K2M’s New Surgical Solutions to Enhance MESA® 2 Deformity Spinal System with Next-Generation Cricket™ Technology

Posted On May 26, 2017 By OrthoSpineNews In Spine /

LEESBURG, Va., May 25, 2017 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (NASDAQ:KTWO) (the “Company” or “K2M”), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance^™, today announced the launch of the MESA 2 Cricket^™, an enhancement to the Company’s innovative MESA^® 2 Deformity Spinal System. The MESA 2 Cricket provides surgeons the ability to efficiently complete challenging correction maneuvers in all three anatomical planes, with the goal of achieving three-dimensional balance in patients with complex spinal deformities.

The MESA 2 Cricket offers an innovative, 360-degree approach to more easily capture, manipulate, and align a deformed spine as compared to traditional MESA deformity correction instrumentation. This new instrumentation—available for both rods and K2M’s MESA Rail^™—eliminates the need for reduction screws and allows for simultaneous multi-axial translation and reduction, as well as for quick removal.

“I have been a long-time user of MESA, and have used it to treat multiple spinal pathologies over the years,” said William Clark, MD, an orthopedic surgeon at the Tulsa Bone and Joint Spine Center in Oklahoma and an associate fellow of the Scoliosis Research Society. “I’m excited about this next-generation Cricket; easy just got easier.”

MESA 2—the Company’s flagship platform featuring the innovative MESA Technology—is a state-of-the-art pedicle screw system with wide ranging implants and versatile instruments necessary in the treatment of complex spinal pathologies. Top-loading, dual-lead thread, and low-profile MESA 2 screws feature Zero-Torque Technology^®, when combined with one-handed locking instruments, and compared to original MESA screws, increase operative efficiency and eliminate surgical steps without applying torsional stress to the spine.

“We are excited to add the MESA 2 Cricket to our MESA 2 portfolio to coincide with this year’s deformity season,” said K2M’s President and CEO Eric Major. “For over a decade, K2M’s MESA Technology has transformed how surgeons treat complex spinal deformities by focusing on operative efficiency, ease of use, and three-dimensional spinal balance as essential to achieving quality outcomes in patients. We’ve utilized these 3D-correction principles inherent in our MESA Technology as the foundation of our Balance ACS^™ (or BACS^™) platform, and will continue integrating our core competencies in complex spine innovations—and advancements in 3D solutions—to help achieve Total Body Balance for patients with spinal disorders.”

K2M’s Balance ACS is a comprehensive platform applying three-dimensional solutions across the entire clinical care continuum to help drive quality outcomes in spine patients. BACS provides solutions focused on achieving balance of the spine by addressing each anatomical vertebral segment with a 360-degree approach to the axial, coronal, and sagittal planes, emphasizing Total Body Balance as an important component of surgical success.

To date, more than 56,000 surgical cases using MESA Deformity Spinal Systems have been completed. For more information about the MESA 2 Deformity Spinal System and K2M, visit www.K2M.com. For more information about K2M’s Balance ACS platform, visit www.BACS.com.

About K2M

K2M Group Holdings, Inc. is a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance. Since its inception, K2M has designed, developed, and commercialized innovative complex spine and minimally invasive spine technologies and techniques used by spine surgeons to treat some of the most complicated spinal pathologies. K2M has leveraged these core competencies into Balance ACS, a platform of products, services, and research to help surgeons achieve three-dimensional spinal balance across the axial, coronal, and sagittal planes, with the goal of supporting the full continuum of care to facilitate quality patient outcomes. The Balance ACS platform, in combination with the Company’s technologies, techniques, and leadership in the 3D-printing of spinal devices, enable K2M to compete favorably in the global spinal surgery market. For more information, visit www.K2M.com and connect with us on Facebook, Twitter, Instagram, LinkedIn, and YouTube.

Forward-Looking Statements

This press release contains forward-looking statements that reflect current views with respect to, among other things, operations and financial performance. Forward-looking statements include all statements that are not historical facts such as our statements about our expected financial results and guidance and our expectations for future business prospects. In some cases, you can identify these forward-looking statements by the use of words such as “outlook,” “guidance,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “could,” “seeks,” “predicts,” “intends,” “plans,” “estimates,” “anticipates” or the negative version of these words or other comparable words. Such forward-looking statements are subject to various risks and uncertainties including, among other things: our ability to achieve or sustain profitability in the future; our ability to demonstrate to spine surgeons the merits of our products; pricing pressures and our ability to compete effectively generally; collaboration and consolidation in hospital purchasing; inadequate coverage and reimbursement for our products from third-party payors; lack of long-term clinical data supporting the safety and efficacy of our products; dependence on a limited number of third-party suppliers; our ability to maintain and expand our network of direct sales employees, independent sales agencies and international distributors and their level of sales or distribution activity with respect to our products; proliferation of physician-owned distributorships in our industry; decline in the sale of certain key products; loss of key personnel; our ability to enhance our product offerings through research and development; our ability to manage expected growth; our ability to successfully acquire or invest in new or complementary businesses, products or technologies; our ability to educate surgeons on the safe and appropriate use of our products; costs associated with high levels of inventory; impairment of our goodwill and intangible assets; disruptions in our main facility or information technology systems; our ability to ship a sufficient number of our products to meet demand; our ability to strengthen our brand; fluctuations in insurance cost and availability; our ability to comply with extensive governmental regulation within the United States and foreign jurisdictions; our ability to maintain or obtain regulatory approvals and clearances within the United States and foreign jurisdictions; voluntary corrective actions by us or our distribution or other business partners or agency enforcement actions; recalls or serious safety issues with our products; enforcement actions by regulatory agencies for improper marketing or promotion; misuse or off-label use of our products; delays or failures in clinical trials and results of clinical trials; legal restrictions on our procurement, use, processing, manufacturing or distribution of allograft bone tissue; negative publicity concerning methods of tissue recovery and screening of donor tissue; costs and liabilities relating to environmental laws and regulations; our failure or the failure of our agents to comply with fraud and abuse laws; U.S. legislative or Food and Drug Administration regulatory reforms; adverse effects of medical device tax provisions; potential tax changes in jurisdictions in which we conduct business; our ability to generate significant sales; potential fluctuations in sales volumes and our results of operations over the course of the year; uncertainty in future capital needs and availability of capital to meet our needs; our level of indebtedness and the availability of borrowings under our credit facility; restrictive covenants and the impact of other provisions in the indenture governing our convertible senior notes and our credit facility; continuing worldwide economic instability; our ability to protect our intellectual property rights; patent litigation and product liability lawsuits; damages relating to trade secrets or non-competition or non-solicitation agreements; risks associated with operating internationally; fluctuations in foreign currency exchange rates; our ability to comply with the Foreign Corrupt Practices Act and similar laws; increased costs and additional regulations and requirements as a result of being a public company; our ability to implement and maintain effective internal control over financial reporting; potential volatility in our stock due to sales of additional shares by our pre-IPO owners or otherwise; our lack of current plans to pay cash dividends; our ability to take advantage of certain reduced disclosure requirements and exemptions as a result of being an emerging growth company; potential dilution by the future issuances of additional common stock in connection with our incentive plans, acquisitions or otherwise; anti-takeover provisions in our organizational documents and our ability to issue preferred stock without shareholder approval; potential limits on our ability to use our net operating loss carryforwards; and other risks and uncertainties, including those described under the section entitled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the SEC, as such factors may be updated from time to time in our periodic filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements. These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this release and our filings with the SEC.

