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February 2-4, 2017

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February 23, 2017 OrthoSpineNews

Pain management doctor, Andrew Cottingham, MD of OPTIMAL Pain & Regenerative Medicine is the first physician in North Texas to implant the new Vertiflex Superion Indirect Decompression System®. The Vertiflex Superion is a minimally invasive, safe, out-patient procedure that gives patients an alternative to spine surgery for the treatment of lumbar spinal stenosis.

Back and leg pain affects millions of Americans every year. Lumbar spinal stenosis is caused by aging and “wear” on the discs between the vertebrae. The degeneration of the discs causes the spinal canal to narrow, which leads to additional pressure on the nerves in the lower back. This pressure leads to lower back pain and radiating leg, buttock and/or groin pain. Symptoms typically intensify during standing and walking and decrease when sitting and bending forward.

Conservative treatment of lumbar spinal stenosis typically involves rest, physical therapy, medication management and epidural steroid injections. When non-surgical treatment does not alleviate symptoms, surgical treatment historically involves direct compression surgery. The Vertiflex Superion device is an FDA approved minimally invasive treatment option for patients suffering from lower back pain and radiating leg pain caused by lumbar spinal stenosis.

The procedure uses a Superion implant, which is a small titanium device that is inserted through a small incision in the lower back. The implant is then placed in the spinal structure to keep the spine positioned such that the nerves in the spinal canal are not compressed. The device has been implanted in more than 2,000 patients worldwide. The clinical trial results showed a decrease in pain. Four years post-procedure, almost 90% of the clinical trial patients expressed continuing satisfactory results.

“The Vertiflex Superion is an elegant, minimally invasive procedure that can change so many people’s lives who are suffering from lower back pain and radiating leg pain caused by lumbar spinal stenosis,” said Dr. Andrew Cottingham.

To learn if you are a candidate, please call us at 817-468-4343 or visit our website: The Vertiflex Superion Procedure.

About OPTIMAL Pain & Regenerative Medicine

The pain management doctors at OPTIMAL, Drs. Cottingham, Berlin and Phillips, are dedicated to staying on the forefront of pain management and regenerative medicine procedures. Each physician is double-board certified in anesthesiology and pain medicine. Through their collective expertise, the OPTIMAL team delivers comprehensive, current and compassionate medical care to patients in Dallas, Fort Worth and Arlington, Texas.


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February 23, 2017 OrthoSpineNews

VALENCIA, Calif., Feb. 22, 2017 /PRNewswire/ — Bioness, Inc., the leading provider of cutting edge, clinically supported rehabilitation therapies, today announced the first series of successful StimRouter Neuromodulation System implantations in Europe at Radboud University Medical Center (Nijmegen, Netherlands), South Victoria University (Cork, Ireland), and Kliniek Park Leopold Chirec (Brussels, Belgium). With the successful launch continuing, Bioness plans to further support clinicians across the continent who are looking to support patients seeking minimally-invasive, long-term pain relief.

Erkan Kurt, MD (The Netherlands), Dominic Hegarty, MD (Ireland), and Jean Pierre van Buyten, MD (Belgium) implanted the StimRouter to manage chronic pain conditions originating from varied peripheral neuralgias. With an estimated 100 million Europeans suffering from chronic pain, there has never been a greater need for innovative pain management options.

“For many years we have had limited solutions to help our patients manage their debilitating pain,” shared Dominic Hegarty, MD, a trained Interventional Neuromodulation and Pain Management Specialist. “I’m very pleased to be able to provide the best neuromodulation options for my patients. I am confident that the StimRouter technology will be suitable for a greater range of patients in the future.”

“The StimRouter promises to be a breakthrough in neurostimulation because it is a much smaller device to implant and therefore easier to target pain at its origin,” stated Jean Pierre van Buyten, MD, an internationally renowned Pain Anesthesiologist. “Another advantage is that it minimizes cost and recovery time when compared to other more invasive treatments.”

“Peripheral neuropathy is a very common and often painful disorder. As a neurosurgeon with more than 20 years of neuromodulation experience, the StimRouter provides a unique opportunity to deliver patients relief from chronic pain, especially among those with peripheral nerve damage and scar tissue around the targeted nerve,” explained Erkan Kurt, MD. “Where percutaneous implantation might be a difficult procedure, the StimRouter is a small device that takes a minimally invasive approach that is easy to perform. Another great advantage is the transdermal electrical stimulation which makes implantation of an implantable pulse generator unnecessary.”

