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News Article | May 8, 2017
Site: globenewswire.com

SALT LAKE CITY, May 08, 2017 (GLOBE NEWSWIRE) -- Lipocine Inc. (NASDAQ:LPCN), a specialty pharmaceutical company, today announced financial results for the first quarter ended March 31, 2017. • Announced completion of enrollment in both the dosing validation (“DV”) and dosing flexibility (“DF”) studies for LPCN 1021.  LPCN 1021 is an oral testosterone product candidate for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone, also known as hypogonadism. • Received additional guidance from the FDA regarding the pivotal Phase 3 clinical study design for LPCN 1107 which is being developed for reducing the risk of preterm birth (“PTB”) in women with singleton pregnancy who have a history of singleton spontaneous PTB. • Promoted Gregory Bass to Executive Vice President and Chief Commercial Officer. Mr. Bass will be responsible for leading the commercialization of Lipocine's product candidates, including its testosterone replacement franchise. “During 2017, we have made substantial progress in advancing our product candidates in preparation for upcoming data disclosures and planned regulatory filings,” said Dr. Mahesh Patel, Chairman, President and CEO of Lipocine.  “We plan to report top-line results from the on-going LPCN 1021 studies in June and expect to resubmit our NDA to the FDA in the third quarter of 2017.  For LPCN 1107, we are preparing to submit the proposed Phase 3 trial design via an SPA in the second quarter of 2017.” Lipocine reported a net loss of $4.9 million, or $0.26 per diluted share, for the first quarter ended March 31, 2017, compared with a net loss of $7.0 million, or $0.38 per diluted share, in the first quarter ended March 31, 2016. Research and development expenses were $3.1 million in the first quarter of 2017, compared with $2.7 million in the first quarter of 2016.  The change was primarily due to an increase in contract research organization costs in 2017 related to the on-going studies for LPCN 1021 offset by a decrease in manufacturing costs for LPCN 1021 as well as decrease in personnel costs as a result of our 2016 restructurings. General and administrative expenses were $1.8 million in the first quarter of 2017, compared with $4.4 million in the first quarter of 2016. The change was primarily due to a decrease in business development, market research and pre-commercialization activities related to LPCN 1021 as well as decrease in personnel costs as a result of our 2016 restructurings. As of March 31, 2016, Lipocine had cash, cash equivalents and marketable investment securities of $26.8 million, compared with cash and cash equivalents of $26.8 million as of December 31, 2016. Lipocine Inc. is a specialty pharmaceutical company developing innovative pharmaceutical products for use in men's and women's health using its proprietary drug delivery technologies. Lipocine’s clinical development pipeline includes three development programs LPCN 1021, LPCN 1111 and LPCN 1107.  LPCN 1021, a novel oral prodrug of testosterone containing testosterone undecanoate, is designed to help restore normal testosterone levels in hypogonadal men. LPCN 1021, was well tolerated and met the primary efficacy end-point in Phase 3 testing, which utilized 24-hour pharmacokinetic data for dose adjustments, and is currently being studied in two additional Phase 3 clinical trials.  LPCN 1111, a novel oral prodrug of testosterone, originated with and is being developed by Lipocine as a next-generation oral testosterone product with potential for once-daily dosing and is currently in Phase 2 testing.  LPCN 1107, the potentially first oral hydroxyprogesterone caproate product candidate indicated for the prevention of recurrent preterm birth, has been granted orphan drug designation by the FDA. An End of Phase 2 meeting with the FDA has been completed. For more information, please visit www.lipocine.com. Forward-Looking Statements This release contains “forward looking statements” that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding Lipocine’s product candidates and related clinical trials and the FDA review process relating to its product candidates, plans related to clinical trials, the possible outcome and timing of such clinical trials, the expected timing of clinical trial results or any related FDA review process, the path to approvability by the FDA of Lipocine’s development programs, the potential uses and benefits of our product candidates, and our product development efforts. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risks that the FDA will not approve any of our products, risks related to our products, expected product benefits not being realized, clinical and regulatory expectations and plans not being realized, advance regulatory developments and requirements, risks related to the FDA approval process, the receipt of regulatory approvals, the results and timing of clinical trials, patient acceptance of Lipocine’s products, the manufacturing and commercialization of Lipocine’s products, and other risks detailed in Lipocine’s filings with the SEC, including, without limitation, its Form 10-K and other reports on Forms 8-K and 10-Q, all of which can be obtained on the SEC website at www.sec.gov. Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law.


