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— Today, Best Floor Sanding Melbourne hits the news to announce their floor sanding and polishing services to the public. The company boasts the capacity to perform floor staining, repair, coating, recoating or restoration services on practically any floor type; from hardwood, laminated, engineered, bamboo, decking floorboards. Such diversity and acclaimed expertise in service might just be what people who put a lot of emphasis on a good-looking floor or might like. There would be no other way to deliver emphatic floor sanding and polishing without the right equipment, and words from the company suggest they use the latest and appropriate equipment out there, “We take pride in owning the latest equipment in the market to deliver the very best”. The Melbourne Floor Sanding and polishing company is situated just located around Ringwood North Victoria, however, they extend their services across Balwyn, Hawthorn, Kew, St. Kilda, South Melbourne, Box Hill, Blackburn, Doncaster, Malvern, Ringwood, Glen Waverley, Surrey hills, Burwood, Vermont, Mitcham, Clayton, Dandenong, Lilydale, Croydon, Frankston, South yarra, Bayside area and all the surrounding area. The highly regarded Melbourne Floor Sanding and polishing company insist on a policy where they serve just about any class of customers with the same enthusiasm and guile. So, big or small, far or near, it is believed they will be right where they are needed. It would take experts to deliver quality services in any company, so, the clams of having only well-trained staff members is refreshing to the public. About Best Floor Sanding Melbourne The company is a Melbourne Floor Sanding company with 20 years’ worth of apparent valuable experience. With pride, the company website recalls working to bring commercial and residential satisfaction to their clients For more information, please visit http://www.bestfloorsandingmelbourne.com.au/


