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Winona, Minnesota headquartered Fastenal Co.'s stock finished Thursday's session 0.80% lower at $43.29. A total volume of 3.28 million shares was traded, which was above their three months average volume of 2.79 million shares. The Company's shares are trading below their 200-day moving average by 5.68%. Furthermore, shares of Fastenal, which together with its subsidiaries, engages in the wholesale distribution of industrial and construction supplies in the US, Canada, and internationally, have a Relative Strength Index (RSI) of 35.37. Visit us today and download your complete report on FAST for free at: Shares in Atlanta, Georgia headquartered HD Supply Holdings Inc. ended at $41.32, up 0.34% from the last trading session. The stock recorded a trading volume of 1.90 million shares, which was above its three months average volume of 1.80 million shares. The Company's shares have gained 2.00% in the last one month. The stock is trading 2.19% above its 50-day moving average and 7.00% above its 200-day moving average. Moreover, shares of HD Supply, which operates as an industrial distributor in North America, have an RSI of 57.46. The complimentary research report on HDS can be accessed at: Phoenix, Arizona headquartered Avnet Inc.'s stock ended yesterday's session 0.44% higher at $36.86 with a total trading volume of 979,370 shares. The Company's shares are trading 11.84% below their 50-day moving average. Shares of the Company, which together with its subsidiaries, distributes electronic components, enterprise computer, networking and storage products and software, IT solutions and services, and embedded subsystems in the Americas, Europe, Middle-East, Africa, and the Asia/Pacific, have an RSI of 34.51. On April 28th, 2017, research firm SunTrust downgraded the Company's stock rating from 'Buy' to 'Hold'. Register for free on Stock-Callers.com and download the PDF research report on AVT at: On Thursday, shares in Lake Forest, Illinois-based W.W. Grainger Inc. recorded a trading volume of 923,318 shares, and finished 0.53% lower at $176.37. The stock is trading below its 50-day moving average by 15.61%. Shares of the Company, which distributes maintenance, repair, and operating supplies; and other related products and services that are used by businesses and institutions in the US, Canada, Europe, Asia, and Latin America, have an RSI of 24.44. On May 18th, 2017, research firm Deutsche Bank downgraded the Company's stock rating from 'Hold' to 'Sell' while revising its previous target price from $246 a share to $145 a share. Get free access to your research report on GWW at: Stock Callers (SC) produces regular sponsored and non-sponsored reports, articles, stock market blogs, and popular investment newsletters covering equities listed on NYSE and NASDAQ and micro-cap stocks. 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SANTA CLARA, Calif., May 11, 2017 (GLOBE NEWSWIRE) -- Hitachi Data Systems (HDS), a wholly owned subsidiary of Hitachi, Ltd. (TSE:6501), today announced that the latest version of Hitachi Content Platform (HCP) Anywhere puts the right tools in the hands of employees to make them more engaged, productive and efficient. Expanding on the platform’s heritage in enterprise-class features and security, HCP Anywhere adds more collaboration, usability and data protection capabilities with a refined user experience, allowing organizations to transform to a digital workplace that is virtual, mobile and highly collaborative. Hitachi Content Platform Anywhere is the industry’s only private enterprise mobility solution that allows employees to collaborate with co-workers and external parties to share files or folders anytime, anywhere, on any device, without compromising security or control of corporate information. Hitachi Data Systems’ enterprise expertise and superior information security over consumer-class offerings give IT managers greater visibility, control and governance over company data in corporate issued PCs and virtual desktop environments as well as bring-your-own-device (BYOD) tablets and smartphones. “With this latest release, Hitachi Content Platform Anywhere is more than a simple sync and share tool. With enhancements to collaboration, content mobilization and user data protection, it has become an enterprise mobility solution and a foundation for transforming to a digital workplace.”— Scott Sinclair, Senior Analyst, ESG The combination of HCP Anywhere and the rest of the HCP portfolio of object storage, cloud file gateway, content intelligence and search is an easy first step for organizations pursuing digital transformation. By modernizing file services with cloud home directories, enterprise mobility and content analytics, IT departments can become more relevant than ever before. They can offer new, compelling IT services to the rest of the organization, serve as a cloud broker to other functional groups, and give developers new in-house tools to create new applications to better serve employees and customers. “HCP Anywhere has been a success for Hitachi Data Systems. Customers recognize the power HCP Anywhere has to transform not just the way they deliver user file services, but the way the HCP portfolio can transform their business. As a result, we are approaching one million paid enterprise users and realized 2X revenue growth over the previous fiscal year. Our strong compliance and security heritage coupled with our expertise in understanding and integrating into some of the most complex enterprise IT environments are just a few of the reasons we are seeing security conscious customers choose our solution over consumer oriented Dropbox or Box.” – Bob Primmer, Vice President, Content, Mobility and Analytics, Hitachi Data Systems About the Hitachi Content Platform Portfolio The Hitachi Content Platform portfolio allows organizations to advance their digital workplace experience in a way that incorporates existing content repositories, delivers new age file sharing, collaboration and end-user data protection capabilities, simplify searches and provides APIs to design new workflows and customize the user experience. At the core is object storage software that allows organizations to broker a holistic approach to the digital workplace spanning data within the enterprise and in the cloud. The HCP portfolio intelligently automates tasks related to compliance, protection, security, and management. This allows organizations to speed operations, retain visibility and control with faster, simpler methods to find, analyze and share. HCP Anywhere v3.0 Lays the Foundation for a Digital Workplace About Hitachi Data Systems Hitachi Data Systems, a wholly owned subsidiary of Hitachi, Ltd., offers an integrated portfolio of services and solutions that enable digital transformation through enhanced data management, governance, mobility and analytics. We help global organizations open new revenue streams, increase efficiencies, improve customer experience and ensure rapid time to market in the digital age. Only Hitachi Data Systems powers the digital enterprise by integrating the best information technology and operational technology from across the Hitachi family of companies. We combine this experience with Hitachi expertise in the internet of things to deliver the exceptional insights business and society need to transform and thrive. Visit us at HDS.com. About Hitachi, Ltd. Hitachi, Ltd. (TSE: 6501), headquartered in Tokyo, Japan, delivers innovations that answer society's challenges with our talented team and proven experience in global markets. The company's consolidated revenues for fiscal 2014 (ended March 31, 2015) totaled 9,761 billion yen ($81.3 billion). Hitachi is focusing more than ever on the Social Innovation Business, which includes power & infrastructure systems, information & telecommunication systems, construction machinery, high functional materials & components, automotive systems, healthcare and others. For more information on Hitachi, please visit the company's website at http://www.hitachi.com. HITACHI is a trademark or registered trademark of Hitachi, Ltd. IBM is a trademark or registered trademark of International Business Machines Corporation. All other trademarks, service marks, and company names are properties of their respective owners.


