Sealy, North America's No. 1 mattress brand, is helping Americans get a better night's sleep by making it easier to shop for a mattress. The new sealy.com solves mattress buyers' greatest frustration -- determining which mattress is most right for them.

"We conducted extensive consumer research prior to building the new website," said Jodi Allen, Sealy Chief Marketing Officer. "We found only 18 percent of consumers felt prepared to buy a mattress after conducting online research, and more than two-thirds said online research was not helpful in deciding which brand of mattress to buy, making the in-store shopping experience very confusing. We took their feedback to heart and designed the new site specifically to help end their confusion."

The website offers an easy-to-navigate user experience that is unique to the bedding industry, allowing consumers to explore the various types of mattresses as well as Sealy's portfolio of brands on the homepage before making a single click. In addition, the site features several innovative tools to help connect the online research experience to the in-store shopping experience.

The site empowers consumers by allowing them to easily search for mattress information in the way they request it -- by brand, technology or product promotions. It walks consumers through the mattress buying process effortlessly, breaking down industry terminology into relatable, clear language, while helping them learn which mattress best fits their sleep behavior and lifestyle. Sealy.com also features easy-to-understand video and text-based content that explains the different brands, products, features and technologies.

The site will feature the entire family of Sealy brands, including Sealy Posturepedic®, Stearns & Foster®, Embody® by Sealy and Sealy Brand. Once consumers identify which brand best fits their needs, they are able to access the first-of-its-kind Sealy mattress-builder, where they can choose the features that meet their personal preferences.

As consumers select features, the suggested retail price will adjust accordingly. Once the consumer has built their perfect mattress, Sealy's mattress-builder creates a printable fact sheet that consumers can take into the retail store when they are ready to purchase.

"In addition to conducting our own research, we looked outside of our industry at leaders who have changed the online shopping experience to better meet consumer expectations," said Margo Borgione, Director, Global Marketing for Sealy. "By listening to our consumers and utilizing best-in-class techniques from other industries, we have created a dramatically better experience for online mattress shopping."

Sealy worked with its marketing agency Cramer-Krasselt/Chicago to build and develop the new website. The new site is now live. For more information visit www.sealy.com.  

The "Sealy.com Mattress Study" survey was conducted online by MarketTools, Inc., on behalf of Sealy. The poll, which gathered feedback from over 1,000 mattress shoppers across the U.S. who had recently purchased a mattress or were planning to in the near future, was conducted in April 2009 in effort to understand the role the Internet plays when shopping for a new mattress.

Rest Easy with Affordable, Reliable Sleep Solutions(SM)

CPAP-supplies.com, the newest provider of on-line CPAP devices and supplies, is now open for business.  Graymark Healthcare, Inc. (Nasdaq: GRMH), the second largest comprehensive sleep care provider in the United States, created the ecommerce site to offer Obstructive Sleep Apnea (OSA) patients a professional and cost effective on-line source for their CPAP devices and supplies.   

Graymark Healthcare, Inc. provides comprehensive OSA therapy in over 90 communities; with Board Certified sleep medicine physicians overseeing all aspects of care, including diagnosis, therapy and ongoing clinical support.  Through CPAP-supplies.com Graymark Healthcare allows patients who know what machines or supplies they are looking for to benefit from Graymark's experience in providing care and its purchasing power.  We offer a wonderful opportunity for patients to acquire their treatment products at the lowest cost available regardless of where they live.

"Most obstructive sleep apnea patients have visited a doctor or sleep center and have used CPAP machines and masks before," says Timothy Lebens, Vice President for Marketing for CPAP-supplies.com.  "They don't need a lot of hand-holding or medical direction because they have already been instructed in the proper use of the equipment.  They will find they can order the exact same supplies online with a significant savings."

CPAP-supplies.com is staffed by certified respiratory therapists who are available to answer customer questions from 7 a.m. to 7 p.m.  Offering customer support from knowledgeable medical professionals sets the company apart from other online suppliers, according to Lebens.

"Our objective is to provide optimum solutions for patients at the lowest cost.  It is an easy, affordable and reliable sleep disorder solution," he said.  "We can provide the same products and services without having to provide the intensive level of care of a sleep center."