ST. HELIER, Jersey--(BUSINESS WIRE)--Novocure™ (NASDAQ:NVCR) announced today results from health-related quality of life analyses from its phase 3, pivotal EF-14 trial adding Optune to standard temozolomide chemotherapy for the treatment of newly diagnosed glioblastoma. The data, presented at this year’s World Federation of Neuro-oncology Societies 5th Quadrennial Meeting in Zurich, showed that Optune with temozolomide did not negatively impact health-related quality of life, except for itchy skin, which was most likely due to skin irritation beneath Optune’s transducer arrays. The combination treatment of Optune with temozolomide improved deterioration-free survival of several predefined health-related quality of life scales, compared to temozolomide alone, likely related to improved progression free and overall survival. “Some physicians and patients have expressed concerns regarding the possible negative impact of Optune on patient quality of life” said Eilon Kirson, M.D., Ph.D., Novocure’s Chief Science Officer and Head of Research and Development. “The health-related quality of life analyses presented this weekend show conclusively that not only was quality of life not harmed by the use of Optune with temozolomide but deterioration in quality of life was delayed compared to temozolomide alone in several health related quality of life scales, most likely due to the longer progression free and overall survival of patients treated with Optune with temozolomide.” Patients completed two validated health-related quality of life questionnaires (EORTC QLQ-C30 and BN20) at the beginning of the trial, and every three months thereafter. Health-related quality of life over time was assessed for nine preselected scales: global health, physical, cognitive, role, social and emotional functioning, itchy skin, pain and weakness of legs. The results were as follows: “This data further cements our belief that Optune plus temozolomide should be offered as an essential combination therapy to every newly diagnosed patient with glioblastoma,” said Asaf Danziger, Novocure’s CEO. “We are pleased to offer a treatment that may not only provide a survival benefit in terms of duration of life but also has the potential to provide stability or improvement in the quality of life during that time compared to the use of temozolomide alone.” Novocure is an oncology company developing a profoundly different cancer treatment centered on a proprietary therapy called TTFields, the use of electric fields tuned to specific frequencies to disrupt solid tumor cancer cell division. Novocure’s commercialized product, Optune, is approved for the treatment of adult patients with glioblastoma. Novocure has ongoing or completed clinical trials investigating TTFields in brain metastases, non-small cell lung cancer, pancreatic cancer, ovarian cancer and mesothelioma. Headquartered in Jersey, Novocure has U.S. operations in Portsmouth, New Hampshire, Malvern, Pennsylvania, and New York City. Additionally, the company has offices in Germany, Switzerland and Japan, and a research center in Israel. For additional information about the company, please visit www.novocure.com or follow us at www.twitter.com/novocure. In the United States, Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM). In the United States, Optune with temozolomide is indicated for the treatment of adult patients with newly diagnosed, supratentorial glioblastoma following maximal debulking surgery and completion of radiation therapy together with concomitant standard of care chemotherapy. In the United States, for the treatment of recurrent GBM, Optune is indicated following histologically-or radiologically-confirmed recurrence in the supratentorial region of the brain after receiving chemotherapy. The device is intended to be used as a monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted. In the European Union, Optune is intended for the treatment of patients with newly diagnosed GBM, after surgery and radiotherapy with adjuvant temozolomide, concomitant to maintenance temozolomide. The treatment is intended for adult patients, 18 years of age or older, and should be started more than 4 weeks after surgery and radiation therapy with adjuvant temozolomide. Treatment may be given together with maintenance temozolomide and after maintenance temozolomide is stopped. In the European Union, Optune is also intended for the treatment of patients with recurrent GBM who have progressed after surgery, radiotherapy and temozolomide treatment for their primary disease. The treatment is intended for adult patients, 18 years of age or older, and should be started more than 4 weeks after the latest surgery, radiation therapy or chemotherapy. Patients should only use Optune under the supervision of a physician properly trained in use of the device. Full prescribing information is available at www.optune.com/safety or by calling toll free 1-855-281-9301 in the US or by email at