31 Oct

Atlas Spine, Inc., Announces FDA 510(k) Clearance on Ortus Expandable Posterior Lumbar Interbody System

Jupiter, Florida., October 31, 2017 (PR NEWSWIRE) — Atlas Spine, Inc., a high technology, spinal implant and instrumentation company based in Jupiter, Florida, today announced that the Ortus™ Expandable Posterior Lumbar Interbody System has been 510(k) cleared by the U.S. Food and Drug Administration (FDA). The device is designed to be delivered using either minimally invasive or open surgical approach. The Ortus™ PL is clearly differentiated from other expandable technology. For example it has one of the smallest starting heights (6.5mm) of any expandable device on the market, and relies on a unique, patented design that allows for implant expansion while restoring natural anatomic alignment in a single step. The device also features an open architecture that allows the surgeon to pack ample graft material after the device is deployed and expanded. This is the first implant in a comprehensive line of expandable interbody intellectual property that utilizes anterior, PLIF, oblique, and minimally invasive approaches and devices that the company plans on launching. “Atlas has a deep pipeline of expandable technology and the Ortus™ 510(k) clearance presents a tremendous opportunity to establish our company as an expandable interbody technology market leader. The Ortus™ platform provides options and capabilities for surgeons focused on restoring spinal balance that is yet to be provided by other devices and companies. Paired with a minimally invasive surgical approach, Ortus™ PL is a powerful tool for spine surgeons seeking reliable fusions with minimal complexity and post-operative morbidity. Furthermore, the Ortus™ PL platform is well suited for anterior, posterior, lateral and oblique approaches, in addition to MIS,” notes Atlas Spine’s co-founder and CTO Matthew Baynham. Atlas Spine’s CEO Douglass Watson adds, “We are thrilled to be in the expandable posterior lumbar interbody market. The response from key, opinion-leading surgeons is tremendous. We are preparing to launch the Ortus™ PL interbody device with our distributor network in the near future and look forward to numerous additional differentiated device clearances over the next several quarters.” The U.S. FDA notified the company on the first day of the North Atlantic Spine Society (NASS) meeting. This is Atlas Spine, Inc’s 12th product to receive 510(k) clearance by the U.S. FDA and allows the Company to access distribution channels and gain measurable market share. It also allows the company to focus on commercializing other significant projects in the pipeline. About Atlas Spine, Inc. Our mission is to create spinal implants and instrument systems that treat a variety of pathologies combining the highest level of performance with ease of use which translate to physician satisfaction and enhanced patient outcomes. The company has over 50 issued and pending patents and currently distributes a number of interbody and posterior stabilization systems and has also licensed technology to other companies in the spinal device market. For more information about Atlas Spine, please visit atlasspine.com. Contact:  Matthew Miller, Atlas Spine Inc., (561) 741-1108 or mmiller@atlasspine.com. Atlas Spine Inc., 1555 Jupiter Park Drive, Suite 1; Jupiter, Florida 33458.

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31 Oct

OMNIlife science™, Inc. Announces First Clinical Evaluations of Revolutionary OMNIBotics® Active Spacer Robotic Tissue Balancing Device

RAYNHAM, Mass.Oct. 31, 2017 /PRNewswire/ -- OMNIlife science, Inc. ("OMNI™"), a privately-held, established medical technology company targeting the $15 billion global hip and knee replacement device market, announced today that they have begun clinical evaluations of their exclusive OMNIBotics Active Spacer robotic tissue balancing device at three U.S. sites. This technology received 510(k) clearance from the FDA on September 1, 2017.
The OMNIBotics Active Spacer, in clinical use since March in Australia, provides the surgeon with a quantitative tool to actively manage the soft tissue envelope with dynamic real-time feedback. When combined with the accuracy of alignment and bone cuts provided by the OMNIBotics system, the result is a completely customized procedure from both a skeletal and a soft tissue perspective. "I believe that the active spacer technology is the tool we have been looking for to create even better predictability and reproducibility for knee replacement surgery," said Jeffrey M. Lawrence, M.D. Viroqua, WI. "I'm very excited to offer this system to my patients." Of his early experience, John M. Keggi, MD, Middlebury, CT said, "The active spacer technology is a great step forward that brings the most advanced measurement and analysis tools directly to each patient and surgeon right in the operating room. It's an unprecedented, real-time evaluation of the knee that optimizes each step of the procedure." Studies indicate that a significant percentage of knee replacement patients do not achieve full satisfaction even with well-placed implants. One potential contributing factor is sub-optimal soft tissue balancing. "The active spacer is an amazing new technology for knee replacement. It actually shows your surgeon, in real time, how tight or loose your knee is on each side as it bends. This information is then fed into a robot, which plans how your knee is replaced on an individual basis for optimum results," said Amber Randall, MD an orthopedic surgeon in Arizona. OMNI, a pioneer in robotic-assisted total knee replacement, now offers the only robotic technology that quantitatively drives the total knee replacement surgical procedure with both alignment and ligament balancing. Dr. Randall continues, "I believe that this revolutionary, never before seen technology will get us not one--but several--steps closer to the Holy Grail of knee replacement: the freely moving, perfectly stable and pain free knee." ABOUT OMNI OMNI is a privately held company with a proprietary robotic platform, OMNIBotics®, which allows surgeons to conduct patient-specific total knee surgery designed to enhance patient satisfaction and reduce hospital costs. In addition, OMNI designs, engineers, manufactures and distributes a wide range of proprietary hip and knee implants and is focused on providing cutting edge technologies to transform outcomes in joint replacement surgery and enhance a surgeon's ability to help patients live active and pain-free lives. For more information about OMNI, please visit www.omnils.com. FORWARD LOOKING STATEMENTS Statements in this press release concerning the future business, operations and prospects of OMNIlife science, Inc., including its plans specific to OMNIBotics systems, as well as statements using the terms "plans," "believes" or similar expressions are "forward-looking" statements as defined in the Private Securities Litigation Reform Act of 1995. These statements are based upon management's current expectations and are subject to a number of factors and uncertainties. Information contained in these forward-looking statements is inherently uncertain, and actual performance and results may differ materially due to many important factors. Such factors include, among others, changes in competitive conditions and pricing in OMNI's markets, decrease in the demand for OMNI's products, delays in OMNI's product research and development cycles, decreases in the use of OMNI's principal product lines or in procedure volume, unanticipated issues in complying with domestic or foreign regulatory requirements related to OMNI's current products or securing regulatory clearance or approvals for new products or upgrades or changes to OMNI's current products, the impact of the United States healthcare reform legislation on hospital spending and reimbursement, any unanticipated impact arising out of the securities class action or any other litigation, inquiry, or investigation brought against OMNI, increases in costs of OMNI's sales force and distributors, and unanticipated intellectual property expenditures required to develop, market, and defend OMNI's products. OMNI cannot guarantee any future results, levels of activity, performance or achievement. OMNI undertakes no obligation to update any of its forward-looking statements after the date of this press release. CONTACT Cindy Holloway, Director of Marketing Communications Phone: (508) 824-2444 cholloway@omnils.com   SOURCE OMNIlife science, Inc.

