ChoiceSpine announces the launch of HARRIER™ ALIF

Knoxville, TN- February 6, 2017- ChoiceSpine, a Knoxville, TN based spinal implant company, announced the launch of HARRIER™, an anterior lumbar interbody fusion system.  ChoiceSpine received 510K clearance the HARRIER™ in November 2016 and it will be the 1st of 4 new products launching in 2017.

“Harrier fills a long needed gap in our product portfolio” says Anderson Collins, ChoiceSpine’s Director of Business Development.  “We have had strong growth over the past 4 years, which has been a function of two key drivers, bringing new products to market and working the right distributor partners.  Adding HARRIER™ to our portfolio gives us another revenue source that our distributor and surgeon partners can utilize to improve patients’ lives.”

ChoiceSpine’s Vice President of R&D Steve Ainsworth adds, “Our product pipeline is full of products we plan to launch over the next 2 years.  HARRIER™ and other new products will help sustain the growth we have experienced over the past few years.  Our R&D team has worked diligently with our distributor and surgeon partners to roll out HARRIER™ and we are confident it will be received well in the market.

 

NuVasive To Present At Leerink Partners 6th Annual Global Healthcare Conference 2017

SAN DIEGO, Feb. 6, 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced that management will present at the Leerink Partners 6th Annual Healthcare Conference at the Lotte New York Palace Hotel in New York, New York on Wednesday, February 15, 2017 at 11:00 a.m. ET / 8:00 a.m. PT.

A live webcast of the presentation will be available online from the Investor Relations page of the Company’s website at www.nuvasive.com. A replay of the presentation will remain available on the website for 30 days after the applicable live webcast.

About NuVasive NuVasive, Inc. (NASDAQ: NUVA) is a world leader in minimally invasive, procedurally-integrated spine solutions. From complex spinal deformity to degenerative spinal conditions, NuVasive is transforming spine surgery with innovative technologies designed to deliver reproducible and clinically proven surgical outcomes. NuVasive’s highly differentiated, procedurally-integrated solutions include access instruments, implantable hardware and software systems for surgical planning and reconciliation technology that centers on achieving the global alignment of the spine. With $811 million in revenues (2015), NuVasive has an approximate 2,300 person workforce in more than 40 countries around the world. For more information, please visit www.nuvasive.com.

Forward-Looking Statements NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA™ platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

SOURCE NuVasive, Inc.

Related Links

http://www.nuvasive.com

EOI Announces that Dr. Henry Ruiz is the First to Implant the FLXfit™ 3D Expandable Cage in Alabama

OR AKIVA, Israel, February 6, 2017 /PRNewswire/ —

Expanding Orthopedics Inc. (EOI), a privately held medical device company focused on developing and commercializing innovative expandable devices for spine surgery, is excited to announce that Dr. Henry Ruiz of the Gadsden Regional Medical Center has been the first surgeon in Alabama to adopt the FLXfit™ articulated and lordotic expandable cage as his choice of treatment for his TLIF fusion surgeries. Dr. Henry Ruiz says that „I have used many different cages throughout my career and in the last few years I have shifted to expandable cages as I believe this technology provides great benefit to patients, especially in minimal invasive surgery”. He added that „the FLXfit expandable cage is a very unique design and different from other expandable devices I have used before and is a real game-changer in my practice”.

Dr. Ruiz notes that „many of the current expandable cages have a small surface area and expand in the weak part of the bone which can potentially enhance subsidence and compromise long term clinical outcome. The FLXfit has a very large surface area and a unique articulation mechanism which enables me to drive the cage to the front of the disc space and expand it exactly where I want it, on the strong part of the bone”. He summarizes that „I’m very excited with the FLXfit cage as it provides everything I wanted with an expandable cage in my practice, large footprint with lordotic expansion in the right location in the disc space with a very easy to use instrumentation. I’m confident that with this kind of device, I provide the best treatment for my patients”.

Ofer Bokobza, CEO of Expanding Orthopedics, says that „we are excited to collaborate with Dr. Ruiz and his team and congratulate them for joining a growing list of spine surgeons selecting the FLXfit as their new standard of care.”

About Expanding Orthopedics Inc.

Expanding Orthopedics Inc. is medical device company developing and marketing innovative products designed to address unmet clinical needs for spine care and improve long-term patients’ outcome. The Company is spearheaded by seasoned management team, and is backed by prominent spine surgeons. EOI owns a broad patent portfolio around anatomically fit, expandable devices for enhanced stability through a minimally invasive approach.

Contact info:
David Elkaim, VP Marketing and Sales
E-mail: david@xortho.com
Phone: +1-(347)-3219683

SOURCE Expanding Orthopedics Inc. (EOI)

MiMedx Comments On FDA Decision Not To Finalize HCT/P Guidance Documents This Year

MARIETTA, Ga., Feb. 3, 2017 /PRNewswire/ — MiMedx Group, Inc. MDXG 2.31%, the leading regenerative medicine company utilizing human amniotic tissue and patent-protected processes to develop and market advanced products and therapies for the Wound Care, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic, and Dental sectors of healthcare, commented today regarding the Food and Drug Administration’s (“FDA’s”) recently published 2017 calendar year guidance agenda. The tissue-related Guidances to be finalized in calendar year 2017 do not include Guidances on Human Cells, Tissues, and Cellular and Tissue Based Products (HCT/Ps), including minimal manipulation and homologous use of HCT/Ps.