supportEMEA@novocure.com in the European Union. Contraindications: Do not use Optune if you have an active implanted medical device, a skull defect (such as, missing bone with no replacement), or bullet fragments. Use of Optune together with implanted electronic devices has not been tested and may theoretically lead to malfunctioning of the implanted device. Use of Optune together with skull defects or bullet fragments has not been tested and may possibly lead to tissue damage or render Optune ineffective. Do not use Optune if you are known to be sensitive to conductive hydrogels. In this case, skin contact with the gel used with Optune may commonly cause increased redness and itching, and rarely may even lead to severe allergic reactions such as shock and respiratory failure. Warnings and Precautions: Use Optune only after receiving training from qualified personnel, such as your doctor, a nurse, or other medical personnel who have completed a training course given by Novocure (the device manufacturer). Do not use Optune if you are pregnant, you think you might be pregnant or are trying to get pregnant. It is not known if Optune is safe or effective in these populations. The most common (≥10%) adverse events involving Optune in combination with temozolomide were low blood platelet count, nausea, constipation, vomiting, fatigue, scalp irritation from device use, headache, convulsions, and depression. The most common (≥10%) adverse events seen when using Optune alone were scalp irritation from device use and headache. The following adverse reactions were considered related to Optune when using the device alone: scalp irritation from device use, headache, malaise, muscle twitching, fall and skin ulcer. All servicing procedures must be performed by qualified and trained personnel. Do not use any parts that do not come with the Optune Treatment Kit, or that were not sent to you by the device manufacturer or given to you by your doctor. Do not wet the device or transducer arrays. If you have an underlying serious skin condition on the scalp, discuss with your doctor whether this may prevent or temporarily interfere with Optune treatment. Please see http://www.optune.com/safety to see the Optune Instructions For Use (IFU) for complete information regarding the device’s indications, contraindications, warnings, and precautions. In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Novocure’s current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, development of potential products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or other words and terms of similar meaning. Novocure’s performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions as well as more specific risks and uncertainties facing Novocure such as those set forth in its Annual Report on Form 10-K filed on February 23, 2017, with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Novocure does not intend to update publicly any forward-looking statement, except as required by law. Any forward-looking statements herein speak only as of the date hereof. The Private Securities Litigation Reform Act of 1995 permits this discussion.


News Article | May 3, 2017
Site: globenewswire.com

Bank of America Merrill Lynch – May 17-18 UBS – May 22 Craig-Hallum – May 31 SOUTH JORDAN, Utah, May 03, 2017 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ:MMSI), a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology, radiology and endoscopy, today announced that it will participate at three investor conferences during May 2017. On Thursday, May 18, at 10:40 a.m. PT, Merit’s Chairman and Chief Executive Officer Fred P. Lampropoulos will present at the Bank of America Merrill Lynch Healthcare Conference at the Encore at the Wynn in Las Vegas.  He will also participate in one-on-one meetings on May 17-18. On Monday, May 22, at 1:30 p.m. ET, Lampropoulos will present at the UBS Global Healthcare Conference at the Grand Hyatt in New York City.  He will also participate in one-on-one meetings throughout the day. On Wednesday, May 31, Merit’s Chief Financial Officer Bernard Birkett will participate at the 14th Annual Craig-Hallum Institutional Investor Conference at The Depot Renaissance Minneapolis Hotel.  He will host one-on-one meetings throughout the day. Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture and distribution of proprietary disposable medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology and endoscopy. Merit serves client hospitals worldwide with a domestic and international sales force totaling approximately 290 individuals.  Merit employs approximately 4,500 people worldwide with facilities in South Jordan, Utah; Pearland, Texas; Richmond, Virginia; Malvern, Pennsylvania; Rockland, Massachusetts; San Jose, California; Maastricht and Venlo, The Netherlands; Paris, France; Galway, Ireland; Beijing, China; Tijuana, Mexico; Joinville, Brazil; Markham, Ontario, Canada; Melbourne, Australia; Tokyo, Japan; and Singapore.