News Article | May 8, 2017
Site: globenewswire.com

SALT LAKE CITY, May 08, 2017 (GLOBE NEWSWIRE) -- Lipocine Inc. (NASDAQ:LPCN), a specialty pharmaceutical company, today announced financial results for the first quarter ended March 31, 2017. • Announced completion of enrollment in both the dosing validation (“DV”) and dosing flexibility (“DF”) studies for LPCN 1021.  LPCN 1021 is an oral testosterone product candidate for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone, also known as hypogonadism. • Received additional guidance from the FDA regarding the pivotal Phase 3 clinical study design for LPCN 1107 which is being developed for reducing the risk of preterm birth (“PTB”) in women with singleton pregnancy who have a history of singleton spontaneous PTB. • Promoted Gregory Bass to Executive Vice President and Chief Commercial Officer. Mr. Bass will be responsible for leading the commercialization of Lipocine's product candidates, including its testosterone replacement franchise. “During 2017, we have made substantial progress in advancing our product candidates in preparation for upcoming data disclosures and planned regulatory filings,” said Dr. Mahesh Patel, Chairman, President and CEO of Lipocine.  “We plan to report top-line results from the on-going LPCN 1021 studies in June and expect to resubmit our NDA to the FDA in the third quarter of 2017.  For LPCN 1107, we are preparing to submit the proposed Phase 3 trial design via an SPA in the second quarter of 2017.” Lipocine reported a net loss of $4.9 million, or $0.26 per diluted share, for the first quarter ended March 31, 2017, compared with a net loss of $7.0 million, or $0.38 per diluted share, in the first quarter ended March 31, 2016. Research and development expenses were $3.1 million in the first quarter of 2017, compared with $2.7 million in the first quarter of 2016.  The change was primarily due to an increase in contract research organization costs in 2017 related to the on-going studies for LPCN 1021 offset by a decrease in manufacturing costs for LPCN 1021 as well as decrease in personnel costs as a result of our 2016 restructurings. General and administrative expenses were $1.8 million in the first quarter of 2017, compared with $4.4 million in the first quarter of 2016. The change was primarily due to a decrease in business development, market research and pre-commercialization activities related to LPCN 1021 as well as decrease in personnel costs as a result of our 2016 restructurings. As of March 31, 2016, Lipocine had cash, cash equivalents and marketable investment securities of $26.8 million, compared with cash and cash equivalents of $26.8 million as of December 31, 2016. Lipocine Inc. is a specialty pharmaceutical company developing innovative pharmaceutical products for use in men's and women's health using its proprietary drug delivery technologies. Lipocine’s clinical development pipeline includes three development programs LPCN 1021, LPCN 1111 and LPCN 1107.  LPCN 1021, a novel oral prodrug of testosterone containing testosterone undecanoate, is designed to help restore normal testosterone levels in hypogonadal men. LPCN 1021, was well tolerated and met the primary efficacy end-point in Phase 3 testing, which utilized 24-hour pharmacokinetic data for dose adjustments, and is currently being studied in two additional Phase 3 clinical trials.  LPCN 1111, a novel oral prodrug of testosterone, originated with and is being developed by Lipocine as a next-generation oral testosterone product with potential for once-daily dosing and is currently in Phase 2 testing.  LPCN 1107, the potentially first oral hydroxyprogesterone caproate product candidate indicated for the prevention of recurrent preterm birth, has been granted orphan drug designation by the FDA. An End of Phase 2 meeting with the FDA has been completed. For more information, please visit www.lipocine.com. Forward-Looking Statements This release contains “forward looking statements” that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding Lipocine’s product candidates and related clinical trials and the FDA review process relating to its product candidates, plans related to clinical trials, the possible outcome and timing of such clinical trials, the expected timing of clinical trial results or any related FDA review process, the path to approvability by the FDA of Lipocine’s development programs, the potential uses and benefits of our product candidates, and our product development efforts. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risks that the FDA will not approve any of our products, risks related to our products, expected product benefits not being realized, clinical and regulatory expectations and plans not being realized, advance regulatory developments and requirements, risks related to the FDA approval process, the receipt of regulatory approvals, the results and timing of clinical trials, patient acceptance of Lipocine’s products, the manufacturing and commercialization of Lipocine’s products, and other risks detailed in Lipocine’s filings with the SEC, including, without limitation, its Form 10-K and other reports on Forms 8-K and 10-Q, all of which can be obtained on the SEC website at www.sec.gov. Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law.


