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Financial

Orthofix International Reports Second Quarter 2017 Financial Results

August 8, 2017 OrthoSpineNews

August 07, 2017

LEWISVILLE, Texas–(BUSINESS WIRE)–Orthofix International N.V. (NASDAQ:OFIX) today reported its financial results for the second quarter ended June 30, 2017. Net sales were $108.9 million, diluted earnings per share from continuing operations was $0.26 and adjusted earnings per share from continuing operations was $0.42.

“The key take-away from the second quarter is the strong sales performance of our Biologics and Spine Fixation businesses. Both have averaged mid-single digit year-over-year growth over the last three quarters,” said Brad Mason, President and Chief Executive Officer. “We believe these growth rates are sustainable in both businesses due to the renewed engagement of our sales partners, the addition of new distributors in underserved markets and our flow of new products to the field.

“The BioStim and Extremity Fixation businesses also performed better than we expected in the second quarter with BioStim delivering another solid top line performance and, when excluding planned subsidiary restructuring and the loss of sales due to the discontinuation of a non-core business last year, Extremity Fixation delivered good constant currency growth.

“Our bottom line performance was in line with our expectations for the period. Our primary focus this year is investing in the areas necessary to support a sustainable increase to our top line growth rate, rather than margin expansion. As we move into next year, without sacrificing our top line growth, we expect to return to adjusted EBITDA margin expansion as a result of a number of opportunities we see across the P&L.”

Financial Results Overview

The following table provides net sales by strategic business unit (“SBU”):

Three Months Ended June 30,
(Unaudited, U.S. Dollars, in thousands) 2017 2016 Change

Constant
Currency
Change
BioStim $ 47,174 $ 44,758 5.4 % 5.4 %
Biologics 15,661 14,256 9.9 % 9.9 %
Extremity Fixation 24,747 26,817 (7.7 %) (6.0 %)
Spine Fixation 21,360 18,244 17.1 % 17.1 %
Net sales $ 108,942 $ 104,075 4.7 % 5.1 %

Gross profit increased $4.2 million to $85.8 million. Gross margin improved slightly to 78.7% compared to 78.4% in the prior year period, which was slightly below our expectations due primarily to larger than usual inventory reserve expenses. Non-GAAP net margin, an internal metric that we define as gross profit less sales and marketing expenses, was $35.3 million compared to $35.5 million in the prior year period. The decrease in non-GAAP net margin was primarily due to higher sales and marketing expenses in Biologics and Extremity Fixation.

Net income from continuing operations was $4.7 million, or $0.26 per share, compared to net loss of ($6.3) million, or ($0.35) per share in the prior year period. Adjusted net income from continuing operations was $7.8 million, or $0.42 per share, compared to adjusted net income of $7.5 million, or $0.40 per share in the prior year period.

EBITDA was $14.0 million, compared to $2.6 million in the prior year period. Adjusted EBITDA was $20.5 million, or 18.8% of net sales, for the second quarter, compared to $19.2 million, or 18.5% of net sales, in the prior year period.

Liquidity

As of June 30, 2017, cash and cash equivalents were $44.3 million compared to $39.6 million as of December 31, 2016. As of June 30, 2017, we had no outstanding indebtedness and borrowing capacity of $125 million. Cash flow from operations decreased $11.6 million to $9.7 million and free cash flow decreased $9.9 million to $1.1 million.

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 $ 411.0 $ 415.0 $ 422.0

(1)

 $ 425.0

(1)
Net income from continuing operations $ 20.6 $ 23.7 $ 17.7

(2)

 $ 21.4

(2)
Adjusted EBITDA $ 76.0 $ 79.0 $ 79.0

(3)

 $ 81.0

(3)
EPS from continuing operations $ 1.12 $ 1.29 $ 0.96

(4)

 $ 1.16

(4)
Adjusted EPS from continuing operations $ 1.48 $ 1.58 $ 1.54

(5)

 $ 1.60

(5)

1 Represents a year-over-year increase of 3.0% to 3.7% on a reported basis
2 Represents a year-over-year increase of 406.1% to 512.0%
3 Represents a year-over-year decrease of 0.4% to an increase of 2.1%
4 Represents a year-over-year increase of 405.3% to 510.5%
5 Represents a year-over-year increase of 5.5% to 9.6%

