RESMED INC ANNOUNCES ENTRANCE INTO ORAL APPLIANCE THERAPY. IS CPAP STILL THE GOLD STANDARD FOR APNEA TREATMENT?

Michael Farrell is the global head of ResMed’s Sleep Business Unit. As a Senior Vice President of the second largest maker of CPAP his October 1,2009 announcement that it had acquired Laboratoires Narval (“Narval”) in Lyon. Narval is the French manufacturer and distributer of oral appliances for the treatment of sleep
Disordered breathing. Laboratoires Narval primarily sells its products in France but has had booths at dental meetings in the United States.

ResMed’s offering of the Narval MAS (mandibular advancement splint) as an alternative treatment to CPAP for patients who reject the use of CPAP machines or who are non-compliant is a brilliant tactical move. Oral Appliance therapy has seen explosive growth in recent years. Historically only 23-45% of patients tolerated CPAP use and the latest study showed that 60% of patients abandon their CPAP. For many years patients were not aware that there were other treatments available. In the February 2006 issue of Sleep guidelines were set up for the parameters of care with oral appliance therapy in lieu of CPAP. Oral appliances are now considered a first-line treatment for mild to moderate sleep apnea along with CPAP and as an Alternative to CPAP for severe apnea when patients do not tolerate CPAP. Dr Ira L Shapira, a pioneer of Dental Sleep Medicine has been promoting oral appliance therapy as a comfortable alternative to CPAP thru his I HATE CPAP! Website (http://www.ihatecpap.com). The website has seen incredible growth with close to 10,000 monthly visitors seeking comfortable alternatives to CPAP.

Dentists from across the country have joined I HATE CPAP LLC to promote the practice of Dental Sleep Medicine. Sleep physicians diagnose Sleep Apnea, and it is important that physicians evaluate the all patients with expertise in sleep medicine. “Dentists should not be diagnosing and/or treating sleep apnea without physician involvement” according to I HATE CPAP fonder Dr Ira L Shapira a Diplomate of the American Board of Dental Sleep Medicine. Dr Shapira practices general dentistry and dental sleep medicine in his Gurnee office, Delany Dental Care.

In the press release from Resmed the company talked about oral appliances for treatment of mild sleep apnea. The American Academy of Sleep Medicine actually considers oral appliances a first line treatment of mild and moderate sleep apnea along with CPAP. Oral appliances are also considered an alternative treatment for severe apnea when patients do not tolerate CPAP. A study posted on the website of the American Academy of Dental Sleep Medicine discusses the success of oral appliances in treating Severe Sleep Apnea. Patients who use CPAP average only 4-5 hours of nightly use not the recommended 7 1/2- 8 hours per night. Patients utilizing Oral Appliance therapy are much more compliant and Dr Shapira believes that in the near future oral appliances will be considered the Gold Standard for mild to moderate sleep apnea and CPAP will be used primarily for severe apnea and for patients who do not tolerate oral appliances. Studies have shown that most patients prefer oral appliances to CPAP when offered a choice. The real advantage to oral appliances over CPAP is the high compliance rates compared to the dismal long-term compliance with CPAP.

Somnomed manufactures the Somnodent Appliance and is one of the major players in Dental Sleep Medicine. The company was pleased with the Resmed announcement. Ralf Barschow, CEO of SomnoMed said, “The acquisition of Laboratoires Narval by ResMed is very positive news for SomnoMed. We are expecting that ResMed’s endorsement of oral appliance therapy will accelerate the growth in dental sleep medicine worldwide. It will, without doubt, raise the awareness that oral appliances are an excellent alternative therapy for sleep disordered breathing, in fact that for many patients it should be the first line treatment. We are hoping that ResMed will join SomnoMed’s global efforts
in education and research, especially through our recently founded SomnoMed Academy.”

