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News Article | May 12, 2017
Site: www.sciencenews.org

One of the most pressing and perplexing questions parents have to answer is what to do about screen time for little ones. Even scientists and doctors are stumped. That’s because no one knows how digital media such as smartphones, iPads and other screens affect children.   The American Academy of Pediatrics recently put out guidelines, but that advice was based on a frustratingly slim body of scientific evidence, as I’ve covered. Scientists are just scratching the surface of how screen time might influence growing bodies and minds. Two recent studies point out how hard these answers are to get. But the studies also hint that the answers might be important. In the first study, Julia Ma at the University of Toronto and colleagues found that, in children younger than 2, the more time spent with a handheld screen, such as a smartphone or tablet, the more likely the child was to show signs of a speech delay. Ma presented the work May 6 at the 2017 Pediatric Academic Societies Meeting in San Francisco. The team used information gleaned from nearly 900 children’s 18-month checkups. Parents answered a questionnaire about their child’s mobile media use and then filled out a checklist designed to identify heightened risk of speech problems. This checklist is a screening tool that picks up potential signs of trouble; it doesn’t offer a diagnosis of a language delay, points out study coauthor Catherine Birken, a pediatrician at The Hospital for Sick Children in Toronto. Going into the study, the researchers didn’t have expectations about how many of these toddlers were using handheld screens. “We had very little clues, because there is almost no literature on the topic,” Birken says. “There’s just really not a lot there.” It turns out that about 1 in 5 of the toddlers used handheld screens, and those kids had an average daily usage of about a half hour. Handheld screen time was associated with potential delays in expressive language, the team found. For every half hour of mobile media use, a child’s risk of language delay increased by about 50 percent. “The relationship is not that strong,” Birken says, and those numbers come with big variations. Still, a link exists. And finding that association means there’s a lot more work to do, Birken says. In this study, researchers looked only at time spent with handheld screens. Future studies could investigate whether parents watching along with a child, the type of content or even time of day might change the calculation. A different study, published April 13 in Scientific Reports, looked at handheld digital device use among young children and its relationship to sleep. As a group, kids from ages 6 months to 3 years who spent more time using mobile touch screen devices got less sleep at night. Parent surveys filled out online indicated that each hour of touch screen use was linked to 26.4 fewer minutes of night sleep and 10.8 minutes more sleep during the day. Extra napping time “may go some way to offset the disturbed nighttime sleep, but the total sleep time of high users is still less than low users,” says study coauthor Tim Smith, a cognitive psychologist at Birkbeck, University of London. Each additional hour of touch screen use is linked to about 15 minutes less sleep over 24 hours. By analyzing 20 independent studies, an earlier study found a similar link between portable screen use and less sleep among older children. The new results offer “a consistent message that the findings from older children translate into those younger,” says Ben Carter of King’s College London, who was a coauthor on the study of older children. So the numbers are in. Daily doses of Daniel Tiger’s Neighborhood on a mobile device equals 7.5 minutes less sleep and a 50 percent greater risk of expressive language delay for your toddler, right? Well, no. It’s tempting to grab onto these numbers, but the science is too preliminary. In both cases, the results show that the two things go together, not that one caused the other. It may be a long time before scientists have answers about how digital technology affects children. In the meantime, you can follow the American Academy of Pediatrics’ recently updated guidelines, which discourage screens (except for video chatting) before 18 months of age and for all children during meals or in bedrooms. We now live in a world where smartphones are ever-present companions, a saturation that normalizes the sight of small screens in tiny hands. But I think we should give that new norm some extra scrutiny. The role of mobile devices in our kids’ lives — and our own — is something worth thinking about, hard.