News Article | May 8, 2017
Site: globenewswire.com

SALT LAKE CITY, May 08, 2017 (GLOBE NEWSWIRE) -- Lipocine Inc. (NASDAQ:LPCN), a specialty pharmaceutical company, today announced financial results for the first quarter ended March 31, 2017. • Announced completion of enrollment in both the dosing validation (“DV”) and dosing flexibility (“DF”) studies for LPCN 1021.  LPCN 1021 is an oral testosterone product candidate for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone, also known as hypogonadism. • Received additional guidance from the FDA regarding the pivotal Phase 3 clinical study design for LPCN 1107 which is being developed for reducing the risk of preterm birth (“PTB”) in women with singleton pregnancy who have a history of singleton spontaneous PTB. • Promoted Gregory Bass to Executive Vice President and Chief Commercial Officer. Mr. Bass will be responsible for leading the commercialization of Lipocine's product candidates, including its testosterone replacement franchise. “During 2017, we have made substantial progress in advancing our product candidates in preparation for upcoming data disclosures and planned regulatory filings,” said Dr. Mahesh Patel, Chairman, President and CEO of Lipocine.  “We plan to report top-line results from the on-going LPCN 1021 studies in June and expect to resubmit our NDA to the FDA in the third quarter of 2017.  For LPCN 1107, we are preparing to submit the proposed Phase 3 trial design via an SPA in the second quarter of 2017.” Lipocine reported a net loss of $4.9 million, or $0.26 per diluted share, for the first quarter ended March 31, 2017, compared with a net loss of $7.0 million, or $0.38 per diluted share, in the first quarter ended March 31, 2016. Research and development expenses were $3.1 million in the first quarter of 2017, compared with $2.7 million in the first quarter of 2016.  The change was primarily due to an increase in contract research organization costs in 2017 related to the on-going studies for LPCN 1021 offset by a decrease in manufacturing costs for LPCN 1021 as well as decrease in personnel costs as a result of our 2016 restructurings. General and administrative expenses were $1.8 million in the first quarter of 2017, compared with $4.4 million in the first quarter of 2016. The change was primarily due to a decrease in business development, market research and pre-commercialization activities related to LPCN 1021 as well as decrease in personnel costs as a result of our 2016 restructurings. As of March 31, 2016, Lipocine had cash, cash equivalents and marketable investment securities of $26.8 million, compared with cash and cash equivalents of $26.8 million as of December 31, 2016. Lipocine Inc. is a specialty pharmaceutical company developing innovative pharmaceutical products for use in men's and women's health using its proprietary drug delivery technologies. Lipocine’s clinical development pipeline includes three development programs LPCN 1021, LPCN 1111 and LPCN 1107.  LPCN 1021, a novel oral prodrug of testosterone containing testosterone undecanoate, is designed to help restore normal testosterone levels in hypogonadal men. LPCN 1021, was well tolerated and met the primary efficacy end-point in Phase 3 testing, which utilized 24-hour pharmacokinetic data for dose adjustments, and is currently being studied in two additional Phase 3 clinical trials.  LPCN 1111, a novel oral prodrug of testosterone, originated with and is being developed by Lipocine as a next-generation oral testosterone product with potential for once-daily dosing and is currently in Phase 2 testing.  LPCN 1107, the potentially first oral hydroxyprogesterone caproate product candidate indicated for the prevention of recurrent preterm birth, has been granted orphan drug designation by the FDA. An End of Phase 2 meeting with the FDA has been completed. For more information, please visit www.lipocine.com. Forward-Looking Statements This release contains “forward looking statements” that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding Lipocine’s product candidates and related clinical trials and the FDA review process relating to its product candidates, plans related to clinical trials, the possible outcome and timing of such clinical trials, the expected timing of clinical trial results or any related FDA review process, the path to approvability by the FDA of Lipocine’s development programs, the potential uses and benefits of our product candidates, and our product development efforts. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risks that the FDA will not approve any of our products, risks related to our products, expected product benefits not being realized, clinical and regulatory expectations and plans not being realized, advance regulatory developments and requirements, risks related to the FDA approval process, the receipt of regulatory approvals, the results and timing of clinical trials, patient acceptance of Lipocine’s products, the manufacturing and commercialization of Lipocine’s products, and other risks detailed in Lipocine’s filings with the SEC, including, without limitation, its Form 10-K and other reports on Forms 8-K and 10-Q, all of which can be obtained on the SEC website at www.sec.gov. Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law.


News Article | May 8, 2017
Site: globenewswire.com

SALT LAKE CITY, May 08, 2017 (GLOBE NEWSWIRE) -- Lipocine Inc. (NASDAQ:LPCN), a specialty pharmaceutical company, today announced financial results for the first quarter ended March 31, 2017. • Announced completion of enrollment in both the dosing validation (“DV”) and dosing flexibility (“DF”) studies for LPCN 1021.  LPCN 1021 is an oral testosterone product candidate for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone, also known as hypogonadism. • Received additional guidance from the FDA regarding the pivotal Phase 3 clinical study design for LPCN 1107 which is being developed for reducing the risk of preterm birth (“PTB”) in women with singleton pregnancy who have a history of singleton spontaneous PTB. • Promoted Gregory Bass to Executive Vice President and Chief Commercial Officer. Mr. Bass will be responsible for leading the commercialization of Lipocine's product candidates, including its testosterone replacement franchise. “During 2017, we have made substantial progress in advancing our product candidates in preparation for upcoming data disclosures and planned regulatory filings,” said Dr. Mahesh Patel, Chairman, President and CEO of Lipocine.  “We plan to report top-line results from the on-going LPCN 1021 studies in June and expect to resubmit our NDA to the FDA in the third quarter of 2017.  For LPCN 1107, we are preparing to submit the proposed Phase 3 trial design via an SPA in the second quarter of 2017.” Lipocine reported a net loss of $4.9 million, or $0.26 per diluted share, for the first quarter ended March 31, 2017, compared with a net loss of $7.0 million, or $0.38 per diluted share, in the first quarter ended March 31, 2016. Research and development expenses were $3.1 million in the first quarter of 2017, compared with $2.7 million in the first quarter of 2016.  The change was primarily due to an increase in contract research organization costs in 2017 related to the on-going studies for LPCN 1021 offset by a decrease in manufacturing costs for LPCN 1021 as well as decrease in personnel costs as a result of our 2016 restructurings. General and administrative expenses were $1.8 million in the first quarter of 2017, compared with $4.4 million in the first quarter of 2016. The change was primarily due to a decrease in business development, market research and pre-commercialization activities related to LPCN 1021 as well as decrease in personnel costs as a result of our 2016 restructurings. As of March 31, 2016, Lipocine had cash, cash equivalents and marketable investment securities of $26.8 million, compared with cash and cash equivalents of $26.8 million as of December 31, 2016. Lipocine Inc. is a specialty pharmaceutical company developing innovative pharmaceutical products for use in men's and women's health using its proprietary drug delivery technologies. Lipocine’s clinical development pipeline includes three development programs LPCN 1021, LPCN 1111 and LPCN 1107.  LPCN 1021, a novel oral prodrug of testosterone containing testosterone undecanoate, is designed to help restore normal testosterone levels in hypogonadal men. LPCN 1021, was well tolerated and met the primary efficacy end-point in Phase 3 testing, which utilized 24-hour pharmacokinetic data for dose adjustments, and is currently being studied in two additional Phase 3 clinical trials.  LPCN 1111, a novel oral prodrug of testosterone, originated with and is being developed by Lipocine as a next-generation oral testosterone product with potential for once-daily dosing and is currently in Phase 2 testing.  LPCN 1107, the potentially first oral hydroxyprogesterone caproate product candidate indicated for the prevention of recurrent preterm birth, has been granted orphan drug designation by the FDA. An End of Phase 2 meeting with the FDA has been completed. For more information, please visit www.lipocine.com. Forward-Looking Statements This release contains “forward looking statements” that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding Lipocine’s product candidates and related clinical trials and the FDA review process relating to its product candidates, plans related to clinical trials, the possible outcome and timing of such clinical trials, the expected timing of clinical trial results or any related FDA review process, the path to approvability by the FDA of Lipocine’s development programs, the potential uses and benefits of our product candidates, and our product development efforts. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risks that the FDA will not approve any of our products, risks related to our products, expected product benefits not being realized, clinical and regulatory expectations and plans not being realized, advance regulatory developments and requirements, risks related to the FDA approval process, the receipt of regulatory approvals, the results and timing of clinical trials, patient acceptance of Lipocine’s products, the manufacturing and commercialization of Lipocine’s products, and other risks detailed in Lipocine’s filings with the SEC, including, without limitation, its Form 10-K and other reports on Forms 8-K and 10-Q, all of which can be obtained on the SEC website at www.sec.gov. Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law.


