Graham Baker appointed Chief Financial Officer

30 November 2016

Smith & Nephew plc (LSE:SN, NYSE:SNN), the global medical technology business, today announces the appointment of Graham Baker as Chief Financial Officer. He will formally begin the role on 1 March 2017 when he will also be appointed to the Board as an Executive Director.

Graham joins from Alvogen, a fast-growing generic pharmaceuticals company, where he is Chief Financial Officer. Alvogen has 35 offices globally across US, Europe and Asia and is owned by the founder and major private equity firms led by CVC and Temasek.

Prior to Alvogen, Graham worked for AstraZeneca PLC for 20 years, holding multiple senior roles  including, most recently, Vice President, Finance , International (2013-2015) with responsibility for all emerging markets, Vice President, Global Financial Services (2010-2013) and Vice President Finance & Chief Financial Officer, North America (2008-10).

Graham qualified as a Chartered Accountant and Chartered Tax Advisor with Arthur Andersen. He is a British national.

Olivier Bohuon, Chief Executive Smith & Nephew, commented:

“Graham’s blue-chip experience, deep sector knowledge and extensive exposure to established and emerging markets set him apart as the ideal next CFO for Smith & Nephew. He has a strong track record of delivering operational excellence and has relevant experience across major finance roles and geographic markets, leading large teams responsible for significant budgets. With his hands-on approach, I have no doubt that he will successfully ensure effective financial stewardship for Smith & Nephew.”

Graham Baker commented:

“It took a compelling opportunity to tempt me from Alvogen, but I could not ignore the potential of this role and the business at Smith & Nephew.  I look forward to joining the Board and working with Olivier and his team to deliver further success in the business, as well as ensuring that the Finance function adds ever more value, as Smith & Nephew continues its transformation.”

No further disclosure obligations arise under paragraphs (1) to (6) of LR 9.6.13 R of the UK Listing Authority’s Listing Rules in respect of this appointment.

Remuneration

Mr Baker will be paid in accordance with the Remuneration Policy approved by shareholders in 2014, as set out in the Annual Report 2015. He will receive a base salary of £510,000 per annum and participate in the Annual Incentive Plan (cash and equity) and the Performance Share Plan. He will also receive a payment in lieu of pension and standard benefits as set out in the Annual Report. An updated Remuneration Policy will be put to shareholders for approval at the 2017 AGM and any future awards will be subject to performance conditions and measures in force at the time of the award. His notice period will be 6 months, 12 months from the Company. No additional payment will be made on recruitment.

Enquiries

Investors
Ingeborg Øie
+44 (0) 20 7960 2285
Smith & Nephew

Media
Charles Reynolds
+44 (0) 1923 477314
Smith & Nephew

Ben Atwell / Matthew Cole
+44 (0) 20 3727 1000
FTI Consulting

About Smith & Nephew

Smith & Nephew is a global medical technology business dedicated to helping healthcare professionals improve people’s lives. With leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma & Extremities, Smith & Nephew has around 15,000 employees and a presence in more than 100 countries. Annual sales in 2015 were more than $4.6 billion. Smith & Nephew is a member of the FTSE100 (LSE:SN, NYSE:SNN).

For more information about Smith & Nephew, please visit our website www.smith-nephew.com, follow @SmithNephewplc on Twitter or visit SmithNephewplc on Facebook.com.