News Article | May 9, 2017
Site: globenewswire.com

NEW YORK, May 09, 2017 (GLOBE NEWSWIRE) -- Delcath Systems, Inc. (NASDAQ:DCTH), an interventional oncology Company focused on the treatment of primary and metastatic liver cancers, announces financial results for the three months ended March 31, 2017. Highlights for the first quarter of 2017 and recent weeks include: “During the first three months of 2017 we continued to advance our clinical development programs in ocular melanoma liver metastases and intrahepatic cholangiocarcinoma, while making steady progress with commercialization of CHEMOSAT in Europe,” said Jennifer K. Simpson, Ph.D., MSN, CRNP President and CEO of Delcath.  “As we announced recently, we have concluded a new SPA agreement with the FDA for the initiation of a pivotal trial for the use of Melphalan/HDS in patients with ICC. This new trial will enroll approximately 295 ICC patients at about 40 clinical sites in the U.S. and Europe, with the primary endpoint of overall survival and with secondary and exploratory endpoints that include safety, progression-free survival, objective response rate and quality-of-life measures.  The trial is designed to be cost-effective and conducted in a financially prudent manner, with modest investment in this fiscal year. In conjunction with the FOCUS Trial in ocular melanoma liver metastases, our clinical development programs now include two paths toward potential U.S. market approvals. “In Europe, we continue to make steady progress with the commercialization of CHEMOSAT.  Our first quarter revenue of more than $0.7 million was double the prior year period’s sales, driven primarily by national reimbursement in Germany under the ZE system. With coverage under the ZE system now in place, we expect product sales growth from this market for the remainder of 2017. Elsewhere in Europe, we continue to focus on building the clinical and pharmacoeconomic data to support reimbursement applications in other key markets.  We expect that positive negotiations for coverage in Germany will support our efforts for payment levels in other markets such as the U.K. and the Netherlands. Securing reimbursement coverage in additional European markets remains critical to future revenue growth for CHEMOSAT,” concluded Dr. Simpson. Revenue for the three months ended March 31, 2017 was $0.74 million, an increase of 100% from $0.37 million for the prior year period. Selling, general and administrative expenses were approximately $2.4 million, unchanged from the prior year quarter.  Research and development expenses for the current quarter increased to $2.3 million from $1.3 million in the prior year quarter.   Total operating expenses for the current quarter were $4.7 million compared with $3.7 million in the prior year quarter. The Company reported a net loss for the 2017 first quarter of $11.3 million, or $0.25 per share based on 45.1 million weighted average common shares outstanding, compared with a net loss in the prior year period of $1.8 million or $1.25 per share based on 1.5 million weighted average common shares outstanding.  The increase is primarily due to an $8.4 million increase in interest expense primarily related to the amortization of debt discounts, a non-cash item, and a $1.0 million increase in operating expenses primarily related to increased investment in clinical trial initiatives. This was offset by a $0.4 million change in the fair value of the warrant liability, a non-cash item, and a $0.27 million improvement in gross profit due to higher sales. As of March 31, 2017, Delcath had cash and cash equivalents of $6.4 million, compared with $4.4 million as of December 31, 2016.  During the first quarter of 2017, the Company used $3.8 million of cash to fund operating activities. Delcath believes it has sufficient capital and access to committed capital to fund its operating activities through the end of 2017. On April 2, 2017, Delcath entered into separate Warrant Repurchase Agreements with each of the investors named on the Schedule of Buyers attached to our Securities Purchase Agreement dated June 6, 2016. Pursuant to the Warrant Repurchase Agreements, each investor agreed to a Controlled Account Release in an aggregate amount equal to $7,876,312, which funds in each case were paid to the respective investor in exchange for cancellation of the Warrants issued to each investor under the Securities Purchase Agreement. Delcath anticipates that the cash remaining in the Controlled Accounts after this transaction will be sufficient to fund operating activities through the end of 2017. Delcath Systems, Inc. is an interventional oncology Company focused on the treatment of primary and metastatic liver cancers. Our investigational product—Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS) —is designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects. We have commenced a global Phase 3 FOCUS clinical trial for Patients with Hepatic Dominant Ocular Melanoma (OM) and plan to initiate a Registration trial for intrahepatic cholangiocarcinoma (ICC) in the Fall of 2017. Melphalan/HDS has not been approved by the U.S. Food & Drug Administration (FDA) for sale in the U.S.  In Europe, our system has been commercially available since 2012 under the trade name Delcath Hepatic CHEMOSAT® Delivery System for Melphalan (CHEMOSAT), where it has been used at major medical centers to treat a wide range of cancers of the liver. Forward Looking Statements: Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by the Company or on its behalf. This news release contains forward-looking statements, which are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to, uncertainties relating to:  the timing and results of the Company’s  clinical trials including without limitation the OM and ICC  clinical trial programs,  timely enrollment and treatment of patients in the global Phase 3 OM clinical trial, IRB or ethics committee clearance of the  Phase 3 OM and ICC Registration trial  protocols from  participating sites and the timing of site activation and subject enrollment in each trial, the impact of the presentations at major medical conferences and future clinical results consistent with the data presented, approval of Individual Funding Requests for reimbursement of the CHEMOSAT procedure, the impact, if any  of ZE reimbursement on potential CHEMOSAT product use and sales in Germany, clinical adoption, use and resulting sales, if any, for the CHEMOSAT system to deliver and filter melphalan in Europe including the key markets of Germany and the UK, the Company’s ability to successfully commercialize the Melphalan HDS/CHEMOSAT system and the potential of the Melphalan HDS/CHEMOSAT system as a treatment for patients with primary and metastatic disease in the liver, our ability to obtain reimbursement for the CHEMOSAT system in various markets,, approval of the current or future Melphalan HDS/CHEMOSAT system for delivery and filtration of melphalan or other chemotherapeutic agents for various indications in the U.S. and/or in foreign markets, actions by the FDA or other foreign regulatory agencies, the Company’s ability to successfully enter into strategic partnership and distribution arrangements in foreign markets and the timing and revenue, if any, of the same, uncertainties relating to the timing and results of research and development projects, our ability to maintain NASDAQ listing, and uncertainties regarding the Company’s ability to obtain financial and other resources for any research, development, clinical trials and commercialization activities. These factors, and others, are discussed from time to time in our filings with the Securities and Exchange Commission. You should not place undue reliance on these forward-looking statements, which speak only as of the date they are made. We undertake no obligation to publicly update or revise these forward-looking statements to reflect events or circumstances after the date they are made.