News Article | March 30, 2017
Site: globenewswire.com

SOUTH JORDAN, Utah, March 30, 2017 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ:MMSI), a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology, radiology and endoscopy, today announced that it will present at the 16th Annual Needham Healthcare Conference being held April 4-5 at the Westin New York Grand Central Hotel. On Wednesday, April 5, at 3:40 p.m. ET, Merit’s Chairman and Chief Executive Officer Fred P. Lampropoulos will give a presentation regarding Merit’s history, products, financial performance and prospects.  He will also participate in one-on-one meetings throughout the day. ABOUT MERIT Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture and distribution of proprietary disposable medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology and endoscopy. Merit serves client hospitals worldwide with a domestic and international sales force totaling approximately 280 individuals.  Merit employs approximately 4,500 people worldwide with facilities in South Jordan, Utah; Pearland, Texas; Richmond, Virginia; Malvern, Pennsylvania; Rockland, Massachusetts; San Jose, California; Maastricht and Venlo, The Netherlands; Paris, France; Galway, Ireland; Beijing, China; Tijuana, Mexico; Joinville, Brazil; Markham, Ontario, Canada; Tokyo, Japan; Singapore; and Melbourne, Australia.


News Article | April 20, 2017
Site: www.materialstoday.com

Suppliers of analytical instrumentation Malvern Instruments and PANalytical have merged their activities. Both companies are owned by Spectris plc within the Materials Analysis segment. PANalytical focuses on X-ray instrumentation and software for materials analysis while Malvern Instruments specializes in materials and biophysical characterization technology. This story uses material from Malvern, with editorial changes made by Materials Today. The views expressed in this article do not necessarily represent those of Elsevier.


MALVERN, Pa., May 05, 2017 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led biotechnology company focused on identifying, developing and commercializing innovative and differentiated therapies to address significant unmet needs in medical and aesthetic dermatology, today announced it has completed a Phase 1 clinical trial of ATI-50001, an investigational oral Janus Kinase (JAK) 1/3 inhibitor. Aclaris is developing ATI-50001 as a treatment for patients with alopecia areata (AA), including the more severe forms of AA that result in total scalp hair loss, known as alopecia totalis, and total hair loss on the scalp and body, known as alopecia universalis. This Phase 1 cross-over trial was conducted in 12 healthy volunteers at one investigational center in the United States to assess the safety, bioavailability, and pharmacodynamics of ATI-50001. In the trial, treatment with ATI-50001 capsules was well tolerated, with a safety profile similar to placebo. No clinically significant laboratory abnormalities were observed. These data are consistent with results from an earlier Phase 1 clinical trial in 44 healthy volunteers conducted by Rigel Pharmaceuticals in which the study drug was well tolerated at all doses, with a safety profile similar to placebo. In addition to this oral formulation of the JAK 1/3 inhibitor, Aclaris also plans to develop a topical formulation, known as ATI-50002, for the treatment of AA, vitiligo, and androgenetic alopecia (AGA). Specifically, Aclaris plans to: Through exclusive licenses, Aclaris has built an extensive intellectual property estate consisting of selective JAK 1/3 compounds, highly selective JAK 3 compounds, and methods of using JAK inhibitors to treat AA, AGA, and various other hair loss disorders. Aclaris has exclusively licensed a patent portfolio from Columbia University directed to methods of using JAK inhibitors for the treatment of AA, AGA, and other hair loss disorders. This portfolio includes a recently issued U.S. patent and recently allowed U.S. applications directed to methods of treating AA, AGA and other hair loss disorders by administering ruxolitinib, baricitinib or decernotinib, and a recently issued patent in Japan directed to pharmaceutical compositions comprising ruxolitinib or baricitinib for use in treating AA, AGA and other hair loss disorders. Aclaris will continue to prosecute additional intellectual property to protect our interests. About Alopecia Areata Alopecia areata is an autoimmune disease that results in partial or complete loss of hair on the scalp and body. The scalp is the most commonly affected area, but any hair-bearing site can be affected alone or together with the scalp. Onset of the disease can occur throughout life and affects both women and men. AA can be associated with serious psychological consequences, including anxiety and depression. AA affects up to 2.0% of people globally at some point during their lifetime (i.e. incidence) and up to 0.2% of people are affected at any given time (i.e. prevalence). There are currently no drugs approved by the U.S. Food and Drug Administration (FDA) for the treatment of AA. About Aclaris Therapeutics, Inc. Aclaris Therapeutics, Inc. is a dermatologist-led biotechnology company focused on identifying, developing and commercializing innovative and differentiated therapies to address significant unmet needs in medical and aesthetic dermatology.  Aclaris is based in Malvern, Pennsylvania and more information can be found by visiting the Aclaris website at www.aclaristx.com. Cautionary Note Regarding Forward-Looking Statements Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe”, “expect”, “may”, “plan,” “potential,” “will,” and similar expressions, and are based on Aclaris’ current beliefs and expectations. These forward-looking statements include expectations regarding the clinical development of Aclaris’ JAK 1/3 inhibitor drug candidates for the treatment of dermatological conditions and Aclaris’ intellectual property strategy. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Aclaris’ reliance on third parties over which it may not always have full control, risks associated with maintaining its intellectual property portfolio and other risks and uncertainties that are described in Aclaris’ Annual Report on Form 10-K for the year ended December 31, 2016 and other filings Aclaris makes with the SEC from time to time. These documents are available under the “Financial Information” section of the Investors page of Aclaris’ website at http://www.aclaristx.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to Aclaris as of the date of this release, and Aclaris assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.


