Tuesday, May 10, 2016

News: Exactech Receives FDA 510(k) Clearance for Vantage™ Total Ankle

Clearance Marks Company’s Latest Product Development in Extremities Line

April 25, 2016 09:20 AM Eastern Daylight Time

GAINESVILLE, Fla.--()--Exactech Inc. (Nasdaq:EXAC), a developer and producer of bone and joint restoration products for extremities, knee, hip, spine and biologic materials, announced today it has received clearance from the U.S. Food and Drug Administration to market the Vantage™ Total Ankle to treat patients who suffer from arthritis in the ankle. The Vantage Total Ankle is the latest product in the company’s extremities line, and its first in the foot and ankle market.

“With the introduction of the Vantage Ankle, Exactech continues its precedent of innovation in the extremities market, which began with our industry-leading Equinoxe® platform shoulder system”
Tweet this
“With the introduction of the Vantage Ankle, Exactech continues its precedent of innovation in the extremities market, which began with our industry-leading Equinoxe® platform shoulder system,” said Darin Johnson, Exactech vice president of marketing for extremities. “The ankle market is in need of advances in total ankle technologies. We have had the pleasure of working with a world-class design team that includes surgeons who have dedicated their careers to treatment of the ankle. Together, we have developed an implant that we believe will be an improvement for patients who need a total ankle.”
“I am impressed with Exactech’s ability to convert concepts from their other successful total joint replacement systems,” said Mark Easley, MD, design team member and president of the American Orthopaedic Foot and Ankle Society. “The company’s engineers have successfully turned our ideas into an exciting new treatment option for end-stage ankle arthritis. On behalf of the design team and engineers, I look forward to sharing the Vantage ankle with other surgeons so their patients may benefit from this meaningful new technology.”
Designed to conserve bone, the Vantage Total Ankle is an easy-to-use solution that allows for both stability and mobility in total ankle arthroplasty. The curved surface talar component is engineered to fit the anatomy of the diseased talus and restore the joint line, and both the curved talus and anatomic tibia designs are intended to improve implant stability and return anatomic kinematics. The system incorporates the signature press-fit bone cage design used in the Equinoxe shoulder system, developed to allow for initial and long-term fixation.
Exactech plans to initiate targeted clinical evaluation of the fixed-bearing Vantage Total Ankle this summer, with full-scale release scheduled for the first quarter of 2017.
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 Inc. can be found at http://www.exac.com. Copies of Exactech’s press releases, SEC filings, current price quotes and other valuable information for investors may be found at 
An investment profile on Exactech may be found at 
http://www.hawkassociates.com/profile/exac.cfm. To receive future releases in e-mail alerts, sign up at 
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.

Contacts

Exactech Inc.
Investor contacts
Jody Phillips, 352-377-1140
Executive Vice President of Finance &
Chief Financial Officer
or
Hawk Associates
Julie Marshall or Frank Hawkins, 305-451-1888
or
Media contact
Priscilla Bennett, 352-377-1140
Vice President, Corporate & Marketing Communication

Published at BusinessWire

News: SpinalCyte, LLC Receives New Canadian Patent for Spinal Disc Tissue Engineering

April 22, 2016 03:55 PM Eastern Daylight Time

HOUSTON--()--SpinalCyte, LLC, a Texas-based tissue engineering technology company focused on regrowth of the spinal disc nucleus using human dermal fibroblasts, announced today the issuance of Canadian Patent No. 2641170, “Methods And Compositions For Repair Of Cartilage Using An In Vivo Bioreactor.” The technology described in the patent involves incorporating a matrix constructed of a synthetic polymer, a natural hydrogel, or a synthetic hydrogel to expose the fibroblasts to a mechanical strain using intermittent hydrostatic pressure and/or fluid shear stress. Other claims provide for growth factors such as BMP-2, BMP-4, BMP-6, BMP-7, transforming growth factor (TGF-β), and insulin growth factor (IGF-I).
“Methods And Compositions For Repair Of Cartilage Using An In Vivo Bioreactor.”
Tweet this
“We are excited the Canadian Patent Office has recognized the uniqueness of our technology and this continues to build on our leading position in intellectual property surrounding the use of human dermal fibroblasts for tissue engineering which includes 12 U.S. and foreign patents issued and directly owned by the company, along with 38 patents pending,” said Pete O’Heeron, Chief Executive Officer for SpinalCyte.
About SpinalCyte, LLC
Based in Houston, Texas, SpinalCyte, LLC is a tissue engineering technology company founded for the purpose of developing an innovative solution for spinal nucleus replacement using human dermal fibroblasts. To date, SpinalCyte has been funded entirely by angel investors.

