Archive for November, 2016

$WLDN Elects Thomas D. Brisbin Chairman, Announces Senior Management Promotions

Willdan Group, Inc. (NASDAQ: WLDN), a provider of professional technical and consulting services, today announced that the Board of Directors has elected Thomas D. Brisbin as Chairman of the Board. Tom, who has served as Willdan’s President and CEO since 2007, succeeds Win Westfall, who will continue to serve on Willdan’s Board of Directors.

Willdan also announced the following senior management promotions:

  • Michael A. Bieber (Mike) has been named President of Willdan Group, Inc.
  • Daniel Chow has been named to the newly-created position of Chief Operating Officer of Willdan Group, Inc.

Tom, who previously had the title of President and Chief Executive Officer of Willdan Group, Inc., will continue to serve as Chief Executive Officer of the Company in addition to his new role as Chairman of the Board.

Mike has served as Senior Vice President, Corporate Development of Willdan since joining the Company in December 2014. Daniel has been in senior management positions at Willdan since joining the Company in 2008, most recently serving as President and Chief Executive Officer of our subsidiaries, Willdan Engineering and Willdan Energy Solutions.

“The senior management appointments announced today reflect the Board of Directors’ goal to create a management structure and team that supports the continued growth of Willdan and reflects our succession planning efforts,” said Tom Brisbin. “Since joining Willdan in 2014, Mike has spearheaded the M&A activity that has expanded our energy efficiency services capabilities, and has significantly contributed to our strong growth in revenue, earnings and cash flow. Daniel has done an excellent job leading our Engineering Services segment, which has steadily grown its customer base and generated higher levels of revenue and profits in each of the past three years. We believe we have exceptional opportunities to create additional long-term value for our shareholders, and Mike and Daniel have the skill set, experience and expertise to effectively lead the Company in the years ahead.”

About Thomas D. Brisbin

Thomas D. Brisbin was appointed President and Chief Executive Officer of Willdan Group in April 2007. Tom previously was vice president of and consultant for AECOM Technology Corporation, or AECOM, since spring 2004. At AECOM, a company focused on infrastructure, environment and facilities engineering contracts, Tom was responsible for developing the company’s environmental business. Prior to joining AECOM, Tom was chief operating officer and executive vice president of Tetra Tech, Inc., or Tetra Tech, a leading provider of consulting, engineering and technical services, for five years. Prior to that, he was employed by Planning Research Corporation, or PRC, a systems analysis and management consulting company and wholly-owned subsidiary of The Black & Decker Corporation, from 1978 to 1995 and was co-founder and President of PRC Environmental Management, Inc. During his tenure at PRC, he was involved in all aspects of operations, marketing and finance. Before joining PRC, he was a research associate at Argonne National Laboratory. He has also served as an adjunct professor at the Illinois Institute of Technology. Tom holds a B.S. degree from Northern Illinois University and a Ph.D. in Environmental Engineering from Illinois Institute of Technology. He also completed Harvard Business School’s Advanced Management Program in 1988.

About Michael A. Bieber

Michael A. Bieber was appointed Senior Vice President, Corporate Development of Willdan Group, Inc. in December 2014. Previously, he served as Senior Vice President at Tetra Tech, where he served in a number of leadership roles for over 18 years. From March 2007 to December 2014, Mike managed Tetra Tech’s mergers and acquisitions and investor relations functions, overseeing over fifty acquisitions. From 2005 to 2007, Mike managed Tetra Tech’s corporate business development group, where he was responsible for overseeing internal business development, marketing and communications. From January 2000 to December 2014, Mike also worked in Tetra Tech’s investor relations group. From 1996 to 2000, he was a proposal manager in Tetra Tech’s corporate marketing group. From 1994 to 1996, he served at CRC, Inc., and its successor, as a strategic business development consultant to large defense, infrastructure, and environmental firms. Prior to 1994, Mike worked for IT Corporation (now CB&I) where he served as project manager and engineer on government nuclear and commercial environmental projects. Mike holds a B.S. degree in Civil Engineering from the Tennessee Technological University.

About Daniel Chow

Daniel Chow has served as President and Chief Executive Officer of our subsidiaries Willdan Engineering and Willdan Energy Solutions since August 2016. Daniel joined Willdan in December 2008 as President and Chief Executive Officer of Willdan Engineering. Prior to joining Willdan, Daniel was the Vice President of AMEC Earth & Environmental, Inc., a subsidiary of AMEC plc, a global provider of high value consultancy, engineering and project management services to the energy, power and process industries, from April 2004 to December 2008. Prior to AMEC, Daniel worked at Tetra Tech EM Inc. (formerly PRC Environmental Management, Inc.) for over 20 years and held various senior management positions, including Vice President of US operations. During Daniel’s tenure with these firms, he was responsible for establishing new offices and developing and implementing management systems firmwide to enhance operations. He also led the pursuit and management of multi-million dollar contracts for government clients that included the U.S. Navy and the U.S. Army Corps of Engineers. Daniel received his B.Sc. in Mechanical Engineering from Tennessee Technological University and his Master’s Degree in Environmental Engineering from Illinois Institute of Technology. He is a registered professional engineer in the state of Illinois and Guam.

About Willdan

Willdan provides professional consulting and technical services to utilities, public agencies and private industry throughout the United States. Willdan’s service offerings span a broad set of complementary disciplines that include energy efficiency and sustainability, engineering and planning, financial and economic consulting, and national preparedness. Willdan provides integrated technical solutions to extend the reach and resources of its clients, and provides all services through its subsidiaries specialized in each segment. For additional information, visit Willdan’s website at www.willdan.com.

Forward-Looking Statements

Statements in this press release that are not purely historical, including statements regarding Willdan’s intentions, hopes, beliefs, expectations, representations, projections, estimates, plans or predictions of the future are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The forward-looking statements involve risks and uncertainties including, but not limited to, the risk that Willdan will not be able to continue the growth it has experienced in recent years. It is important to note that Willdan’s actual results could differ materially from those in any such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, a slowdown in the local and regional economies of the states where Willdan conducts business and the loss of or inability to hire additional qualified professionals. Willdan’s business could be affected by a number of other factors, including the risk factors listed from time to time in Willdan’s SEC reports including, but not limited to, the Annual Report on Form 10-K filed for the year ended January 1, 2016. Willdan cautions investors not to place undue reliance on the forward-looking statements contained in this press release. Willdan disclaims any obligation to, and does not undertake to, update or revise any forward-looking statements in this press release.

 

Willdan Group, Inc.
Stacy McLaughlin
Chief Financial Officer
714-940-6300
smclaughlin@willdan.com
or
Investor/Media Contact
Financial Profiles, Inc.
Tony Rossi, 310-622-8221
trossi@finprofiles.com

Thursday, November 3rd, 2016 Uncategorized Comments Off on $WLDN Elects Thomas D. Brisbin Chairman, Announces Senior Management Promotions

$ITRI to Present at #Baird’s 46th Annual #GlobalIndustrialConference

Itron, Inc. (NASDAQ: ITRI) announced today that Philip Mezey, Itron’s president and chief executive officer, will present at Baird’s 46th Annual Global Industrial Conference at the Four Seasons Hotel in Chicago. The company’s investor presentation will be webcast live on Wednesday, Nov. 9, 2016 at 5:30 p.m. EST / 2:30 p.m. PST.

The live audio webcast and investor presentation will be accessible via Itron’s Investor Relations website at http://investors.itron.com/events.cfm. A replay of the webcast will be available for 30 days following the event.

About Itron

Itron is a world-leading technology and services company dedicated to the resourceful use of energy and water. We provide comprehensive solutions that measure, manage and analyze energy and water. Our broad product portfolio includes electricity, gas, water and thermal energy measurement devices and control technology; communications systems; software; as well as managed and consulting services. With thousands of employees supporting nearly 8,000 customers in more than 100 countries, Itron applies knowledge and technology to better manage energy and water resources. Together, we can create a more resourceful world. Join us: www.itron.com.

Itron® is a registered trademark of Itron, Inc. All third-party trademarks are property of their respective owners and any usage herein does not suggest or imply any relationship between Itron and the third party unless expressly stated.

 

Itron, Inc.
Barbara Doyle, 509-891-3443
Vice President, Investor Relations

Thursday, November 3rd, 2016 Uncategorized Comments Off on $ITRI to Present at #Baird’s 46th Annual #GlobalIndustrialConference

$CCRN 2016 #PhysicianLeadershipCompensationSurvey Results Released

Findings Reveal Higher Earnings for Those Defining New Care Models in Response to Health Care Reform

ST. LOUIS, Nov. 3, 2016  — Cejka Executive SearchSM ― in partnership with the American Association for Physician Leadership® ― today announced the results of the 10th biennial Physician Leadership Compensation Survey. According to the survey, total median compensation for physicians in leadership in 2016 is $350,000, a three-year gain of 8% since the last survey in 2013. While fairly consistent with growth over the past seven years, this lags pre-recession two-year growth rates of 12% reported in 2007.

“Given health care reform and the continued attention on costs, including executive compensation, we don’t expect physician leader compensation to return to pre-recession growth rates anytime soon,” said Paul Esselman, Cejka Executive Search’s Senior EVP and Managing Director. “However, there are emerging roles in response to the shift toward value-based care that provide physician leaders with significantly greater opportunities for earnings, as well as strategic input and organizational influence.”

Chief Executive Officer Not Always the Highest Paying Job

The highest-paid physician executives on average earned $499,000 and served in emerging roles that include: Physician in Chief, Chief Strategy Officer, Chief Transformational Officer, Chief Innovation Officer and Chief Integration Officer.

“Physicians in these transformative roles are often tasked with ‘connecting the dots’ across the organization and care continuum to achieve the greater efficiency and effectiveness of care required by newer reimbursement models, including population health management and accountable care,” said Joyce Tucker, Cejka Executive Search EVP and Managing Principal.