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31 Oct

Use of Ceterix NovoStitch® Plus System for Repair of Horizontal Meniscus Tears Supported by Three New Studies

October 30, 2017

FREMONT, Calif.--(BUSINESS WIRE)--Ceterix® Orthopaedics today announced the publication of three new studies in the journal Arthroscopy Techniques supporting the use of the company’s NovoStitch® Plus device for the repair of horizontal cleavage meniscal tears: “These publications illustrate the growing recognition that horizontal meniscus tears, previously deemed irreparable, can in fact be repaired with advanced technology,” said Dr. Kenneth Brooks, orthopaedic surgeon and author of one of the reports. “The NovoStitch Plus has given surgeons increased flexibility to develop advanced meniscal repair techniques specifically designed to treat horizontal tears. This allows us to preserve the meniscus in more patients, reducing the likelihood of developing arthritis or requiring knee replacement surgery later in life.” Patients with meniscus tears often undergo meniscectomy – total or partial removal of the meniscus – due to the difficulty of access and limitations of current arthroscopic instruments. However, meniscectomy significantly increases the risk of arthritis or total knee replacement later in life.1 In contrast, meniscus repair, a procedure in which the tear is sutured and allowed to heal naturally, is associated with improved long-term outcomes and overall cost savings relative to meniscectomy.2 Meniscus surgery is the single most common arthroscopic procedure in the United States, with roughly one million performed annually. The NovoStitch Plus device allows orthopaedic surgeons to address horizontal, radial, and other complex meniscal tears in ways not previously possible. The system enables the placement of a circumferential compression stitch around the meniscus, which provides uniform compression during healing and allows orthopaedic surgeons to treat these complex injuries. About Ceterix Orthopaedics Ceterix® Orthopaedics develops surgical tools that expand and improve what is possible for physicians who treat soft tissue joint injuries such as meniscus tears. Founded in 2010 with the vision of improving outcomes of arthroscopic procedures, Ceterix’s novel meniscal repair system enables surgeons to place suture patterns that were previously only possible in open procedures, or not at all. The NovoStitch Plus meniscal repair system has received 510k clearance in the United States and is indicated for approximation of soft tissue in meniscal repair procedures. The company is based in Fremont, Calif. and is backed by investors Versant Ventures, 5AM Ventures and CRG. For more information, please visit www.ceterix.com. 1 Papalia, R. et. al. Meniscectomy as a risk factor for knee osteoarthritis: a systematic review. British Medical Bulletin. 2011; 99:89 – 106. 2 Feeley, B. et. al. The Cost-Effectiveness of Meniscal Repair versus Partial Meniscectomy: A Model-based Projection of Clinical Outcomes and Costs in the United States Healthcare System. ISPOR Annual Meeting 2015.

Contacts

For Ceterix Orthopaedics Jessica Volchok, 310-849-7985 jessica@healthandcommerce.com

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30 Oct

Orthofix International Reports Third Quarter 2017 Financial Results

October 30, 2017

LEWISVILLE, Texas--(BUSINESS WIRE)--Orthofix International N.V. (NASDAQ:OFIX) today reported its financial results for the third quarter ended September 30, 2017. Net sales were $105.2 million, diluted earnings per share from continuing operations was $0.18 and adjusted earnings per share from continuing operations was $0.42. “We continue to execute on our strategy of increasing the organic growth and profitability of each of our four strategic business units while rationalizing corporate costs in all areas. This has resulted in an accelerating sales growth rate each quarter thus far this year, and positioned us for solid mid-single digit organic revenue growth and the opportunity for meaningful margin expansion in the years to come,” said Brad Mason, President and Chief Executive Officer. Financial Results Overview The following table provides net sales by strategic business unit (“SBU”):
Three Months Ended September 30,
(Unaudited, U.S. Dollars, in thousands) 2017 2016 Change Constant

Currency

Change

BioStim $ 44,427 $ 42,956 3.4 % 3.4 %
Biologics 15,218 14,335 6.2 % 6.2 %
Extremity Fixation 25,447 24,314 4.7 % 1.4 %
Spine Fixation 20,155 16,892 19.3 % 19.1 %
Net sales $ 105,247 $ 98,497 6.9 % 6.0 %
Gross profit increased $2.9 million to $81.5 million. Gross margin decreased to 77.5% compared to 79.8% in the prior year period due primarily to sales mix, the impact of converting to stocking distributors in Brazil in our Extremity Fixation SBU, and $0.6 million of non-recurring expenses relating to our U.S. restructuring plan. Non-GAAP net margin, an internal metric that we define as gross profit less sales and marketing expenses, was $34.0 million compared to $36.9 million in the prior year period. The decrease in non-GAAP net margin was primarily due to higher commission expenses from geographic mix in Extremity Fixation and higher rates from Spine Fixation and Biologics distributors, as well as increased sales and use tax benefits realized in the third quarter of 2016. Net income from continuing operations was $3.3 million, or $0.18 per share, compared to $10.4 million, or $0.56 per share in the prior year period. Adjusted net income from continuing operations was $7.7 million, or $0.42 per share, compared to adjusted net income of $6.6 million, or $0.36 per share in the prior year period. EBITDA was $14.5 million, compared to $14.1 million in the prior year period. Adjusted EBITDA was $21.1 million, or 20.1% of net sales, for the third quarter, compared to $23.5 million, or 23.9% of net sales, in the prior year period. Liquidity As of September 30, 2017, cash and cash equivalents were $53.9 million compared to $39.6 million as of December 31, 2016. As of September 30, 2017, we had no outstanding indebtedness and borrowing capacity of $125 million. Cash flow from operations was $23.5 million, a decrease of $14.9 million, and free cash flow was $10.2 million, a decrease of $13.9 million when compared to the prior year period. 2017 Outlook For the year ending December 31, 2017, the Company expects the following results, assuming exchange rates are the same as those currently prevailing.
Previous 2017 Outlook Current 2017 Outlook
(Unaudited, U.S. Dollars, in millions, except per share data) Low High Low High
Net sales $ 422.0 $ 425.0 $ 428.0

(1)

$ 431.0

(1)

Net income from continuing operations $ 17.7 $ 21.4 $ 14.2

(2)

$ 17.0

(2)

Adjusted EBITDA $ 79.0 $ 81.0 $ 79.0

(3)

$ 82.0

(3)

EPS from continuing operations $ 0.96 $ 1.16 $ 0.77

(4)

$ 0.92

(4)

Adjusted EPS from continuing operations $ 1.54 $ 1.60 $ 1.54

(5)

$ 1.63

(5)