News Article | May 15, 2017
Site: www.npr.org

American Indian and Alaska Native families are much more likely to have an infant die suddenly and unexpectedly, and that risk has remained higher than in other ethnic groups since public health efforts were launched to prevent sudden infant death syndrome in the 1990s. African-American babies also face a higher risk, a study finds. American Indians and Alaska Natives had a rate of 177.6 sudden, unexplained infant deaths per 100,000 live births in 2013 (down from 237.5 per 100,000 in 1995), compared to 172.4 for non-Hispanic blacks (down from 203), 84.5 for non-Hispanic whites (down from 93), 49.3 for Hispanics (down from 62.7) and 28.3 for Asians and Pacific Islanders (down from 59.3). The declines were statistically significant only among non-Hispanic blacks, Hispanics and Asians/Pacific Islanders. "There are still significant gaps and disparities between races and ethnicities," says Lori Feldman-Winter, a professor of pediatrics at Cooper University Health Care in Camden, N.J., who wasn't involved with this study and was a co-author of the most recent sleep guidelines from the American Academy of Pediatrics, released last fall. Overall rates of sudden unexpected infant death, which includes sudden infant death syndrome (SIDS) as well as accidental suffocation or strangulation in bed and other unexplained deaths, declined sharply in the five or so years after 1994, when a national campaign was launched to encourage caregivers to put babies to sleep on their backs. But the rates have not declined since 2000. Researchers at the Centers for Disease Control and Prevention wanted to know whether those changes were uniform across racial and ethnic groups. "We had the overall picture, but no one had really taken a close look at what was happening within that," says Sharyn Parks, an epidemiologist at the CDC and an author of the study, published Monday in Pediatrics. The reasons behind those changes, and why rates among American Indians/Alaskan Natives and African-Americans remain so much higher than those of non-Hispanic whites, Hispanics and Asians/Pacific Islanders aren't known, though. One important consideration is that the study didn't control for socioeconomic or other factors, such as prenatal or postnatal exposure to alcohol or tobacco, or breast-feeding patterns. So disparities or changes might be influenced by other factors besides race and ethnicity, say, the differences in the prevalence of prenatal care, says Parks. It's also not possible to determine if of the public health campaign on safe sleeping played a role in reducing death rates. An editorial accompanying the study notes that while non-Hispanic black infants saw death rates decline significantly, separate research has shown that African-Americans are also less likely than other racial and ethnic groups to embrace the safe sleeping recommendations. That suggests something else may have helped drive the improvement in that group, says Richard Goldstein, an author of the editorial and a pediatrician at Dana-Farber Cancer Institute and Boston Children's Hospital. He says it's important to consider all the factors that might have helped improve survival, including advances in care for premature infants and a decline in the rate of women younger than 20 having babies. Both preemies and infants born to young mothers are at higher risk of sudden unexplained death. Goldstein's own research looks whether an underlying vulnerability might account for some sudden unexplained infant deaths, and possibly other infant deaths that occur soon before and after birth. For example, he and colleagues showed that sudden unexplained deaths in infancy and later in childhood were both associated with a brain abnormality usually seen in temporal lobe epilepsy. It's not clear whether the abnormality caused the deaths, though. Parks says research into potential biological factors, including brain abnormalities and genetic variations, is important. She also says that it's essential to do more research on the assumption that continued disparities are in part due to differences in sleeping behaviors, such as bed sharing, between ethnic and racial groups, and what would help change those behaviors. "Something continues to hamper the ability to get the message out, or for folks in different cultures to receive the message," says Feldman-Winter. Socioeconomic status can be a big factor, she says; while the AAP recommends against bed sharing, she notes that some families may not be able to afford a crib. "People should do whatever they can to reduce the risk," says Goldstein. Katherine Hobson is a freelance health and science writer based in Brooklyn, N.Y. She's on Twitter: @katherinehobson.