Trending Compensation for C-Suite Physician Leaders
(Median compensation 2016 vs. 2013)
Emerging Roles, C-Suite: $499,000 vs. $469,000, up 6%
Chief Executive Officer/President: $437,500 vs. $410,000, up 7%
Chief Medical Officer: $388,000 vs. $365,000, up 6%
Chief Quality/Patient Safety Officer: $375,000 vs. $375,000
Chief Information Officer/Chief Medical Information Officer: $372,500 vs. $315,000, up 18%

The Growing Role of “Big Data” Drives Compensation Higher 

The greatest increase in C-suite compensation since 2013 was 18% for physicians in the Chief Information Officer (CIO) or Chief Medical Information Officer (CMIO) roles. The spike can be explained by the roles’ shift in focus ― from electronic medical records implementation to ensuring the usability of data to support preventative care at the individual provider level and risk-based accountable care at the enterprise-level. “Clearly, there is perceived value in having a physician leader drive these initiatives and facilities are willing to compensate accordingly,” said Esselman.

Other Pathways to Higher Compensation

Those who operate at a system-wide level, hold post-graduate degrees or certifications or whose compensation is most aligned with organizational goals, also earned more. For example, physician leaders working at the corporate or parent-level of a health system saw an average 67% spike in median compensation since 2013.  As compared to physician leaders with no post-graduate degrees, a master’s in business administration (MBA) earned respondents on average 13% more and a certified physician executive (CPE) on average earned 4% more.  In addition, leaders who allocated more time to administration and whose performance-based pay was a higher percentage of total compensation earned more as well.

Demand for Clinical Quality Leadership Remains Strong

Outside of the C-suite, the highest three-year pay gain was 26% for physician leaders focused on clinical initiatives serving as president of the medical staff or medical director, assistant or associate. The number of respondents in these positions also rose as a percent of total physician leaders, from 5% in 2013 to 8% in 2016. This indicates an emphasis on building the next organizational level of quality leaders in response to quality outcome measures now increasingly tied to reimbursements.

More Complex Physician Leader Roles Call for Expanded Skills

Physician leaders are serving in more strategic and complex roles than in the past. For example, 61% say they have more strategic input than the previous year, and more than half (54%) have multiple or shared administrative reporting relationships. Of those, 49% (versus 24% in 2013) are administratively accountable to more than one person, and 29% (versus 19% in 2013) have shared direct reports.

“Education areas selected by physician leaders as those having the greatest ability to enhance their job performance, demonstrate the strategic nature of physician leader responsibilities,” said Dr. Peter Angood, American Association for Physician Leadership® CEO and President.

These include: financial analysis, change management, strategic planning, population health management, physician engagement and conflict resolution.

About the Survey

The 2016 Physician Leadership Compensation Survey was conducted by Cejka Executive Search in partnership with the American Association for Physician Leadership®. It contains self-reported compensation data collected from 2,353 physician leaders in July 2016 based on 2015 total compensation. This includes salary, bonuses, incentive payments, research stipends, honoraria and distribution of profits. The data also includes the total compensation received for both administrative duties and the clinical practice of medicine. For more research results or to purchase a copy of the full 2016 Physician Leadership Compensation Survey visit www.cejkaexecutivesearch.com/2016-physician-leadership-compensation-survey

About Cejka Executive Search

Cejka Executive Search ranks among the top five largest health care executive search firms in the United States, providing services exclusively to the healthcare industry for more than 35 years. The firm partners with health care organizations to identify and recruit talented C-level executives, physician leaders, key members of senior management and academic medicine faculty. Cejka Executive Search is a Cross Country Healthcare Inc.® (Nasdaq: CCRN) company, a diversified leader in health care staffing services.

About the American Association for Physician Leadership®

The American Association for Physician Leadership® is the preeminent U.S.-based organization for physician leaders worldwide. Since its founding in 1975, the association, formerly known as the American College of Physician Executives (ACPE), has grown to serve physicians at all stages of their careers through leadership education, career support and policy advocacy. The organization has an active membership — including chief executive officers, chief medical officers, vice presidents of medical affairs and other leadership physicians in 47 countries. The expanding portfolio of the association includes more than 100 courses, numerous certificate programs, five master’s degree programs and a specialized career support program customized for physicians.

Media Contact:

Lisa McCarthy
on behalf of Cejka Executive Search lisamc@digitalinfusion.net, (954) 328-1745

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$ENOC #DemandResponse Portfolio in #Korea Surpasses One Gigawatt

BOSTON, Nov. 03, 2016  — EnerNOC, Inc. (Nasdaq:ENOC), a leading provider of energy intelligence software (EIS) and demand response solutions, announced today that its demand response portfolio in Korea surpassed one gigawatt—roughly equivalent to the amount of power generated by a nuclear power plant.

EnerNOC entered the market in late 2014, following legislation earlier that year that introduced demand response into the country’s wholesale capacity market. Since establishing operations in Korea, EnerNOC has become the preferred demand response provider to some of the region’s largest enterprises, public institutions, and universities, including S-Oil, COEX, Korea University, and Seoul City Government.

“We partnered with EnerNOC because they’re the world’s leader in demand response. They have the experience we rely on to ensure that we can participate in demand response without compromising our operations,” said JaeHee Kang, Facility Manager at Korea University.

Demand response has grown rapidly in Korea, propelled by the government’s strong commitment to creating a sustainable and competitive market and EnerNOC’s ability to leverage its industry-leading technology and experience to scale quickly.

“Korea relies on fuel imports to meet nearly 100% of its electricity needs. Demand response gives the Korean government increased flexibility to meet demand in a clean, cost-efficient way, with a reliable domestic energy resource, while at the same time allowing Korean businesses to use their flexibility to earn valuable new revenue streams,” said David Brewster, President, EnerNOC.

“Our success in Korea has been instrumental in stimulating interest throughout Asia. We’re excited about the emerging opportunities we see on the horizon to make DR a more integral part of the resource mix throughout the region,” added Brewster.

About EnerNOC

EnerNOC is a leading provider of energy intelligence software (EIS) and demand response solutions. With capabilities to better address budgets and procurement, utility bill management, facility analysis and optimization, sustainability and reporting, project tracking, and demand management, EnerNOC’s SaaS platform helps enterprises control energy costs, mitigate risk, and streamline compliance and sustainability reporting. EnerNOC also offers access to more demand response programs worldwide than any other provider, offering enterprises a valuable payment stream to further enhance bottom line results and utilities and grid operators a reliable, cost-effective demand-side resource. For more information, visit www.enernoc.com.

Safe Harbor Statement

Statements in this press release regarding management’s future expectations, beliefs, intentions, goals, strategies, plans or prospects, including, without limitation, statements relating to the Company’s future financial performance on both a GAAP and non-GAAP basis, and the future growth and success of the Company’s energy intelligence software and demand response solutions, may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements can be identified by terminology such as “anticipate,” “believe,” “could,” “could increase the likelihood,” “estimate,” “expect,” “intend,” “is planned,” “may,” “should,” “will,” “will enable,” “would be expected,” “look forward,” “may provide,” “would” or similar terms, variations of such terms or the negative of those terms. Such forward-looking statements involve known and unknown risks, uncertainties and other factors including those risks, uncertainties and factors referred to under the section “Risk Factors” in EnerNOC’s most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, as well as other documents that may be filed by EnerNOC from time to time with the Securities and Exchange Commission. As a result of such risks, uncertainties and factors, the Company’s actual results may differ materially from any future results, performance or achievements discussed in or implied by the forward-looking statements contained herein. EnerNOC is providing the information in this press release as of this date and assumes no obligations to update the information included in this press release or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

 

EnerNOC Media Relations: 
Sarah McAuley
617.532.8195
news@enernoc.com

EnerNOC Investor Relations:
Christopher Sands
617.692.2569
ir@enernoc.com
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$SPI Announces New #Director and #Management Appointments

SHANGHAI, Nov. 2, 2016  — SPI Energy Co., Ltd. (“SPI Energy” or the “Company”) (Nasdaq: SPI), a global provider of photovoltaic (PV) solutions for business, residential, government and utility customers and investors, today announced changes to the senior management team and board of directors of the Company (the “Board”), effective on October 29, 2016:

Mr. Roger Dejun Ye has resigned as Executive Vice President in charge of the Company’s solar business but will remain as a non-executive director of the Board;

Mr. Minghua Zhao, who currently serves as Joint Chief Operating Officer (“COO”) of the Company’s China domestic business, has been appointed as a director to the Board; and

Mr. Fei Yun, who previously served as General Manager of Xinghang PV Technology (Suzhou) Co., Ltd., has joined the Company as Senior Vice President in charge of R&D and Solar Technology Development.

“I would like to thank Roger for his contributions to the development of Company’s solar business during his tenure and we look forward to continuing to work closely with Roger in his role as a director of the Board. On behalf of the management team and the Board, I also would like to extend our warm welcome to Minghua in joining the Board and Fei in joining the Company,” said Xiaofeng Peng, Chairman and Chief Executive Officer of SPI Energy.

Mr. Minghua Zhao currently serves as Joint COO of the Company’s China domestic business and previously served as Senior Vice President of the Company’s finance service business between February 2015 and June 2016. Before he joined the Company in February 2015, Mr. Zhao served as general manager of Suzhou Industrial Park Chengcheng Enterprises Guarantee Co., Ltd., a financial services company, and from 2003 to 2009 as president of Suzhou Industrial Park Branch of Suzhou Bank. Prior to that, he worked at CITIC Bank for six years. Mr. Zhao graduated from Jiangsu Province Business School in 1997 with a degree in Business Administration and from Southwestern University of Finance and Economics in 2008 with a degree in Business Management.

Mr. Fei Yun has more than 30 years of experience in the research and development of solar cells, PV systems and senior management role in the industry in Australia and China. Mr. Fei Yun joined us from Xinghang PV Technology (Suzhou) Co., Ltd. where he has served as General Manager since July 2014. Previously, Mr. Yun held senior management positions at various solar companies, including as Vice President of Technology at LDK Solar Co., Ltd. from February 2010 to June 2013; Chief Technology Officer at Solar Enertech Corp. from December 2007 to January 2010; Vice President of Technology at SolarFun (Now Hanwha Solar One) from July 2006 to November 2007; General Manager and Chief Engineer at Tera Solar Technologies from March 2004 to June 2006. Mr. Yun received his bachelor’s degree in Physics from Jinan University, his master’s degree in Solar Energy from the Asian Institute of Technology(AIT) in Bangkok, Thailand. He also had nearly 10 years of research and development experience in silicon-based solar cells at the ARC Photovoltaics Centre of Excellence at the University of New South Wales in Sydney, Australia, his expertise is focused on the high efficiency silicon solar cell.

About SPI Energy Co., Ltd.