The website http://www.ihatecpap.com is one of the leading reasons for the explosion in Dental Sleep Medicine in the United States. Thousands and thousands of unique visitors go to the site every single month to learn more about the dangers of sleep apnea and about comfortable oral appliances to treat sleep Apnea. Dr Ira Shapira founded I HATE CPAP LLC and stresses that he does not HATE CPAP. “CPAP is currently the Gold Standard of treatment” according to Dr Shapira, “but unfortunately the majority of patients prescribed CPAP abandon its use. Historically only 23-45% of patients continue CPAP use and the most recent study showed that 60% of patients abandon the use of CPAP.” An interesting fact is that about 25% of CPAP users love their CPAP from the first day and rarely if ever experience problems or discontinue use. Typically these patients know from the very first day that they love their CPAP machines.”

ResMed advised that it would initially concentrate on marketing the Narval device in its core market, France before expanding into other European markets. A copy of the press release from Resmed is reproduced at the bottom of this posting. ResMed is considered one of the most important companies in sleep medicine worldwide.

Respironics the other leading company in sleep medicine already has an oral appliance that it is promoting thru its professional marketing team. Fisher-Paykel has seen some of its top sales team leave to join Airway Management the maker of the TAP (Thorton Anterior Positioner) Appliance. Dr Keith Thorton the inventor of the TAP appliance who is leading the way in combination therapy utilizing oral appliances and CPAP to increase comfort and decrease CPAP pressures in severe apneic patients founded airway Management.

Dr Shapira teaches a course in Dental Sleep Medicine limited to small groups for a more intensive learning experience. The dentists who take his course have access to his expertise as they develop their diagnostic and treatment skills. His next course will be held on November 13-14. Dr Alexander Golbin of Sleep and Behavioral Medicine Institute gives the participants an introduction into more complex sleep issues and an orientation into how a sleep lab functions. The course participants spend approximately three hours at his Vernon Hills Sleep Lab and research facility on the first evening.

Dr Shapira is the founder of Chicagoland Dental Sleep Medicine Associates and offers snoring treatment and treatment of obstructive sleep apnea in the five offices. Patients wishing to see Dr Shapira can contact him toll free at 1-8-NO-PAP-MASK or thru his websites http://delanydentalcare.com : http://www.chicagoland.ihatecpap.com/
Dr Shapira has recently created a new website http://www.ihateheadaches.org that explains the connections between headaches, TMJ, TMD and Neuromuscular Dentistry. The NHLBI (National Heart Lung and Blood Institute) report on “Cardiovascular and Sleep Related Consequences of Temporomandibular Disorders” can be found at:
http://www.nhlbi.nih.gov/meetings/workshops/tmj_wksp.pdf Additional stories of interest in Sleep and Health Journal include :
SUFFER NO MORE: DEALING WITH THE GREAT IMPOSTER
http://www.sleepandhealth.com/story/suffer-no-more-dealing-great-impostor

Oral Appliances vrs CPAP, Shapira
ORAL APPLIANCES VS CPAP – Good news for patients who say “I Hate CPAP”
http://www.sleepandhealth.com/oral-appliances-vrs-cpap-shapira

SLEEP APNEA TREATMENT: ARE DENTAL APPLIANCES MORE SUCCESSFUL THAN SURGERY?
http://www.sleepandhealth.com/story/sleep-apnea-treatment-are-dental-appliances-more-successful-surgery

NEUROMUSCULAR DENTISTRY (originally published in the American Equilibration Society magazine)
http://www.sleepandhealth.com/neuromuscular-dentistry

Press Release
” Acquires Laboratoires Narval
Expands Current Therapy Range and Patient Reach through Acquisition
SAN DIEGO, Oct. 5 /PRNewswire-FirstCall/ — ResMed Inc. (NYSE: RMD), a leading developer, manufacturer and distributor of sleep and respiratory medical equipment, announced today that it has acquired Laboratoires Narval. Based in France, Laboratoires Narval manufactures and distributes the Narval O.R.M.(TM), an innovative mandibular repositioning device (MRD) that offers a solution to patients for snoring and obstructive sleep apnea (OSA), especially for those with mild OSA. With this acquisition, ResMed adds another therapy to supplement its existing positive airway pressure-based solutions, providing a broader offering for this patient group. ResMed plans to commercialize this device in selected European markets.