As a minimally invasive device designed to reduce pain by specifically targeting the affected peripheral nerve, the StimRouter is intended to be a cost-effective and long-term alternative to immobilization, injections, and prescription opioids. The implant procedure is usually completed in less than 30 minutes and uses only local anesthesia.

“As we continue to see impressive clinical results in the US and now Europe we are excited to further our mission of supporting clinicians looking to improve the lives of patients,” said Todd Cushman, President and CEO of Bioness. “Patients and their loved ones are looking for true relief from the downward spiral of chronic pain. With greater awareness of opioid addiction, alternative choices which deliver life improving results are needed. We are thrilled to be bringing expanded treatment options to those who care for patients.”

StimRouter was the first FDA cleared minimally-invasive, long-term, minimally invasive neuromodulation medical device indicated to treat chronic pain of a peripheral nerve origin. The StimRouter System then received CE mark in February of 2014 and the Company began expanding its focus into the European Union. The patient controlled medical device is an adjunct to other modes of therapy and is being well received by patients and clinicians alike.

The StimRouter is currently being implanted at prestigious clinical institutions across the United States to treat chronic peripheral nerve pain, with specific focus on the following conditions or areas:

  • Axillary nerve (e.g. post-stroke shoulder pain)
  • Ulnar nerve (e.g. cubital tunnel syndrome)
  • Suprascapular
  • Superior Cluneal nerve (e.g. lower back neuralgia)
  • Genicular nerve
  • Median nerve
  • Peroneal nerves

For more information on the StimRouter as well as videos of real patients sharing their StimRouter experience, please visit www.stimrouter.com.

About StimRouterNeuromodulation System

StimRouter is cleared by the FDA to treat chronic pain of peripheral nerve origin. StimRouter is a minimally invasive neuromodulation medical device consisting of a thin, implanted lead with conductive electrode, external pulse transmitter (EPT), and hand-held wireless patient programmer. Electrical signals are transmitted transdermally from the EPT through the electrode, down the lead to the target nerve. StimRouter is programmed at the direction of the physician to meet patient requirements but is controlled by the patient to address the patients specific, changing pain management needs.

About Bioness, Inc.

Bioness is the leading provider of innovative technologies helping people regain mobility and independence. Bioness solutions include implantable and external neuromodulation systems, robotic systems and software based therapy programs providing functional and therapeutic benefits for individuals affected by pain, central nervous system disorders and orthopedic injuries. Currently, Bioness offers six medical devices within its commercial portfolio which are distributed and sold on five continents and in over 25 countries worldwide. Bioness innovations have been implemented in the most prestigious and well-respected institutions around the globe with 17 of the top 20 rehabilitation hospitals in the United States currently using one or more Bioness solution. Bioness has a singular focus on aiding large, underserved customer groups with innovative, evidence-based solutions and we will continue to develop and make commercially available new products that address the growing and changing needs of our customers. Individual results vary. Consult with a qualified physician to determine if this product is right for you. Contraindications, adverse reactions and precautions are available online at www.bioness.com.

Media Relations Contact Information
Next Step Communications
bioness@nextstepcomms.com
781.326.1741

StimRouter™ and Bioness® are trademarks of Bioness, Inc. | www.bioness.com | Rx Only | Additional information about StimRouter can be found at www.stimrouter.com

SOURCE Bioness, Inc.

Related Links

http://www.bioness.com


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February 23, 2017 OrthoSpineNews

TAMPA, Fla., Feb. 22, 2017 /PRNewswire/ — Corin Group announced today the launch of the Humelock Reversed Shoulder System, a device used to treat patients with both a massive rotator cuff tear and a severe form of shoulder arthritis. The condition, known as cuff tear arthropathy, causes pain and reduced mobility in the arm and shoulder.

The Humelock Reversed Shoulder System, which was developed by FX Solutions, a privately-held upper extremities technology company based near Lyon, France, received FDA clearance for the device in January 2017. The device is already available in Europe and other international markets.

Corin Group holds a distribution agreement for the device, as well as the Humelock II™ Cementless and Cemented Anatomical and Reversible Fracture Shoulder Systems. The agreement includes distribution rights in the United States, Germany and the United Kingdom.

“Our partnership with FX Solutions allows Corin to increase their offering in shoulder arthroplasty, whilst we continue to expand solutions in hip and knee. Our goal is to provide surgeons, hospitals, health systems, and patients with a new and comprehensive approach to orthopaedics and joint replacement,” said Paul Berman, President, Corin USA. “The launch of the Humelock Reversed Shoulder System means patients in the U.S. will have access to an important new option for reverse shoulder replacement.”