Conference Call

Orthofix will host a conference call today at 4:30 PM Eastern time to discuss the Company’s financial results for the second quarter of 2017. Interested parties may access the conference call by dialing (800) 406-5345 in the U.S. and (719) 325-4807 outside the U.S., and referencing the conference ID 7718902. A replay of the call will be available for two weeks by dialing (888) 203-1112 in the U.S. and (719) 457-0820 outside the U.S., and entering the conference ID 7718902. 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 Six Months Ended
June 30, June 30,
(Unaudited, U.S. Dollars, in thousands, except share and per share data) 2017 2016 2017 2016
Net sales $ 108,942 $ 104,075 $ 211,680 $ 202,754
Cost of sales 23,177 22,516 45,758 44,653
Gross profit 85,765 81,559 165,922 158,101
Sales and marketing 50,471 46,043 99,003 90,865
General and administrative 20,409 18,545 38,691 35,550
Research and development 6,887 6,796 14,311 14,436
Charges related to U.S. Government resolutions — 12,870 — 12,870
Operating income (loss) 7,998 (2,695 ) 13,917 4,380
Interest income (expense), net 76 (113 ) 121 (151 )
Other income (expense), net 585 147 (3,763 ) 1,980
Income (loss) before income taxes 8,659 (2,661 ) 10,275 6,209
Income tax expense (3,924 ) (3,685 ) (7,848 ) (7,979 )
Net income (loss) from continuing operations 4,735 (6,346 ) 2,427 (1,770 )
Discontinued operations
Loss from discontinued operations (1,300 ) (1,572 ) (1,827 ) (2,562 )
Income tax benefit 418 474 599 728
Net loss from discontinued operations (882 ) (1,098 ) (1,228 ) (1,834 )
Net income (loss) $ 3,853 $ (7,444 ) $ 1,199 $ (3,604 )
Net income (loss) per common share—basic
Net income (loss) from continuing operations $ 0.26 $ (0.35 ) $ 0.13 $ (0.10 )
Net loss from discontinued operations (0.05 ) (0.06 ) (0.06 ) (0.10 )
Net income (loss) per common share—basic $ 0.21 $ (0.41 ) $ 0.07 $ (0.20 )
Net income (loss) per common share—diluted
Net income (loss) from continuing operations $ 0.26 $ (0.35 ) $ 0.13 $ (0.10 )
Net loss from discontinued operations (0.05 ) (0.06 ) (0.06 ) (0.10 )
Net income (loss) per common share—diluted $ 0.21 $ (0.41 ) $ 0.07 $ (0.20 )
Weighted average number of common shares:
Basic 18,050,551 18,147,681 18,015,308 18,312,781
Diluted 18,343,038 18,147,681 18,288,050 18,312,781
ORTHOFIX INTERNATIONAL N.V.
Condensed Consolidated Balance Sheets
(U.S. Dollars, in thousands except share data) June 30,

2017

 December 31,

2016
(unaudited)
Assets
Current assets
Cash and cash equivalents $ 44,330 $ 39,572
Restricted cash — 14,369
Accounts receivable, net of allowances of $8,480 and $8,396, respectively 61,213 57,848
Inventories 75,869 63,346
Prepaid expenses and other current assets 17,192 19,238
Total current assets 198,604 194,373
Property, plant and equipment, net 46,651 48,916
Patents and other intangible assets, net 9,508 7,461
Goodwill 53,565 53,565
Deferred income taxes 42,685 47,325
Other long-term assets 16,664 20,463
Total assets $ 367,677 $ 372,103
Liabilities and shareholders’ equity
Current liabilities
Accounts payable $ 14,245 $ 14,353
Other current liabilities 50,858 69,088
Total current liabilities 65,103 83,441
Other long-term liabilities 25,627 25,185
Total liabilities 90,730 108,626
Contingencies
Shareholders’ equity
Common shares $0.10 par value; 50,000,000 shares authorized; 18,119,430 and

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

2016, respectively

 1,812 1,783
Additional paid-in capital 211,990 204,095
Retained earnings 65,378 64,179
Accumulated other comprehensive loss (2,233 ) (6,580 )
Total shareholders’ equity 276,947 263,477
Total liabilities and shareholders’ equity $ 367,677 $ 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

June 30,

 Six Months Ended

June 30,
(Unaudited, U.S. Dollars, in thousands) 2017 2016 2017 2016
Net income (loss) from continuing operations $ 4,735 $ (6,346 ) $ 2,427 $ (1,770 )
Interest expense (income), net (76 ) 113 (121 ) 151
Income tax expense 3,924 3,685 7,848 7,979
Depreciation and amortization 5,372 5,130 10,447 10,003
EBITDA $ 13,955 $ 2,582 $ 20,601 $ 16,363
Share-based compensation 2,676 1,913 5,492 4,012
Foreign exchange impact (618 ) (185 ) (1,631 ) (2,000 )
Strategic investments 2,226 206 9,326 404
SEC / FCPA matters and related costs 560 545 701 790
Infrastructure investments — 1,284 — 2,246
Legal judgments/settlements 1,392 — 1,619 —
International restructuring 321 — 82 —
Charges related to U.S. Government resolutions — 12,870 — 12,870
Adjusted EBITDA $ 20,512 $ 19,215 $ 36,190 $ 34,685
As a % of net sales 18.8 % 18.5 % 17.1 % 17.1 %

Adjusted Net Income from Continuing Operations
Three Months Ended

June 30,

 Six Months Ended

June 30,
(Unaudited, U.S. Dollars, in thousands) 2017 2016 2017 2016
Net income (loss) from continuing operations $ 4,735 $ (6,346 ) $ 2,427 $ (1,770 )
Foreign exchange impact (618 ) (185 ) (1,631 ) (2,000 )
Strategic investments 2,226 206 9,326 404
SEC / FCPA matters and related costs 560 545 701 790
Infrastructure investments — 1,284 — 2,246
Legal judgments/settlements 1,392 — 1,619 —
International restructuring 321 — 82 —
Charges related to U.S. Government resolutions — 12,870 — 12,870
Long-term income tax rate adjustment (841 ) (897 ) 107 182
Adjusted net income from continuing operations $ 7,775 $ 7,477 $ 12,631 $ 12,722

Adjusted Earnings per Share from Continuing Operations
Three Months Ended

June 30,

 Six Months Ended

June 30,
(Unaudited, per diluted share) 2017 2016 2017 2016
EPS from continuing operations $ 0.26 $ (0.35 ) $ 0.13 $ (0.10 )
Foreign exchange impact (0.03 ) (0.01 ) (0.09 ) (0.11 )
Strategic investments 0.12 0.01 0.51 0.02
SEC / FCPA matters and related costs 0.03 0.03 0.04 0.04
Infrastructure investments — 0.07 — 0.12
Legal judgments/settlements 0.08 — 0.09 —
International restructuring 0.02 — — —
Charges related to U.S. Government resolutions — 0.70 — 0.69
Long-term income tax rate adjustment (0.06 ) (0.05 ) 0.01 0.02
Adjusted EPS from continuing operations $ 0.42 $ 0.40 $ 0.69 $ 0.68
Weighted average number of diluted common shares 18,343,038 18,511,978 18,288,050 18,645,280