News Article | April 27, 2017
Site: globenewswire.com

* Constant currency revenue, core revenue, non-GAAP EPS, non-GAAP gross margin and non-GAAP net income (referenced below) are non-GAAP financial measures. A reconciliation of these and other non-GAAP financial measures used in this release to their most directly comparable GAAP financial measure is included under the heading “Non-GAAP Financial Measures” below. SOUTH JORDAN, Utah, April 27, 2017 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ:MMSI), a leading manufacturer and marketer of proprietary disposable devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology and endoscopy, today announced sales of $171.1 million for the quarter ended March 31, 2017, an increase of 23.9% over sales of $138.1 million for the quarter ended March 31, 2016.  On a constant currency basis, sales for the first quarter of 2017 would have been up 24.8% over sales for the comparable quarter of 2016. Merit’s GAAP net income for the first quarter of 2017 was $14.8 million, or $0.32 per share, compared to $4.4 million, or $0.10 per share, for the first quarter of 2016. GAAP net income for the first quarter of 2017 included a bargain purchase gain of approximately $12.2 million, or $0.27 per share pre-tax, which Merit recognized as a result of its acquisition of the critical care division of Argon Medical Devices, Inc., and approximately $(4.8) million, or $(0.11) per share pre-tax, of legal expenses Merit incurred in responding to the pending subpoena from the Department of Justice.  Merit’s non-GAAP net income* for the quarter ended March 31, 2017 was $12.7 million, or $0.28 per share, compared to $8.3 million, or $0.19 per share, for the quarter ended March 31, 2016. Given the circumstances of the Argon acquisition, which closed during the first quarter of 2017, and the complexity of the transaction, the entire purchase price allocation for the transaction (as well as the gain on bargain purchase) is considered provisional at this time and is subject to adjustment to reflect new information obtained about factors and circumstances that existed as of the acquisition date that, if known, would have affected the measurement of the amounts recognized as of that date, while the measurement period remains open. Merit’s sales by category for the three months ended March 31, 2017, compared to the corresponding period in 2016, were as follows: “Our management team is pleased with our performance during the first quarter, especially with the activities involved in the integration of the acquisitions of DFINE, the critical care division of Argon and the assets of Catheter Connections,” said Fred P. Lampropoulos, Merit’s Chairman and Chief Executive Officer.  “We delivered strong revenue growth across all sales divisions in the first quarter.” “We continue to focus on our promised deliverables, revenue growth, gross margin expansion, our R&D pipeline, and discipline in controlling our SG&A expenses,” Lampropoulos said. “We plan to deliver a two-year extension of our three-year plan following the second quarter of 2017,” Lampropoulos added.  “We reaffirm our revenue guidance of $713-$723 million and non-GAAP earnings of $1.15-$1.20 per share for the year ending December 31, 2017, without reduction due to our recent public stock offering.  Our guidance on GAAP EPS for the year ending December 31, 2017 is updated from $0.54-$0.60 to $0.80-$0.86 to reflect the bargain purchase gain recognized from the Argon acquisition.” 2017 GUIDANCE Based upon information currently available to Merit's management, Merit estimates that for the year ending December 31, 2017, absent material acquisitions or non-recurring transactions, Merit's revenues will be in the range of $713-$723 million, an increase of approximately 18-20%, compared to revenues of $603.8 million for the year ended December 31, 2016.  Also, based on information currently available to Merit's management, Merit estimates that, absent material acquisitions or non-recurring transactions, Merit's GAAP earnings per share for 2017 will be in the range of $0.80-$0.86 and non-GAAP* earnings per share for 2017 will be in the range of $1.15-$1.20. Merit’s financial guidance for the year ending December 31, 2017 is subject to risks and uncertainties, including, but not limited to, potential accounting adjustments attributable to Merit’s ongoing valuation of intangibles and other financial assets acquired from Argon Medical Devices, Inc. and Catheter Connections, Inc., as well as risks and uncertainties identified in Merit’s public filings. CONFERENCE CALL Merit will hold its investor conference call (conference ID 1848749) today, Thursday, April 27, 2017, at 5:00 p.m. Eastern (4:00 p.m. Central, 3:00 p.m. Mountain, and 2:00 p.m. Pacific).  The domestic telephone number is (844) 578-9672, and the international number is (508) 637-5656.  A live webcast will also be available for the conference call at www.merit.com/investors. Non-GAAP Financial Measures Although Merit’s financial statements are prepared in accordance with accounting principles which are generally accepted in the United States of America (“GAAP”), Merit’s management believes that certain non-GAAP financial measures referred to in this release provide investors with useful information regarding the underlying business trends and performance of Merit’s ongoing operations and can be useful for period-over-period comparisons of such operations.  Non-GAAP financial measures used in this release include: Merit’s management team uses these non-GAAP financial measures to evaluate Merit’s profitability and efficiency, to compare operating results to prior periods, to evaluate changes in the operating results of its operating segments, and to measure and allocate financial resources internally. However, Merit’s management does not consider such non-GAAP measures in isolation or as an alternative to such measures determined in accordance with GAAP. Readers should consider non-GAAP measures used in this release in addition to, not as a substitute for, financial reporting measures prepared in accordance with GAAP.  These non-GAAP financial measures exclude some, but not all, items that may affect Merit's net income. In addition, they are subject to inherent limitations as they reflect the exercise of judgment by management about which items are excluded. Merit believes it is useful to exclude such expenses in the calculation of non-GAAP earnings per share, non-GAAP gross margin and non-GAAP net income (in each case, as further illustrated in the reconciliation table below) because such amounts in any specific period may not directly correlate to the underlying performance of Merit’s business operations and can vary significantly between periods as a result of factors such as new acquisitions, non-cash expense related to amortization of previously acquired tangible and intangible assets, unusual compensation expenses or expense resulting from litigation or governmental proceedings.  Merit may incur similar types of expenses in the future, and the non-GAAP financial information included in this release should not be viewed as a statement or indication that these types of expenses will not recur.  