“Our continuing partnership with Corin provides U.S. clinicians access to our surgeon-designed shoulder systems, which have demonstrated clinical success in European markets,” said FX Solutions’ President and CEO Jean-Jacques Martin. “Corin is a valued partner committed to innovation that improves health outcomes and increases both patient and surgeon satisfaction. We look forward to continued success together.”

About Corin Group

Corin is a European orthopaedic manufacturer based in the UK that markets its products throughout the world.

Corin is committed to:

…improving patient satisfaction with personalized technologies that optimize our clinically proven joint replacements
…delivering a personal approach to our customers, combining the spirit of our local companies with the strength of our global, integrated organization
…empowering and rewarding our global talented teams to deliver excellence to our customers

For further information about Corin, please visit www.coringroup.com.

This news release contains forward-looking statements. These statements appear in a number of places in this news release and include statements regarding our intentions, beliefs or current expectations, concerning, among other things, our results of operations, turnover, financial condition, liquidity, prospects, growth, strategies, new products, the level of new launches and the markets in which we operate. Readers are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ markedly from those in the forward-looking statements as a result of various factors. We undertake no obligation publicly to revise any forward-looking statements, except as may be required by law.

 

SOURCE Corin USA

Related Links

http://www.coringroup.com


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February 23, 2017 OrthoSpineNews

Minimus Spine, manufacturer of the Triojection® system for herniated spinal discs, is announcing the appointment of Jeffrey R. Binder to its Board of Directors. Mr. Binder was the CEO of Biomet from 2007 until it was acquired for approximately $14 billion by Zimmer Holdings in 2015. Mr. Binder is currently the President and CEO of Immucor. Prior to his time at Biomet, Mr. Binder was president of Abbott Diagnostics from 2006 to 2007 and the CEO of Spinal Concepts from 2000 until it was acquired by Abbott Laboratories in 2003 and became Abbott Spine. Prior to Spinal Concepts, Mr. Binder was President of Depuy Orthopedics and he has spent most of his career in orthopedics and spine.

David Hooper, PhD, Minimus Spine’s President and CEO said, “Jeff brings a wealth of intellect and experience to Minimus. He has successfully orchestrated several significant transactions in spine and orthopedics and is unquestionably a blue-chip addition as we strengthen the team around Triojection. Our management team and board worked together at Spinal Concepts. While that was a great result, the market need has expanded far beyond spinal hardware. We share the vision that Minimus is part of the future of spine and we expect continued success as we plan the initial commercial launch of Triojection in Europe this summer.”

Mr. Binder added: “I am very pleased to join the board of this exciting and innovative young company. Clinicians and patients are searching for solutions that address spinal disorders and reduce pain with less invasive approaches. I’m looking forward to working again with David and fellow director Wes Johnson, who were both so instrumental to our success at Spinal Concepts.”

Minimus Spine is dedicated to the non-surgical treatment of disc herniation patients using an intradiscal injection of ozone gas to the herniated disc. Minimus Spine is the manufacturer of the Triojection System, which involves a sterile, single-use, syringe cartridge that is processed in the operating room using the Triojection console. Triojection provides the physician with confidence in both the sterility of the procedure and the concentration of ozone delivered to the patient.


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February 23, 2017 OrthoSpineNews

BELGRADE, Mont., Feb. 22, 2017 (GLOBE NEWSWIRE) — Xtant Medical Holdings, Inc. (NYSE MKT:XTNT), a leader in the development of regenerative medicine products and medical devices, today announced the appointment of Carl O’Connell as the permanent CEO, effective February 17th, 2017. Mr. O’Connell previously served as president of Xtant since October of 2016 and was appointed as interim CEO on January 21st, 2017.

Prior to joining Xtant Medical, Mr. O’Connell most recently served as the Vice President Global Marketing – Extremities for Wright Medical, a recognized leader in the global foot and ankle market. Mr. O’Connell lead marketing teams and initiatives that were instrumental in achieving US growth initiatives that exceeded 28%, and 23% globally. He also lead the completion of marketing integration of 3 acquired businesses within a year, recruited top talent to his team, and supported the launch of multiple product line extensions and new products, including the successful launch of the market leading Infinity Total Ankle. During his tenure as Global Vice President Marketing for Stryker Spine, Mr. O’Connell drove marketing leadership and brand differentiation programs to support a 20% growth imperative, which was achieved through strategic cross divisional collaboration and the successful launches of line extensions and product upgrades. Mr. O’Connell served as the President and CEO of MedSurg – ITOCHU International, a division of ITOCHU Corporation, the 3rd largest Japanese trading corporation with over $70B in sales transactions, where he was responsible for the reorganization of three recently impaired acquisitions by supporting success attributes, acquiring new vendor contracts, stabilizing and growing top line sales at double digit growth rates, and driving the division to profitability.