Lebens says CPAP-supplies.com carries the same high quality masks, supplies and machines as supplied by doctors or sleep centers, but the costs are much lower because they can provide the products more efficiently through the internet.  "People who already have a prescription and have visited a doctor or a sleep center are familiar with the mask and CPAP device options and they understand how to use the equipment.  CPAP-supplies.com allows patients to purchase the same equipment without going back to a clinic."

CPAP-supplies.com also reminds customers every three to six months that it is time to replace filters or tubes.  The reminder makes it easy for patients to re-order or remember when they need new supplies.

Lebens says CPAP-supplies.com was designed with patient input to make the process of ordering anything they need for OSA as comfortable an experience as possible.  "Graymark Healthcare, Inc. launched CPAP-supplies.com in an effort to increase patient compliance with the CPAP use and decrease the hassle of ordering supplies.  "We have created a reputable, professional and affordable solution for CPAP users," Lebens said.

For more information, visit www.CPAP-supplies.com.

For a great shopping experience, great value and knowledgeable care providers; visit us:  www.CPAP-supplies.com Rest Easy with Affordable, Reliable Sleep Solutions(SM).

Graymark Healthcare, Inc. is a diversified medical holding company that owns and operates diagnostic sleep centers that treat a wide range of sleep disorders; independent pharmacies that serve the needs of local markets; and a medical equipment company that provides both disposable and durable medical equipment. Graymark plans to continue its growth both internally and through strategic acquisitions within the medical industry.  (NASDAQ: GRMH)

SOURCE Graymark Healthcare, Inc.

Hollandia International, manufacturer of the world's most luxurious sleep systems and the leading bedding retailer in Israel, has formed a strategic alliance with global mattress brand Therapedic. Under terms of the deal, Hollandia will own the Therapedic license for Israel and Cyprus, and said it planned to open Therapedic retail stores in Israeli cities over the next year. Additionally, both companies have announced that they will form a joint research and development team that will create products leveraging Hollandia innovation, which would be sold throughout the world.

"Hollandia makes some of the most luxurious products in our industry, and on the retail side of their business, they understand the importance of selling the benefits of a good night's sleep," said Gerry Borreggine, Therapedic president and CEO. "Together, I think we make a powerful combination in the bedding industry."

Hollandia CEO Avi Barssessat said he had been looking for sometime to find the right U.S. sleep products brand to bring to Israel.

"Israelis love American brands, and Therapedic is an outstanding sleep products company that offers a full range of product choices. I think the brand will resonate well here in Israel," he said. "We have examined the growth of Therapedic internationally to benchmark what has worked outside of the United States, and we believe our strategy will make it the fastest growing brand in Israel."

Hollandia now operates in more than 120 locations throughout the world including two retail showrooms in Philadelphia and Short Hills, N.J. All its products are manufactured in Israel.

Hollandia draws upon more than 29 years of perfecting sleep systems, to create a unique customer experience combining superior service with the highest quality materials In addition to its innovative sleep systems, Hollandia manufactures a full range of complementary sleep essentials such as plush pillows, fitted sheets, blankets and mattress protectors.  Committed to innovation and technology, Hollandia also offers custom-made style essentials such as a daybed or ottoman that can easily transform into an extremely comfortable guest bed. For more information please go to www.hollandiainternational.com.

Therapedic International is a 53-year-old mattress and sleep products manufacturer, with over 50 licensees producing products under the Therapedic brand label throughout the world. 

The U.S. market for sleep apnea diagnostic and therapeutic devices is rapidly expanding and attempts to address a patient population that is becoming increasingly diverse. Even with the economic challenges within the healthcare market over the past 18 months, this segment of the industry has remained resilient.

Multiple variables influence success in this market, and the competitive advantage has not always been centered on technology. New product designs are launched at a feverish pace, and success is based on possession of a broad product line and established sales channels. Competitive advantages based on technology have historically been quickly matched or overcome by competitors.

