31 Oct

Innovasive™ Granted FDA Clearance for DualX™ Expanding Interbody Spinal Device

Innovasive, a privately-held spinal device company, focuses on developing and commercializing minimally-invasive, innovative spinal technologies. Today, Innovasive announced that they have received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market their DualX technology, a titanium, dual expanding, interbody device for spinal fusion procedures in the lumbar spine.

“DualX is a unique expandable interbody that expands in two independent directions,” explained Andy Choi, Chief Executive Officer, Innovasive, Inc. “First, it expands laterally to provide a wide base for stability and spinal support. DualX then expands vertically with lordosis to aide in the restoration of sagittal alignment of the lumbar spine.”

The DualX technology is comprised of a family of titanium expandable interbody devices designed to be used in transforaminal lumbar interbody fusion (TLIF), posterior lumbar interbody fusion (PLIF) and lateral lumbar interbody fusion (LLIF) spinal procedures. The product portfolio contains varying footprints, heights and degrees of lordosis with post-expansion bone grafting to provide a customized anatomical fit for a clinically successful fusion environment.

“The ability of DualX to provide expansion in two planes is essential for achieving a successful surgical outcome. DualX accomplishes the goals of creating a biomechanically stable environment for spinal fusion, as well as supporting normal sagittal and coronal alignment; both of which are essential factors for restoring optimal spinal balance. These critical factors will help spine surgeons achieve the primary goals of performing surgeries that lead to successful, minimally invasive spinal fusion procedures.” said, Jeffrey Roh, MD, MBA, MSc, Director of Minimally Invasive Spine Surgery at the Swedish Neuroscience Institute in Seattle, WA.

“We are excited to receive FDA clearance and look forward to a successful product launch in the near future,” said Mr. Choi. DualX will be available for implantation in spinal fusion procedures before the end of this year.

About Innovasive 

Innovasive, Inc. is a privately-held spinal device company located in Mission Viejo, CA. The Company focuses on developing and commercializing innovative, minimally-invasive technologies for spine surgery. Innovasive is a portfolio company of IntuitiveX, a life science innovation incubator.

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31 Oct

Stimwave Receives FDA Clearance for World’s Only Opioid Free Pain Management Wireless System iPhone-iWatch Controllers

October 31, 2018

POMPANO BEACH, Fla.--(BUSINESS WIRE)--Stimwave Technologies, the leading innovator of wireless medical device bioelectronic technology, today announced that it has received FDA clearance for the WaveCrest MobileTM iOS Platform patient controllers for opioid free pain management. This revolutionary new system now gives patients iPhone® and Apple Watch® mobile control over WaveMasterTM multi-waveform automated programming for the Wireless Freedom Spinal Cord Stimulator (SCS) System for relief of chronic pain. The Freedom SCS System is the world’s first wireless, fully-programmable SCS neuromodulation device providing a life-changing technological breakthrough for the more than 90 million people in the U.S. who endure daily chronic back and leg pain. WaveCrest Mobile allows a patient to use an iPhone, iPod touch®, or Apple Watch to adjust their pain relief therapy. This is the first FDA-cleared software that allows the AppleWatch to control a neuromodulation device implanted inside the body. The software is designed to be easy to use and secure. WaveCrest Mobile enables pain sufferers to fine-tune the power level, visualize battery life, and modify programs that were pre-programmed by their clinician to control pain without opioids. “Pain suffers are rapidly migrating to the Stimwave Freedom wireless pain relief system as an opioid free option to control their pain- and now they can adjust their therapy with the swipe of their finger through their Apple Watch or iPhone/iPod Touch discretely any time as needed,” said Stimwave Chairman and CEO Laura Tyler Perryman. “Transformation of pain treatment moving from opioids and pills to interventional solutions like Stimwave can only happen as a result of empowering the masses to take control of their pain, which is now as easy as 1-2-3 with WaveCrest Mobile.” Stimwave’s Freedom Stimulators are implanted in an outpatient procedure with no need for general anesthesia, a large surgical incision or a bulky internal battery known to lead to numerous complications from other legacy older technologies. These products are expected to significantly reduce the lifetime cost of care for chronic pain patients and offer a safe, viable and effective alternative to opioids. “Patients’ needs in pain management are unique and customized programming is a must. The Freedom System not only is the smallest option available for patients eliminating the complexities of an implanted lithium ion battery, but offers a wide variety of advanced programming features that the patient can choose through their mobile device,” said Dr. Ellen Lin, M.D., medical director of San Antonio’s Advanced Spine and Pain Center. “WaveCrest Mobile provides patients with a high-tech approach to controlling their pain through their mobile device and future features and upgradeability options they never had before.” Utilizing the Stimwave Freedom System, clinicians utilize an iPad application to easily program the system using WaveMaster advanced therapy waveforms offering the ability to easily and quickly provide patients with the widest array of programming waveforms, frequencies and combinations of options to ensure long term pain relief, all selectable from the AppleWatch or iPhone controller. Apple and iPhone are trademarks of Apple Inc. registered in the U.S. and other countries. About Stimwave Stimwave Technologies Incorporated is a privately held medical device company engaged in the development, manufacture, and commercialization of wirelessly powered, injectable, microtechnology neurostimulators, providing patients with a convenient, safe, minimally invasive, and highly cost-effective pain management solution that is easily incorporated into their daily lives. Stimwave’s goal is to evolve its patented, cutting-edge platform into the default for neuromodulation, increasing the accessibility for patients worldwide while lowering the economic impact of pain management. www.stimwave.com

Contacts

GlodowNead Communications Rosemary O'Brien, 415-394-6500 StimwavePR@GlodowNead.com

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31 Oct

OrthoPediatrics Corp. Reports Third Quarter 2018 Financial Results

WARSAW, Ind., Oct. 31, 2018 (GLOBE NEWSWIRE) -- OrthoPediatrics Corp. (NASDAQ: KIDS), a company exclusively focused on advancing the field of pediatric orthopedics, today announced financial results for the third quarter ended September 30, 2018 and increased revenue guidance for full year 2018.

Third Quarter & Recent Highlights

  • Increased total revenue to $15.8 million for third quarter 2018, up 27.8% from $12.4 million in third quarter 2017
  • Deployed $2.3 million of consignment sets during the third quarter 2018
  • Converted Canada to sales agency model
  • Fully launched Pediatric Nailing Platform | FEMUR and announced expanded indications for FIREFLY® Pedicle Screw Navigation Guides, patient-specific, 3D printed guides, in July
  • Received FDA 510(k) clearance for 26th surgical system, RESPONSE 4.5/5.0mm System, to treat smaller stature, younger patients with complex scoliosis in October
  • Increased revenue growth guidance to a range of 25.0% to 25.5% and investment in consignment sets to $12.0 million for full year 2018

Mark Throdahl, Chief Executive Officer of OrthoPediatrics, stated, “Our strong performance represents another consecutive quarter of record revenues, driven by continued strength across all segments of our business. In the third quarter, we further consolidated our leading position in pediatric orthopedics with particularly strong domestic sales, led by our U.S. scoliosis business and reflecting the initial benefits from increased investment in consigned sets. With the additional $2.3 million of set deployment during the quarter, we continue to address the robust demand for our surgical systems. Furthermore, our demonstrated ability to develop a consistent cadence of innovative products provides further expansion opportunities. We are very pleased with our steady execution that led to another quarter of outperformance and supports our increased guidance for the full year.”

Third Quarter 2018 Financial Results

Total revenue for the third quarter 2018 was $15.8 million, representing 27.8% growth, compared to total revenue of $12.4 million for the third quarter 2017. U.S. revenue for the third quarter of 2018 increased 30.0% to $12.4 million, compared to $9.6 million for the same period last year, and represented 78.5% of total revenue. International revenue increased 20.6% to $3.4 million, compared to $2.8 million for the same period last year and represented 21.5% of total revenue.

Trauma and Deformity revenue for third quarter 2018 increased 21.0% to $10.6 million compared to $8.7 million for the same period last year. Scoliosis revenue increased 52.4% to $5.0 million compared to $3.3 million for the third quarter 2017. Sports Medicine/Other revenue for the third quarter of 2018 decreased 33.2% to $0.2 million compared to $0.3 million for the same period last year.