“We are proud to announce Carl O’Connell has been promoted to the position of CEO” said Kent Swanson, Chairman of Xtant Medical’s Board of Directors. “With his extensive leadership in the medical device industry and commercialization expertise, we are confident that he is the right choice to lead Xtant to new levels of growth and profitability. Since joining the organization as President in 2016, he has made significant contributions to the record performance of the Company in Q4 2016 and we share his enthusiasm for the outlook of the Company.”

“I am excited to lead what I feel has the potential to be a world-class organization and a considerable competitor in the market” said Carl O’Connell, now CEO of Xtant Medical. “Since joining the organization, I have had a chance to assess the talented Xtant Medical team, the quality of our products, the commitment to our customers, the respect for the gift of donation, and the opportunity that lies ahead. I look forward to continuing to work with this team, expanding upon our recent successes and continuing to establish the strategic course to take Xtant Medical to the next level.  I am appreciative of the confidence bestowed in me by the executive management team, the board of directors, and our stakeholders.”

Carl O’Connell has over 30 years of experience in the healthcare and medical device arena. In addition to the positions held above, Mr. O’Connell also served as a Principal at Hudson Healthcare Partners, and President for Carl Zeiss Surgical, Inc. Mr. O’Connell’s responsibilities have spanned from global marketing, sales, manufacturing, leadership development, regulatory affairs, corporate quality systems, research, product and business development functions. Carl received a bachelor’s degree in Psychology and an M.B.A. from Mount St. Mary’s College, Maryland. Through the span of his career, Mr. O’Connell has launched more than 100 products and participated in numerous M&A events.

About Xtant Medical

Xtant Medical develops, manufactures and markets regenerative medicine products and medical devices for domestic and international markets. Xtant Medical products serve the specialized needs of orthopedic and neurological surgeons, including orthobiologics for the promotion of bone healing, implants and instrumentation for the treatment of spinal disease, tissue grafts for the treatment of orthopedic disorders, and biologics to promote healing following cranial, and foot and ankle surgeries. With core competencies in both biologic and non-biologic surgical technologies, Xtant Medical can leverage its resources to successfully compete in global neurological and orthopedic surgery markets. For further information, please visit www.xtantmedical.com.

Important Cautions Regarding Forward-looking Statements

This press release contains certain disclosures that may be deemed forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to significant risks and uncertainties. Forward-looking statements include statements that are predictive in nature, that depend upon or refer to future events or conditions, or that include words such as “continue,” “efforts,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” “projects,” “forecasts,” “strategy,” “will,” “goal,” “target,” “prospects,” “potential,” “optimistic,” “confident,” “likely,” “probable” or similar expressions or the negative thereof.

Statements of historical fact also may be deemed to be forward-looking statements. We caution that these statements by their nature involve risks and uncertainties, and actual results may differ materially depending on a variety of important factors, including, among others: our ability to integrate the acquisition of X-spine Systems, Inc. and any other business combinations or acquisitions successfully; our ability to remain listed on the NYSE MKT; our ability to obtain financing on reasonable terms; our ability to increase revenue; our ability to comply with the covenants in our credit facility; our ability to maintain sufficient liquidity to fund our operations; the ability of our sales force to achieve expected results; our ability to remain competitive; government regulations; our ability to innovate and develop new products; our ability to obtain donor cadavers for our products; our ability to engage and retain qualified technical personnel and members of our management team; the availability of our facilities; government and third-party coverage and reimbursement for our products; our ability to obtain regulatory approvals; our ability to successfully integrate recent and future business combinations or acquisitions; our ability to use our net operating loss carry-forwards to offset future taxable income; our ability to deduct all or a portion of the interest payments on the notes for U.S. federal income tax purposes; our ability to service our debt; product liability claims and other litigation to which we may be subjected; product recalls and defects; timing and results of clinical studies; our ability to obtain and protect our intellectual property and proprietary rights; infringement and ownership of intellectual property; our ability to remain accredited with the American Association of Tissue Banks; influence by our management; our ability to pay dividends; our ability to issue preferred stock; and other factors.