SPI Energy Co., Ltd. is a global provider of photovoltaic (PV) solutions for business, residential, government and utility customers and investors. SPI Energy focuses on the downstream PV market including the development, financing, installation, operation and sale of utility-scale and residential solar power projects in China, Japan, Europe and North America. The Company operates an innovative online energy e-commerce and investment platform, www.solarbao.com, which enables individual and institutional investors to purchase innovative PV-based investment and other products; as well as www.solartao.com, a B2B e-commerce platform offering a range of PV products for both upstream and downstream suppliers and customers. The Company has its operating headquarters in Shanghai and maintains global operations in Asia, Europe, North America and Australia.

 

Safe Harbor Statement

This release contains certain “forward-looking statements.” These statements are forward-looking in nature and subject to risks and uncertainties that may cause actual results to differ materially. All forward-looking statements included in this release are based upon information available to the Company as of the date of this release, which may change, and the Company undertakes no obligation to update or revise any forward-looking statements, except as may be required under applicable securities law.

For investors and media inquiries please contact:

Investor Relations Department
SPI Energy Co., Ltd.
pearl.peng@spisolar.com
+86 21 8012 9135

Tony Tian, CFA
Weitian Group LLC
tony.tian@weitian-ir.com
+1 732 910 9692

Wednesday, November 2nd, 2016 Uncategorized Comments Off on $SPI Announces New #Director and #Management Appointments

$MSCC Achieves #MILSTD883 #ClassB Qualification for #RTG4 FPGA

RTG4 Space Flight Devices are Now Available in Various Screening Flows

ALISO VIEJO, Calif., Nov. 2, 2016  — Microsemi Corporation (Nasdaq: MSCC), a leading provider of semiconductor solutions differentiated by power, security, reliability and performance, today announced its RTG4™ high-speed signal processing radiation-tolerant field programmable gate arrays (FPGAs) have achieved MIL-STD-883 Class B qualification, meeting the industry’s standard for qualifying microelectronic devices suitable for use within aerospace and defense electronic systems. Microsemi also announced the availability of RTG4 space flight models in various screening flows including the B Flow and the Extended Flow (E Flow), providing additional screening options and a higher level of reliability assurance required in many critical space applications.

“Achieving this important qualification strengthens Microsemi’s leadership position in space and reinforces our commitment to providing the highest quality and reliability solutions to meet the increasing demands of modern satellite payloads,” said Minh Nguyen, Microsemi’s senior marketing manager, space and aviation. “Customers can now procure RTG4 FPGAs screened to B Flow per MIL-STD-883 Class B and Microsemi’s E Flow, making it easy for customers to select RTG4 for programs requiring the highest performing FPGAs.”

Microsemi is a Qualified Manufacturers List (QML)-certified manufacturer of high reliability FPGAs for space applications. Meeting the stringent standards of the MIL-STD-883 Class B qualification paves the way for Microsemi’s RTG4 FPGAs to secure QML Class Q and QML Class V qualifications in the near future. Adding Microsemi’s E Flow to these devices offers additional testing for space applications requiring a screening level beyond the MIL-STD-883 Class B standard.

To achieve the new qualification, Microsemi’s RTG4 FPGAs passed a series of environmental tests to determine resistance to deleterious effects of natural elements and conditions surrounding defense and space operations, as well as mechanical and electrical tests. RTG4 units from multiple wafer lots successfully completed 1,000-hour high temperature life tests, proving the high reliability of RTG4 flash cells in extreme conditions.

RTG4 FPGAs bring new capabilities to the market and help solve satellite signal processing congestion, while having high reliability as shown in the recent MIL-STD-883 Class B qualification. According to Euroconsult’s 2015 report titled, “Satellites to Be Built and Launched by 2024,” 60 percent more satellites will be launched by 2024 versus the past decade. This increase is driven primarily by civilian government agencies as established space countries replace and expand their in-orbit satellite systems and more countries acquire their first operational satellite systems.

About Microsemi’s RTG4 FPGAs and Development Kit
RTG4 FPGAs bring new capabilities to the market and combine a wealth of features with the highest quality and reliability to meet the increasing demands of modern satellite payloads. The devices feature reprogrammable flash configuration, making prototyping easier for customers. RTG4’s reprogrammable flash technology offers complete immunity to radiation-induced configuration upsets in the harshest radiation environments, without the configuration scrubbing required with SRAM FPGA technology. RTG4 supports space applications requiring up to 150,000 logic elements, and each includes a LUT4 and a flip-flop with built-in triple module redundancy (TMR). The devices also features total ionizing dose (TID) beyond 100 kilorads, as well as high system performance of up to 300 MHz without single event transient (SET) mitigation.

The RTG4 Development Kit features Microsemi’s Libero SoC Design Suite, offering high productivity with its comprehensive, easy to learn, easy to adopt development tools for designing with Microsemi’s radiation-tolerant FPGAs. The suite integrates industry standard Synopsys SynplifyPro synthesis and Mentor Graphics ModelSim simulation with best-in-class constraints management, debug capabilities and secure production programming support.

RTG4 is Microsemi’s latest development in a long history of radiation-tolerant FPGAs that are found in many NASA and international space programs. For more information, visit http://www.microsemi.com/products/fpga-soc/radtolerant-fpgas/rtg4.

Microsemi Leading Space Innovation for More than Half a Century
With one of the industry’s most comprehensive portfolios of space products, Microsemi provides radiation-tolerant (FPGAs, radiation-hardened mixed-signal integrated circuits (ICs), radiation-hardened DC-to-DC converters, precision time and frequency solutions, linear and POL hybrids, custom hybrid solutions, and radiation-hardened discretes including the broadest portfolio of JANS Class diodes and bipolar products. Microsemi is committed to supporting its products throughout the lifetime of its customer programs. The company continues to innovate and expand its portfolio, with recent additions including its LX7730 radiation-tolerant telemetry controller IC providing key functions for sensor monitoring, attitude and payload control, as well as its RTG4™ high-speed signal processing radiation-tolerant FPGA family. The RTG4’s reprogrammable flash technology offers complete immunity to radiation-induced configuration upsets in the harshest radiation environments, requiring no configuration scrubbing, unlike SRAM FPGA technology. For more information about Microsemi’s space products, visit http://www.microsemi.com/applications/space.

About Microsemi
Microsemi Corporation (Nasdaq: MSCC) offers a comprehensive portfolio of semiconductor and system solutions for aerospace & defense, communications, data center and industrial markets. Products include high-performance and radiation-hardened analog mixed-signal integrated circuits, FPGAs, SoCs and ASICs; power management products; timing and synchronization devices and precise time solutions, setting the world’s standard for time; voice processing devices; RF solutions; discrete components; enterprise storage and communication solutions, security technologies and scalable anti-tamper products; Ethernet solutions; Power-over-Ethernet ICs and midspans; as well as custom design capabilities and services. Microsemi is headquartered in Aliso Viejo, California, and has approximately 4,800 employees globally. Learn more at www.microsemi.com.

Microsemi and the Microsemi logo are registered trademarks or service marks of Microsemi Corporation and/or its affiliates. Third-party trademarks and service marks mentioned herein are the property of their respective owners.

“Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995: Any statements set forth in this news release that are not entirely historical and factual in nature, including without limitation statements related to its RTG4™ high-speed signal processing radiation-tolerant field programmable gate arrays (FPGAs) achieving MIL-STD-883 Class B qualification, meeting the industry’s standard for qualifying microelectronic devices suitable for use within aerospace and defense electronic systems, and its potential effects on future business, are forward-looking statements. These forward-looking statements are based on our current expectations and are inherently subject to risks and uncertainties that could cause actual results to differ materially from those expressed in the forward-looking statements. The potential risks and uncertainties include, but are not limited to, such factors as rapidly changing technology and product obsolescence, potential cost increases, variations in customer order preferences, weakness or competitive pricing environment of the marketplace, uncertain demand for and acceptance of the company’s products, adverse circumstances in any of our end markets, results of in-process or planned development or marketing and promotional campaigns, difficulties foreseeing future demand, potential non-realization of expected orders or non-realization of backlog, product returns, product liability, and other potential unexpected business and economic conditions or adverse changes in current or expected industry conditions, difficulties and costs in implementing the company’s acquisitions and divestitures strategy or integrating acquired companies, uncertainty as to the future profitability of acquired businesses and realization of accretion from acquisition transactions, difficulties and costs of protecting patents and other proprietary rights, inventory obsolescence and difficulties regarding customer qualification of products. In addition to these factors and any other factors mentioned elsewhere in this news release, the reader should refer as well to the factors, uncertainties or risks identified in the company’s most recent Form 10-K and all subsequent Form 10-Q reports filed by Microsemi with the SEC. Additional risk factors may be identified from time to time in Microsemi’s future filings. The forward-looking statements included in this release speak only as of the date hereof, and Microsemi does not undertake any obligation to update these forward-looking statements to reflect subsequent events or circumstances.

Wednesday, November 2nd, 2016 Uncategorized Comments Off on $MSCC Achieves #MILSTD883 #ClassB Qualification for #RTG4 FPGA

$EBAY Recommends Shareholders Reject Mini #TenderOffer by #TRCCapital

eBay Inc. (NASDAQ:EBAY), a global commerce leader, announced today that it received notice of an unsolicited “mini-tender” offer by TRC Capital Corporation (TRC) to purchase up to 4,000,000 shares of eBay’s common stock at a price of $27.35 per share in cash. The offering price is 4.37% below the closing price per share of eBay’s common stock on October 28, 2016, the last trading day before the offer was commenced. The offer is for approximately 0.36% of the outstanding shares of eBay’s common stock.

eBay does not endorse TRC Capital’s unsolicited mini-tender offer and recommends that shareholders not tender their shares. eBay is not associated with TRC Capital, its mini-tender offer or the mini-tender offer documentation.

Mini-tender offers are not subject to many of the investor protections afforded to larger tender offers, including the filing of disclosure and other tender offer documents with the Securities and Exchange Commission (SEC) and other procedures mandated by U.S. securities laws.

The SEC has cautioned investors that some bidders making mini-tender offers at below-market prices are, “hoping that they will catch investors off guard if the investors do not compare the offer price to the current market price.” The SEC’s guidance to investors on mini-tender offers is available at http://www.sec.gov/investor/pubs/minitend.htm. TRC Capital has made many similar unsolicited mini-tender offers for shares of other public companies.