News Article | May 11, 2017
Site: globenewswire.com

REDWOOD CITY, Calif., May 11, 2017 (GLOBE NEWSWIRE) -- Capnia, Inc. (NASDAQ:CAPN), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today provided a corporate update following its recent annual meeting and announced financial results for the three months ended March 31, 2017. At Capnia’s annual meeting, held on May 8, 2017, shareholders approved all of the proposed proxy initiatives, including the Company’s name change to Soleno Therapeutics, Inc., the re-election of Ernest Mario, Anish Bhatnagar, Stuart Collinson, and William Harris as Class III directors and, at the discretion of the Board of Directors, approval to conduct a reverse stock split, if needed.  Separately, Capnia was recently granted a 180-day extension by NASDAQ to regain compliance with the exchange’s minimum bid price rule. The name change to Soleno Therapeutics, Inc. and the Company’s shares trading under the NASDAQ ticker symbol, “SLNO”, are both currently expected to become effective on May 12, 2017. “The recent merger between Capnia and Essentialis has refocused our business on the development and commercialization of novel therapeutics for the treatment of rare diseases, such as PWS, where our lead product candidate, DCCR, has demonstrated significant potential,” said Anish Bhatnagar, M.D., Chief Executive Officer of Capnia. “Our name change to Soleno Therapeutics reflects this new focus.  We strengthened our balance sheet through the completion of a $10 million financing that closed concurrently with the merger, and are well-positioned to further advance the development program for DCCR.” “We are looking forward to our upcoming interactions with FDA and EMA to discuss our proposed development program for DCCR as a treatment for patients with PWS,” continued Dr. Bhatnagar.  “Following receipt of their guidance, we expect to initiate the subsequent clinical trial for PWS later in 2017.” Total revenue recognized in the three months ended March 31, 2017, was $0.3 million, compared to $0.4 million for the same period in 2016. Research and development expenses in the first quarter of 2017 were $1.0 million, compared to $1.8 million for the same period in 2016.  The decrease was primarily due to a decrease in compensation expense, as a result of a reduction in personnel. Sales and marketing expenses in the first quarter of 2017 were $0.1 million, compared to $0.5 million for the same period in 2016. The decrease was primarily due to a reduction in direct sales personnel. General and administrative expenses in the first quarter of 2017 were $1.2 million, compared to $1.9 million for the same period in 2016. The decrease was primarily due to a decrease in compensation expense, as a result of a reduction in personnel. The change in fair value of warrants income for the three months ended March 31, 2017, was $0.1 million, which represents a decrease in the fair value of the Series A and Series C Warrants compared to the value of the warrants at December 31, 2016. The change in fair value of warrants income in the first quarter of 2016 was $1.2 million, which represented an increase in the fair value of the Series A, Series B and Series C Warrants compared to the value of the warrants at December 31, 2015. Net loss for the first quarter of 2017 was $2.9 million, or a loss of $0.11 per share, compared to a net loss of $3.2 million, or a loss of $0.22 per share, for the first quarter of 2016. Cash and cash equivalents at March 31, 2017, totaled $10.5 million, compared to $2.7 million at December 31, 2016. PWS is a rare and complex genetic neurobehavioral/metabolic disorder affecting appetite, growth, metabolism, cognitive function and behavior.  The committee on genetics of the American Academy of Pediatrics states PWS affects both genders equally and occurs in people from all geographic regions: its estimated incidence is one in 15,000 to 25,000 live births. There are currently no approved therapies to treat the hyperphagia/appetite, metabolic, cognitive function, or behavioral aspects of the disorder.  This disorder is typically characterized by hyperphagia, a chronic feeling of insatiable hunger, behavioral problems, cognitive disabilities, low muscle tone, short stature (when not treated with growth hormone), the accumulation of excess body fat, developmental delays, and incomplete sexual development.  Hyperphagia, in the absence of effective limitations to access to food, can lead to morbid obesity.  In a global survey conducted by the Foundation for Prader-Willi Research, 96.5% of respondents (parent and caregivers) rated hyperphagia, which is the unrelenting hunger that severely diminishes the quality of life for patients and their families, as the most important or a very important symptom to be relieved by a new medicine. DCCR has received Orphan Drug Designation from the US FDA for the treatment of PWS. Diazoxide choline controlled-release tablet is a novel, proprietary controlled-release, crystalline salt formulation of diazoxide, which is administered once-daily.  The parent molecule, diazoxide, as an oral suspension, has been used for decades in thousands of patients in a few rare diseases in neonates, children and/or adults, but not in PWS.  Essentialis conceived of and established extensive patent protection on the therapeutic use of diazoxide and DCCR in patients with PWS.  The DCCR development program is supported by positive data from two completed Phase II clinical studies and six completed Phase I clinical studies in various metabolic indications, as well as a pilot study in PWS patients.  In the PWS pilot study, DCCR showed promise in addressing the hallmark symptoms of PWS, most notably hyperphagia. Soleno Therapeutics, Inc. (Soleno) is focused on the development and commercialization of novel therapeutics for the treatment of rare diseases.  The company is currently advancing its lead candidate, DCCR, a once-daily oral tablet for the treatment of PWS, into a Phase II/III clinical development program during 2017.  Soleno continues to market Capnia’s innovative medical devices, including the CoSense® End-Tidal Carbon Monoxide (ETCO) monitor, which measures ETCO and is used by hospitals to detect hemolysis in newborns, Serenz® Nasal Relief, an over-the-counter nasal allergy relief wash available in the US, and the NeoForce portfolio of neonatal pulmonary resuscitation solutions. It is expected that these products will be monetized and will not be a focus for the company in the long term. For more information, please visit www.soleno.life. This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, our ability to initiate the Phase II/III clinical development program of DCCR in PWS in the second half of 2017. We may use terms such as "believes," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should," "approximately" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this presentation. As a result of these factors, we cannot assure you that the forward-looking statements in this presentation will prove to be accurate. Additional factors that could materially affect actual results can be found in Capnia’s Form 10-Q filed with the Securities and Exchange Commission on May 11, 2017, including under the caption titled "Risk Factors." Capnia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.


Hossein Aliabadi, MD, FAAP, Pediatric Urologist at Pediatric Urology Associates, and affiliated with the Children’s Hospitals & Clinics of Minnesota and Park Nicollet Methodist Hospital, has been named a 2017 Top Doctor in Minneapolis, Minnesota. Top Doctor Awards is dedicated to selecting and honoring those healthcare practitioners who have demonstrated clinical excellence while delivering the highest standards of patient care. Dr. Hossein Aliabadi is a very experienced urologist, having been in practice for more than 36 years. His medical career began in India in 1980, when he graduated from the All India Institute of Medical Sciences in New Delhi. After moving to the United States, he completed residencies at Regions Hospital in St. Paul and at the University of Minnesota Medical Center in Minneapolis. Dr. Aliabadi then completed a fellowship at the University of Toronto Hospital for Sick Children in Ontario, Canada. Dr. Aliabadi is certified by the American Board of Urology, has earned the coveted title of Fellow of the American Academy of Pediatrics, and is renowned across Minnesota and beyond as a specialist in pediatric urology. He is a noted expert in prenatally diagnosed fetal anomalies, and in genitourinary tract reconstruction, and has published a number of medical papers in these areas. Dr. Aliabadi is committed to keeping up to date with the latest technological advances in pediatric urology. He does this through his membership of professional organizations including the Society of Laparoendoscopic Surgeons and the American College of Surgeons. His expertise and dedication makes Dr. Hossein Aliabadi a very deserving winner of a 2017 Top Doctor Award. Top Doctor Awards specializes in recognizing and commemorating the achievements of today’s most influential and respected doctors in medicine. Our selection process considers education, research contributions, patient reviews, and other quality measures to identify top doctors.


