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February 22, 2017 OrthoSpineNews

February 22, 2017

MEMPHIS, Tenn.–(BUSINESS WIRE)–Active Implants, a company that develops orthopedic implant solutions, today announced that Ted Davis has been appointed president and chief executive officer. Davis succeeds Henry Klyce, who will continue as chairman of the board.

A current member of the Active Implants board, Davis has 25 years of experience in the life sciences industry as an investor and senior executive, including chief executive officer of MicroPort Orthopedics and president of its predecessor Wright Medical Technology’s global OrthoRecon division from 2012 through 2015. Prior to leading the carve out and integration of the OrthoRecon platform, Davis led Wright’s business development, corporate development and research & development functions from 2006 to 2012, with increasing responsibility for the business development, government affairs, national accounts, reimbursement, medical education and global research & development teams. Davis oversaw the acquisition and integration of a series of extremities and biologics platforms during Wright’s transformation into the market leader in the extremities market segment. Prior to joining Wright in 2006, Davis spent 10 years in the life sciences venture capital field, serving on the boards of multiple biotechnology and medical device companies while at MB Venture Partners and Vector Fund Management. He holds an MBA from the J.L. Kellogg Graduate School of Management at Northwestern University and a bachelor’s degree in engineering from Vanderbilt University.

“Ted’s expert business vision, along with his extensive experience providing strategy and leadership at orthopedic companies, makes him an extraordinary fit for Active Implants,” Klyce said. “A proven leader with a track record of delivering results, Ted brings the experience necessary to guide us through our next stage of growth.”

“I am honored and excited to lead Active Implants as we prepare for the next phase of development for the NUsurface Meniscus Implant around the world,” Davis said. “We have an opportunity to fulfill a significant unmet need in the orthopedic market here in the U.S. and worldwide, helping the millions of patients with persistent knee pain following meniscectomy. I look forward to continuing to work with Henry, given his successful track record in the orthopedics and spine medical technology industry and the outstanding progress he has led in the clinical development programs for the NUsurface Meniscus Implant here at Active Implants.”

The NUsurface® Meniscus Implant is an investigational treatment for patients with persistent knee pain following medial meniscus surgery. It is made from medical grade plastic and, as a result of its unique materials, composite structure and design, does not require fixation to bone or soft tissues. The NUsurface Meniscus Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint. The NUsurface Meniscus Implant has been used in Europe under CE Mark since 2008 and in Israel since 2011. Clinical trials are underway in the U.S., Europe and Israel to verify the safety and effectiveness of the NUsurface Meniscus Implant.

About Active Implants LLC

Active Implants LLC develops orthopedic implant solutions that complement the natural biomechanics of the musculoskeletal system, allowing patients to maintain or return to an active lifestyle. Active Implants is privately held with headquarters in Memphis, Tennessee. European offices are in Driebergen, The Netherlands, with R&D facilities in Netanya, Israel. For more information, visit www.activeimplants.com.

CAUTION Investigational device. Limited by United States law to investigational use.

Contacts

Merryman Communications
Joni Ramirez, 323-532-0746
joni@merrymancommunications.com


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February 22, 2017 OrthoSpineNews

By Michael Mezher – 21 February 2017

Sens. Johnny Isakson (R-GA) and Michael Bennett (D-CO) have introduced a bill that looks to dramatically alter the US Food and Drug Administration’s (FDA) process for inspecting device manufacturers.

Specifically, the bill calls for FDA to implement a more consistent, risk-based inspection process, as well as to improve communications with device makers regarding inspections and findings.

“The current device facility inspection process lacks transparency, predictability and consistency between facilities,” Isakson said. “This bill is designed to improve communication and consistency in the device facility inspections process, which will allow both FDA and device manufacturers to make more efficient use of resources.”

According to the bill, inconsistencies in how inspections are conducted across FDA’s foreign and domestic offices create challenges for device makers.

“The frequency and nature of inspections of device establishments are not consistently risk-based and a comprehensive, transparent, risk-based approach to inspections would result in greater focus on more significant risks to public health while reducing the burdens on establishments with a strong track record of compliance,” the bill states.

 

READ THE REST HERE



February 21, 2017 OrthoSpineNews

FoxNews.com

A Dallas jury sentenced a neurosurgeon dubbed “Dr. Death” by local media to life in prison on Monday, over his role in a botched back surgery that left his elderly patient crippled and in constant pain. Christopher Duntsch, 46, was arrested in July 2015 on five aggravated-assault charges after four of his patients were left crippled and two others died between July 2012 and June 2013, Dallas News reported.  

His trial focused on only one charge of injury to an elderly individual, with victim Mary Efurd testifying that she had trusted Duntsch to perform the 2012 procedure. Efurd, who was then 74, lost a third of her blood and the full use of her legs, Dallas News reported.

“I trusted that he would do what was right,” Efurd said, according to the report.

