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News Article | May 16, 2017
Site: www.eurekalert.org

For the first time, a team of researchers under the leadership of TU Darmstadt and with the participation of scientists from the Physikalisch-Technische Bundesanstalt (PTB) has succeeded in measuring the transition between energy levels of the lithium-like ions of bismuth with such precision that it has become possible to reassess underlying theories. This has led to a surprising result. The scientists have now published this result in "Nature Communications": the understanding of the interaction between an electron and an atomic nucleus that we have had until now might be erroneous. At the surface of the nuclei of bismuth atoms, magnetic fields exist which are otherwise only present at the surface of massive neutron stars. The behavior of electrons in these fields has been investigated by a group of researchers under the leadership of the Technische Universität Darmstadt. Only recently have they achieved a breakthrough by observing for the first time a special transition in lithium-like ions of this element. They have now succeeded in measuring this transition at the GSI Helmholtzzentrum für Schwerionenforschung in Darmstadt with such precision that it was possible for the first time to reassess the underlying theory convincingly. In the latest issue of the specialist journal "Nature Communications", the scientists give an account of their surprising result: the discrepancy between the theory and the experiment is striking. It suggests an error in our understanding of how an electron interacts with the complex inner structure of a nucleus. Simple atoms consisting of a single nucleus and one or a few electrons are ideal systems to check our understanding of the underlying physical forces at stake. We have a better grasp of the theory of the atom's electron shell based on quantum electrodynamics (QED) than of the actual structure of the atomic nucleus. QED allows the properties of the electrons and the states in which the atom can exist to be calculated with great accuracy. These calculations are then checked by means of precision measurements. To date, QED has passed all these tests with flying colors. When using heavy nuclei, the scientists are mainly interested in the influence of the gigantic electric and magnetic fields on the electrons bound in the shell. Only very few experimental verifications of this theory have been carried out under these extreme conditions, and they do not - by far - exhibit the same accuracy as the experiments performed with light nuclei. The strong fields make the theoretical calculations much more difficult. In addition, the complex inner structure of the nuclei is not know with sufficient precision although it has a strong influence on the atomic shell. In order to by-pass this difficulty, theoreticians calculate certain differences for systems with different numbers of electrons, but with the same atomic nucleus. These so-called "specific differences" are of such a nature that the contributions of the nucleus' structure should eliminate themselves almost exactly and that they can be used by the researchers as a starting point to check the QED calculations with more precision. The results that have now been published, however, seem to question the concept of specific difference. In its experiment, the team first generated hydrogen-like and lithium-like bismuth ions. These ions were injected into the experimental storage ring (ESR) which has a circumference of 108 m and is equipped with two straight sections where experiments can be carried out. In one of those sections, an electron beam of defined energy is superimposed with the ion beam. After a few seconds, the ions' speed adjusts to that of the electrons. In this section, a pulsed laser beam is, in addition, superimposed with the ion beam. The laser's wavelength is then modified in tiny increments. When the laser reaches exactly the wavelength of the transition of the ion to be investigated, the ions absorb light particles (photons) - and thus energy - from the laser beam. Ions that are excited in this way release this energy after a short while, thereby emitting a very small number of photons. This small number of photons was efficiently detected by means of a special mirror and single-photon detection system which was developed at the University of Münster. Due to the high speed, the wavelength of the laser is compressed or stretched by a factor of approx. 2.4, for a counterpropagating or a copropagating laser, respectively. This factor depends on the accelerating voltage of the electrons. To measure this high voltage of approx. 214,000 volts with an accuracy on the order of 1 V, a high-voltage divider developed at PTB in Braunschweig was used. Scientists from TU Darmstadt were responsible, among other things for the data acquisition and the time-dependent synchronization of the laser pulses, which only last a few billionths of a second (nanoseconds) with the revolution of the ions inside the storage ring. They also analyzed the data. The specific difference in the transition wavelengths measured in hydrogen-like and lithium-like bismuth does not agree with the theoretical prediction, even when taking all known sources of systematic errors into consideration. The cause for this deviation is not known yet and is to be investigated within the scope of further measurements with other isotopes of bismuth. These isotopes are, however, radioactive and must therefore be produced before being injected into the storage ring. These possibilities are available at the GSI Helmholtzzentrum. The new accelerator facility, FAIR, whose construction in Darmstadt will soon begin, will provide new possibilities for further investigations of this subject. The results published in "Nature Communications" are based on a cooperation project between the Westfälische Wilhelms-Universität Münster, PTB Braunschweig, the Johannes-Gutenberg-Universität Mainz, the GSI Helmholtzzentrum Darmstadt für Schwerionenforschung, and the Helmholtz-Institut Jena as well as other institutions under the leadership of the Institut für Kernphysik (Institute of Nuclear Physics) of the Technische Universität Darmstadt.