Shareholders should obtain current market quotations for their shares, consult with their broker or financial advisor, and exercise caution with respect to TRC Capital’s mini-tender offer. eBay recommends that shareholders who have not responded to TRC Capital’s offer take no action. Shareholders who have already tendered their shares may withdraw them at any time prior to 12:01 a.m., New York City time, on November 30, 2016, in accordance with TRC’s offering documents.

eBay encourages brokers and dealers, as well as other market participants, to review the SEC’s letter regarding broker-dealer mini-tender offer dissemination and disclosure at http://www.sec.gov/divisions/marketreg/minitenders/sia072401.htm.

eBay requests that a copy of this press release be included with all distributions of materials relating to TRC Capital’s mini-tender offer related to eBay shares of common stock.

About eBay

eBay Inc. (NASDAQ: EBAY) is a global commerce leader including the Marketplace, StubHub and Classifieds platforms. Collectively, we connect millions of buyers and sellers around the world, empowering people and creating opportunity through Connected Commerce. Founded in 1995 in San Jose, Calif., eBay is one of the world’s largest and most vibrant marketplaces for discovering great value and unique selection. In 2015, eBay enabled $82 billion of gross merchandise volume. For more information about the company and its global portfolio of online brands, visit www.ebayinc.com.

 

eBay Inc.
Investor Relations Contact:
Selim Freiha
ir@ebay.com
or
Media Relations Contact:
Abby Smith
press@ebay.com
or
Company News:
https://www.ebayinc.com/stories/news/
or
Investor Relations website:
https://investors.ebayinc.com

Wednesday, November 2nd, 2016 Uncategorized Comments Off on $EBAY Recommends Shareholders Reject Mini #TenderOffer by #TRCCapital

$SKLN Expands Relationship with #GLGPharma

MINNEAPOLIS, Nov. 02, 2016  — Skyline Medical Inc. (NASDAQ:SKLN) (“Skyline” or “the Company”), producer of the FDA-approved STREAMWAY® System for automated, direct-to-drain medical fluid disposal, announces that it has agreed to grant GLG Pharma, LLC (“GLG”) exclusive rights to market and distribute the STREAMWAY® System in Poland and certain other countries in Central Europe.  This builds upon a previously announced arrangement granting GLG exclusive rights to market and distribute STREAMWAY in the U.K. and an initial agreement to develop rapid diagnostic tests that utilize fluid and tissue collected by the STREAMWAY System during procedures.

GLG will be responsible for all sales and marketing activities, including hiring and training the appropriate number of direct sales representatives to cover the 3,800 operating rooms in Poland.  Marketing is expected to begin immediately upon receipt of the CE Mark and will be managed from GLG’s facility in Gdansk, Poland.

The agreement will also include the Czech Republic, Latvia, Estonia and Lithuania, with sales activities expected to begin in those countries soon after the introduction in Poland. Skyline applied for CE Mark approval to market STREAMWAY in the European Union and certain other countries in July 2016, following receipt of ISO 13485:2003 certification.

“We are excited to further solidify and expand our relationship with Skyline Medical with this expansion of our exclusive sales and marketing territory, the second agreement we have we have announced this week,” said Richard Gabriel, Co-founder and Chief Operating Officer of GLG Pharma. “Central Europe is expected to be a very attractive market for STREAMWAY System sales, orchestrated by our general manager in Poland.  We currently have pharmaceutical and diagnostic development laboratories in Poland, which are supported by grants from the Polish government. The STREAMWAY System will make an excellent addition to our portfolio of products in development.”

In June 2016 STREAMWAY received ISO 13485:2003 certification, an internationally recognized quality standard for medical devices that is awarded when an organization demonstrates its ability to provide medical devices and related services that consistently meet customer and regulatory requirements applicable to medical devices and related services, and is a requirement for medical device clearance in Canada, the EU and a majority of other countries that require products meet EU safety, health and environmental requirements.

Under the terms of an agreement announced in September 2016, GLG intends to develop rapid diagnostic tests that utilize fluid and tissue collected by the STREAMWAY System during procedures.  Initial tests are anticipated to include cancer biomarkers and infectious diseases.  The oncology test panels will feature GLG’s patented inhibitors of Signal Transducers and Activators of Transcription 3 (STAT3), which are in preclinical development for a new generation of targeted therapies.

About GLG, LLC.
Founded in 2009 and located in Jupiter, Fla., GLG Pharma, LLC is a privately held, early stage, biotechnology company developing personalized therapies for patients with cancer and other proliferative diseases. GLG Pharma’s therapeutics are expected to aid in the treatment of a wide variety of cancers and address unmet needs in the multi-billion dollar anti-cancer market with potentially greater efficacy and fewer side effects than existing therapies. For more information on GLG Pharma visit: http://www.glgpharma.com.

About the STREAMWAY System
Skyline Medical’s revolutionary, FDA-cleared STREAMWAY System is the first true direct-to-drain fluid disposal system designed specifically for medical applications, such as radiology, endoscopy, urology and cystoscopy procedures. It connects directly to a facility’s plumbing system to automate the collection, measurement and disposal of waste fluids, and minimizes human intervention for better safety while improving compliance with Occupational Safety and Health Administration (OSHA) and other regulatory agency safety guidelines. It also provides unlimited capacity for increased efficiency in the operating room, which leads to greater profitability. The STREAMWAY eliminates canisters to reduce overhead costs and provides greater environmental stewardship by helping to eliminate the approximately 50 million potentially disease-infected canisters that go into landfills annually in the U.S.

About Skyline Medical Inc.
Skyline Medical Inc. produces a fully automated, patented, FDA-cleared, waste fluid disposal system that virtually eliminates staff exposure to blood, irrigation fluid and other potentially infectious fluids found in the healthcare environment. Antiquated manual fluid handling methods — which require hand carrying and emptying filled fluid canisters — present an exposure risk and potential liability. Skyline Medical’s STREAMWAY System fully automates the collection, measurement and disposal of waste fluids and is designed to: 1) reduce overhead costs to hospitals and surgical centers, 2) improve compliance with OSHA and other regulatory agency safety guidelines, 3) improve efficiency in the operating room, and radiology and endoscopy departments — leading to greater profitability, and 4) provide greater environmental stewardship by helping to eliminate the approximately 50 million potentially disease-infected canisters that go into landfills annually in the United States. For additional information, please visit www.skylinemedical.com.

Forward-looking Statements:
Certain of the matters discussed in this announcement contain forward-looking statements that involve material risks to and uncertainties in the Company’s business that may cause actual results to differ materially from those anticipated by the statements made herein. Such risks and uncertainties include, among other things, current negative operating cash flows and a need for additional funding to finance our operating plan; the terms of any further financing, which may be highly dilutive and may include onerous terms; unexpected costs and operating deficits, and lower than expected sales and revenues; uncertain willingness and ability of customers to adopt new technologies and other factors that may affect further market acceptance, if our product is not accepted by our potential customers, it is unlikely that we will ever become profitable, adverse economic conditions;  the potential delisting of the Company’s common stock on The Nasdaq Capital Market as a result of the Company’s failures to comply with listing standards, in which case the liquidity of our common stock would likely be impaired and there would likely be a reduction in our coverage by security analysts and the news media, thereby resulting in lower prices for our common stock than might otherwise prevail; adverse results of any legal proceedings; the volatility of our operating results and financial condition; inability to attract or retain qualified senior management personnel, including sales and marketing personnel; our ability to establish and maintain the proprietary nature of our technology through the patent process, as well as our ability to possibly license from others patents and patent applications necessary to develop products; the Company’s ability to implement its long range business plan for various applications of its technology, including the possibility that the development of applicable technologies by GLG Pharma, LLC will be delayed, will not occur or will not receive applicable regulatory approvals on a timely basis; the Company’s ability to consummate its joint venture with Electronic On-Ramp, Inc.; the Company’s ability to enter into agreements with any necessary marketing and/or distribution partners; the impact of competition, the obtaining and maintenance of any necessary regulatory clearances applicable to applications of the Company’s technology; and management of growth and other risks and uncertainties that may be detailed from time to time in the Company’s reports filed with the Securities and Exchange Commission, which are available for review at www.sec.gov.  This is not a solicitation to buy or sell securities and does not purport to be an analysis of the Company’s financial position. See the Company’s most recent Annual Report on Form 10-K, and subsequent reports and other filings at www.sec.gov.

Contact:
Investors
LHA
Kim Sutton Golodetz
(212) 838-3777
kgolodetz@lhai.com

MoneyInfo, LLC
Charles Moskowitz
(781) 826-8882
cam@moneyinfo-llc.com
Wednesday, November 2nd, 2016 Uncategorized Comments Off on $SKLN Expands Relationship with #GLGPharma

$IQNT Agrees to be Acquired by #GTCR

GTCR to pay $23.00 per share, representing a 37% premium to Inteliquent’s closing stock price on November 1, 2016
Transaction valued at approximately $800 million

CHICAGO, Nov. 02, 2016  — Inteliquent, Inc. (NASDAQ:IQNT), a premier interconnection partner for communications service providers of all types, announced today that it has entered into a definitive agreement to be acquired by an affiliate of GTCR LLC, a leading private equity firm, and merged with a subsidiary of Onvoy, LLC a fast-growing leader in Communications Enablement services. Under the terms of the agreement, Inteliquent stockholders of record will receive $23.00 in cash per share of common stock, which represents a 37% premium to Inteliquent’s closing stock price on November 1, 2016. The value of the transaction is approximately $800 million.

“Over the past several quarters, Inteliquent has been transforming its business to become a leader in the next-generation communications services market,” said Matt Carter, Inteliquent’s Chief Executive Officer. “The acquisition of Inteliquent by GTCR and Onvoy validates our Growth Forward strategy. We believe this transaction will deliver immediate, significant and certain cash value to our stockholders while creating a market leading provider.”

“We are excited to partner with the Inteliquent and Onvoy management teams to create a leading provider of communications enablement solutions,” added GTCR Managing Director Lawrence Fey. “The combination of Inteliquent and Onvoy is transformational and creates an entity that is well positioned to provide robust next-generation solutions to the communications enablement market.”