Parker H. Petit, Chairman and CEO, said, “Last September when the FDA convened its hearing on the proposed Draft Guidances on minimal manipulation and homologous use of HCT/Ps, there was an overwhelming response and considerable input given to the FDA by industry, academia, healthcare practitioners and patients. The almost universal sentiment from industry and the scientific community was that these Draft Guidances should be amended significantly or withdrawn in their entirety. Certain presenters at the September 2016 hearings also noted that some provisions of the Draft Guidances were outside the scope of FDA’s authority to regulate HCT/Ps and thus would require notice and comment rulemaking.”

Petit added, “I am encouraged that the FDA has not included these Draft Guidances in their 2017 calendar of those to be finalized. The massive amount of input that the FDA received during the hearing was certainly impactful, and it seems as if the Agency is not in a position to finalize Guidances in 2017 regarding the key HCT/P guidance documents related to homologous use and minimal manipulation.”

Bill Taylor, President and COO, commented, “There was a tremendous amount of data and scientific evidence presented to the FDA at last year’s hearings on HCT/Ps. The absence of any planned finalized Guidances on the key HCT/P guidance related documents is encouraging. Their absence on this year’s calendar gives us confidence that, when eventually finalized, these Guidances will have taken into consideration the valuable input of industry, academia, practitioners, patients, and the scientific community.”

About MiMedx
MiMedx® is an integrated developer, processor and marketer of patent protected and proprietary regenerative biomaterial products and bioimplants processed from human amniotic membrane and other human birth tissues, such as amniotic fluid, umbilical cord and placental collagen, and human skin and bone.  “Innovations in Regenerative Biomaterials” is the framework behind our mission to give physicians products and tissues to help the body heal itself.  We process the human amniotic membrane utilizing our proprietary PURION® Process, to produce a safe and effective implant. MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization.  MiMedx is the leading supplier of amniotic tissue, having supplied over 700,000 allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare.

Safe Harbor Statement
This press release includes statements that look forward in time or that express management’s beliefs, expectations or hopes.  Such statements are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  These statements include, but are not limited to, the  input from the hearings in 2016 impacted the decision not to finalize the HCT/P guidances in 2017,  the delay in finalizing the HCT/P guidances is a positive,  and the absence of the HCT/P guidances on this year’s calendar gives confidence that when eventually finalized, the guidances will have taken into consideration the valuable input of industry, academia, practitioners, patients, and the scientific community.  Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include that other factors may be impacting the timing of the finalization of the HCT/P guidances, the final guidances may not necessarily take into consideration the valuable input of industry, academia, practitioners, patients, and the scientific community, the delay could have a negative impact rather than a positive one, and the risk factors detailed from time to time in the Company’s periodic Securities and Exchange Commission filings, including, without limitation, its 10-K filing for the fiscal year ended December 31, 2015, and its most recent Form 10Q filing.  By making these forward-looking statements, the Company does not undertake to update them in any manner except as may be required by the Company’s disclosure obligations in filings it makes with the Securities and Exchange Commission under the federal securities laws.

PRESS RELEASE  CONTACT:

Michael Senken

Phone: (770) 651-9100

THE OLD MUTUAL GLOBAL INVESTORS UK LTD. INVESTS $901,000 IN ANIKA THERAPEUTICS INC. (ANIK)

Old Mutual Global Investors UK Ltd. purchased a new position in Anika Therapeutics Inc. (NASDAQ:ANIK) during the third quarter, according to its most recent disclosure with the Securities and Exchange Commission. The firm purchased 18,841 shares of the company’s stock, valued at approximately $901,000. Old Mutual Global Investors UK Ltd. owned about 0.13% of Anika Therapeutics at the end of the most recent quarter.

A number of other hedge funds and other institutional investors have also made changes to their positions in the company. Chicago Equity Partners LLC acquired a new position in shares of Anika Therapeutics during the third quarter worth about $294,000. Texas Permanent School Fund raised its position in shares of Anika Therapeutics by 2.7% in the third quarter. Texas Permanent School Fund now owns 11,258 shares of the company’s stock worth $539,000 after buying an additional 300 shares during the period. Great West Life Assurance Co. Can raised its position in shares of Anika Therapeutics by 7.3% in the third quarter. Great West Life Assurance Co. Can now owns 20,075 shares of the company’s stock worth $960,000 after buying an additional 1,366 shares during the period. HL Financial Services LLC raised its position in shares of Anika Therapeutics by 23.4% in the third quarter. HL Financial Services LLC now owns 57,551 shares of the company’s stock worth $2,754,000 after buying an additional 10,920 shares during the period. Finally, Louisiana State Employees Retirement System raised its position in shares of Anika Therapeutics by 3.2% in the third quarter. Louisiana State Employees Retirement System now owns 6,500 shares of the company’s stock worth $311,000 after buying an additional 200 shares during the period. Institutional investors own 76.01% of the company’s stock.