Represents a year-over-year increase of 4.4% to 5.2% on a reported basis Represents a year-over-year increase of 306.1% to 386.1% Represents a year-over-year decrease of 0.4% to an increase of 3.4% Represents a year-over-year increase of 305.3% to 384.2% Represents a year-over-year increase of 5.5% to 11.6% Conference Call Orthofix will host a conference call today at 4:30 PM Eastern time to discuss the Company's financial results for the third quarter of 2017. Interested parties may access the conference call by dialing (844) 809-1992 in the U.S. and (612) 979-9886 outside the U.S., and referencing the conference ID 2078866. A replay of the call will be available for two weeks by dialing (855) 859-2056 in the U.S. and (404) 537-3406 outside the U.S., and entering the conference ID 2078866. A webcast of the conference call may be accessed by going to the Company's website at www.orthofix.com, by clicking on the Investors link and then the Events and Presentations page. About Orthofix Orthofix International N.V. is a diversified, global medical device company focused on improving patients' lives by providing superior reconstructive and regenerative orthopedic and spine solutions to physicians worldwide. Headquartered in Lewisville, Texas, the Company has four strategic business units: BioStim, Biologics, Extremity Fixation and Spine Fixation. Orthofix products are widely distributed via the Company's sales representatives and distributors. In addition, Orthofix is collaborating on research and development activities with leading clinical organizations such as Brown University, Sinai Hospital of Baltimore, Cleveland Clinic, Texas Scottish Rite Hospital for Children, and the Musculoskeletal Transplant Foundation. For more information, please visit www.orthofix.com. Forward-Looking Statements This communication contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended (“the Exchange Act”), and Section 27A of the Securities Act of 1933, as amended, relating to our business and financial outlook, which are based on our current beliefs, assumptions, expectations, estimates, forecasts and projections. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “intends,” “predicts,” “potential,” or “continue” or other comparable terminology. These forward-looking statements are not guarantees of our future performance and involve risks, uncertainties, estimates and assumptions that are difficult to predict. Therefore, our actual outcomes and results may differ materially from those expressed in these forward-looking statements. You should not place undue reliance on any of these forward-looking statements. Further, any forward-looking statement speaks only as of the date hereof, unless it is specifically otherwise stated to be made as of a different date. We undertake no obligation to further update any such statement, or the risk factors described in Part I, Item 1A under the heading Risk Factors in our Form 10-K for the year ended December 31, 2016, to reflect new information, the occurrence of future events or circumstances or otherwise.

ORTHOFIX INTERNATIONAL N.V.

Condensed Consolidated Statements of Operations
Three Months Ended Nine Months Ended
September 30, September 30,
(Unaudited, U.S. Dollars, in thousands, except share and per share data) 2017 2016 2017 2016
Net sales $ 105,247 $ 98,497 $ 316,927 $ 301,251
Cost of sales 23,717 19,880 69,475 64,533
Gross profit 81,530 78,617 247,452 236,718
Sales and marketing 47,493 41,717 146,496 132,582
General and administrative 18,068 19,272 56,759 54,822
Research and development 6,935 6,858 21,246 21,294
Charges related to U.S. Government resolutions 1,499 14,369
Operating income 9,034 9,271 22,951 13,651
Interest income (expense), net (15 ) 471 106 320
Other income (expense), net 479 (634 ) (3,284 ) 1,346
Income before income taxes 9,498 9,108 19,773 15,317
Income tax benefit (expense) (6,150 ) 1,276 (13,998 ) (6,703 )
Net income from continuing operations 3,348 10,384 5,775 8,614
Discontinued operations
Income (loss) from discontinued operations 65 (1,018 ) (1,762 ) (3,580 )
Income tax benefit 43 530 642 1,258
Net income (loss) from discontinued operations 108 (488 ) (1,120 ) (2,322 )
Net income $ 3,456 $ 9,896 $ 4,655 $ 6,292
Net income (loss) per common share—basic
Net income from continuing operations $ 0.18 $ 0.57 $ 0.32 $ 0.47
Net income (loss) from discontinued operations 0.01 (0.02 ) (0.06 ) (0.13 )
Net income per common share—basic $ 0.19 $ 0.55 $ 0.26 $ 0.34
Net income (loss) per common share—diluted
Net income from continuing operations $ 0.18 $ 0.56 $ 0.31 $ 0.46
Net income (loss) from discontinued operations 0.01 (0.02 ) (0.06 ) (0.12 )
Net income per common share—diluted $ 0.19 $ 0.54 $ 0.25 $ 0.34
Weighted average number of common shares:
Basic 18,180,845 18,091,650 18,071,093 18,238,533
Diluted 18,572,791 18,382,118 18,394,542 18,569,861
ORTHOFIX INTERNATIONAL N.V.
Condensed Consolidated Balance Sheets
(U.S. Dollars, in thousands except share data) September 30,

2017

December 31,

2016

(unaudited)
Assets
Current assets
Cash and cash equivalents $ 53,925 $ 39,572
Restricted cash 14,369
Accounts receivable, net of allowances of $8,925 and $8,396, respectively 61,187 57,848
Inventories 80,124 63,346
Prepaid expenses and other current assets 18,172 19,238
Total current assets 213,408 194,373
Property, plant and equipment, net 46,678 48,916
Patents and other intangible assets, net 9,915 7,461
Goodwill 53,565 53,565
Deferred income taxes 47,052 47,325
Other long-term assets 15,683 20,463
Total assets $ 386,301 $ 372,103
Liabilities and shareholders’ equity
Current liabilities
Accounts payable $ 13,352 $ 14,353
Other current liabilities 60,718 69,088
Total current liabilities 74,070 83,441
Other long-term liabilities 26,920 25,185
Total liabilities 100,990 108,626
Contingencies
Shareholders’ equity
Common shares $0.10 par value; 50,000,000 shares authorized; 18,212,916 and

17,828,155 issued and outstanding as of September 30, 2017 and December 31,

2016, respectively

1,821 1,783
Additional paid-in capital 215,778 204,095
Retained earnings 68,834 64,179
Accumulated other comprehensive loss (1,122 ) (6,580 )
Total shareholders’ equity 285,311 263,477
Total liabilities and shareholders’ equity $ 386,301 $ 372,103

ORTHOFIX INTERNATIONAL N.V. Non-GAAP Financial Measures

The following tables present reconciliations of net income (loss) from continuing operations, earnings per share (“EPS”) from continuing operations, gross profit, and net cash from operating activities, in each case calculated in accordance with U.S. generally accepted accounting principles (“GAAP”), to, as applicable, non-GAAP financial measures, referred to as "EBITDA," "Adjusted EBITDA," "Adjusted net income from continuing operations," "Adjusted earnings per share from continuing operations," "Non-GAAP net margin" and "Free cash flow" that exclude items specified in the tables. A more detailed explanation of the items excluded from these non-GAAP financial measures, as well as why management believes the non-GAAP financial measures are useful to them, is included following the reconciliations.