News Article | February 20, 2017
Site: physicsworld.com

Two independent groups of physicists in Germany and China have built portable optical clocks that are more accurate than the best caesium devices. They say that their instruments could be used to compare the timekeeping of different optical clocks distributed across the globe, and so take us closer to an overhaul of the SI definition of the second. They also reckon their compact clocks could be used by geodesists to determine the height difference between two widely spaced points on the Earth's surface. All atomic clocks rely on counting the oscillations of an electromagnetic wave with a frequency that is locked to that of a known atomic transition. Traditional atomic clocks use a microwave transition in caesium-133 to fix the output of a crystal oscillator, whereas optical clocks use much higher optical frequencies generated when a monochromatic laser beam interacts with various species of trapped ions or with clouds of cold atoms. These clocks now have accuracies and stabilities that are nearly two orders of magnitude higher than those of the best caesium devices – at levels of a few parts in 1018 rather than 1 part in 1016. These improvements have led to calls for a change in the definition of the second within the SI system of units, from one based on the caesium-133 transition to another based on an optical standard. However, such a move requires a way of comparing the ticking rate of optical clocks located in different laboratories around the world – which is harder to do than a comparison of microwave frequencies. Now, Christian Lisdat and colleagues at the Physikalisch-Technische Bundesanstalt (PTB) in Braunschweig have shown how this could be done by making a compact optical clock that can be transported in an air-conditioned trailer. Their clock consists of several thousand neutral strontium-87 atoms that are held in place, cooled and excited by lasers. Lisdat says that among the main challenges involved in building the portable system were shrinking the laser systems for cooling and preparation of the atoms. Also difficult was to build a vacuum system for holding the atoms that is compact but at the same time doesn't cause the lasers to misalign when it is transported. Another major hurdle the group had to overcome, says Lisdat, was holding in place the optical cavity used to stabilize the frequency of the monochromatic laser that excites the strontium atoms. The kind of soft pads used to support the cavity in a laboratory, he explains, would not survive the clock's journey by road. The solution, developed by group member Uwe Sterr, was to mount the cavity inside a 3D arrangement of wires that squeeze the cavity to keep its length set to a very precise value. "If you don't make these corrections, even a tiny vibration will degrade the quality of the laser," says Sterr. As Lisdat and colleagues used their clock to carry out two measurement campaigns on the road, and by comparing its performance against that of a stationary optical clock, they showed it was accurate to 7.4 parts in 1017. In particular, they found it was an order of magnitude more accurate and two orders of magnitude more stable than the best portable caesium clock. They are now working to improve the clock's accuracy by better understanding the behaviour of the lasers used to trap the strontium atoms, and describe their current clock in a paper in Physical Review Letters. Meanwhile in China, a team led by Xueren Huang of the Wuhan Institute of Physics and Mathematics has obtained a similar uncertainty (7.7 parts in 1017) from its own transportable optical clock. The system is based on a transition of a single ion of calcium-40 and is described in a preprint on arXiv. According to Rachel Godun of the National Physical Laboratory in the UK, the Chinese system has the advantage of simplicity, which, she says, makes it smaller – at just half a cubic metre (minus the electronics) – and cheaper. Writing in an article in Physics that accompanies the Physical Review Letters paper, she says that the PTB set-up benefits from having more atoms and therefore a better signal-to-noise ratio. This, she explains, means it can reach a given statistical uncertainty much more quickly – allowing it to make measurements in minutes rather than days. Comparisons between atomic clocks in different parts of the world are often carried out using satellites, but noise limits the sensitivity of such comparisons. Optical-fibre networks offer a better method of comparison, but these need special amplifiers at intervals of about 100 km to compensate for lost power. While this can be done on land, creating a similar link between continents would be far costlier. It is here, according to Godun, that the new transportable optical clocks would be very useful. They "could travel between laboratory clocks located anywhere in the world", she says, so enabling "significant progress towards a redefinition of the SI second". Godun points out that these portable clocks could also have other applications, including in geodesy. General relativity tells us that time runs more quickly further away from a massive object, which means that clocks on Earth will tick at very slightly different rates, depending on how high up they are. Optical clocks with accuracies of one part in 1017 could resolve height differences of a mere 10 cm, she says, so making them competitive when it comes to comparing the heights of sites that are separated by hundreds of kilometres – a time-consuming task when using the traditional technique of spirit levelling. Godun adds that optical clocks transported to remote locations could also be used for "long-term environmental monitoring by measuring height changes in ice sheets and ocean levels".