Additional risk factors are listed in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q under the heading “Risk Factors.” You should carefully consider the trends, risks and uncertainties described in this document, the Form 10-K and other reports filed with or furnished to the SEC before making any investment decision with respect to our securities. If any of these trends, risks or uncertainties actually occurs or continues, our business, financial condition or operating results could be materially adversely affected, the trading prices of our securities could decline, and you could lose all or part of your investment. The Company undertakes no obligation to release publicly any revisions to any forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. All forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by this cautionary statement.

Investor Contact 
CG CAPITAL
Rich Cockrell 
877.889.1972
investorrelations@cg.capital 

Company Contact
Xtant Medical 
Molly Mason
mmason@xtantmedical.com

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February 22, 2017 OrthoSpineNews

DUBLIN – February 21, 2017 – Medtronic plc (NYSE:MDT) today announced financial results for its third quarter of fiscal year 2017, which ended January 27, 2017.

The company reported third quarter worldwide revenue of $7.283 billion, an increase of 5 percent, or 6 percent on a constant currency basis.  Foreign currency exchange had a negative $40 million impact on revenue.  Third quarter GAAP net income and diluted earnings per share (EPS) were $821 million and $0.59, decreases of 25 percent and 23 percent, respectively.  Third quarter non-GAAP net income and diluted EPS were $1.553 billion and $1.12, representing increases of 3 percent and 6 percent, respectively.  After adjusting for the negative 5 cent impact from foreign currency exchange, non-GAAP diluted EPS increased 10 percent.

“In Q3, we achieved solid results across all of our business groups and geographies,” said Omar Ishrak, Medtronic chairman and chief executive officer. “At the same time, we produced meaningful operating profit growth based largely on our synergy programs from the Covidien integration, as well as our focus on operating excellence initiatives.”

The third quarter GAAP operating margin was 15.7 percent, a 380 basis point decline.  The third quarter non-GAAP operating margin was 28.2 percent, a 40 basis point improvement.  After adjusting for the 90 basis point negative impact from foreign currency exchange, the third quarter non-GAAP operating margin was 29.1 percent, representing a 130 basis point improvement.

U.S. revenue of $4.106 billion represented 56 percent of company revenue and increased 4 percent.  Non-U.S. developed market revenue of $2.193 billion represented 30 percent of company revenue and increased 6 percent, or 7 percent on a constant currency basis.  Emerging market revenue of $984 million represented 14 percent of company revenue and increased 9 percent, or 11 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 $2.548 billion increased 5 percent, or 6 percent on a constant currency basis, driven by high-single digit constant currency growth in CRHF and APV, and low-single digit constant currency growth in CSH.

  • CRHF revenue of $1.371 billion increased 7 percent, or 8 percent on a constant currency basis, with mid-single digit constant currency growth in Arrhythmia Management, high-teens constant currency growth in Heart Failure, and low-double digit constant currency growth in Services & Solutions.  Arrhythmia Management growth was driven in part by the continued adoption of the Arctic Front Advance® cryoballoons and Reveal LINQ® insertable cardiac monitoring systems.  Heart Failure growth was driven in part by the company’s first quarter acquisition of HeartWare International, Inc.
  • CSH revenue of $751 million increased 2 percent, or 3 percent on a constant currency basis, with low-double digit constant currency growth in Structural Heart, partially offset by mid-single digit constant currency declines in Coronary.  Structural Heart growth was driven in part by the recent U.S. launch of the CoreValve® Evolut® R 34 mm transcatheter aortic heart valve.  Coronary had double-digit constant currency declines in drug-eluting stents in the U.S. and Japan.
  • APV revenue of $426 million increased 6 percent on both a reported and constant currency basis, with high-single digit growth in Peripheral Vascular and mid-single digit growth in Aortic.  Growth was driven by the continued adoption of the company’s Endurant® IIs stent graft, IN.PACT® Admiral® drug-coated balloon, as well as the recent launch of the HawkOne(TM) 6 French directional atherectomy system.

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 $2.417 billion increased 5 percent, or 6 percent on a constant currency basis, with high-single digit constant currency growth in Surgical Solutions and mid-single digit constant currency growth in PMR.

  • Surgical Solutions revenue of $1.343 billion increased 6 percent, or 7 percent on a constant currency basis, driven primarily by its Open to Minimally Invasive Surgery growth initiative, including innovative 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 revenue of $1.074 billion increased 5 percent on both a reported and constant currency basis.  This is a result of strong growth in the Airways and Ventilation business, driven by continued adoption of the Puritan Bennett(TM) 980 ventilator, and in the Patient Monitoring business, driven by strength in Nellcor(TM) pulse oximetry.  PMR also benefitted from the fiscal year 2016 fourth quarter acquisition of Bellco in the Renal Care Solutions business.