Forward-looking statements

This document may contain forward-looking statements that may or may not prove accurate. For example, statements regarding expected revenue growth and trading margins, market trends and our product pipeline are forward-looking statements. Phrases such as “aim”, “plan”, “intend”, “anticipate”, “well-placed”, “believe”, “estimate”, “expect”, “target”, “consider” and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from what is expressed or implied by the statements. For Smith & Nephew, these factors include: economic and financial conditions in the markets we serve, especially those affecting health care providers, payers and customers; price levels for established and innovative medical devices; developments in medical technology; regulatory approvals, reimbursement decisions or other government actions; product defects or recalls or other problems with quality management systems or failure to comply with related regulations; litigation relating to patent or other claims; legal compliance risks and related investigative, remedial or enforcement actions; disruption to our supply chain or operations or those of our suppliers; competition for qualified personnel; strategic actions, including acquisitions and dispositions, our success in performing due diligence, valuing and integrating acquired businesses; disruption that may result from transactions or other changes we make in our business plans or organisation to adapt to market developments; and numerous other matters that affect us or our markets, including those of a political, economic, business, competitive or reputational nature. Please refer to the documents that Smith & Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith & Nephew’s most recent annual report on Form 20-F, for a discussion of certain of these factors. Any forward-looking statement is based on information available to Smith & Nephew as of the date of the statement. All written or oral forward-looking statements attributable to Smith & Nephew are qualified by this caution. Smith & Nephew does not undertake any obligation to update or revise any forward-looking statement to reflect any change in circumstances or in Smith & Nephew’s expectations.

Trademark of Smith & Nephew. Certain marks registered US Patent and Trademark Office.

New Study to Evaluate Virtual Rehabilitation Platform for Physical Therapy after Total Knee Replacement Surgery

November 29, 2016 – SAN DIEGO–(BUSINESS WIRE)–

Reflexion Health, Inc., a digital healthcare company, in conjunction with the Duke Clinical Research Institute (DCRI) announced the enrollment of the first patients in Virtual Exercise Rehabilitation In-home Therapy: A Research Study (VERITAS), which is designed to evaluate the cost and outcomes of using a virtual rehabilitation platform to deliver physical therapy following total knee replacement (TKR) surgery.

According to the Centers for Disease Control and Prevention, 700,000 total knee replacements are performed each year in the United States. TKR is the most frequently performed procedure in the hospital and is more common among women than men.1 The average Medicare expenditure for surgery, hospitalization, and recovery ranges from $16,500 to $33,000 across geographic areas.2 With a significant growth in TKR among younger adults with knee osteoporosis3, an aging population working longer, and a shift to value-based care, the demand for TKR surgery is expected to exceed three million by the year 2030 while at the same time, healthcare systems will continue to optimize costs.

“Physical therapy is often a critical component of care for patients who have TKR surgery. Digital health technology, including virtual and telehealth options, may increase access, improve quality, and lower healthcare costs,” said Janet Prvu Bettger, ScD, associate professor with the Duke Department of Orthopaedic Surgery and principal investigator for the study at the DCRI. “Extending the reach of physical therapists into the home using a digital healthcare platform like VERA can provide remote guidance and supervision for a home-based therapy program; however, implementation in the U.S. has not been widely evaluated until now.”

VERITAS is a multi-center, randomized controlled trial and will enroll approximately 300 adult participants scheduled for TKR surgery at six U.S. sites. The treatment group will include 150 adults who will receive Reflexion Health’s proprietary virtual exercise rehabilitation assistant, VERA™, both pre- and post-surgery, compared with a control group of 150 adults who will receive traditional in-home or clinic-based physical therapy at participating sites. Clinical outcomes, health service use, and costs will be examined for three months after surgery.

“With VERITAS, we are eager to confirm what we’ve already demonstrated with hospitals and clinicians in pilot studies — VERA is a cost-effective, scalable, and effective option for improving compliance and recovery in home-based physical therapy following total knee replacement surgery,” said Joseph (Joe) Smith, MD, PhD, President and CEO of Reflexion Health. “VERA embodies our commitment to delivering solutions that improve the patient experience by saving time, travel and costs for both patients and healthcare systems.”

About the Duke Clinical Research Institute

The Duke Clinical Research Institute (DCRI), part of the Duke University School of Medicine, is the largest academic research organization in the world. Its mission is to develop and share knowledge that improves the care of patients through innovative clinical research. The DCRI conducts groundbreaking multinational clinical trials, manages major national patient registries, and performs landmark outcomes research. DCRI research spans multiple disciplines, from pediatrics to geriatrics, primary care to subspecialty medicine, and genomics to proteomics. The DCRI also is home to the Duke Databank for Cardiovascular Diseases, the largest and oldest institutional cardiovascular database in the world, which continues to inform clinical decision-making more than 40 years after its founding.