Frost & Sullivan (www.patientmonitoring.frost.com) finds U.S. revenues in the sleep apnea diagnostic and therapeutic devices market totaled approximately $1.35 billion in 2008, with a 16.2 percent growth rate. Revenues expect to increase within the next few years due to the expansion of the installed base and increased awareness in obstructive sleep apnea, after which growth is likely to moderately stabilize. Also included are further breakouts within the diagnostic and therapeutic markets containing revenues, units, and resulting growth rates forecasting through 2015.

The largest factors for growth in this market are the expanding number of sleep apnea product users, the evolving patient mix, increasing obesity trends, greater awareness and appreciation for the benefits of sleep apnea treatment, and a steady growth of sleep service providers.

"The patient population for this segment of the market is becoming more diverse as its use and acceptability expands," notes Frost & Sullivan Research Analyst Gary Burk. "Preparation and proper planning to navigate the future landscape of this environment will directly compete with future cutting-edge technology."

The greatest restraints in this market include a high degree of competition, the ever-evolving competitive bidding and reimbursement process, the future of healthcare reform, and patient compliance.

"As with any rapidly expanding market, the ability to address and navigate these challenges will not ensure success or guarantee profitability," continues Burk.

If you are interested in more information on this study, please send an e-mail to Johanna Haynes, Corporate Communications, at johanna.haynes@frost.com, with your full name, company name, title, telephone number, company e-mail address, company website, city, state and country.

Frost & Sullivan, the Growth Partnership Company, enables clients to accelerate growth and achieve best-in-class positions in growth, innovation and leadership. The company's Growth Partnership Service provides the CEO and the CEO's Growth Team with disciplined research and best-practice models to drive the generation, evaluation, and implementation of powerful growth strategies. Frost & Sullivan leverages over 45 years of experience in partnering with Global 1000 companies, emerging businesses and the investment community from 40 offices on six continents. To join our Growth Partnership, please visit http://www.frost.com.

The Wireless-Life Sciences Alliance (WLSA) is now accepting registrations for its fifth Annual WLSA Convergence Summit, a three-day conference sponsored by the premier non-profit trade organization dedicated solely to creating value and improving health through wireless communications technologies. The conference is scheduled for May 11-13 at Estancia Hotel & Spa, La Jolla, California.

This unique conference between the leadership of wireless companies, global product companies, consumers, payors, providers and service organizations, offers attendees the distinct opportunity to discuss the most significant emerging market trends, address and propose solutions to industry issues, create new partnerships and demonstrate new solutions - all in one exclusive venue.

Among the organizations presenting are senior management from WLSA members, including Ascension Health, AT&T, CareFusion, Johnson & Johnson, OptumHealth, QUALCOMM and St. Jude Medical, who will provide insights into their interest in the field and best practices for incorporating innovative, new wireless technologies into new products, applications and services, as well as how to bring these to providers and patients.  

"WLSA created the Convergence Summit to bring key elements of the wireless health community together to meet, share ideas and demonstrate new products and solutions," said Robert B. McCray, WLSA President & CEO. "Our goal is to provide a forum that directly addresses emerging wireless technology in healthcare and enables participants to gain a thorough understanding of how to succeed in this dynamic market."

The event begins with the Investor's Meeting and Triple Tree I Award Program for Wireless-Life Sciences Alliance® on Day 1, followed by the WLSA Convergence Summit on Day 2, and ends with Commercialization Day on Day 3.

The Summit's first day (May 11) features the Investors' Meeting, an invitational event for qualified investors, WLSA partners, and I Award finalists. A limited number of seats are open to the public.  Keynote speakers on Day 1 will include Terrance H. Gregg, President & CEO, DexCom, Inc., and Dr. Mohit Kaushal, Director of Connected Health, FCC Omnibus Broadband Initiative.  Additionally, winners of the prestigious I Award, which recognizes companies for Best Operational Effectiveness Solution, Best Clinical Solution, and Best Consumer Experience Solution, will be announced.  Award finalists include technologies such as remote monitoring technologies, home healthcare solutions, advanced imaging software, cloud computing and personal health improvement opportunities.  Twelve finalists were chosen through a competitive process from approximately 50 applicants.