News Article | May 9, 2017
Site: globenewswire.com

NEW YORK, May 09, 2017 (GLOBE NEWSWIRE) -- Delcath Systems, Inc. (NASDAQ:DCTH), an interventional oncology Company focused on the treatment of primary and metastatic liver cancers, announces financial results for the three months ended March 31, 2017. Highlights for the first quarter of 2017 and recent weeks include: “During the first three months of 2017 we continued to advance our clinical development programs in ocular melanoma liver metastases and intrahepatic cholangiocarcinoma, while making steady progress with commercialization of CHEMOSAT in Europe,” said Jennifer K. Simpson, Ph.D., MSN, CRNP President and CEO of Delcath.  “As we announced recently, we have concluded a new SPA agreement with the FDA for the initiation of a pivotal trial for the use of Melphalan/HDS in patients with ICC. This new trial will enroll approximately 295 ICC patients at about 40 clinical sites in the U.S. and Europe, with the primary endpoint of overall survival and with secondary and exploratory endpoints that include safety, progression-free survival, objective response rate and quality-of-life measures.  The trial is designed to be cost-effective and conducted in a financially prudent manner, with modest investment in this fiscal year. In conjunction with the FOCUS Trial in ocular melanoma liver metastases, our clinical development programs now include two paths toward potential U.S. market approvals. “In Europe, we continue to make steady progress with the commercialization of CHEMOSAT.  Our first quarter revenue of more than $0.7 million was double the prior year period’s sales, driven primarily by national reimbursement in Germany under the ZE system. With coverage under the ZE system now in place, we expect product sales growth from this market for the remainder of 2017. Elsewhere in Europe, we continue to focus on building the clinical and pharmacoeconomic data to support reimbursement applications in other key markets.  We expect that positive negotiations for coverage in Germany will support our efforts for payment levels in other markets such as the U.K. and the Netherlands. Securing reimbursement coverage in additional European markets remains critical to future revenue growth for CHEMOSAT,” concluded Dr. Simpson. Revenue for the three months ended March 31, 2017 was $0.74 million, an increase of 100% from $0.37 million for the prior year period. Selling, general and administrative expenses were approximately $2.4 million, unchanged from the prior year quarter.  Research and development expenses for the current quarter increased to $2.3 million from $1.3 million in the prior year quarter.   Total operating expenses for the current quarter were $4.7 million compared with $3.7 million in the prior year quarter. The Company reported a net loss for the 2017 first quarter of $11.3 million, or $0.25 per share based on 45.1 million weighted average common shares outstanding, compared with a net loss in the prior year period of $1.8 million or $1.25 per share based on 1.5 million weighted average common shares outstanding.  The increase is primarily due to an $8.4 million increase in interest expense primarily related to the amortization of debt discounts, a non-cash item, and a $1.0 million increase in operating expenses primarily related to increased investment in clinical trial initiatives. This was offset by a $0.4 million change in the fair value of the warrant liability, a non-cash item, and a $0.27 million improvement in gross profit due to higher sales. As of March 31, 2017, Delcath had cash and cash equivalents of $6.4 million, compared with $4.4 million as of December 31, 2016.  During the first quarter of 2017, the Company used $3.8 million of cash to fund operating activities. Delcath believes it has sufficient capital and access to committed capital to fund its operating activities through the end of 2017. On April 2, 2017, Delcath entered into separate Warrant Repurchase Agreements with each of the investors named on the Schedule of Buyers attached to our Securities Purchase Agreement dated June 6, 2016. Pursuant to the Warrant Repurchase Agreements, each investor agreed to a Controlled Account Release in an aggregate amount equal to $7,876,312, which funds in each case were paid to the respective investor in exchange for cancellation of the Warrants issued to each investor under the Securities Purchase Agreement. Delcath anticipates that the cash remaining in the Controlled Accounts after this transaction will be sufficient to fund operating activities through the end of 2017. Delcath Systems, Inc. is an interventional oncology Company focused on the treatment of primary and metastatic liver cancers. Our investigational product—Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS) —is designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects. We have commenced a global Phase 3 FOCUS clinical trial for Patients with Hepatic Dominant Ocular Melanoma (OM) and plan to initiate a Registration trial for intrahepatic cholangiocarcinoma (ICC) in the Fall of 2017. Melphalan/HDS has not been approved by the U.S. Food & Drug Administration (FDA) for sale in the U.S.  In Europe, our system has been commercially available since 2012 under the trade name Delcath Hepatic CHEMOSAT® Delivery System for Melphalan (CHEMOSAT), where it has been used at major medical centers to treat a wide range of cancers of the liver. Forward Looking Statements: Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by the Company or on its behalf. This news release contains forward-looking statements, which are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to, uncertainties relating to:  the timing and results of the Company’s  clinical trials including without limitation the OM and ICC  clinical trial programs,  timely enrollment and treatment of patients in the global Phase 3 OM clinical trial, IRB or ethics committee clearance of the  Phase 3 OM and ICC Registration trial  protocols from  participating sites and the timing of site activation and subject enrollment in each trial, the impact of the presentations at major medical conferences and future clinical results consistent with the data presented, approval of Individual Funding Requests for reimbursement of the CHEMOSAT procedure, the impact, if any  of ZE reimbursement on potential CHEMOSAT product use and sales in Germany, clinical adoption, use and resulting sales, if any, for the CHEMOSAT system to deliver and filter melphalan in Europe including the key markets of Germany and the UK, the Company’s ability to successfully commercialize the Melphalan HDS/CHEMOSAT system and the potential of the Melphalan HDS/CHEMOSAT system as a treatment for patients with primary and metastatic disease in the liver, our ability to obtain reimbursement for the CHEMOSAT system in various markets,, approval of the current or future Melphalan HDS/CHEMOSAT system for delivery and filtration of melphalan or other chemotherapeutic agents for various indications in the U.S. and/or in foreign markets, actions by the FDA or other foreign regulatory agencies, the Company’s ability to successfully enter into strategic partnership and distribution arrangements in foreign markets and the timing and revenue, if any, of the same, uncertainties relating to the timing and results of research and development projects, our ability to maintain NASDAQ listing, and uncertainties regarding the Company’s ability to obtain financial and other resources for any research, development, clinical trials and commercialization activities. These factors, and others, are discussed from time to time in our filings with the Securities and Exchange Commission. You should not place undue reliance on these forward-looking statements, which speak only as of the date they are made. We undertake no obligation to publicly update or revise these forward-looking statements to reflect events or circumstances after the date they are made.