News Article | May 14, 2017
Site: www.prweb.com

HealthyChildren.org, the official American Academy of Pediatrics website for parents, presents a new webinar for parents on the topic of medication safety. “Giving Medicine to Kids: Dosing, Droppers, and Other Dos and Don’ts,” will stream live on May 25, 2017 at 1 p.m. ET. The free webinar will be hosted by David Hill, MD, FAAP, a father, practicing pediatrician and author of Dad to Dad: Parenting Like a Pro. “When your child is sick, you may need to give him or her medicine – but any kind of medicine or vitamin can harm your child if you give the wrong dose, at the wrong time, or in the wrong way,” Dr. Hill said. Parents will learn how to safely give medicines, including reading medicine labels, determining the correct dosage, keeping medicines out of kids’ reach, and reacting in an emergency. The webinar will run 45 minutes and will include an audiovisual presentation. A live question and answer session with Dr. Hill will follow. Parents can register to attend the webinar at https://cc.readytalk.com/r/uj5kjn2wjixg&eom. An archived version of the webinar will be available to registrants. This webinar has been planned and developed by the American Academy of Pediatrics (AAP). The presenter and contributors are experts in the field of pediatrics and pediatric subspecialties. The AAP is grateful for the sponsorship of Johnson & Johnson Consumer Inc. The Academy’s acceptance of sponsorship does not constitute or imply an endorsement of any product or service. About HealthyChildren.org The only parenting website backed by 66,000 American Academy of Pediatrics member physicians, HealthyChildren.org offers trustworthy, up-to-the-minute health advice and guidance for parents and caregivers, along with interactive tools and personalized content. The site also offers a Find a Pediatrician service, an Ask the Pediatrician tool, the KidsDoc Symptom Checker, and thousands of articles on children’s health and safety in English and Spanish. Registered users receive a free bi-weekly e-newsletter, a customized home page, and special offers.


News Article | May 11, 2017
Site: globenewswire.com

REDWOOD CITY, Calif., May 11, 2017 (GLOBE NEWSWIRE) -- Capnia, Inc. (NASDAQ:CAPN), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today provided a corporate update following its recent annual meeting and announced financial results for the three months ended March 31, 2017. At Capnia’s annual meeting, held on May 8, 2017, shareholders approved all of the proposed proxy initiatives, including the Company’s name change to Soleno Therapeutics, Inc., the re-election of Ernest Mario, Anish Bhatnagar, Stuart Collinson, and William Harris as Class III directors and, at the discretion of the Board of Directors, approval to conduct a reverse stock split, if needed.  Separately, Capnia was recently granted a 180-day extension by NASDAQ to regain compliance with the exchange’s minimum bid price rule. The name change to Soleno Therapeutics, Inc. and the Company’s shares trading under the NASDAQ ticker symbol, “SLNO”, are both currently expected to become effective on May 12, 2017. “The recent merger between Capnia and Essentialis has refocused our business on the development and commercialization of novel therapeutics for the treatment of rare diseases, such as PWS, where our lead product candidate, DCCR, has demonstrated significant potential,” said Anish Bhatnagar, M.D., Chief Executive Officer of Capnia. “Our name change to Soleno Therapeutics reflects this new focus.  We strengthened our balance sheet through the completion of a $10 million financing that closed concurrently with the merger, and are well-positioned to further advance the development program for DCCR.” “We are looking forward to our upcoming interactions with FDA and EMA to discuss our proposed development program for DCCR as a treatment for patients with PWS,” continued Dr. Bhatnagar.  “Following receipt of their guidance, we expect to initiate the subsequent clinical trial for PWS later in 2017.” Total revenue recognized in the three months ended March 31, 2017, was $0.3 million, compared to $0.4 million for the same period in 2016. Research and development expenses in the first quarter of 2017 were $1.0 million, compared to $1.8 million for the same period in 2016.  