The second day (May 12) is reserved for the Convergence Summit, an invitation-only program for C-level executives from WLSA members and featuring presentations by attendees and moderated conversations between executive leadership and thought leaders within the wireless, healthcare and convergence spaces. Among the themes and questions to be addressed are:

• How can we convince physicians to adopt wireless and connected health innovation in the delivery of their services?
• How can the U.S. healthcare innovation community learn from the "frugal innovation" of India and China?
• Where can we find significant adoption of wireless health innovation?
• How can we apply the lessons of online commerce, like Amazon.com, to wireless health?
• Is Moore's Law coming to healthcare? Can we leverage the cost curve to reduce the cost of delivering more healthcare to more consumers?
• Does clinical innovation and business monetization need to begin in the United States or will U.S. companies increasingly look to international markets?

The third day of the Summit, Commercialization Day, is open for general registration, and features workshops facilitated by IDEO and Insight Product Development aimed at identifying solutions to numerous industry challenges, including the clinical validation of new technologies and tech-enabled services; modification of healthcare business and payment models to support opportunities; and seamless integration of products into consumers' and patients' daily lives.

Showcased during the day will be:

• IDEO- and Insight-hosted interactive workshops focusing on issues associated with innovative approaches to product definition, business monetization and go-to-market strategies.  
• These workshops will utilize actual case studies from pressing social challenges, such as teen obesity and sleep disorders, for context. Participants will leave with a toolkit of techniques that can be applied to any complex problem, system or workflow.
• WLSA partners and others will share their products and services during an end-of-the-day demo and reception.

Throughout all three days of the Summit, global leaders in wireless healthcare and life sciences industries will staff demo booths that provide product demonstrations and informative presentations.

"The entire conference will leverage the experiences and processes from other industries to mitigate risk in our industry," McCray said. "The sessions are designed to lead attendees toward true innovation and to provide real value to their organizations.  It is our insight that the initial shape of an important new market is driven by a relatively small number of committed organizations and thought leaders.  Our meetings are designed to identify and bring the best wireless health leaders together in a quality setting to enhance their discovery of business partners."

For information or to register for WLSA's 5th Annual Summit, visit www.wirelesslifesciences.org.

It's an unforgettable scene in "The Blind Side," when the future NFL star Michael Oher tells his benefactor - played by Academy Award winning actress Sandra Bullock - that he's never had a bed of his own before.  One in 50 children is homeless in the United States every year, according to a report from The National Center on Family Homelessness, which estimates more than 1.5 million children are without a home.(1.) Moreover, the agency predicts that as foreclosures and layoffs continue, the number of children and families without homes in the United States is likely to increase.

In an effort to provide those in need with a good night's sleep, 1800Mattress.com, a family-owned national mattress company, is taking a leadership role by partnering with HomeAid, the leading national non-profit provider of housing for today's homeless, to provide more than 500 beds to shelters nationwide.

"At 1800Mattress.com, we believe that everyone is entitled to a good night's sleep and we are proud to support HomeAid as they conquer homelessness one build at a time," said Adam Blank, 1800Mattress.com's Chief Operating Officer.  "A sound night's sleep starts with a great mattress and we are dedicated to providing those in need with a place to sleep at night while they rebuild their lives during the day."

While 1800Mattress.com has already provided beds to HomeAid projects in Orange County, CA, and Houston, the partnership officially begins at HomeAid Atlanta's Phoenix Pass build in Atlanta, Georgia.  A dedication ceremony for the Phoenix Pass project, one of HomeAid's largest projects, is set for April 14 with support from former Atlanta Mayor, Shirley Franklin.  The report by the National Center on Family Homelessness, which analyzed data from 2005-06, found that Georgia was one of the states most affected by child homelessness.

"We are grateful for the support of 1800Mattress.com as 2010 is poised to be a busy year for our chapters nationwide," said Jeffrey Slavin, CEO of HomeAid. "The folks in our shelters list a bed as one of the comforts of home that they miss the most, so we are excited to help them rest easier via this partnership."

HomeAid was founded in 1989. The HomeAid mission is to build and maintain dignified housing where homeless families and individuals can rebuild their lives. This is accomplished through the donation of construction services and materials from members of the homebuilding industry.  To date, the organization has provided transitional housing for more than 100,000 individuals including those temporarily out of work, abused children, victims of domestic violence, at-risk teens, people living with HIV/AIDS and victims of natural disasters.  HomeAid currently has projects in 15 states nationwide.