News Article | May 9, 2017
Site: globenewswire.com

NEW YORK, May 09, 2017 (GLOBE NEWSWIRE) -- Delcath Systems, Inc. (NASDAQ:DCTH), an interventional oncology Company focused on the treatment of primary and metastatic liver cancers, announces financial results for the three months ended March 31, 2017. Highlights for the first quarter of 2017 and recent weeks include: “During the first three months of 2017 we continued to advance our clinical development programs in ocular melanoma liver metastases and intrahepatic cholangiocarcinoma, while making steady progress with commercialization of CHEMOSAT in Europe,” said Jennifer K. Simpson, Ph.D., MSN, CRNP President and CEO of Delcath.  “As we announced recently, we have concluded a new SPA agreement with the FDA for the initiation of a pivotal trial for the use of Melphalan/HDS in patients with ICC. This new trial will enroll approximately 295 ICC patients at about 40 clinical sites in the U.S. and Europe, with the primary endpoint of overall survival and with secondary and exploratory endpoints that include safety, progression-free survival, objective response rate and quality-of-life measures.  The trial is designed to be cost-effective and conducted in a financially prudent manner, with modest investment in this fiscal year. In conjunction with the FOCUS Trial in ocular melanoma liver metastases, our clinical development programs now include two paths toward potential U.S. market approvals. “In Europe, we continue to make steady progress with the commercialization of CHEMOSAT.  Our first quarter revenue of more than $0.7 million was double the prior year period’s sales, driven primarily by national reimbursement in Germany under the ZE system. With coverage under the ZE system now in place, we expect product sales growth from this market for the remainder of 2017. Elsewhere in Europe, we continue to focus on building the clinical and pharmacoeconomic data to support reimbursement applications in other key markets.  We expect that positive negotiations for coverage in Germany will support our efforts for payment levels in other markets such as the U.K. and the Netherlands. Securing reimbursement coverage in additional European markets remains critical to future revenue growth for CHEMOSAT,” concluded Dr. Simpson. Revenue for the three months ended March 31, 2017 was $0.74 million, an increase of 100% from $0.37 million for the prior year period. Selling, general and administrative expenses were approximately $2.4 million, unchanged from the prior year quarter.  Research and development expenses for the current quarter increased to $2.3 million from $1.3 million in the prior year quarter.   Total operating expenses for the current quarter were $4.7 million compared with $3.7 million in the prior year quarter. The Company reported a net loss for the 2017 first quarter of $11.3 million, or $0.25 per share based on 45.1 million weighted average common shares outstanding, compared with a net loss in the prior year period of $1.8 million or $1.25 per share based on 1.5 million weighted average common shares outstanding.  The increase is primarily due to an $8.4 million increase in interest expense primarily related to the amortization of debt discounts, a non-cash item, and a $1.0 million increase in operating expenses primarily related to increased investment in clinical trial initiatives. This was offset by a $0.4 million change in the fair value of the warrant liability, a non-cash item, and a $0.27 million improvement in gross profit due to higher sales. As of March 31, 2017, Delcath had cash and cash equivalents of $6.4 million, compared with $4.4 million as of December 31, 2016.  During the first quarter of 2017, the Company used $3.8 million of cash to fund operating activities. Delcath believes it has sufficient capital and access to committed capital to fund its operating activities through the end of 2017. On April 2, 2017, Delcath entered into separate Warrant Repurchase Agreements with each of the investors named on the Schedule of Buyers attached to our Securities Purchase Agreement dated June 6, 2016. Pursuant to the Warrant Repurchase Agreements, each investor agreed to a Controlled Account Release in an aggregate amount equal to $7,876,312, which funds in each case were paid to the respective investor in exchange for cancellation of the Warrants issued to each investor under the Securities Purchase Agreement. Delcath anticipates that the cash remaining in the Controlled Accounts after this transaction will be sufficient to fund operating activities through the end of 2017. Delcath Systems, Inc. is an interventional oncology Company focused on the treatment of primary and metastatic liver cancers. Our investigational product—Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS) —is designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects. We have commenced a global Phase 3 FOCUS clinical trial for Patients with Hepatic Dominant Ocular Melanoma (OM) and plan to initiate a Registration trial for intrahepatic cholangiocarcinoma (ICC) in the Fall of 2017. Melphalan/HDS has not been approved by the U.S. Food & Drug Administration (FDA) for sale in the U.S.  In Europe, our system has been commercially available since 2012 under the trade name Delcath Hepatic CHEMOSAT® Delivery System for Melphalan (CHEMOSAT), where it has been used at major medical centers to treat a wide range of cancers of the liver. Forward Looking Statements: Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by the Company or on its behalf. This news release contains forward-looking statements, which are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to, uncertainties relating to:  the timing and results of the Company’s  clinical trials including without limitation the OM and ICC  clinical trial programs,  timely enrollment and treatment of patients in the global Phase 3 OM clinical trial, IRB or ethics committee clearance of the  Phase 3 OM and ICC Registration trial  protocols from  participating sites and the timing of site activation and subject enrollment in each trial, the impact of the presentations at major medical conferences and future clinical results consistent with the data presented, approval of Individual Funding Requests for reimbursement of the CHEMOSAT procedure, the impact, if any  of ZE reimbursement on potential CHEMOSAT product use and sales in Germany, clinical adoption, use and resulting sales, if any, for the CHEMOSAT system to deliver and filter melphalan in Europe including the key markets of Germany and the UK, the Company’s ability to successfully commercialize the Melphalan HDS/CHEMOSAT system and the potential of the Melphalan HDS/CHEMOSAT system