 

READ THE REST HERE

Asterias Biotherapeutics Extends the Expiration Date of Certain Warrants and Provides Update on Cash Position

FREMONT, Calif., Feb. 3, 2017 /PRNewswire/ — Asterias Biotherapeutics, Inc. (NYSE MKT: AST), a biotechnology company pioneering the field of regenerative medicine, today announced the company is extending the expiration date of certain warrants. The decision to extend the warrants takes into consideration Asterias’ recent announcement of positive interim efficacy results from its ongoing SCiStar Phase 1/2a clinical trial that showed additional motor function improvement at 6 months and 9 months following administration of 10 million AST-OPC1 cells in patients with complete cervical spinal cord injuries (AIS-A patients).  Further data will become available in the third quarter of 2017 evaluating 12-month safety and efficacy results for this AIS-A 10 million cell cohort, as well as 6-month efficacy and safety data for the currently-enrolling AIS-A 20 million cell and AIS-B 10 million cell cohorts.

“We were excited by the recent positive read-out on the AIS-A 10 million cell cohort in our SCiStar clinical trial.  This data reinforced the very positive motor function improvements observed in complete cervical spinal cord injury patients announced in September 2016,” said Steve Cartt, Chief Executive Officer of Asterias. “We hope to see continued positive results when we report additional data read-outs later this year.  In addition, we expect to make significant progress during 2017 as we complete enrollment in the SCiStar clinical trial and engage in discussions with the FDA to design a new AST-OPC1 randomized-controlled trial that we expect to commence in early 2018.”

The company is extending the expiration date of warrants to purchase up to an aggregate of 3,329,035 shares of the company’s Series A common stock, par value $0.0001 per share. The expiration date for these warrants, which otherwise would have expired on February 15, 2017, has been extended to 5:00 p.m. New York City time on September 29, 2017.  The company is also extending the expiration date of the warrants to purchase up to an aggregate of 409,152 shares of common stock held by Romulus Films Ltd.  The expiration date for the warrants held by Romulus has also been extended to 5:00 p.m. New York City time on September 29, 2017.

In addition, Asterias provided an update on its cash position. As of December 31, 2016, the company’s cash and cash equivalents totaled $19.8 million (unaudited) and its cash, cash equivalents and available-for-sale securities totaled $35.1 million (unaudited).

“Asterias’ cash position at the end of 2016 is significantly improved from the same time last year, and positions us to further advance our development programs through key milestones for the company, including completing enrollment of the SCiStar study, during 2017,” said Ryan Chavez, Chief Financial Officer. “Management believes the company’s cash, cash equivalents and available-for-sale securities will be sufficient to fund operations through at least the first quarter of 2018.”                                                            

About Asterias Biotherapeutics

Asterias Biotherapeutics, Inc. is a biotechnology company pioneering the field of regenerative medicine. The company’s proprietary cell therapy programs are based on its immunotherapy and pluripotent stem cell platform technologies. Asterias is presently focused on advancing three clinical-stage programs which have the potential to address areas of very high unmet medical need in the fields of neurology and oncology. AST-OPC1 (oligodendrocyte progenitor cells) is currently in a Phase 1/2a dose escalation clinical trial in spinal cord injury.

AST-VAC1 (antigen-presenting autologous dendritic cells) is undergoing continuing development by Asterias based on promising efficacy and safety data from a Phase 2 study in Acute Myeloid Leukemia (AML) and completing a successful end-of-Phase 2 meeting with the FDA. The company is currently focused on streamlining and modernizing the manufacturing process for AST-VAC1 in advance of a planned initiation of a Phase 2b study designed to set the registration pathway. AST-VAC2 (antigen-presenting allogeneic dendritic cells) represents a second generation, allogeneic immunotherapy. The company’s research partner, Cancer Research UK, plans to begin a Phase 1/2a clinical trial of AST-VAC2 in non-small cell lung cancer in the second quarter of 2017. Additional information about Asterias can be found at www.asteriasbiotherapeutics.com

Spinal Simplicity Announces Receipt of FDA Clearance for Minuteman® G3-R Removable End Fusion Implant

Spinal Simplicity, a medical device company developing innovative solutions to treat complex surgical problems, has received its third 510(k) clearance from FDA for the Minuteman G3-R spinal implant, part of the Minuteman family of supplemental fusion and fixation devices. The Minuteman G3-R may be implanted via a minimally invasive lateral approach and will have a lower profile upon placement of the device.

“The lower profile of the Minuteman G3-R provides an aesthetic enhancement while maintaining the key elements of strength of the device and its minimally invasive nature. The interest that surgeons have expressed in this new product has been outstanding,” says Todd Moseley, Co-Founder and CEO of Spinal Simplicity. “Spinal Simplicity continues to raise the bar in the industry as we bolster our product portfolio and provide physicians with diverse options for patient treatments that utilize minimally invasive technologies”.