We operate in a very competitive and challenging environment. New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this release. We cannot assure you that the results, events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results, events or circumstances could differ materially from those described in the forward-looking statements.

The forward-looking statements made in this press release relate only to events as of the date on which the statements are made. We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Unless specifically stated otherwise, our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, investments or other strategic transactions we may make.

Media Contact:
Zeno Group on behalf of K2M Group Holdings, Inc.
Christian Emering, 212-299-8985
Christian.Emering@ZenoGroup.com 

Investor Contact:
Westwicke Partners on behalf of K2M Group Holdings, Inc.
Mike Piccinino, CFA, 443-213-0500
K2M@westwicke.com

Keck School of Medicine of USC receives $2.2 million NIH grant for bone repair research

Posted On May 26, 2017 By OrthoSpineNews In Financial, Top Stories /

LOS ANGELES – Jay R. Lieberman, MD, chair and professor of orthopedic surgery at the Keck School of Medicine of the University of Southern California has received a five-year, $2.2 million grant from the National Institutes of Health’s National Institute of Arthritis and Musculoskeletal and Skin Diseases to research gene therapy to enhance repair of extensive bone injuries. Examples of these types of injuries include fractures with extensive bone loss, non-healing fractures, failed spinal fusion and revision of total joint replacement.

Lieberman will genetically manipulate human bone marrow cells to overproduce bone morphogenetic protein (BMP), a protein that spurs progenitor cells to produce bone.

“There are a number of bone injuries that are very difficult to repair and lack satisfactory solutions,” Lieberman says. “My goal with this grant is to determine whether genetically modifying human bone marrow cells to overproduce BMP will help heal large bone defects in an animal model and, ultimately, provide a better alternative for repairs in humans.”

Lieberman’s study will determine the efficacy and safety of the gene therapy as well as establish a cellular dose of the genetically manipulated cells that can be scaled up for potential use in humans.

An abstract of the grant, 2R01AR057076-06A1, is available on the NIH RePORTER website.

ABOUT THE KECK SCHOOL OF MEDICINE OF USC

Founded in 1885, the Keck School of Medicine of USC is among the nation’s leaders in innovative patient care, scientific discovery, education, and community service. It is part of Keck Medicine of USC, the University of Southern California’s medical enterprise, one of only two university-owned academic medical centers in the Los Angeles area. This includes the Keck Medical Center of USC, composed of the Keck Hospital of USC and the USC Norris Cancer Hospital. The two world-class, USC-owned hospitals are staffed by more than 500 physicians who are faculty at the Keck School. The school today has approximately 1,650 full-time faculty members and voluntary faculty of more than 2,400 physicians. These faculty direct the education of approximately 700 medical students and 1,000 students pursuing graduate and post-graduate degrees. The school trains more than 900 resident physicians in more than 50 specialty or subspecialty programs and is the largest educator of physicians practicing in Southern California. Together, the school’s faculty and residents serve more than 1.5 million patients each year at Keck Hospital of USC and USC Norris Cancer Hospital, as well as USC-affiliated hospitals Children’s Hospital Los Angeles and Los Angeles County + USC Medical Center. Keck School faculty also conduct research and teach at several research centers and institutes, including the USC Norris Comprehensive Cancer Center, the Zilkha Neurogenetic Institute, the Eli and Edythe Broad Center for Stem Cell Research and Regenerative Medicine at USC, the USC Cardiovascular Thoracic Institute, the USC Roski Eye Institute and the USC Institute of Urology.

In 2017, U.S. News & World Report ranked Keck School of Medicine among the Top 40 medical schools in the country. For more information, go to keck.usc.edu.

This press release references support by the National Institutes of Health under award number 2R01AR057076-06A1 ($2,284,028 over five years). One hundred percent of the project’s funding will be federally funded.

Disclaimer: AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert system.

Medtronic Reports Fourth Quarter and Fiscal Year 2017 Financial Results

Posted On May 26, 2017 By OrthoSpineNews In Financial /

DUBLIN – May 25, 2017 – Medtronic plc (NYSE: MDT) today announced financial results for its fourth quarter and fiscal year 2017, which ended April 28, 2017.

The company reported fourth quarter worldwide revenue of $7.916 billion, compared to the $7.567 billion reported in the fourth quarter of fiscal year 2016, an increase of 5 percent on both a reported and constant currency basis. Foreign currency translation had a negative $37 million impact on fourth quarter revenue. As reported, fourth quarter GAAP net income and diluted earnings per share (EPS) were $1.163 billion and $0.84, respectively. As detailed in the financial schedules included through the link at the end of this release, fourth quarter non-GAAP net income and diluted earnings per share (EPS) were $1.836 billion and $1.33, an increase of 2 percent and 5 percent, respectively.

Fourth quarter U.S. revenue of $4.403 billion represented 56 percent of company revenue and increased 4 percent. Non-U.S. developed market revenue of $2.452 billion represented 31 percent of company revenue and increased 2 percent, or 4 percent on a constant currency basis. Emerging market revenue of $1.061 billion represented 13 percent of company revenue and increased 11 percent, or 10 percent on a constant currency basis.