News Article | December 19, 2016
Site: globenewswire.com

SALT LAKE CITY, Dec. 19, 2016 (GLOBE NEWSWIRE) -- Sera Prognostics, Inc., a women’s healthcare company, today announced the recent publication of two reports showing significant clinical utility of assessing preterm birth risk early in pregnancy with novel biomarker tests.  These reports describe treatment paradigms that use existing interventions with significant potential to improve the health of premature babies, including reduction in mortality rates, as well as a corresponding reduction of direct medical costs to the health care system. “These important publications analyze better ways to address the severe health and economic impact of prematurity on US families,” stated Gregory C. Critchfield, MD, MS, Chairman and CEO of Sera Prognostics, “and demonstrate the value of knowing early in pregnancy a woman’s risk for premature delivery.  By using interventions earlier, physicians can seek to prolong pregnancies as a strategy to improve the chances of healthier babies.  Sera is proud to offer the PreTRM® test, the only clinically validated blood test for the early prediction of preterm birth risk, as we work to make the company’s vision a reality:  To improve the health of women and infants and decrease the costs of healthcare worldwide.” A comprehensive analysis conducted by a group of noted health economists entitled, Clinical and Cost Impact Analysis of a Novel Prognostic Test for Early Detection of Preterm Birth, was published in the American Journal of Perinatology Reports, and available at https://www.thieme-connect.de/products/ejournals/pdf/10.1055/s-0036-1593866.pdf. The authors concluded that “the use of a prognostic test for reducing spontaneous preterm birth is a dominant strategy that could reduce costs and improve outcomes.”  Other findings from the report state that preterm birth risk testing and intervention could result in: “The clinical and financial impact of preterm birth continues to increase and contribute to the rising cost of healthcare in the US,” said Jay D. Iams, MD, Emeritus Professor of Obstetrics and Gynecology at The Ohio State University College of Medicine.  “The outcome of our in-depth analysis showed the potential significance of a novel prognostic test such as PreTRM, to improve neonatal health and achieve subsequent reduction of overall costs of preterm birth on the healthcare system.” A separate article entitled Preterm Birth: can we do better? was published in Proceedings in Obstetrics and Gynecology, and is available at http://ir.uiowa.edu/cgi/viewcontent.cgi?article=1049&context=pog_in_press. The authors present a clinical treatment protocol for testing women early in pregnancy with a validated biomarker test for preterm birth risk, and administering recommended interventions based on a woman’s individual risk. The paper discusses: Scott A. Sullivan, MD, MSCR, Professor and Division Director of Maternal-Fetal Medicine at the Medical University of South Carolina, stated “For the first time, our team of experts have recommended a treatment algorithm that suggests increased use of a range of interventions, based on a woman’s individual risk prediction from a validated biomarker test, now available, that all doctors can follow with the goal of improving neonatal outcomes.” According to the March of Dimes, globally preterm birth affects 15 million infants each year, with 1 million deaths occurring from prematurity.  Of the 4 million babies born annually in the U.S., approximately one in ten is born prematurely. Preterm birth is defined as any birth before 37 weeks gestation, and is the leading cause of illness and death in newborns. Prematurity is associated with a significantly increased risk of major long-term medical complications, including learning disabilities, cerebral palsy, chronic respiratory illness, intellectual disability, seizures, vision and hearing loss, and can generate significant costs throughout the lives of affected children. The PreTRM® test is the first and only clinically validated blood test that provides an early and individual risk prediction for spontaneous preterm birth in asymptomatic, singleton pregnancies. Using proteomic technology, the PreTRM® test measures and analyzes proteins in the blood that are highly predictive of preterm birth.  The PreTRM® test can help physicians identify early in the pregnancy (as early as 19 weeks of gestation) which women are at increased risk for premature delivery, enabling more informed clinical decisions based on each woman’s individual risk. The PreTRM® test enables researchers to better understand the causes of preterm birth and to develop new therapies to improve newborn health. The PreTRM® test is ordered by a medical professional. For more information about the PreTRM® test, please visit www.PreTRM.com and the PreTRM® test YouTube Channel.  You can also join the conversation on Facebook and @PreTRM. Sera Prognostics, a women’s health company, develops innovative diagnostic tests focused on the early prediction of preterm birth (PTB) risk and other complications of pregnancy. Sera has launched its PreTRM® test, the first and only clinically validated blood test to accurately predict early in pregnancy the risk of premature birth. The test objectively reports to the physician the risk of premature delivery, enabling earlier proactive interventions designed to prolong gestation and improve neonatal health outcomes. Sera’s proprietary technology addresses both the health and economic challenges of PTB. The Company’s strong management team has significant clinical development and women's healthcare diagnostic experience. Sera is backed by highly respected healthcare investors, including Domain Associates, InterWest Partners, Catalyst Health Ventures, and the Bill & Melinda Gates Foundation. Currently, Sera is working with the Gates Foundation to translate the Company’s discoveries into technologies well suited for low-income countries in its journey to improve maternal and infant health globally.  Sera Prognostics is located in Salt Lake City, Utah. For more information, please visit the company's website at www.seraprognostics.com.