The Minuteman® G3-R is a sterile packed, posterior, non-pedicle supplemental fusion and fixation device for use in the non-cervical spine (T1-S1). As an alternative to traditional pedicle screws, it is a plating system intended for supplemental fusion in patients with degenerative disc disease, spondylolisthesis, trauma and tumor. The device is available in the U.S. with hydroxyapatite coating and a removable 12mm portion of the implant body. The Minuteman® is intended for use with bone graft material and is not intended for stand-alone use.

About Spinal Simplicity
Spinal Simplicity, LLC, headquartered in Overland Park, KS, is dedicated to the creation of simple solutions for the treatment of complex spinal disorders. Spinal Simplicity has regulatory clearance for the Minuteman system in the US, Europe and Canada. Our vision is to be the global leader in innovative, simplified surgical solutions, while delivering uncompromising quality. For more information, please visit http://www.spinalsimplicity.com

Flower Orthopedics Launches FlowerAdvantage, an Ambulatory Surgery Center Efficiency and Savings Partnership

HORSHAM, Pa., Feb. 3, 2017 /PRNewswire/ — Flower Orthopedics, the leader in Ready-For-Surgery™ extremity implant systems, announces the release of its FlowerAdvantage™ Program, a multi-level initiative designed to reduce the costs of providing care in the ambulatory surgery center setting.  “The FlowerAdvantage™ Program has four pillars that generate costs savings and positively impact the operations of surgery centers, while providing patients with the highest standard of care,” said Oliver Burckhardt, President and CEO of Flower Orthopedics.

The four pillars of costs savings in the FlowerAdvantage™ Program are FlowerBucketPrice™ where all components needed for the case are identified, bundled and sold without any hidden or extra costs; Flower ECO Implant™ Line is a value based implant portfolio capable of accommodating challenging reimbursement scenarios; FlowerBuyBack™ Program allows the surgery center to sell back to Flower used single-use instruments from the case; and Flower Ready-For-Surgery™ eliminates operational costs associated with processing trays, inherent case delays & cancellations, and infection risks.

“The FlowerAdvantage™ Program meets a significant unmet need in the outpatient surgery market. With bundled payments and other initiatives driving down reimbursements, surgery centers must find other means to cut costs without diminishing patient care,” said Mr. Burckhardt.  The FlowerAdvantage™ Program provides costs savings through the efficiency-based value proposition that other companies cannot provide. The Ready-For-Surgery FlowerCube™ relieves the burden of the surgery center to clean, sterilize, track and manage implant trays, saving considerable time and cost. Flower is focused on providing its customers with many options that improve the level of patient care, while reducing the costs incurred by the healthcare system as a whole.

About Flower: Flower Orthopedics was founded in 2012 to develop technologies that drive efficiencies translating into cost savings for all stakeholders in healthcare. Flower’s development team works tirelessly with leading surgeons to create advanced implant and instrument systems, that are always Ready-For-Surgery.

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/flower-orthopedics-launches-floweradvantage-an-ambulatory-surgery-center-efficiency-and-savings-partnership-300402105.html

SOURCE Flower Orthopedics

Mazor Robotics to Report Fourth Quarter and Full Year Financial Results on February 16, 2017

February 02, 2017

CAESAREA, Israel–(BUSINESS WIRE)–Mazor Robotics Ltd. (TASE:MZOR; NASDAQGM:MZOR), a pioneer and a leader in the field of surgical guidance systems, announced today that it will report financial results for the fourth quarter and full year ended December 31, 2016, before the U.S. markets open on Thursday, February 16, 2017.

The company will host a conference call to discuss these results on Thursday, February 16, 2017, at 8:30 AM ET (3:30 PM IST). Investors within the United States interested in participating are invited to call 888-312-3052. Participants in Israel can use the toll free dial-in number 1 80 924 5905. All other international participants can use the dial-in number 719-457-2695.

A replay of the event will be available for two weeks following the conclusion of the call. To access the replay, callers in the United States can call 1-866-375-1919 and reference the Replay Access Code: 2887710. All international callers can dial +1 719-457-0820, using the same Replay Access Code. To access the webcast, please visit www.mazorrobotics.com and select ‘Investor Relations.’

About Mazor

Mazor Robotics (TASE: MZOR; NASDAQGM: MZOR) believes in healing through innovation by developing and introducing revolutionary technologies and products aimed at redefining the gold standard of quality care. Mazor Robotics Guidance Systems enable surgeons to conduct spine and brain procedures in an accurate and secure manner. For more information, please visit www.MazorRobotics.com.

Contacts

U.S. Contacts:
EVC Group
Investors
Michael Polyviou, 212-850-6020
mpolyviou@evcgroup.com
or
Doug Sherk, 646-445-4800
dsherk@evcgroup.com

CONMED Corporation Announces Fourth Quarter and Fiscal Year 2016 Financial Results

February 01, 2017

UTICA, N.Y.–(BUSINESS WIRE)–CONMED Corporation (Nasdaq:CNMD) today announced financial results for the fourth quarter and fiscal year ended December 31, 2016.