The 13-day trial included testimony from a doctor who treated Efurd after Duntsch’s procedure and said he found implants placed on muscle instead of bone, and a screw drilled into her spinal cavity.

“It’s as egregious as you can imagine,” Dr. Robert Henderson said, according to Dallas News.  

Jurors heard from other patients, including one who woke from surgery paralyzed from the neck down, another who passes out from chronic pain and a third who talks in a permanent whisper after she was left with a puncture wound in her throat.

 

READ THE REST HERE


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February 21, 2017 OrthoSpineNews

ROSEMONT, Ill., Feb. 21, 2017 /PRNewswire-USNewswire/ — The American Academy of Orthopaedic Surgeons (AAOS) announced the selection of Thomas E. Arend, Jr., CAE, to the position of Chief Executive Officer, effective April 1, 2017. As CEO, Arend will work directly with the AAOS Board of Directors and executive management team to oversee a staff of 250 and manage an annual budget of $60 million.

“The Academy is very pleased that Tom Arend, an experienced and proven health care leader, will serve as our next CEO,” said AAOS President Gerald R. Williams Jr., MD. “Tom is a strong strategic thinker and visionary leader who understands the complexities of the changing health care arena. He will serve our members and staff well.”

Arend currently serves as Executive Vice President, Chief Operating Officer and General Counsel at the American College of Cardiology (ACC), a 52,000-member organization in Washington, DC. In this role, he is responsible for ensuring the ACC’s overall financial health, operational effectiveness and strategic direction. In addition, he is responsible for all aspects of the College’s legal, risk management and compliance activities.

Since joining the ACC in 2004, Arend has led the College through two CEO transitions and played critical roles in the development of comprehensive relationship with industry standards and code of ethics, as well as the College’s  five-year strategic plan and more recent governance restructuring.  Arend has also spearheaded several successful collaborations with other medical societies and stakeholders that directly benefit the ACC’s mission to transform cardiovascular care and improve heart health. Most recently, he was responsible for the addition of hospital accreditation services to the ACC’s suite of hospital quality improvement offerings.

“I am excited to join the AAOS, and I am honored and humbled to be leading this strong and vibrant organization,” said Arend. “I look forward to advancing the mission of the Academy and working closely with the volunteer leaders, members and staff.”

Prior to joining ACC, Arend served as an attorney at Shaw Pittman, LLP and Jenner & Block. He received a Juris Doctor degree from the Washington College of Law at The American University, a Master of Arts in International Law and Diplomacy from The Fletcher School of Law and Diplomacy at Tufts University, and a Bachelor of Arts from Kenyon College. He is a member of the Maryland and District of Columbia Bar associations, the American Society of Association Executives and the American College of Healthcare Executives.

Arend is replacing AAOS CEO Karen L. Hackett, FACHE, CAE, who is retiring after 14 years at the organization’s helm. The AAOS Board of Directors retained executive search firm Korn Ferry to lead the search for a new CEO.

About the AAOS
With more than 39,000 members, the American Academy of Orthopaedic Surgeons is the world’s largest medical association of musculoskeletal specialists. The AAOS provides educational programs for orthopaedic surgeons and allied health professionals, champions and advances the highest quality musculoskeletal care for patients, and is the authoritative source of information on bone and joint conditions, treatments and related issues.

Visit AAOS at:
Newsroom.aaos.org for bone and joint health news, stats, facts, images and interview requests.
ANationinMotion.org for inspirational patient stories, and orthopaedic surgeon tips on maintaining bone and joint health, avoiding injuries, treating musculoskeletal conditions and navigating recovery.
Orthoinfo.org for patient information on hundreds of orthopaedic diseases and conditions.

SOURCE American Academy of Orthopaedic Surgeons


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February 21, 2017 OrthoSpineNews

MAHWAH, N.J., Feb. 21, 2017 /PRNewswire/ — Stryker Orthopaedics is pleased to announce its second PGA TOUR stop of 2017 with a first-ever appearance at The Honda Classic in Palm Beach Gardens, FL. Throughout the tournament, Stryker will further its commitment to joint health and to the nation’s military through a series of engaging activities for fans and tournament goers. On Thursday, Stryker will host a special K9s For Warriors ceremony, presenting one military hero with a service dog – Stryker’s first official canine sponsorship donation of the year.

As an extension of a successful relationship that began last year, in 2017 Stryker will continue to give a new leash on life to military heroes by sponsoring service canines and empowering veterans to return to civilian life with dignity and independence. Tournament goers can also show their support to veterans by purchasing the same hat that PGA TOUR professionals and longtime brand ambassadors, Fred Funk and Hal Sutton wear on TOUR at the newly renovated Mobility Zone – Stryker’s premiere “joint health” destination. With each hat purchase, Stryker will make a donation to the K9s For Warriors organization.