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

SALT LAKE CITY, Feb. 09, 2017 (GLOBE NEWSWIRE) -- Sera Prognostics, a women’s heath company, today announced that PreTRM®, the first and only clinically-validated blood test that provides an early and individualized prediction of preterm birth risk, has been named a 2017 Award Finalist by the internationally renowned Edison Awards™.   These distinguished awards, inspired by Thomas Edison’s persistence and inventiveness, recognize leadership in innovation, creativity and ingenuity in the global economy. “It’s exciting to see companies like Sera Prognostics continuing Thomas Edison’s legacy of challenging conventional thinking,” said Frank Bonafilia, Edison Awards’ executive director.  “Edison Awards recognizes the game-changing products and services, and the teams that brought them to consumers.” Award winners will be announced April 20, 2017 at the Edison Awards Annual Gala, held in the historic Ballroom of the Capitale in New York City. “We are honored to have been selected by the prestigious awards committee from hundreds of submissions as a finalist for Sera’s innovative PreTRM blood test,” said Gregory C. Critchfield, M.D., M.S., chairman and chief executive officer of Sera Prognostics. “The Edison Awards celebrate innovations that have a meaningful impact around the world.  Sera’s goal of improving neonatal health and healthcare economics in the U.S. and worldwide is congruent with the Edison Awards mission.  Through our PreTRM test, we are working to reduce the social and economic burden of prematurity by providing both physicians and patients the opportunity to intervene earlier, with the goal of improving the lives of women and their babies.” Edison Awards nominees are judged by more than 3,000 senior business executives and academics from across the nation whose votes acknowledge the Finalists’ success in meeting the award’s stringent criteria of quality.  The voting panel includes members of: Chief Marketing Officer Council (CMO) Design Management Institute (DMI) American Productivity & Quality Center (APQC) American Society of Mechanical Engineers (ASME) Georgia State Marketing Roundtable (GSU) Product Development and Management Association (PDMA)   Assoc. of Technology Mgmt & Applied Engineering (ATMAE) BPI Network Past Edison Award winners Marketing professionals Scientists Designers Engineers   Academics The PreTRM® test is the first and only clinically validated blood test that provides an early and individual risk prediction for spontaneous preterm birth in asymptomatic, singleton pregnancies. The PreTRM® test measures and analyzes proteins in the blood that are highly predictive of preterm birth.  The PreTRM® test can help physicians identify early in the pregnancy (as early as 19 weeks of gestation) which women are at increased risk for premature delivery, enabling more informed clinical decisions based on each woman’s individual risk. The PreTRM® test enables researchers to better understand the causes of preterm birth and to develop new therapies to improve newborn health. The PreTRM® test is ordered by a medical professional. For more information about the PreTRM test, please visit www.PreTRM.com and the PreTRM® test YouTube Channel.  You can also join the conversation on Facebook and @PreTRM. Sera Prognostics, a women’s health company, develops innovative diagnostic tests focused on the early prediction of preterm birth (PTB) risk and other complications of pregnancy. Sera has launched its PreTRM® test, the first and only clinically validated blood test to accurately predict early in pregnancy the risk of premature birth. The test objectively reports to the physician the risk of premature delivery, enabling earlier proactive interventions designed to prolong gestation and improve neonatal health outcomes. Sera’s technology addresses both the health and economic challenges of PTB. The Company’s strong management team has significant clinical development and women's healthcare diagnostic experience. Sera is backed by highly respected healthcare investors, including Domain Associates, InterWest Partners, Catalyst Health Ventures, the Bill & Melinda Gates Foundation, and LabCorp, who recently entered into an agreement with the Company to become the exclusive US distributor of the PreTRM® test. Currently, Sera is working with the Gates Foundation to translate the Company’s discoveries into technologies well suited for low-income countries in its journey to improve maternal and infant health globally. Sera Prognostics is located in Salt Lake City, Utah. For more information, please visit the company's website at www.seraprognostics.com. The Edison Awards is a program conducted by Edison Universe, a 501(c)(3) charitable organization dedicated to fostering  future innovators.   For more information about the Edison Awards, Edison Universe and a list of past winners, visit www.edisonawards.com.


News Article | November 21, 2016
Site: globenewswire.com

SALT LAKE CITY, Nov. 21, 2016 (GLOBE NEWSWIRE) -- Sera Prognostics, Inc., a women’s healthcare company, today announced that Gregory C. Critchfield, M.D., M.S., Chairman and Chief Executive Officer, will present at the upcoming 28th Annual Piper Jaffray Healthcare Conference. Dr. Critchfield’s presentation will take place at 11:30 AM ET on Tuesday, November 29th, at the Lotte New York Palace in New York. Sera Prognostics management will be participating in one-on-one meetings with conference attendees during the day. Sera Prognostics, a women’s health company, develops innovative diagnostic tests focused on the early prediction of preterm birth (PTB) risk and other complications of pregnancy. Sera has launched its PreTRM® test, the first and only clinically validated blood test to accurately predict early in pregnancy the risk of premature birth. The test objectively reports to the physician the risk of premature delivery, enabling earlier proactive interventions designed to prolong gestation and improve neonatal health outcomes. Sera’s proprietary technology addresses both the health and economic challenges of PTB. Its strong management team has significant clinical development and women's healthcare diagnostic experience. Sera is backed by highly respected healthcare investors, including Domain Associates, InterWest Partners, Catalyst Health Ventures, and the Bill & Melinda Gates Foundation. Currently, Sera is working with the Gates Foundation to translate the Company’s discoveries into alternative technologies ideal for low-income countries in its journey to improve maternal and infant health globally.  Sera Prognostics is located in Salt Lake City, Utah. For more information, please visit the company's website at www.seraprognostics.com.