About Phoenix Pass:

Phoenix Pass is a nonprofit organization designed as a partnership between First Baptist Church of Conyers and Rockdale Emergency Relief.  The mission of Phoenix Pass is to serve the needs of families experiencing temporary homelessness by giving them an opportunity to reestablish self-sufficiency in a residential setting. The focus of the program is to empower homeless families with supportive services and the resources to recover and rebuild a productive, stable lifestyle for themselves and their family.  Phoenix Pass operates under the vision that those who have successfully completed the program will remain in the Conyers-Rockdale County area to live, work and contribute back to the community the education, life skills and job skills acquired during their tenure in the program.  It is expected that residents will transition from Phoenix Pass into the community as productive and self-sufficient citizens.  

The Phoenix Pass complex will eventually accommodate up to 90 people at any given time, providing housing for up to two years along with case management, a mentorship program, life skills classes and aftercare programs.  Phoenix Pass is located on the campus of Light House Village in Conyers, and is one of three nonprofit programs on the 27-acre campus. 

For some, the phrase "spring is in the air" is quite literal. When the winter snow melts and flowers bloom, pollen and other materials can wreak havoc on those suffering from seasonal allergies, usually causing a habit called "mouth breathing." The physical, medical and social problems associated with mouth breathing are not recognized by most health care professionals, according to a study published in the January/February 2010 issue of General Dentistry, the peer-reviewed clinical journal of the Academy of General Dentistry (AGD).

Dentists typically request that their patients return every six months, which means that some people see their dentist more frequently than they see their physician. As a result, dentists may be the first to identify the symptoms of mouth breathing. And, because dentists understand the problems associated with mouth breathing, they can help prevent the adverse effects.

"Allergies can cause upper airway obstruction, or mouth breathing, in patients," said Yosh Jefferson, DMD, author of the study. "Almost every family has someone with mouth breathing problems."

Over time, children whose mouth breathing goes untreated may suffer from abnormal facial and dental development, such as long, narrow faces and mouths, gummy smiles, gingivitis and crooked teeth. The poor sleeping habits that result from mouth breathing can adversely affect growth and academic performance. As Dr. Jefferson notes in his article, "Many of these children are misdiagnosed with attention deficit disorder (ADD) and hyperactivity." In addition, mouth breathing can cause poor oxygen concentration in the bloodstream, which can cause high blood pressure, heart problems, sleep apnea and other medical issues.

"Children who mouth breathe typically do not sleep well, causing them to be tired during the day and possibly unable to concentrate on academics," Dr. Jefferson said. "If the child becomes frustrated in school, he or she may exhibit behavioral problems."

Treatment for mouth breathing is available and can be beneficial for children if the condition is caught early. A dentist can check for mouth breathing symptoms and swollen tonsils. If tonsils and/or adenoids are swollen, they can be surgically removed by an ear-nose-throat (ENT) specialist. If the face and mouth are narrow, dentists can use expansion appliances to help widen the sinuses and open nasal airway passages.

"After surgery and/or orthodontic intervention, many patients show improvement in behavior, energy level, academic performance, peer acceptance and growth," says Leslie Grant, DDS, spokesperson for the AGD. "Seeking treatment for mouth breathing can significantly improve quality of life."

At this time, many health care professionals are not aware of the health problems associated with mouth breathing. If you or your child suffers from this condition, speak with a health care professional who is knowledgeable about mouth breathing.

To learn more about oral health, visit www.KnowYourTeeth.com.

The Academy of General Dentistry (AGD) is a professional association of more than 35,000 general dentists dedicated to staying up to date in the profession through continuing education. Founded in 1952, the AGD has grown to become the second-largest dental association in the United States, and it is the only association that exclusively represents the needs and interest of general dentists. More than 772,000 persons are employed directly in the field of dentistry. A general dentist is the primary care provider for patients of all ages and is responsible for the diagnosis, treatment, management and overall coordination of services related to patients' oral health needs. For more information about the AGD, please visit www.agd.org.