“This donation is just one of many ways in which we are honored to show our appreciation towards our nation’s veterans,” said Bill Huffnagle, President, Stryker’s Joint Replacement Division. “Stryker is proud to support our military and continue our mission to educate people about joint health and mobility in local communities across the nation.”

In addition to offering hats for sale to benefit K9s For Warriors, fans visiting The Mobility Zone will be able to learn about hip and knee pain and treatment options, as well as participate in fun, health inspired activities. Inside The Mobility Zone, fans can participate in the 2017 Stryker Challenge – a hands-on experience featuring Art H. Ritis, a life-size model that aims to provide tournament goers a basic understanding of joint replacement surgery and Stryker’s products. In addition, fans who stop by The Mobility Zone will be able to enter for a chance to win a trip for two to Atlanta, GA for the TOUR Championship® and walk inside the ropes as an honorary observer – a true VIP experience.1,2

Finally, to further demonstrate its commitment to motivating fans to stay active, Stryker will host the Health Walk at The Honda Classic. The Health Walk highlights joint health facts and tips along the course to educate fans as they follow their favorite golfers.

For a full list of tournaments stops, additional information on the Stryker Challenge as well as K9s For Warriors involvement, please visit: www.StrykerChallenge.com.

  1. Healthcare Professionals (HCPs) are not eligible to enter the Stryker Challenge Sweepstakes or participate in the any of these promotions. HCPs are defined as those individuals or entities involved in the provision of health care services and/or items to patients, which purchase, lease, recommend, use, arrange for the purchase or lease of, or prescribe Stryker’s products.
  2. No purchase necessary to enter or win Sweepstakes.  Void where prohibited by law.  For official rules visit StrykerChallenge.com.  Open to legal residents of the US & US Territories, 21+ as of date of entry.  Sweepstakes begins at 12:01 am ET on 1/11/17 and ends at 11:59 pm ET on 8/27/17.  Sponsored by Stryker.

About Stryker
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.

About PGA TOUR
The PGA TOUR is the world’s premier membership organization for touring professional golfers, co-sanctioning more than 130 tournaments on the PGA TOUR, PGA TOUR Champions, Web.com Tour, PGA TOUR Latinoamérica, Mackenzie Tour-PGA TOUR Canada and PGA TOUR China.


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February 21, 2017 OrthoSpineNews

IRVINE, Calif., Feb. 20, 2017 /PRNewswire/ — GS Solutions Inc., DBA GS Medical USA (GSM), a global manufacturer and supplier of spinal implants, instrumentation and developer of high-quality surgical solutions, today announced several influential advancements for the organization. Following a strong close to the 2016 fiscal year, GSM is poised and prepared for an impactful, growth-oriented year in 2017.

“2017 begins anew for GS Medical with the regeneration of our ‘Expanding New Horizons’ concept,” remarks James Shin, CEO. “Our leadership team has worked tirelessly to lay the foundation for a unique infrastructure system which will continue to cultivate and foster new and existing relationships among our distributor colleagues, surgeons, industry contacts, and hospital partners.” Shin further mentions that many customers already engaged with GSM are excited about the direction and progression of the company.

GSM is pleased to announce the confirmed and pending launch of several products to their existing FDA 510k approved product portfolio. GSM currently offers products under the GSS™ and AnyPlus® product lines, and soon plans to launch the AnyPlus® Anterior Cervical Interbody Fusion (ACIF) implant and the AnyPlus® Dual-Lead Pedicle Screw System in March of 2017. This is in addition to the AnyPlus® Direct Lateral Interbody Fusion (DLIF) implant, slated for a Q2 2017 launch. “The company’s research and development team continues to focus on the essential needs of surgeon partners and their patients, thus yielding fundamental product design and manufacturing that fits the bill on a multitude of levels,” explains Shin. “The introduction of our comprehensive interbody line into the marketplace provides surgeons the option to select the appropriate implant that corresponds with the clinical indications of each individual patient,” states Chris Estuesta, Operations Manager at GSM.

With increased demand for the GS products, the company is also actively seeking distributor partnership opportunities. “Our sales team and industry partners are the lifeline of our company,” explains Adam Lampart, Director of US Sales. “We are always looking for qualified partners who desire to work with a company that is end-user focused, and delivers solid products with timely customer service.” For more information about distributor partner opportunities, please contact sales@gsmedicalusa.com.

About GS Medical USA
GS Medical features many spinal products spanning lumbar, thoracic and cervical applications. GSM products have been used in thousands of spine surgeries throughout the USA, and hundreds of thousands globally. Staffed with a network of industry leaders, medical sales distributors, accomplished engineers, and collaborating physicians, GSM is at the forefront of high-quality, value-added medical technology with a number of innovative implant solutions in the commercialization pipeline. Corporate headquarters are in Irvine, California and with international offices located in Seoul, Korea.