Medtronic’s fiscal year 2017 revenue of $29.710 billion increased 3 percent, or approximately 5 percent on a constant currency, constant week basis. Foreign currency translation had a negative $34 million impact on fiscal year 2017 revenue. The first quarter of fiscal year 2017 contained 13 weeks, one less week than the first quarter of fiscal year 2016. The extra week occurs every six years as a result of the company’s 52-53 week fiscal year calendar. While it is difficult to calculate an exact impact from the extra week, the company estimates that it resulted in an approximate $450 million benefit to revenue and $0.08 to $0.10 benefit to non-GAAP diluted earnings per share (EPS) in the first quarter of the prior fiscal year. As reported, fiscal year 2017 net earnings were $4.028 billion or $2.89 per diluted share. As detailed in the link at the end of this release, fiscal year 2017 non-GAAP earnings and diluted EPS were $6.395 billion and $4.60, representing increases of approximately 8 to 9 percent and approximately 11 to 12 percent, respectively, on a constant currency, constant week basis.

“Our fourth quarter results were a strong finish to the fiscal year, with balanced, diversified growth across our groups and regions,” said Omar Ishrak, Medtronic chairman and chief executive officer. “Fiscal year 2017 was a solid year overall for Medtronic. We delivered record revenue, made progress in each of our growth strategies, executed on our Covidien cost synergy commitments, generated strong free cash flow growth, and deployed our capital in line with our stated priorities, balancing the return of cash to our shareholders together with disciplined reinvestment in our businesses.”

Cardiac and Vascular Group
The Cardiac and Vascular Group (CVG) includes the Cardiac Rhythm & Heart Failure (CRHF), Coronary & Structural Heart (CSH), and Aortic & Peripheral Vascular (APV) divisions. CVG worldwide fourth quarter revenue of $2.848 billion increased 4 percent, or 5 percent on a constant currency basis. CVG revenue performance was driven by strong, balanced growth across all three divisions.

CRHF fourth quarter revenue of $1.544 billion increased 3 percent, or 4 percent on a constant currency basis, with mid-single digit growth on a constant currency basis in Arrhythmia Management driven by the continued global adoption of the Reveal LINQ® insertable cardiac monitor, as well as high-teens growth in AF Solutions on a constant currency basis. Heart Failure growth was driven in part by the company’s first quarter acquisition of HeartWare International, Inc.
CSH fourth quarter revenue of $847 million increased 4 percent on both a reported and constant currency basis, led by mid-thirties growth on a constant currency basis in transcatheter aortic valves as a result of strong customer adoption of the CoreValve® Evolut® R platform, including the 34mm launch in the U.S. and Europe.
APV fourth quarter revenue of $457 million increased 5 percent, or 6 percent on a constant currency basis, driven by mid-single digit growth in Aortic and high-single digit growth in Peripheral, both on a constant currency basis. Aortic growth was led by the continued strength of the Endurant® IIs aortic stent graft and solid adoption of the Heli-FX® EndoAnchor® System. Peripheral was driven by low-twenties growth of the clinically differentiated IN.PACT® Admiral® drug-coated balloon and high-single digit growth in atherectomy.

Minimally Invasive Therapies Group
The Minimally Invasive Therapies Group (MITG) includes the Surgical Solutions and the Patient Monitoring & Recovery (PMR) divisions. MITG worldwide fourth quarter revenue of $2.605 billion increased 6 percent on both a reported and constant currency basis. MITG had a strong quarter with high-single digit growth in Surgical Solutions and mid-single digit growth in PMR.

Surgical Solutions fourth quarter revenue of $1.459 billion increased 7 percent, or 8 percent on a constant currency basis, driven by new products in Advanced Stapling and Advanced Energy, including endo stapling specialty reloads, the Valleylab(TM) FT10 energy platform, and LigaSure(TM) vessel sealing instruments. The division also benefitted from the second quarter acquisition of Smith & Nephew’s gynecology business.
PMR fourth quarter revenue of $1.146 billion increased 4 percent on both a reported and constant currency basis, with the above market growth driven by the re-commercialization of the Puritan Bennett(TM) 980 ventilator and the Capnostream(TM) 20 capnography monitor, growth in capnography disposables, as well as strength in Nellcor(TM) pulse oximetry products.

Restorative Therapies Group
The Restorative Therapies Group (RTG) includes the Spine, Brain Therapies, Specialty Therapies, and Pain Therapies divisions. RTG worldwide fourth quarter revenue of $1.951 billion increased 4 percent, or 5 percent on a constant currency basis. Group results were driven by high-single digit growth in Brain Therapies and Specialty Therapies and low-single digit growth in Spine, offsetting declines in Pain Therapies.

Spine fourth quarter revenue of $676 million increased 3 percent on both a reported and constant currency basis, demonstrating sustained improvement. Bone Morphogenetic Protein (BMP) grew in the low-double digits on a constant currency basis. Core Spine grew in the low-single digits on a constant currency basis, driven in part by the focus on “Speed-to-Scale” new product launches and strength in Other Biologics.
Brain Therapies revenue of $585 million increased 9 percent on both a reported and constant currency basis, with strength in Neurovascular and Neurosurgery. Neurovascular grew in the mid-teens on a constant currency basis, driven by strength in sales of the Axium(TM) Prime Extra Soft detachable coils and Solitaire(TM) revascularization devices. Neurosurgery grew in the low-double digits on a constant currency basis, driven by strong sales of the O-arm® O2 surgical imaging system. Brain Modulation grew in the low-single digits on a constant currency basis on sales of the company’s market-leading MR conditional Activa® DBS portfolio.
Specialty Therapies revenue of $396 million increased 7 percent on both a reported and constant currency basis. All three businesses contributed to growth, with Advanced Energy growing in the low-double digits, Pelvic Health growing in the high-single digits, and ENT growing in the mid-single digits, all on a constant currency basis.
Pain Therapies revenue of $294 million decreased 2 percent on both a reported and constant currency basis. Pain Therapies had mid-single digit constant currency declines in Spinal Cord Stimulation, as the business faced competitive pressures, partially offset by low-single digit constant currency growth in Drug Pumps and Interventional.