Graymark Healthcare, Inc. (Nasdaq: GRMH) today announced progress on Fiscal 2009 Initiatives and financial results for the year ending December 31, 2009.

In 2009 Graymark Healthcare implemented a core market changing strategy where it integrated the diagnostic and treatment components of care for Obstructive Sleep Apnea.  While the industry has historically managed these components separately, Graymark recognized the clinical requirement that they be integrated in order to optimize patients' compliance with care.  In 2009 the Company integrated the business components wherever feasible and has shown industry leading compliance rates as a result.

Additionally, fiscal year 2009 was highlighted by two significant acquisitions in late Q3 that nearly doubled the size of the Company's SMS segment.  These acquisitions reflected the Company's stated strategy of being a key aggregator of well run assets in the sleep diagnostic and treatment space.

With the addition of the acquired businesses the Company had sufficient scale in its SMS segment to develop central, standardized core services including billing and collection, IT, marketing, HR and Business Development.  These services will allow the Company to acquire quickly and integrate efficiently ensuring that acquisition synergies are maximally realized.  

As a result of such centralized, standardized core services, at the end of 2009 management was able to identify cost cutting measures of over $1 million on an annualized basis.  These cost saving are being fully implement in the first quarter of 2010, and additional efficiencies are also being examined.

"Although others might have been focused purely on the current period, we recognized the need in 2009 to focus on building an infrastructure that would allow us to optimize the opportunity we see to aggregate the sleep diagnostic and treatment space," said Stanton Nelson, Chairman and CEO of Graymark Healthcare.  "Industry consolidation can only be successful if the acquiring entity possesses best demonstrated operating practices and the leadership to quickly integrate those practices within acquired entities while maintaining a high level of quality clinical practice, customer service and staff morale.  We are happy with our progress in 2009 and are looking forward to driving consolidation in the marketplace with our quality and efficiency in 2010 and beyond.  We can now demonstrate leadership in quality of care combined with an optimized cost to serve."  Nelson continued.

For 2009, consolidated net revenues were $107.2 million, an increase of 11% over 2008 revenue of $96.6 million.  This included a net revenue increase of 16% for the Company's Sleep Management Solutions or SMS segment, comprised of our sleep diagnostic and sleep therapy business to $17.6 million in 2009 from $15.2 million in 2008 and an increase of 10% for the Company's ApothecaryRx segment, which owns and operates independent retail pharmacies, to $89.7 million for 2009, from 2008 revenue of $81.3 million.

After-tax net loss attributable to Graymark was approximately ($5.2 million) for 2009, or a loss of ($0.18) per diluted share, compared to net income of $0.7 million, or $0.03 per diluted share for 2008.  Included in the net loss for 2009 are expenses of $0.5 million related to the acquisitions we made during the third quarter and the change in accounting estimate in the second quarter of $2.6 million, as well as a onetime expense reduction related to a legal settlement net of related legal fees of $0.4 million.

The increase in net revenue for the SMS segment was due primarily to a $4.0 million contribution from the Somni and Eastern Q3 acquisitions and $2.3 million in incremental revenue from new sleep labs acquired or opened in 2008 and 2009.  These increases were offset by a decrease in same store revenues of $4.0 million, which is due to a combination of lower volumes and lower average revenue per sleep study compared to 2008.  Revenue in our existing sleep therapy business was flat in 2009 compared to 2008 as lower sleep study volumes translated to fewer CPAP set-ups in 2009.  The reduced set-up volume was offset by the successful growth of our PRSP or re-supply business which we instituted in 2009.  Gross margin for the Company's SMS segment was 56%, compared to 62% in 2008; the decrease driven primarily by the lower average net revenue per sleep study in 2009.  2009 net loss for SMS was ($4.0 million) compared to net income of $1.9 million for 2008.  The onetime adjustment related to the change in accounting estimate of $2.6 million was recorded in our SMS segment.