Restorative Therapies Group

The Restorative Therapies Group (RTG) includes the Spine, Brain Therapies, Specialty Therapies, and Pain Therapies divisions.  RTG worldwide revenue of $1.817 billion increased 4 percent on both a reported and constant currency basis.  Group results were driven by high-single digit growth in Brain Therapies, mid-single digit growth in Specialty Therapies, and low-single digit growth in Spine, offsetting declines in Pain Therapies, all on a constant currency basis.

  • Spine revenue of $657 million increased 3 percent on both a reported and constant currency basis, the division’s strongest growth in over 7 years.  Core Spine grew in the low-single digits on a constant currency basis, as the focus on “Speed-to-Scale” new product launches continues to drive improved results.  BMP also grew in the low-single digits on a constant currency basis.
  • Brain Therapies revenue of $518 million increased 7 percent, or 8 percent on a constant currency basis.  Neurovascular grew in the low-double digits on a constant currency basis, driven in part by sales of the Axium(TM) Prime Extra Soft detachable coil and the Pipeline(TM) Flex embolization device.  Neurosurgery grew in the high-single digits on a constant currency basis, driven by strong growth in navigation capital equipment and disposables, as well as continued solid adoption of the O-arm® O2 surgical imaging system.  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 $370 million increased 4 percent, or 5 percent on a constant currency basis.  All three businesses contributed to growth, with Advanced Energy growing in the low-double digits, Pelvic Health growing in the mid-single digits, and ENT growing in the low-single digits, all on a constant currency basis.
  • Pain Therapies revenue of $272 million decreased 3 percent, or 2 percent on a 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 was flat on both a reported and constant currency basis.  Pain Therapies had low-single digit constant currency declines in Spinal Cord Stimulation, as the business faced competitive pressures, and low-single digit constant currency declines in Drug Pumps, partially offset by high-single digit constant currency growth in the Interventional business.

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 $501 million increased 6 percent, or 7 percent on a constant currency basis, with all three divisions contributing to growth.

  • IIM grew in the low double-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.  In addition, the division delivered high-single digit constant currency growth in international markets as a result of continued strong sales in Europe and Asia Pacific of the MiniMed® 640G system.  The division continues to be on track for a spring U.S. launch of the MiniMed® 670G system, the world’s first hybrid closed loop insulin delivery system.
  • NDT grew in the high-teens on a constant currency basis, led by the 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, with double-digit constant currency growth in international markets as a result of strong growth in consumables and Diabeter clinic revenue, offsetting low-single digit U.S. declines.

Outlook and Guidance

The company today reiterated its fiscal year 2017 revenue outlook, EPS guidance, and free cash flow outlook.

The company continues to expect fiscal year 2017 revenue growth to be within the mid-single digit range on a constant currency, constant weeks basis, which is consistent with the company’s long-term, mid-single digit constant currency revenue growth expectation.  The company expects revenue growth for the fourth quarter of fiscal year 2017 to be in the lower half of the mid-single digit range on a constant currency basis.  While the impact from foreign currency exchange is fluid, if current exchange rates remain similar for the remainder of the fiscal year, the company’s full year revenue and fourth fiscal quarter would both be negatively affected by approximately $20 million to $40 million.

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.  Taking into account the estimated 8 to 10 cent impact from the extra week in the first quarter last fiscal year, the estimated negative impact from foreign currency exchange of approximately 20 cents, and 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.

For fiscal year 2017, the company continues to expect free cash flow to be in the range of $5 billion to $6 billion.

“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 also into the future,” said Ishrak. “With our differentiated growth platforms and leadership in strong healthcare growth markets, we believe we are well positioned to create long-term, dependable value for our shareholders.”

Webcast Information

Medtronic will host a webcast today, February 21, 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 third quarter financial schedules and non-GAAP reconciliations, click here.  To view the third 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, 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 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 third 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 Third Quarter Financial Schedules & Non-GAAP Reconciliations

View FY17 Third Quarter Earnings Presentation

Contacts:

Fernando Vivanco

Public Relations

+1-763-505-3780

Ryan Weispfenning

Investor Relations

+1-763-505-4626

This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.

The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.

Source: Medtronic plc via Globenewswire

 

This article appears in: News Headlines

Referenced Stocks: MDT

Read more: http://www.nasdaq.com/press-release/medtronic-reports-third-quarter-financial-results-20170221-00332#ixzz4ZRpevyDv


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February 22, 2017 OrthoSpineNews

TEMPE, Ariz., Feb. 20, 2017 /PRNewswire/ — MedPlast, Inc., a global services provider to the medical device industry, announced today that it has signed a definitive agreement to acquire Vention Medical’s Device Manufacturing Services business.   The acquisition broadens MedPlast’s portfolio of capabilities and bolsters its position as a leading services provider to the world’s largest original equipment manufacturers.