“Inteliquent’s commitment to the core switching infrastructure has earned the trust of the nation’s top carriers. We believe this will lead to additional opportunities for other carriers to partner with Inteliquent to outsource network infrastructure and achieve cost savings without sacrificing quality and reliability,” said Fritz Hendricks, Chief Executive Officer of Onvoy. “We look forward to working with the Inteliquent team to continue the network expansion and to empower innovation for our shared customer base.”

The combined company intends to continue to maintain a significant presence in Chicago.

Additional Transaction Details

The Inteliquent Board of Directors unanimously approved the transaction and agreed to recommend that Inteliquent’s stockholders vote to adopt the definitive agreement. The transaction is subject to certain conditions, including approval from Inteliquent stockholders, the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as well as FCC and state regulatory approvals, approvals and other customary closing conditions. There is no financing condition associated with the proposed acquisition. Inteliquent expects to hold a special meeting of its stockholders to consider and act upon the transaction as promptly as practicable. The transaction is expected to close in the first half of 2017.

Under the terms of the agreement, for a period of 30 calendar days, Inteliquent may solicit alternative proposals from third parties. Inteliquent does not anticipate that it will disclose any developments with regard to this process unless and until the Inteliquent Board of Directors makes a decision with respect to a potential superior proposal. There are no guarantees that this process will result in a superior proposal.

Perella Weinberg Partners is acting as exclusive financial advisor to Inteliquent with Kirkland & Ellis LLP serving as legal counsel. Credit Suisse is acting as exclusive financial advisor to GTCR and Onvoy with Latham & Watkins LLP serving as legal counsel.

Inteliquent Third Quarter Earnings Results
In light of today’s transaction, Inteliquent has canceled its third quarter 2016 earnings conference call previously scheduled to take place on Thursday, November 3, 2016 at 10:00 am Eastern Time. Inteliquent will file its Form 10-Q for the third quarter of 2016 on or before November 9, 2016.

About Inteliquent
Inteliquent is a premier interconnection partner for communication service providers of all types. As the nation’s highest quality provider of voice and messaging interconnection services, Inteliquent is used by nearly all national and regional wireless carriers, cable companies, and CLECs in the markets it serves, and its network carries approximately 21 billion minutes of traffic per month. With the recent launch of its Omni IQsm solution, Inteliquent is now also fully dedicated to supporting the growing market of next generation service providers. For more information, please visit www.inteliquent.com.

About GTCR
Founded in 1980, GTCR is a leading private equity firm focused on investing in growth companies in the Financial Services & Technology, Healthcare, Technology, Media & Telecommunications and Growth Business Services industries. The Chicago-based firm pioneered The Leaders Strategy™ – finding and partnering with management leaders in core domains to identify, acquire and build market-leading companies through transformational acquisitions and organic growth. Since its inception, GTCR has invested more than $12 billion in over 200 companies. For more information, please visit www.gtcr.com.

About Onvoy
Onvoy is a leading Communications Enabler offering voice, messaging and mobility solutions supported by our nationwide carrier-grade network. Committed to empowering customers with the solutions they need to enable global communications across various applications in a continuously changing environment, Onvoy employs state of the art technology and provides customers control of their core communications infrastructure via carrier platforms and APIs. These interfaces allow customers to build, provision and support more innovative and integrated communication services. For more information, please visit www.onvoy.com.

Important Information and Where to Find It

In connection with the proposed merger contemplated by the Agreement and Plan of Merger, dated November 2, 2016, by and among Inteliquent, Onvoy Igloo Merger Sub, Inc. and Onvoy, LLC (the “Merger Agreement”), Inteliquent will file with the Securities and Exchange Commission (the “SEC”) and furnish to Inteliquent’s stockholders a definitive proxy statement. BEFORE MAKING ANY VOTING DECISION, INTELIQUENT’S STOCKHOLDERS ARE URGED TO READ THE DEFINITIVE PROXY STATEMENT CAREFULLY AND IN ITS ENTIRETY WHEN IT BECOMES AVAILABLE AND ANY OTHER DOCUMENTS TO BE FILED WITH THE SEC IN CONNECTION WITH THE PROPOSED MERGER OR INCORPORATED BY REFERENCE INTO THE DEFINITIVE PROXY STATEMENT (IF ANY) BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION AND THE PARTIES TO THE PROPOSED TRANSACTION. Investors and stockholders may obtain a free copy of documents filed by Inteliquent with the SEC at the SEC’s website at http://www.sec.gov. In addition, investors and stockholders may obtain a free copy of Inteliquent’s filings with the SEC at Inteliquent’s website at http://ir.inteliquent.com/sec.cfm or by directing a written request to: Inteliquent, Inc., 550 West Adams Street, Suite 900, Chicago, Illinois 60661, Attn: Investor Relations.

Inteliquent and certain of its directors, executive officers, and certain other members of management and employees of Inteliquent may be deemed to be participants in the solicitation of proxies from stockholders of Inteliquent in favor of the proposed merger. Information about directors and executive officers of Inteliquent is set forth in the proxy statement for Inteliquent’s 2016 annual meeting of stockholders, as filed with the SEC on Schedule 14A on April 8, 2016. Additional information regarding these individuals and other persons who may be deemed to be participants in the solicitation of proxies, as well as any direct or indirect interests they may have in the proposed merger, will be included in the definitive proxy statement with respect to the proposed merger Inteliquent will file with the SEC and furnish to Inteliquent’s stockholders.

Forward Looking Statements

Statements herein regarding the proposed transaction between Inteliquent, Onvoy, LLC and Onvoy Igloo Merger Sub, Inc., future financial and operating results, benefits and synergies of the transaction, future opportunities for the companies and any other statements about future expectations and the intent of any parties about future actions constitute “forward-looking statements” as defined in the federal securities laws. Forward-looking statements may be identified by words such as “believe,” “expects,” “anticipates,” “projects,” “intends,” “should,” “estimates” or similar expressions. Such statements are based upon current beliefs, expectations and assumptions and are subject to significant risks and uncertainties. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: (1) conditions to the closing of the transaction may not be satisfied; (2) the transaction may involve unexpected costs, liabilities or delays; (3) the business of Inteliquent may suffer as a result of uncertainty surrounding the transaction; (4) the outcome of any legal proceedings related to the transaction; (5) Inteliquent may be adversely affected by other economic, business, and/or competitive factors; (6) the occurrence of any event, change or other circumstances that could give rise to the termination of the Merger Agreement; (7) the ability to recognize benefits of the transaction; (8) risks that the transaction disrupts current plans and operations and the potential difficulties in employee retention as a result of the transaction; and (9) other risks to consummation of the transaction, including the risk that the transaction will not be consummated within the expected time period or at all. If the transaction is consummated, stockholders unaffiliated with the transaction will cease to have any equity interest in Inteliquent and will have no right to participate in its earnings and future growth. Inteliquent, GTCR, and Onvoy believe these forward-looking statements are reasonable; however, undue reliance should not be placed on any forward-looking statements, which are based on current expectations. All written and oral forward-looking statements attributable to Inteliquent, GTCR, or Onvoy or persons acting on behalf of Inteliquent, GTCR, or Onvoy’s behalf are qualified in their entirety by these cautionary statements. Further, forward-looking statements speak only as of the date they are made, and Inteliquent, GTCR, and Onvoy undertake no obligation to update or revise forward-looking statements to reflect changed assumptions, the occurrence of unanticipated events or changes to future operating results over time unless required by law. Past financial or operating performance are not necessarily reliable indicators of future performance and you should not use our historical performance to anticipate results or future period trends.

Additional factors that may affect future results are contained in Inteliquent’s filings with the SEC, including its Annual Report on Form 10-K for the year ended December 31, 2015, which are available at the SEC’s website at http://www.sec.gov. The information set forth herein speaks only as of the date hereof, and any intention or obligation to update any forward-looking statements as a result of developments occurring after the date hereof is hereby disclaimed unless required by law.

 

CONTACT INFORMATION

For Inteliquent:

Investor Contact
Emily Naylor
investorrelations@inteliquent.com

For GTCR:

Eileen Rochford
eileenr@theharbingergroup.com

For Onvoy:

Marketing Director
Andi Cook
andi.cook@onvoy.com
Wednesday, November 2nd, 2016 Uncategorized Comments Off on $IQNT Agrees to be Acquired by #GTCR

$ONVO Receives Strong Customer Response for #ExVive Human #Kidney Tissue Launch

SAN DIEGO, Nov. 01, 2016  — Organovo Holdings, Inc. (NASDAQ:ONVO) (“Organovo”), a three-dimensional biology company focused on delivering scientific and medical breakthroughs using its 3D bioprinting technology, today announced that it has received a strong customer response for its second tissue service, the ExViveTM Human Kidney Tissue.  This kidney proximal tubule model was launched in September, and is a natural expansion of the Company’s preclinical product and service portfolio.  Customers use Organovo’s 3D bioprinted kidney tissue to study the effects of drug exposure through toxicology panels and transporter studies.  The Company already has multiple commercial orders from several customers, including with two, global, top 25 pharmaceutical companies.

“Nephrotoxicity is a key concern in drug development and the proximal tubule is the primary site of renal toxicity,” said Dr. Caroline Lee, senior director, Ardea Biosciences, Inc.  “Specifically, transporters in the proximal tubule play a crucial role in the distribution and accumulation of drugs in the kidney.  The ExVive Human Kidney Tissue provides an ideal means to study the impact of renal transporters on the disposition of drugs because it closely resembles native human kidney proximal tubule, with its polarized renal epithelial cells and tubulointerstitial interface and in particular its native expression level of transporters enabling formation of the transport network.”  Ardea Biosciences, Inc. is a wholly-owned subsidiary of AstraZeneca PLC.

“At La Jolla Pharmaceutical Company, we incorporate in vitro models to assess nephrotoxicity in the preclinical stage of drug development,” said Dr. Andrew Seacat, director, preclinical development, La Jolla Pharmaceutical Company.  “Early safety prediction of compounds is challenging and many drugs fail in the clinic because of renal toxicity.  Organovo has developed an in vitro human kidney tissue model that allows for study of renal toxicity, biomarker expression, and overall cellular and tissue health following compound exposure.  La Jolla currently utilizes the ExVive Human Kidney Tissue model to assess the renal impact of our compounds during development.”