Media Relations Contact:
Amanda Collins
146989@email4pr.com
Phone: 831.477.1307 x213
FAX: 866.600.9712
6 Wrigley
Irvine, CA 92618

www.gsmedicalusa.com

SOURCE GS Medical USA

Related Links

http://www.gsmedicalusa.com


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February 21, 2017 OrthoSpineNews

By for Zero Day – February 21, 2017

The heat is on medical device vendors, healthcare providers, and security firms to tackle the emerging problem of cyberattacks focused on the Internet of Medical Things (IoMT).

Hardly a week goes by when we don’t hear of the latest company to fall victim to hackers, but the ability to compromise medical devices may go far beyond the consequences of standard malware infections and the theft of personally identifiable information (PII).

Attacks against medical devices can occur due to social engineering and network infiltration, as well as vulnerabilities in hardware and software. The most common threats today include ransomware, man-in-the-middle (MiTM) attacks, phishing and, on occasion, physically compromising devices.

Strong networks can create a barrier between attackers and healthcare systems, but medical devices can suffer from the same vulnerabilities, exploits, outdated firmware and security flaws that plague traditional computer systems.

Medical device security hit the spotlight in 2012 when IOActive security researcher Barnaby Jack discovered transmitter security flaws which could be used to deliver lethal shocks to pacemakers. Recently, medical equipment maker St. Jude Medical was forced to patch security holes in the firm’s cardiac devices.

While medical devices may be targeted for the purposes of causing harm to individual patients or blackmail, one of the main reasons appears to be for financial gain.

In March 2016, US hospital chain MedStar’s IT infrastructure was crippled after a successful malware attack, and California’s Hollywood Presbyterian Medical Center paid attackers thousands of dollars after ransomware disrupted critical services in the same year.

Speaking to ZDNet, Jason Allaway, vice president of RES UK & Ireland, said the main threat to hospitals is ransomware due to the “devastatingly effectiveness” of attacks — and “because the consequence of losing data goes far beyond a financial cost.”

“Unlike data held by other organizations, such as those operating in finance, medical data holds a life or death value,” Allaway says. “Medical organizations can’t even give out the most basic of painkillers if their data is not fully available. […] Unless hospitals have a stringent backup policy, there is little option other than paying a ransom so that staff can continue to provide critical medical care.”

 

READ THE REST HERE


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February 21, 2017 OrthoSpineNews

February 21, 2017

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–TransEnterix, Inc. (NYSE MKT: TRXC) announced today that it plans to release fourth quarter and fiscal year 2016 financial and operating results after the market closes on Monday, March 6, 2017. Todd M. Pope, President and Chief Executive Officer and Joseph P. Slattery, Executive Vice President and Chief Financial Officer will host a conference call to discuss these results starting at 4:30 pm Eastern Time the same day. The call will be concurrently webcast.

To listen to the conference call on your telephone, please dial, 888-724-9516 for domestic callers and 913-312-0978 for international callers, and reference TransEnterix Call approximately ten minutes prior to the start time. To access the live audio webcast or archived recording, use the following link http://ir.transenterix.com/events.cfm. The replay will be available on the Company’s website.

About TransEnterix

TransEnterix is a medical device company that is pioneering the use of robotics to improve minimally invasive surgery by addressing the clinical and economic challenges associated with current laparoscopic and robotic options. The company is focused on the commercialization of the Senhance™ Surgical Robotic System, a multi-port robotic system that brings the advantages of robotic surgery to patients while enabling surgeons with innovative technology such as haptic feedback and eye sensing camera control. The company is also developing the SurgiBot™ System, a single-port, robotically enhanced laparoscopic surgical platform. The Senhance Surgical Robotic System has been granted a CE Mark but is not currently available for sale in the United States. For more information, visit the TransEnterix website at www.transenterix.com.

Contacts

For TransEnterix, Inc.
Investor Contact:
Mark Klausner, +1 443-213-0501
invest@transenterix.com
Or
Media Contact:
(For EU) Conrad Harrington, +44 (0)20 3178 8914
(For US) Hannah Dunning, +1 415-618-8750
TransEnterix-SVC@sardverb.com


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February 21, 2017 OrthoSpineNews

February 21, 2017

GAINESVILLE, Fla.–(BUSINESS WIRE)–Exactech, Inc. (Nasdaq: EXAC), a developer and producer of bone and joint restoration products and biologic solutions for extremities, knee and hip, announced today that revenue for 2016 increased 7% to $257.6 million from $241.8 million in 2015. Domestic revenue increased 5% to $176.8 million and international revenue increased 10% to $80.8 million in 2016. Diluted earnings per share for the year was $0.01 based on net income of $0.2 million, including the impact of $1.17 in earnings per share charges related to impairment, restructuring and tax valuation allowances, compared to 2015 net income of $14.8 million and diluted earnings per share of $1.04. Net income and diluted earnings per share for 2016 were significantly impacted by $14.5 million, net of taxes, in impairment and restructuring charges and $2.2 million in tax valuation allowances or $1.17 per share that were recognized in the fourth quarter of 2016. Excluding these charges, 2016 adjusted net income and adjusted diluted earnings per share were $16.8 million and $1.18, respectively; an 18% increase compared to 2015 adjusted net income and adjusted diluted earnings per share of $13.9 million and $0.98, respectively.