News Article | May 16, 2017
Site: www.prnewswire.com

The University of Puerto Rico, one of the awardees, reported a 20% PTB rate for CenteringPregnancy enrollees which is a 41% difference compared to the PTB rate among patients receiving traditional prenatal care.  Similarly, Amerigroup of Louisiana's PTB rate decreased 35% from 15% at initiative launch to 9.7% in year three. These findings are aligned with what other published studies1 have found. "This report expands the research that CenteringPregnancy can reduce the risk of preterm birth, which is the number one cause of infant mortality in the U.S." says Angie Truesdale, CEO of Centering Healthcare Institute. The awardees also noted other positive outcomes: CenteringPregnancy brings 8-12 pregnant women into a group setting and follows the recommended schedule of ten prenatal visits. Each visit is 90 minutes to two hours long, giving patients ten times more time with their provider team versus individual prenatal care. The combination of health assessment, interactive activities and community building allows learning from the provider and from one another. Centering Healthcare Institute is improving health by transforming care through Centering groups. It has developed and sustained the Centering model in more than 470 practice sites and in some of the largest health systems. For more information, visit www.centeringhealthcare.org. The Strong Start for Mothers and Newborn Initiative is an effort between the Centers for Medicare & Medicaid Services, the Health Resources & Services Administration, and the Administration on Children & Families. For the full report, visit https://innovation.cms.gov/initiatives/strong-start/. 1Ickovics, et al. (2007) "Group prenatal care and perinatal outcomes: a randomized controlled trial." Picklesimer, Amy, et al. (2012) "The effect of CenteringPregnancy group prenatal care." To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/strong-outcomes-shown-in-centeringpregnancy-300458360.html


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.


At the surface of the nuclei of bismuth atoms, magnetic fields exist which are otherwise only present at the surface of massive neutron stars. The behaviour of electrons in these fields has been investigated by a group of researchers under the leadership of Technische Universität Darmstadt. Only recently have they achieved a breakthrough by observing for the first time a special transition in lithium-like ions of this element. They have now succeeded in measuring this transition at the GSI Helmholtzzentrum für Schwerionenforschung in Darmstadt with such precision that it was possible for the first time to reassess the underlying theory convincingly. In the latest issue of the specialist journal Nature Communications, the scientists give an account of their surprising result: the discrepancy between the theory and the experiment is striking. It suggests an error in our understanding of how an electron interacts with the complex inner structure of a nucleus. Simple atoms consisting of a single nucleus and one or a few electrons are ideal systems to check our understanding of the underlying physical forces at stake. We have a better grasp of the theory of the atom's electron shell based on quantum electrodynamics (QED) than of the actual structure of the atomic nucleus. QED allows the properties of the electrons and the states in which the atom can exist to be calculated with great accuracy. These calculations are then checked by means of precision measurements. To date, QED has passed all these tests with flying colors. When using heavy nuclei, the scientists are mainly interested in the influence of the gigantic electric and magnetic fields on the electrons bound in the shell. Only very few experimental verifications of this theory have been carried out under these extreme conditions, and they do not – by far – exhibit the same accuracy as the experiments performed with light nuclei. The strong fields make the theoretical calculations much more difficult. In addition, the complex inner structure of the nuclei is not known with sufficient precision although it has a strong influence on the atomic shell. In order to by-pass this difficulty, theoreticians calculate certain differences for systems with different numbers of electrons, but with the same atomic nucleus. These so-called "specific differences" are of such a nature that the contributions of the nucleus' structure should eliminate themselves almost exactly and that they can be used by the researchers as a starting point to check the QED calculations with more precision. The results that have now been published, however, seem to question the concept of specific difference. In its experiment, the team first generated hydrogen-like and lithium-like bismuth ions. These ions were injected into the experimental storage ring (ESR) at the GSI accelerator facility which has a circumference of 108 m and is equipped with two straight sections where experiments can be carried out. In one of those sections, an electron beam of defined energy is superimposed with the ion beam. After a few seconds, the ions' speed adjusts to that of the electrons. In this section, a pulsed laser beam is, in addition, superimposed with the ion beam. The laser's wavelength is then modified in tiny increments. When the laser reaches exactly the wavelength of the transition of the ion to be investigated, the ions absorb light particles (photons) – and thus energy – from the laser beam. Ions that are excited in this way release this energy after a short while, thereby emitting a very small number of photons. This small number of photons was efficiently detected by means of a special mirror and single-photon detection system which was developed at the University of Münster. Due to the high speed, the wavelength of the laser is compressed or stretched by a factor of approximately 2.4, for a counterpropagating or a copropagating laser, respectively. This factor depends on the accelerating voltage of the electrons. To measure this high voltage of approximately 214,000 volts with an accuracy on the order of 1 V, a high-voltage divider developed at PTB in Braunschweig was used. Scientists from TU Darmstadt were responsible, among other things for the data acquisition and the time-dependent synchronisation of the laser pulses, which only last a few billionths of a second (nanoseconds) with the revolution of the ions inside the storage ring. They also analyzed the data. The specific difference in the transition wavelengths measured in hydrogen-like and lithium-like bismuth does not agree with the theoretical prediction, even when taking all known sources of systematic errors into consideration. The cause for this deviation is not known yet and is to be investigated within the scope of further measurements with other isotopes of bismuth. These isotopes are, however, radioactive and must therefore be produced before being injected into the storage ring. These possibilities are available at the GSI Helmholtzzentrum. The new accelerator facility, FAIR, whose construction in Darmstadt will soon begin, will provide new possibilities for further investigations of this subject. Explore further: First spectroscopic investigation of element nobelium More information: Johannes Ullmann et al. High precision hyperfine measurements in Bismuth challenge bound-state strong-field QED, Nature Communications (2017). DOI: 10.1038/NCOMMS15484


