus that occurred upon closing of the Globus transaction.

Nine Months Ended September 30, 2016

U.S. net revenues for the nine months ended September 30, 2016 were $82.4 million, down 3.1%, compared to $85.1 million reported for the nine months ended September 30, 2015.   Sales in the Company’s direct hospital business increased over the same period in the prior year, however, this growth was partially offset by mid-single digit price declines consistent with pricing trends the Company has experienced for the past several years.  Revenue from the Company’s stocking business is down approximately 50% from the same period in the prior year.

U.S. gross profit and gross margin for the nine months ended September 30, 2016 were $56.4 million and 68.4%, respectively, compared to $58.1 million and 68.3%, respectively, for the nine months ended September 30, 2015.

Gross margin increased slightly from the prior period primarily as a result of the absence of one-time charges that were present during the nine months in 2015 that are not present over the same period in 2016.

Total operating expenses for the nine months ended September 30, 2016, excluding charges for restructuring and intangible asset impairment, were $66.3 million, reflecting a decrease of $3.8 million compared to the nine months ended September 30, 2015.  The 5.5% improvement from prior period is primarily driven by expense reductions across R&D, marketing and G&A.

GAAP net loss for the nine months ended September 30, 2016 was $25.6 million or ($1.91) per share (basic and diluted), compared to a net loss of $168.8 million, or ($19.92) per share basic and diluted for the nine months ended September 30, 2015.  GAAP net loss for the nine months ended September 30, 2015 was unfavorably impacted by $164.3 million of non-cash impairment charges, as well as favorable $6.3 million of warrant fair-value adjustments attributable to the Company’s underlying stock price.

Adjusted EBITDA in the nine months ended September 30, 2016 was $3.3 million, or 3.5% of revenues, compared to $7.1 million, or 7.1% of revenues reported in the nine months ended September 30, 2015.  Nine months ended September 30, 2016 adjusted EBITDA represents net income excluding effects of interest, taxes, depreciation, amortization, stock-based compensation and restructuring expenses.

Non-GAAP Information

Alphatec Spine reports certain non-GAAP financial measures such as non-GAAP earnings and earnings per share, adjusted for effects of amortization and other non-recurring or expense items, such as impairments, loss on extinguishment of debt, and restructuring expenses.  Adjusted EBITDA included in this press release is a non-GAAP financial measure that represents net income (loss) excluding the effects of interest, taxes, depreciation, amortization, stock-based compensation expenses, in process research and development (IPR&D) expenses and other non-recurring income or expense items, such as impairments, restructuring expenses, severance expenses, litigation expenses, damages associated with ongoing litigation and transaction-related expenses.  The Company believes that non-GAAP adjusted EBITDA provides investors with an additional tool for evaluating the Company’s core performance, which management uses in its own evaluation of continuing operating performance, and a base-line for assessing the future earnings potential of the Company.  For completeness, management uses non-GAAP adjusted EBITDA in conjunction with GAAP earnings and earnings per common share measures.  These non-GAPP financial measures should be considered in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP.   Included below are reconciliations of the non-GAAP financial measures to the comparable GAAP financial measure.

About Alphatec Spine

Alphatec Spine, Inc., a wholly owned subsidiary of Alphatec Holdings, 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 delivering advancements in spinal fusion technologies. The Company markets products in the U.S. via a direct sales force and independent distributors.

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

Forward Looking Statements

This press release may contain “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. Alphatec Spine 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 success of the Company’s initiatives to drive sales growth, increase margins and increase operating efficiencies.  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 Alphatec Spine’s pipeline, including the products discussed in this press release; 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 Alphatec Spine’s products by the surgeon community, including Battalion, Arsenal Deformity and XYcor; the Company’s ability to meet the product supply obligations set forth in the supply agreement with Globus Medical; failure to obtain FDA clearance or approval or international regulatory approvals for new products, including the products discussed in this press release, or unexpected or prolonged delays in the process; continuation of favorable third party payor 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.  Please refer to the risks detailed from time to time in Alphatec Spine’s SEC reports, including its Annual Report Form 10-K for the year ended December 31, 2015, filed on March 15, 2016 with the Securities and Exchange Commission, and its Amended Annual Report Form 10-K/A filed on April 29, 2016, as well as other filings on Form 10-Q and periodic filings on Form 8-K. Alphatec Spine 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.

CONTACT: Investor/Media Contact:

Christine Zedelmayer

Investor Relations

Alphatec Spine, Inc.

(760) 494-6610

czedelmayer@alphatecspine.com

DUBLIN and DALLAS – Nov. 10, 2016 – Medtronic plc (NYSE: MDT) today announced the launch of Medtronic Orthopedic Solutions, a comprehensive offering for total joint replacement episodes of care designed to drive clinical and economic outcomes. This offering is in response to the high costs associated with hip and knee replacements, along with the growing emphasis on improving patient outcomes, and specifically addresses the Centers for Medicare & Medicaid Services (CMS) recently implemented Comprehensive Care for Joint Replacement (CJR) model – a bundled payment initiative that holds approximately 800 hospitals accountable for the quality of care they deliver for hip and knee replacements. Medtronic Orthopedic Solutions offers a consultative program designed to help providers meet CJR requirements by reducing system costs while addressing patient satisfaction and outcomes; it will support providers from pre-surgical planning through the 90th day post discharge. In addition, Medtronic is launching a value-based total knee arthroplasty system at the American Association of Knee and Hip Surgeons Annual Meeting (AAKHS), which is currently taking place in Dallas. The Total Knee Arthroplasty System will be widely available in the first half of 2017.