as a treatment for patients with primary and metastatic disease in the liver, our ability to obtain reimbursement for the CHEMOSAT system in various markets,, approval of the current or future Melphalan HDS/CHEMOSAT system for delivery and filtration of melphalan or other chemotherapeutic agents for various indications in the U.S. and/or in foreign markets, actions by the FDA or other foreign regulatory agencies, the Company’s ability to successfully enter into strategic partnership and distribution arrangements in foreign markets and the timing and revenue, if any, of the same, uncertainties relating to the timing and results of research and development projects, our ability to maintain NASDAQ listing, and uncertainties regarding the Company’s ability to obtain financial and other resources for any research, development, clinical trials and commercialization activities. These factors, and others, are discussed from time to time in our filings with the Securities and Exchange Commission. You should not place undue reliance on these forward-looking statements, which speak only as of the date they are made. We undertake no obligation to publicly update or revise these forward-looking statements to reflect events or circumstances after the date they are made.


SANTA CLARA, Calif., May 11, 2017 (GLOBE NEWSWIRE) -- Hitachi Data Systems (HDS), a wholly owned subsidiary of Hitachi, Ltd. (TSE:6501), today announced that the latest version of Hitachi Content Platform (HCP) Anywhere puts the right tools in the hands of employees to make them more engaged, productive and efficient. Expanding on the platform’s heritage in enterprise-class features and security, HCP Anywhere adds more collaboration, usability and data protection capabilities with a refined user experience, allowing organizations to transform to a digital workplace that is virtual, mobile and highly collaborative. Hitachi Content Platform Anywhere is the industry’s only private enterprise mobility solution that allows employees to collaborate with co-workers and external parties to share files or folders anytime, anywhere, on any device, without compromising security or control of corporate information. Hitachi Data Systems’ enterprise expertise and superior information security over consumer-class offerings give IT managers greater visibility, control and governance over company data in corporate issued PCs and virtual desktop environments as well as bring-your-own-device (BYOD) tablets and smartphones. “With this latest release, Hitachi Content Platform Anywhere is more than a simple sync and share tool. With enhancements to collaboration, content mobilization and user data protection, it has become an enterprise mobility solution and a foundation for transforming to a digital workplace.”— Scott Sinclair, Senior Analyst, ESG The combination of HCP Anywhere and the rest of the HCP portfolio of object storage, cloud file gateway, content intelligence and search is an easy first step for organizations pursuing digital transformation. By modernizing file services with cloud home directories, enterprise mobility and content analytics, IT departments can become more relevant than ever before. They can offer new, compelling IT services to the rest of the organization, serve as a cloud broker to other functional groups, and give developers new in-house tools to create new applications to better serve employees and customers. “HCP Anywhere has been a success for Hitachi Data Systems. Customers recognize the power HCP Anywhere has to transform not just the way they deliver user file services, but the way the HCP portfolio can transform their business. As a result, we are approaching one million paid enterprise users and realized 2X revenue growth over the previous fiscal year. Our strong compliance and security heritage coupled with our expertise in understanding and integrating into some of the most complex enterprise IT environments are just a few of the reasons we are seeing security conscious customers choose our solution over consumer oriented Dropbox or Box.” – Bob Primmer, Vice President, Content, Mobility and Analytics, Hitachi Data Systems About the Hitachi Content Platform Portfolio The Hitachi Content Platform portfolio allows organizations to advance their digital workplace experience in a way that incorporates existing content repositories, delivers new age file sharing, collaboration and end-user data protection capabilities, simplify searches and provides APIs to design new workflows and customize the user experience. At the core is object storage software that allows organizations to broker a holistic approach to the digital workplace spanning data within the enterprise and in the cloud. The HCP portfolio intelligently automates tasks related to compliance, protection, security, and management. This allows organizations to speed operations, retain visibility and control with faster, simpler methods to find, analyze and share. HCP Anywhere v3.0 Lays the Foundation for a Digital Workplace About Hitachi Data Systems Hitachi Data Systems, a wholly owned subsidiary of Hitachi, Ltd., offers an integrated portfolio of services and solutions that enable digital transformation through enhanced data management, governance, mobility and analytics. We help global organizations open new revenue streams, increase efficiencies, improve customer experience and ensure rapid time to market in the digital age. Only Hitachi Data Systems powers the digital enterprise by integrating the best information technology and operational technology from across the Hitachi family of companies. We combine this experience with Hitachi expertise in the internet of things to deliver the exceptional insights business and society need to transform and thrive. Visit us at HDS.com. About Hitachi, Ltd. Hitachi, Ltd. (TSE: 6501), headquartered in Tokyo, Japan, delivers innovations that answer society's challenges with our talented team and proven experience in global markets. The company's consolidated revenues for fiscal 2014 (ended March 31, 2015) totaled 9,761 billion yen ($81.3 billion). Hitachi is focusing more than ever on the Social Innovation Business, which includes power & infrastructure systems, information & telecommunication systems, construction machinery, high functional materials & components, automotive systems, healthcare and others. For more information on Hitachi, please visit the company's website at http://www.hitachi.com. HITACHI is a trademark or registered trademark of Hitachi, Ltd. IBM is a trademark or registered trademark of International Business Machines Corporation. All other trademarks, service marks, and company names are properties of their respective owners.