The increase in revenue for the ApothecaryRx segment was primarily due to the full year impact of pharmacies acquired in March and June of 2008, partially offset by a slight decline in same store revenues driven by the continued shift towards generic drugs, which have a lower revenue per script compared to brand, and a decline in front-end sales, which we attribute to the continued softness in the general economy driving lower discretionary purchases.  Gross margin for the ApothecaryRx segment was 24% in both 2009 and 2008.  2009 net income for ApothecaryRx increased 126% to $2.0 million compared to $0.9 million in 2008.  The $0.4 million onetime favorable legal settlement net of legal fees was in this segment.  During 2009, Graymark Healthcare owned and operated 18 retail pharmacies in five states.  

Graymark Healthcare, Inc. is a diversified medical holding company that owns and operates diagnostic sleep centers that treat a wide range of sleep disorders; independent pharmacies that serve the needs of local markets; and a medical equipment company that provides both disposable and durable medical equipment.  Graymark plans to continue its growth both internally and through strategic acquisitions within the medical industry.

Sereno, The Center for Snoring Solutions, Educates the Public During National Sleep Awareness Week(R)-

Introduced by the National Sleep Foundation (NSF) to educate the public about the importance of sleep to both health and lifestyle, National Sleep Awareness Week® is March 7-13, 2010.  

One very common, but major detriment to adequate, high quality sleep is snoring.  NSF research suggests that:

• Approximately 90 million Americans suffer from snoring
• 23% of couples sleep apart because of snoring
• A substantial percentage of couples are too tired or fatigued for a normal sex life

Historically, snoring has been considered an inconvenience rather than a serious medical condition. That perception is rapidly changing. The effects of sleep loss caused by snoring include fatigue, lack of focus and productivity.  But more importantly, research now indicates a strong link between loss of sleep and medical conditions such as stroke, heart attack, diabetes and hypertension.  Snoring can also have a significant lifestyle impact on couples, and can be a cause of tension or resentment in a marriage or relationship.

SERENO, THE CENTER FOR SNORING SOLUTIONS, a new medical practice based in San Francisco, offers leading-edge, medically proven treatments for snoring in a confidential, professional environment.  

Dr. Matthew Mingrone, medical director of Sereno and a board-certified Otolaryngologist, is a specialist in the treatment of snoring and sleep apnea.  According to Dr. Mingrone, "Snoring treatments now available are safe, minimally invasive, simple, and potentially life-changing.   Sereno is ground-breaking in its unique, patient-centered, and highly effective approach to improving the lives of snorers.  We understand and treat this area of medicine specifically, and far more comprehensively than would be undertaken by a traditional medical practice.   Sereno is the premier practice in the United States dedicated entirely to the treatment of snoring and mild to moderate sleep apnea."

A recent Sereno patient had the following to say about his treatment, "The level of excellence from pre-patient to post-patient care to results far exceeded my cautious optimism.  Last night was the first time since childhood that I didn't snore during a night's sleep.   I, along with my father, underwent the minimally invasive procedure to reduce/cure snoring. Our significant others, the true beneficiaries, have been thrilled with the results. Clearly, I'm a believer and so is my father. We recommend this procedure for all our fellow snorers."

Dr. Matthew Mingrone has extensive experience treating snoring and obstructive sleep apnea and has worked with hundreds of patients whose snoring has had an impact on their marriages, relationships, work, quality of life, and general health.  Using FDA-approved, minimally invasive procedures, which are virtually painless, Dr. Mingrone makes a positive difference in the lives of his patients.  "We recognize the other health issues associated with lack of sleep caused by snoring.  While each patient needs to be individually evaluated, we can make a substantial improvement to the condition in most people. Two things are certain: Snoring is nothing to be ashamed of.  And snoring is definitely not funny."

Visit www.serenocenter.com to learn more.

Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) announced today an update on its plans to seek U.S. Food and Drug Administration (FDA) approval of Intermezzo® (zolpidem tartrate sublingual tablet) for use as-needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep.  Transcept met with the FDA on January 20, 2010 to discuss the Complete Response Letter (CRL) dated October 28, 2009, and received the official FDA minutes of this meeting on February 19, 2010.  Subsequent to the meeting, Transcept submitted a revised proposal for the resubmission of the Intermezzo® New Drug Application (NDA) to the FDA for evaluation and comment.