Additionally, the non-GAAP financial measures used in this release may not be comparable with similarly titled measures of other companies.  Merit urges investors and potential investors to review the reconciliations of its non-GAAP financial measures to the comparable GAAP financial measures, and not to rely on any single financial measure to evaluate Merit’s business or results of operations. Constant Currency Reconciliation Merit’s revenue on a constant currency basis is prepared by translating the current-period reported sales of subsidiaries whose functional currency is other than the U.S. dollar at the applicable foreign exchange rates in effect during the comparable prior-year period.  The constant currency revenue adjustment of $1.3 million for the three-month period ended March 31, 2017 was calculated using the applicable average foreign exchange rates for the three-month period ended March 31, 2016. Core Revenue Merit’s core revenue is defined as reported revenue excluding revenues from the acquisitions of the HeRO® Graft (excluded January 2017 only) and DFINE, Inc. in 2016 and Catheter Connections, Inc. and the critical care division of Argon Medical Devices, Inc. in 2017. Other Non-GAAP Financial Measure Reconciliation The following table sets forth supplemental financial data and corresponding reconciliations of non-GAAP net income and non-GAAP earnings per share to Merit’s net income and earnings per share prepared in accordance with GAAP for the three-month periods ended March 31, 2017 and 2016.  Non-GAAP gross margin is calculated by reducing GAAP cost of sales by amounts recorded for amortization of intangible assets and inventory mark-up related to acquisitions. The non-GAAP income adjustments referenced in the following table do not reflect stock-based compensation expense of approximately $577,000 and $624,000 for the three-month periods ended March 31, 2017 and 2016, respectively. (a) Reflects the tax effect of the non-GAAP adjustments (d) Represents changes in the fair value of contingent consideration liabilities and contingent receivables as a result of acquisitions (e) Costs incurred in responding to an inquiry from the U.S. Department of Justice (f) Represents the bargain purchase gain realized from the acquisition of the critical care division of Argon Medical Devices, Inc. *Represents sales from the acquisitions of Hero in February 2016; DFINE in July 2016; Catheter Connections in 2017; and the critical care division of Argon Medical Devices in 2017 **The constant currency revenue adjustment of $1.3 million for the three-month period ended March 31, 2017 was calculated using the applicable average foreign exchange rates for the three-month period ended March 31, 2016. ABOUT MERIT Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture and distribution of proprietary disposable medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology and endoscopy. Merit serves client hospitals worldwide with a domestic and international sales force totaling approximately 290 individuals.  Merit employs approximately 4,500 people worldwide with facilities in South Jordan, Utah; Pearland, Texas; Richmond, Virginia; Malvern, Pennsylvania; Rockland, Massachusetts; San Jose, California; Maastricht and Venlo, The Netherlands; Paris, France; Galway, Ireland; Beijing, China; Tijuana, Mexico; Joinville, Brazil; Markham, Ontario, Canada; Melbourne, Australia; Tokyo, Japan; and Singapore. FORWARD-LOOKING STATEMENTS Statements contained in this release which are not purely historical, including, without limitation, statements regarding Merit's forecasted plans, revenues, net income, financial results or anticipated or completed acquisitions, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties such as those described in Merit's Annual Report on Form 10-K for the year ended December 31, 2016 and subsequent filings with the Securities and Exchange Commission.  Such risks and uncertainties include risks relating to Merit's potential inability to successfully manage growth through acquisitions, including the inability to commercialize technology acquired through completed, proposed or future transactions; product recalls and product liability claims; expenditures relating to research, development, testing and regulatory approval or clearance of Merit's products and risks that such products may not be developed successfully or approved for commercial use; governmental scrutiny and regulation of the medical device industry, including governmental inquiries, investigations and proceedings involving Merit; reforms to the 510(k) process administered by the U.S. Food and Drug Administration; restrictions on Merit's liquidity or business operations resulting from its current debt agreements; infringement of Merit's technology or the assertion that Merit's technology infringes the rights of other parties; the potential of fines, penalties or other adverse consequences if Merit's employees or agents violate the U.S. Foreign Corrupt Practices Act or other laws or regulations; laws and regulations targeting fraud and abuse in the healthcare industry; potential for significant adverse changes in governing regulations; changes in tax laws and regulations in the United States or other countries; increases in the prices of commodity components; negative changes in economic and industry conditions in the United States or other countries; termination or interruption of relationships with Merit's suppliers, or failure of such suppliers to perform; fluctuations in exchange rates;  concentration of a substantial portion of Merit's revenues among a few products and procedures; development of new products and technology that could render Merit's existing products obsolete; market acceptance of new products; volatility in the market price of Merit's common stock; modification or limitation of governmental or private insurance reimbursement policies; changes in healthcare policies or markets related to healthcare reform initiatives; failure to comply with applicable environmental laws; changes in key personnel; work stoppage or transportation risks; introduction of products in a timely fashion; price and product competition; availability of labor and materials; fluctuations in and obsolescence of inventory; and other factors referred to in Merit's Annual Report on Form 10-K for the year ended December 31, 2016 and other materials filed with the Securities and Exchange Commission. All subsequent forward-looking statements attributable to Merit or persons acting on its behalf are expressly qualified in their entirety by these cautionary statements. Actual results will likely differ, and may differ materially, from anticipated results. Financial estimates are subject to change and are not intended to be relied upon as predictions of future operating results, and Merit assumes no obligation to update or disclose revisions to those estimates. TRADEMARKS Unless noted otherwise, trademarks and registered trademarks used in this release are the property of Merit Medical Services, Inc., in the United States and other jurisdictions.