Diabetes Group
The Diabetes Group includes the Intensive Insulin Management (IIM), Diabetes Service & Solutions (DSS), and Non-Intensive Diabetes Therapies (NDT) divisions. Diabetes Group worldwide fourth quarter revenue of $512 million increased 3 percent, or 4 percent on a constant currency basis.

IIM grew in the high-single digits on a constant currency basis, with low-double digit growth in the U.S. driven by strong interest in the MiniMed® 630G system and the Priority Access Program for the MiniMed® 670G system, the world’s first hybrid closed loop insulin delivery system. In addition, the division delivered high-single digit constant currency growth in international markets due to strong growth of continuous glucose monitor (CGM) sensors and the continued strength of the MiniMed® 640G system.
NDT declined in the low-single digits on a constant currency basis. The division grew in the mid-single digits in the U.S. on sales to primary care physicians of the iPro®2 Professional CGM technology with Pattern Snapshot.
DSS declined in the low-single digits on a constant currency basis. While results were flat on a constant currency basis in international markets, the business did see strong adoption of the Guardian® Connect mobile CGM system. In the U.S., the division had mid-single digit declines due to more stringent payer requirements and lower order sizes.

Guidance
The company today provided its initial fiscal year 2018 revenue and EPS growth guidance.

In fiscal year 2018, the company expects constant currency revenue growth to be in the range of 4 to 5 percent. While the impact of foreign currency is fluid, if current exchange rates remain similar for the remainder of the fiscal year, the company’s revenue would be positively affected by approximately $75 million to $175 million for the fiscal year, including an approximate negative $10 to negative $60 million impact in the first fiscal quarter.

In fiscal year 2018, the company expects diluted non-GAAP EPS growth to be in the range of 9 to 10 percent on a constant currency basis. Assuming current exchange rates remain similar for the rest of the year, the company’s non-GAAP EPS would be negatively affected by approximately $0.05 to $0.10, including an approximate $0.03 to $0.05 impact in the first fiscal quarter.

The company reiterated its long-term expectation of mid-single digit revenue growth and double digit EPS growth, both on a constant currency basis. In addition, the company noted that the fiscal year 2018 outlook and guidance does not include the impact of the previously announced divestiture of a portion of its Patient Monitoring and Recovery division to Cardinal Health, which the company continues to expect to close in the second fiscal quarter. The company intends to update its guidance upon close of the transaction.

“We are creating distinct competitive advantages and capitalizing on the long-term trends in healthcare: namely, the desire to improve clinical outcomes; the growing demand for expanded access to care; and the optimization of cost and efficiency within healthcare systems. These trends, along with an aging population in most countries, produce secular growth tailwinds that we believe represent sustainable, long-term opportunities for Medtronic,” said Ishrak. “As we look forward, we have a number of catalysts that make us optimistic about our ability to deliver on our commitments and expand patient access around the world to our products and services. Our leadership team and employees continue to focus on driving excellence and impact in all that we do, and we look forward to the fiscal year ahead.”

Webcast Information
Medtronic will host a webcast today, May 25, at 8:00 a.m. EDT (7:00 a.m. CDT) to provide information about its businesses for the public, analysts, and news media. This quarterly webcast can be accessed by clicking on the Investor Events link at investorrelations.medtronic.com and this earnings release will be archived at newsroom.medtronic.com. Medtronic will be live tweeting during the webcast on our Newsroom Twitter account, @Medtronic. Within 24 hours of the webcast, a replay of the webcast and transcript of the company’s prepared remarks will be available by clicking on the Investor Events link at investorrelations.medtronic.com.

Financial Schedules
To view the fourth quarter financial schedules and non-GAAP reconciliations, click here. To view the fourth quarter earnings presentation, click here. Both documents can also be accessed by visiting newsroom.medtronic.com.

About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world’s largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 88,000 people worldwide, serving physicians, hospitals and patients in approximately 160 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

FORWARD LOOKING STATEMENTS
This press release contains forward-looking statements related to product and service growth drivers, market position and opportunities, the transforming healthcare environment, strategies for and sustainability of growth, benefits from collaborations and acquisitions, availability of and plans for cash, the creation of shareholder value and shareholder returns, product launches, and Medtronic’s future results of operations, which are subject to risks and uncertainties, such as competitive factors, difficulties and delays inherent in the development, manufacturing, marketing and sale of medical products, challenges with respect to third-party collaborations and integration of acquired businesses, effectiveness of growth and restructuring strategies, challenges relating to our worldwide operations, challenges or unforeseen risks in implementing our growth strategies, government regulation, fluctuations in foreign currency exchange rates, future revenue and earnings growth, and general economic conditions and other risks and uncertainties described in Medtronic’s periodic reports and other filings with the U.S. Securities and Exchange Commission (the “SEC”). Anticipated results only reflect information available to Medtronic at this time and may differ from actual results. Medtronic does not undertake to update its forward-looking statements or any of the information contained in this press release. Certain information in this press release includes calculations or figures that have been prepared internally and have not been reviewed or audited by our independent registered public accounting firm, including but not limited to, certain information in the financial schedules accompanying this press release. Use of different methods for preparing, calculating or presenting information may lead to differences and such differences may be material.

NON-GAAP FINANCIAL MEASURES
This press release contains financial measures and guidance, including free cash flow figures (defined as operating cash flows less property, plant and equipment additions), revenue and growth rates on a constant currency and constant week basis, net income, and diluted EPS, all of which are considered “non-GAAP” financial measures under applicable SEC rules and regulations. Unless otherwise noted, all revenue amounts given in this press release are stated in accordance with U.S. generally accepted accounting principles (GAAP). References to quarterly or annual figures increasing or decreasing are in comparison to the fourth quarter of fiscal year 2016 and full fiscal year 2016, respectively.

Medtronic management believes that in order to properly understand its short-term and long-term financial trends, including period over period comparisons of the company’s operations, investors may find it useful to exclude the effect of certain charges or gains that contribute to or reduce earnings but that result from transactions or events that management believes may or may not recur with similar materiality or impact to operations in future periods (Non-GAAP Adjustments). Medtronic generally uses non-GAAP financial measures to facilitate management’s review of the operational performance of the company and as a basis for strategic planning. Non-GAAP financial measures should be considered supplemental to and not a substitute for financial information prepared in accordance with GAAP, and investors are cautioned that Medtronic may calculate non-GAAP financial measures in a way that is different from other companies. Management strongly encourages investors to review the company’s consolidated financial statements and publicly filed reports in their entirety. Reconciliations of the non-GAAP financial measures to the most directly comparable GAAP financial measures are included in the financial schedules accompanying this press release.