EBITDA and Adjusted EBITDA

Three Months Ended

September 30,

Nine Months Ended

September 30,

(Unaudited, U.S. Dollars, in thousands) 2017 2016 2017 2016
Net income from continuing operations $ 3,348 $ 10,384 $ 5,775 $ 8,614
Interest expense (income), net 15 (471 ) (106 ) (320 )
Income tax expense (benefit) 6,150 (1,276 ) 13,998 6,703
Depreciation and amortization 4,974 5,480 15,421 15,483
EBITDA $ 14,487 $ 14,117 $ 35,088 $ 30,480
Share-based compensation 3,632 7,862 9,124 11,874
Foreign exchange impact (794 ) 566 (2,425 ) (1,434 )
Strategic investments 293 (62 ) 9,619 342
SEC / FCPA matters and related costs 1,150 691 1,851 1,481
Infrastructure investments 827 3,073
Legal judgments/settlements 179 (3,000 ) 1,798 (3,000 )
Charges related to U.S. Government resolutions 1,499 14,369
Restructuring 2,160 2,242
Succession charges 1,026 1,026
Adjusted EBITDA $ 21,107 $ 23,526 $ 57,297 $ 58,211
As a % of net sales 20.1 % 23.9 % 18.1 % 19.3 %

Adjusted Net Income from Continuing Operations

Three Months Ended

September 30,

Nine Months Ended

September 30,

(Unaudited, U.S. Dollars, in thousands) 2017 2016 2017 2016
Net income from continuing operations $ 3,348 $ 10,384 $ 5,775 $ 8,614
Foreign exchange impact (794 ) 566 (2,425 ) (1,434 )
Strategic investments 293 (62 ) 9,619 342
SEC / FCPA matters and related costs 1,150 691 1,851 1,481
Infrastructure investments 827 3,073
Legal judgments/settlements 179 (3,000 ) 1,798 (3,000 )
Charges related to U.S. Government resolutions 1,499 14,369
Restructuring 2,160 2,242
Succession charges 1,026 1,026
Long-term income tax rate adjustment 1,405 (5,325 ) 1,512 (5,143 )
Adjusted net income from continuing operations $ 7,741 $ 6,606 $ 20,372 $ 19,328

Adjusted Earnings per Share from Continuing Operations

Three Months Ended

September 30,

Nine Months Ended

September 30,

(Unaudited, per diluted share) 2017 2016 2017 2016
EPS from continuing operations $ 0.18 $ 0.56 $ 0.31 $ 0.46
Foreign exchange impact (0.04 ) 0.03 (0.13 ) (0.08 )
Strategic investments 0.02 0.52 0.02
SEC / FCPA matters and related costs 0.06 0.04 0.10 0.08
Infrastructure investments 0.04 0.17
Legal judgments/settlements 0.01 (0.16 ) 0.10 (0.16 )
Charges related to U.S. Government resolutions 0.08 0.77
Restructuring 0.12 0.12
Succession charges 0.06 0.06
Long-term income tax rate adjustment 0.07 (0.29 ) 0.09 (0.28 )
Adjusted EPS from continuing operations $ 0.42 $ 0.36 $ 1.11 $ 1.04
Weighted average number of diluted common shares 18,572,791 18,382,118 18,394,542 18,569,861

Non-GAAP Net Margin

Three Months Ended

September 30,

Nine Months Ended

September 30,

(Unaudited, U.S. Dollars, in thousands) 2017 2016 2017 2016
Gross profit $ 81,530 $ 78,617 $ 247,452 $ 236,718
Sales and marketing (47,493 ) (41,717 ) (146,496 ) (132,582 )
Non-GAAP net margin $ 34,037 $ 36,900 $ 100,956 $ 104,136
BioStim $ 18,285 $ 19,996 $ 54,887 $ 54,980
Biologics 6,010 6,821 18,651 19,642
Extremity Fixation 7,723 8,834 20,901 24,170
Spine Fixation 2,122 1,388 6,825 5,925
Corporate (103 ) (139 ) (308 ) (581 )
Non-GAAP net margin $ 34,037 $ 36,900 $ 100,956 $ 104,136

Free Cash Flow

Nine Months Ended

September 30,

(Unaudited, U.S. Dollars, in thousands) 2017 2016
Net cash from operating activities $ 23,494 $ 38,396
Capital expenditures (13,290 ) (14,261 )
Free cash flow $ 10,204 $ 24,135