Fourth Quarter 2016 Highlights

  • Sales of $204.1 million increased 6.8% as reported compared to the fourth quarter of 2015. On a constant currency basis, sales increased 9.1% but declined 1.5% organically.
  • International reported revenue grew 6.0% year over year and 0.4% organically. On an organic constant currency basis, international markets increased 4.8%, delivering a third consecutive quarter of growth across all three reporting categories.
  • Domestic General Surgery sales grew 33.4% as reported, driven by continued strength in the AirSeal® platform. On an organic basis, domestic General Surgery sales increased 1.5%.
  • Diluted net earnings per share (GAAP) were $0.24, compared to diluted net earnings per share (GAAP) of $0.28 in the fourth quarter of 2015.
  • Adjusted diluted net earnings per share(1) were $0.54 versus $0.60 in the prior-year period.

Fiscal Year 2016 Highlights

  • Sales of $763.5 million increased 6.2% as reported compared to the full year 2015. On a constant currency basis, sales increased 8.6% but declined 1.1% organically.
  • AirSeal® contribution of $68.4 million to full year 2016 sales exceeded the Company’s forecasted range of $62 to $67 million.
  • Diluted net earnings per share (GAAP) were $0.52, compared to $1.09 in 2015.
  • Adjusted diluted net earnings per share(1) were $1.84 versus $1.98 in the prior-year period.

“Our International business and the domestic General Surgery category, which represent 78% of our total revenue, exited the year with positive momentum. Overall, we are demonstrating consistent and improving performance across these areas. Clearly, these successes were offset by ongoing challenges in domestic Orthopedics, where we believe we are taking the appropriate steps to drive improvement in this business over the coming quarters,” commented Curt R. Hartman, CONMED’s President and Chief Executive Officer.

Sales Analysis

For the quarter ended December 31, 2016, domestic sales, which represented 51.5% of total revenue, increased 7.6%, despite declines in Orthopedics and Visualization, due to continued strength in General Surgery, as the SurgiQuest acquisition and organic growth contributed to 33.4% year-over-year growth in the business. International sales, which represented 48.5% of total revenue, increased 6.0% compared to the fourth quarter of 2015 on a reported basis. Foreign currency exchange rates, including the effects of the FX hedging program, had a negative impact of $4.4 million on fourth quarter sales. In constant currency, international sales increased 10.7% versus the prior-year period.

For the fiscal year ended December 31, 2016, domestic sales, which represented 52.3% of total revenue, increased 10.4% as positive results in General Surgery, driven by AirSeal® sales growth, were partially offset by weaker than expected sales in Orthopedics and, to a lesser extent, Visualization. International sales, which represented 47.7% of total revenue, increased 1.9% compared to 2015 on a reported basis. Foreign currency exchange rates, including the effects of the FX hedging program, had a negative impact of $17.3 million on fiscal year 2016 sales. In constant currency, international sales increased 6.7% versus the prior-year period.

Earnings Analysis

For the quarter ended December 31, 2016, reported net earnings totaled $6.7 million, compared to reported net earnings of $7.9 million a year ago. Reported diluted net earnings per share were $0.24 in the quarter, compared to reported diluted net earnings per share of $0.28 in the prior-year period. Reported net earnings for both 2016 and 2015 include business acquisition and restructuring costs. The effect of each of these items on reported net earnings and reported diluted net earnings per share appears in the reconciliation of GAAP to non-GAAP measures below.

The Company excludes the after-tax costs of special items including acquisitions, restructuring, the gain on the sale of an asset and debt refinancing, as well as amortization of intangible assets, net of tax, from its adjusted diluted net earnings per share. Excluding the impact of these items, adjusted net earnings(2) of $15.1 million decreased 8.8% year over year and adjusted diluted net earnings per share(1) of $0.54 decreased 10.0% year over year. The decrease in adjusted net earnings resulted primarily from unfavorable impact of foreign exchange rates, partially offset by a lower tax rate during the quarter.

For the fiscal year ended December 31, 2016, reported net earnings totaled $14.7 million, compared to reported net earnings of $30.5 million in the prior year. Reported diluted net earnings per share were $0.52, compared to $1.09 in the prior-year period. Excluding the impact of the special items as described above and as provided in the reconciliation of GAAP to non-GAAP measures below, adjusted net earnings(2) of $51.4 million decreased 6.4% year over year and adjusted diluted net earnings per share(1) of $1.84 decreased 7.1% from the prior year.

2017 Outlook

The Company expects 2017 constant currency sales growth in the range of 1% to 3%. Based on exchange rates as of January 27, 2017, the negative impact to 2017 sales from foreign exchange is anticipated to be approximately 0.5%.

In addition, the Company forecasts adjusted diluted net earnings per share in the range of $1.85 to $1.95, which includes an estimated negative impact from foreign exchange based on exchange rates as of January 27, 2017. The adjusted diluted net earnings per share estimates for 2017 exclude the cost of special items including acquisition costs and restructuring costs, which are estimated in the range of $8.0 to $10.0 million, net of tax, and amortization of intangible assets, which are estimated in the range of $12 to $14 million, net of tax.

Supplemental Financial Disclosures

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

(2) A reconciliation of reported net earnings to adjusted net earnings, a non-GAAP financial measure, appears below.