Gross profit for the third quarter of 2018 was $12.0 million, a 26.2% increase compared to $9.5 million for the same period last year. Gross profit margin for the third quarter of 2018 was 75.7%, compared to 76.7% for the same period last year due to lower international margins.

Total operating expenses for the third quarter of 2018 were $13.1 million, a 28.3% increase compared to $10.2 million for the same period last year. The increase in operating expenses was driven by a 26.9% increase in sales and marketing, including higher commissions, and unusually higher, non-recurring professional fees associated with legal expense. Operating loss for the quarter increased to ($1.2) million from ($0.8) million for the same period last year.

Net interest expense for the third quarter of 2018 was $0.6 million, a 20.1% decrease compared to $0.8 million for the same period last year.

Net loss attributable to common stock holders for the period was ($1.9) million, compared to ($3.0) million for the third quarter of 2017. Net loss per share attributable to common stockholders for the third quarter of 2018 was ($0.15) per basic and diluted share compared to ($1.70) per basic and diluted share for the same period prior year.

Adjusted EBITDA for the third quarter of 2018 was $1.0 million as compared to $0.3 million for the third quarter of 2017. The change was primarily driven by the significant increase in revenue. See below for additional information and a reconciliation of non-GAAP financial information.

The weighted average number of diluted shares outstanding as of September 30, 2018 was 12,624,858 shares.

In the third quarter of 2018, our independent sales agencies in the United States employed 86 full-time equivalent sales representatives specifically focused on pediatrics.

Purchases of property and equipment during the third quarter of 2018 were essentially flat at $1.1 million when compared to the same period last year, reflecting the deployment of consigned sets that included procedure specific implants, instruments, and cases and trays. Including the implants, $2.3 million of consigned sets were deployed during the third quarter of 2018. This compared to $2.2 million during the third quarter of 2017 most of which were international set sales due to the conversion to an agency model from a stocking distributor in select markets.

As of September 30, 2018, cash and cash equivalents were $24.5 million, compared to $26.5 million as of June 30, 2018, and the Company had approximately $25.4 million in total outstanding indebtedness, including $3.9 million outstanding under the revolving credit facility.

Full Year 2018 Financial Guidance

OrthoPediatrics is updating financial guidance for the full year 2018, as follows:

  • Revenue growth in a range of 25.0% to 25.5%, up from prior guidance of 23% to 24%.
  • Consigned set investments of approximately $12.0 million, up from prior guidance of $11.0 million.

Conference Call

OrthoPediatrics will host a conference call on Thursday, November 1, 2018, at 8:00 a.m. ET to discuss the results. The dial-in numbers are (855) 289-4603 for domestic callers and (614) 999-9389 for international callers. The conference ID number is 6099725. A live webcast of the conference call will be available online from the investor relations page of the OrthoPediatrics’ corporate website at www.orthopediatrics.com.

A replay of the webcast will remain available on OrthoPediatrics’ website, www.orthopediatrics.com, until the Company releases its full year 2018 financial results. In addition, a telephonic replay of the call will be available until November 8, 2018. The replay dial-in numbers are (855) 859-2046 for domestic callers and (404) 537-3406 for international callers. Please use the replay conference ID number 6099725.

Forward-Looking Statements

This press release includes "forward-looking statements" within the meaning of U.S. federal securities laws. You can identify forward-looking statements by the use of words such as "may," "might," "will," "should," "expect," "plan," "anticipate," "could," "believe," "estimate," "project," "target," "predict," "intend," "future," "goals," "potential,” "objective," "would" and other similar expressions. Forward-looking statements involve risks and uncertainties, many of which are beyond OrthoPediatrics’ control. Important factors could cause actual results to differ materially from those in the forward-looking statements, including, among others, the risks, uncertainties and factors set forth under "Risk Factors" in OrthoPediatrics’ Annual Report on Form 10-K filed with the SEC on March 15, 2018. Forward-looking statements speak only as of the date they are made. OrthoPediatrics assumes no obligation to update forward-looking statements to reflect actual results, subsequent events, or circumstances or other changes affecting such statements except to the extent required by applicable securities laws.

Use of Non-GAAP Financial Measures

This press release includes the non-GAAP financial measure of Adjusted EBITDA, which differs from financial measures calculated in accordance with U.S. generally accepted accounting principles (“GAAP”). Adjusted EBITDA in this release represents net loss, plus interest expense (income), net plus other expense (income), depreciation and amortization, stock-based compensation expense, accelerated vesting of restricted stock upon our IPO, public company costs and initial public offering costs. Adjusted EBITDA is presented because the Company believes it is a useful indicator of its operating performance. Management uses the metric as a measure of the Company’s operating performance and for planning purposes, including financial projections. The Company believes this measure is useful to investors as supplemental information because it is frequently used by analysts, investors and other interested parties to evaluate companies in its industry. The Company believes Adjusted EBITDA is useful to its management and investors as a measure of comparative operating performance from period to period. Adjusted EBITDA is a non-GAAP financial measure and should not be considered as an alternative to, or superior to, net income or loss as a measure of financial performance or cash flows from operations as a measure of liquidity, or any other performance measure derived in accordance with GAAP, and it should not be construed to imply that the Company’s future results will be unaffected by unusual or non-recurring items. In addition, the measure is not intended to be a measure of free cash flow for management’s discretionary use, as it does not reflect certain cash requirements such as debt service requirements, capital expenditures and other cash costs that may recur in the future. Adjusted EBITDA contains certain other limitations, including the failure to reflect our cash expenditures, cash requirements for working capital needs and other potential cash requirements. In evaluating Adjusted EBITDA, you should be aware that in the future the Company may incur expenses that are the same or similar to some of the adjustments in this presentation. The Company’s presentation of Adjusted EBITDA should not be construed to imply that its future results will be unaffected by any such adjustments. Management compensates for these limitations by primarily relying on the Company’s GAAP results in addition to using Adjusted EBITDA on a supplemental basis. The Company’s definition of this measure is not necessarily comparable to other similarly titled captions of other companies due to different methods of calculation. The schedules below contain a reconciliation of Net Loss to non-GAAP Adjusted EBITDA.

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 25 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This offering spans trauma & deformity, scoliosis, and sports medicine/other procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and 38 countries outside the United States.