2017 Outlook

Previous 2017 Outlook Current 2017 Outlook
(Unaudited, U.S. Dollars, in millions) Low High Low High
Net income from continuing operations $ 17.7 $ 21.4 $ 14.2 $ 17.0
Interest expense, net 0.2 0.1
Income tax expense 15.7 15.5 16.7 17.0
Depreciation and amortization 20.0 20.0 20.2 20.2
EBITDA $ 53.6 $ 57.0 $ 51.1 $ 54.2
Share-based compensation 13.0 13.0 13.0 13.0
Foreign exchange impact (1.6 ) (1.6 ) (2.4 ) (2.4 )
Strategic investments 10.3 9.3 10.2 10.2
SEC / FCPA matters and related costs 1.2 1.0 2.4 2.4
Legal judgments/settlements 1.6 1.6 1.8 1.8
Restructuring 0.9 0.7 2.9 2.8
Adjusted EBITDA $ 79.0 $ 81.0 $ 79.0 $ 82.0
Previous 2017 Outlook Current 2017 Outlook
(Unaudited, per diluted share) Low High Low High
EPS from continuing operations $ 0.96 $ 1.16 $ 0.77 $ 0.92
Foreign exchange impact (0.09 ) (0.09 ) (0.13 ) (0.13 )
Strategic investments 0.56 0.51 0.55 0.55
SEC / FCPA matters and related costs 0.07 0.05 0.13 0.13
Legal judgments/settlements 0.09 0.09 0.10 0.10
Restructuring 0.05 0.04 0.16 0.15
Long-term income tax rate adjustment (0.10 ) (0.16 ) (0.04 ) (0.09 )
Adjusted EPS from continuing operations $ 1.54 $ 1.60 $ 1.54 $ 1.63
Weighted average number of diluted common shares 18,400,000 18,400,000 18,400,000 18,400,000
Non-GAAP Measures: Constant Currency Constant currency is a non-GAAP measure, which is calculated by using foreign currency rates from the comparable, prior-year period, to present net sales at comparable rates. Constant currency can be presented for numerous GAAP measures, but is most commonly used by management to analyze net sales without the impact of changes in foreign currency rates. EBITDA EBITDA is a non-GAAP financial measure, which is calculated by adding interest income (expense), net; income tax expense; and depreciation and amortization to net income (loss) from continuing operations. EBITDA provides management with additional insight to its results of operations. Adjusted EBITDA, Adjusted Net Income from Continuing Operations and Adjusted Earnings per Share from Continuing Operations These non-GAAP financial measures provide management with additional insight to its results of operations and are calculated using the following adjustments:
  • Share-based compensation – costs related to our share-based compensation plans, which include stock options, restricted stock awards, performance-based restricted stock awards, market-based restricted stock awards and our stock purchase plan
  • Foreign exchange impact – gains and losses related to foreign currency transactions; guidance presented does not include the impact of any future foreign exchange fluctuations
  • Strategic investments – costs related to our strategic investments, including our investment in eNeura, Inc.
  • SEC / FCPA matters and related costs – legal and other professional fees associated with the SEC Investigation, Securities Class Action Complaint and Brazil subsidiary compliance review
  • Infrastructure investments – costs associated with our multi-year process and systems improvement effort, "Bluecore,” which was completed in 2016
  • Legal judgments/settlements – adverse or favorable legal judgments or negotiated legal settlements
  • Charges related to U.S. Government resolutions – charges related to the settlement with the SEC as further discussed in our Form 10-K for the year ended December 31, 2016
  • Restructuring – costs related to a planned restructuring, primarily consisting of severance charges and the write-down of certain assets
  • Succession charges – costs related to the succession of certain of our former named executive officers
  • Long-term income tax rate adjustment – reflects management’s expectation of a long-term normalized effective tax rate of 38%, which is based on current tax law and current expected income. Actual tax expense will ultimately be based on GAAP performance and may differ from the 38% effective tax rate due to a variety of factors, including jurisdictions in which profits are determined to be earned and taxed, and discrete items, such as the resolutions of issues arising from tax audits with various tax authorities and the ability to realize deferred tax assets
Non-GAAP Net Margin Non-GAAP net margin is an internal non-GAAP metric, which we define as gross profit less sales and marketing expense. Non-GAAP net margin is the primary metric used by our Chief Operating Decision Maker in managing our business. Free Cash Flow Free cash flow is a non-GAAP financial measure, which is calculated by subtracting capital expenditures from cash flow from operating activities. Free cash flow is an important indicator of how much cash is generated or used by our normal business operations, including capital expenditures. Management uses free cash flow as a measure of progress on its capital efficiency and cash flow initiatives. Usefulness and Limitations of Non-GAAP Financial Measures Management uses non-GAAP measures to evaluate performance period-over-period, to analyze the underlying trends in our business, to assess performance relative to competitors and to establish operational goals and forecasts that are used in allocating resources. Management uses these non-GAAP measures as the basis for assessing the ability of the underlying operations to generate cash. In addition, management uses these non-GAAP measures to further its understanding of the performance of our business units. Material Limitations Associated with the Use of Non-GAAP Financial Measures The non-GAAP measures used in this press release may have limitations as analytical tools, and should not be considered in isolation or as a replacement for GAAP financial measures. Some of the limitations associated with the use of these non-GAAP financial measures are that they exclude items that reflect an economic cost and can have a material effect on cash flows. Similarly, certain non-cash expenses, such as share-based compensation, do not directly impact cash flows, but are part of total compensation costs accounted for under GAAP. Compensation for Limitations Associated with Use of Non-GAAP Financial Measures We compensate for the limitations of our non-GAAP financial measures by relying upon GAAP results to gain a complete picture of our performance. The GAAP results provide the ability to understand our performance based on a defined set of criteria. The non-GAAP measures reflect the underlying operating results of our businesses, which we believe is an important measure of our overall performance. We provide a detailed reconciliation of the non-GAAP financial measures to our most directly comparable GAAP measures, and encourage investors to review this reconciliation. Usefulness of Non-GAAP Financial Measures to Investors We believe that providing non-GAAP financial measures that exclude certain items provides investors with greater transparency to the information used by senior management in its financial and operational decision-making. Management believes it is important to provide investors with the same non-GAAP metrics it uses to supplement information regarding the performance and underlying trends of our business operations in order to facilitate comparisons to its historical operating results and internally evaluate the effectiveness of our operating strategies. Disclosure of these non-GAAP financial measures also facilitates comparisons of our underlying operating performance with other companies in the industry that also supplement their GAAP results with non-GAAP financial measures.

Contacts

Orthofix International N.V. Mark Quick, 214-937-2924 markquick@orthofix.com

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30 Oct

Exactech Q3 Revenue $61.4 Million

October 30, 2017

GAINESVILLE, Fla.--(BUSINESS WIRE)--Exactech, Inc. (Nasdaq: EXAC), a developer and producer of bone and joint restoration products and biologic solutions for extremities, knee and hip, announced today that revenue for the third quarter of 2017 increased 2% to $61.4 million from $59.9 million in the third quarter of 2016, and 2% on a constant currency basis. Domestic revenue increased 2% to $43.3 million, and international revenue increased 2% to $18.1 million in the third quarter of 2017. Diluted earnings per share for the third quarter was $0.20 based on net income of $2.9 million, compared to third quarter 2016 net income of $3.2 million and diluted earnings per share of $0.22. Third Quarter Segment Performance
  • Extremities revenue increased 18% to $27.7 million from $23.4 million, an 18% constant currency increase
  • Knee revenue decreased 3% to $16.5 million, a 3% constant currency decrease
  • Hip revenue decreased 3% to $11.3 million from $11.6 million, a 3% constant currency decrease
  • Other revenue decreased 25% to $5.9 million from $7.9 million, a 27% constant currency decrease. The Other segment includes an aggregation of the former Biologics and Spine segment
Nine Months Highlights and Segment Performance For the first nine months of 2017, revenue was $198.2 million, an increase of 4% over $191.3 million for the comparable period last year. On a constant currency basis, revenue for the first nine months of 2017 was up 4%. Net income for the first nine months of 2017 was $12.3 million, or $0.84 per diluted share compared to $12.0 million, or $0.84 per diluted share, for the first nine months of 2016. First nine month product revenue was as follows:
  • Extremities revenue increased 19% to $87.1 million, a 19% constant currency increase
  • Knee revenue was flat at $56.2 million, flat on constant currency
  • Hip revenue decreased 2% to $35.0 million, a 1% constant currency decrease
  • Other revenue decreased 24% to $20.0 million, a 24% constant currency decrease
Management Comment Exactech CEO and President David Petty said, “For the first nine months of 2017, we reported a 4% increase in our revenue. During the third quarter, we continued to work on launch plans for the new Truliant® knee system, Vantage® ankle, ExactechGPS® shoulder application, and Alteon® H.A. hip stem and are very pleased with the early response we hear from surgeon users,” Petty said. Chief Financial Officer Jody Phillips said, “Gross margins increased to 70.3% from 68.7% for the third quarter a year ago. Total operating expenses for the quarter increased 7% to $39.2 million. As a result, our net income decreased 10% to $2.9 million and $0.20 diluted EPS for the third quarter which was in the range of our expectations.” On October 23, 2017, Exactech announced that it had entered into a definitive agreement with TPG Capital to go private. It is expected the transaction will be closed in early 2018. The financial statements are below. About Exactech Based in Gainesville, Fla., Exactech develops and markets orthopaedic implant devices, related surgical instruments and biologic materials and services to hospitals and physicians. The company manufactures many of its orthopaedic devices at its Gainesville facility. Exactech’s orthopaedic products are used in the restoration of bones and joints that have deteriorated as a result of injury or diseases such as arthritis. Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Additional information about Exactech can be found at http://www.exac.com. This release contains various forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which represent the company’s expectations or beliefs concerning future events of the company’s financial performance. These forward-looking statements are further qualified by important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include the effect of competitive pricing, the company’s dependence on the ability of third party manufacturers to produce components on a basis which is cost-effective to the company, market acceptance of the company’s products and the effects of government regulation. Results actually achieved may differ materially from expected results included in these statements.