Medtronic calculates forward-looking non-GAAP financial measures based on internal forecasts that omit certain amounts that would be included in GAAP financial measures. For instance, forward-looking revenue growth and EPS projections exclude the impact of foreign currency exchange fluctuations. Forward-looking non-GAAP EPS guidance also excludes other potential charges or gains that would be recorded as non-GAAP adjustments to earnings during the fiscal year, such as amortization of intangible assets and acquisition-related, certain tax and litigation, and restructuring charges or gains. Medtronic does not attempt to provide reconciliations of forward-looking non-GAAP EPS guidance to projected GAAP EPS guidance because the combined impact and timing of recognition of these potential charges or gains is inherently uncertain and difficult to predict and is unavailable without unreasonable efforts. In addition, we believe such reconciliations would imply a degree of precision and certainty that could be confusing to investors. Such items could have a substantial impact on GAAP measures of financial performance.

View FY17 Fourth Quarter Financial Schedules & Non-GAAP Reconciliations
View FY17 Fourth Quarter Earnings Presentation

Contacts:
Fernando Vivanco
Public Relations
+1-763-505-3780

Ryan Weispfenning
Investor Relations
+1-763-505-4626

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Invibio demonstrates biomaterial for implants at China workshop

Posted On May 26, 2017 By OrthoSpineNews In Spine /

May 25, 2017 – Medical Plastic News

At the recent congress of the Chinese Association of Orthopaedic Surgeons (CAOS), Invibio Biomaterial Solutions of the UK, and China’s Double Medical Technology collaborated on an interbody spine surgery workshop to help expand knowledge of the implantation of Double Medical’s Direct Lateral Interbody Fusion (DLIF) spinal cages made with PEEK-Optima .

The biomaterial PEEK-Optima polymer by Invibio was introduced to medical device manufacturers in China after the approval by the China Federal Drug Administration (CFDA) in 2004.

Hosted in conjunction with the North American Spine Society (NASS), the CAOS workshop “Principles and Techniques of Complex Spine Surgery Workshop” took place on May 12, 2017, at the Zhongshan School of Medicine, Sun Yat-sen University, in Guangzhou. The event was the fifth joint NASS-CAOS workshop and delivered a full day of hands-on cadaver labs with over one hundred surgeons attending and multiple one-hour product demonstrations streamed live to the audience, including the demonstration of Double Medical and medical-grade PEEK innovator Invibio.

Double Medical, a large medical equipment group whose broad product range includes orthopaedic implants, dental implants, general surgical products, neurosurgical products and electronic medical devices, and Invibio have been working together since 2009. At this jointly planned NASS-CAOS event, the two companies demonstrated a Direct Lateral Interbody Fusion (DLIF) spinal cage made with PEEK-Optima and showed how the DLIF cage, which has already been used in lumbar surgeries, can provide a better overall therapeutic experience for patients.

READ THE REST HERE

SurGenTec’s GRAFTGUN Receives Key Patent

Posted On May 26, 2017 By OrthoSpineNews In Regulatory, Top Stories / 1

May 25, 2017

BOCA RATON, Fla.–(BUSINESS WIRE)–SurGenTec®, a minimally invasive orthobiologics company, has announced that the United States Patent and Trademark Office has granted a new patent for its bone graft delivery technology.

The proprietary GRAFTGUN® delivery system enables surgeons to deliver the bone graft of their choice (synthetic, allograft, or autograft) in a minimally invasive fashion.

Traditionally, surgeons have used a metal funnel and tamp to place bone graft; these surgeons have sought a solution to overcome the difficulties and dangers with this technique. The GRAFTGUN provides a simple, safe and ergonomic solution to deliver bone graft in hard to reach places.

The GRAFTGUN kit includes a loading device and multiple tube sizes to support a variety of surgical procedures and patient sizes. The tubes have embedded radiopaque markers which enable the surgeon to visualize where their bone graft is being placed on fluoroscopy. The ratcheting technology provides the force necessary to extrude the majority of bone grafts on the market.

SurGenTec develops minimally invasive surgical technologies to help surgeons provide optimal care for their patients. SurGenTec believes the GRAFTGUN will be an asset to surgeons in both spine and orthopedic procedures.

The patent adds to SurGenTec’s portfolio of existing patents and patents pending.

SurGenTec also has several up-and-coming technologies that will be rolled out over the course of this year.

SurGenTec, a privately owned medical device company based out of Boca Raton, FL, plans to release the GRAFTGUN this summer.

Contacts

For SurGenTec
Andrew Shoup, 714-350-2546
Ashoup@SurGenTec.com
www.SurGenTec.com

Bodycad Receives EU Product Notification Confirmation for Personalized Unicompartmental Knee System

Posted On May 26, 2017 By OrthoSpineNews In Recon, Regulatory /

QUEBEC CITY, QUEBEC, CANADA, May 24, 2017 /EINPresswire.com/ — Bodycad announced today that it has received product notification confirmation from the Belgian Federal Agency for Medicines and Health Products in Brussels, the legislative capital for the European Union, for its Bodycad Unicompartmental Knee System. This enables Bodycad to commercially launch this truly personalized orthopaedic restoration within the European Union in accordance with EU Medical Device Directive for custom devices. Bodycad is the first Canadian company to receive EU product notification confirmation for a joint reconstruction implant system.

Bodycad’s revolutionary Unicompartmental Knee System is designed to optimize personalized restoration of the patient’s unique anatomical features and kinematics. The system is based on proprietary 3D rendering of medical images of the patient’s anatomy. The restoration is delivered as a “procedure in a box” that completely revolutionizes the way orthopaedic implant and instrument applications are delivered and utilized in the operating room environment.

“The personalized restoration is created only after proper acquisition of data from the patient on an individualized level,” says Etienne Belzile, MD, orthopaedic surgeon and assistant professor at Laval University. “The benefit of personalized restoration is the possibility of a better fit to the individual, less trauma to the soft tissue, and potentially a faster recovery overall.”