News Article | March 20, 2017
Site: globenewswire.com

SOUTH JORDAN, Utah, March 20, 2017 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ:MMSI) (“Merit”), a leading manufacturer and marketer of proprietary disposable devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology and endoscopy, today announced that it has commenced an underwritten public offering of shares of its common stock.  Merit expects to offer $125.0 million of shares of common stock and also plans to grant the underwriters participating in the offering a 30-day option to buy up to an additional $18.75 million of shares of common stock. The offering is subject to market conditions that make completion of the offering, and the size and terms thereof, uncertain. Merit expects to use the net proceeds from the offering to repay debt under its existing credit facility. BofA Merrill Lynch and Piper Jaffray & Co. are acting as joint book-running managers and representatives of the underwriters for the offering.  Wells Fargo Securities is also acting as a joint book-running manager.  Canaccord Genuity, Raymond James, and SunTrust Robinson Humphrey are acting as co-managers. Copies of the preliminary prospectus supplement and accompanying prospectus relating to the offering may be obtained, when available, free of charge on the Securities and Exchange Commission’s website at www.sec.gov or by sending a request to (a) BofA Merrill Lynch, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attn: Prospectus Department (or by email at dg.prospectus_requests@baml.com), or (b) Piper Jaffray & Co., 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, Attn: Prospectus Department (or by e-mail at prospectus@pjc.com or telephone at (800) 747-3924). This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities described herein, nor will there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. The securities discussed herein will be offered and sold pursuant to an effective shelf registration statement on Form S-3 previously filed with the Securities and Exchange Commission, and the offering will be made only by means of a prospectus supplement and accompanying prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended (the “Securities Act”). ABOUT MERIT Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture and distribution of proprietary disposable medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology and endoscopy. Merit serves client hospitals worldwide with a domestic and international sales force totaling approximately 280 individuals.  Merit employs approximately 4,500 people worldwide with facilities in South Jordan, Utah; Pearland, Texas; Richmond, Virginia; Malvern, Pennsylvania; Rockland, Massachusetts; San Jose, California; Maastricht and Venlo, The Netherlands; Paris, France; Galway, Ireland; Beijing, China; Tijuana, Mexico; Joinville, Brazil; Markham, Ontario, Canada; Tokyo, Japan; Singapore; and Melbourne, Australia. This release includes “forward-looking statements” within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended. 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These risks and uncertainties include risks relating to the sufficiency of demand for our common stock, the price we are able to obtain for our common stock and satisfaction of customary closing conditions for the offering for an underwritten offering of securities, as well as the risks and uncertainties that could affect Merit’s business and financial results described in the preliminary prospectus supplement and accompany prospectus referenced above, as well as Merit’s other filings with the SEC, including under the caption “Risk Factors” in Merit’s Annual Report on Form 10-K for the fiscal year ended December 31, 2016. Forward-looking statements relate only to events as of the date on which the statements are made and actual results or events may differ materially from anticipated results or events. Except as required by law, Merit undertakes no obligation to update or revise any forward-looking statements, even if subsequent events cause its views to change.