Contacts

SpinalCyte, LLC
Pete O’Heeron, 281.461.6211
CEO

Published at BusinessWire

News: Cartiva, Inc. Announces Positive FDA Advisory Committee Review of Cartiva SCI

Panel Votes Positively on Safety, Efficacy and Risk/Benefit Ratio

April 21, 2016 08:30 AM Eastern Daylight Time

ALPHARETTA, Ga.--()--Cartiva, Inc., (Company) a developer of innovative products for the treatment of cartilage injuries, osteoarthritis and other musculoskeletal conditions, announced today that the Orthopaedic and Rehabilitation Devices Panel convened by the U.S. Food and Drug Administration (FDA) voted 10 to two in favor of the safety of the Company’s Cartiva Synthetic Cartilage Implant (SCI) for the treatment of osteoarthritis at the base of the great toe, nine to three in favor of the efficacy of Cartiva SCI and eight to two, with two abstentions, that the benefits outweighed the risks. The panel made their recommendations based on the results from a 236-patient prospective and randomized clinical trial, the largest ever conducted for this condition.
“We thank the panel members for their insights and will continue to work with the FDA to make Cartiva SCI available to patients in the United States.”
Tweet this
The FDA is not bound by the panel’s recommendation, but will take it into consideration, among other things, when reviewing the Company’s Premarket Approval application (PMA). The Company expects a final decision on approval of the PMA later this year. If approved, Cartiva SCI will be the first synthetic cartilage device ever approved by the FDA and the first PMA for any product in the forefoot.
“We are extremely pleased with the positive results of the panel vote, which is one of the final milestones towards the commercialization of Cartiva in the United States,” said Timothy J. Patrick, president and CEO of the Company. “We thank the panel members for their insights and will continue to work with the FDA to make Cartiva SCI available to patients in the United States.”
About Cartiva, Inc.
Based in Alpharetta, Ga., Cartiva, Inc. develops and markets innovative solutions for patients with osteoarthritis, cartilage damage and other musculoskeletal conditions. Cartiva’s venture investors include New Enterprise Associates, Windham Venture Partners and Domain Associates. Additional information is available on the company’s website at www.cartiva.net.

Contacts

Cartiva, Inc.
Peter Pizzo, 770-754-3855
Chief Financial Officer

Published at BusinessWire

News: Stryker reports first quarter 2016 results

Kalamazoo, Michigan - April 20, 2016 - Stryker Corporation (NYSE:SYK) reported operating results for the first quarter of 2016:
First Quarter Highlights
Net sales grew 4.9% to $2.5 billion (6.1% constant currency)

Orthopaedics3.3%or4.6% constant currency
MedSurg3.4%or4.6% constant currency
Neurotechnology and Spine12.0%or13.1% constant currency
Reported net earnings per diluted share in creased 84.5% to $1.07
Adjusted net earnings per diluted share(1) increased 11.7% to $1.24


"We are pleased by our first quarter performance and expect the momentum to continue," said Kevin A. Lobo, Chairman and Chief Executive Officer. "As a result, we have raised our full year guidance for both sales and adjusted net earnings."

Sales Analysis
Consolidated net sales of $2.5 billion increased 4.9% in the quarter as reported and 6.1% in constant currency, as foreign currency exchange rates negatively impacted net sales by 1.3%. Acquisitions did not significantly impact net sales in the quarter.  Net sales in constant currency increased by 7.5% from increased unit volume partially offset by 1.4% due to lower prices.

Orthopaedics net sales of $1.1 billion increased 3.3% in the quarter as reported and 4.6% in constant currency, as foreign currency exchange rates negatively impacted net sales by 1.4%. Net sales in constant currency increased by 6.3% from increased unit volume partially offset by 1.7% due to lower prices.

MedSurg net sales of $958 million increased 3.4% in the quarter as reported and 4.6% in constant currency, as foreign currency exchange rates negatively impacted net sales by 1.2%. Acquisitions did not significantly impact net sales in the quarter. Net sales in constant currency increased by 5.0% from increased unit volume partially offset by 0.6% due to lower prices.

Neurotechnology and Spine net sales of $480 million increased 12.0% in the quarter as reported and 13.1% in constant currency, as foreign currency exchange rates negatively impacted net sales by 1.1%. Net sales in constant currency increased by 15.5% from increased unit volume partially offset by 2.4% due to lower prices.