MedPlast’s acquisition will further expand the company’s capabilities in assembly and packaging, enabling it to offer customers a comprehensive suite of services producing a wide range of medical products.  It also will extend MedPlast’s global footprint to 22 manufacturing facilities located in key markets throughout North and Central America, Asia and Europe.  Once complete, the acquisition will more than double MedPlast’s size.  The company will employ more than 3,500 engineers, technicians and assembly workers specializing in producing surgical, orthopedic, diagnostic and other medical devices.

“This acquisition will significantly strengthen MedPlast’s leadership position in the medical device manufacturing industry,” said MedPlast Chief Executive Officer Harold Faig.  “We will provide our customers a broad spectrum of integrated manufacturing capabilities and services from strategic locations around the world.  This is something our customers have been asking for, and we are committed to continuing to expand our capabilities in areas that will bring value to our customers.”

Bill Flaherty, president of Vention Medical’s Device Manufacturing Services business, added, “We are excited to come together with MedPlast.  We serve many of the same customers who will benefit from our combined offering and shared commitment to providing the highest quality standards and facilities in the industry.”

MedPlast’s acquisition comes two months after the company partnered with two investment firms to expand its offering.  JLL Partners, a middle-market private equity firm, and Water Street Healthcare Partners, a strategic investor focused exclusively on the health care industry, invested in MedPlast in December 2016.

“This is the first of what we expect will be more strategic acquisitions to build MedPlast into a market leader. Water Street and JLL are working closely with management to identify and pursue opportunities that will achieve MedPlast’s goal of offering customers a comprehensive, integrated portfolio of end-to-end product solutions,” said Kevin Swan, partner, Water Street.

The transaction is expected to close in the second quarter of 2017.  Financial terms of the agreement are not being disclosed.

About MedPlast
MedPlast is a global services provider to the medical device industry.  The company offers a range of engineering and manufacturing capabilities that support the world’s leading original equipment manufacturers with producing diagnostic, orthopedic, surgical and other medical products.  Headquartered in Tempe, Ariz., the company operates 11 ISO-certified facilities around the world.  For more information about MedPlast, visit medplastgroup.com.

About Vention Medical
Vention Medical is a global integrated solutions provider with more than 30 years of experience in design, engineering and manufacturing of complex medical devices and components.  Vention Medical specializes in molded components, and finished device assembly and packaging for the interventional and minimally invasive surgical markets.
Visit Vention at ventionmedical.com.

 

SOURCE MedPlast, Inc.

Related Links

http://www.medplastgroup.com


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February 22, 2017 OrthoSpineNews

SUWANEE, GA–(Marketwired – Feb 21, 2017) – SANUWAVE Health, Inc. ( OTCQB : SNWV ) is pleased to announce the hiring of André Mouton to head the Company’s international sales and relations. SANUWAVE began a process 18 months ago of re-igniting their international efforts. This meant re-designing distribution agreements, restructuring partner economics, letting go of certain distributors, and adding new partners. The Company has also installed applicator refurbishment centers closer to the regions where the device is being used and this has had a strong acceptance among SANUWAVE’s customers. As SANUWAVE grows and expands on a country by country basis, the Company has found three models which work well for us: Distribution, Joint Ventures, and Exclusive Rights Agreements. Since the Company’s refocus on international sales the number of countries actively served has grown from 3 to 10, the number of device placements has tripled, and sales have increased as well.

Currently, SANUWAVE anticipates adding an additional 5 to 8 countries/regions in 2017. To assist in accelerating international growth and centralize the managing of the existing base the Company decided to bring on a senior level executive to streamline that process. SANUWAVE is pleased to announce André Mouton as the new VP of International Sales and Relations. André brings a strong history of growth and success in the healthcare community and deep relations globally. Kevin Richardson, SANUWAVE’s Acting CEO, stated, “André will allow us to manage and handle the massive growth and demand for SANUWAVE’s product internationally. His experience fits with the culture of solving the patients’ problems using shock wave technology.” André will also assist in the varied clinical work taking place internationally, which will in turn support all regions of the globe.