The decrease was primarily due to a decrease in compensation expense, as a result of a reduction in personnel. Sales and marketing expenses in the first quarter of 2017 were $0.1 million, compared to $0.5 million for the same period in 2016. The decrease was primarily due to a reduction in direct sales personnel. General and administrative expenses in the first quarter of 2017 were $1.2 million, compared to $1.9 million for the same period in 2016. The decrease was primarily due to a decrease in compensation expense, as a result of a reduction in personnel. The change in fair value of warrants income for the three months ended March 31, 2017, was $0.1 million, which represents a decrease in the fair value of the Series A and Series C Warrants compared to the value of the warrants at December 31, 2016. The change in fair value of warrants income in the first quarter of 2016 was $1.2 million, which represented an increase in the fair value of the Series A, Series B and Series C Warrants compared to the value of the warrants at December 31, 2015. Net loss for the first quarter of 2017 was $2.9 million, or a loss of $0.11 per share, compared to a net loss of $3.2 million, or a loss of $0.22 per share, for the first quarter of 2016. Cash and cash equivalents at March 31, 2017, totaled $10.5 million, compared to $2.7 million at December 31, 2016. PWS is a rare and complex genetic neurobehavioral/metabolic disorder affecting appetite, growth, metabolism, cognitive function and behavior.  The committee on genetics of the American Academy of Pediatrics states PWS affects both genders equally and occurs in people from all geographic regions: its estimated incidence is one in 15,000 to 25,000 live births. There are currently no approved therapies to treat the hyperphagia/appetite, metabolic, cognitive function, or behavioral aspects of the disorder.  This disorder is typically characterized by hyperphagia, a chronic feeling of insatiable hunger, behavioral problems, cognitive disabilities, low muscle tone, short stature (when not treated with growth hormone), the accumulation of excess body fat, developmental delays, and incomplete sexual development.  Hyperphagia, in the absence of effective limitations to access to food, can lead to morbid obesity.  In a global survey conducted by the Foundation for Prader-Willi Research, 96.5% of respondents (parent and caregivers) rated hyperphagia, which is the unrelenting hunger that severely diminishes the quality of life for patients and their families, as the most important or a very important symptom to be relieved by a new medicine. DCCR has received Orphan Drug Designation from the US FDA for the treatment of PWS. Diazoxide choline controlled-release tablet is a novel, proprietary controlled-release, crystalline salt formulation of diazoxide, which is administered once-daily.  The parent molecule, diazoxide, as an oral suspension, has been used for decades in thousands of patients in a few rare diseases in neonates, children and/or adults, but not in PWS.  Essentialis conceived of and established extensive patent protection on the therapeutic use of diazoxide and DCCR in patients with PWS.  The DCCR development program is supported by positive data from two completed Phase II clinical studies and six completed Phase I clinical studies in various metabolic indications, as well as a pilot study in PWS patients.  In the PWS pilot study, DCCR showed promise in addressing the hallmark symptoms of PWS, most notably hyperphagia. Soleno Therapeutics, Inc. (Soleno) is focused on the development and commercialization of novel therapeutics for the treatment of rare diseases.  The company is currently advancing its lead candidate, DCCR, a once-daily oral tablet for the treatment of PWS, into a Phase II/III clinical development program during 2017.  Soleno continues to market Capnia’s innovative medical devices, including the CoSense® End-Tidal Carbon Monoxide (ETCO) monitor, which measures ETCO and is used by hospitals to detect hemolysis in newborns, Serenz® Nasal Relief, an over-the-counter nasal allergy relief wash available in the US, and the NeoForce portfolio of neonatal pulmonary resuscitation solutions. It is expected that these products will be monetized and will not be a focus for the company in the long term. For more information, please visit www.soleno.life. This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, our ability to initiate the Phase II/III clinical development program of DCCR in PWS in the second half of 2017. We may use terms such as "believes," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should," "approximately" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this presentation. As a result of these factors, we cannot assure you that the forward-looking statements in this presentation will prove to be accurate. Additional factors that could materially affect actual results can be found in Capnia’s Form 10-Q filed with the Securities and Exchange Commission on May 11, 2017, including under the caption titled "Risk Factors." Capnia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.