SANTA CLARA, Calif., May 11, 2017 (GLOBE NEWSWIRE) -- Hitachi Data Systems (HDS), a wholly owned subsidiary of Hitachi, Ltd. (TSE:6501), today announced that the latest version of Hitachi Content Platform (HCP) Anywhere puts the right tools in the hands of employees to make them more engaged, productive and efficient. Expanding on the platform’s heritage in enterprise-class features and security, HCP Anywhere adds more collaboration, usability and data protection capabilities with a refined user experience, allowing organizations to transform to a digital workplace that is virtual, mobile and highly collaborative. Hitachi Content Platform Anywhere is the industry’s only private enterprise mobility solution that allows employees to collaborate with co-workers and external parties to share files or folders anytime, anywhere, on any device, without compromising security or control of corporate information. Hitachi Data Systems’ enterprise expertise and superior information security over consumer-class offerings give IT managers greater visibility, control and governance over company data in corporate issued PCs and virtual desktop environments as well as bring-your-own-device (BYOD) tablets and smartphones. “With this latest release, Hitachi Content Platform Anywhere is more than a simple sync and share tool. With enhancements to collaboration, content mobilization and user data protection, it has become an enterprise mobility solution and a foundation for transforming to a digital workplace.”— Scott Sinclair, Senior Analyst, ESG The combination of HCP Anywhere and the rest of the HCP portfolio of object storage, cloud file gateway, content intelligence and search is an easy first step for organizations pursuing digital transformation. By modernizing file services with cloud home directories, enterprise mobility and content analytics, IT departments can become more relevant than ever before. They can offer new, compelling IT services to the rest of the organization, serve as a cloud broker to other functional groups, and give developers new in-house tools to create new applications to better serve employees and customers. “HCP Anywhere has been a success for Hitachi Data Systems. Customers recognize the power HCP Anywhere has to transform not just the way they deliver user file services, but the way the HCP portfolio can transform their business. As a result, we are approaching one million paid enterprise users and realized 2X revenue growth over the previous fiscal year. Our strong compliance and security heritage coupled with our expertise in understanding and integrating into some of the most complex enterprise IT environments are just a few of the reasons we are seeing security conscious customers choose our solution over consumer oriented Dropbox or Box.” – Bob Primmer, Vice President, Content, Mobility and Analytics, Hitachi Data Systems About the Hitachi Content Platform Portfolio The Hitachi Content Platform portfolio allows organizations to advance their digital workplace experience in a way that incorporates existing content repositories, delivers new age file sharing, collaboration and end-user data protection capabilities, simplify searches and provides APIs to design new workflows and customize the user experience. At the core is object storage software that allows organizations to broker a holistic approach to the digital workplace spanning data within the enterprise and in the cloud. The HCP portfolio intelligently automates tasks related to compliance, protection, security, and management. This allows organizations to speed operations, retain visibility and control with faster, simpler methods to find, analyze and share. HCP Anywhere v3.0 Lays the Foundation for a Digital Workplace About Hitachi Data Systems Hitachi Data Systems, a wholly owned subsidiary of Hitachi, Ltd., offers an integrated portfolio of services and solutions that enable digital transformation through enhanced data management, governance, mobility and analytics. We help global organizations open new revenue streams, increase efficiencies, improve customer experience and ensure rapid time to market in the digital age. Only Hitachi Data Systems powers the digital enterprise by integrating the best information technology and operational technology from across the Hitachi family of companies. We combine this experience with Hitachi expertise in the internet of things to deliver the exceptional insights business and society need to transform and thrive. Visit us at HDS.com. About Hitachi, Ltd. Hitachi, Ltd. (TSE: 6501), headquartered in Tokyo, Japan, delivers innovations that answer society's challenges with our talented team and proven experience in global markets. The company's consolidated revenues for fiscal 2014 (ended March 31, 2015) totaled 9,761 billion yen ($81.3 billion). Hitachi is focusing more than ever on the Social Innovation Business, which includes power & infrastructure systems, information & telecommunication systems, construction machinery, high functional materials & components, automotive systems, healthcare and others. For more information on Hitachi, please visit the company's website at http://www.hitachi.com. HITACHI is a trademark or registered trademark of Hitachi, Ltd. IBM is a trademark or registered trademark of International Business Machines Corporation. All other trademarks, service marks, and company names are properties of their respective owners.