In conjunction with this earnings press release, CONMED has prepared a supplemental financial disclosure, which is available on the home page of the “Investors – Financial Reports” section of the Company’s website at www.conmed.com.

Conference Call

The Company’s management will host a conference call today at 4:30 p.m. ET to discuss its fourth quarter and fiscal year 2016 results.

To participate in the conference call, dial 844-889-7792 (domestic) or 661-378-9936 (international) and enter the passcode 46955565.

This conference call will also be webcast and can be accessed from the “Investors” section of CONMED’s web site at www.conmed.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

A recording of the call will also be available from 7:30 p.m. ET on Wednesday, February 1, 2017, until 7:30 p.m. ET on Wednesday, February 15, 2017. To hear this recording, dial 855-859-2056 (domestic) or 404-537-3406 (international) and enter the passcode 46955565.

About CONMED Corporation

CONMED is a medical technology company that provides surgical devices and equipment for minimally invasive procedures. The Company’s products are used by surgeons and physicians in a variety of specialties, including orthopedics, general surgery, gynecology, neurosurgery and gastroenterology. The Company distributes its products worldwide from several manufacturing locations. CONMED has a direct selling presence in 17 countries, and international sales constitute approximately 50% of the Company’s total sales. Headquartered in Utica, New York, the Company employs approximately 3,300 people. For more information, visit www.conmed.com.

Forward-Looking Statements

This press release and today’s conference call may contain forward-looking statements based on certain assumptions and contingencies that involve risks and uncertainties, which could cause actual results, performance, or trends to differ materially from those expressed in the forward-looking statements herein or in previous disclosures. For example, in addition to general industry and economic conditions, factors that could cause actual results to differ materially from those in the forward-looking statements may include, but are not limited to, the risk factors discussed in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2015. Any and all forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and relate to the Company’s performance on a going-forward basis. The Company believes that all forward-looking statements made by it have a reasonable basis, but there can be no assurance that management’s expectations, beliefs or projections as expressed in the forward-looking statements will actually occur or prove to be correct.

Supplemental Information – Reconciliation of GAAP to Non-GAAP Financial Measures

The Company supplements the reporting of its 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; adjusted gross profit; cost of sales excluding specified items; adjusted selling and administrative expenses; adjusted operating income; adjusted income tax expense; adjusted effective income tax rate; adjusted net earnings and adjusted diluted net earnings per share (EPS). The Company believes that these non-GAAP measures provide meaningful information to assist investors and 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 the Company’s underlying business. Further, the presentation of EBITDA is a non-GAAP measurement that management considers useful for measuring aspects of the Company’s cash flow. Management uses these non-GAAP financial measures for reviewing the operating results 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, the Company removes the impact of changes in foreign currency exchange rates that affect the comparability and trend of sales. To measure earnings performance on a consistent and comparable basis, the Company excludes certain items that affect the comparability of operating results and the trend of earnings. These adjustments are irregular in timing, may not be indicative of our past and future performance and are therefore excluded to allow investors to better understand underlying operating trends.

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, cost of sales, selling and administrative expenses, operating income, income tax expense, effective income tax rate, net earnings and diluted net earnings per 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. The Company strongly encourages investors and shareholders to review our financial statements and publicly-filed reports in their entirety and not to rely on any single financial measure.

Consolidated Condensed Statements of Income
(in thousands, except per share amounts, unaudited)

Three Months Ended Twelve Months Ended
December 31, December 31,
2016 2015 2016 2015
Net sales $ 204,094 $ 191,017 $ 763,520 $ 719,168
Cost of sales 97,135 88,641 355,190 337,466
Gross profit 106,959 102,376 408,330 381,702
% of sales 52.4% 53.6% 53.5% 53.1%
Selling and administrative expense 86,719 82,668 338,400 303,091
Research & development 7,634 6,741 32,254 27,436
Income from operations 12,606 12,967 37,676 51,175
% of sales 6.2% 6.8% 4.9% 7.1%
Other expense 2,942
Interest expense 3,911 1,578 15,359 6,031
Income before income taxes 8,695 11,389 19,375 45,144
Provision for income taxes 1,987 3,537 4,711 14,646
Net income $ 6,708 $ 7,852 $ 14,664 $ 30,498
Basic EPS $ 0.24 $ 0.28 $ 0.53 $ 1.10
Diluted EPS 0.24 0.28 0.52 1.09
Basic shares 27,832 27,707 27,804 27,653
Diluted shares 27,987 27,875 27,964 27,858

Consolidated Condensed Balance Sheets
(in thousands, unaudited)

December December
2016 2015
Assets:
Cash and cash equivalents $ 27,428 $ 72,504
Accounts receivable, net 148,244 133,863
Inventories 135,869 133,361
Other current assets 18,971 20,076
Total Current Assets 330,512 359,804
Property, plant and equipment, net 122,029 125,452
Goodwill 397,664 260,651
Other intangible assets, net 419,549 308,171
Other assets 59,229 47,622
Total Assets $ 1,328,983 $ 1,101,700
Liabilities and Shareholders’ Equity:
Current liabilities $ 113,952 $ 119,718
Long-term debt, excluding current maturities 488,288 269,471
Other liabilities 146,167 127,438
Shareholders’ equity 580,576 585,073
Total Liabilities and Shareholders’ Equity $ 1,328,983 $ 1,101,700