News Article | May 11, 2017
Site: globenewswire.com

REDWOOD CITY, Calif., May 11, 2017 (GLOBE NEWSWIRE) -- Capnia, Inc. (NASDAQ:CAPN), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today provided a corporate update following its recent annual meeting and announced financial results for the three months ended March 31, 2017. At Capnia’s annual meeting, held on May 8, 2017, shareholders approved all of the proposed proxy initiatives, including the Company’s name change to Soleno Therapeutics, Inc., the re-election of Ernest Mario, Anish Bhatnagar, Stuart Collinson, and William Harris as Class III directors and, at the discretion of the Board of Directors, approval to conduct a reverse stock split, if needed.  Separately, Capnia was recently granted a 180-day extension by NASDAQ to regain compliance with the exchange’s minimum bid price rule. The name change to Soleno Therapeutics, Inc. and the Company’s shares trading under the NASDAQ ticker symbol, “SLNO”, are both currently expected to become effective on May 12, 2017. “The recent merger between Capnia and Essentialis has refocused our business on the development and commercialization of novel therapeutics for the treatment of rare diseases, such as PWS, where our lead product candidate, DCCR, has demonstrated significant potential,” said Anish Bhatnagar, M.D., Chief Executive Officer of Capnia. “Our name change to Soleno Therapeutics reflects this new focus.  We strengthened our balance sheet through the completion of a $10 million financing that closed concurrently with the merger, and are well-positioned to further advance the development program for DCCR.” “We are looking forward to our upcoming interactions with FDA and EMA to discuss our proposed development program for DCCR as a treatment for patients with PWS,” continued Dr. Bhatnagar.  “Following receipt of their guidance, we expect to initiate the subsequent clinical trial for PWS later in 2017.” Total revenue recognized in the three months ended March 31, 2017, was $0.3 million, compared to $0.4 million for the same period in 2016. Research and development expenses in the first quarter of 2017 were $1.0 million, compared to $1.8 million for the same period in 2016.  The decrease was primarily due to a decrease in compensation expense, as a result of a reduction in personnel. Sales and marketing expenses in the first quarter of 2017 were $0.1 million, compared to $0.5 million for the same period in 2016. The decrease was primarily due to a reduction in direct sales personnel. General and administrative expenses in the first quarter of 2017 were $1.2 million, compared to $1.9 million for the same period in 2016. The decrease was primarily due to a decrease in compensation expense, as a result of a reduction in personnel. The change in fair value of warrants income for the three months ended March 31, 2017, was $0.1 million, which represents a decrease in the fair value of the Series A and Series C Warrants compared to the value of the warrants at December 31, 2016. The change in fair value of warrants income in the first quarter of 2016 was $1.2 million, which represented an increase in the fair value of the Series A, Series B and Series C Warrants compared to the value of the warrants at December 31, 2015. Net loss for the first quarter of 2017 was $2.9 million, or a loss of $0.11 per share, compared to a net loss of $3.2 million, or a loss of $0.22 per share, for the first quarter of 2016. Cash and cash equivalents at March 31, 2017, totaled $10.5 million, compared to $2.7 million at December 31, 2016. PWS is a rare and complex genetic neurobehavioral/metabolic disorder affecting appetite, growth, metabolism, cognitive function and behavior.  The committee on genetics of the American Academy of Pediatrics states PWS affects both genders equally and occurs in people from all geographic regions: its estimated incidence is one in 15,000 to 25,000 live births. There are currently no approved therapies to treat the hyperphagia/appetite, metabolic, cognitive function, or behavioral aspects of the disorder.  This disorder is typically characterized by hyperphagia, a chronic feeling of insatiable hunger, behavioral problems, cognitive disabilities, low muscle tone, short stature (when not treated with growth hormone), the accumulation of excess body fat, developmental delays, and incomplete sexual development.  Hyperphagia, in the absence of effective limitations to access to food, can lead to morbid obesity.  In a global survey conducted by the Foundation for Prader-Willi Research, 96.5% of respondents (parent and caregivers) rated hyperphagia, which is the unrelenting hunger that severely diminishes the quality of life for patients and their families, as the most important or a very important symptom to be relieved by a new medicine. DCCR has received Orphan Drug Designation from the US FDA for the treatment of PWS. Diazoxide choline controlled-release tablet is a novel, proprietary controlled-release, crystalline salt formulation of diazoxide, which is administered once-daily.  The parent molecule, diazoxide, as an oral suspension, has been used for decades in thousands of patients in a few rare diseases in neonates, children and/or adults, but not in PWS.  Essentialis conceived of and established extensive patent protection on the therapeutic use of diazoxide and DCCR in patients with PWS.  The DCCR development program is supported by positive data from two completed Phase II clinical studies and six completed Phase I clinical studies in various metabolic indications, as well as a pilot study in PWS patients.  In the PWS pilot study, DCCR showed promise in addressing the hallmark symptoms of PWS, most notably hyperphagia. Soleno Therapeutics, Inc. (Soleno) is focused on the development and commercialization of novel therapeutics for the treatment of rare diseases.  The company is currently advancing its lead candidate, DCCR, a once-daily oral tablet for the treatment of PWS, into a Phase II/III clinical development program during 2017.  Soleno continues to market Capnia’s innovative medical devices, including the CoSense® End-Tidal Carbon Monoxide (ETCO) monitor, which measures ETCO and is used by hospitals to detect hemolysis in newborns, Serenz® Nasal Relief, an over-the-counter nasal allergy relief wash available in the US, and the NeoForce portfolio of neonatal pulmonary resuscitation solutions. It is expected that these products will be monetized and will not be a focus for the company in the long term. For more information, please visit www.soleno.life. This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, our ability to initiate the Phase II/III clinical development program of DCCR in PWS in the second half of 2017. We may use terms such as "believes," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should," "approximately" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this presentation. As a result of these factors, we cannot assure you that the forward-looking statements in this presentation will prove to be accurate. Additional factors that could materially affect actual results can be found in Capnia’s Form 10-Q filed with the Securities and Exchange Commission on May 11, 2017, including under the caption titled "Risk Factors." Capnia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.