About Organovo Holdings, Inc.
Organovo designs and creates functional, three-dimensional human tissues for use in medical research and therapeutic applications.  The Company develops 3D human tissue models through internal development and in collaboration with pharmaceutical, academic and other partners.  Organovo’s 3D human tissues have the potential to accelerate the drug discovery process, enabling treatments to be developed faster and at lower cost.  The Company’s ExVive Human Liver and Kidney Tissues are used in toxicology and other preclinical drug testing.  The Company also actively conducts early research on specific tissues for therapeutic use in direct surgical applications.  In addition to numerous scientific publications, the Company’s technology has been featured in The Wall Street Journal, Time Magazine, The Economist, Forbes, and numerous other media outlets.  Organovo is changing the shape of life science research and transforming medical care.  Learn more at www.organovo.com.

Forward-Looking Statements

Any statements contained in this press release that do not describe historical facts constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995.  Any forward-looking statements contained herein are based on current expectations, but are subject to a number of risks and uncertainties.  The factors that could cause the Company’s actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company’s ability to develop, market and sell products and services based on its technology; the expected benefits and efficacy of the Company’s products, services and technology; the market acceptance of the Company’s products and services; the Company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies; the Company’s ability to successfully complete the contracts and recognize the revenue represented by the contracts included in its previously reported total contract bookings and secure additional contracted collaborative relationships; the final results of the Company’s preclinical studies may be different from the Company’s studies or interim preclinical data results and may not support further clinical development of its therapeutic tissues; the Company may not successfully complete the required preclinical and clinical trials required to obtain regulatory approval for its therapeutic tissues on a timely basis or at all; the risk of further adjustments to the Company’s select preliminary financial results for the second quarter of fiscal 2016; and the Company’s ability to meet its fiscal year 2017 outlook and/or its long-range outlook. These and other factors are identified and described in more detail in the Company’s filings with the SEC, including its Annual Report on Form 10-K filed with the SEC on June 9, 2016, its Quarterly Report on Form 10-Q filed with the SEC on August 4, 2016 and other filings with the SEC.  You should not place undue reliance on these forward-looking statements, which speak only as of the date that they were made.  These cautionary statements should be considered with any written or oral forward-looking statements that the Company may issue in the future.  Except as required by applicable law, including the securities laws of the United States, the Company does not intend to update any of the forward-looking statements to conform these statements to reflect actual results, later events or circumstances or to reflect the occurrence of unanticipated events.  

Investor Contact:

Steve Kunszabo
Organovo Holdings, Inc.
+1 (858) 224-1092 
skunszabo@organovo.com 

Press Contact:

Jessica Yingling
Little Dog Communications
+1 (858) 344-8091
jessica@litldog.com
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$AVXS Single-Arm Design for US Pivotal Study of #AVXS101

– Company provides update following receipt of FDA minutes from Type B meeting –

– Conference call and webcast November 1 at 4:30 p.m. EDT –

CHICAGO, Nov. 01, 2016  — AveXis, Inc. (NASDAQ:AVXS), a clinical-stage gene therapy company developing treatments for patients suffering from rare and life-threatening neurological genetic diseases, today announced that the planned pivotal study of AVXS-101 in spinal muscular atrophy (SMA) Type 1 will reflect a single-arm design, using natural history of the disease as a comparator, and enroll approximately 20 patients. This update is based on the receipt of the minutes following the Type B meeting with the U.S. Food and Drug Administration (FDA) held on September 30, 2016.

In addition to evaluating safety, the planned program is expected to evaluate achievement of motor milestones, specifically patients’ ability to sit unassisted, as well as an efficacy measure defined by the time from birth to an “event,” defined as death or requiring at least 16 hours per day of ventilation support for breathing for greater than two weeks in the absence of an acute reversible illness, or perioperatively.

At the Type B meeting and in the meeting minutes, the FDA acknowledged the company’s rationale for a single-arm pivotal study and provided a number of constructive suggestions to help optimize such a trial design. The FDA also indicated its preference for a design with co-primary endpoints consisting of a measure of developmental milestone achievement (such as sitting unassisted) along with a clinically meaningful measure of survival (such as time to an “event” as described above). Based on FDA’s suggestions as well as other expert input, AveXis continues to evaluate a number of the details of the trial design. More specific information will be made available at the time the study is initiated, which is expected in the first half of 2017.

“We believe the Type B meeting had a positive tone, with FDA offering a number of constructive suggestions which we believe will better enable implementation of a pivotal study design that is most appropriate for the patients suffering from this devastating disease,” said Sean Nolan, President and Chief Executive Officer of AveXis. “With the feedback needed from the FDA to move forward with our pivotal trial, we plan to proceed as expeditiously as possible to begin the study in the first half of 2017.”

With regard to the ongoing Phase 1 trial of AVXS-101, the FDA stated the following in the meeting minutes: “We strongly recommend that at the completion of the study, you request an end-of-Phase 1 meeting to evaluate the adequacy of data to support future product development, including a discussion of whether the data from the Phase 1 study might provide the substantial evidence necessary to support a marketing application.”

The company’s strategy with the SMA Type 1 program is to complete the ongoing Phase 1 trial and, in parallel, execute on the single-arm pivotal trial, while continuing collaborative discussions with the FDA regarding the most expeditious pathways for FDA approval of AVXS-101.

Conference Call Information
AveXis will host a conference call and webcast at 4:30 p.m. EDT today, November 1, 2016, to discuss the clinical development pathway for AVXS-101 in SMA Type 1.

Analysts and investors can participate in the conference call by dialing (844) 889-6863 for domestic callers and (661) 378-9762 for international callers, using the conference ID 12184733. The webcast can be accessed live on the Events and Presentations page in the Investors and Media section of the AveXis website, www.AveXis.com. The webcast will be archived on the company’s website for 30 days, and will be available for telephonic replay for 14 days following the call by dialing (855) 859-2056 (Domestic) or (404) 537-3406 (International), conference ID 12184733.

This call is in lieu of the previously announced conference call scheduled for Thursday, November 10, 2016 at 4:30 p.m. EST. AveXis will report financial and operating results for the third quarter ended September 30, 2016 on Thursday, November 10 after the close of U.S.-based financial markets, but will no longer host a conference call and webcast.

About SMA
SMA is a severe neuromuscular disease characterized by the loss of motor neurons leading to progressive muscle weakness and paralysis. SMA is caused by a genetic defect in the SMN1 gene that codes SMN, a protein necessary for the survival of motor neurons. The incidence of SMA is approximately one in 10,000 live births.

The most severe form of SMA is Type 1, a lethal genetic disorder characterized by motor neuron loss and associated muscle deterioration, which results in mortality or the need for permanent ventilation support before the age of two for greater than 90 percent of patients. SMA Type 1 is the leading genetic cause of infant mortality.

About AVXS-101
AVXS-101 is a proprietary gene therapy candidate of a one-time treatment for SMA Type 1 and is designed to address the monogenic root cause of SMA and prevent further muscle degeneration by addressing the defective and/or loss of the primary SMN gene. AVXS-101 also targets motor neurons, providing rapid onset of effect, and crosses the blood brain barrier allowing an IV dosing route and effective targeting of both central and systemic features.

About AveXis, Inc.
AveXis is a clinical-stage gene therapy company developing treatments for patients suffering from rare and life-threatening neurological genetic diseases. The company’s initial proprietary gene therapy candidate, AVXS-101, is in an ongoing Phase 1 clinical trial for the treatment of SMA Type 1. For additional information, please visit www.avexis.com.

Forward-Looking Statements
This press release contains “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, regarding, among other things, AveXis’ research, development and regulatory plans for AVXS-101, including the potential of AVXS-101 to positively impact quality of life and alter the course of disease in children with SMA Type 1, expectations regarding design and timing of the pivotal trial of AVXS-101 as well as the overall clinical development of AVXS-101. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual results to differ materially from those projected in its forward-looking statements. Meaningful factors which could cause actual results to differ include, but are not limited to, the scope, progress, expansion, and costs of developing and commercializing AveXis’ product candidates; regulatory developments in the United States and foreign countries, as well as other factors discussed in the “Risk Factors” included as Exhibit 99.1 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on September 7, 2016 and the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” section of AveXis’ Annual Report on Form 10-Q for the quarter ended June 30, 2016, filed with the SEC on August 12, 2016. In addition to the risks described above and in the Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the SEC, other unknown or unpredictable factors also could affect AveXis’ results. There can be no assurance that the actual results or developments anticipated by AveXis will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, AveXis. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.

All forward-looking statements contained in this press release are expressly qualified by the cautionary statements contained or referred to herein. AveXis cautions investors not to rely too heavily on the forward-looking statements AveXis makes or that are made on its behalf. These forward-looking statements speak only as of the date of this press release (unless another date is indicated). AveXis undertakes no obligation, and specifically declines any obligation, to publicly update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

 

Media Inquiries:
Lauren Barbiero
W2O Group
646-564-2156
lbarbiero@w2ogroup.com

Investor Inquiries:
Jim Goff
AveXis, Inc.
650-862-4134
jgoff@avexis.com
Tuesday, November 1st, 2016 Uncategorized Comments Off on $AVXS Single-Arm Design for US Pivotal Study of #AVXS101

$JBSS Board Declares Special #Cash #Dividend of $2.50 per share

John B. Sanfilippo & Son, Inc. (NASDAQ: JBSS) (the “Company”) today announced that its Board of Directors (the “Board”) declared a special cash dividend (the “Dividend”) of $2.50 per share on all issued and outstanding shares of Common Stock of the Company and $2.50 per share on all issued and outstanding shares of Class A Common Stock of the Company.

The Dividend will be paid on December 13, 2016 to stockholders of record as of the close of business on November 30, 2016.

“We are pleased to announce this $2.50 per share special cash dividend,” stated Jeffrey T. Sanfilippo, Chairman and Chief Executive Officer. “Our financial performance in fiscal 2016 and in the first quarter of fiscal 2017 has provided us the opportunity to return profits to our stockholders through this dividend. This special dividend, like our previous dividends, further reinforces our goal of creating long-term stockholder value through the responsible use of cash. This dividend would not be possible without the hard work and dedication of all our employees.”

ABOUT THE COMPANY

John B. Sanfilippo & Son, Inc. is a processor, packager, marketer and distributor of nut and dried fruit based products that are sold under a variety of private brands and under the Company’s Fisher®, Orchard Valley Harvest®, Fisher® Nut Exactly® and Sunshine Country® brand names.