Non-GAAP Net Margin
Three Months Ended

June 30,

 Six Months Ended

June 30,
(Unaudited, U.S. Dollars, in thousands) 2017 2016 2017 2016
Gross profit $ 85,765 $ 81,559 $ 165,922 $ 158,101
Sales and marketing (50,471 ) (46,043 ) (99,003 ) (90,865 )
Non-GAAP net margin $ 35,294 $ 35,516 $ 66,919 $ 67,236
BioStim $ 19,469 $ 18,575 $ 36,602 $ 34,983
Biologics 6,470 6,718 12,641 12,822
Extremity Fixation 6,766 8,161 13,178 15,336
Spine Fixation 2,696 2,201 4,703 4,536
Corporate (107 ) (139 ) (205 ) (441 )
Non-GAAP net margin $ 35,294 $ 35,516 $ 66,919 $ 67,236

Free Cash Flow
Six Months Ended

June 30,
(Unaudited, U.S. Dollars, in thousands) 2017 2016
Net cash from operating activities $ 9,727 $ 21,373
Capital expenditures (8,593 ) (10,356 )
Free cash flow $ 1,134 $ 11,017

2017 Outlook
Previous 2017 Outlook Current 2017 Outlook
(Unaudited, U.S. Dollars, in millions) Low High Low High
Net income from continuing operations $ 20.6 $ 23.7 $ 17.7 $ 21.4
Interest expense, net 0.1 0.2 0.2 0.1
Income tax expense 13.6 14.3 15.7 15.5
Depreciation and amortization 20.0 20.0 20.0 20.0
EBITDA $ 54.3 $ 58.2 $ 53.6 $ 57.0
Share-based compensation 11.8 11.8 13.0 13.0
Foreign exchange impact (1.0 ) (1.0 ) (1.6 ) (1.6 )
Strategic investments 8.6 8.1 10.3 9.3
SEC / FCPA matters and related costs 1.3 1.0 1.2 1.0
International restructuring 0.8 0.7 0.9 0.7
Legal judgments/settlements 0.2 0.2 1.6 1.6
Adjusted EBITDA $ 76.0 $ 79.0 $ 79.0 $ 81.0
Previous 2017 Outlook Current 2017 Outlook
(Unaudited, per diluted share) Low High Low High
EPS from continuing operations $ 1.12 $ 1.29 $ 0.96 $ 1.16
Foreign exchange impact (0.05 ) (0.05 ) (0.09 ) (0.09 )
Strategic investments 0.46 0.44 0.56 0.51
SEC / FCPA matters and related costs 0.07 0.05 0.07 0.05
International restructuring 0.04 0.04 0.05 0.04
Legal judgments/settlements 0.01 0.01 0.09 0.09
Long-term income tax rate adjustment (0.17 ) (0.20 ) (0.10 ) (0.16 )
Adjusted EPS from continuing operations $ 1.48 $ 1.58 $ 1.54 $ 1.60
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
  • International restructuring – costs related to a planned restructuring, primarily consisting of severance charges and the write-down of certain assets
  • 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
  • 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 the jurisdictions in which profits are determined to be earned and taxed, 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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Financial

Zimmer Biomet Announces Quarterly Dividend for Third Quarter of 2017

August 8, 2017 OrthoSpineNews

WARSAW, Ind., Aug. 7, 2017 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced that its Board of Directors has approved the payment of a quarterly cash dividend to stockholders for the third quarter of 2017.

The cash dividend of $0.24 per share will be paid on or about October 27, 2017 to stockholders of record as of the close of business on September 22, 2017.  Future declarations of dividends are subject to approval of the Board of Directors and may be adjusted as business needs or market conditions change.

About Zimmer Biomet

Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products.

We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.

We have operations in more than 25 countries around the world and sell products in more than 100 countries. For more information, visit www.zimmerbiomet.com, or follow Zimmer Biomet on Twitter at www.twitter.com/zimmerbiomet.

ZBH-Fin

SOURCE Zimmer Biomet Holdings, Inc.

Related Links

http://www.zimmerbiomet.com

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Biologics

Bioventus Names Greg Anglum Senior V.P and CFO, Tony D’Adamio Senior V.P and General Counsel

August 8, 2017 OrthoSpineNews

August 07, 2017

DURHAM, N.C.–(BUSINESS WIRE)–Bioventus®, a leader in orthobiologic solutions, today announced two changes to its executive leadership team. Greg Anglum has been promoted to Senior Vice President and Chief Financial Officer. Anglum, who joined Bioventus in 2016 as its Chief Accounting Officer, brings more than 20 years of experience driving financial and growth strategies for both private and public companies in various industries. He will also be responsible for the business intelligence and IT teams at Bioventus.

In addition, Bioventus is pleased to announce Anthony (Tony) D’Adamio has joined the company as its Senior Vice President and General Counsel. D’Adamio has nearly 30 years of senior legal executive experience with diagnostic, health care data and clinical service companies. He will be responsible for all general and corporate legal matters as well as the ethics and compliance functions at Bioventus. Both Anglum and D’Adamio will also join the company’s executive leadership team and report to its CEO, Tony Bihl.

“Greg has done an exceptional job serving as Interim CFO for the past three months, seamlessly integrating into our executive team in this important role. He has provided the financial reporting, guidance, analysis, and leadership that gives us great confidence in his ability to perform and grow moving forward,” said Bihl. “One of Tony’s strengths is his ability to provide exceptional legal advice while always seeking to achieve the best overall business solution. His global experience in complex regulated healthcare industries, along with his engaging and collaborative approach make him a great addition to our leadership team.”