Earnings Analysis
Reported net earnings of $402 million increased 79.5% in the quarter. Reported net earnings per diluted share of $1.07 increased 84.5% in the quarter.  Reported net earnings include certain charges for the Rejuvenate and ABG II recall, amortization of intangible assets, legal matters, acquisition and integration related activities and restructuring-related activities. The effect of each of these matters on reported net earnings and net earnings per diluted share appears in the attached reconciliation of actual results to adjusted results. Excluding the impact of these charges, gross profit margin in the quarter increased from 67.9% to 68.0% and operating income margin increased in the quarter from 20.8% to 24.2%.

Excluding the impact of the items described above, ajusted net earnings(2) of $468 million increased 10.4% in the quarter.  Adjusted net earnings per diluted share(1) of $1.24 increased 11.7% in the quarter.

2016 Outlook
We now expect 2016 organic sales growth to be in the range of 5.5% - 6.5% compared to our prior guidance of 5.0% - 6.0%. We now expect 2016 adjusted net earnings per diluted share to be in the range of $5.65-$5.80, compared to our prior guidance of $5.57 - $5.77. For the second quarter we expect adjusted net earnings per diluted share to be in the range of $1.33 - $1.38. If foreign currency exchange rates hold near current levels, we expect net sales in both the second quarter and full year to be negatively impacted by approximately 1.0% and adjusted net earnings per diluted share to be negatively impacted by approximately $0.03 in the second quarter and $0.10-$0.12 in the full year.

(1) A reconciliation of reported net earnings per diluted share to adjusted net earnings per diluted share, a non-GAAP financial measure, and other important information, appears below.
(2) A reconciliation of reported net earnings to adjusted net earnings, a non-GAAP financial measure, and other important information, appears below.

Conference Call on Wednesday, April 20, 2016
As previously announced, the Company will host a conference call on Wednesday, April 20, 2016 at 4:30 p.m., Eastern Time, to discuss the Company's operating results for the quarter ended March 31, 2016 and provide an operational update.

To participate in the conference call dial (844) 826-0610 (domestic) or (973) 453-3249 (international) and be prepared to provide confirmation number 57643412 to the operator.

A simultaneous webcast of the call will be accessible via the Company's website at www.stryker.com. The call will be archived on this site for 90 days.

A recording of the call will also be available from 8:00 p.m., Eastern Time, on Wednesday, April 20, 2016, until 11:59 p.m., Eastern Time, on Wednesday, April 27, 2016. To hear this recording you may dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and enter the conference ID number 57643412.

Caution Concerning Forward-Looking Statements
This press release contains information that includes or is based on forward-looking statements within the meaning of the federal securities law that are subject to various risks and uncertainties that could cause our actual results to differ materially from those expressed or implied in such statements. Such factors include, but are not limited to: weakening of economic conditions that could adversely affect the level of demand for our products; pricing pressures generally, including cost-containment measures that could adversely affect the price of or demand for our products; changes in foreign exchange markets; legislative and regulatory actions; unanticipated issues arising in connection with clinical studies and otherwise that affect U.S. Food and Drug Administration approval of new products; changes in reimbursement levels from third-party payors; a significant increase in product liability claims; the ultimate total cost with respect to the Rejuvenate and ABG II matter; the impact of investigative and legal proceedings and compliance risks; resolution of tax audits; the impact of the federal legislation to reform the United States healthcare system; changes in financial markets; changes in the competitive environment; our ability to integrate acquisitions; and our ability to realize anticipated cost savings. Additional information concerning these and other factors is contained in our filings with the U.S. Securities and Exchange Commission, including our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q.
Stryker is one of the world's leading medical technology companies and, together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. Stryker is active in over 100 countries around the world. Please contact us for more information at www.stryker.com.
For investor inquiries please contact:
Katherine A. Owen, Stryker Corporation, 269-385-2600 or katherine.owen@stryker.com


STRYKER CORPORATION
For the Three Months Ended March 31
(Unaudited - Millions of Dollars, Except Per Share Amounts)
CONDENSED STATEMENTS OF EARNINGS
 