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

ORTHOPEDIATRICS CORP.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In Thousands, Except Share Data)
  September 30, December 31,
    2018   2017
    (unaudited)  
ASSETS
Current assets:
Cash $ 24,463 $ 42,582
Accounts receivable - trade, less allowance for doubtful accounts of
$131 and $143, respectively 9,456 5,603
Inventories, net 26,646 19,498
Inventories held by international distributors, net 234 1,047
Prepaid expenses and other current assets 1,045 831
Total current assets 61,844 69,561
Property and equipment, net 12,774 10,391
Other assets:
Amortizable intangible assets, net 2,000 2,089
Other intangible assets 260 260
Total other assets 2,260 2,349
Total assets $ 76,878 $ 82,301
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable - trade $ 5,903 $ 5,495
Accrued compensation and benefits 3,302 2,905
Current portion of long-term debt with affiliate 117 113
Other current liabilities 1,594 954
Total current liabilities 10,916 9,467
Long-term liabilities:
Long-term debt with affiliate, net of current portion 21,330 21,418
Revolving credit facility with affiliate 3,947 3,921
Total long-term liabilities 25,277 25,339
Total liabilities 36,193 34,806
Commitments and contingencies
Stockholders' equity:
Common stock, $0.00025 par value; 50,000,000 shares authorized;
12,807,520 shares and 12,621,781 shares issued and outstanding as
of September 30, 2018 (unaudited) and December 31, 2017 2 2
Additional paid-in capital 153,649 150,424
Accumulated deficit (112,623 ) (103,066 )
Accumulated other comprehensive income (343 ) 135
Total stockholders' equity 40,685 47,495
Total liabilities and stockholders' equity $ 76,878 $ 82,301
ORTHOPEDIATRICS CORP.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(In Thousands, Except Share and Per Share Data)
Three Months Ended September 30, Nine Months Ended September 30,
2018 2017 2018 2017
Net revenue $ 15,820 $ 12,375 $ 42,991 $ 33,939
Cost of revenue 3,843 2,884 10,825 8,321
Gross profit 11,977 9,491 32,166 25,618
Operating expenses:
Sales and marketing 7,150 5,633 20,005 15,122
General and administrative 4,877 3,487 16,393 10,282
Research and development 1,122 1,127 3,455 2,482
Total operating expenses 13,149 10,247 39,853 27,886
Operating loss (1,172 ) (756 ) (7,687 ) (2,268 )
Other expenses:
Interest expense 608 761 1,722 1,857
Other expense (income) 85 20 148 (38 )
Total other expenses 693 781 1,870 1,819
Net loss $ (1,865 ) $ (1,537 ) $ (9,557 ) $ (4,087 )
Net loss attributable to common stockholders $ (1,865 ) $ (3,021 ) $ (9,557 ) $ (8,451 )
Weighted average common shares - basic and diluted 12,624,858 1,773,385 12,417,972 1,754,576
Net loss per share attributable to common stockholders - basic and diluted $ (0.15 ) $ (1.70 ) $ (0.77 ) $ (4.82 )
ORTHOPEDIATRICS CORP.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(In Thousands)
For the Nine Months Ended September 30,
2018 2017
OPERATING ACTIVITIES
Net loss $ (9,557 ) $ (4,087 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization 2,177 1,748
Stock-based compensation 2,899 1,081
Changes in certain current assets and liabilities:
Accounts receivable - trade (4,077 ) (1,588 )
Inventories (6,087 ) (3,276 )
Inventories held by international distributors 813 345
Prepaid expenses and other current assets (214 ) (382 )
Accounts payable - trade 408 1,559
Accrued expenses and other liabilities 798 513
Other (15 ) 193
Net cash used in operating activities (12,855 ) (3,894 )
INVESTING ACTIVITIES
Purchases of licenses (195 ) (1,337 )
Purchases of property and equipment (5,311 ) (3,949 )
Net cash used in investing activities (5,506 ) (5,286 )
FINANCING ACTIVITIES
Proceeds from issuance of debt with affiliate - 10,139
Payments on mortgage notes (84 ) (80 )
Proceeds from exercise of stock options 326 -
Payments of deferred offering costs - (250 )
Net cash provided by financing activities 242 9,809
NET INCREASE (DECREASE) IN CASH (18,119 ) 629
Cash, beginning of year 42,582 1,609
Cash, end of period $ 24,463 $ 2,238
SUPPLEMENTAL DISCLOSURES
Cash paid for interest $ 1,722 $ 1,856
Accretion of redeemable convertible preferred stock $ - $ 4,364
Transfer of instruments from property and equipment to inventory $ 1,061 $ 1,196
ORTHOPEDIATRICS CORP.
NET REVENUE BY GEOGRAPHY AND PRODUCT CATEGORY
(Unaudited)
(In Thousands)
Three Months Ended September 30, Nine Months Ended September 30,
Product sales by geographic location: 2018 2017 2018 2017
U.S. $ 12,421 $ 9,556 $ 32,532 $ 26,085
International 3,399 2,819 10,459 7,854
Total $ 15,820 $ 12,375 $ 42,991 $ 33,939
Three Months Ended September 30, Nine Months Ended September 30,
Product sales by category: 2018 2017 2018 2017
Trauma and deformity $ 10,562 $ 8,730 $ 29,545 $ 24,339
Scoliosis 5,027 3,299 12,609 8,652
Sports medicine/other 231 346 837 948
Total $ 15,820 $ 12,375 $ 42,991 $ 33,939
ORTHOPEDIATRICS CORP.
RECONCILIATION OF NET LOSS TO NON-GAAP ADJUSTED EBITDA
(Unaudited)
(In Thousands)
Three Months Ended September 30, Nine Months Ended September 30,
2018 2017 2018 2017
Net Loss $ (1,865 ) $ (1,537 ) $ (9,557 ) $ (4,087 )
Interest expense, net 608 761 1,722 1,856
Other expense 85 20 148 (38 )
Depreciation and amortization 777 656 2,177 1,748
Stock-based compensation 594 394 1,239 1,121
Accelerated vesting of restricted stock upon our IPO - - 1,986 -
Public company costs 340 - 1,014 -
Non-recurring professional services fees 473 - 2,241 -
Adjusted EBITDA $ 1,012 $ 294 $ 970 $ 600
 

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31 Oct

What Does Knee Surgery Cost? Few Know, and That’s a Problem

By Melanie Evans / Aug. 21, 2018 For nearly a decade, Gundersen Health System’s hospital in La Crosse, Wis., boosted the price of knee-replacement surgery an average of 3% a year. By 2016, the average list price was more than $50,000, including the surgeon and anesthesiologist.

Yet even as administrators raised the price, they had no real idea what it cost to perform the surgery—the most common for hospitals in the U.S. outside of those related to childbirth. They set a price using a combination of educated guesswork and a canny assessment of market opportunity. Prompted by rumblings from Medicare and private insurers over potential changes to payments, Gundersen decided to nail down the numbers. During an 18-month review, an efficiency expert trailed doctors and nurses to record every minute of activity and note instruments, resources and medicines used. The hospital tallied the time nurses spent wheeling around VCR carts, a mismatch of available postsurgery beds, unnecessarily costly bone cement and delays dispatching physical therapists to get patients moving. The actual cost? $10,550 at most, including the physicians. The list price was five times that amount. Competitive forces are out of whack in health care. Hospitals are often ignorant about their actual costs. Instead, they often increase prices to meet profit targets. Patients, especially those with insurance, often don’t know the price of a procedure and rarely shop around. This dynamic is a driving force in the explosion in health-care spending in the U.S., which will soon reach close to 20% of GDP. Americans spend more per capita on health care than any other developed nation, even though they aren’t buying more health care overall. The rise in hospital prices has outpaced economywide inflation for decades. “When price isn’t tightly linked to cost, that is a sign that the market isn’t competitive,” said Harvard economist Leemore Dafny. Hospitals can be shielded from the competition that forces other industries to wring out expenses and slash prices. Hospital list prices are a starting point for negotiations with insurance companies over what they will actually pay, and those deals are confidential. Consolidation has given hospitals greater pricing power in many markets, according to health-economics researchers. “Being cost effective was not an imperative in that type of market dynamic,” said Derek Haas, chief executive officer of Avant-garde Health, a health-care cost and quality analytics company that worked with Gundersen. On knee-replacement surgery, higher-cost hospitals spent almost twice the amount lower-cost hospitals spent, despite largely similar quality and roughly comparable patients, research by Mr. Haas and Harvard Business School Professor Robert Kaplan showed. “It’s a standard procedure” that doesn’t vary much from one hospital to another, and nor should its costs, Mr. Kaplan said. “Carve out the old knee and put in a new joint.”
  READ THE REST HERE

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31 Oct

Extremity Medical Announces the Release of the Omni Plating System

Parsippany, NJ – Oct 30, 2018 Extremity Medical, a global extremity implant company that provides innovative products for the upper and lower extremities, today announced the release of its newest implant system—the Omni Plating System. The Omni Plating System is designed to address a broad range of fusion procedures for the foot, and is integrated with the unique PlantarFiXTM Post. The PlantarFiX Post is a state-of-the-art technology that produces a broader surface area of compression across the joint to be fused. This compression advantage, along with the stability of the plate, eliminates the risk of plantar gapping seen in other dorsal plates and greatly assists in fusion, regardless of indication and patient bone quality. “Now more than ever, Extremity Medical continues to expand our portfolio with innovative products that service the leading procedures for the foot and ankle surgeon,” said Matt Lyons, President of Extremity Medical. “Our philosophy is to create fusion technology based on the biomechanical principles of delivering consistent compression across the joint. That philosophy is behind the new PlantarFiX Post technology, which has been developed to integrate throughout the Omni plates.” Lyons further explains “We are committed to delivering exciting new technology to meet the needs of the foot and ankle surgeon and to provide highly differentiated products. This portfolio expansion continues to demonstrate the Company’s strategic efforts to deliver the most differentiated portfolio in the extremity market.” Extremity Medical, LLC is an orthopedic device company specializing in the development of next generation systems addressing unmet needs for the extremity surgeon. The Company, which is privately held, is based in Parsippany, NJ and markets its products in the U.S. via independent sales agents. For more information, please visit: http://www.extremitymedical.com

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31 Oct

Alphatec Announces Participation at Stifel 2018 Healthcare Conference

CARLSBAD, Calif., Oct. 31, 2018 (GLOBE NEWSWIRE) -- Alphatec Holdings, Inc. (“ATEC” 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 it will present at the Stifel 2018 Healthcare Conference on November 14, 2018, at 2:00 P.M. EST at the Lotte New York Palace Hotel.