“We are pleased with our strong performance in 2016 and we believe we are well positioned for another solid year in 2017. The 2016 results reflect excellent surgeon acceptance of Exactech innovations, including our three new revision systems, as well as the positive impact of our sales channel development strategy. ”

2016 Full Year Highlights and Segment Performance

• Extremity revenues increased 16% to $100.3 million from $86.7 million, a 16% constant currency increase

• Knee revenue increased 4% to $76.2 million from $73.1 million, a 4% constant currency increase

• Hip revenue increased 8% to $46.7 million from $43.1 million, a 7% constant currency increase

• Biologic & spine revenues decreased 14% to $19.5 million from $22.8 million, a 14% constant currency decrease

• Other revenues decreased 9% to $14.8 million from $16.2 million, an 8% constant currency decrease

2016 Fourth Quarter Highlights and Segment Performance

For the fourth quarter of 2016, revenue was $66.2 million, an increase of 6% from $62.7 million in 2015 and an increase of 5% on a constant currency basis. Domestic sales increased 1% to $45.3 million and international sales increased 17% to $20.9 million compared to the fourth quarter of 2015. Net loss for the fourth quarter of 2016 was $11.8 million, or $0.82 per diluted share, compared to $4.1 million in net income, or $0.29 per diluted share income, for the fourth quarter of 2015. Fourth quarter net income was impacted by the entire $1.17 diluted earnings per share charges noted above. Fourth quarter segment revenues were as follows:

• Extremity revenues increased 16% to $27.3 million from $23.4 million, a 17% constant currency increase

• Knee revenue increased 7% to $19.8 million from $18.5 million, a 6% constant currency increase

• Hip revenue increased 2% to $11.2 million from $11.0 million, unchanged constant currency

• Biologic & spine revenues decreased 28% to $4.3 million from $6.0 million, a 27% constant currency decrease

• Other revenues decreased 6% to $3.7 million from $3.9 million, a 5% constant currency decrease

Management Comment

Exactech CEO and President David Petty said, “We are pleased with our strong performance in 2016 and we believe we are well positioned for another solid year in 2017. The 2016 results reflect excellent surgeon acceptance of Exactech innovations, including our three new revision systems, as well as the positive impact of our sales channel development strategy.

“Total sales for the year were up 7% to $257.6 million. Domestic revenue increased 5% to $176.8 million, and international revenue increased 10% to $80.8 million. For the fourth quarter of 2016, total sales rose 6% to $66.2 million. Domestic sales were up 1% to $45.3 million and International sales increased 17% to $20.9 million.

“We are enthusiastic about a return to double-digit growth in our extremities business, Exactech’s largest operating segment, which led the way with a 16% gain while reaching a milestone of $100 million in annual revenue. Once again this underscores the market’s support for our comprehensive Equinoxe® shoulder system and its highly competitive range of glenoid solutions along with the early acceptance of our Equinoxe Humeral Reconstruction Prosthesis. We were also pleased to begin cases with our new Vantage® Total Ankle System. We recorded another solid year in our knee segment with a 4% gain as we ramped up the revision knee rollout in the fourth quarter which should carry momentum into 2017. Our hip segment revenues rose 8% reflecting contributions from the increased availability of the Alteon® Monoblock Revision Hip Stem.

“Looking ahead, we plan to launch a new comprehensive knee system, TruliantTM, during the second half of 2017. We are expanding our ExactechGPS® computer assisted surgery system from one to four applications including two additions to further support knee surgery as well as our first application for the shoulder. We will continue to execute our sales force development initiative, which has been an important contributor to our growth. These plans, in addition to our decision to exit the spine business and some other strategic restructuring, position Exactech for improved profitability in 2017 and beyond. We are proud of Exactech people around the world who remain dedicated to making the company and our products better than ever,” Petty said.

Chief Financial Officer Jody Phillips said, “We are optimistic about 2017 based on the momentum in revenue growth in our large joint segments in the latter portion of 2016. The $14.5 million net of tax in impairment and restructuring charges, primarily related to the spine business, were largely non-cash in nature and put us in a solid position to focus on driving sales growth and operating margin expansion going forward. Due to profitability challenges in certain European and Asian markets, we also recognized $2.2 million in tax valuation allowances during the fourth quarter that significantly impacted our effective tax rate, net income and diluted earnings per share. On an adjusted basis, excluding the impact of the restructuring, impairment and tax valuation charges, our fourth quarter and full year net income was within the range of our original expectations for 2016 and adjusted diluted earnings per share was $1.18 for the full year and $0.34 for the fourth quarter. A detailed reconciliation of this adjusted basis income and diluted earnings per share is provided later in this press release. Full year gross margins decreased to 68.8% from 69.6% primarily due to currency and pricing pressures in our international business. During the first quarter of 2017, we are anticipating an additional $0.9 million in charges related to the divestiture of the spine assets which is expected to impact first quarter diluted earnings per share by $0.04.”