About Reflexion Health, Inc.

Reflexion Health is a digital healthcare company dedicated to transforming traditional medicine and improving clinical outcomes by using innovative technology solutions to deliver patient-centered care at reduced costs. VERA™, Reflexion Health’s signature solution, is an FDA-cleared Virtual Exercise Rehabilitation Assistant that detects motion and remotely monitors the effectiveness of prescribed physical therapy in real-time. VERA brings the guidance of a physical therapist into the home to coach and motivate patients through recovery from joint replacement surgery or as a preventative therapy to reduce falls. For more information, visit www.reflexionhealth.com and follow us at @ReflexionHealth.

Microbot completes merger with Stem Cell

29/11/2016, Gali Weinreb

Israeli company Microbot, which three months ago announced its merger into Nasdaq-listed US company Stem Cell, yesterday announced that the merger had been completed. Microbot was founded as investment company MEDX Ventures Group, led by Harel Gadot and based on technology developed by Prof. Moshe Shoham, who also developed the technology of Mazor Robotics Ltd. (Nasdaq: MZOR; TASE:MZOR), a company with a $550 million market cap.

Microbot develops miniature robots. The companies first app is for cleaning drainage pipes in the body, for example in the urethra or the brain, thereby removing the necessity for surgery to replace them. The miniature robot functions in the same way as a robot that cleans swimming pools or homes. It is made of titanium, and has arms that move around it. It can be controlled from outside the body and directed within the urethra, so that accumulations of dirt are released, and can be swept out of the drain.

In the future, the product is likely to also prove suitable for cleaning plaque from blood vessels in order to prevent heart attacks and stroke and obviate the need for a balloon or stent. More remote apps include a robot with a camera for taking photographs within the body (like Given Imaging’s camera pill, but with the added capability of controlling the location and camera angle) and release of a drug in a specific place.

 

READ THE REST HERE

Medtronic Reports Second Quarter Financial Results

DUBLIN – November 22, 2016 – Medtronic plc (NYSE: MDT) today announced financial results for its second quarter of fiscal year 2017, which ended October 28, 2016.

The company reported second quarter worldwide revenue of $7.345 billion, an increase of 4 percent, or 3 percent on a constant currency basis.  Foreign currency had a positive $50 million impact on revenue.  Second quarter GAAP net income and diluted earnings per share (EPS) were $1.115 billion and $0.80, increases of 114 percent and 122 percent, respectively.  As detailed in the financial schedules included through the link at the end of this release, second quarter non-GAAP net income and diluted EPS were $1.561 billion and $1.12, representing increases of 6 percent and 9 percent, respectively.  After adjusting for the negative 6 cent impact from foreign currency, non-GAAP diluted EPS increased 15 percent.

“Q2 revenue was disappointing and did not meet our expectations.  We faced issues that affected our growth, including slower than expected revenue as we await new product introductions, particularly in CVG and Diabetes,” said Omar Ishrak, Medtronic chairman and chief executive officer. “Despite this revenue shortfall, we produced a strong improvement in operating margins and double digit constant currency earnings per share growth.”

The second quarter GAAP operating margin was 18.9 percent, a 50 basis point improvement.  As detailed in the financial schedules included through the link at the end of this release, the second quarter non-GAAP operating margin was 28.9 percent on a constant currency basis, a 150 basis point improvement.

U.S. revenue of $4.152 billion represented 57 percent of company revenue and increased 1 percent.  Non-U.S. developed market revenue of $2.209 billion represented 30 percent of company revenue and increased 8 percent, or 5 percent on a constant currency basis.  Emerging market revenue of $984 million represented 13 percent of company revenue and increased 8 percent, or 10 percent on a constant currency basis.

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 revenue of $2.584 billion increased 4 percent, or 3 percent on a constant currency basis, driven by CRHF growth from the recent acquisition of HeartWare and strong growth in other CRHF businesses, as well as growth in APV.  CSH revenue growth was flat as strong growth in Structural Heart partially offset declines in Coronary.