News Article | December 1, 2016
Site: www.newsmaker.com.au

This report studies Impact Modifier in Global market, especially in North America, Europe, China, Japan, Southeast Asia and India, focuses on top manufacturers in global market, with capacity, production, price, revenue and market share for each manufacturer, covering  Dupont  Ruifengchemical  Kaneka  Arkema  LG Chem  Akdeniz Kimya  Addivant  SAFIC-ALCAN  Akzo Nobel N.V.  BASF SE  Chemtura  Clariant AG  Evonik Industries AG  Lanxess AG  The DOW Chemical Company Market Segment by Regions, this report splits Global into several key Regions, with production, consumption, revenue, market share and growth rate of Impact Modifier in these regions, from 2011 to 2021 (forecast), like  North America  Europe  China  Japan  Southeast Asia  India Split by product type, with production, revenue, price, market share and growth rate of each type, can be divided into  ABS  MBS  AIM  ASA  EPDM  TPE  CPE  Other Split by application, this report focuses on consumption, market share and growth rate of Impact Modifier in each application, can be divided into  PVC  Nylon  PTB  Engineering Plastics  Others Global Impact Modifier Market Research Report 2016  1 Impact Modifier Market Overview  1.1 Product Overview and Scope of Impact Modifier  1.2 Impact Modifier Segment by Type  1.2.1 Global Production Market Share of Impact Modifier by Type in 2015  1.2.2 ABS  1.2.3 MBS  1.2.4 AIM  1.2.5 ASA  1.2.6 EPDM  1.2.7 TPE  1.2.8 CPE  1.2.9 Other  1.3 Impact Modifier Segment by Application  1.3.1 Impact Modifier Consumption Market Share by Application in 2015  1.3.2 PVC  1.3.3 Nylon  1.3.4 PTB  1.3.5 Engineering Plastics  1.3.6 Others  1.4 Impact Modifier Market by Region  1.4.1 North America Status and Prospect (2011-2021)  1.4.2 Europe Status and Prospect (2011-2021)  1.4.3 China Status and Prospect (2011-2021)  1.4.4 Japan Status and Prospect (2011-2021)  1.4.5 Southeast Asia Status and Prospect (2011-2021)  1.4.6 India Status and Prospect (2011-2021)  1.5 Global Market Size (Value) of Impact Modifier (2011-2021) 7 Global Impact Modifier Manufacturers Profiles/Analysis  7.1 Dupont  7.1.1 Company Basic Information, Manufacturing Base and Its Competitors  7.1.2 Impact Modifier Product Type, Application and Specification  7.1.2.1 Type I  7.1.2.2 Type II  7.1.3 Dupont Impact Modifier Capacity, Production, Revenue, Price and Gross Margin (2015 and 2016)  7.1.4 Main Business/Business Overview  7.2 Ruifengchemical  7.2.1 Company Basic Information, Manufacturing Base and Its Competitors  7.2.2 Impact Modifier Product Type, Application and Specification  7.2.2.1 Type I  7.2.2.2 Type II  7.2.3 Ruifengchemical Impact Modifier Capacity, Production, Revenue, Price and Gross Margin (2015 and 2016)  7.2.4 Main Business/Business Overview  7.3 Kaneka  7.3.1 Company Basic Information, Manufacturing Base and Its Competitors  7.3.2 Impact Modifier Product Type, Application and Specification  7.3.2.1 Type I  7.3.2.2 Type II  7.3.3 Kaneka Impact Modifier Capacity, Production, Revenue, Price and Gross Margin (2015 and 2016)  7.3.4 Main Business/Business Overview  7.4 Arkema  7.4.1 Company Basic Information, Manufacturing Base and Its Competitors  7.4.2 Impact Modifier Product Type, Application and Specification  7.4.2.1 Type I  7.4.2.2 Type II  7.4.3 Arkema Impact Modifier Capacity, Production, Revenue, Price and Gross Margin (2015 and 2016)  7.4.4 Main Business/Business Overview  7.5 LG Chem  7.5.1 Company Basic Information, Manufacturing Base and Its Competitors  7.5.2 Impact Modifier Product Type, Application and Specification  7.5.2.1 Type I  7.5.2.2 Type II  7.5.3 LG Chem Impact Modifier Capacity, Production, Revenue, Price and Gross Margin (2015 and 2016)  7.5.4 Main Business/Business Overview  7.6 Akdeniz Kimya  7.6.1 Company Basic Information, Manufacturing Base and Its Competitors  7.6.2 Impact Modifier Product Type, Application and Specification  7.6.2.1 Type I  7.6.2.2 Type II  7.6.3 Akdeniz Kimya Impact Modifier Capacity, Production, Revenue, Price and Gross Margin (2015 and 2016)  7.6.4 Main Business/Business Overview  7.7 Addivant  7.7.1 Company Basic Information, Manufacturing Base and Its Competitors  7.7.2 Impact Modifier Product Type, Application and Specification  7.7.2.1 Type I  7.7.2.2 Type II  7.7.3 Addivant Impact Modifier Capacity, Production, Revenue, Price and Gross Margin (2015 and 2016)  7.7.4 Main Business/Business Overview  7.8 SAFIC-ALCAN  7.8.1 Company Basic Information, Manufacturing Base and Its Competitors  7.8.2 Impact Modifier Product Type, Application and Specification  7.8.2.1 Type I  7.8.2.2 Type II  7.8.3 SAFIC-ALCAN Impact Modifier Capacity, Production, Revenue, Price and Gross Margin (2015 and 2016)  7.8.4 Main Business/Business Overview  7.9 Akzo Nobel N.V.  7.9.1 Company Basic Information, Manufacturing Base and Its Competitors  7.9.2 Impact Modifier Product Type, Application and Specification  7.9.2.1 Type I  7.9.2.2 Type II  7.9.3 Akzo Nobel N.V. Impact Modifier Capacity, Production, Revenue, Price and Gross Margin (2015 and 2016)  7.9.4 Main Business/Business Overview  7.10 BASF SE  7.10.1 Company Basic Information, Manufacturing Base and Its Competitors  7.10.2 Impact Modifier Product Type, Application and Specification  7.10.2.1 Type I  7.10.2.2 Type II  7.10.3 BASF SE Impact Modifier Capacity, Production, Revenue, Price and Gross Margin (2015 and 2016)  7.10.4 Main Business/Business Overview  7.11 Chemtura  7.12 Clariant AG  7.13 Evonik Industries AG  7.14 Lanxess AG  7.15 The DOW Chemical Company