Looking forward, Exactech confirmed 2017 revenue guidance of $264-$272 million and diluted EPS target of $1.20-$1.28, including the impact of the first quarter $0.04 diluted earnings per share charge related to the spine business transition. On an adjusted basis diluted EPS target is $1.24-$1.32. For the first quarter of 2017, the company anticipates revenues of $66-$68 million and diluted EPS of $0.26-$0.28, including the first quarter charges. On an adjusted basis diluted EPS target is $0.30-$0.32 for the first quarter of 2017. The foregoing statements regarding targets for the quarter and full year are forward-looking and actual results may differ materially. These are the company’s targets, not predictions of actual performance.

The financial statements are below.

Conference Call

The company will hold a conference call with CEO David Petty and key members of the management team today, Tuesday, February 21st at 10:00 a.m. Eastern Time. The call will cover Exactech’s fourth quarter and year-end 2016 results. Mr. Petty will open the conference call and a question-and-answer session will follow.

To participate in the call, dial 1-888-471-3836 any time after 9:50 a.m. Eastern on February 21. International and local callers should dial 1-719-325-2475. A live and archived webcast of the call will be available at http://www.hawkassociates.com/profile/exac.cfm or http://public.viavid.com/index.php?id=122940. This call will be archived for approximately 90 days.

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 http://www.exac.com and http://www.hawkassociates.com.

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 http://www.hawkassociates.com/about/alert.

This release contains various forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which represent the company’s expectations or beliefs concerning future events of the company’s financial performance. These forward-looking statements are further qualified by important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include the effect of competitive pricing, the company’s dependence on the ability of third party manufacturers to produce components on a basis which is cost-effective to the company, market acceptance of the company’s products and the effects of government regulation. Results actually achieved may differ materially from expected results included in these statements.

EXACTECH, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS

(in thousands)
(unaudited) (audited)
December 31, December 31,
2016 2015
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 13,052 $ 12,713
Trade receivables, net of allowances of $1,473 and $1,011 53,051 52,442
Prepaid expenses and other assets, net 3,075 2,552
Income taxes receivable 2,140 486
Inventories, current 65,264 71,429
Assets held for sale 6,477
Total current assets 143,059 139,622
PROPERTY AND EQUIPMENT:
Land 4,474 4,494
Machinery and equipment 42,034 37,008
Surgical instruments 132,134 123,533
Furniture and fixtures 4,700 4,655
Facilities 21,726 20,348
Projects in process 2,473 1,218
Total property and equipment 207,541 191,256
Accumulated depreciation (100,234 ) (96,713 )
Net property and equipment 107,307 94,543
OTHER ASSETS:
Deferred financing and deposits, net 968 858
Equity investment 2,047
Deferred tax asset 887
Non-current inventory 15,723 8,995
Product licenses and designs, net 9,102 11,121
Patents and trademarks, net 821 1,426
Customer relationships, net 476 92
Goodwill 13,819 18,850
Total other assets 43,843 41,342
TOTAL ASSETS $ 294,209 $ 275,507
LIABILITIES AND SHAREHOLDERS’ EQUITY
CURRENT LIABILITIES:
Accounts payable $ 17,566 $ 13,932
Income taxes payable 780 603
Accrued expenses 11,832 9,498
Other current liabilities 2,927 792
Total current liabilities 33,105 24,825
LONG-TERM LIABILITIES:
Deferred tax liabilities 1,773 443
Long-term debt, net of current portion 20,000 16,000
Other long-term liabilities 5,089 5,850
Total long-term liabilities 26,862 22,293
Total liabilities 59,967 47,118
COMMITMENTS AND CONTINGENCIES
SHAREHOLDERS’ EQUITY:
Common stock 144 142
Additional paid-in capital 87,319 81,963
Treasury Stock (3,042 )
Accumulated other comprehensive loss, net of tax (8,611 ) (11,986 )
Retained earnings 158,432 158,270
Total shareholders’ equity 234,242 228,389
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY $ 294,209 $ 275,507
EXACTECH, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF INCOME
(in thousands, except per share amounts)
(Unaudited)
Three Month Periods Twelve Month Periods
Ended December 31, Ended December 31,
2016 2015 2016 2015
NET SALES $ 66,232 $ 62,732 $ 257,573 $ 241,838
COST OF GOODS SOLD 20,843 19,066 80,251 73,639
Gross profit 45,389 43,666 177,322 168,199
OPERATING EXPENSES:
Sales and marketing 23,614 23,194 92,452 87,095
General and administrative 5,442 5,680 22,182 22,483
Research and development 5,882 4,995 21,377 19,384
Restructuring and impairment 15,673 15,673
Depreciation and amortization 4,682 4,243 18,008 16,940
Total operating expenses 55,293 38,112 169,692 145,902
INCOME (LOSS) FROM OPERATIONS (9,904 ) 5,554 7,630 22,297
OTHER INCOME (EXPENSE):
Interest income (20 ) 2 15 9
Other income (loss) 333 377 448 468
Interest expense (297 ) (453 ) (1,013 ) (1,313 )
Foreign currency exchange loss (997 ) (269 ) (332 ) (1,131 )
Total other income (expenses) (981 ) (343 ) (882 ) (1,967 )
INCOME (LOSS) BEFORE INCOME TAX AND EQUITY IN LOSS OF INVESTEE (10,885 ) 5,211 6,748 20,330
PROVISION FOR INCOME TAXES 853 1,095 6,533 5,563
INCOME BEFORE EQUITY IN LOSS OF INVESTEE (11,738 )