  • CRHF revenue of $1.400 billion increased 6 percent, or 5 percent on a constant currency basis, driven by growth from the company’s recent acquisition of HeartWare, high-twenties growth in AF Solutions on a constant currency basis, mid-teens growth in Diagnostics on a constant currency basis, partially offset by declines in core cardiac rhythm implantables, which declined in-line with the global market.
  • CSH revenue of $753 million was flat on both a reported and constant currency basis.  Structural Heart was driven by high-teens growth on a constant currency basis in transcatheter aortic heart valves as a result of strong customer adoption of the CoreValve®Evolut® Coronary declined in the mid-single digits on a constant currency basis, driven by double-digit declines in drug-eluting stents in the US and Japan, as the company awaits approval of Resolute Onyx(TM).  This was partially offset by mid-single digit growth on a constant currency basis in drug-eluting stents in Western Europe resulting from continued strong sales of the Resolute Onyx(TM) platform.
  • APV revenue of $431 million increased 5 percent, or 4 percent on a constant currency basis, with low-single digit growth on a constant currency basis in the Aortic business, driven by the success of the Heli-FX®EndoAnchor® The Peripheral Vascular business grew in the mid-single digits on a constant currency basis, with mid-twenties growth on a constant currency basis in drug-coated balloons, driven by the clinically differentiated IN.PACT® Admiral® DCB, which holds the leading market position in the U.S. and globally.

Minimally Invasive Therapies Group
The Minimally Invasive Therapies Group (MITG) includes the Surgical Solutions and the Patient Monitoring & Recovery (PMR) divisions.  MITG worldwide revenue of $2.473 billion increased 5 percent, or 4 percent on a constant currency basis, led by MITG growth drivers, primarily Open-to-MIS, Emerging Markets, and Renal Care, as well as contributions from recent acquisitions and strength in Ventilation.

  • Surgical Solutions revenue of $1.361 billion increased 5 percent, or 4 percent on a constant currency basis, driven primarily by its Open-to-MIS growth driver, including strong product sales from Valleylab(TM) FT10 energy platform and continued performance in endo stapling specialty reloads.  In addition, there was solid contribution from Emerging Markets with overachievement in Latin America and China.  The division also benefitted from the recent acquisition of Smith & Nephew’s gynecology business.  At the same time, Surgical Solutions growth was offset in the U.S. by competitive pressures stemming from reprocessing of advanced energy instruments, and in the Middle East from the timing of tenders.
  • PMR revenue of $1.112 billion increased 4 percent, or 3 percent on a constant currency basis, driven by mid-single digit growth in the Respiratory & Patient Monitoring business as a result of strong sales of the Puritan Bennett(TM) 980 ventilator.  The Renal Care Solutions business benefitted from the recent acquisition of Bellco.

Restorative Therapies Group
The Restorative Therapies Group (RTG) includes the Spine, Brain Therapies, Specialty Therapies, and Pain Therapies divisions.  RTG worldwide revenue of $1.826 billion increased 4 percent, or 3 percent on a constant currency basis.  Group results were driven by mid-single digit growth in Brain Therapies and Specialty Therapies and continued improvement in Spine, offsetting declines in Pain Therapies, all on a constant currency basis.