Terry Rich, ATEC’s President and Chief Operating Officer, will provide a business overview of the during the live presentation. Management will also be available to participate in one-on-one meetings with investors who are registered to attend the conference.

A copy of the presentation will be available online from the investor relations page of the Company's corporate website at www.atecspine.com. The conference will be webcast live. To access the webcast, please visit http://wsw.com/webcast/stifel14/atec/. The webcast replay will remain available for 90 days following the live presentation.

About Alphatec Holdings, Inc.

Alphatec Holdings, Inc., through its wholly-owned subsidiaries, Alphatec Spine, Inc. and SafeOp Surgical, 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

Forward-Looking Statements

Statements made in this press release and made during the investor events referenced herein 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. 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 ATEC 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; 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, LLC 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. ATEC 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: Tina Jacobsen ir@atecspine.com (760) 494-6790 Company Contact: Jeff Black Executive Vice President and Chief Financial Officer Alphatec Holdings, Inc. ir@atecspine.com

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31 Oct

Integra LifeSciences Reports Third Quarter 2018 Financial Results

PLAINSBORO, N.J., Oct. 31, 2018 (GLOBE NEWSWIRE) -- Integra LifeSciences Holdings Corporation (NASDAQ: IART), a leading global medical technology company, today reported financial results for the third quarter ending September 30, 2018. Third Quarter 2018 Consolidated Results

  • Reported revenue was $365.9 million, an increase of 31.2% compared to the third quarter of 2017 with the acquisition of Codman contributing $78.9 million, and organic revenues increased 6.2% over the third quarter of 2017;
  • GAAP earnings per share was $0.15, compared to $0.04 in the third quarter of 2017;
  • Adjusted earnings per share was $0.59, reflecting an increase of 31.1% compared to the third quarter of 2017;
  • The company is revising its full-year 2018 guidance as follows:
    • Total revenue is now expected to be a range of $1.467 billion to $1.472 billion (previously $1.475 billion to $1.490 billion);
      • Guidance range reflects lower forecasted revenue from extremities orthopedics, Codman revenue in select countries outside the U.S. where commercial operations have not yet transferred to Integra ("Day 2 Countries"), and a lower foreign currency benefit;
    • Organic revenue growth guidance is now expected to be approximately 4% (previously approximately 5%);
  • The company is reiterating its full-year 2018 GAAP earnings per share of $0.71 to $0.77 and adjusted earnings per share of $2.36 to $2.42.
Total revenues for the third quarter of 2018 were $365.9 million, reflecting an increase of 31.2% over the third quarter of 2017. Sales in the Codman Specialty Surgical segment increased 45.1% compared to the third quarter of 2017, driven by the Codman acquisition and strong performance in the Dural Access and Repair, Advanced Energy, and Neuro Monitoring businesses.  Sales in the Orthopedics and Tissue Technologies segment increased 11.2%, reflecting continued strength in our Regenerative Technologies and Private Label businesses. Total organic revenues increased 6.2% over the third quarter of 2017, excluding acquisitions, divestitures and the effect of currency exchange rates. "Despite some revenue softness in the second half of the year, we continue to make solid progress with the Codman integration and the channel expansion efforts, particularly in Regenerative Technologies," said Peter Arduini, Integra's president and chief executive officer.  "We remain confident that 2019 organic sales will grow within our targeted long-term range of 5% to 7% and accelerate from our full-year 2018 results." The company reported GAAP net income of $13.3 million, or $0.15 per diluted share, for the third quarter of 2018, compared to GAAP net income of $3.2 million, or $0.04 per diluted share, in the third quarter of 2017. The increase in GAAP net income is a result of higher revenues, better operating expense leverage and a lower tax rate. The adjusted measures discussed below are computed with the adjustments to GAAP reporting that are set forth in the attached reconciliation. Adjusted EBITDA for the third quarter of 2018 was $84.3 million, or 23.0% of revenue, compared to $63.0 million, or 22.6% of revenue, in the third quarter of 2017. The margin improvement was largely based on better operating expense leverage, mostly from selling, general and administrative costs. Adjusted net income for the third quarter of 2018 was $50.6 million, an increase of 40.2% from the prior year's third quarter. Adjusted earnings per share for the third quarter of 2018 was $0.59, an increase of 31.1% over the prior year's quarter. 2018 Full-Year Outlook The company is revising its full-year 2018 total revenue guidance to a new range of $1.467 billion to $1.472 billion.  This includes an expectation for organic growth of approximately 4% for the full year 2018 versus the previous guidance of approximately 5%. The company is reiterating its full-year 2018 GAAP earnings per share guidance range of $0.71 to $0.77, and adjusted earnings per share guidance range of $2.36 to $2.42.

In the future, the company may record, or expects to record, certain additional revenues, gains, expenses, or charges as described in the Discussion of Adjusted Financial Measures below, which will be excluded from the calculation of adjusted EBITDA, adjusted earnings per share for historical periods and in adjusted earnings per share guidance.