Prior to joining Bioventus, Anglum held CFO positions at Overture, a Raleigh-based technology company and StrikeIron, a Software-as-a-Service (SaaS) company. He also spent several years in public accounting roles with Arthur Andersen and Grant Thornton. Anglum earned a Bachelor of Arts degree in economics from Vanderbilt University and an MBA from the Owen Graduate School of Management at Vanderbilt.

D’Adamio most recently served as General Counsel & Secretary of Siemens Medical Solutions and earlier was Deputy General Counsel & Secretary of Siemens Healthcare Diagnostics. He also spent five years as Senior Counsel within the Diagnostics Division of Bayer Healthcare, prior to the acquisition of this business by Siemens. D’Adamio began his legal career at the law firm of Bond, Schoeneck & King before taking corporate legal positions with companies including Group Health Incorporated, Quest Diagnostics and Covance. He received his Juris Doctor cum laude from Howard University School of Law and a Bachelor of Arts from the State University of New York at Binghamton.

About Bioventus

Bioventus is an orthobiologics company that delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The company has two product portfolios for orthobiologics, Bioventus Active Healing Therapies and Bioventus Surgical that make it a global leader in active orthopaedic healing. Its EXOGEN® Ultrasound Bone Healing System uses safe, effective low intensity pulsed ultrasound (LIPUS) to stimulate the body’s natural healing process. EXOGEN has been used to treat more than 1 million patients worldwide and numerous regulatory agencies including the FDA, Health Canada, BSi, TGA, Medsafe, UAE Ministry of Health and SFDA have granted their approval of the product. Today it is the leading bone healing system in the market with complaints for lack of efficacy averaging less than 1%.

Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. For more information, visit www.BioventusGlobal.com and follow the company on Twitter @Bioventusglobal.

Bioventus, the Bioventus logo and EXOGEN are registered trademarks of Bioventus LLC.

Contacts

Bioventus
Thomas Hill, 919-474-6715
thomas.hill@bioventusglobal.com

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BiologicsTop Stories

Anika Announces Publication of Data Demonstrating the Efficacy and Safety of HYALOFAST® in Combination with Stem Cells for the Treatment of Cartilage Lesions on the Knee

August 7, 2017 OrthoSpineNews

August 07, 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 publication of data demonstrating that HYALOFAST®, a biodegradable HA-based scaffold, used in combination with autologous adult mesenchymal stem cells (MSCs), regardless of a patients’ age, is a viable and effective option for the treatment of cartilage lesions of the knee joint. The data, published in the Knee Surgery Sports Traumatology Arthroscopy – Volume 25 – Number 8 edition of August 2017, demonstrated that treatment outcomes were equally effective among patients under the age of 45 as they were with patients over the age of 45, who are difficult to treat with traditional approaches such as microfracture.

“Cartilage lesions are reported in almost 2 out of 3 patients aged 40 to 50 years who are undergoing knee arthroscopy, and current interventions for cartilage repair have limited utility, in part due to the age-related decrease in regenerative potential of articular chondrocytes observed in vitro,” said Charles H. Sherwood, Ph.D., Chief Executive Officer of Anika Therapeutics. “This study shows that we may be able to fill a significant treatment gap in the management of cartilage defects among older patients, and offer a more convenient and cost-effective alternative or adjunct to traditional, invasive approaches such as microfracture with HYALOFAST.”

The study evaluated 40 patients with full thickness cartilage lesions of the knee joint, 20 of whom were over the age of 45 and the remaining, who were under the age of 45. All patients were implanted with HYALOFAST soaked in bone marrow aspirate concentrate (BMAC) containing MSCs, and were prospectively evaluated for 4 years. Functional outcomes were assessed using a variety of validated scales1 preoperatively, at 2-years and at the final follow-up at 4 years. At final follow-up, all functional outcomes’ scores significantly improved (P < 0.001) in both groups of patients, and researchers concluded that the outcomes were not impacted by age or concomitant surgical procedures, but by the size and quantity of lesions.

“We’re encouraged by the results of this long-term study that shows the potential clinical utility of combining stem cells with the HYALOFAST biodegradable hyaluronic acid-based scaffold to treat cartilage defects in a simple one-step procedure,” said Alberto Gobbi, President of the OASI Bioresearch Foundation Gobbi NPO, visiting professor at the UC San Diego, the next President of the International Cartilage Repair Society (ICRS), and the study’s lead author. “One of the key learnings from our four-year follow-up was that cartilage lesion size and quantity might be a better indicator for surgery than advanced age, which we concluded did not impact outcomes associated with the use of stem cells and HYALOFAST.”

HYALOFAST is a non-woven biodegradable hyaluronic acid-based scaffold for hyaline-like cartilage regeneration to treat cartilage injuries and defects. HYALOFAST is commercially available in over 15 countries and has been used in more than 11,000 patients to date. HYALOFAST is pending regulatory submission in the United States and its ‘FastTRACK’ Phase III trial is currently enrolling patients across the U.S. and Europe.

The full manuscript is available here: https://link.springer.com/article/10.1007/s00167-016-3984-6

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 ORTHOVISC®, MONOVISC®, 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.

1 Visual Analog Scale (VAS) for pain, International Knee Documentation Committee (IKDC), Knee Injury & Osteoarthritis Outcome Score (KOOS), and Tegner.

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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ExtremitiesSports Medicine

Knee surgery: Have we been doing it wrong?