Bodycad uses proprietary imaging algorithms to rapidly produce a precise 3D image of the patient’s knee. Its suite of Personalized Restoration Software enables a seamless integration of the image to implant process called the PREP (personalized restoration evaluation process). The efficient and rapid process is designed to increase patient satisfaction, improve manufacturing precision while improving economic quality metrics.

“Our proprietary software is based on 20 years of research in anthropometric data and is the first CAD/CAM software specifically developed for the personalization of orthopaedic implant and instrument design,” says Jean Robichaud, founder and CEO of Bodycad. “I am delighted to have European product notification confirmation to bring this important technological advancement to market. Our goal is to transform the way surgeons, patients and insurers think about the potential of mass customization to optimize patient care.”

About Bodycad

Bodycad is a Quebec City-based developer and manufacturer of personalized orthopaedics. Its personalized restorations offer patients a high level of conformity to their unique anatomy, with the potential for greater comfort, fit and durability that make the pursuit of orthopaedic perfection possible. Learn more at www.bodycad.com.

Andrew McLeod
Bodycad
1 418 527 1388
email us here

SANUWAVE Announces Appointment of LITHOMED as Distributor for Orthopedics Products in Taiwan

Posted On May 26, 2017 By OrthoSpineNews In Biologics /

SUWANEE, GA–(Marketwired – May 25, 2017) – SANUWAVE Health, Inc. (OTCQB: SNWV) is pleased to announce that the company has appointed LITHOMED to act as distributors for SANUWAVE’s Orthopedic products in Taiwan.

Kevin Richardson II, CEO and Chairman, stated, “SANUWAVE has committed to deliver 3-5 new distribution partners in the second quarter and 7-10 by the end of the year. This is the first step in achieving or beating our target. We are also excited to be able to support our science advisor Dr. Chin-Jen Wang, Professor of Orthopedic Surgery at Chang Gung Memorial Hospital, and his newly founded Shockwave Institute in BANG DONG, Taiwan.”

André Mouton, V.P. International Sales and Relations of SANUWAVE, stated, “We are very pleased with this new relationship. LITHOMED has a wealth of experience within this specific indication and will be the right fit for our needs within the orthopedic market segment in Taiwan. Their access and relationships with Key Opinion Leaders (KOL’s) will prove to be of immense value for market development and revenue growth. Taiwan is the first country where we shall have a definitive split within our distribution model. We recognize that Orthopedics and Wound Care have a different customer base and the designated distributor needs to address that. We are expecting sales from this region to be well over $500,000 within the next three years, with a maximum value of $3 million. We have more than 200 of our devices in use in Europe and we are sure the Asia market and usage will progress accordingly. Taiwan will be our second territory within Asia,” concluded André Mouton.

William Kao, Managing Director: “LITHOMED is very pleased to be the distributor for SANUWAVE’s orthopedic products in Taiwan. The orthoPACE® device, with its patented focused shock wave technology, is an important advancement in orthopedic and musculoskeletal care and offers a wide range of non-invasive treatment procedures for hospitals and doctor’s offices. I am certain it will be welcomed by Taiwanese orthopedists and their patients. These innovative products will fit perfectly within our portfolio and will be a welcomed addition to our current network of loyal customers and users. The orthoPACE device has been proven safe and effective for the treatment of chronic tendonitis and joint pain in the musculoskeletal environment. orthoPACE treatments have been especially effective in treating tendonitis and plantar fasciitis, which commonly require surgery. orthoPACE is designed to effectively treat bone conditions requiring osteogenesis, calcific joints, conditions causing painful joints, and chronic pain caused by musculoskeletal disorders. orthoPACE uses focused, shock wave treatments that are non-invasive which dramatically reduce the risk of infection. In many indications, orthoPACE has a proven success rate that is equal to or greater than that of surgery — usually with just one procedure and without the inherent risks, complications, or lengthy recovery time of invasive surgery. orthoPACE treatments require a minimal amount of treatment time. In conditions such as plantar fasciitis, patients can bear weight immediately and return to pre-treatment activity within a few days of the procedure,” concluded William Kao.

About SANUWAVE Health, Inc.

SANUWAVE Health, Inc. (OTCQB: SNWV) (www.sanuwave.com) is a shock wave technology company initially focused on the development and commercialization of patented noninvasive, biological response activating devices for the repair and regeneration of skin, musculoskeletal tissue and vascular structures. SANUWAVE’s portfolio of regenerative medicine products and product candidates activate biologic signaling and angiogenic responses, producing new vascularization and microcirculatory improvement, which helps restore the body’s normal healing processes and regeneration. SANUWAVE applies its patented PACE technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions. Its lead product candidate for the global wound care market, dermaPACE®, is CE Marked throughout Europe and has device license approval for the treatment of the skin and subcutaneous soft tissue in Canada, Australia and New Zealand. In the U.S., dermaPACE is currently under the FDA’s de novo petition review process for the treatment of diabetic foot ulcers. SANUWAVE researches, designs, manufactures, markets and services its products worldwide, and believes it has demonstrated that its technology is safe and effective in stimulating healing in chronic conditions of the foot (plantar fasciitis) and the elbow (lateral epicondylitis) through its U.S. Class III PMA approved OssaTron® device, as well as stimulating bone and chronic tendonitis regeneration in the musculoskeletal environment through the utilization of its OssaTron, Evotron® and orthoPACE® devices in Europe, Asia and Asia/Pacific. In addition, there are license/partnership opportunities for SANUWAVE’s shock wave technology for non-medical uses, including energy, water, food and industrial markets.

About LITHOMED
Litho Med Trading Company has been established in 1994. The company specializes in distribution of medical equipment with a key focus on Shockwave Technology. It has been involved with clinical studies with OssaTron in 1998 and the company is closely working with the Key Opinion Leaders (KOL’s) within Shockwave technology within Taiwan since. The company is the sole distributor for Edaptms for UST since 2010. The orthoPACE technology and usage will be an added indication to complete the current product offering.

Litho Med Trading Co., Ltd.
TEL:06-2903269 FAX:06-2903297
3F-7, No.293 Sec 3, Dung-Men Road.
Tainan 701, Taiwan, R.O.C.