News Article | May 17, 2017
Site: globenewswire.com

SALT LAKE CITY, May 17, 2017 (GLOBE NEWSWIRE) -- Sera Prognostics, Inc., a women’s healthcare company, announced today that Nadia F. Altomare has joined the company as chief commercial officer.  Ms. Altomare will lead all commercial activities for Sera as the company makes its groundbreaking PreTRM® test available to physicians and patients.  The PreTRM test is the first and only broadly clinically-validated blood test that provides an early and individualized prediction of preterm birth risk. “We are very excited to have Nadia join Sera’s executive team.  Nadia has deep and broad experience in leading life sciences companies to successfully launch and establish market-leading positions.  She will help us to grow our company as we commercialize the PreTRM test to address the enormous challenges of prematurity,” said Gregory C. Critchfield, M.D., M.S., chairman and chief executive officer of Sera Prognostics. “Nadia will play a key role for Sera as we execute on our vision to improve the health of women and newborns worldwide.” Ms. Altomare has more than 20 years of women’s healthcare experience and an extensive knowledge in developing and implementing strategic plans to drive commercial growth in the life sciences, biotechnology, and diagnostic industries.  Ms. Altomare has held senior management positions in single and multi-product/service environments spanning from entrepreneurial to Fortune 500 companies. Most recently, Ms. Altomare served as chief executive officer of an early detection of cancer diagnostics company, Abcodia Limited, where she shaped the global commercial, regulatory and fundraising strategies for the business. Prior to that, Ms. Altomare served as vice president and general manager of the DNA analysis business at ThermoFisher Scientific (formerly Life Technologies).  Ms. Altomare also held leadership roles at PerkinElmer from 2007-2012, serving as the vice president & general manager of the cytogenetic DNA testing business where she right-sized the business while increasing productivity and as vice president of commercial operations, where she integrated the ViaCord acquisition into the broader diagnostic unit. “I am delighted to join Sera at such an exciting time in its development,” stated Altomare.  “I look forward to leading our commercial expansion strategy and to working closely with our partners, clinicians, patients, societies, and key opinion leaders to decrease the frequency and severity of preterm birth, advocating for the implementation over time of a new standard to detect premature birth early.” According to the March of Dimes, globally preterm birth affects 15 million infants each year, with 1 million deaths occurring from prematurity.  Of nearly 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, and vision and hearing loss, and can generate significant costs throughout the lives of affected children. The PreTRM® test is the first and only broadly 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 broadly 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 U.S. 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.