4,116

215 14,767
EQUITY IN LOSS OF INVESTEE, NET OF TAX (53 ) (53 )
NET INCOME (LOSS) $ (11,791 ) $ 4,116 $ 162 $ 14,767
BASIC EARNINGS (LOSS) PER SHARE $ (0.83 ) $ 0.29 $ 0.01 $ 1.05
DILUTED EARNINGS (LOSS) PER SHARE $ (0.83 ) $ 0.29 $ 0.01 $ 1.04
SHARES – BASIC 14,198 14,100 14,078 14,022
SHARES – DILUTED 14,198 14,179 14,281 14,202

Non-GAAP Disclosure and Reconciliation

We present certain non-GAAP results as a supplement to our financial results based on GAAP, as we believe it is useful to exclude certain items in order to focus on what we regard to be a more reliable indicator of the underlying operating performance of our business. Because we operate internationally, we present the percentage change in sales by reporting segment on a constant currency basis, which is a non-GAAP financial measure. We calculate this change on a constant currency basis by translating current period sales at the comparable average historical exchange rates for the same period in the prior year. We believe that presenting the percentage change in sales on a constant currency basis assists in the understanding of actual sales fluctuations by excluding the impact of foreign currency fluctuations.

Additionally, we report on a non-GAAP basis adjusted net income and adjusted diluted earnings per share excluding certain charges related to restructuring activities, asset impairment charges, tax valuation allowances, and asset sale gains or losses. We believe the exclusion of these charges provides the reader with more comparable financials to better analyze historical company trends. The following items have been adjusted to assist in the comparability:

  • Discontinuation of an international distributor and the gross margin impact of expected sales return due to dissolution of the agreement;
  • Restructuring related charges including legal and compensation charges;
  • Gain on sale of a product line in 2015
  • Tangible and intangible asset impairment of our spine assets as a result of annual testing and subsequent sale of spine assets;
  • Impairment of biologics assets related to the abandonment of our cartilage project;
  • Biologics and spine goodwill impairment, resulting from the annual goodwill impairment test;
  • Tax benefit resulting from the impairment and restructuring charges; and
  • Tax valuation allowances related to continued losses of certain foreign subsidiaries.
Three Months Ended December 31, Twelve Months Ended December 31,
2016 2015 2016 2015
(in thousands, except per share amounts) Net Income Diluted EPS Net Income Diluted EPS Net Income Diluted EPS Net Income Diluted EPS
Reported $ (11,791 ) $ (0.83 ) $ 4,116 $ 0.29 $ 162 $ 0.01 $ 14,767 $ 1.04
Gross margin:
Distributor sales return 406 0.03 406 0.03
Spine inventory impairment 694 0.04 694 0.04
Gross margin adjustment 1,100 1,100
Operating expenses:
Restructuring expenses 1,274 0.07 1,274 0.07
Sale of product line (301 ) (0.02 )
Spine asset impairment 5,307 0.24 5,307 0.24
Biologics impairment 1,539 0.11 1,539 0.11
Goodwill impairment 7,553 0.53 7,553 0.53
Operating expense adjustment 15,673 15,673
Tax benefit on adjustments (2,260 ) (2,260 )
Tax valuation allowances 2,156 0.15 2,156 0.15 (536 ) (0.04 )
Total adjustments 16,669 1.17 16,669 1.17 (837 ) (0.06 )
Adjusted results $ 4,878 $ 0.34 $ 4, 116 $ 0.29 $ 16,831 $ 1.18 $ 13,930 $ 0.98

We also provide adjusted forward looking guidance on diluted earnings per share for the first quarter and full year for 2017. We believe this adjusted guidance will assist in comparative measures. The following reconciles the guidance ranges to expected guidance on a GAAP basis:

Three Months Ended Twelve Months Ended
March 31, 2017 December 31, 2017
Expected diluted EPS range on GAAP basis $0.26 – $0.28 $1.20 – $1.28
Spine asset divestiture 0.06 0.06
Tax benefit of adjustments (0.02) (0.02)
Total adjustments 0.04 0.04
Adjusted total diluted EPS range $0.30-$0.32 $1.24-$1.32

Contacts

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


visuel_vexim.jpg

February 21, 2017 OrthoSpineNews

Toulouse, February 21st, 2017 (8:00AM CET)VEXIM (FR0011072602 – ALVXM), a medical device company specializing in the minimally-invasive treatment of vertebral fractures, today announces enrollment completion of its FDA clinical trial.