News Article | May 11, 2017
Site: globenewswire.com

REDWOOD CITY, Calif., May 11, 2017 (GLOBE NEWSWIRE) -- Capnia, Inc. (NASDAQ:CAPN), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today provided a corporate update following its recent annual meeting and announced financial results for the three months ended March 31, 2017. At Capnia’s annual meeting, held on May 8, 2017, shareholders approved all of the proposed proxy initiatives, including the Company’s name change to Soleno Therapeutics, Inc., the re-election of Ernest Mario, Anish Bhatnagar, Stuart Collinson, and William Harris as Class III directors and, at the discretion of the Board of Directors, approval to conduct a reverse stock split, if needed.  Separately, Capnia was recently granted a 180-day extension by NASDAQ to regain compliance with the exchange’s minimum bid price rule. The name change to Soleno Therapeutics, Inc. and the Company’s shares trading under the NASDAQ ticker symbol, “SLNO”, are both currently expected to become effective on May 12, 2017. “The recent merger between Capnia and Essentialis has refocused our business on the development and commercialization of novel therapeutics for the treatment of rare diseases, such as PWS, where our lead product candidate, DCCR, has demonstrated significant potential,” said Anish Bhatnagar, M.D., Chief Executive Officer of Capnia. “Our name change to Soleno Therapeutics reflects this new focus.  We strengthened our balance sheet through the completion of a $10 million financing that closed concurrently with the merger, and are well-positioned to further advance the development program for DCCR.” “We are looking forward to our upcoming interactions with FDA and EMA to discuss our proposed development program for DCCR as a treatment for patients with PWS,” continued Dr. Bhatnagar.  “Following receipt of their guidance, we expect to initiate the subsequent clinical trial for PWS later in 2017.” Total revenue recognized in the three months ended March 31, 2017, was $0.3 million, compared to $0.4 million for the same period in 2016. Research and development expenses in the first quarter of 2017 were $1.0 million, compared to $1.8 million for the same period in 2016.  The decrease was primarily due to a decrease in compensation expense, as a result of a reduction in personnel. Sales and marketing expenses in the first quarter of 2017 were $0.1 million, compared to $0.5 million for the same period in 2016. The decrease was primarily due to a reduction in direct sales personnel. General and administrative expenses in the first quarter of 2017 were $1.2 million, compared to $1.9 million for the same period in 2016. The decrease was primarily due to a decrease in compensation expense, as a result of a reduction in personnel. The change in fair value of warrants income for the three months ended March 31, 2017, was $0.1 million, which represents a decrease in the fair value of the Series A and Series C Warrants compared to the value of the warrants at December 31, 2016. The change in fair value of warrants income in the first quarter of 2016 was $1.2 million, which represented an increase in the fair value of the Series A, Series B and Series C Warrants compared to the value of the warrants at December 31, 2015. Net loss for the first quarter of 2017 was $2.9 million, or a loss of $0.11 per share, compared to a net loss of $3.2 million, or a loss of $0.22 per share, for the first quarter of 2016. Cash and cash equivalents at March 31, 2017, totaled $10.5 million, compared to $2.7 million at December 31, 2016. PWS is a rare and complex genetic neurobehavioral/metabolic disorder affecting appetite, growth, metabolism, cognitive function and behavior.  The committee on genetics of the American Academy of Pediatrics states PWS affects both genders equally and occurs in people from all geographic regions: its estimated incidence is one in 15,000 to 25,000 live births. There are currently no approved therapies to treat the hyperphagia/appetite, metabolic, cognitive function, or behavioral aspects of the disorder.  This disorder is typically characterized by hyperphagia, a chronic feeling of insatiable hunger, behavioral problems, cognitive disabilities, low muscle tone, short stature (when not treated with growth hormone), the accumulation of excess body fat, developmental delays, and incomplete sexual development.  Hyperphagia, in the absence of effective limitations to access to food, can lead to morbid obesity.  In a global survey conducted by the Foundation for Prader-Willi Research, 96.5% of respondents (parent and caregivers) rated hyperphagia, which is the unrelenting hunger that severely diminishes the quality of life for patients and their families, as the most important or a very important symptom to be relieved by a new medicine. DCCR has received Orphan Drug Designation from the US FDA for the treatment of PWS. Diazoxide choline controlled-release tablet is a novel, proprietary controlled-release, crystalline salt formulation of diazoxide, which is administered once-daily.  The parent molecule, diazoxide, as an oral suspension, has been used for decades in thousands of patients in a few rare diseases in neonates, children and/or adults, but not in PWS.  Essentialis conceived of and established extensive patent protection on the therapeutic use of diazoxide and DCCR in patients with PWS.  The DCCR development program is supported by positive data from two completed Phase II clinical studies and six completed Phase I clinical studies in various metabolic indications, as well as a pilot study in PWS patients.  In the PWS pilot study, DCCR showed promise in addressing the hallmark symptoms of PWS, most notably hyperphagia. Soleno Therapeutics, Inc. (Soleno) is focused on the development and commercialization of novel therapeutics for the treatment of rare diseases.  The company is currently advancing its lead candidate, DCCR, a once-daily oral tablet for the treatment of PWS, into a Phase II/III clinical development program during 2017.  Soleno continues to market Capnia’s innovative medical devices, including the CoSense® End-Tidal Carbon Monoxide (ETCO) monitor, which measures ETCO and is used by hospitals to detect hemolysis in newborns, Serenz® Nasal Relief, an over-the-counter nasal allergy relief wash available in the US, and the NeoForce portfolio of neonatal pulmonary resuscitation solutions. It is expected that these products will be monetized and will not be a focus for the company in the long term. For more information, please visit www.soleno.life. This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, our ability to initiate the Phase II/III clinical development program of DCCR in PWS in the second half of 2017. We may use terms such as "believes," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should," "approximately" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this presentation. As a result of these factors, we cannot assure you that the forward-looking statements in this presentation will prove to be accurate. Additional factors that could materially affect actual results can be found in Capnia’s Form 10-Q filed with the Securities and Exchange Commission on May 11, 2017, including under the caption titled "Risk Factors." Capnia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.