October 28, 2009 Complete Response Letter

As previously announced, the FDA stated in the CRL that it believes Transcept has submitted substantial evidence of effectiveness for the use of Intermezzo® in the as-needed treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep.  However, the FDA indicated that the intended use of Intermezzo® in the middle of the night represents a unique insomnia indication and dosing strategy for which safety has not been previously established, and that the Intermezzo® NDA could not be approved in its present form.

The FDA further recognized that the Intermezzo® data submitted by Transcept did not indicate next day residual effects significantly different from placebo.  However, the FDA requested additional data demonstrating that Intermezzo®, when taken as directed in the middle of the night, would not present an unacceptable risk of residual effects, with particular reference to next day driving ability.  

The FDA expressed two concerns regarding the possibility of patient dosing errors in the middle of the night that could lead to next day residual effects, with particular reference to next day driving ability.  Specifically, the FDA asked Transcept to address methods to avoid inadvertent dosing with less than four hours of bedtime remaining and inadvertent re-dosing in a single night.  

Redesigned Packaging and Patient Instructions

In the briefing document submitted prior to the January 20, 2010 meeting, Transcept proposed a new Intermezzo® bedside unit-dose package and patient instructions designed to reduce the possibility of patient dosing errors.  In the meeting minutes, the FDA indicated that the revised packaging appeared to reduce the potential for inadvertently taking more than one dose in a single night.  However, the FDA expressed a remaining concern that the revised packaging may not adequately address the risk of dosing with less than four hours of time remaining in bed, with particular regard to the possibility of impaired driving.

Transcept and the FDA also reviewed the types of data that could support the evaluation of the proposed packaging and instructions, including data from pre-approval assessments of patient understanding of dosing instructions and a potential patient use study of the new Intermezzo® packaging.  As requested by the FDA, Transcept has provided information on the challenges and limitations of pre-approval patient use studies, and has submitted a plan to assess and optimize patient understanding of the new packaging and patient instructions.

Intermezzo® Safety Profile Characterization

To further understand the safety of dosing Intermezzo® in the middle of the night, Transcept has proposed to the FDA to conduct a pre-approval highway driving study to assess the effect of Intermezzo® on driving ability beginning at approximately three hours and four hours post-dosing.  Transcept has also submitted additional supportive analyses of data from a previously conducted Intermezzo® pharmacokinetic and pharmacodynamic study at time points up to four hours post-dosing.  Results from this study were published in a 2008 article titled "Daytime pharmacodynamic and pharmacokinetic evaluation of low-dose sublingual transmucosal zolpidem hemitartrate" in the journal Human Psychopharmacology, an abstract of which is publicly available at www.interscience.wiley.com.

FDA Review of Transcept Post-Meeting Proposals

In the meeting on January 20, 2010, the FDA agreed to review the revised proposal for the Intermezzo® NDA resubmission and consider its adequacy to support the potential approval of Intermezzo®.  The FDA has not set a date for the completion of its review of this proposal or the timing of its response to Transcept.  Transcept plans to provide an update on the Intermezzo® development program, as appropriate, after it receives the results of the FDA's review of the revised proposal.  

Glenn A. Oclassen, President and Chief Executive Officer of Transcept, commented, "We are encouraged by the progress made in our recent interactions with the FDA, and appreciate the FDA's willingness to engage in a collaborative dialogue in order to help define the steps necessary for us to resubmit the Intermezzo® NDA."

Transcept Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of proprietary products that address important therapeutic needs in neuroscience. The most advanced Transcept product candidate is Intermezzo® (zolpidem tartrate sublingual tablet), for which a New Drug Application (NDA) was submitted to the U.S. Food and Drug Administration (FDA) in September 2008 seeking approval as a prescription sleep aid for use in the middle of the night at the time a patient awakens and has difficulty returning to sleep. In October 2009, Transcept received a Complete Response Letter from the FDA on the Intermezzo® NDA and is working to respond to issues raised in the letter. Transcept and Purdue Pharmaceutical Products, L.P. have entered into a collaboration agreement for the development and commercialization of Intermezzo® in the United States. For further information, please visit the company's website at: www.transcept.com.