  Three Months 
  2016 2015 % Change 
Net sales $2,495  $2,379  4.9% 
Cost of sales 801  826  (3.0)% 
  Gross profit $1,694  $1,553  9.1% 
 % of sales 67.9% 65.3%   
Research, development and engineering expenses 159  152  4.6% 
Selling, general and administrative expenses 944  892  5.8% 
Recall charges 19  54  (64.8)% 
Intangible asset amortization 53  49  8.2% 
  Total operating expenses $1,175  $1,147  2.4% 
 Operating income 519  406  27.8% 
 % of sales 20.8% 17.1%   
Other income (expense), net (38) (29) 31.0% 
  Earnings before income taxes $481  $377  27.6% 
Income taxes 79  153  (48.4)% 
  Net earnings $402  $224  79.5% 
        
Net earnings per share of common stock:       
Basic $1.08  $0.59  83.1% 
Diluted $1.07  $0.58  84.5% 
        
Weighted-average shares outstanding - in millions:       
Basic 373.2 378.9   
Diluted 377.4 383.5   

CONDENSED BALANCE SHEETS
 March 31 December 31
 2016 2015
ASSETS   
Cash and cash equivalents$6,976  $3,379 
Marketable securities507  700 
Accounts receivable, net1,591  1,662 
Inventories1,768  1,639 
Other current assets483  563 
Total current assets$11,325  $7,943 
Property, plant and equipment, net1,224  1,199 
Goodwill and other intangibles, net5,945  5,930 
Other assets1,174  1,151 
Total assets$19,668  $16,223 
LIABILITIES AND SHAREHOLDERS' EQUITY   
Current liabilities$2,580  $2,808 
Accrued recall expenses606  694 
Other noncurrent liabilities968  980 
Long-term debt, excluding current maturities6,706  3,230 
Shareholders' equity8,808  8,511 
Total liabilities and shareholders' equity$19,668  $16,223 

CONDENSED STATEMENTS OF CASH FLOWS
  Three Months
  20162015
Operating activities   
Net earnings $402 $224 
Depreciation 49 45 
Amortization of intangible assets 53 49 
Changes in operating assets and liabilities and other, net (301)62 
Net cash provided by operating activities $203 $380 
Investing activities   
Acquisitions, net of cash acquired $(23)$(84)
Change in marketable securities, net 195 456 
Purchases of property, plant and equipment (115)(46)
Net cash provided by investing activities $57 $326 
Financing activities   
Borrowings/repayments of debt, net $3,455 $(500)
Dividends paid (142)(131)
Repurchase of common stock (13)(130)
Other financing 18 27 
Net cash provided by (used in) financing activities $3,318 $(734)
Effect of exchange rate changes on cash and cash equivalents 19 (93)
Change in cash and cash equivalents $3,597 $(121)

STRYKER CORPORATION
For the Three Months Ended March 31
(Unaudited - Millions of Dollars)
CONDENSED NET SALES ANALYSIS
 Three Months
   % Change
 20162015As ReportedConstant
Currency
Geographic net sales:    
United States$1,822 $1,673 8.9%8.9%
International673 706 (4.6)(0.4)
Total net sales$2,495 $2,379 4.9%6.1%
Worldwide net sales:    
Orthopaedics$1,057 $1,023 3.3%4.6%
MedSurg958 927 3.4 4.6 
Neurotechnology and Spine480 429 12.0 13.1 
Total net sales$2,495 $2,379 4.9%6.1%

SUPPLEMENTAL  NET SALES GROWTH ANALYSIS
 Three Months
   Percentage Change
     United StatesInternational
 20162015As ReportedConstant CurrencyAs ReportedAs ReportedConstant Currency
Knees$361 $345 4.4%5.8%9.0%(6.6)%(2.0)%
Hips316 312 1.2 2.9 4.5 (4.1)0.3 
Trauma and Extremities327 313 4.6 5.7 11.0 (4.9)(2.1)
Other53 53 0.4 1.6 3.8 (14.6)(8.1)
Total Orthopaedics$1,057 $1,023 3.3%4.6%7.9%(5.3)%(1.4)%
Instruments$365 $346 5.6%6.8%10.2%(8.3)%(3.4)%
Endoscopy328 321 2.5 3.8 8.7 (14.7)(9.9)
Medical207 205 0.6 1.8 2.5 (7.6)(1.2)
Sustainability58 55 6.0 6.1 6.1 (10.3)(1.0)
Total MedSurg$958 $927 3.4%4.6%7.6%(10.8)%(5.6)%
Neurotechnology$301 $252 19.5%20.9%21.2%16.6%20.3%
Spine179 177 1.1 1.9 5.8 (12.0)(8.9)
Total Neurotechnology and Spine$480 $429 12.0%13.1%14.3%6.9%10.4%