Conference Call and Presentation Available Online Integra has scheduled a conference call for 8:30 AM ET today, Wednesday, October 31, 2018, to discuss financial results for the third quarter and forward-looking financial guidance. The conference call will be hosted by Integra's senior management team and will be open to all listeners. Additional forward-looking information may be discussed in a question and answer session following the call. Integra's management team will reference a presentation during the conference call. The presentation can be found on investor.integralife.com. Access to the live call is available by dialing (334) 323-0522 and using the passcode 3216000. The call can also be accessed via a webcast link provided on investor.integralife.com.  A replay of the call will be available through November 5, 2018 by dialing (719) 457-0820 and using the passcode 3216000. The webcast will also be archived on the website. About Integra Integra LifeSciences is a global leader in regenerative technologies, neurosurgical and extremity orthopedic solutions dedicated to limiting uncertainty for clinicians, so they can focus on providing the best patient care. Integra offers a comprehensive portfolio of high quality, leadership brands that include AmnioExcel®, Bactiseal®, Cadence®, Certas™, Codman®, CUSA®, DuraGen®, DuraSeal®, ICP Express®, Integra®, MediHoney®, MicroFrance®, PriMatrix®, Salto Talaris®, SurgiMend®, TCC-EZ®, Titan™ and VersaTru™.  For the latest news and information about Integra and its brands, please visit www.integralife.com. This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties, and reflect the Company's judgment as of the date of this release.  All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements. Some of these forward-looking statements may contain words like “will,” “believe,” “may,” “could,” “would,” “might,” “possible,” “should,” “expect,” “intend,” “plan,” “anticipate,” or “continue,” the negative of these words, other terms of similar meaning or they may use future dates. Forward-looking statements contained in this news release include, but are not limited to, statements concerning future financial performance, including projections for revenues, expected revenue growth (both reported and organic), GAAP and adjusted net income, GAAP and adjusted earnings per diluted share, non-GAAP adjustments such as global enterprise resource planning ("ERP") system implementation charges, acquisition-related charges, litigation charges, goodwill impairment charges, non-cash amortization of imputed interest for convertible debt, intangible asset amortization, and income tax expense (benefit) related to non-GAAP adjustments.  It is important to note that the Company’s goals and expectations are not predictions of actual performance.  Such forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from predicted or expected results. Such risks and uncertainties include, but are not limited, to the following: the Company's ability to execute its operating plan effectively; the Company’s ability to achieve sales growth in a timely fashion and successfully complete its channel expansion in its Orthopedics and Tissue Technologies segment; the Company’s ability to successfully integrate the Codman Neurosurgery business and other acquired businesses, including the realignment of acquired global sales territories; the Company's ability to manufacture and ship sufficient quantities of its products to meet its customers' demands; the ability of third-party suppliers to supply us with raw materials and finished products; global macroeconomic and political conditions; the Company's ability to manage its direct sales channels effectively; the sales performance of third-party distributors on whom the Company relies to generate revenue for certain products and geographic regions; the Company's ability to maintain relationships with customers of acquired entities and businesses; physicians' willingness to adopt and third-party payors' willingness to provide or maintain reimbursement for the Company's recently launched, planned and existing products; initiatives launched by the Company's competitors; downward pricing pressures from customers; the Company's ability to secure regulatory approval for products in development; the Company's ability to remediate quality systems violations; fluctuations in hospitals' spending for capital equipment; the Company's ability to comply with and obtain approvals for products of human origin and comply with regulations regarding products containing materials derived from animal sources; difficulties in controlling expenses, including costs to procure and manufacture our products; the impact of changes in management or staff levels; the impact of goodwill and intangible asset impairment charges if future operating results of acquired businesses are significantly less than the results anticipated at the time of the acquisitions, the Company's ability to leverage its existing selling organizations and administrative infrastructure; the Company's ability to increase product sales and gross margins, and control non-product costs; the Company’s ability to achieve anticipated growth rates, margins and scale and execute its strategy generally; the amount and timing of acquisition and integration-related costs; the geographic distribution of where the Company generates its taxable income; the effect of legislation effecting healthcare reform in the United States and internationally; fluctuations in foreign currency exchange rates; the amount of our bank borrowings outstanding and other factors influencing liquidity; and the economic, competitive, governmental, technological, and other risk factors and uncertainties identified under the heading “Risk Factors” included in Item 1A of Integra's Annual Report on Form 10-K for the year ended December 31, 2017 and information contained in subsequent filings with the Securities and Exchange Commission, including in Item 1A of Integra’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2018. These forward-looking statements are made only as of the date hereof, and the Company undertakes no obligation to update or revise the forward-looking statements, whether as a result of new information, future events, or otherwise. Discussion of Adjusted Financial Measures In addition to our GAAP results, we provide organic revenues, adjusted earnings before interest, taxes, depreciation and amortization ("EBITDA"), adjusted net income, adjusted earnings per diluted share, free cash flow and adjusted free cash flow conversion.  Organic revenues consist of total revenues excluding the effects of currency exchange rates, acquired revenues and product discontinuances.  Adjusted EBITDA consists of GAAP net income excluding: (i) depreciation and amortization; (ii) other income (expense); (iii) interest income and expense; (iv) income tax expense (benefit); and (v) those operating expenses also excluded from adjusted net income.  The measure of adjusted net income consists of GAAP net income, excluding: (i) hurricane related expenses; (ii) structural optimization charges; (iii) acquisition- and integration-related charges; (iv) litigation charges; (v) intangible asset amortization expense; (vi) discontinued product lines charges; (vii) income tax impact from adjustments; and (viii) impairment charges.  The adjusted earnings per diluted share measure is calculated by dividing adjusted net income attributable to diluted shares by diluted weighted average shares outstanding.  The measure of free cash flow consists of GAAP net cash provided by operating activities from less purchases of property and equipment.  The adjusted free cash flow conversion measure is calculated by dividing free cash flow by adjusted net income. Reconciliations of GAAP revenues to adjusted revenues and GAAP Adjusted Net Income to adjusted EBITDA, and adjusted net income, and GAAP earnings per diluted share to adjusted earnings per diluted share all for the quarters ended September 30, 2018 and 2017, and the free cash flow and free cash flow conversion for the quarters ended September 30, 2018 and 2017, appear in the financial tables in this release. The Company believes that the presentation of organic revenues and the other non-GAAP measures provide important supplemental information to management and investors regarding financial and business trends relating to the Company's financial condition and results of operations.  For further information regarding why Integra believes that these non-GAAP financial measures provide useful information to investors, the specific manner in which management uses these measures, and some of the limitations associated with the use of these measures, please refer to the Company's Current Report on Form 8-K regarding this earnings press release filed today with the Securities and Exchange Commission.  This Current Report on Form 8-K is available on the SEC's website at www.sec.gov or on our website at www.integralife.com.
Investor Relations Contacts:
Sravan Emany
Senior Vice President, Strategy, Treasury & Investor Relations
(609) 936-2488
sravan.emany@integralife.com
Michael Beaulieu
Director, Investor Relations
(609) 750-2827
michael.beaulieu@integralife.com
Media Contact:
Laurene Isip
Senior Director, Global Corporate Communications
(609) 750-7984
laurene.isip@integralife.com

INTEGRA LIFESCIENCES HOLDINGS CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(UNAUDITED)

(In thousands, except per share amounts)
Three Months Ended September 30, Nine Months Ended September 30,
2018 2017 2018 2017
Total revenues, net $ 365,854 $ 278,834 $ 1,089,126 $ 819,634
Costs and expenses:
Cost of goods sold 143,245 101,757 425,032 287,340
Research and development 20,309 15,034 57,742 46,275
Selling, general and administrative 173,355 145,945 513,518 433,457
Intangible asset amortization 5,268 5,456 15,944 14,976
Total costs and expenses 342,177 268,192 1,012,236 782,048
Operating income 23,677 10,642 76,890 37,586
Interest income 75 89 325 160
Interest expense (14,478 ) (6,761 ) (50,750 ) (18,073 )
Other income (expense), net 1,750 (735 ) 6,422 (3,691 )
Income before taxes 11,024 3,235 32,887 15,982
Income tax expense (benefit) (2,271 ) 76 (2,776 ) (4,406 )
Net income $ 13,295 $ 3,159 $ 35,663 $ 20,388
Net income per share:
Diluted net income per share $ 0.15 $ 0.04 $ 0.43 $ 0.26
Weighted average common shares outstanding for diluted net income per share 86,299 79,455 83,142 78,973
Segment revenues and growth in total revenues excluding the effects of currency exchange rates, acquisitions, and discontinued products are as follows: (In thousands)
Three Months Ended September 30,
2018 2017 Change
Codman Specialty Surgical $ 239,035 $ 164,760 45.1 %
Orthopedics and Tissue Technologies 126,819 114,074 11.2 %
Total revenues $ 365,854 $ 278,834 31.2 %
Impact of changes in currency exchange rates 1,109 -
Less contribution of revenues from acquisitions(1) (78,872 ) -
Less contribution of revenues from discontinued and divested products(2) (2,074 ) (9,637 )
Total organic revenues $ 286,017 $ 269,197 6.2 %
(1) Acquisitions include Codman Neurosurgery (2) Organic Revenues have been adjusted to reflect revenues under the TMA to Natus in the current year and restated for prior year 2017 to account for divestitures to Natus related to the Codman acquisition. Items included in GAAP net income and location where each item is recorded are as follows: (In thousands)

Three Months Ended September 30, 2018

Item Total Amount COGS(a) SG&A(b) Amort.(c) OI&E(d) Tax(e)
Structural optimization charges 3,345 974 2,371
Acquisition and integration related charges(1) 23,515 5,458 18,057
Litigation charges 1,637 1,637
Intangible asset amortization expense 16,479 11,211 5,268
Impairment charges 4,941 4,941
Estimated income tax impact from above adjustments (12,633 ) (12,633 )
Total adjustments $ 37,284 $ 22,584 $ 22,065 $ 5,268 $ $ (12,633 )
Depreciation expense 10,709
 
a) COGS - Cost of goods sold
b) SG&A - Selling, general and administrative
c) Amort. - Intangible asset amortization
d) OI&E - Interest (income) expense, net and other (income) expense, net
e) Tax - Income tax expense
(1) Acquisition related charges are primarily associated with the Derma Sciences and Codman Neurosurgery acquisitions and include banking, legal, consulting, systems, and other expenses.