  • Spine revenue of $663 million increased 2 percent, or 1 percent on a constant currency basis, the division’s strongest growth in 7 quarters.  The Core Spine business grew in the low-single digits in the U.S., as the focus on “Speed-to-Scale” new product launches is driving improved results.  BMP grew in the low-single digits on a constant currency basis, with high-single digit growth in the U.S. partially offset by the loss of InductOs(TM) sales in Europe as a result of a shipping hold.
  • Brain Therapies revenue of $506 million increased 7 percent, or 6 percent on a constant currency basis.  Neurosurgery grew in the high-single digits on a constant currency basis, driven in part by strong imaging and navigation capital equipment sales.  Neurovascular grew in the mid-single digits on a constant currency basis, slower growth than in prior quarters due to a recently announced voluntary recall of certain product lines.  Brain Modulation grew in the low-single digits on a constant currency basis on the strength of the company’s MR conditional Activa DBS portfolio.
  • Specialty Therapies revenue of $369 million increased 6 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 low-single digits, all on a constant currency basis.
  • Pain Therapies revenue of $288 million decreased 2 percent on both a reported and constant currency basis.  After adjusting for the divestiture of the division’s drug business, which occurred in the third quarter of fiscal year 2016, Pain Therapies revenue increased 1 percent on a constant currency basis.  This was a result of mid-single digit declines on a constant currency basis in Spinal Cord Stimulation, as the business faced competitive pressures, partially offset by the Interventional business, which grew in the high-single digits, and Drug Pumps, which grew in the mid-single digits, both on a constant currency basis.

Diabetes Group
The Diabetes Group includes the Intensive Insulin Management (IIM), Non-Intensive Diabetes Therapies (NDT), and Diabetes Service & Solutions (DSS) divisions.  Diabetes Group worldwide revenue of $462 million increased 3 percent on both a reported and constant currency basis.  Growth was slower this quarter than in previous quarters due to the dynamics associated with the U.S. FDA approval of the MiniMed® 630G System and earlier-than-expected U.S. FDA approval of the MiniMed® 670G System, which the company expects to become commercially available in the Spring of 2017.

  • IIM grew in the mid-single digits on a constant currency basis, including mid-teens growth on a constant currency basis in International markets as a result of continued strong sales in Europe and Asia Pacific of the MiniMed®640G System.  This was offset by low-single digit declines in the U.S. driven by the timing between approval and shipments for both the MiniMed® 630G System and MiniMed® 670G System.  In addition, the company is deferring a portion of its MiniMed® 630G System sales due to its Priority Access Program.
  • NDT grew in the high-thirties on a constant currency basis, led by strong sales of the iPro®2 Professional Continuous Glucose Monitor (CGM) technology with Pattern Snapshot to primary care physicians.
  • DSS grew in the low-single digits on a constant currency basis as a result of growth in consumables, Diabeter clinics in Europe, and continued strong growth of the MiniMed®Connect, offset by the impact of buying patterns due to the previously mentioned insulin pump approvals.

Outlook 
The company today updated its fiscal year 2017 revenue and free cash flow outlook and  EPS guidance.  Consistent with the company’s long-term, mid-single digit constant currency revenue growth expectation, the company now expects fiscal year 2017 revenue growth to be within the mid-single digit range on a constant currency, constant weeks basis, as opposed to the upper half of the mid-single digit range signaled previously.  The company expects revenue growth for the second half of fiscal year 2017 to also be in the mid-single range on a constant currency basis.  While the impact from foreign currency is fluid, if current exchange rates remain similar for the remainder of the fiscal year, the company’s full year revenue would be negatively affected by approximately $20 million to $60 million, including an approximate $10 million to $30 million negative impact in the third fiscal quarter.

In addition, the company updated its diluted non-GAAP EPS guidance for fiscal year 2017.  The company continues to expect fiscal year 2017 diluted non-GAAP EPS growth to be in the double digits on a constant currency, constant week basis, which is consistent with the company’s long-term, double digit constant currency EPS growth expectation.  The company expects non-GAAP diluted EPS growth for the second half of fiscal year 2017 to be in the 8 percent to 10 percent range on a constant currency basis.  While the impact from foreign currency is fluid, taking into account the estimated 8 to 10 cent impact from the extra week in the first quarter last fiscal year, as well as an estimated negative impact from foreign currency to fiscal year 2017 EPS of 20 to 22 cents, assuming current exchange rates remain similar for the rest of the year, this growth guidance implies fiscal year 2017 non-GAAP diluted EPS in the range of $4.55 to $4.60.

Starting this quarter, the company is modifying its free cash flow outlook methodology to more closely align the company’s free cash flow projection with the results it reports each quarter.  The company previously provided an adjusted free cash flow outlook, which would exclude cash payments related to non-GAAP items that might occur during the year, and will now provide an actual free cash flow outlook, which includes these items in projected free cash flow.  The company expects free cash flow for fiscal year 2017 to be in the range of $5 to $6 billion.