EXACTECH, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS
(in thousands)
(unaudited) (audited)
September 30, December 31,
2017 2016

ASSETS

CURRENT ASSETS:
Cash and cash equivalents $ 11,718 $ 13,052
Trade receivables, net of allowances of $2,043 and $1,473 56,940 53,051
Prepaid expenses and other assets, net 3,585 3,075
Income taxes receivable 895 2,140
Inventories, current 69,885 65,264
Assets held for sale 6,477
Total current assets 143,023 143,059
PROPERTY AND EQUIPMENT:
Land 4,550 4,474
Machinery and equipment 45,622 42,034
Surgical instruments 146,827 132,134
Furniture and fixtures 4,715 4,700
Facilities 23,062 21,726
Projects in process 6,739 2,473
Total property and equipment 231,515 207,541
Accumulated depreciation (111,434 ) (100,234 )
Net property and equipment 120,081 107,307
OTHER ASSETS:
Deferred financing, deposits and other 4,416 968
Equity investment 1,916 2,047
Deferred tax asset 887
Non-current inventory 12,799 15,723
Product licenses and designs, net 8,994 9,102
Patents and trademarks, net 664 821
Customer relationships, net 452 476
Goodwill 14,860 13,819
Total other assets 44,101 43,843

TOTAL ASSETS

$ 307,205 $ 294,209
LIABILITIES AND SHAREHOLDERS’ EQUITY
CURRENT LIABILITIES:
Accounts payable $ 18,338 $ 17,566
Income taxes payable 568 780
Accrued expenses 13,547 11,832
Other current liabilities 2,616 2,927
Total current liabilities 35,069 33,105
LONG-TERM LIABILITIES:
Deferred tax liabilities 4,181 1,773
Long-term debt, net of current portion 14,000 20,000
Other long-term liabilities 3,653 5,089
Total long-term liabilities 21,834 26,862
Total liabilities 56,903 59,967
COMMITMENTS AND CONTINGENCIES
SHAREHOLDERS’ EQUITY:
Common stock 145 144
Additional paid-in capital 91,051 87,319
Treasury Stock (3,042 ) (3,042 )
Accumulated other comprehensive loss, net of tax (8,561 ) (8,611 )
Retained earnings 170,709 158,432
Total shareholders’ equity 250,302 234,242
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY $ 307,205 $ 294,209

EXACTECH, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF INCOME

(in thousands, except per share amounts)

(Unaudited)
Three Month Periods Nine Month Periods
Ended September 30, Ended September 30,
2017 2016 2017 2016
NET SALES $ 61,404 $ 59,919 $ 198,213 $ 191,341
COST OF GOODS SOLD 18,232 18,772 59,927 59,408
Gross profit 43,172 41,147 138,286 131,933
OPERATING EXPENSES:
Sales and marketing 22,713 21,684 71,335 68,838
General and administrative 5,908 5,186 18,065 16,740
Research and development 5,729 5,096 17,333 15,495
Depreciation and amortization 4,892 4,592 14,283 13,326
Total operating expenses 39,242 36,558 121,016 114,399
INCOME FROM OPERATIONS 3,930 4,589 17,270 17,534
OTHER INCOME (EXPENSE):
Interest income 32 29 87 35
Other income (loss) (28 ) 43 300 115
Interest expense (229 ) (186 ) (693 ) (716 )
Foreign currency exchange gain 470 73 1,200 665
Total other income (expenses) 245 (41 ) 894 99
INCOME BEFORE INCOME TAXES 4,175 4,548 18,164 17,633
PROVISION FOR INCOME TAXES 1,277 1,383 5,756 5,680
INCOME BEFORE EQUITY IN LOSS OF INVESTEE 2,898 3,165 12,408 11,953
EQUITY IN LOSS OF INVESTEE, NET OF TAX (36 ) (131 )
NET INCOME $ 2,862 $ 3,165 $ 12,277 $ 11,953
BASIC EARNINGS PER SHARE $ 0.20 $ 0.22 $ 0.86 $ 0.85
DILUTED EARNINGS PER SHARE $ 0.20 $ 0.22 $ 0.84 $ 0.84
SHARES - BASIC 14,352 14,123 14,315 14,108
SHARES - DILUTED 14,613 14,370 14,578 14,303

Contacts

Exactech Investor contacts: Jody Phillips, 352-377-1140 Executive Vice President of Finance & Chief Financial Officer or Priscilla Bennett, 352-377-1140 Priscilla@exac.com

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30 Oct

Arthrosurface acquires an acellular dermal technology from WASAS, LLC

FRANKLIN, Mass.Oct. 30, 2017 /PRNewswire/ -- Arthrosurface, Inc. announced today that it has completed the acquisition of an acellular dermal stabilization device technology, including the intellectual property rights to and associated with this technology, from WASAS, LLC based in Fort Lauderdale, Florida. Arthrosurface plans to use this technology to develop and market a platform of novel methods to be used to correct orthopedic challenges in multiple therapeutic areas.
Acellular dermis is derived from a human source, a process is used to remove cells and retain portions of the extracellular matrix (ECM). Dermal allografts have a history of human use in a wide range of clinical indications. "The availability of this allograft to Arthrosurface will allow us to execute on a pipeline of clinical applications that we have identified with our surgeon partners over the past several years," said Steve Ek, CEO of Arthrosurface. About Arthrosurface Arthrosurface, Inc. is a global orthopedic medical technology business providing a broad portfolio of essential products and instrumentation used to treat upper and lower extremity orthopedic conditions caused by trauma, injury and arthritic disease. The product offerings include devices, instruments and orthobiologics designed to preserve and restore the joints so patients can regain and maintain an active lifestyle. The Company offers a variety of unique systems that provide less invasive technologies for surgeons that can be used to treat a wide range of joint conditions. Founded in 2002, Arthrosurface markets and distributes its products in the US and around the world and has succeeded in helping patients return to activity for over 13 years. For more information, please go to our website at www.arthrosurface.com   SOURCE Arthrosurface, Inc.