August 7, 2017 OrthoSpineNews

August 7, 2017, MDLinx/University at Buffalo Health and Medicine News

Cleaning up loose cartilage is not always beneficial, according to a new University at Buffalo study that could impact athletes and seniors, reduce health care costs.
A team of University at Buffalo medical doctors has published a study that challenges a surgical practice used for decades during arthroscopic knee surgery.

When treating meniscal tears surgeons also have clipped and smoothed any dislodged cartilage they found in the belief it was helping patients. But the new study finds that practice does not benefit the patient. Patients who did not have dislodged cartilage removed, recovered faster, with less pain, and ended up a year later with identical results.

“Those with less surgery got better faster in comparison with the people we did more surgery on,” said Leslie J. Bisson, MD, professor and chair in the Department of Orthopaedics at the Jacobs School of Medicine and Biomedical Sciences at UB and lead author of the study.

The finding was so surprising that an editor at The Journal of Bone & Joint Surgery, which published the study, also published a commentary that said, “The conclusion that unstable cartilage lesions do not need debridement could have a dramatic impact on practice management, save health–care dollars, and improve early patient outcomes.”

The American Academy of Orthopaedic Surgeons also distributed the study on its weekly collection of papers of note.

 

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Financial

SeaSpine Reports Second Quarter 2017 Financial Results

August 7, 2017 OrthoSpineNews

CARLSBAD, Calif., Aug. 03, 2017 (GLOBE NEWSWIRE) — SeaSpine Holdings Corporation (NASDAQ:SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, announced today financial results for the second quarter ended June 30, 2017.

Second Quarter 2017 Financial Highlights and Recent Accomplishments

  • Revenue of $34.2 million, an increase of 3.0% year-over-year
  • U.S. revenue of $30.4 million, an increase of 1.1% year-over-year
    — U.S. orthobiologics revenue of $16.0 million
    — U.S. spinal instrumentation revenue of $14.4 million
  • International revenue of $3.8 million, an increase of 20.5% year-over-year
  • Full commercial launch of the Mariner® Posterior Fixation System, a modular pedicle screw system that provides surgeons with multiple intra-operative options to facilitate posterior lumbar fixation
  • Limited commercial launch of the Skipjack™ Expandable Interbody System, an expandable interbody system that provides in-situ expansion in either height or lordosis for an improved anatomical fit

“We are pleased with our second quarter results, which reflect our ongoing commitment to develop innovative and cost effective solutions to treat spinal disorders and expand our distributor footprint,” said Keith Valentine, President and Chief Executive Officer. “We remain focused on our mission to drive improved procedural solutions that combine efficient spinal instrumentation systems with industry leading orthobiologics to deliver clinical value to surgeons, hospitals, and patients.”

Second Quarter 2017 Financial Results
Revenue for the second quarter of 2017 totaled $34.2 million, a 3.0% increase compared to the same period of the prior year. Total revenue in the U.S. was $30.4 million, a 1.1% increase compared to the same period of the prior year due primarily to the improved performance of orthobiologics distributors during the current year period.

Orthobiologics revenue totaled $17.6 million, a 4.8% increase compared to the second quarter of 2016. The growth in orthobiologics revenue was driven by an increase in U.S. sales. Spinal instrumentation revenue totaled $16.6 million, a 1.1% increase compared to the second quarter of 2016 that was driven by stocking orders from a recently added distributor in Latin America.

Gross margin for the second quarter of 2017 was 59.1%, compared to 58.0% for the same period in 2016.  The increase in gross margin was mainly driven by lower manufacturing costs for orthobiologics products manufactured at the Company’s Irvine, California facility.  This was partially offset by a $0.2 million increase in non-cash amortization of technology intangible assets acquired in September 2016 from N.L.T. Spine Ltd and by lower gross margins associated with international sales, which were slightly higher as a percentage of total revenue in the second quarter of 2017 compared to the same period of the prior year.

Operating expenses for the second quarter of 2017 totaled $28.4 million, compared to $31.5 million for the same period of the prior year.  The $3.1 million decrease in operating expenses was driven by lower selling, general and administrative and intangible amortization expenses.

Net loss for the second quarter of 2017 was $8.0 million, compared to a net loss of $12.0 million for the second quarter of 2016.

Cash and cash equivalents at June 30, 2017 were $12.3 million and the Company had $4.0 million of outstanding borrowings against its $30.0 million credit facility. The Company realized $4.6 million in net proceeds in the second quarter of 2017 through the sale of approximately 477,000 shares of its common stock under its “at the market” equity offering program.

2017 Financial Outlook
SeaSpine expects full-year 2017 revenue to be in the range of $130.0 million to $133.0 million, reflecting growth of 1% to 3% over full-year 2016 revenue.

Webcast and Conference Call Information
The Company’s management team will host a conference call beginning today at 1:30pm PT/4:30pm ET to discuss the financial results and recent business developments. Individuals interested in listening to the conference call may do so by dialing (877) 418-4766 for domestic callers or (614) 385-1253 for international callers, using Conference ID: 49156714. To listen to the webcast, please visit the investor relations section of the SeaSpine website at www.seaspine.com.