The VEXIM FDA trial is a European, prospective and randomized multicenter study. It aims to compare safety and efficacy of the SpineJack® vs balloon kyphoplasty on 152 patients with osteoporotic vertebral compression fractures. It is being conducted in 12 centers in Germany, France, Italy, Spain and Switzerland. The study is intended to provide clinical data to support a 510(k) submission in the United States, which is expected to be filed by the end of 2017.

« Vertebral Compression Fractures (VCF) represent a true concern in aging population with more than 1.5 million osteoporotic VCF reported each year globally, » explains Professor David Noriega, one of the study investigators.

« Those fractures are very crippling because patients experience acute and chronic back pain, as well as a progressive deformation of the spine that can lead to additional pathologies. Thanks to its jack mechanism, which is designed to restore vertebra from the inside through a mini invasive surgery, the SpineJack® is intended to provide a quick and efficient way of treating those fractures and to restore spine balance[1]. »

VEXIM’s clinical trial compares improvements in terms of back pain, functional and physical capability, quality of life, device safety, analgesic usage and vertebral height restoration, on patients suffering osteoporotic vertebral compression fractures and treated with the SpineJack® and balloon kyphoplasty. Trial’s success will be defined by showing the SpineJack®‘s non-inferiority to balloon kyphoplasty on a primary endpoint which is a composite measure of pain reduction, maintenance or improvement in function and absence of device related serious adverse event.

As of today, all 152 patients planned have been randomized. Half of them within SpineJack® treatment group, the other half in the balloon kyphoplasty group. The finalization of patient enrollment represents an important milestone in the trial’s schedule. SpineJack® 510(k) file is planned to be submitted to the FDA[2] before the end of year 2017.

« The finalization of our FDA clinical study enrollment is a key milestone on the path to commercialize the SpineJack® in the United States. We keep our target to submit our 510(k) in 2017 that would lead, subject to FDA clearance, to a SpineJack® commercialization in the US during the first half of 2018. This is also a demonstration of VEXIM’s capacity to run a large international trial. In the name of VEXIM, I want to thank warmly all our site investigators and coordinators for their active participation that allowed us to achieve this phase of the trial, » concludes Vincent Gardès, VEXIM’s CEO.

Financial reporting schedule:

2016 Full-Year Results: March 22nd, 2017[3]

 

About VEXIM, the innovative back microsurgery specialist

Based in Balma, near Toulouse (France), VEXIM is a medical device company created in February 2006. The Company has specialized in the creation and marketing of minimally-invasive solutions for treating traumatic spinal pathologies. Benefitting from the financial support of it longstanding shareholder, Truffle Capital[4], and from OSEO public subsidies, VEXIM has designed and developed the SpineJack®, a unique implant capable of repairing a fractured vertebra and restoring the balance of the spinal column. The Company currently has 60 members on its staff. It has its own sales teams in France, Germany, Italy, Spain, Switzerland and the United Kingdom, as well as distributors in Turkey, Argentina, India and in the following countries where the product is currently being registered: Mexico, Brazil, Colombia, Venezuela, Chile, Ecuador and Peru. VEXIM has been listed on NYSE Alternext Paris since May 3rd 2012. For further information, please visit www.vexim.com

SpineJack®, an innovative implant for treating Vertebral Compression Fractures

The SpineJack® is designed to restore a fractured vertebra to its original shape, restore the spinal column’s optimal anatomy and thus remove pain and enable the patient to recover their functional capabilities. Thanks to a specialized range of instruments, inserting the implants into the vertebra is carried out by minimally-invasive surgery, guided by X-ray, in approximately 30 minutes, which is intended to enable the patient to be discharged shortly after surgery. The SpineJack® range consists of 3 titanium implants with 3 different diameters, thus covering 95% of vertebral compression fractures and all patient morphologies.

SpineJack® technology benefits from the support of international scientific experts in the field of spine surgery and worldwide patent protection through to 2029.

 

 

CONTACTS
VEXIM

Vincent Gardès, Directeur Général

José Da Gloria, Directeur Administratif et Financier

investisseur@vexim.com

Tél. : +33 5 61 48 48 38

 

RELATIONS PRESSE

ALIZE RP

Caroline Carmagnol / Wendy Rigal

vexim@alizerp.com

Tél. : +33 1 44 54 36 66

Tél. : +33 6 48 82 18 94