FORWARD-LOOKING STATEMENTS

Some of the statements in this release are forward-looking. These forward-looking statements may be generally identified by the use of forward-looking words and phrases such as “will”, “intends”, “may”, “believes”, “anticipates”, “should” and “expects” and are based on the Company’s current expectations or beliefs concerning future events and involve risks and uncertainties. Consequently, the Company’s actual results could differ materially. The Company undertakes no obligation to update publicly or otherwise revise any forward-looking statements, whether as a result of new information, future events or other factors that affect the subject of these statements, except where expressly required to do so by law. Among the factors that could cause results to differ materially from current expectations are: (i) the risks associated with our vertically integrated model with respect to pecans, peanuts and walnuts; (ii) sales activity for the Company’s products, such as a decline in sales to one or more key customers, a decline in sales of private brand products or changing consumer preferences; (iii) changes in the availability and costs of raw materials and the impact of fixed price commitments with customers; (iv) the ability to pass on price increases to customers if commodity costs rise and the potential for a negative impact on demand for, and sales of, our products from price increases; (v) the ability to measure and estimate bulk inventory, fluctuations in the value and quantity of the Company’s nut inventories due to fluctuations in the market prices of nuts and bulk inventory estimation adjustments, respectively; (vi) the Company’s ability to appropriately respond to, or lessen the negative impact of, competitive and pricing pressures; (vii) losses associated with product recalls, product contamination, food labeling or other food safety issues, or the potential for lost sales or product liability if customers lose confidence in the safety of the Company’s products or in nuts or nut products in general, or are harmed as a result of using the Company’s products; (viii) the ability of the Company to retain key personnel; (ix) the effect of the actions and decisions of the group that has the majority of the voting power with regard to the Company’s outstanding common equity (which may make a takeover or change in control more difficult), including the effect of any agreements pursuant to which such group has pledged a substantial amount of its securities of the Company; (x) the potential negative impact of government regulations and laws and regulations pertaining to food safety, such as the Food Safety Modernization Act; (xi) uncertainty in economic conditions, including the potential for economic downturn; (xii) the timing and occurrence (or nonoccurrence) of other transactions and events which may be subject to circumstances beyond the Company’s control; (xiii) the adverse effect of labor unrest or disputes, litigation and/or legal settlements, including potential unfavorable outcomes exceeding any amounts accrued; (xiv) losses due to significant disruptions at any of our production or processing facilities; (xv) the inability to implement our Strategic Plan or realize efficiency measures, including controlling medical and personnel costs; (xvi) technology disruptions or failures; (xvii) the inability to protect the Company’s brand value, intellectual property or avoid intellectual property disputes; (xviii) the Company’s ability to manage successfully the price gap between its private brand products and those of its branded competitors; and (xix) potential increased industry-specific regulation pending the U.S. Food and Drug Administration assessment of the risk of Salmonella contamination associated with tree nuts.

 

John B. Sanfilippo & Son, Inc.
Michael Valentine, Chief Financial Officer
(847) 214-4509
or
William Pokrajac, Vice President of Risk Management and Investor Relations
(847) 214-4514

Tuesday, November 1st, 2016 Uncategorized Comments Off on $JBSS Board Declares Special #Cash #Dividend of $2.50 per share

$SKLN Agreement for #GLGPharma to be Exclusive #Distributor of #STREAMWAY in #UK

GLG to Begin Sales and Marketing Immediately upon Receipt of CE Mark

MINNEAPOLIS, Nov. 01, 2016  — Skyline Medical Inc. (NASDAQ:SKLN) (“Skyline” or “the Company”), producer of the FDA-approved STREAMWAY® System for automated, direct-to-drain medical fluid disposal, announces the signing of a distribution agreement granting GLG Pharma, LLC (“GLG”) exclusive rights to market and distribute the STREAMWAY® System in the U.K.

Under the terms of the agreement, GLG will be responsible for all sales and marketing activities, including hiring and training the appropriate number of direct sales representatives to cover the 3,600 operating rooms in the U.K.  Marketing is expected to begin immediately upon receipt of the CE Mark.  Skyline applied for CE Mark approval to market STREAMWAY in the European Union and certain other countries in July 2016, following receipt of ISO 13485:2003 certification.

“We look forward to bringing the benefits of the STREAMWAY System to healthcare professionals and facilities across the U.K. and to an even closer relationship with Skyline,” said Richard Gabriel, Co-founder and Chief Operating Officer of GLG Pharma. “We have considerable experience with bringing medical products to EU facilities, which will be invaluable to our work with the STREAMWAY System,” Mr. Gabriel added.

In June 2016 STREAMWAY received ISO 13485:2003 certification, an internationally recognized quality standard for medical devices that is awarded when an organization demonstrates its ability to provide medical devices and related services that consistently meet customer and regulatory requirements applicable to medical devices and related services, and is a requirement for medical device clearance in Canada, the EU and a majority of other countries that require products meet EU safety, health and environmental requirements.

Under the terms of an agreement announced in September 2016, GLG intends to develop rapid diagnostic tests that utilize fluid and tissue collected by the STREAMWAY System during procedures.  Initial tests are anticipated to include cancer biomarkers and infectious diseases.  The oncology test panels will feature GLG’s patented inhibitors of Signal Transducers and Activators of Transcription 3 (STAT3), which are in preclinical development for a new generation of targeted therapies.

About GLG, LLC.
Founded in 2009 and located in Jupiter, Fla., GLG Pharma, LLC is a privately held, early stage, biotechnology company developing personalized therapies for patients with cancer and other proliferative diseases. GLG Pharma’s therapeutics are expected to aid in the treatment of a wide variety of cancers and address unmet needs in the multi-billion dollar anti-cancer market with potentially greater efficacy and fewer side effects than existing therapies. For more information on GLG Pharma visit: http://www.glgpharma.com.

About the STREAMWAY System
Skyline Medical’s revolutionary, FDA-cleared STREAMWAY System is the first true direct-to-drain fluid disposal system designed specifically for medical applications, such as radiology, endoscopy, urology and cystoscopy procedures. It connects directly to a facility’s plumbing system to automate the collection, measurement and disposal of waste fluids, and minimizes human intervention for better safety while improving compliance with Occupational Safety and Health Administration (OSHA) and other regulatory agency safety guidelines. It also provides unlimited capacity for increased efficiency in the operating room, which leads to greater profitability. The STREAMWAY eliminates canisters to reduce overhead costs and provides greater environmental stewardship by helping to eliminate the approximately 50 million potentially disease-infected canisters that go into landfills annually in the U.S.

About Skyline Medical Inc.
Skyline Medical Inc. produces a fully automated, patented, FDA-cleared, waste fluid disposal system that virtually eliminates staff exposure to blood, irrigation fluid and other potentially infectious fluids found in the healthcare environment. Antiquated manual fluid handling methods — which require hand carrying and emptying filled fluid canisters — present an exposure risk and potential liability. Skyline Medical’s STREAMWAY System fully automates the collection, measurement and disposal of waste fluids and is designed to: 1) reduce overhead costs to hospitals and surgical centers, 2) improve compliance with OSHA and other regulatory agency safety guidelines, 3) improve efficiency in the operating room, and radiology and endoscopy departments — leading to greater profitability, and 4) provide greater environmental stewardship by helping to eliminate the approximately 50 million potentially disease-infected canisters that go into landfills annually in the United States. For additional information, please visit www.skylinemedical.com.

Forward-looking Statements:
Certain of the matters discussed in this announcement contain forward-looking statements that involve material risks to and uncertainties in the Company’s business that may cause actual results to differ materially from those anticipated by the statements made herein. Such risks and uncertainties include, among other things, current negative operating cash flows and a need for additional funding to finance our operating plan; the terms of any further financing, which may be highly dilutive and may include onerous terms; unexpected costs and operating deficits, and lower than expected sales and revenues; uncertain willingness and ability of customers to adopt new technologies and other factors that may affect further market acceptance, if our product is not accepted by our potential customers, it is unlikely that we will ever become profitable, adverse economic conditions;  the potential delisting of the Company’s common stock on The Nasdaq Capital Market as a result of the Company’s failures to comply with listing standards, in which case the liquidity of our common stock would likely be impaired and there would likely be a reduction in our coverage by security analysts and the news media, thereby resulting in lower prices for our common stock than might otherwise prevail; adverse results of any legal proceedings; the volatility of our operating results and financial condition; inability to attract or retain qualified senior management personnel, including sales and marketing personnel; our ability to establish and maintain the proprietary nature of our technology through the patent process, as well as our ability to possibly license from others patents and patent applications necessary to develop products; the Company’s ability to implement its long range business plan for various applications of its technology, including the possibility that the development of applicable technologies by GLG Pharma, LLC will be delayed, will not occur or will not receive applicable regulatory approvals on a timely basis; the Company’s ability to consummate its joint venture with Electronic On-Ramp, Inc.; the Company’s ability to enter into agreements with any necessary marketing and/or distribution partners; the impact of competition, the obtaining and maintenance of any necessary regulatory clearances applicable to applications of the Company’s technology; and management of growth and other risks and uncertainties that may be detailed from time to time in the Company’s reports filed with the Securities and Exchange Commission, which are available for review at www.sec.gov.  This is not a solicitation to buy or sell securities and does not purport to be an analysis of the Company’s financial position. See the Company’s most recent Annual Report on Form 10-K, and subsequent reports and other filings at www.sec.gov.

 

Contact:
Investors
LHA
Kim Sutton Golodetz
(212) 838-3777
kgolodetz@lhai.com

MoneyInfo, LLC
Charles Moskowitz
(781) 826-8882
cam@moneyinfo-llc.com
Tuesday, November 1st, 2016 Uncategorized Comments Off on $SKLN Agreement for #GLGPharma to be Exclusive #Distributor of #STREAMWAY in #UK

$NSPR #CGuard #Embolic Prevention System for #Stroke New #ClinicalData

BOSTON, MA–(Nov 1, 2016) – InspireMD, Inc. (NYSE MKT: NSPR) (NYSE MKT: NSPR.WS) (“InspireMD” or the “Company”), a leader in embolic prevention systems (EPS), neurovascular devices and thrombus management technologies, today announced 12-month follow up data from PARADIGM-101 of the CGuard™ Embolic Prevention System (EPS) which were presented in two presentations at the Transcatheter Cardiovascular Therapeutics (TCT) 2016 scientific symposium, taking place October 29 – November 2 in Washington, D.C. at the Walter E. Washington Convention Center.