Three Months Ended September 30, 2017

(In thousands)
Item Total Amount COGS (a) SG&A (b) Amort. (c) OI&E (d) Tax (e)
Structural optimization charges 1,944 1,309 635
Acquisition and integration related charges(1) 24,904 1,572 23,332
Hurricane-related losses 1,261 1,261
Intangible asset amortization expense 12,499 7,043 5,456
Impairment charges 3,290 3,290
Estimated income tax impact from above adjustments (10,991 ) (10,991 )
Total adjustments $ 32,907 $ 14,475 $ 23,967 $ 5,456 $ $ (10,991 )
Depreciation expense 8,470
a) COGS - Cost of goods sold
b) SG&A - Selling, general and administrative
c) Amort. - Intangible asset amortization
d) OI&E - Interest (income) expense, net and other (income) expense, net
e) Tax - Income tax expense
(1) Acquisition related charges are primarily associated with the Derma Sciences and Codman Neurosurgery acquisitions and include banking, legal, consulting, systems, and other expenses.
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31 Oct

Amedica Announces Corporate Name Change to SINTX Technologies, Inc.

SALT LAKE CITY, Oct. 31, 2018 (GLOBE NEWSWIRE) -- Amedica Corporation (NASDAQ: AMDA), a company that develops and commercializes silicon nitride for biomedical applications, announced that it has changed its corporate name to SINTX Technologies, Inc. in order to better reflect its focus on silicon nitride science and technologies and robust pipeline of silicon nitride based products in various biomedical applications. The company expects to change its trading symbol on the NASDAQ Capital Market to “SINT” in approximately 10 days. In the meantime, shares will continue to trade under the symbol “AMDA.”

“The previous name, i.e., Amedica, has transferred to CTL Medical, which is now CTL-Amedica. Our new corporate brand reflects both our core competence in the science and production of silicon nitride ceramics, as well as encouraging prospects for the future, as an OEM supplier of spine implants to CTL-Amedica, and several opportunities outside of spine,” said Dr. B. Sonny Bal, Chairman and CEO of SINTX Technologies. “As SINTX Technologies, we will focus on developing silicon nitride in terms of product design, and future biomaterial formulations, for a variety of OEM customers.”

SINTX Technologies is an innovative biomaterials and OEM company that develops and commercializes silicon nitride for various biomedical applications including the spine, dental, oral maxillofacial, podiatry, and arthroplasty markets.

In connection with its name change, the new CUSIP number for the Company’s shares of common stock is 829392109.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (“PSLRA”) that are subject to a number of risks and uncertainties. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management’s current estimates, projections, expectations and beliefs. A discussion of those risks and uncertainties can be found in Sintx's Risk Factors disclosure in its Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on March 29, 2018, and in Sintx's other filings with the SEC. SINTX disclaims any obligation to update any forward-looking statements. Sintx undertakes no obligation to publicly revise or update the forward-looking statements to reflect events or circumstances that arise after the date of this report.

Contacts: SINTX IR 801-839-3502 IR@SINTX.com

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30 Oct

Stryker reports third quarter 2018 operating results

Kalamazoo, Michigan - October 25, 2018 - Stryker (NYSE:SYK) reported operating results for the third quarter of 2018:

Third Quarter Highlights

2018 Net Sales Growth Overview
Reported Excluding ASC 606 Adoption(2) Foreign Currency Exchange Constant Currency Acquisitions Organic
Orthopaedics 3.4 % 4.0 % (1.0 )% 5.0 % - % 5.0 %
MedSurg 8.0 9.5 (0.9 ) 10.4 1.6 8.8
Neurotechnology and Spine 16.7 17.4 (0.9 ) 18.3 6.4 11.9
Total 7.9 % 8.8 % (1.0 )% 9.8 % 1.9 % 7.9 %

"We had another impressive quarter, as our talented teams continue to deliver strong results and execute on acquisitions," said Kevin A. Lobo, Chairman and Chief Executive Officer. "The strength of our operating model and culture is evident in the consistency of our performance over time, and we remain optimistic about the future."

Sales Analysis (percentages exclude ASC 606(2) adoption impact)

Consolidated net sales of $3.2 billion increased 8.8% in the quarter and 9.8% in constant currency. Organic net sales increased 7.9% in the quarter including 9.5% from increased unit volume partially offset by 1.6% from lower prices.

Orthopaedics net sales of $1.2 billion increased 4.0% in the quarter and 5.0% in constant currency. Organic net sales increased 5.0% in the quarter including 7.6% from increased unit volume partially offset by 2.6% from lower prices.

MedSurg net sales of $1.4 billion increased 9.5% in the quarter and 10.4% in constant currency. Organic net sales increased 8.8% in the quarter including 9.5% from increased unit volume partially offset by 0.7% from lower prices.

Neurotechnology and Spine net sales of $0.6 billion increased 17.4% in the quarter and 18.3% in constant currency. Organic net sales increased 11.9% in the quarter including 13.5% from increased unit volume partially offset by 1.6% from lower prices.

Earnings Analysis

Reported net earnings of $590 million increased 35.9% in the quarter. Reported net earnings per diluted share of $1.55 increased 36.0% in the quarter. Reported net earnings include certain items, such as charges for acquisition and integration-related activities, the amortization of purchased intangible assets, restructuring-related and other charges, costs to comply with European Medical Devices Regulation, Rejuvenate and other recall-related matters, regulatory and legal matters and tax matters. The effect of each of these matters on reported net earnings and net earnings per diluted share appear in the reconciliation of GAAP to non-GAAP financial measures. Excluding the aforementioned items decreases gross profit margin from 66.5% to 66.3% in the quarter and increases operating income margin from 17.8% to 24.9%(1), including a 20 basis point favorable impact related to the adoption of the new revenue recognition standard(2). Excluding the impact of the items described above, adjusted net earnings(4) of $643 million increased 11.2% in the quarter. Adjusted net earnings per diluted share(3) of $1.69 increased 11.2% in the quarter.

2018 Outlook

Based on our year-to-date performance we now expect 2018 organic net sales growth, which excludes the impact related to adoption of the new revenue recognition standard(2), to be at the high end of the range of 7.0% to 7.5% and expect adjusted net earnings per diluted share(5) to be in the range of $7.25to $7.30. In 2018 our calculation of organic net sales growth excludes the impact of adopting ASC 606(2), which includes primarily the reclassification of costs previously reported within selling expenses to a reduction of sales, which for 2017 was approximately $112 million ($28 million per quarter). For the fourth quarter we expect adjusted net earnings per diluted share(5) to be in the range of $2.13 to $2.18. If foreign currency exchange rates hold near current levels, we expect net sales in the fourth quarter will be negatively impacted by approximately 1.0% and full year will be positively impacted by approximately 0.5%, and net earnings per diluted share will be neutral in the fourth quarter and positively impacted by $0.05 in the full year.

(1) A reconciliation of operating income to adjusted operating income, a non-GAAP financial measure, and other important information accompanies this press release.

(2) Consistent with previous press releases and financial disclosures, we adopted Accounting Standards Update 2014-09, Revenue From Contracts with Customers, as well as related amendments (ASC 606), issued by the Financial Accounting Standards Board on a modified retrospective basis, effective January 1, 2018. The impact of the adoption of ASC 606 related primarily to the reclassification of certain costs previously presented as selling, general and administrative expenses to net sales.

(3) A reconciliation of reported net earnings per diluted share to adjusted net earnings per diluted share, a non-GAAP financial measure, and other important information accompanies this press release.

(4) A reconciliation of reported net earnings to adjusted net earnings, a non-GAAP financial measure, and other important information accompanies this press release.

(5) We are unable to present a quantitative reconciliation of our expected net earnings per diluted share to expected adjusted net earnings per diluted share as we are unable to predict with reasonable certainty and without unreasonable effort the impact and timing of restructuring-related and other charges, acquisition-related expenses and fair value adjustments to inventory and the outcome of certain regulatory, legal and tax matters. The financial impact of these items is uncertain and is dependent on various factors, including timing, and could be material to Stryker's Consolidated Statements of Earnings.