“While some of the challenges that affected revenue in Q2 could persist in the near term, we remain confident in our ability to deliver mid-single digit constant currency revenue growth and double-digit constant currency EPS growth, not only in our current fiscal year, but on a sustained basis into the future,” said Ishrak. “As always, we remain committed to applying our medical technology and solutions to help address the universal healthcare needs of improving clinical outcomes, expanding access to care, and optimizing cost and efficiency, which combined represent a perpetual source of opportunity in healthcare.”

Webcast Information
Medtronic will host a webcast today, November 22, at 8:00 a.m. EST (7:00 a.m. CST) to provide information about its businesses for the public, investors, 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 second quarter financial schedules and non-GAAP reconciliations, click here.  To view the second quarter earnings presentation, click here.  Both of these 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, 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 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 figures increasing or decreasing are in comparison to the second quarter of fiscal year 2016.

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.

-end-

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

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

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

HD Surgical Acquires Assets from PAK Manufacturing

November 28, 2016

HD Surgical, a custom surgical instrument & implant manufacturer for the Orthopaedic industry, has recently acquired certain assets of PAK Manufacturing, Inc. This new acquisition positions HD Surgical as one of the largest manufacturers of both forged and machined instrumentation in the USA.

HD Surgical offers custom‐manufactured instruments, full service instrument repairs and refurbishing to OEM standards, as well as implant manufacturing capabilities. HD Surgical, a division of Harwood Design, was founded in 1990 and is an ISO 13485 Certified and FDA Registered company.

The transaction supports HD Surgical’s strategy to continue as a North American instrumentation supplier offering design engineering and regulatory guidance submission strategies. Plans are underway to expand the company’s overall capacity, with a new building slated to begin construction in 2017.

 

For further information, please contact:

Richard J. Stephens, Vice President Sales & Marketing

Office: 215‐826‐8250 / Fax: 215‐826‐8253

Custom Instruments & Implants

HD Surgical (A Division of Harwood Design Inc.)

1507 Clyde Waite Drive, Bristol PA 19007

www.hdsurgical.com

 

 

MinInvasive Announces a New Round of Financing and Strategic Partnership with MicroPort Scientific Corporation

Magal, Israel, November 27, 2016 – MinInvasive Ltd., developer of the OmniCuff™ device for the treatment of rotator cuff repair, announced today the completion of a financing transaction and a strategic partnership with MicroPort Scientific Corporation (HKSE:0853). MicroPort is leading a financing round in MinInvasive and will be granted an exclusive right to distribute OmniCuff™ in the China market.

The field of shoulder rotator cuff repair is a fast growing market segment within the sports medicine market, with over one million procedures performed worldwide annually and an annual growth rate of 7%. The OmniCuff™ System enables arthroscopic rotator cuff repair, which obviates the need for suture anchors, provides the clinical advantages of minimally invasive transosseous repair and reduces overall procedure costs.

MinInvasive’s CEO, Ronen Raz, stated, “The partnership with MicroPort, a leading medical device company and a strategic global player, is a significant milestone for the company and we look forward to expanding our activity into the Chinese market with MicroPort.”

MinInvasive Ltd.

MinInvasive, founded in 2011 in the ATI incubator, is a privately held medical device company, with key investors Anatomy Medical Technology Fund, Access Medical Ventures and several private investors from Israel and the U.S. The company has developed the OmniCuff™ System – a disposable device enabling arthroscopic, transosseous rotator cuff repair that obviates the need for suture anchors. The company recently completed a successful post-market multi-center clinical study in leading medical centers in the U.S., with excellent clinical results and high patient and surgeon satisfaction. The company plans to initiate commercialization of the OmniCuff™ System with a partner in the U.S. in 2017.