In an oral presentation today in the Featured Clinical Research Session titled “Twelve-month Safety and Efficacy of CGuard™ Micronet-Covered Embolic Prevention Stent System: Routine Use to Perform Carotid Revascularization in Symptomatic and Increased Stroke Risk Asymptomatic Patients: The PARADIGM All-Comer Prospective Academic Study,” Prof. Piotr Musialek, MD, DPhil, FESC, from the Jagiellonian University Department of Cardiac & Vascular Diseases, in Krakow, Poland, reported 12-month follow up data from PARADIGM-101. PARADIGM-101 is an investigator-led clinical study evaluating the use of CGuard™ EPS in 101 consecutive patients with carotid artery stenosis. Key findings from the presentation included:

  • Zero device-related adverse events at 12 months
  • CGuard™ EPS device and procedure success were each 99.1%. The device showed excellent placement precision, and there was no foreshortening or elongation
  • Vessel narrowing was reduced from 83±9% to only 6.7±5% (p < 0.001) by independent core lab analysis
  • Peri-procedural death/major stroke/myocardial infarction (MI) was 0%.
  • One peri-procedural event was adjudicated by the Clinical Events Committee as a minor stroke (0.9%), with no change in NIH Stroke Scale or modified Ranking scale and no clinical sequel
  • At 12 months the device showed a normal healing profile, and the patency of the external carotid artery was normal

“These data further reinforce the strong safety and efficacy profiles reported in previous trials of the CGuard™ EPS, and validate the system as an important option for endovascular management of patients with carotid artery disease,” said Prof. Musialek. “Importantly, the very low incidence of peri- or post-procedural complications and stroke create a positive risk-benefit profile for CGuard™ EPS in patients with asymptomatic carotid artery disease. These patients are frequently denied intervention due to fear of the complications associated with conventional intervention, and are left with a substantial risk of stroke when treated only with medication. Our study found that CGuard™ EPS is applicable in up to 90% of all-comer patients with carotid stenosis. These data indicate that CGuard™ EPS may fundamentally alter the paradigm for managing patients with carotid artery disease, whether they have symptoms or not.”

In addition, a poster titled “Highly Calcific Carotid Lesions Endovascular Revascularizaton Using a Novel Dual-layer Carotid Stent System CGuard™: Analysis from the PARADIGM Study,” was presented by Adam Mazurek, MD, also from the Jagiellonian University Department of Cardiac & Vascular Diseases. Dr. Mazurek’s study described the use of CGuard™ EPS to treat highly calcific carotid stenosis. Because patients with highly calcified carotid lesions are typically contraindicated for endovascular intervention due to suboptimal procedural outcomes with conventional stents, CGuard provides an important new treatment solution.

Key findings from Dr. Mazurek’s presentation included:

  • 16 of the 101 patients in PARADIGM-101 had hepatocellular carcinoma (HCC) lesions
  • No difference in procedural success rates with CGuard™ EPS between highly calcified lesions and other lesions treated in this trial
  • Use of CGuard™ EPS in management of highly calcified lesions was safe, with no neurologic or cardiac events during the procedure and during the stent healing period
  • Highly calcified lesions treated with CGuard™ EPS showed no restenosis at 12 months

“Highly calcified lesions are particularly difficult to manage with conventional endovascular intervention due to the difficulty in achieving optimal procedure results on one hand, and the risk of carotid artery rupture or perforation on the other. Patients with these lesions remain at risk of stroke, and they require a safe treatment,” said Dr. Mazurek. “The results of this study show that the design and mechanical properties of CGuard™ EPS enable safe and effective endovascular management and revascularization of highly calcified lesions. I believe CGuard™ EPS has significant potential as a new approach to managing these difficult lesions and reducing the risk of stroke in patients with highly calcified lesions. Additional studies of CGuard EPS™ in this patient population should further validate common use of this innovative embolic prevention stent system to improve the treatment and outcomes of carotid artery disease.”

The data presented at TCT add to a growing body of clinical evidence validating the use of the CGuard as a proven treatment for both symptomatic and asymptomatic patients with carotid artery disease.

About PARADIGM

PARADIGM is an investigator-initiated Prospective evaluation of All-comer peRcutaneous cArotiD revascularization In symptomatic and increased-risk asymptomatic carotid artery stenosis, using CGuard™ Mesh-covered embolic prevention stent system. Dr. Musialek previously presented data from the first cohort in the PARADIGM study, which comprised 71 CGuard™ EPS procedures in unselected all-comer patients, at EuroPCR 2015. The early outcome data in the target cohort of 101 patients were presented as a Late-Breaking Clinical Trial at EuroPCR 2016 and were simultaneously published in EuroIntervention. These data showed a 100% success rate for the CGuard Embolic Prevention System during the placement procedure. Importantly, there were no procedure-related complications during CGuard™ EPS placement and at 30 days post procedure. Similarly, there were no major adverse cardiac or neurological events, as determined by operator-independent neurologist and non-invasive cardiologist evaluation. The new data presented at TCT are important because they confirm safety and durability of the CGuard™ EPS innovative treatment over 12 months.

About CGuard™ EPS

The CGuard™ EPS is designed to prevent peri-procedural and late embolization by trapping potential emboli against the arterial wall while maintaining excellent perfusion to the external carotid artery.

MicroNet™ is a bio-stable mesh woven from a single strand of 20 micron Polyethylene Terephthalate (PET).

CGuard™ EPS is CE Marked and not approved for sale in the U.S. by the U.S. Food and Drug Administration at this time.

Carotid stenosis is a narrowing of the carotid arteries, the major arteries that supply blood and oxygen to the brain. This narrowing results from a buildup of plaque inside the blood vessel and reduces blood flow to the brain. The presence of plaque in the blood vessel can also cause the development of blood clots, which may also reduce blood flow to the brain. In some cases, plaque may rupture or dislodge from the vessel wall and block smaller downstream arteries. Patients with carotid stenosis have an increased risk of stroke as a result of cerebral embolism and decreased blood flow to the brain.

Patients with symptomatic carotid stenosis are typically treated by placement of a stent inside the blood vessel in order to re-open the carotid artery and improve blood flow to the brain. InspireMD’s CGuard™ EPS uses the company’s patented MicroNet™ technology to provide the revascularization benefits of a stent with a mesh “safety net” that secures the plaque against the blood vessel’s arterial wall and thereby prevents plaque and other debris from flowing through the stent’s scaffold.

About InspireMD, Inc.

InspireMD seeks to utilize its proprietary MicroNet™ technology to make its products the industry standard for embolic protection and to provide a superior solution to the key clinical issues of current stenting in patients with a high risk of distal embolization, no reflow and major adverse cardiac events.

InspireMD intends to pursue applications of this MicroNet technology in coronary, carotid (CGuard™), neurovascular, and peripheral artery procedures. InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR and certain warrants are quoted on the NYSE MKT under the ticker symbol NSPR.WS.

Forward-looking Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) market acceptance of our existing and new products, (ii) negative clinical trial results or lengthy product delays in key markets, (iii) an inability to secure regulatory approvals for the sale of our products, (iv) intense competition in the medical device industry from much larger, multinational companies, (v) product liability claims, (vi) product malfunctions, (vii) our limited manufacturing capabilities and reliance on subcontractors for assistance, (viii) insufficient or inadequate reimbursement by governmental and other third party payers for our products, (ix) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (x) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xi) our reliance on single suppliers for certain product components, (xii) the fact that we will need to raise additional capital to meet our business requirements in the future and that such capital raising may be costly, dilutive or difficult to obtain and (xiii) the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction. More detailed information about the Company and the risk factors that may affect the realization of forward looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

Investor Contacts:
InspireMD, Inc.
Craig Shore
Chief Financial Officer
Phone: 1-888-776-6804 FREE
Email: craigs@inspiremd.com

Lazar Partners
David Carey
Investor Relations
Phone: (212) 867-1768
Email: dcarey@lazarpartners.com

Tuesday, November 1st, 2016 Uncategorized Comments Off on $NSPR #CGuard #Embolic Prevention System for #Stroke New #ClinicalData

$MTBC Q3 2016 #FinancialResults, #ConferenceCall on Nov 10

SOMERSET, NJ–(Nov 1, 2016) – MTBC (NASDAQ: MTBC) (NASDAQ: MTBCP), a leading provider of proprietary, web-based electronic health records, practice management and mHealth solutions, will release its third quarter financial results for the three months ended September 30, 2016, before the market opens on Thursday, November 10, 2016. The Company will follow with a conference call for investors on November 10 at 8:30 a.m. EDT to review highlights of its quarterly results and discuss its business outlook, recent MediGain acquisition and other matters.

The call can be accessed by dialing 844-802-2438, or 412-317-5131 for international callers, and then referencing “MTBC Third Quarter 2016 Earnings Call.” An audio webcast of the call will be available until December 31, 2016 on MTBC’s investor relations website at ir.mtbc.com.

A replay of the conference call will be available approximately one hour after the conclusion of the call and will be accessible through December 31, 2016. The replay can be accessed by dialing 877-344-7529, or 412-317-0088 for international callers, and then providing access code 10095250.

About MTBC

Medical Transcription Billing, Corp. (MTBC) is a healthcare information technology company that provides a fully integrated suite of proprietary web-based solutions, together with related business services, to healthcare providers practicing in ambulatory care settings. Our integrated Software-as-a-Service (or SaaS) platform helps our customers increase revenues, streamline workflows and make better business and clinical decisions, while reducing administrative burdens and operating costs. MTBC’s common stock trades on the NASDAQ Capital Market under the ticker symbol “MTBC,” and its Series A Preferred Stock trades on the NASDAQ Capital Market under the ticker symbol “MTBCP.”

For additional information, please visit our website at www.mtbc.com.

Follow MTBC on TWITTER, LINKEDIN and FACEBOOK.

SOURCE MTBC

Investor and Media Contact:
Christine J. Petraglia
Managing Director
PCG Advisory Group
Christine@pcgadvisory.com
(646) 731-9817

Company Contact:
Bill Korn
Chief Financial Officer
Medical Transcription Billing, Corp.
bkorn@mtbc.com
(732) 873-5133

Tuesday, November 1st, 2016 Uncategorized Comments Off on $MTBC Q3 2016 #FinancialResults, #ConferenceCall on Nov 10