Related Links

http://arthrosurface.com

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30 Oct

GS Medical USA Announces New Product Portfolio of Spinal Solutions

IRVINE, Calif.Oct. 25, 2017 /PRNewswire/ -- Today, GS Solutions Inc., DBA GS Medical USA (GSM), a U.S. supplier of spinal implants and instrumentation and provider of high-quality surgical solutions, announced the full launch of the AnyPlus® Direct Lateral Interbody Fusion (DLIF) System after three months of an alpha launch period, and the Anterior and Posterior Disc Prep Sets. Following strong sales growth of 32% in Q2 2017 versus the prior quarter, the GSM leadership team expects continued, positive growth for Q4 2017 and FY2018, supported by the launch of the aforementioned products. "The company's success thus far is in large part thanks to our strong relationship with surgeon partners and distributors, and we are thrilled to offer these new products in our portfolio of spinal solutions," said James Shin, CEO. The company's newest Direct Lateral System will be streamlined with unique features that offer many implant and instrument options to complement surgeon preferences. "We understand the ever-evolving needs of our surgeon partners, and we continually strive to develop new and innovative implants and instrumentation, with the ultimate goal of providing value-enhanced, multi-faceted surgical solutions and outstanding patient care." GSM continues to make further advancements in engineering and development with the recent growth of its spine products portfolio. Earlier this year GSM expanded its offerings within several other systems including the AnyPlus® Anterior Cervical Interbody Fusion (ACIF) System, the AnyPlus® Dual Lead Screw System, and an anterior cervical plate solution. GSM is also finalizing the launch of the company's Chrome Cobalt Rod System for scoliosis application, as well as making upgrades to its AnyPlus® NX Percutaneous Pedicle Screw System to provide for better user experience. In the coming months, GSM looks to launch its advanced, Stand-Alone interbody system and Posterior Cervical application, as well expand distribution partnerships with preferred partners who offer DBM, Allograft and Kyphoplasty. "We expect that the remainder of this year and 2018 will continue to be strong for GSM as we have a number of products in development," said Kurt Neesley, U.S. Sales and Business Development Director. Given the company's expanded suite of product offerings, GSM expects demand for the company's spinal solutions to increase substantially. "We are focused on growing our sales team and curating a strong network of distributor partnerships to meet surgeon demand," Neesley stated. "GSM is committed to providing best-in-class service to our distributors and surgeons to promote better patient outcomes." For more information about distributor partnership opportunities, please contact kneesley@gsmedicalusa.com. Media Relations Contact: Amanda Collins 182068@email4pr.com  I  Phone: 949.380.6385 x213 FAX: 866.600.9712 6 Wrigley Irvine, CA 92618 www.gsmedicalusa.com SOURCE GS Medical

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27 Oct

Misonix Cites Significant Healthcare Cost Savings Using BoneScalpel in Bone Removal Procedures

FARMINGDALE, N.Y., Oct. 25, 2017 (GLOBE NEWSWIRE) -- Misonix, Inc. (NASDAQ:MSON), a provider of minimally invasive therapeutic ultrasonic medical devices that enhance clinical outcomes, today cited data that demonstrated the use of BoneScalpel can produce up to a 40% cost reduction in biologic grafting material spend in spinal fusion procedures.

The data was presented today by Dr. Wade Jensen of the Center for Neurosciences, Orthopaedics & Spine (“CNOS”), at the 32nd Annual Meeting of the North American Spine Society (“NASS”) in Orlando, Florida.  The data showed an average cost savings of $1,066 in bone graft material when the Misonix BoneScalpel was employed compared to the use of standard power drill instruments. The Misonix BoneScalpel ultrasonically cuts bone using a 1mm thick blunt blade. The result is a clean cut that preserves healthy bone which can be used for grafting, and spares the surrounding soft tissue. The study is based on a retrospective analysis including 144 cases, 44 of which were done using the Misonix BoneScalpel. The remaining 100 cases were done with a 3mm rotating matchstick drill bit (“burr”) currently in broad use in surgical suites throughout the U.S. An estimated $1.9 billion is spent annually on bone graft substitutes. Stavros Vizirgianakis, President and Chief Executive Officer of Misonix, said, “The data presented today are a strong validation of the efficacy of the BoneScalpel in producing significant cost savings in the surgical suite. This data demonstrates the value of using ultrasonic bone removal over standard electric power instruments both in the precision of the bone removal and the reduction in overall bone destruction. The ability to ultrasonically remove bone in a manner that enhances the ability for successful bone grafting while minimizing the need for biological grafting material represents an important step forward for patients, surgeons and medical institutions. We believe that the BoneScalpel can become the standard of care for precision bone cutting while sparing soft tissue and delivering significant cost savings to the healthcare process.” Misonix will be exhibiting at NASS 2017 at booth #765 from Wednesday, October 25, 2017 through Saturday, October 28, 2017. About NASS The North American Spine Society (“NASS”) is a global multidisciplinary medical society that utilizes education, research and advocacy to foster the highest quality, ethical, ​value- and evidence-based spine care for patients. About Misonix Misonix, Inc. designs, develops, manufactures and markets therapeutic ultrasonic medical devices. Misonix's therapeutic ultrasonic platform is the basis for several innovative medical technologies. Addressing a combined market estimated to be in excess of $1.5 billion annually; Misonix's proprietary ultrasonic medical devices are used in spine surgery, neurosurgery, orthopedic surgery, wound debridement, cosmetic surgery, laparoscopic surgery, and other surgical and medical applications.  Additional information is available on the Company's Web site at www.misonix.com. Safe Harbor Statement With the exception of historical information contained in this press release, content herein may contain "forward looking statements" that are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and are subject to uncertainty and changes in circumstances. Investors are cautioned that forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from the statements made. These factors include general economic conditions, delays and risks associated with the performance of contracts, risks associated with international sales and currency fluctuations, uncertainties as a result of research and development, acceptable results from clinical studies, including publication of results and patient/procedure data with varying levels of statistical relevancy, risks involved in introducing and marketing new products, potential acquisitions, consumer and industry acceptance, litigation and/or court proceedings, including the timing and monetary requirements of such activities, the timing of finding strategic partners and implementing such relationships, regulatory risks including approval of pending and/or contemplated 510(k) filings, the ability to achieve and maintain profitability in the Company's business lines, the impact of the pending investigation by the Department of Justice and Securities Exchange Commission, and other factors discussed in the Company's Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The Company disclaims any obligation to update its forward-looking relationships. Corporate Contact Misonix Contact: Joe Dwyer 631-694-9555 invest@misonix.com Investor Contact Joe Diaz Lytham Partners 602-889-9700 info@misonix.com  