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

Forward-Looking Statements
SeaSpine cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that are based on the Company’s current expectations and assumptions. Such forward-looking statements include, but are not limited to, statements relating to: revenue expectations for full-year 2017.  Among the factors that could cause or contribute to material differences between the Company’s actual results and the expectations indicated by the forward-looking statements are risks and uncertainties that include, but are not limited to: surgeons’ willingness to continue to use the Company’s existing products and to adopt its newly launched products, including the risk that the Company’s products do not demonstrate adequate safety or efficacy, independently or relative to competitive products, to support expected levels of demand or pricing; the ability of newly launched products to perform as designed and intended and to meet the clinical needs of surgeons and patients; the Company’s ability to attract and retain new, high-quality distributors, whether as a result of inability to reach agreement on financial or other contractual terms or otherwise, disruption to the Company’s existing distribution network as new distributors are added, and the ability of new distributors to generate growth or offset disruption to existing distributors; continued pricing pressure, whether as a result of consolidation in hospital systems, competitors or others, as well as exclusion from major healthcare systems, whether as a result of unwillingness to provide required pricing or otherwise; unexpected expense, including as a result of developing and supporting the launch of new products; the Company’s ability to continue to invest in product development and sales and marketing initiatives at levels sufficient to drive future revenue growth; the limited clinical experience supporting the commercial launch of new products and the risk that such products may require substantial additional development activities, which could introduce unexpected expense and delay; the lack of long-term clinical data supporting the safety and efficacy of the Company’s products; the risk of supply shortages, including as a result of the Company’s dependence on a limited number of third-party suppliers for components and raw materials, or otherwise; general economic and business conditions in the markets in which the Company does business, both in the U.S. and abroad; and other risks and uncertainties more fully described in the Company’s news releases and periodic filings with the Securities and Exchange Commission. The Company’s public filings with the Securities and Exchange Commission are available at www.sec.gov.

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

SEASPINE HOLDINGS CORPORATION
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)
Three Months Ended June 30, Six Months Ended June 30,
2017 2016 2017 2016
Total revenue, net $ 34,196 $ 33,201 $ 66,090 $ 64,600
Cost of goods sold 13,994 13,930 27,166 28,213
Gross profit 20,202 19,271 38,924 36,387
Operating expenses:
Selling, general and administrative 24,249 26,989 48,219 52,363
Research and development 3,344 3,181 6,394 5,934
Intangible amortization 792 1,281 1,584 2,562
Total operating expenses 28,385 31,451 56,197 60,859
Operating loss (8,183 ) (12,180 ) (17,273 ) (24,472 )
Other income (expense), net 185 (232 ) 172 26
Loss before income taxes (7,998 ) (12,412 ) (17,101 ) (24,446 )
Provision (benefit) for income taxes 45 (429 ) 45 (456 )
Net loss $ (8,043 ) $ (11,983 ) $ (17,146 ) $ (23,990 )
Net loss per share, basic and diluted $ (0.68 ) $ (1.07 ) $ (1.46 ) $ (2.15 )
Weighted average shares used to compute basic and diluted net loss per share 11,888 11,179 11,705 11,173
SEASPINE HOLDINGS CORPORATION
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEET DATA
(In thousands)
June 30, 2017 December 31, 2016
Cash and cash equivalents $ 12,287 $ 14,566
Trade accounts receivable, net of allowances of $522 and $483 21,689 20,982
Inventories 42,515 45,299
Short-term debt — 445
  Total current liabilities 25,617 24,418
Long-term borrowings under credit facility 3,994 3,835
Total stockholders’ equity 105,466 110,977

 

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

OrthoPediatrics Corp. Launches New Pediatric Specific Clavicle Plates

August 7, 2017 OrthoSpineNews

WARSAW, INDIANA (PRWEB) AUGUST 04, 2017

OrthoPediatrics Corp. is pleased to announce the launch of the PediFrag™ Pediatric Specific Clavicle Plate. This innovative new plate is specifically designed for treating mid-shaft clavicle fractures in young patients. The OP Clavicle Plates are unique due to their pre-contoured shape. This curvature was derived from studying 36 pediatric clavicle skeletons from OrthoPediatrics’ exclusive access to the Hamann-Todd skeletal collection in Cleveland, Ohio.

Joe Hauser, OrthoPediatrics’ Vice President of Trauma and Deformity Correction, is excited to bring another device to the Pediatric Orthopedic market – saying, “We are successfully implementing our strategy of surrounding pediatric surgeons with all the surgical systems they need. The breadth and depth of our Trauma and Deformity Correction portfolio is unmatched and we are continuing to develop new products.”

President and Chief Executive Officer, Mark Throdahl echoed this excitement, adding “The launch of our clavicle plates is one more example of our continued growth. OrthoPediatrics is committed to improving the lives of children with orthopedic conditions through the development of new products and supporting clinical education for pediatric orthopedic surgeons.”

About OrthoPediatrics Corp. 
Founded in 2006, OrthoPediatrics is the only 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 20 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This offering spans trauma and deformity, complex spine and ACL reconstruction procedures. OrthoPediatrics also has the only global sales organization focused exclusively on pediatric orthopedics and distributes its products to 32 countries outside the United States.

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NeuroRegulatory

Mainstay Medical’s ReActiv8-B Clinical Trial Passes Mid-point

August 7, 2017 OrthoSpineNews

August 03, 2017

Mainstay Medical International plc (“Mainstay” or the “Company”, Euronext Paris: MSTY.PA and ESM of the Irish Stock Exchange: MSTY.IE), a medical device company focused on bringing to market ReActiv8®, an implantable restorative neurostimulation system to treat disabling Chronic Low Back Pain (“CLBP”), announces that over half the required number of implants in the ReActiv8-B Clinical Trial have been performed.

The trial is intended to gather data in support of an application for pre-market approval (PMA) from the US Food and Drug Administration (FDA), a key step towards commercialization of ReActiv8 in the US. Information about the trial can be found at https://clinicaltrials.gov/show/NCT02577354.

69 subjects have been implanted with ReActiv8 in the trial. The trial design requires 128 subjects in the pivotal cohort to reach the 120-day endpoint before data are made available. An “interim look” for sample size re-estimation is planned when half the implanted subjects have data from the 120-day visit. The enrolment rate has been accelerating as the number of active sites has increased during 2017.