ST. HELIER, Jersey--(BUSINESS WIRE)--Novocure (NASDAQ:NVCR) announced today two pilot trials are open and actively recruiting pediatric patients with high grade gliomas to evaluate the safety and feasibility of Tumor Treating Fields (TTFields) in this population. The trials are sponsored by the Pediatric Brain Tumor Consortium and Hackensack University Medical Center. “Although solid tumor cancers are generally rare in children, brain and spinal cord tumors are the third most common type of childhood cancer,” said Dr. Stewart Goldman, Professor of Pediatrics at the Ann & Robert H. Lurie Children Hospital of Chicago. “In order to make a meaningful impact in the lives of these children, we need ongoing research to test the safety and feasibility of potential treatments. We are pleased to see trials testing TTFields in this underserved population.” The first trial, sponsored by the Pediatric Brain Tumor Consortium in collaboration with the National Cancer Institute, will study the feasibility of using TTFields for children with recurrent or progressive suptratentorial high-grade glioma and ependymoma. This study will primarily assess patients’ compliance and number of treatment-related toxicities with secondary outcome measures including the response rate and event-free survival. This trial is actively recruiting an estimated 25 patients. In the second study, the safety, tolerability and preliminary efficacy of TTFields will be tested in pediatric high-grade gliomas in two cohorts. The initial cohort of patients will receive TTFields alone and will consist of children with recurrent high-grade gliomas. The second cohort of patients will receive TTFields in combination with temozolomide and bevacizumab and is open to children with both newly diagnosed and recurrent gliomas. The trial, sponsored by Hackensack University Medical Center, is actively recruiting and is estimated to enroll 12 patients. For more information on the trial designs, visit clinicaltrials.gov and reference NCT03033992 and NCT03128047. Treatment with TTFields is not approved for the treatment of pediatric gliomas by the U.S. Food and Drug Administration. The safety and effectiveness of TTFields therapy for pediatric gliomas has not been established. Novocure is an oncology company developing a profoundly different cancer treatment utilizing a proprietary therapy called TTFields, the use of electric fields tuned to specific frequencies to disrupt solid tumor cancer cell division. Novocure’s commercialized product, Optune, is approved for the treatment of adult patients with glioblastoma. Novocure has ongoing or completed clinical trials investigating TTFields in brain metastases, non-small cell lung cancer, pancreatic cancer, ovarian cancer and mesothelioma. Headquartered in Jersey, Novocure has U.S. operations in Portsmouth, New Hampshire, Malvern, Pennsylvania, and New York City. Additionally, the company has offices in Germany, Switzerland and Japan, and a research center in Israel. For additional information about the company, please visit www.novocure.com or follow us at www.twitter.com/novocure. In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Novocure’s current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, development of potential products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or other words and terms of similar meaning. Novocure’s performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions as well as more specific risks and uncertainties facing Novocure such as those set forth in its Annual Report on Form 10-K filed on February 23, 2017, with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Novocure does not intend to update publicly any forward-looking statement, except as required by law. Any forward-looking statements herein speak only as of the date hereof. The Private Securities Litigation Reform Act of 1995 permits this discussion.


Ma L.,Malvern Inc. | Danoff T.M.,Malvern Inc. | Borish L.,University of Virginia
Journal of Allergy and Clinical Immunology | Year: 2014

Background Anaphylaxis is a serious allergic reaction that can cause death; however, the actual risk of death is unclear. Objective We sought to estimate the case fatality rate among hospitalizations or emergency department (ED) presentations for anaphylaxis and the mortality rate associated with anaphylaxis for the general population. Methods This was a population-based epidemiologic study using 3 national databases: the Nationwide Inpatient Sample (NIS; 1999-2009), the Nationwide Emergency Department Sample (NEDS; 2006-2009), and Multiple Cause of Death Data (MCDD; 1999-2009). Sources for these databases are hospital and ED discharge records and death certificates, respectively. Results Case fatality rates were between 0.25% and 0.33% among hospitalizations or ED presentations with anaphylaxis as the principal diagnosis (NIS+NEDS, 2006-2009). These rates represent 63 to 99 deaths per year in the United States, approximately 77% of which occurred in hospitalized patients. The rate of anaphylaxis-related hospitalizations increased from 21.0 to 25.1 per million population between 1999 and 2009 (annual percentage change, 2.23%; 95% CI, 1.52% to 2.94%), contrasting with a decreasing case fatality rate among hospitalizations (annual percentage change, -2.35%; 95% CI, -4.98% to 0.34%). Overall mortality rates ranged from 0.63 to 0.76 per million population (186-225 deaths per year, MCDD) and appeared stable in the last decade (annual percentage change, -0.31%; 95% CI, -1.54% to 0.93%). Conclusion From 2006 to 2009, the overwhelming majority of hospitalizations or ED presentations for anaphylaxis did not result in death, with an average case fatality rate of 0.3%. Anaphylaxis-related hospitalizations increased steadily in the last decade (1999-2009), but this increase was offset by the decreasing case fatality rate among those hospitalized; both inpatient and overall mortality rates associated with anaphylaxis appeared stable and were well under 1 per million population. Although anaphylactic reactions are potentially life-threatening, the probability of dying is actually very low. With the prevalence of anaphylaxis on the increase, practitioners need to stay vigilant and follow the treatment guidelines to further reduce anaphylaxis-related deaths. © 2013 American Academy of Allergy, Asthma & Immunology.

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