Consolidated Condensed Statements of Cash Flows
Twelve Months Ended December 31, 2016 and 2015
(in thousands, unaudited)

2016 2015
Operating Activities
Net income $ 14,664 $ 30,498
Depreciation and amortization 55,309 43,879
Stock-based compensation expense 8,375 7,499
Deferred income taxes (2,871) 2,251
Changes in operating assets and liabilities and other, net (37,255) (36,059)
Net cash provided by operating activities 38,222 48,068
Investing Activities
Payments related to business acquisitions (256,450) (9,353)
Proceeds from sale of a facility 5,178
Purchases of property, plant and equipment (14,753) (15,009)
Net cash used in investing activities (266,025) (24,362)
Financing Activities
Payments on term loan (8,750)
Proceeds of term loan 175,000
Proceeds of revolver 225,000 142,680
Payments on revolver (162,347) (112,000)
Payments related to debt issue costs (5,556) (1,485)
Payment related to distribution agreement (16,667) (16,667)
Dividend payments on common stock (22,213) (22,105)
Other, net (265) (196)
Net cash provided by (used in) financing activities 184,202 (9,773)
Effect of exchange rate changes on cash and cash equivalents (1,475) (7,761)
Net increase (decrease) in cash and cash equivalents (45,076) 6,172
Cash and cash equivalents at beginning of period 72,504 66,332
Cash and cash equivalents at end of period $ 27,428 $ 72,504

Sales Summary
(in millions, unaudited)

Three Months Ended December 31,
% Change
Domestic International
2016 2015

As
Reported

Constant
Currency

As
Reported

As
Reported

Constant
Currency

Orthopedic Surgery $ 98.0 $ 104.2 -5.9% -3.2% -12.6% -1.1% 3.7%
General Surgery 92.5 70.9 30.5% 32.0% 33.4% 25.2% 29.5%
Surgical Visualization 13.6 15.9 -15.0% -13.9% -27.7% 0.2% 3.3%
$ 204.1 $ 191.0 6.8% 9.1% 7.6% 6.0% 10.7%
Single-use Products $ 160.0 $ 146.8 9.0% 11.3% 10.9% 6.8% 11.8%
Capital Products 44.1 44.2 -0.2% 1.6% -4.7% 3.7% 7.3%
$ 204.1 $ 191.0 6.8% 9.1% 7.6% 6.0% 10.7%
Domestic $ 105.1 $ 97.7 7.6% 7.6%
International 99.0 93.3 6.0% 10.7%
$ 204.1 $ 191.0 6.8% 9.1%
Twelve Months Ended December 31,
% Change
Domestic International
2016 2015

As
Reported

Constant
Currency

As
Reported

As
Reported

Constant
Currency

Orthopedic Surgery $ 370.5 $ 389.0 -4.7% -1.7% -5.4% -4.3% 0.7%
General Surgery 341.4 274.2 24.5% 26.0% 27.9% 18.2% 22.5%
Surgical Visualization 51.6 56.0 -7.8% -5.9% -13.0% -2.2% 2.2%
$ 763.5 $ 719.2 6.2% 8.6% 10.4% 1.9% 6.7%
Single-use Products $ 605.8 $ 567.3 6.8% 9.3% 10.0% 3.3% 8.5%
Capital Products 157.7 151.9 3.8% 6.1% 12.2% -2.8% 1.2%
$ 763.5 $ 719.2 6.2% 8.6% 10.4% 1.9% 6.7%
Domestic $ 399.1 $ 361.5 10.4% 10.4%
International 364.4 357.7 1.9% 6.7%
$ 763.5 $ 719.2 6.2% 8.6%

Reconciliation of Reported Net Earnings to Adjusted Net Earnings
(in thousands, except per share amounts, unaudited)

Three Months Ended December 31, 2016
Gross Profit

Selling &
Administrative
Expense

Operating
Income

Other
Expense

Tax
Expense

Effective
Tax Rate

Net
Income

Diluted
EPS

As reported $ 106,959 $ 86,719 $ 12,606 $ $ 1,987 22.9% $ 6,708 $ 0.24
% of sales 52.4% 42.5% 6.2%
Restructuring costs (1) 2,075 (2,768) 4,843 1,701 3,142 0.11
Business acquisition costs (2) (3,244) 3,244 1,139 2,105 0.08
$ 109,034 $ 80,707 $ 20,693 $ $ 4,827 28.8% $ 11,955 $ 0.43
% of sales 53.4% 39.5% 10.1%
Amortization of intangible assets $ 1,500 $ (3,500) $ 5,000 $ $ 1,857 3,143 0.11
Adjusted earnings $ 15,098 $ 0.54
Three Months Ended December 31, 2015
Gross Profit