Forward-Looking Statements

This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements relating to financial results and plans for future business development activities, and are thus prospective. Forward-looking statements include all statements that are not statements of historical fact regarding intent, belief or current expectations of the Company, its directors or its officers. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond the Company’s ability to control. Actual results may differ materially from those projected in the forward-looking statements. Among the key risks, assumptions and factors that may affect operating results, performance and financial condition are risks associated with the regulatory approval and marketing of the Company’s product candidates and products, unproven pre-clinical and clinical development activities, regulatory oversight, the Company’s ability to manage its capital resource issues, competition, and the other factors discussed in detail in the Company’s periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statement.

For additional information about the Company, visit www.sanuwave.com.

CONTACT INFORMATION

Millennium Park Capital LLC
Christopher Wynne
312-724-7845
cwynne@mparkcm.comSANUWAVE Health, Inc.
Andre Mouton
Vice President International Sales and Relations
+1-615-823-9907 (Cell)
+1-678-569-0881(Fax)
Skype: andre.w.mouton
Andre.Mouton@sanuwave.com

Antibe Therapeutics Inc. Announces Proposed Offering of Units

Posted On May 25, 2017 By OrthoSpineNews In Financial /

TORONTO–(BUSINESS WIRE)–Antibe Therapeutics Inc. (“Antibe” or the “Company“) (TSXV: ATE) (OTCQX: ATBPF) a diversified biotechnology company announced today that it has filed a preliminary short form prospectus in connection with a proposed marketed offering of units of the Company (the “Units”) for minimum gross proceeds of $3,000,000 and maximum gross proceeds of $5,000,000 (the “Offering”). Each Unit will be comprised of one common share of the Company and one half of one common share purchase warrant (each full warrant, a “Warrant”). The Offering will be undertaken on a “best efforts” agency basis in the provinces of Ontario, British Columbia and Alberta pursuant to the Company’s preliminary short form prospectus dated May 24, 2017 (the “Preliminary Prospectus”), filed with securities regulators in Ontario, British Columbia and Alberta.

The number of Units to be distributed, the price of each Unit and the exercise price and term of each Warrant will be determined in the context of the market. Bloom Burton Securities Inc., Dominick Inc., and Echelon Wealth Partners Inc. are co-agents for the Offering (together, the “Agents”).

The Company has granted the Agents an over-allotment option (the “Over-Allotment Option”), exercisable in whole or in part, at the Agents’ sole discretion, at any time and from time to time for a period of 30 days following the final closing, to offer and sell on the same terms as the Offering up to such number of additional Units as is equal to 15% of the number of Units issued under the Offering.

In consideration for the services to be rendered by the Agents in connection with the Offering, the Agents will receive a fee consisting of cash and broker warrants.

If the minimum offering size is completed, the Company intends to use the net proceeds to: (i) complete its Phase 2 GI safety study for the Company’s lead drug, ATB-346 and (ii) commence metabolic studies for ATB-346. If the maximum offering size is completed, the Company intends to use the net proceeds to: (i) complete its Phase 2 GI safety study for ATB-346; (ii) commence its Phase 2 dose-ranging efficacy clinical study for ATB-346; (iii) fully fund the metabolism studies of ATB-346; and (iv) partially fund IND-enabling pre-clinical studies for its second pipeline drug, ATB-352. In addition to clinical development, the Company intends to use a portion of the net proceeds of the Offering for Citagenix product and business development, working capital and general corporate purposes. For additional detail regarding the use of proceeds, please refer to the Preliminary Prospectus.

The Offering is subject to a number of conditions, including, without limitation, receipt of all regulatory approvals, including the approval of the TSX Venture Exchange. There can be no assurance as to whether or when the Offering may be completed, or as to the actual size or terms of the Offering.

A copy of the Preliminary Prospectus, which was filed in each of the provinces of Ontario British Columbia and Alberta, contains important information relating to the Offering and the Units, and is available on SEDAR at www.sedar.com or by contacting Bloom Burton Securities Inc., at ecm@bloomburton.com. The Preliminary Prospectus is still subject to completion or amendment. There will not be any sale or any acceptance of an offer to buy the Units until a receipt for the final prospectus relating to the Offering has been issued.

This press release does not constitute an offer to sell or a solicitation of an offer to buy the Units in any jurisdiction, nor will there be any offer or sale of the Units in any jurisdiction in which such offer, solicitation or sale would be unlawful. The Units have not and will not be registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”), or any U.S. state securities laws, and therefore will not be offered or sold within the United States except pursuant to exemptions from the registration requirements of the U.S. Securities Act and applicable state securities laws.

About Antibe Therapeutics Inc.

Antibe develops safer medicines for pain and inflammation. Antibe’s technology involves linking a hydrogen sulfide-releasing molecule to an existing drug to produce a patented, improved medicine. Antibe’s lead drug ATB-346 targets the global need for a safer drug for chronic pain and inflammation. ATB-352, the second drug in Antibe’s pipeline, targets the urgent global need for a safer, non-addictive analgesic for treating severe acute pain, while ATB-340 is a GI-safe derivative of aspirin.

Antibe’s subsidiary, Citagenix Inc. (“Citagenix”), is a leader in the sales and marketing of tissue regenerative products servicing the orthopedic and dental marketplaces. Since its inception in 1997, Citagenix has become an important source of knowledge and experience for bone regeneration in the Canadian medical device industry. Citagenix is active in 15 countries, operating in Canada through its direct sales teams, and internationally via a network of distributor partnerships.