Conference Call on Thursday, October 25, 2018

As previously announced, Stryker will host a conference call on Thursday, October 25, 2018 at 4:30 p.m., Eastern Time, to discuss the Company's operating results for the quarter ended September 30, 2018 and provide an operational update.

To participate in the conference call dial (844) 826-0610 (domestic) or (973) 453-3249 (international) and be prepared to provide conference ID number 9086309 to the operator.

A simultaneous webcast of the call will be accessible via the Company's website at www.stryker.com. The webcast will be archived on the Investor Relations page of this site.

A recording of the call will also be available from 8:00 p.m., Eastern Time, on Thursday, October 25, 2018, until 11:59 p.m., Eastern Time, on Thursday, November 1, 2018. To hear this recording, you may dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and enter conference ID number 9086309.

Forward-Looking Statements

This press release contains information that includes or is based on forward-looking statements within the meaning of the federal securities laws that are subject to various risks and uncertainties that could cause our actual results to differ materially from those expressed or implied in such statements. Such factors include, but are not limited to: weakening of economic conditions that could adversely affect the level of demand for our products; pricing pressures, including cost-containment measures that could adversely affect the price of or demand for our products; changes in foreign exchange markets; legislative and regulatory actions; the failure to satisfy any of the closing conditions of the K2M Group Holdings, Inc. merger agreement, including the receipt of any required regulatory approvals or approval by K2M's stockholders of the merger; unexpected charges or expenses in connection with the acquisition of K2M; unanticipated issues arising in connection with clinical studies and otherwise that affect U.S. Food and Drug Administration approval of new products; potential supply disruptions; changes in reimbursement levels from third-party payors; a significant increase in product liability claims; the ultimate total cost with respect to the Rejuvenate and ABG II matter; the impact of investigative and legal proceedings and compliance risks; resolution of tax audits; the impact of the federal legislation to reform the United States healthcare system; costs to comply with the European Medical Devices regulation; changes in financial markets; changes in the competitive environment; our ability to integrate acquisitions, including the acquisition of K2M; and our ability to realize anticipated cost savings. Additional information concerning these and other factors is contained in our filings with the U.S. Securities and Exchange Commission, including our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q.

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.

For investor inquiries please contact:

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

For media inquiries please contact:

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

 
STRYKER CORPORATION
For the Three and Nine Months September 30
(Unaudited - Millions of Dollars, Except Per Share Amounts)
CONSOLIDATED STATEMENTS OF EARNINGS
Three Months Nine Months
2018 2017 % Change 2018 2017 % Change
Net sales $ 3,242 $ 3,006 7.9 % $ 9,805 $ 8,973 9.3 %
Cost of sales 1,087 1,022 6.4 3,323 3,034 9.5
Gross profit $ 2,155 $ 1,984 8.6 % $ 6,482 $ 5,939 9.1 %
% of sales 66.5 % 66.0 % 66.1 % 66.2 %
Research, development and engineering expenses 221 198 11.6 641 582 10.1
Selling, general and administrative expenses 1,242 1,103 12.6 3,668 3,335 10.0
Recall charges 4 66 (93.9 ) 10 164 (93.9 )
Amortization of intangible assets 112 92 21.7 324 275 17.8
Total operating expenses $ 1,579 $ 1,459 8.2 % $ 4,643 $ 4,356 6.6 %
Operating income $ 576 $ 525 9.7 % $ 1,839 $ 1,583 16.2 %
% of sales 17.8 % 17.5 % 18.8 % 17.6 %
Other income (expense), net (42 ) (54 ) (22.2 ) (140 ) (169 ) (17.2 )
Earnings before income taxes $ 534 $ 471 13.4 % $ 1,699 $ 1,414 20.2 %
Income taxes (56 ) 37 (251.4 ) 214 145 47.6
Net earnings $ 590 $ 434 35.9 % $ 1,485 $ 1,269 17.0 %
Net earnings per share of common stock:
Basic net earnings per share of common stock $ 1.58 $ 1.16 36.2 % $ 3.97 $ 3.39 17.1 %
Diluted net earnings per share of common stock $ 1.55 $ 1.14 36.0 % $ 3.90 $ 3.34 16.8 %
Weighted-average shares outstanding (in millions):
Basic 374.1 374.2 374.0 373.8
Diluted 380.2 380.2 380.4 379.8
 
CONDENSED CONSOLIDATED BALANCE SHEETS
September 30 December 31
2018 2017
Assets
Cash and cash equivalents $ 1,918 $ 2,542
Marketable securities 292 251
Accounts receivable, net 2,076 2,198
Inventories 2,893 2,465
Prepaid expenses and other current assets 739 537
Total current assets $ 7,918 $ 7,993
Property, plant and equipment, net 2,178 1,975
Goodwill and other intangibles, net 11,097 10,645
Other noncurrent assets 891 1,584
Total assets $ 22,084 $ 22,197
Liabilities and shareholders' equity
Current liabilities $ 4,153 $ 3,485
Long-term debt, excluding current maturities 5,928 6,590
Income taxes 1,251 1,261
Other noncurrent liabilities 892 881
Shareholders' equity 9,860 9,980
Total liabilities and shareholders' equity $ 22,084 $ 22,197
 
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
Nine Months
2018 2017
Operating activities
Net earnings $ 1,485 $ 1,269
Depreciation 223 198
Amortization of intangible assets 324 275
Changes in operating assets and liabilities and other, net (468 ) (862 )
Net cash provided by operating activities $ 1,564 $ 880
Investing activities
Acquisitions, net of cash acquired $ (770 ) $ (712 )
Change in marketable securities, net (41 ) (29 )
Purchases of property, plant and equipment (418 ) (412 )
Net cash used in investing activities $ (1,229 ) $ (1,153 )
Financing activities
(Payments) borrowings of debt, net $ (13 ) $ 300
Dividends paid (528 ) (477 )
Repurchases of common stock (300 ) (230 )
Other financing, net (110 ) (115 )
Net cash used in financing activities $ (951 ) $ (522 )
Effect of exchange rate changes on cash and cash equivalents (8 ) 71
Change in cash and cash equivalents $ (624 ) $ (724 )
 
STRYKER CORPORATION
For the Three and Nine Months September 30
(Unaudited - Millions of Dollars)
 
CONDENSED SALES ANALYSIS
Three Months Nine Months
Percentage Change Percentage Change  
Ex-ASC 606(2)
Percentage Change Percentage Change  
Ex-ASC 606(2)
2018 2017 As Reported Ex-ASC 606(2) Constant
Currency
2018 2017 As Reported Ex-ASC 606(2) Constant
Currency
Geographic:
United States $ 2,381 $ 2,182 9.1 % 10.4 % 10.4 % $ 7,080 $ 6,546 8.2 % 9.4 % 9.4 %
International 861 824 4.5 4.6 8.1 2,725 2,427 12.3 12.5 9.1
Total $ 3,242 $ 3,006 7.9 % 8.8 % 9.8 % $ 9,805 $ 8,973 9.3 % 10.3 % 9.4 %
Segment:
Orthopaedics $ 1,171 $ 1,132 3.4 % 4.0 % 5.0 % $ 3,615 $ 3,408 6.1 % 6.6 % 5.4 %
MedSurg 1,443 1,336 8.0 9.5 10.4 4,325 3,977 8.8 10.4 9.8
Neurotechnology and Spine 628 538 16.7 17.4 18.3 1,865 1,588 17.4 18.1 16.8
Total $ 3,242 $ 3,006 7.9 % 8.8 % 9.8 % $ 9,805 $ 8,973 9.3 % 10.3 % 9.4 %
 