CGG S.A. ANNONCE AVOIR REÇU L'ACCORD DE LA MAJORITE REQUISE DES CREANCIERS DU PRÊT A TERME B ET DES PORTEURS D'OBLIGATIONS 2020, D'OBLIGATIONS 2021 ET D'OBLIGATIONS 2022 ET LA PROLONGATION DE LA CONSULTATION DES PORTEURS D'OBLIGATIONS 2017 CGG S.A. (« CGG ») a annoncé le 6 février 2017 qu'elle lançait la consultation des porteurs de chacune des émissions d'Obligations Senior (la « Consultation des Porteurs d'Obligations Senior ») et des créanciers au titre du Prêt à Terme B (la « Consultation des Créanciers du PTB »). Comme annoncé précédemment, l'objectif de la Consultation des Porteurs d'Obligations Senior et de la Consultation des Créanciers du PTB est de permettre à CGG de modifier la documentation des Obligations Senior et du Prêt à Terme B afin de donner à CGG la possibilité de demander la nomination d'un mandataire ad hoc sans que cette démarche constitue un Cas de Défaut (Event of Default) au titre des Obligations Senior et du Prêt à Terme B. CGG annonce aujourd'hui (i) qu'elle a conclu avec succès la Consultation des Créanciers du PTB en recevant l'accord de la majorité requise des créanciers du Prêt à Terme B, (ii) qu'elle a conclu avec succès la Consultation des porteurs de chacun des émission d'Obligations 2020, d'Obligations 2021 et d'Obligations 2022 en recevant l'accord de la majorité requise des porteurs de ces obligations et (iii) qu'elle a renoncé à la condition relative à la majorité requise pour les Obligations 2017 mentionnée dans le Consent Solicitation Statement en date du 3 février 2017 (le « Consent Solicitation Statement »). En conséquence, la modification de la documentation du Prêt à Terme B est entrée en vigueur et CGG a l'intention de signer les supplemental indentures relatifs aux Obligations 2020, aux Obligations 2021 et aux Obligations 2022 dès que possible afin de mettre en application les modifications proposées dans le Consent Solicitation Statement. CGG annonce également la prolongation de la consultation des porteurs et de la Date Limite de Révocation pour les Obligations 2017 (la « Prolongation de la Consultation des Porteurs d'Obligations 2017 »). La Prolongation de la Consultation des Porteurs d'Obligations 2017 prendra fin le 22 février 2017 à 17h00 heure de New York City. Au 17 février 2017 à 17h00 heure de New York City, CGG a reçu l'accord des porteurs détenant environ 16,3 % du montant nominal total ($8.319.000) des Obligations 2017. Les « Obligations Senior » désignent les obligations senior émises par CGG portant intérêt au taux de 7,750 % et venant à maturité en 2017 (CUSIP : 204386AK2 / ISIN : US204386AK24) (les « Obligations 2017 »), les obligations senior émises par CGG portant intérêt au taux de 6,500 % et venant à maturité en 2021 (CUSIP : 204384AB7 / ISIN : US204384AB76 ; CUSIP : F1704UAD6 / ISIN : USF1704UAD66) (les « Obligations 2021 »), les obligations senior émises par CGG portant intérêt au taux de 5,875 % et venant à maturité en 2020 (Reg. S ISIN : XS1061175607 / Reg. S Common Code : 106117560 ; Rule 144A ISIN : XS1061175862 / Rule 144A Common Code : 106117586) (les « Obligations 2020 ») et les obligations senior émises par CGG portant intérêt au taux de 6,875 % et venant à maturité en 2022 (Reg. S CUSIP : F1704UAC8 / Reg. S ISIN : USF1704UAC83 ; Registered CUSIP : 12531TAB5 / Registered ISIN : US12531TAB52) (les « Obligations 2022 »). Le « Prêt à Terme B » désigne le prêt à terme d'un montant de 342 millions de dollars US conclu par CGG Holding (US) Inc., filiale de CGG, en tant qu'emprunteuse. CGG (www.cgg.com) est un leader mondial de Géosciences entièrement intégré qui offre des compétences de premier plan en géologie, géophysique, caractérisation et développement de réservoirs à une base élargie de clients, principalement dans le secteur de l'exploration et de la production des hydrocarbures. Nos trois activités, Equipement, Acquisition et Géologie, Géophysique & Réservoir (GGR) interviennent sur l'ensemble de  la chaine de valeur  de l'exploration à la production des ressources naturelles. CGG emploie environ 6000 personnes dans le monde, animées par la Passion des Géosciences, pour apporter les meilleures solutions à nos clients. CGG est coté sur Euronext Paris SA (ISIN: 0013181864) et le New York Stock Exchange (sous la forme d'American Depositary Shares, NYSE: CGG).

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