ReActiv8 is designed to electrically stimulate the nerves responsible for contracting muscles which stabilize the lumbar spine. Activation of these muscles to restore functional stability has been shown to facilitate recovery from CLBP. Mainstay received CE Marking for ReActiv8 in May 2016 based on positive results from the ReActiv8-A clinical trial which demonstrated a clinically important, statistically significant and lasting improvement in pain, disability and quality of life in people with disabling CLBP and few other treatment options.Mainstay has begun commercialization in Europe, focusing initially on Germany, where the Company aims to drive adoption of ReActiv8 in a select number of high volume multi-disciplinary spine care centers. More recently, commercialization has begun in Ireland, Mainstay’s home market.

Peter Crosby, CEO of Mainstay, commented: “The ReActiv8-B Clinical Trial is advancing well, and, based on our experience to date, we anticipate completing enrolment around the end of this year, with results available in 2018. The ReActiv8-B trial is a key step towards commercialization in the US, our most significant target market, and we are pleased with the progress.

“Our initial commercialization of ReActiv8 in Europe is well underway. Our strategy is to work with key reference centers in Germany, and then build on that experience and data from the ReActiv8-B Trial to expand commercialization to additional centers and other countries.”

ReActiv8-B Clinical Trial

The ReActiv8-B Clinical Trial is an international, multi-center, prospective randomized sham controlled triple blinded trial with one-way crossover, conducted under an Investigational Device Exemption (IDE). The statistical design of the Clinical Trial requires data from the pivotal cohort of 128 randomized subjects at the 120-day primary outcome assessment visit. Total number of subjects implanted will also include some enrolled and implanted as part of the surgical roll-in phase, in addition to subjects in the pivotal cohort. The Trial is designed with an “interim look” for sample size re-estimation when primary outcome data are available from half the subjects in the pivotal cohort, and if necessary the number of subjects in the pivotal cohort may be increased to achieve the targeted statistical significance. The interim analysis will be performed by a third-party independent statistician under the direction of the Data Monitoring Committee (DMC), and the interim results, other than a DMC recommendation regarding the findings, will remain blinded to the Company, study subjects, investigators and Clinical Trial sites.

The primary efficacy endpoint of the ReActiv8-B Clinical Trial is a comparison of responder rates between the treatment and control arms. The Clinical Trial will be considered a success if there is a statistically significant difference in responder rates between the treatment and control arms. The Clinical Trial, if successful, will provide what is referred to as Level 1A Evidence of efficacy of ReActiv8, which may be used to support applications for favorable reimbursement in the USA. Evidence from the ReActiv8-B Trial will also be used to support market development activities worldwide.

About Mainstay

Mainstay is a medical device company focused on bringing to market an innovative implantable restorative neurostimulation system, ReActiv8®, for people with disabling Chronic Low Back Pain (CLBP). The Company is headquartered in Dublin, Ireland. It has subsidiaries operating in Ireland, the United States, Australia and Germany, and its ordinary shares are admitted to trading on Euronext Paris (MSTY.PA) and the ESM of the Irish Stock Exchange (MSTY.IE).

About the ReActiv8-B Clinical Trial

The ReActiv8-B Clinical Trial is an international, multi-center, prospective randomized sham controlled blinded trial with one-way crossover conducted under an Investigational Device Exemption (IDE). The ReActiv8-B Clinical Trial is designed to generate data to form part of the Pre-Market Approval Application (PMAA) of ReActiv8 to the FDA. Further details can be found at https://clinicaltrials.gov/show/NCT02577354

About Chronic Low Back Pain

One of the recognized root causes of CLBP is impaired control by the nervous system of the muscles that dynamically stabilise the spine in the low back, and an unstable spine can lead to back pain. ReActiv8 is designed to electrically stimulate the nerves responsible for contracting these muscles and thereby help to restore muscle control and improve dynamic spine stability, allowing the body to recover from CLBP.

People with CLBP usually have a greatly reduced quality of life and score significantly higher on scales for pain, disability, depression, anxiety and sleep disorders. Their pain and disability can persist despite the best available medical treatments, and only a small percentage of cases result from an identified pathological condition or anatomical defect that may be correctable with spine surgery. Their ability to work or be productive is seriously affected by the condition and the resulting days lost from work, disability benefits and health resource utilization put a significant burden on individuals, families, communities, industry and governments.

Further information can be found at www.mainstay-medical.com

CAUTION – in the United States, ReActiv8 is limited by federal law to investigational use only.

PR and IR Enquiries:
Consilium Strategic Communications (international strategic communications – business and trade media)
Chris Gardner, Mary-Jane Elliott, Jessica Hodgson, Hendrik Thys
Tel: +44 203 709 5700 / +44 7921 697 654
Email: mainstaymedical@consilium-comms.com
or
FTI Consulting (for Ireland)
Jonathan Neilan
Tel: +353 1 765 0886
Email: jonathan.neilan@fticonsulting.com
or
NewCap (for France)
Louis-Victor Delouvrier
Tel: +: +33 1 44 71 98 53
Email: lvdelouvrier@newcap.fr
or
AndreasBohne.Com/Kötting Consulting (for Germany)
Andreas Bohne
Tel : +49 2102 1485368
Email : abo@andreasbohne.com
Wilhelm Kötting
Tel: +49 69 75913293
Email: wkotting@gmail.com
or
Investor Relations:
LifeSci Advisors, LLC
Brian Ritchie
Tel: +1 (212) 915-2578
Email: britchie@lifesciadvisors.com
or
ESM Advisers:
Davy
Fergal Meegan or Barry Murphy
Tel: +353 1 679 6363
Email: fergal.meegan@davy.ie or barry.murphy2@davy.ie