SANTA CLARA, Calif., May 11, 2017 (GLOBE NEWSWIRE) -- Hitachi Data Systems (HDS), a wholly owned subsidiary of Hitachi, Ltd. (TSE:6501), today announced that the latest version of Hitachi Content Platform (HCP) Anywhere puts the right tools in the hands of employees to make them more engaged, productive and efficient. Expanding on the platform’s heritage in enterprise-class features and security, HCP Anywhere adds more collaboration, usability and data protection capabilities with a refined user experience, allowing organizations to transform to a digital workplace that is virtual, mobile and highly collaborative. Hitachi Content Platform Anywhere is the industry’s only private enterprise mobility solution that allows employees to collaborate with co-workers and external parties to share files or folders anytime, anywhere, on any device, without compromising security or control of corporate information. Hitachi Data Systems’ enterprise expertise and superior information security over consumer-class offerings give IT managers greater visibility, control and governance over company data in corporate issued PCs and virtual desktop environments as well as bring-your-own-device (BYOD) tablets and smartphones. “With this latest release, Hitachi Content Platform Anywhere is more than a simple sync and share tool. With enhancements to collaboration, content mobilization and user data protection, it has become an enterprise mobility solution and a foundation for transforming to a digital workplace.”— Scott Sinclair, Senior Analyst, ESG The combination of HCP Anywhere and the rest of the HCP portfolio of object storage, cloud file gateway, content intelligence and search is an easy first step for organizations pursuing digital transformation. By modernizing file services with cloud home directories, enterprise mobility and content analytics, IT departments can become more relevant than ever before. They can offer new, compelling IT services to the rest of the organization, serve as a cloud broker to other functional groups, and give developers new in-house tools to create new applications to better serve employees and customers. “HCP Anywhere has been a success for Hitachi Data Systems. Customers recognize the power HCP Anywhere has to transform not just the way they deliver user file services, but the way the HCP portfolio can transform their business. As a result, we are approaching one million paid enterprise users and realized 2X revenue growth over the previous fiscal year. Our strong compliance and security heritage coupled with our expertise in understanding and integrating into some of the most complex enterprise IT environments are just a few of the reasons we are seeing security conscious customers choose our solution over consumer oriented Dropbox or Box.” – Bob Primmer, Vice President, Content, Mobility and Analytics, Hitachi Data Systems About the Hitachi Content Platform Portfolio The Hitachi Content Platform portfolio allows organizations to advance their digital workplace experience in a way that incorporates existing content repositories, delivers new age file sharing, collaboration and end-user data protection capabilities, simplify searches and provides APIs to design new workflows and customize the user experience. At the core is object storage software that allows organizations to broker a holistic approach to the digital workplace spanning data within the enterprise and in the cloud. The HCP portfolio intelligently automates tasks related to compliance, protection, security, and management. This allows organizations to speed operations, retain visibility and control with faster, simpler methods to find, analyze and share. HCP Anywhere v3.0 Lays the Foundation for a Digital Workplace About Hitachi Data Systems Hitachi Data Systems, a wholly owned subsidiary of Hitachi, Ltd., offers an integrated portfolio of services and solutions that enable digital transformation through enhanced data management, governance, mobility and analytics. We help global organizations open new revenue streams, increase efficiencies, improve customer experience and ensure rapid time to market in the digital age. Only Hitachi Data Systems powers the digital enterprise by integrating the best information technology and operational technology from across the Hitachi family of companies. We combine this experience with Hitachi expertise in the internet of things to deliver the exceptional insights business and society need to transform and thrive. Visit us at HDS.com. About Hitachi, Ltd. Hitachi, Ltd. (TSE: 6501), headquartered in Tokyo, Japan, delivers innovations that answer society's challenges with our talented team and proven experience in global markets. The company's consolidated revenues for fiscal 2014 (ended March 31, 2015) totaled 9,761 billion yen ($81.3 billion). Hitachi is focusing more than ever on the Social Innovation Business, which includes power & infrastructure systems, information & telecommunication systems, construction machinery, high functional materials & components, automotive systems, healthcare and others. For more information on Hitachi, please visit the company's website at http://www.hitachi.com. HITACHI is a trademark or registered trademark of Hitachi, Ltd. IBM is a trademark or registered trademark of International Business Machines Corporation. All other trademarks, service marks, and company names are properties of their respective owners.


News Article | May 9, 2017
Site: globenewswire.com

NEW YORK, May 09, 2017 (GLOBE NEWSWIRE) -- Delcath Systems, Inc. (NASDAQ:DCTH), an interventional oncology Company focused on the treatment of primary and metastatic liver cancers, announces financial results for the three months ended March 31, 2017. Highlights for the first quarter of 2017 and recent weeks include: “During the first three months of 2017 we continued to advance our clinical development programs in ocular melanoma liver metastases and intrahepatic cholangiocarcinoma, while making steady progress with commercialization of CHEMOSAT in Europe,” said Jennifer K. Simpson, Ph.D., MSN, CRNP President and CEO of Delcath.  “As we announced recently, we have concluded a new SPA agreement with the FDA for the initiation of a pivotal trial for the use of Melphalan/HDS in patients with ICC. This new trial will enroll approximately 295 ICC patients at about 40 clinical sites in the U.S. and Europe, with the primary endpoint of overall survival and with secondary and exploratory endpoints that include safety, progression-free survival, objective response rate and quality-of-life measures.  The trial is designed to be cost-effective and conducted in a financially prudent manner, with modest investment in this fiscal year. In conjunction with the FOCUS Trial in ocular melanoma liver metastases, our clinical development programs now include two paths toward potential U.S. market approvals. “In Europe, we continue to make steady progress with the commercialization of CHEMOSAT.  Our first quarter revenue of more than $0.7 million was double the prior year period’s sales, driven primarily by national reimbursement in Germany under the ZE system. With coverage under the ZE system now in place, we expect product sales growth from this market for the remainder of 2017. Elsewhere in Europe, we continue to focus on building the clinical and pharmacoeconomic data to support reimbursement applications in other key markets.  We expect that positive negotiations for coverage in Germany will support our efforts for payment levels in other markets such as the U.K. and the Netherlands. Securing reimbursement coverage in additional European markets remains critical to future revenue growth for CHEMOSAT,” concluded Dr. Simpson. Revenue for the three months ended March 31, 2017 was $0.74 million, an increase of 100% from $0.37 million for the prior year period. Selling, general and administrative expenses were approximately $2.4 million, unchanged from the prior year quarter.  Research and development expenses for the current quarter increased to $2.3 million from $1.3 million in the prior year quarter.   