Forward-Looking Information

This news release contains certain “forward-looking information” as such term is defined under applicable Canadian securities laws. All statements, other than statements of historical fact, that address activities, events or developments that the Company believes, expects or anticipates will or may occur in the future (including, without limitation, statements relating to the Offering generally, the terms thereof and the use or proceeds from the Offering) constitute forward-looking information. This forward-looking information reflects the current expectations or beliefs of the Company based on information currently available to the Company as well as certain assumptions including, without limitation, the ability of the Company to complete the Offering in a timely manner and on the terms and conditions described in the news release). Forward-looking information is subject to a number of significant risks and uncertainties and other factors that may cause the actual results of the Company to differ materially from those discussed in the forward-looking information, and even if such actual results are realized or substantially realized, there can be no assurance that they will have the expected consequences to, or effects on the Company. Factors that could cause actual results or events to differ materially from current expectations include, but are not limited to, the risk that the Company may not be able to raise the minimum amount of proceeds required to complete the Offering; the failure of the Company to effectively obtain the approval of the TSX Venture Exchange for the Offering; the inability of the Company to satisfy all conditions to the completion of the Offering and the risk of unforeseen delays in the completion of the Offering, if at all, whether as a result of market conditions or otherwise. Reference is also made to the risk factors disclosed under the heading “Risk factors” in the Company’s AIF for the year ended March 31, 2016 which has been filed on SEDAR and is available under the Company’s profile at www.sedar.com.

The TSX Venture Exchange has in no way passed upon the merits of the proposed Offering and has neither approved nor disapproved the contents of this press release. Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Contacts

Antibe Therapeutics Inc.
Dan Legault, +1 416-473-4095
Chief Executive Officer
dan.legault@antibethera.com

Stryker Returns To DEAN & DELUCA Invitational For Second Consecutive Year With Plans To Honor Military Veteran With Service Canine

Posted On May 25, 2017 By OrthoSpineNews In Extremities, Financial /

MAHWAH, N.J., May 24, 2017 /PRNewswire/ — Stryker Orthopaedics announced today plans to activate in Fort Worth, TX for the DEAN & DELUCA Invitational. For the second consecutive year appearing at the tournament, Stryker will continue to engage with fans through its onsite activation, The Mobility Zone – a destination designed to educate golf fans on the importance of joint health through various engaging activities. New for 2017, on Friday, Army Veteran Robert Baker, Stryker’s Vice President of Operations, will present one well-deserving military hero with a service dog in a special K9s For Warriors ceremony – marking the company’s third donation this year.

As an extension of a successful relationship that began last year, throughout the PGA TOUR® and PGA TOUR Champions 2017 season, 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 year marks the 71st anniversary of the tournament being held at Colonial Country Club – making it the longest running PGA TOUR event at the same venue. While on site, Stryker will showcase its commitment to educate Colonial’s dedicated tournament goers about the importance of leading an active lifestyle and having healthy joints. Inside The Mobility Zone, fans can partake in the new Stryker Challenge – a hands-on experience featuring Art H. Ritis, a life-size model that aims to provide tournament goers with 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

“We are proud to continue to serve as a resource for fans onsite to learn about the importance of joint health, while also paying tribute to our brave service men and women,” said Bill Huffnagle, President, Stryker’s Joint Replacement Division. “Tournament goers can visit The Mobility Zone to support our military by purchasing a Stryker hat and learn more about joint health through fun activities and challenges.”

In an effort to reach fans both on and off the golf course, the company recently embarked on a cross- country road trip with brand ambassadors, NFL Hall of Famer Jerome Bettis and PGA TOUR Champions player and GetAroundKnee® patient, Fred Funk. The two have teamed up alongside Stryker to create a video series, demonstrating various ways to stay healthy and keep your joints moving. Earlier this month, Bettis and Funk stopped by Forth Worth to film the second episode of the video series where they went to the local batting cages to hit a few balls, and made a pit stop at the nation’s largest honky-tonk to learn how to line dance. To follow the “Road Trip to a Healthier Lifestyle” series and learn more about Stryker, visit StrykerChallenge.com.

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.
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 leading global platform in professional golf, showcasing the highest expression of excellence, both on and off the course. The PGA TOUR’s mission is to entertain and inspire its fans, deliver substantial value to its partners, create outlets for volunteers to give back, generate significant charitable and economic impact in the communities in which it plays, grow and protect the game of golf and provide financial opportunities for TOUR players.

The PGA TOUR co-sanctions 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. Its members represent the world’s best players, hailing from 24 countries (86 members are from outside the United States). Worldwide, PGA TOUR tournaments are broadcast to more than 1.1 billion households in 227 countries and territories in 23 languages. Virtually all tournaments are organized as non-profit organizations in order to maximize charitable giving. In 2016, tournaments across all Tours generated a record of more than $166 million for local and national charitable organizations, bringing the all-time total to $2.46 billion.

The PGA TOUR’s web site is PGATOUR.COM, the No. 1 site in golf, and the organization is headquartered in Ponte Vedra Beach, Fla.

SOURCE Stryker

NovaBone Announces Irrigation Resistant Products with Carriers that have Synergistic Effect in Bone Formation

Posted On May 25, 2017 By OrthoSpineNews In Biologics, Top Stories /

May 24, 2017

JACKSONVILLE, Fla.–(BUSINESS WIRE)–NovaBone Products, a leading biologics medical device company, announces the addition of NovaBone IRM and NovaBone IRM MacroPOR to its portfolio of biologically active bone graft substitutes.

NovaBone IRM, and NovaBone IRM MacroPOR are the most advanced bioactive synthetic bone graft substitutes available to the orthopedic community today. Both formulations optimize osteogenesis, uniquely signal and stimulate osteoblastic activity, and offer angiogenic potential. By design, both formulations are highly irrigation resistant with excellent cohesion and handling properties.

“NovaBone Products’ base Bioactive Glass technology has proven to out-perform traditional calcium sulfate based synthetic products and demineralized bone matrix products,” said Dennis McBride, Vice President of Sales and Marketing. “We are now advancing our science further by providing formulations with carriers that have a synergistic effect in bone formation and retain molded shapes following implantation and irrigation.”

Novabone offers the broadest portfolio of bioactive synthetic bone graft substitutes in the world, with a robust pipeline of products in development designed to expand the regenerative biologics products the company offers. Presently, products offered include minimally invasive (MIS) delivery devices, strip formulations, putty materials that are hydrated using bone marrow aspirate, and putty formulations that are ready-to-use out of the package.

“We are proud to offer products that allow a surgeon to look to one company when addressing bone grafting needs,” concluded McBride.

NovaBone Products, a privately held company based in Florida, USA since 2002 and a recognized industry leader in bioactive glass design and manufacturing, developed the first bioactive synthetic bone graft offered to the orthopaedic community.

Contacts

NovaBone Products
Arthur Wotiz, President
904-651-0607
awotiz@novabone.com

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