“Obstructive sleep apnea is a serious disease that, left untreated, can have significant long-term impacts on the cardiovascular system, as well as impacts on other serious and chronic health issues,” said Michael Farrell, Senior Vice President of the Sleep Business Unit, ResMed. “The gold-standard therapy for obstructive sleep apnea is continuous positive airway pressure (CPAP) therapy. ResMed will now be able to provide an alternative solution for patients with mild obstructive sleep apnea as well as those with snoring. In addition, in France, there is reimbursement for MRD use as a second line treatment for severe OSA for those who are non-compliant on or refuse CPAP. We have found a good match in Narval as we both strive for clinical excellence and quality therapy solutions through market-leading innovation, education and service.”

The Narval O.R.M. device is an effective and clinically proven mandibular repositioning device with unique features such as a patented articulation to ensure a physiological position of the temporomandibular joint (TMJ) at night, developed with unique computer-aided design software that optimizes the design for each patient, and a scalable computer-aided manufacturing process (CAD/CAM).

“As part of ResMed, we are excited to further broaden the use of our novel and clinically proven O.R.M. device and to further develop our leading CAD/CAM technology,” said Fabrice Paublant, Chief Executive Officer, Laboratoires Narval. “The team at Narval looks forward to working closely with ResMed to expand the marketing and distribution for our technology within Europe.”

Sleep apnea is the most common sleep disorder, yet it remains vastly undiagnosed. Sleep apnea is closely linked with diabetes, obesity, high blood pressure, heart failure and stroke. In obstructive sleep apnea, breathing is interrupted by a physical block to airflow, despite the effort to breathe. Obstructive sleep apnea is a very common disease that affects millions of people worldwide. Recent clinical studies have concluded that left untreated, sleep apnea can increase the risk of dying early by as much as 46%.*

About ResMed

ResMed is a leading developer, manufacturer, and distributor of medical equipment for treating, diagnosing, and managing sleep-disordered breathing and other respiratory disorders. We are dedicated to developing innovative products to improve the lives of those who suffer from these conditions and to increasing awareness among patients and healthcare professionals of the potentially serious health consequences of untreated sleep-disordered breathing. For more information on ResMed, visit www.resmed.com

About Laboratoires Narval

Laboratoires Narval’s mission is to provide innovative therapeutic solutions to treat respiratory sleep disorders. Laboratoires Narval is a French company based in Lyon, created by Ludovic Baratier, the inventor of the O.R.M. device, Laurent Viviani, and Fabrice Paublant and backed by Aurinvest and S.H.A.M. investors. For more information on Laboratoires Narval, please visit www.laboratoiresnarval.com

Statements contained in this release that are not historical facts are “forward-looking” statements as contemplated by the Private Securities Litigation Reform Act of 1995. These forward-looking statements, including statements regarding the Company’s future revenue, earnings or expenses, new product development and new markets for the Company’s products, are subject to risks and uncertainties, which could cause actual results to materially differ from those projected or implied in the forward-looking statements. Those risks and uncertainties are discussed in the Company’s Annual Report on Form 10-K for its most recent fiscal year and in other reports the Company files with the U.S. Securities & Exchange Commission. Those reports are available on the Company’s Web site.

*Sleep-Disordered Breathing and Mortality: A Prospective Cohort Study. Naresh M. Punjabi et al. PLoS Medicine. August 2009/ Volume 6/ Issue 8/ e1000132

SOURCE ResMed Inc.

Global Investor Relations and US/Australian Media, Constance Bienfait of ResMed Inc., San Diego, +1-858-836-5971, or
European Media, Anne Reiser of ResMed France, +33 426100 268″