SUPPLEMENTAL INFORMATION - RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL MEASURES
We supplement the reporting of our financial information determined under accounting principles generally accepted in the United States (GAAP) with certain non-GAAP financial measures, including percentage sales growth in constant currency; percentage organic sales growth; adjusted gross profit; adjusted selling, general and administrative expenses; adjusted operating income; adjusted effective income tax rate; adjusted net earnings; and adjusted net earnings per diluted share. We believe that these non-GAAP measures provide meaningful information to assist shareholders in understanding our financial results and assessing our prospects for future performance. Management believes percentage sales growth in constant currency and the other adjusted measures described above are important indicators of our operations because they exclude items that may not be indicative of or are unrelated to our core operating results and provide a baseline for analyzing trends in our underlying businesses. Management uses these non-GAAP financial measures for reviewing the operating results of reportable business segments and analyzing potential future business trends in connection with our budget process and bases certain management incentive compensation on these non-GAAP financial measures.

To measure percentage sales growth in constant currency, we remove the impact of changes in foreign currency exchange rates that affect the comparability and trend of sales. Percentage sales growth in constant currency is calculated by translating current year results at prior year average foreign currency exchange rates. To measure percentage organic sales growth, we remove the impact of changes in foreign currency exchange rates and acquisitions that affect the comparability and trend of sales.  Percentage organic sales growth is calculated by translating current year results at prior year average foreign currency exchange rates excluding the impact of acquisitions.  To measure earnings performance on a consistent and comparable basis, we exclude certain items that affect the comparability of operating results and the trend of earnings.
Because non-GAAP financial measures are not standardized, it may not be possible to compare these financial measures with other companies' non-GAAP financial measures having the same or similar names. These adjusted financial measures should not be considered in isolation or as a substitute for reported sales growth, gross profit, selling, general and administrative expenses, operating income, effective income tax rate, net earnings and net earnings per diluted share, the most directly comparable GAAP financial measures. These non-GAAP financial measures are an additional way of viewing aspects of our operations that, when viewed with our GAAP results and the reconciliations to corresponding GAAP financial measures below, provide a more complete understanding of our business. We strongly encourage investors and shareholders to review our financial statements and publicly-filed reports in their entirety and not to rely on any single financial measure.
STRYKER CORPORATION
For the Three Months March 31, 2016 and 2015
(Unaudited - Millions of Dollars, Except Per Share Amounts)
RECONCILIATION OF ACTUAL RESULTS TO ADJUSTED RESULTS
 Three Months 2016Gross ProfitSelling, General & Administrative ExpensesIntangible AmortizationOperating IncomeNet EarningsEffective Tax RateDiluted EPS
Reported$1,694 $944 $53 $519 $402 16.4%$1.07 
  Acquisition and integration related charges (a)       
  Other acquisition and integration related- (5)- 5 3 0.1 0.01 
  Amortization of intangible assets- - (53)53 39 1.1 0.10 
  Restructuring-related charges (b)3 (17)- 20 15 0.4 0.04 
  Rejuvenate and other recall matters (c)- - - 19 17 - 0.04 
  Legal matters (d)- 12 - (12)(8)(0.6)(0.02)
Adjusted$1,697 $934 $- $604 $468 17.4%$1.24 

Three Months 2015Gross ProfitSelling, General & Administrative ExpensesIntangible AmortizationOperating IncomeNet EarningsEffective Tax RateDiluted EPS
Reported$1,553 $892 $49 $406 $224 40.6%$0.58 
  Acquisition and integration related charges (a)       
  Inventory stepped up to fair value7 - - 7 4 0.4 0.01 
  Other acquisition and integration related- (13)- 13 9 0.4 0.02 
  Amortization of intangible assets- - (49)49 35 1.2 0.09 
  Restructuring-related charges (b)1 (25)- 26 19 0.5 0.06 
  Rejuvenate and other recall matters (c)- - - 54 49 (1.4)0.13 
  Tax matters (e)- - - - 84 (22.2)0.22 
Adjusted$1,561 $854 $- $555 $424 19.5%$1.11 

(a)Charges represent certain acquisition and integration related costs associated with acquisitions.
(b)Charges represent the cost associated with certain restructuring related charges associated with workforce reductions, facility rationalizations and other restructuring activities.
(c)Charges represent changes in our best estimate of the minimum end of the range of probable loss to resolve the Rejuvenate and ABG II recall.
(d)Amount represents a gain associated with a legal settlement in 2016.
(e)Charges represent the tax impacts related to certain discrete tax items and the establishment of the European regional headquarters in 2015.