May 2017 – Page 2 – Selby Spine

WARSAW, Ind., May 30, 2017 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced that its Board of Directors has approved the payment of a quarterly cash dividend to stockholders for the second quarter of 2017.

The cash dividend of $0.24 per share will be paid on or about July 28, 2017 to stockholders of record as of the close of business on June 23, 2017. Future declarations of dividends are subject to approval of the Board of Directors and may be adjusted as business needs or market conditions change.

About Zimmer Biomet

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

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

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

SOURCE Zimmer Biomet Holdings, Inc.

Contacts

DJO Investor/Media Contact:
DJO Global, Inc.
David Smith
SVP, Treasurer and Investor Relations
760.734.3075
ir@djoglobal.com

Source: The Life Sciences Report – May 29, 2017

Assure Neuromonitoring, a wholly owned subsidiary of Assure Holdings Inc. (IOM:TSX.V), provides intraoperative neuromonitoring (IONM) services. The standard of care in the United States is to provide IONM services to monitor the nervous systems of patients undergoing invasive surgeries such as spine, ear, nose and throat, and others, to monitor the activity and warn the surgeon if he/she is getting close to a nerve, thereby preventing nerve damage.

Most IONM services are staffed by onsite technologists and offsite neurologists who are provided by third-party services, which does not provide consistency or accountability. According to the company, the Assure platform “employs its own staff of highly trained technologists and uses its own state of the art monitoring equipment, handles 100% of intraoperative neuromonitoring scheduling and setup, and bills for all technical services provided.” Assure’s technologists and neurologists are dedicated to specific surgeons and work as a team, thereby developing rapport and trust.

The company notes that “Assure has developed a comprehensive platform that engages all stakeholders including the surgeon, the technologist, the neurologist, and the patient.”

The company began operations in Colorado in 2015 and has primarily serviced spine surgeries. The company plans to expand into additional states and into additional types of surgeries.

READ THE REST HERE

Lydia Ramsey – May 26, 2017

Food and Drug Administration commissioner Dr. Scott Gottlieb has a plan to tackle high drug prices.

“Simply put, too many patients are priced out of the medicines they need,” Gottlieb said Thursday at the FDA’s budget hearing.

The FDA is responsible for regulating food and drugs. It’s also responsible for regulating medical devices, blood donations, veterinary products, cosmetics, and tobacco. The FDA doesn’t directly play a role in setting drug prices.

Even so, Gottlieb said there are a few main ways he thinks the agency can help.

By stopping the industry from gaming regulations to get more time without competition beyond what Congress intended.
Making it more straightforward for complex generic drugs to get to market. Complex drugs are devices like the EpiPen or inhalers that competitors have a hard time getting approved. It’s something Gottlieb has been advocating for for years.
Getting through of the backlog of generic drug applications.

READ THE REST HERE

SALT LAKE CITY, UT–(Marketwired – May 26, 2017) – Amedica Corporation (NASDAQ: AMDA), an innovative biomaterial company which develops and manufactures silicon nitride as a platform for biomedical applications, announced today that it has delayed the filing of its Quarterly Report on Form 10-Q for the quarter ended March 31, 2017 (“Form 10-Q”).

On May 16, 2017, Amedica filed a Form 12b-25, Notification of Late Filing, with the Securities and Exchange Commission (the “SEC”) regarding its delayed Form 10-Q. Prior to filing the Form 10-Q the Company requires additional time to fully consider whether there is any potential impairment in relation to certain of its long-lived assets in connection with the completion of the audit of its 2016 financial results and the filing of its 2016 Annual Report on Form 10-K. Management and the Audit Committee of the Company’s Board of Directors are continuing to work diligently to complete its Annual Report on Form 10-K for the fiscal year ended December 31, 2016 and file it with the SEC as soon as possible. Upon filing of the annual report the Company expects to promptly file the Form 10-Q.