“Medtronic is here to help speed the adoption of value-based healthcare in orthopedics by helping hospitals drive down costs while keeping outcomes top of mind,” said Geoff Martha, EVP and president of Medtronic Restorative Therapies Group. “Our technological and operational efficiency know-how – along with our insight into the various points along the care continuum – helps us develop effective solutions, tailored to client needs. And we back this up by sharing potential savings with our customer, which means we get paid if our program is successful in reducing episode costs for customers. This is about more than just offering implants or individual technologies and services; it’s about partnering with all stakeholders throughout the entire episode of care to enable patient-centered care at the best value.”

CMS targeted hip and knee replacements because they are the most commonly performed inpatient procedures for Medicare patients and often entail lengthy recoveries.¹ More than 400,000 procedures took place in 2014, with hospital costs of $7 billion.¹ There is significant variance in complication rates and overall costs across hospitals and geographies. CJR aims to improve patient care by encouraging hospitals, physicians, and post-acute care providers to work together to improve the quality and coordination of care from the initial hospitalization through recovery, and financially rewarding hospitals for providing cost effective and high quality care, while levying penalties for poor outcomes.

“CJR represents a completely new approach to healthcare with bundled payments rewarding the best outcomes, which will ultimately improve patient care,” said Joseph A. Bosco, M.D., an orthopedic surgeon in New York, NY. “But to succeed, hospitals need new solutions to streamline the delivery of care and evaluate outcomes. The way CJR works, target episode prices will be set in comparison to large regions, so there will be a premium to figuring things out very quickly.”

Medtronic Orthopedic Solutions was developed in partnership with leading physicians who have successfully implemented bundled payment programs. It is designed to create tailored solutions that improve quality and patient experience, while lowering costs across the care continuum. These solutions include:

• Care Pathways – A comprehensive, patient-focused program designed to uncover opportunities to reduce costs and improve efficiencies, patient satisfaction, and outcomes at every point of care. It also provides technology to monitor success and course-correct as needed. This service will be offered as a performance-based partnership; Medtronic is compensated when the company achieves successful outcomes and cost savings for customers.
• Patient Monitoring with Medtronic Care Management Services (MCMS) – Our remote patient monitoring and engagement solutions are designed to help patients recover at home, deliver actionable information to providers to help enable timely and effective clinical interventions, and provide patient context and education important for self-care. With a remote patient monitoring program designed specifically for patients recovering from total hip and total knee arthroscopy, MCMS may help clinicians manage readmission risk and improve patient satisfaction – important factors in CJR evaluations.
• Total Knee Arthroplasty System – Medtronic’s FDA-cleared knee implant was designed to facilitate cost savings by leading orthopedic surgeons who have significant clinical and design experience. The implants are made in the United States using well-studied materials and supported intraoperatively by trained clinical specialists.
• Bleeding Control with the Aquamantys(TM) System – This well-established Medtronic technology combines radiofrequency energy and saline to provide hemostatic sealing of soft tissue and bone. Aquamantys use has been shown to decrease length of stay and hematoma rate, and increase the number of patients discharged to home self-care following primary total hip arthroplasty.² In total knee arthroplasty, Aquamantys use has been shown to reduce blood loss, transfusion rates, and drain output, and to maintain hematocrit levels.³  

“Quality, lower-cost implants are a very attractive option as we seek to improve patient’s lives while also providing value-driven healthcare,” said Richard Scott, M.D., professor of Orthopedic Surgery, Emeritus, at Harvard Medical School and formerly chief of Joint Arthroplasty at The New England Baptist Hospital and co-designer of Medtronic’s total knee arthroplasty system. “We designed Medtronic’s total knee arthroplasty system to be simple, versatile and intuitive without unnecessary complexity and inventory. The goal is to benefit everyone – first and foremost the patients, but also the surgeons, hospitals and payers who are providing their care.”

Medtronic intends to report results from the Medtronic Orthopedic Solutions business as part of its Spine division within the Restorative Therapies Group. For more information about Medtronic Orthopedic Solutions, please visit
http://www.medtronic.com/us-en/healthcare-professionals/services/orthopedic-solutions.html.
Medtronic’s Total Knee Arthroplasty System
Medtronic Launches Orthopedic Solutions Business and Total Knee Arthroplasty System
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About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world’s largest medical technology, services and solutions companies – alleviating pain, restoring health, and extending life for millions of people around the world. Medtronic employs more than 88,000 people worldwide, serving physicians, hospitals and patients in approximately 160 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

References:

1. Comprehensive Care for Joint Replacement Model, Centers for Medicare and Medicaid Services website. https://innovation.cms.gov/initiatives/CJR. Accessed 10-18-16.
2. Ackerman SJ, Tapia CI, Baik R, Pivec R, Mont MA. Use of a bipolar sealer in total hip arthroplasty: medical resource use and costs using a hospital administrative database. Orthopedics. 2014;37(5):e472 – 481.
3. Sah A, Dearborn J. Aquamantys bipolar sealer in primary total knee arthroplasty: experience with 3,172 consecutive knee replacements. Poster presentation at American Academy of Orthopaedic Surgeons Annual Meeting 2012; San Francisco, CA.

Knee replacement surgery is intended to relieve knee pain and improve knee function. There are potential risks with knee replacement surgery such as loosening, wear and infection that may result in the need for additional surgery.

Contacts:
Victor Rocha
Public Relations
+1-901-399-2401

Ryan Weispfenning
Investor Relations
+1-763-505-4626