News Article | May 17, 2017
Site: globenewswire.com

SALT LAKE CITY, May 17, 2017 (GLOBE NEWSWIRE) -- Sera Prognostics, Inc., a women’s healthcare company, announced today that Nadia F. Altomare has joined the company as chief commercial officer.  Ms. Altomare will lead all commercial activities for Sera as the company makes its groundbreaking PreTRM® test available to physicians and patients.  The PreTRM test is the first and only broadly clinically-validated blood test that provides an early and individualized prediction of preterm birth risk. “We are very excited to have Nadia join Sera’s executive team.  Nadia has deep and broad experience in leading life sciences companies to successfully launch and establish market-leading positions.  She will help us to grow our company as we commercialize the PreTRM test to address the enormous challenges of prematurity,” said Gregory C. Critchfield, M.D., M.S., chairman and chief executive officer of Sera Prognostics. “Nadia will play a key role for Sera as we execute on our vision to improve the health of women and newborns worldwide.” Ms. Altomare has more than 20 years of women’s healthcare experience and an extensive knowledge in developing and implementing strategic plans to drive commercial growth in the life sciences, biotechnology, and diagnostic industries.  Ms. Altomare has held senior management positions in single and multi-product/service environments spanning from entrepreneurial to Fortune 500 companies. Most recently, Ms. Altomare served as chief executive officer of an early detection of cancer diagnostics company, Abcodia Limited, where she shaped the global commercial, regulatory and fundraising strategies for the business. Prior to that, Ms. Altomare served as vice president and general manager of the DNA analysis business at ThermoFisher Scientific (formerly Life Technologies).  Ms. Altomare also held leadership roles at PerkinElmer from 2007-2012, serving as the vice president & general manager of the cytogenetic DNA testing business where she right-sized the business while increasing productivity and as vice president of commercial operations, where she integrated the ViaCord acquisition into the broader diagnostic unit. “I am delighted to join Sera at such an exciting time in its development,” stated Altomare.  “I look forward to leading our commercial expansion strategy and to working closely with our partners, clinicians, patients, societies, and key opinion leaders to decrease the frequency and severity of preterm birth, advocating for the implementation over time of a new standard to detect premature birth early.” According to the March of Dimes, globally preterm birth affects 15 million infants each year, with 1 million deaths occurring from prematurity.  Of nearly 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, and vision and hearing loss, and can generate significant costs throughout the lives of affected children. The PreTRM® test is the first and only broadly 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 broadly 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 U.S. 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.


News Article | May 17, 2017
Site: globenewswire.com

SALT LAKE CITY, May 17, 2017 (GLOBE NEWSWIRE) -- Sera Prognostics, Inc., a women’s healthcare company, announced today that Nadia F. Altomare has joined the company as chief commercial officer.  Ms. Altomare will lead all commercial activities for Sera as the company makes its groundbreaking PreTRM® test available to physicians and patients.  The PreTRM test is the first and only broadly clinically-validated blood test that provides an early and individualized prediction of preterm birth risk. “We are very excited to have Nadia join Sera’s executive team.  Nadia has deep and broad experience in leading life sciences companies to successfully launch and establish market-leading positions.  She will help us to grow our company as we commercialize the PreTRM test to address the enormous challenges of prematurity,” said Gregory C. Critchfield, M.D., M.S., chairman and chief executive officer of Sera Prognostics. “Nadia will play a key role for Sera as we execute on our vision to improve the health of women and newborns worldwide.” Ms. Altomare has more than 20 years of women’s healthcare experience and an extensive knowledge in developing and implementing strategic plans to drive commercial growth in the life sciences, biotechnology, and diagnostic industries.  Ms. Altomare has held senior management positions in single and multi-product/service environments spanning from entrepreneurial to Fortune 500 companies. Most recently, Ms. Altomare served as chief executive officer of an early detection of cancer diagnostics company, Abcodia Limited, where she shaped the global commercial, regulatory and fundraising strategies for the business. Prior to that, Ms. Altomare served as vice president and general manager of the DNA analysis business at ThermoFisher Scientific (formerly Life Technologies).  Ms. Altomare also held leadership roles at PerkinElmer from 2007-2012, serving as the vice president & general manager of the cytogenetic DNA testing business where she right-sized the business while increasing productivity and as vice president of commercial operations, where she integrated the ViaCord acquisition into the broader diagnostic unit. “I am delighted to join Sera at such an exciting time in its development,” stated Altomare.  “I look forward to leading our commercial expansion strategy and to working closely with our partners, clinicians, patients, societies, and key opinion leaders to decrease the frequency and severity of preterm birth, advocating for the implementation over time of a new standard to detect premature birth early.” According to the March of Dimes, globally preterm birth affects 15 million infants each year, with 1 million deaths occurring from prematurity.  Of nearly 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, and vision and hearing loss, and can generate significant costs throughout the lives of affected children. The PreTRM® test is the first and only broadly 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 broadly 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 U.S. 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.

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