Because the filing of the Company’s Form 10-Q has been delayed beyond the 5-day extension period of Form 12b-25, on May 23, 2017, Amedica received a written notice from the Listing Qualifications Department of The Nasdaq Stock Market (“NASDAQ”) indicating that the Company is not in compliance with Listing Rule 5250(c)(1) because the Company has failed to file its Quarterly Report on Form 10-Q for the quarter ended March 31, 2017.

Under the NASDAQ Listing Rules, because the Company is also delinquent on filing its Annual Report on Form 10-K for the period ended December 31, 2016, the Company has until June 19, 2017 to submit a plan to NASDAQ as to how it plans to regain compliance with NASDAQ’s continued listing requirements. If the Company is still unable to file its Form 10-K and Form 10-Q by that time, then the Company intends to submit a compliance plan on or prior to that date. If NASDAQ accepts the Company’s plan, NASDAQ can grant an exception of up to 180 calendar days from the filing’s due date, or until September 27, 2017, to regain compliance. The Company may regain compliance at any time during this 180-day period upon filing with the SEC its Form 10-K and Form 10-Q, as well as all subsequent required periodic financial reports that are due within that period. If NASDAQ does not accept the Company’s plan, Amedica will have the opportunity to appeal that decision to a NASDAQ Hearings Panel.

The NASDAQ notification letter has no immediate effect on the listing of Amedica’s common stock on the NASDAQ Capital Market.

About Amedica Corporation
Amedica is focused on the development and application of medical-grade silicon nitride ceramics. Amedica markets spinal fusion products and is developing a new generation of wear- and corrosion-resistant implant components for hip and knee arthroplasty. The Company manufactures its products in its ISO 13485 certified manufacturing facility and, through its partnership with Kyocera, the world’s largest ceramic manufacturer. Amedica’s spine products are FDA-cleared, CE-marked, and are currently marketed in the U.S. and select markets in Europe and South America through its distributor network and its OEM partnerships.

For more information on Amedica or its silicon nitride material platform, please visit www.amedica.com.

Cautionary Note Regarding Forward-Looking Statements
This press release contains statements that constitute forward-looking statements within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. These statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of various factors and uncertainties. For example, there can be no assurance that we will be able to maintain our listing on any NASDAQ market. Other factors that could cause actual results to differ materially from those contemplated within this press release can also be found in Amedica’s Risk Factors disclosure in its Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on March 23, 2016, and in Amedica’s other filings with the SEC. Forward-looking statements contained in this press release speak only as of the date of this press release. We undertake no obligation to update any forward-looking statements as a result of new information, events or circumstances or other factors arising or coming to our attention after the date hereof.

CONTACT INFORMATION

Contact:
Amedica IR
801-839-3502
IR@amedica.com

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

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.

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

VictrexUK_235_Surgeons-learning-advanced-technology-at-CAOS-NASS-workshop_C-CAOS-2017_2.jpg

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

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

Newer Posts

Older Posts

Search

3 days / 6 sessions
Current Issues in Spine

Zimmer Biomet Announces Quarterly Dividend for Second Quarter of 2017

Related Links

DJO Global Announces Appointment of Jeffery McCaulley as Global President, DJO Surgical

Contacts

Neuromonitoring Company Founded by Former NFL Quarterback Set to Go Public

Here’s what Trump’s head of the FDA wants to do about high drug prices

Amedica Announces Delayed Filing of Quarterly Report on Form 10-Q and Receipt of Nasdaq Letter

CONTACT INFORMATION

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

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

Medtronic Reports Fourth Quarter and Fiscal Year 2017 Financial Results

Invibio demonstrates biomaterial for implants at China workshop

SurGenTec’s GRAFTGUN Receives Key Patent

Contacts

STAR Ankle Joint Replacements Last Long Term and Provide Relief for Patients

Medacta USA’s Spine Division Begins 2017 with Key Appointment, Significant Growth

Spinal Stabilization Technologies Announces Start of LOPAIN 2 Clinical Trial in South America for Lumbar Degenerative Disc Disease

$250K Pediatric Device Competition Now Accepting Proposals

First Single-Use Rigid Endoscope to be Demonstrated at AAOS