The global structural heart devices market is expected to reach USD 9.1 billion by 2025. The market is expected to witness an exponential growth over the next 8 years due to the rapid increase in cardiovascular conditions and increasing power of healthcare expenditure. The defects are mostly present at birth, thereby directly affecting the under-5 mortality rate of a country. Therefore, rigorous actions are being undertaken by various government bodies across the globe to increase access to treatment. The Centers for Disease Control and Prevention have a public action plan to efficient management of cardiac conditions. In addition, other organizations are working on improving the scenario for structural heart diseases treatment. For instance, in November 2016, the Cardiovascular Research Foundation (CRF) announced a launch of a journal focusing on diagnosis and treatment of structural heart defects. It was titled Structural Heart: The Journal of the Heart Team and is expected to be launched in May 2017. This is expected to trigger research & development activities along with capital invested in this field, resulting in technological advancements. Surgical Aortic Valve Replacement (SAVR) dominated the market in 2016, closely followed by Transcatheter Aortic Valve Replacement (TAVR). It can be attributed to the longest presence of the technique in the treatment regimen of aortic stenosis. Left Atrial Appendage Closure (LAAC) is anticipated to be one of the fastest growing segment owing to the minimally invasive nature of the procedure. It also helps in reduction of risk of stroke, thus is projected to have a higher demand. Geographically, North America held the largest market share in 2016 and is expected to maintain its position during the forecast period. High prevalence of cognitive heart diseases is the key reason for this dominance. Moreover, the mandatory CCHD screening for newborns imposed by the Centers for Disease Control and Prevention (CDC) and American Academy of Pediatrics (AAP) in September 2014 also contributes to the growth in this region. For more information about this report visit http://www.researchandmarkets.com/research/l8shzs/structural_heart To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/structural-heart-devices-market-to-reach-9-billion-by-2025---by-type-region--segment---research-and-markets-300461526.html


News Article | May 17, 2017
Site: www.scientificamerican.com

Perhaps the most terrifying aspect of parenthood is the realization that, at some point, you’re going to screw up. From birth methods to feeding types, from sleeping arrangements to education and daycare options, raising a child is a veritable minefield of choice. Nowhere are parental decisions more fraught than for the caregivers of intersex children—kids who are born with biological differences of sex development. Because of the stigma and shame associated with intersex, statistics on its prevalence vary widely, but the incidence of intersex traits is thought to be as high as 1-2 percent, while intersex conditions leading to medical attention occur in approximately 1 in every 2000 births. In medical school, I was taught that a consult for what is often called “ambiguous genitalia” (a controversial term used by health professionals that is exactly what it sounds like) was considered an emergency. While it is true that one of the syndromes (Congenital Adrenal Hyperplasia) that falls under the intersex umbrella can be life-threatening if not treated, being intersex in itself is not a medical emergency. What most of my attendings felt, however, was that the parental anxiety surrounding intersex diagnoses was a psychological Defcon One. Driven in part by the perception that the distress felt by intersex moms and dads desperately needed to be alleviated, some pediatric urologist have sought to “correct” intersex for decades, performing irreversible surgeries to “normalize” the genitalia of infants. Over the past two decades, there been a growing chorus of intersex adults who have grown up with the devastating consequences of the decisions made by their parents in a time of great stress and confusion, often with incomplete information. When surgical decision making is driven by fear, by anxiety of the unknown, and by ingrown assumptions about what a person’s chromosomes say about what gender they will identify as or who they will be attracted to, the patient and their family suffers. More and more, clinicians are realizing that psychosocial support, rather than surgery, may be key treatment of intersex. Indeed, decisional regret (a kind of surgical buyer’s remorse) is present in up to half of parents who allowed cosmetic procedures on their children’s genitalia. Because if there’s anything I know as a surgeon, it’s this: all surgeries can have complications. The litany of suffering visited upon intersex bodies is long. Some have lived with painful intercourse for their entire lives. Others have been rendered menopausal before they’re even old enough to drive. Then there are the people who were surgically assigned one gender at birth, only to identify as the other as they grew older. Stories like this are what prompted me to write my novel None of the Above, which was loosely based on my experience treating an intersex girl in residency. My patient’s family, in retrospect, never really understood what they were getting into when they signed their child up for surgery. The process of obtaining consent for an infant whose personality and values are not formed yet is not easy, and more often than not parents accede to the suggestions of their doctors, who have invariably internalized a corrective agenda. Yet, as the mother of two young children, I know it’s impossible to predict my child’s favorite lunchmeat in high school, let alone their gender identity or body preferences. Keeping this uncertainty in mind is something that parents can hold on to as they make their decisions, because make no mistake, taking the time to step back, rather than taking the path of least resistance offered by one’s medical professional, requires fortitude and a profound empathy for the person your child will become. That’s why in parenting, as in medicine, my core philosophy has always been the same: First, do no harm. This minimally invasive approach protects both intersex children, many of whom grow up with fraught family relationships due to the long term damage of their surgeries, and intersex parents, some of whom have lifelong guilt over the decisions they made to operate. In 2006, the American Academy of Pediatrics issued the first consensus statement on the management of intersex. In a seemingly commonsense move, they recommended a multidisciplinary, whole-patient approach to treating intersex, and put the brakes on the rush to surgical correction. The statement emphasized the need for functional outcomes rather than cosmetic ones, and indicated that there is no good evidence to support the assumption that early surgery relieves parental distress. A decade later, surgical intervention does appear to be on the decline overall. But it remains a common practice, despite being condemned by such international human rights organizations as the United Nations, the World Health Organization and Amnesty International. Thus far, the Society for Pediatric Urology—which met recently—has failed to suggest to its members that elective surgery be postponed until patients are able to participate in their own medical decision-making. Until my fellow doctors can be trusted to provide parents with a full picture of the potential outcomes of surgeries that the UN considers a human rights violation, I must trust in my fellow parents to help turn the tide against surgery: If you are ever in the position to make a medical decision for an intersex baby, remember that the best parents make choices for their children that close the fewest doors.

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