Forward looking statements

This announcement includes statements that are, or may be deemed to be, forward looking statements. These forward looking statements can be identified by the use of forward looking terminology, including the terms “anticipates”, “believes”, “estimates”, “expects”, “intends”, “may”, “plans”, “projects”, “should”, “will”, or “explore” or, in each case, their negative or other variations or comparable terminology, or by discussions of strategy, plans, objectives, goals, future events or intentions. These forward looking statements include all matters that are not historical facts. They appear throughout this announcement and include, but are not limited to, statements regarding the Company’s intentions, beliefs or current expectations concerning, among other things, the Company’s results of operations, financial position, prospects, financing strategies, expectations for product design and development, regulatory applications and approvals, reimbursement arrangements, costs of sales and market penetration.

By their nature, forward looking statements involve risk and uncertainty because they relate to future events and circumstances. Forward looking statements are not guarantees of future performance and the actual results of the Company’s operations, and the development of its main product, the markets and the industry in which the Company operates, may differ materially from those described in, or suggested by, the forward looking statements contained in this announcement. In addition, even if the Company’s results of operations, financial position and growth, and the development of its main product and the markets and the industry in which the Company operates, are consistent with the forward looking statements contained in this announcement, those results or developments may not be indicative of results or developments in subsequent periods. A number of factors could cause results and developments of the Company to differ materially from those expressed or implied by the forward looking statements including, without limitation, the successful launch and commercialisation of ReActiv8®, the progress and success of the ReActiv8-B Clinical Trial, general economic and business conditions, the global medical device market conditions, industry trends, competition, changes in law or regulation, changes in taxation regimes, the availability and cost of capital, the time required to commence and complete clinical trials, the time and process required to obtain regulatory approvals, currency fluctuations, changes in its business strategy, political and economic uncertainty. The forward-looking statements herein speak only at the date of this announcement.

Short Name: Mainstay Medical
Category Code: STR
Sequence Number: 600858
Time of Receipt (offset from UTC): 20170802T174402+0100

Contacts

Mainstay Medical

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Spine

SpineSource Awarded Department of Defense Distribution and Pricing Agreement

August 7, 2017 OrthoSpineNews

August 02, 2017

CHESTERFIELD, Mo.–(EON: Enhanced Online News)–SpineSource, Inc. today announced it has been awarded a national contract from the U.S. Department of Defense for its L-Varlock® Expandable Lumbar Cage. Under the contract, SpineSource will supply L-Varlock® through a Distribution and Pricing Agreement (DAPA) by the Defense Logistics Agency which offers U.S. military medical treatment facilities access to a full spectrum of medical products for active U.S. military personnel and veterans.

“The L-Varlock® continues to impress,” said Tom Mitchell, Founder/CEO of SpineSource. “The fundamental nature of spinal bone healing, sagittal balance and disc height restoration are all found within this implant.”

The L-Varlock® is the only lordotic expandable device in the United States that can be expanded from any range of zero to 24.5° of angle, and from zero to 7.1 mm of expansion within the disc space. Made of titanium alloy, it provides a preferred material for bony osteointegration and a wide open framework for bony in-growth.

 

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Biologics

SurGenTec’s GRAFTGUN Receives Core Patent for Post Filling Cages Using Their Graft Delivery Technology

August 4, 2017 OrthoSpineNews

August 03, 2017

BOCA RATON, Fla.–(BUSINESS WIRE)–SurGenTec® has been issued device and method patent No. 9,668,881 from the United States Patent and Trademark Office for its graft loading technology to post-fill implant cages. The Graftgun® is a universal graft delivery system that allows surgeons to use the bone graft of their choice. The device permits minimally invasive delivery of bone graft material into bone voids, disc spaces, cages, and implants. Once the implant has been positioned and the inserter is removed, the device can be connected to post-fill a variety of implants. The Graftgun kit will include a universal loading device which enables surgeons to load allograft, autograft, or synthetic biologics into the gun’s delivery tube and dispense it to an orthopedic site.

“We now have intellectual property that protects our ability to post-fill cages in situ,” said Travis Greenhalgh, CEO of SurGenTec. “One of the challenges when using expandable or monolithic cages is the ability to post-fill them once inserted into the disc space. The traditional way to post-fill a cage is to use a funnel or an elongated syringe. Most types of bone graft require significant force to extrude the material into the aperture of a cage. Our ratcheting technology provides users the force needed to extrude an array of bone graft materials, while maintaining superior control of the amount of graft that enters the cage and disc space. A concern with expandable cages is the ability to pack the implant with enough bone graft to provide maximum endplate contact. If there is a void between the bone graft and endplate there may be a higher risk of non-unions. The Graftgun ratcheting technology can help ensure the void is filled.”

SurGenTec has the capacity to customize the Graftgun so that it can be paired with nearly any cage on the market without requiring changes to their instruments. This will allow implant manufacturers seamless access to the Graftgun’s innovative technology, and the ability to offer an advantageous graft delivery solution to their end users. With the expandable cage market growing, this should be a viable option to optimize graft volume within a variety of implants.

SurGenTec looks forward to becoming the leader in bone graft delivery technologies, and has allocated a considerable amount of resources to ensure that they are on the forefront of this sector of orthopedic and spine surgery.

SurGenTec is a privately owned medical device company based out of Boca Raton, FL. They are focused on developing minimally invasive surgical technologies to help surgeons provide optimal care for their patients. SurGenTec anticipates the Graftgun to be released this summer.

Contacts

SurGenTec
Andrew Shoup, 561-990-7882

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