SUPPLEMENTAL SALES GROWTH ANALYSIS
Three Months
Percentage Change Ex-ASC 606(2)
Percentage Change International
2018 2017 As Reported Ex-ASC 606(2) Constant Currency United States Ex-ASC 606(2) Constant Currency
Orthopaedics:
Knees $ 395 $ 369 7.0 % 7.7 % 8.7 % 8.4 % 5.7 % 9.6 %
Hips 316 313 1.0 1.2 2.5 2.4 (0.6 ) 2.8
Trauma and Extremities 376 367 2.5 3.2 4.0 3.2 3.1 5.5
Other 84 83 1.2 1.6 2.7 (0.9 ) 13.1 19.3
$ 1,171 $ 1,132 3.4 % 4.0 % 5.0 % 4.4 % 3.0 % 6.3 %
MedSurg:
Instruments $ 442 $ 404 9.4 % 10.7 % 11.6 % 13.7 % 0.3 % 4.3 %
Endoscopy 443 404 9.7 10.8 11.9 11.0 10.4 15.2
Medical 492 464 6.0 7.5 8.5 12.4 (8.1 ) (4.2 )
Sustainability 66 64 3.1 7.0 7.0 7.0 10.9 15.0
$ 1,443 $ 1,336 8.0 % 9.5 % 10.4 % 12.0 % 0.2 % 4.5 %
Neurotechnology and Spine:
Neurotechnology $ 435 $ 353 23.2 % 23.8 % 24.8 % 28.7 % 15.4 % 18.2 %
Spine 193 185 4.3 5.2 5.9 2.4 13.4 16.5
$ 628 $ 538 16.7 % 17.4 % 18.3 % 18.6 % 14.9 % 17.8 %
Total $ 3,242 $ 3,006 7.9 % 8.8 % 9.8 % 10.4 % 4.6 % 8.1 %
 
Nine Months
Percentage Change Ex-ASC 606(2)
Percentage Change International
2018 2017 As Reported Ex-ASC 606(2) Constant Currency United States Ex-ASC 606(2) Constant Currency
Orthopaedics:
Knees $ 1,236 $ 1,149 7.6 % 8.0 % 7.1 % 7.3 % 9.8 % 6.6 %
Hips 983 955 2.9 3.3 2.2 1.9 5.5 2.6
Trauma and Extremities 1,152 1,070 7.7 8.5 6.9 6.3 12.5 8.0
Other 244 234 4.3 4.2 3.9 3.9 5.4 4.2
$ 3,615 $ 3,408 6.1 % 6.6 % 5.4 % 5.3 % 9.2 % 5.7 %
MedSurg:
Instruments $ 1,292 $ 1,190 8.6 % 10.2 % 9.5 % 10.8 % 8.0 % 5.0 %
Endoscopy 1,335 1,183 12.8 14.2 13.6 14.8 11.8 9.5
Medical 1,508 1,413 6.7 8.3 7.7 7.4 11.5 8.7
Sustainability 190 191 (0.5 ) 2.5 2.5 2.4 17.3 15.7
$ 4,325 $ 3,977 8.8 % 10.4 % 9.8 % 10.3 % 10.5 % 7.8 %
Neurotechnology and Spine:
Neurotechnology $ 1,282 $ 1,036 23.7 % 24.5 % 23.0 % 25.3 % 23.1 % 19.1 %
Spine 583 552 5.6 6.1 5.2 1.1 22.1 18.2
$ 1,865 $ 1,588 17.4 % 18.1 % 16.8 % 15.8 % 22.9 % 18.9 %
Total $ 9,805 $ 8,973 9.3 % 10.3 % 9.4 % 9.4 % 12.5 % 9.1 %
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30 Oct

Aetna Offers Expanded Coverage for EXPAREL® in Select Ambulatory Surgical Centers

PARSIPPANY, N.J., Oct. 30, 2018 (GLOBE NEWSWIRE) -- Aetna has announced that they will reimburse select ambulatory surgical centers (ASCs) for the use of EXPAREL® (bupivacaine liposome injectable suspension) as part of a pilot program in Florida and New Jersey. The purpose of the program is to incentivize the use of non-opioid therapies for postsurgical pain management in ASCs. This expanded coverage of EXPAREL advances Aetna’s clinical strategy of supporting increased member access to non-opioid pain treatment options and encouraging reductions in inappropriate opioid prescribing. In 2017, the company began reimbursing for EXPAREL for select impacted third molar (wisdom tooth) extractions. EXPAREL provides patients prolonged pain control that can help reduce or eliminate reliance on opioids, their associated side effects and the long-term risks of addiction or dependence. “Aetna is demonstrating its commitment to addressing the opioid epidemic by leading the way in expanding coverage of EXPAREL in the ASC setting,” said Dave Stack, chairman and chief executive officer at Pacira Pharmaceuticals. “We look forward to continuing our work with Aetna to prevent future opioid misuse or dependence by providing a safer, non-opioid option like EXPAREL for all patients undergoing surgery.” Studies continue to show that surgery is an inadvertent gateway to persistent opioid use. According to new research examining seven orthopedic and soft tissue surgical procedures, patients were prescribed an average of 82 opioid pills to manage postsurgical pain. Approximately 9 percent of surgical patients became newly persistent users in 2017, continuing to take these opioids at least three to six months after their operation1.  Unused opioids after surgery also pose the risk of diversion, another avenue to opioid misuse or dependence. The reimbursement for EXPAREL in the ASC setting is demonstrative of Aetna’s ongoing collaborations with Pacira to combat the opioid epidemic. Recent initiatives include Aetna’s update to its online provider directory to help members easily identify surgeons who are trained to administer EXPAREL, as well as the creation of a national program launched by Pacira, Aetna and the American Association of Oral and Maxillofacial Surgeons (AAOMS). The program aims to reduce the number of opioid tablets prescribed to Aetna patients undergoing impacted wisdom tooth extractions through the use of EXPAREL. About Pacira Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) is a specialty pharmaceutical company dedicated to advancing and improving postsurgical outcomes for acute care practitioners and their patients. The company’s flagship product, EXPAREL® (bupivacaine liposome injectable suspension) was commercially launched in the United States in April 2012. EXPAREL utilizes DepoFoam®, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. To learn more about Pacira, including the corporate mission to reduce overreliance on opioids, visit www.pacira.com. About Aetna Aetna is one of the nation’s leading diversified health care benefits companies, serving an estimated 38.8 million people with information and resources to help them make better informed decisions about their health care. Aetna offers a broad range of traditional, voluntary and consumer-directed health insurance products and related services, including medical, pharmacy, dental and behavioral health plans, and medical management capabilities, Medicaid health care management services, workers’ compensation administrative services and health information technology products and services. Aetna’s customers include employer groups, individuals, college students, part-time and hourly workers, health plans, health care providers, governmental units, government-sponsored plans, labor groups and expatriates. For more information, see www.aetna.com and learn about how Aetna is helping to build a healthier world. @AetnaNews Important Safety Information EXPAREL is contraindicated in obstetrical paracervical block anesthesia. In clinical trials, the most common adverse reactions (incidence ≥10%) following EXPAREL administration were nausea, constipation, and vomiting. EXPAREL is not recommended to be used in the following patient population: patients <18 years old and/or pregnant patients. Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, EXPAREL should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations. EXPAREL is not recommended for the following types or routes of administration: epidural, intrathecal, regional nerve blocks, or intravascular or intra-articular use. Non-bupivacaine-based local anesthetics, including lidocaine, may cause an immediate release of bupivacaine from EXPAREL if administered together locally. The administration of EXPAREL may follow the administration of lidocaine after a delay of 20 minutes or more. Formulations of bupivacaine other than EXPAREL should not be administered within 96 hours following administration of EXPAREL. Central Nervous System (CNS) Reactions: There have been reports of adverse neurologic reactions with the use of local anesthetics. These include persistent anesthesia and paresthesias. CNS reactions are characterized by excitation and/or depression. Cardiovascular System Reactions: Toxic blood concentrations depress cardiac conductivity and excitability which may lead to dysrhythmias sometimes leading to death. Allergic Reactions: Allergic-type reactions (eg, anaphylaxis and angioedema) are rare and may occur as a result of hypersensitivity to the local anesthetic or to other formulation ingredients. Chondrolysis: There have been reports of chondrolysis (mostly in the shoulder joint) following intra-articular infusion of local anesthetics, which is an unapproved use. Company Contact: Pacira Pharmaceuticals, Inc. Amber Sears, (973) 254-3587 Amber.Sears@pacira.com Media Contact: Coyne Public Relations Alyssa Schneider, (973) 588-2270 aschneider@coynepr.com 1 Pacira. Exposing a Silent Gatewa

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