MicroPort Scientific Corporation

MicroPort Scientific Corporation (the “MicroPort Group”) is a leading medical device company with business focusing on innovating, manufacturing and marketing high- ERM/1006776v1 quality and high-end medical devices globally. With a diverse portfolio of products now being used at an average rate of one for every 15 seconds in thousands of major hospitals around the world, the MicroPort Group maintains world-wide operations in a broad range of business segments including Cardiovascular, Orthopedic, Electrophysiology, Endovascular, Neurovascular, Surgical, Diabetes Care and Endocrinal Management and others. The MicroPort Group is dedicated to becoming a patient oriented global enterprise improving and reshaping patient lives through the application of innovative science and technology.

 

Contact: Ronen Raz, CEO MinInvasive Ltd. 137 Hashachaf, Magal, Israel info@mininvasive.com +972-4-6287455

 

Israeli spinal implant co ApiFix raises $5m

Misonix Reports Nasdaq’s Acceptance of Its Plan to Regain Listing Compliance

FARMINGDALE, N.Y., Nov. 28, 2016 /PRNewswire/ — Misonix, Inc. (NASDAQ: MSON) (“Misonix” or the “Company”), an international surgical device company that designs, manufactures and markets innovative therapeutic ultrasonic products for spine surgery, neurosurgery, wound debridement, skull based surgery, laparoscopic surgery and other surgical applications, announced that The Nasdaq Stock Market LLC (“Nasdaq”) has accepted the Company’s plan to regain compliance with Nasdaq Listing Rule 5250(c)(1) which would permit the continued listing of Misonix common stock on the Nasdaq Global Market.

As previously disclosed, on September 15, 2016, the Company received a deficiency letter from Nasdaq indicating that the Company, as a result of not filing its Annual Report on Form 10-K (“10-K”) on September 13, 2016, was not in compliance with Listing Rule 5250(c)(1) of the Nasdaq Listing Rules (the “Listing Rules”) for continued listing.  In addition, on November 10, 2016, the Company received a second deficiency letter from Nasdaq indicating that the Company, as a result of not filing its Quarterly Report on Form 10-Q (the “10-Q”) by November 9, 2016, together with its prior and ongoing failure to timely file its 10-K, was not in compliance with Listing Rule 5250(c)(1) for continued listing. In the letters, Nasdaq requested that Misonix submit a plan to regain compliance with the Listing Rules by November 14, 2016.

On November 14, 2016, Misonix submitted to Nasdaq a plan to regain compliance with the Listing Rules. After reviewing Misonix’s plan to regain compliance, Nasdaq granted an exception to enable the Company to regain compliance with the Listing Rules. Under the terms of the exception, Misonix must file its 10-K and 10-Q on or before March 13, 2017. In the event that Misonix does not satisfy the terms set forth in the extension, Nasdaq will provide written notification that Misonix’s common stock will be delisted. At that time, Misonix may appeal Nasdaq’s determination for a panel review.

About Misonix
Misonix, Inc. designs, develops, manufactures and markets therapeutic ultrasonic medical devices. Misonix’s therapeutic ultrasonic platform is the basis for several innovative medical technologies. Addressing a combined market estimated to be in excess of $1.5 billion annually; Misonix’s proprietary ultrasonic medical devices are used in spine surgery, neurosurgery, orthopedic surgery, wound debridement, cosmetic surgery, laparoscopic surgery, and other surgical and medical applications.  Additional information is available on the Company’s Web site at www.misonix.com.

Safe Harbor Statement
With the exception of historical information contained in this press release, content herein may contain “forward looking statements” that are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and are subject to uncertainty and changes in circumstances. Investors are cautioned that forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from the statements made. These factors include general economic conditions, delays and risks associated with the performance of contracts, risks associated with international sales and currency fluctuations, uncertainties as a result of research and development, acceptable results from clinical studies, including publication of results and patient/procedure data with varying levels of statistical relevancy, risks involved in introducing and marketing new products, potential acquisitions, consumer and industry acceptance, litigation and/or court proceedings, including the timing and monetary requirements of such activities, the timing of finding strategic partners and implementing such relationships, regulatory risks including approval of pending and/or contemplated 510(k) filings, the ability to achieve and maintain profitability in the Company’s business lines, the completion of the investigation related to identified deficiencies in internal control over financial reporting, and other factors discussed in the Company’s Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The Company disclaims any obligation to update its forward-looking relationships.