Total operating expenses for the current quarter were $4.7 million compared with $3.7 million in the prior year quarter. The Company reported a net loss for the 2017 first quarter of $11.3 million, or $0.25 per share based on 45.1 million weighted average common shares outstanding, compared with a net loss in the prior year period of $1.8 million or $1.25 per share based on 1.5 million weighted average common shares outstanding.  The increase is primarily due to an $8.4 million increase in interest expense primarily related to the amortization of debt discounts, a non-cash item, and a $1.0 million increase in operating expenses primarily related to increased investment in clinical trial initiatives. This was offset by a $0.4 million change in the fair value of the warrant liability, a non-cash item, and a $0.27 million improvement in gross profit due to higher sales. As of March 31, 2017, Delcath had cash and cash equivalents of $6.4 million, compared with $4.4 million as of December 31, 2016.  During the first quarter of 2017, the Company used $3.8 million of cash to fund operating activities. Delcath believes it has sufficient capital and access to committed capital to fund its operating activities through the end of 2017. On April 2, 2017, Delcath entered into separate Warrant Repurchase Agreements with each of the investors named on the Schedule of Buyers attached to our Securities Purchase Agreement dated June 6, 2016. Pursuant to the Warrant Repurchase Agreements, each investor agreed to a Controlled Account Release in an aggregate amount equal to $7,876,312, which funds in each case were paid to the respective investor in exchange for cancellation of the Warrants issued to each investor under the Securities Purchase Agreement. Delcath anticipates that the cash remaining in the Controlled Accounts after this transaction will be sufficient to fund operating activities through the end of 2017. Delcath Systems, Inc. is an interventional oncology Company focused on the treatment of primary and metastatic liver cancers. Our investigational product—Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS) —is designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects. We have commenced a global Phase 3 FOCUS clinical trial for Patients with Hepatic Dominant Ocular Melanoma (OM) and plan to initiate a Registration trial for intrahepatic cholangiocarcinoma (ICC) in the Fall of 2017. Melphalan/HDS has not been approved by the U.S. Food & Drug Administration (FDA) for sale in the U.S.  In Europe, our system has been commercially available since 2012 under the trade name Delcath Hepatic CHEMOSAT® Delivery System for Melphalan (CHEMOSAT), where it has been used at major medical centers to treat a wide range of cancers of the liver. Forward Looking Statements: Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by the Company or on its behalf. This news release contains forward-looking statements, which are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to, uncertainties relating to:  the timing and results of the Company’s  clinical trials including without limitation the OM and ICC  clinical trial programs,  timely enrollment and treatment of patients in the global Phase 3 OM clinical trial, IRB or ethics committee clearance of the  Phase 3 OM and ICC Registration trial  protocols from  participating sites and the timing of site activation and subject enrollment in each trial, the impact of the presentations at major medical conferences and future clinical results consistent with the data presented, approval of Individual Funding Requests for reimbursement of the CHEMOSAT procedure, the impact, if any  of ZE reimbursement on potential CHEMOSAT product use and sales in Germany, clinical adoption, use and resulting sales, if any, for the CHEMOSAT system to deliver and filter melphalan in Europe including the key markets of Germany and the UK, the Company’s ability to successfully commercialize the Melphalan HDS/CHEMOSAT system and the potential of the Melphalan HDS/CHEMOSAT system as a treatment for patients with primary and metastatic disease in the liver, our ability to obtain reimbursement for the CHEMOSAT system in various markets,, approval of the current or future Melphalan HDS/CHEMOSAT system for delivery and filtration of melphalan or other chemotherapeutic agents for various indications in the U.S. and/or in foreign markets, actions by the FDA or other foreign regulatory agencies, the Company’s ability to successfully enter into strategic partnership and distribution arrangements in foreign markets and the timing and revenue, if any, of the same, uncertainties relating to the timing and results of research and development projects, our ability to maintain NASDAQ listing, and uncertainties regarding the Company’s ability to obtain financial and other resources for any research, development, clinical trials and commercialization activities. These factors, and others, are discussed from time to time in our filings with the Securities and Exchange Commission. You should not place undue reliance on these forward-looking statements, which speak only as of the date they are made. We undertake no obligation to publicly update or revise these forward-looking statements to reflect events or circumstances after the date they are made.


These powerful OWON multimeters come in two versions: XDM3041 which has a 4.5 digital resolution and the XDM3051 which has a 5.5 digital resolution. Both are designed to give a user the capability to view readings in more detail. -- NorthTree Associates introduces the OWON XDM Series of Benchtop Multimeters. These powerful OWON multimeters come in two versions: XDM3041 which has a 4.5 digital resolution and the XDM3051 which has a 5.5 digital resolution. Both are designed for when a simple handheld multimeter doesn't have enough capabilities for a user to view a reading in enough detail.The OWON XDM series benchtop multimeters have a 4 inches LCD screen display, 480*320 pixels high resolution, 4.5 or 5.5 digit display accuracy (200000 counts in max). To add to the strength of these units, each XDM multimeter has up to 150 readings per second measurement speed. Also included are True RMS AC voltage/current measurement, smart voice-reading accessibility where the value can be read out, and support for Wi-Fi control through the use of a smart phone.Operational modes include a data-logger mode which provides a user the ability to record, view, and analyze trends in readings. Users can set up the record interval (5ms in minimum) and max number of readings (1M points for internal storage, 10M points for USB Flash Disk). Data measured by the OWON XDM benchtop multimeter will be recorded and gathered into a trend chart, which makes it easy for users to view data statistics. Readings available are: bar meter, trend chart, and a histogram display for a convenient view. The OWON XDM benchtop multimeters have a dual display capability, 1GB internal memory, and support for external Flash Disk storage. Interfaces include USB Device, USB host, and LAN. A SCPI programming manual is provided, which enables remote control and is compatible with popular multimeter commands list.In addition to representing the OWON XDM Series Benchtop Multimeters, NorthTree Associates also represents other product lines from OWON. These product lines include the customizable XDS Series n-in-1 Multi-Function Oscilloscopes, MSO Series Mixed Signal Oscilloscopes, HDS Series Handheld Oscilloscopes, Multimeters, AG-S Arbitrary Waveform Generators, and DC Power Supplies.Established in 1990, OWON is based in China, specializing in the manufacture of oscilloscopes, waveform generators, multimeters, and programmable DC power supplies. These capable instruments are distributed to customers in the aerospace, automotive, communication, defense, electrical, and education industries in more than 80 countries across the globe.Established in 2004, NorthTree Associates (Cologne, MN) is a North American distributor that provides unique electronic test & measurement tools for design engineers, test engineers and production engineers. https://www.northtreeassociates.com

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