André has a background in Microbiology and obtained his MBA while working for a multi-national pharmaceutical group focusing on strategic marketing. He has resided in South Africa, Indonesia and Singapore and focused on business development and taking new products and services into the South East Asia (SEA) markets as well as Africa. He has held numerous senior positions with P&L responsibility as well as line management experience of staff of over 100 employees. He has assisted in numerous products entering new markets and was key to the process of adapting and entry strategy fit for local conditions and cultural acceptance.

André Mouton stated, “SANUWAVE is in a unique position to make a large impact on the global health community. The innovative dermaPACE® product helps to solve a problem stemming from an unfortunate worldwide epidemic, diabetes. As I have traveled the globe, I have seen firsthand how diabetes is not just an American disease, and in fact, growth rates are even greater in developing countries. With the dermaPACE device SANUWAVE will help these patients live a happier healthier life.”

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


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February 22, 2017 OrthoSpineNews

February 22, 2017

AUSTIN, Texas–(BUSINESS WIRE)–

Wenzel Spine, Inc., a medical technology company focused on providing minimally invasive solutions for the treatment of spinal disorders, today announced that it has completed the acquisition of the PrimaLOK™ SP Interspinous Fusion System and PrimaLOK™ FF Facet Fixation System from OsteoMed, LLC.

The PrimaLOK SP & FF platforms include a polyaxial interspinous process device and percutaneous facet screw system designed for MIS applications in treatment of lumbar spinal disorders. These patented technologies are designed to provide surgeons an expanded MIS solution when used in conjunction with the stand-alone, expandable, VariLift-LX interbody fusion device.

“This acquisition provides our distributors and surgeons a powerful combination of MIS solutions. When paired with our VariLift-LX stand-alone, expandable, interbody technology, surgeons now have the ability to provide supplemental fixation, when needed, without having to revert to pedicle screw constructs,” said Chad Neely, President and Chief Executive Officer of Wenzel Spine. “In addition, this expands our current product portfolio while strengthening our development pipeline and demonstrating our commitment to the development of innovative MIS solutions to our distribution and surgeon partners.”

Dr. Charles Gordon, the inventor of the PrimaLOK SP System, and founder of the Texas Spine & Joint Hospital, commented, “I am pleased that Wenzel Spine has added the PrimaLOK Systems to their product portfolio. We are very happy to be partnered with a Spine focused company and believe Wenzel Spine is the ideal partner to bring the full potential of the PrimaLOK Systems to market.” Dr. Gordon further commented, “There are tremendous MIS innovation opportunities in combining the advantages of the PrimaLOK and VariLift-LX technologies.”

Wenzel Spine plans to integrate the PrimaLOK platforms into the pipeline of innovative MIS solutions currently being developed. The company has completed a limited US release of the PrimaLOK SP & FF Systems and expects to offer wide US release of the products in the second quarter of 2017.

About Wenzel Spine, Inc.

Wenzel Spine, Inc. is a medical technology company focused on providing minimally invasive solutions for the treatment of spinal disorders. Headquartered in Austin, TX, Wenzel Spine is focused on delivering surgical solutions that improve the overall quality of spine care by simplifying procedures and reducing recovery time. Wenzel Spine seeks to improve patient quality of life by designing and producing devices of the highest quality to support our surgeon clients in the care and treatment of their patients. For more information about the company and our products, visit www.wenzelspine.com

Follow Wenzel Spine on LinkedIn: https://www.linkedin.com/company/wenzel-spine
Follow Wenzel Spine on Twitter: https://twitter.com/WenzelSpine
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Follow Wenzel Spine on Instagram: https://Instagram.com/wenzelspine

View source version on businesswire.com: http://www.businesswire.com/news/home/20170222005421/en/


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February 22, 2017 OrthoSpineNews

By Malachi Barrett –  February 22, 2017

KALAMAZOO, MI — One final step remains to approve a brownfield plan for a $150 million Styker Instruments project in Portage.

The Kalamazoo County Board of Commissioners became the last local body to sign off on a County Brownfield Redevelopment Authority financing plan that allows Stryker to capture tax revenue to clean up and develop a 288-acre site. Commissioners voted unanimously to approve the plan during its Feb. 21 meeting, which now goes to the state, who has the final say.

Brent Lalomia, vice president of quality and facilities, told the authority Thursday that the proposal for Stryker’s medical instruments division involves 485,000 square feet of facilities that will include three-stories of office space for sales, marketing and support functions connected to a two-story research and development lab. An atrium in the middle will house a customer experience center and functioning showroom.

Lalomia thanked the county brownfield authority for making the process efficient and collaborative.

The development is projected to retain 966 jobs and create an additional 105, a component of the plan lauded by Portage City Manager Larry Shaffer.

 

READ THE REST HERE