Selling &
Administrative
Expense

Operating
Income

Other
Expense

Tax
Expense

Effective
Tax Rate

Net
Income

Diluted
EPS

As reported $ 102,376 $ 82,668 $ 12,967 $ $ 3,537 31.1% $ 7,852 $ 0.28
% of sales 53.6% 43.3% 6.8%
Restructuring costs (1) 2,837 (4,334) 7,171 2,461 4,710 0.17
Business acquisition costs (2) (2,069) 2,069 172 1,897 0.07
$ 105,213 $ 76,265 $ 22,207 $ $ 6,170 29.9% $ 14,459 $ 0.52
% of sales 55.1% 39.9% 11.6%
Amortization of intangible assets $ 1,500 $ (1,590) $ 3,090 $ $ 963 2,127 0.08
Adjusted earnings $ 16,586 $ 0.60

(1)

In 2016 and 2015, the Company restructured certain operating, sales, marketing and administrative functions and incurred severance and other related costs.

(2)

In 2016 and 2015, the Company incurred consulting fees, legal fees, and integration related costs associated with the acquisition of SurgiQuest, Inc.

Reconciliation of Reported Net Earnings to Adjusted Net Earnings
(in thousands, except per share amounts, unaudited)

Twelve Months Ended December 31, 2016
Gross Profit

Selling &
Administrative
Expense

Operating
Income

Other
Expense

Tax
Expense

Effective
Tax Rate

Net Income

Diluted
EPS

As reported $ 408,330 $ 338,400 $ 37,676 $ 2,942 $ 4,711 24.3% $ 14,664 $ 0.52
% of sales 53.5% 44.3% 4.9%
Restructuring costs (1) 7,612 (6,873) 14,485 4,919 9,566 0.35
Business acquisition costs (2) (20,599) 20,599 7,173 13,426 0.48
Gain on sale of facility (3) 1,890 (1,890) (853) (1,037) (0.04)
Debt refinancing costs (4) (2,942) 930 2,012 0.07
$ 415,942 $ 312,818 $ 70,870 $ $ 16,880 30.4% $ 38,631 $ 1.38
% of sales 54.5% 41.0% 9.3%
Amortization of intangible assets $ 6,000 $ (13,989) $ 19,989 $ $ 7,197 12,792 0.46
Adjusted earnings $ 51,423 $ 1.84
Twelve Months Ended December 31, 2015
Gross Profit

Selling &
Administrative
Expense

Operating
Income

Other
Expense

Tax
Expense

Effective
Tax Rate

Net Income

Diluted
EPS

As reported $ 381,702 $ 303,091 $ 51,175 $ $ 14,646 32.4% $ 30,498 $ 1.09
% of sales 53.1% 42.1% 7.1%
Restructuring costs (1) 8,016 (13,655) 21,671 7,713 13,958 0.51
Business acquisition costs (2) (2,543) 2,543 311 2,232 0.08
$ 389,718 $ 286,893 $ 75,389 $ $ 22,670 32.7% $ 46,688 $ 1.68
% of sales 54.2% 39.9% 10.5%
Amortization of intangible assets $ 6,000 $ (6,486) $ 12,486 $ $ 4,145 8,341 0.30
Adjusted earnings $ 55,029 $ 1.98

(1)

In 2016 and 2015, the Company restructured certain operating, sales, marketing and administrative functions and incurred severance and other related costs. Additionally, in the second quarter of 2016, the Company terminated a product offering and incurred charges mainly related to inventory and fixed assets.

(2)

In 2016 and 2015, the Company incurred investment banking fees, consulting fees, legal fees, and integration related costs associated with the acquisition of SurgiQuest, Inc.

(3)

In 2016, the Company recorded a gain on the sale of its facility in Centennial, Colorado.

(4)

In 2016, in conjunction with the acquisition of SurgiQuest, Inc., the Company refinanced its existing credit facility and incurred one-time fees associated with an agreement between the Company and JP Morgan Chase Bank, N.A., as well as costs associated with the early extinguishment of debt.

Reconciliation of Reported Net Income to EBITDA & Adjusted EBITDA
(in thousands, unaudited)

Three Months Ended Twelve Months Ended
December 31, December 31,
2016 2015 2016 2015
Net income $ 6,708 $ 7,852 $ 14,664 $ 30,498
Provision for income taxes 1,987 3,537 4,711 14,646
Interest expense 3,911 1,578 15,359 6,031
Depreciation 5,237 4,785 20,479 18,704
Amortization 8,601 6,638 33,788 24,581
EBITDA $ 26,444 $ 24,390 $ 89,001 $ 94,460
Stock based compensation 1,869 1,656 7,653 6,478
Restructuring costs 4,843 7,171 14,485 21,671
Business acquisition costs 3,244 2,069 20,599 2,543
Gain on sale of facility (1,890)
Debt refinancing costs 2,942
Adjusted EBITDA $ 36,400 $ 35,286 $ 132,790 $ 125,152
EBITDA Margin
EBITDA 13.0% 12.8% 11.7% 13.1%
Adjusted EBITDA 17.8% 18.5% 17.4% 17.4%

Contacts

CONMED Corporation
Luke A. Pomilio, 315-624-3202
Chief Financial Officer
LukePomilio@conmed.com