Corporate Contact          Investor Contact
Misonix Contact: Joe Diaz
Joseph Dwyer Lytham Partners
631-694-9555 602-889-9700
invest@misonix.com info@misonix.com

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SOURCE Misonix, Inc.

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http://www.misonix.com

The tipping point for medtech: Consumer demands, innovation, and reimbursement

By:  – November 17, 2016

Today, the health care industry appears to be facing an inherent tension. On one side, many consumers – both as patients and caregivers – are demanding new, more efficient technology solutions. On the other side, medtech companies are still trying to figure out when and how to innovate under the new value proposition. While the incentives around value-based care are emerging, the health care industry is still trying to figure out its innovation strategies. This uncertainty has left many medtech companies assessing how best to invest in innovation while balancing the need to generate stakeholder value.

The growing aging population, higher prevalence of obesity and chronic disease, greater preference to age in the home, and increasing interest from caregivers are driving consumer demand for products and technologies. Deloitte’s 2016 Survey of US Health Care Consumers reveals that many consumers (seven in 10 surveyed) are interested in health care Internet of Things (IoT) technologies. Additionally, 82 percent of respondents reported that they would prefer to age-in-place rather than move to a care facility or in with a family member.

Despite personal hesitancy in using certain technologies, our survey found that more consumers say they are likely to use sensor technology, telemedicine, and remote monitoring technology when caring for others.

At the same time, health care reform and the move toward value-based care are fundamentally changing the system and how it pays for services and products. New payment models – shared savings, bundled payments, shared risk, and global capitation – are emerging. The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) is moving the industry in this direction even more rapidly than before – not only impacting physicians, but most health systems also.

Under new value-based care payment models, medtech companies have a new opportunity for reimbursement. Physicians may be willing to spend more on technologies and devices that can help them succeed under risk-based models – which will provide bonuses for physicians tied to improved patient outcomes.

 

READ THE REST HERE

Collagen Matrix, Inc. Names Oystein Valberg as Chief Financial Officer

OAKLAND, N.J., Nov. 22, 2016 /PRNewswire/ — Collagen Matrix, Inc., which advances the science of tissue repair and regeneration by designing, developing and manufacturing collagen and mineral based medical devices that support the body’s natural ability to regenerate, announced today the appointment of Oystein Valberg as its Chief Financial Officer.  Mr. Valberg will oversee finance and administration as well as the human resources team.

Mr. Valberg has more than 20 years of progressive senior corporate finance leadership and business development experience, including 17 years with Medtronic Plc where he earned a reputation as a strong, “hands on” organizational leader.

Most recently, he served as CFO and Vice President of Finance, Strategy and Business Development for Medtronic’s Surgical Technology business unit.  His valuable experience working with Medtronic also included responsibilities in Corporate Development, Treasury and Investor Relations.

Prior to Mr. Valberg’s tenure at Medtronic, he served as an Analyst with US Bankcorp, and as an Auditor for Grant Thornton where he earned his CPA.  Mr. Valberg earned a bachelor’s degree and a master’s degree in business administration from the Carlson School of Management in Minneapolis.

Bart Doedens, Collagen Matrix CEO, commented: “We are excited and pleased to welcome Oystein to our executive team. As we continue to build our framework for growth, Oystein will be one of the contributors to our success.  His background and experience are an excellent fit and will serve us well.”

About Collagen Matrix
Collagen Matrix, Inc., founded in 1997, delivers a full line of the highest-quality collagen and mineral based medical devices that support the body’s natural ability to regenerate.  The Company currently manufactures finished medical devices in the areas of Dental, Neurosurgical, Spine, Orthopaedic and Nerve Repair Surgery. More information about Collagen Matrix can be found at www.collagenmatrix.com.

Contact:
Margo Lane
201-405-1477
mlane@collagenmatrix.com

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