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27 Oct

Medacta Receives FDA Clearance for Anatomic and Reverse Shoulder Systems

October 26, 2017

CHICAGO--(BUSINESS WIRE)--Medacta International, developer of innovative surgical techniques and products for the hip, knee, spine, and sports medicine disciplines, recently expanded its expertise to the world of shoulder surgery. The family-owned orthopedics leader today announced it has received FDA clearance for the Anatomic Shoulder and Reverse Shoulder components of its modular Medacta Shoulder System. The company also announced the successful completion of the first surgery in the United States utilizing the system, which was performed by Matthew D. Saltzman, M.D., Associate Professor of Orthopaedic Surgery at the Northwestern Memorial Hospital in Chicago, Illinois. “The procedure went very well,” said Dr. Saltzman, who specializes in shoulder and elbow surgeries and has been practicing orthopedics for 14 years. “The Medacta Shoulder System’s instrumentation and implants allow for impressive anatomic restoration, resulting in an efficient surgery and, hopefully, improved patient outcomes.” The Medacta Shoulder System, unveiled in February 2017 following its first ever surgery in Europe, is a modular solution that features a broad range of options, including wide-ranging sizes, adjustable offset, and innovative configurations. Developed by an international team of expert surgeons, the platform offers the modularity and compatibility demanded by today’s marketplace, while still respecting anatomic conversion from primary to reverse. The Shoulder System is also supported by the Medacta Orthopaedic Research and Education (M.O.R.E.) Institute’s Clinical Excellence Program and is part of a multi-center, post-marketing, prospective, open clinical study that will collect clinical and radiological outcomes for the next ten years. The M.O.R.E. Institute provides continuous educational and developmental support to Medacta surgeons as they work towards discovering new technologies and supporting patients. “The new Medacta Shoulder System is a continuation of our effort to improve orthopedic implant design and configurability for the benefit of both surgeons and their patients,” said Francesco Siccardi, Executive Vice President of Medacta International. “This latest surgery in the United States marks a milestone for Medacta in line with our company’s patient-centric vision and the same ambition that has helped us become a leader in knee, hip, and spine technology.” Medacta will launch the Shoulder System for the U.S. market at the American Academy of Orthopaedic Surgeons Annual Meeting, which will be held in New Orleans in March 2018. For more information about Medacta, please visit medacta.com or follow @Medacta on Twitter. About Medacta International Medacta® International is a world leading manufacturer of orthopedic implants, neurosurgical systems, and instrumentation. Medacta’s revolutionary approach and responsible innovation have resulted in standard of care breakthroughs in hip replacement with the AMIS® system and total knee replacement with MyKnee® patient matched technology. Over the last 10 years, Medacta has grown dramatically by taking a different approach and placing value on all aspects of the care experience from design to training to sustainability. Medacta is headquartered in Castel San Pietro, Switzerland, and operates in over 30 countries. To learn more about Medacta International, please visit www.medacta.com or follow @Medacta on Twitter.

Contacts

For Medacta International, Inc. Jill Bongiorni, 516-729-2250 Jill@torchcomllc.com

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26 Oct

Anika Completes Enrollment in Second Pivotal Phase III Trial of CINGAL for the Treatment of Knee Pain Associated with Osteoarthritis

October 25, 2017

BEDFORD, Mass.--(BUSINESS WIRE)--Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated orthopedics medicines company specializing in therapeutics based on its proprietary hyaluronic acid ("HA") technology, today announced the completion of enrollment in its second pivotal Phase III trial evaluating CINGAL®, its novel HA-corticosteroid combination viscosupplement1 for the treatment of symptoms associated with osteoarthritis (“OA”) of the knee. CINGAL is poised to be the first and only viscosupplement in the U.S. market to combine triamcinolone hexacetonide, a well-established, FDA-approved steroid utilized to treat inflammation, with Anika's proprietary cross-linked, non-animal-derived hyaluronic acid, which is the active ingredient in the company’s global market-leading viscosupplements, ORTHOVISC® and MONOVISC®. The second pivotal Phase III trial, which will evaluate 576 patients with mild to moderate knee osteoarthritis, is designed to evaluate the safety of CINGAL as well as its effectiveness in improving pain, function, and quality of life measures over a 26-week period, in comparison to MONOVISC and triamcinolone hexacetonide. “We’re proud to have rapidly achieved this major milestone on the path to seeking U.S. regulatory approval for CINGAL, which is key to driving future growth for the company and adding to our market leadership position in orthobiologics,” said Charles H. Sherwood, Ph.D., Chief Executive Officer of Anika Therapeutics. “With its novel and proprietary combination of two proven treatments, and its demonstrated ability to provide immediate and long-lasting pain relief, CINGAL will bridge a significant gap in the non-invasive, non-opioid osteoarthritis treatment landscape, which has not seen a major innovation for over a decade.” Anika recently published results from its initial Phase III trial, which formed the basis for CINGAL’s Health Canada and CE Mark approvals in November 2015 and March 2016, respectively. The trial, which compared the safety and efficacy of CINGAL to MONOVISC and placebo (saline), showed that CINGAL provided superior short term pain relief after injection as compared to HA alone, and superior relief from OA-related pain, stiffness, and function through 26 weeks as compared to placebo (saline). Anika expects to complete the CINGAL second pivotal Phase III trial in the first half of 2018 and anticipates FDA approval the following year. About Anika Therapeutics, Inc. Anika Therapeutics, Inc. (NASDAQ: ANIK) is a global, integrated orthopedic medicines company based in Bedford, Massachusetts. Anika is committed to improving the lives of patients with degenerative orthopedic diseases and traumatic conditions with clinically meaningful therapies along the continuum of care, from palliative pain management to regenerative cartilage repair. The Company has over two decades of global expertise developing, manufacturing, and commercializing more than 20 products based on its proprietary hyaluronic acid (HA) technology. Anika's orthopedic medicine portfolio includes ORTHOVISCMONOVISC, and CINGAL, which alleviate pain and restore joint function by replenishing depleted HA, and HYALOFAST®, a solid HA-based scaffold to aid cartilage repair and regeneration. For more information about Anika, please visit www.anikatherapeutics.com. Forward-Looking Statements The statements made in the first sentences of the second, third, and fifth paragraphs of this press release, which are not statements of historical fact, are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include, but are not limited to, those relating to driving the Company’s future growth and the Company's expectations regarding completion of the second pivotal Phase III study for CINGAL and FDA approval of CINGAL. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks, uncertainties, and other factors. The Company's actual results could differ materially from any anticipated future results, performance, or achievements described in the forward-looking statements as a result of a number of factors including, but not limited to, (i) the Company's ability to successfully commence and/or complete clinical trials of its products on a timely basis or at all; (ii) the Company's ability to obtain pre-clinical or clinical data to support domestic and international pre-market approval applications, 510(k) applications, or new drug applications, or to timely file and receive FDA or other regulatory approvals or clearances of its products; (iii) that such approvals will not be obtained in a timely manner or without the need for additional clinical trials, other testing or regulatory submissions, as applicable; (iv) the Company's research and product development efforts and their relative success, including whether we have any meaningful sales of any new products resulting from such efforts; (v) the cost effectiveness and efficiency of the Company's clinical studies, manufacturing operations, and production planning; (vi) the strength of the economies in which the Company operates or will be operating, as well as the political stability of any of those geographic areas; (vii) future determinations by the Company to allocate resources to products and in directions not presently contemplated; (viii) the Company's ability to successfully commercialize its products, in the U.S. and abroad; (ix) the Company's ability to provide an adequate and timely supply of its products to its customers; and (x) the Company's ability to achieve its growth targets. Additional factors and risks are described in the Company's periodic reports filed with the Securities and Exchange Commission, and they are available on the SEC's website at www.sec.gov. Forward-looking statements are made based on information available to the Company on the date of this press release, and the Company assumes no obligation to update the information contained in this press release. 1 Viscosupplements are injected by a licensed medical professional into synovial joints to replenish the natural cushioning within joints that depletes with age and degenerative orthopedic diseases, causing pain.

Contacts

For Investor Inquiries: Anika Therapeutics, Inc. Sylvia Cheung, 781-457-9000 Chief Financial Officer or For Media Inquiries: Pure Communications Sonal Vasudev, 917-523-1418 sonal@purecommunicationsinc.com

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