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ResMed Gets Into Oral Appliances!?
ResMed is now in the Oral Appliances business + CPAP:
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
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
Views: 273
Replies to This Discussion
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Permalink Reply by Linda Brown on
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I'd like to know if this will be marketed in the US any time soon. I'd love to know more about the costs. I went to the Narval site, but unfortunately I don't speak French. Saw the pictures though. This might work for me since my OSA is not severe. I've used a ResMed CPAP for a year now, and it has really helped me. I'm very compliant, and last weekend was able to sleep in a motel room with my daughter and 3 grandchildren. They said I was quiet all night. That's really a relief to me.
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Permalink Reply by Vicki E Jones on
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Mike -
Great information! I have a retrognathic jaw (jaw too far in, receding chin) and a big tongue and can only sleep on my back. This problem is causing much of my obstructive sleep apnea (or most of it). Have to look into getting a deviated septum fixed, too. I wear an oral appliance, but this one looks better.
So - a few questions:
1. How do I get one of the O.R.M. appliance?
2. From whom do I get it?
3. Will insurance pay for it - if I prove medical necessity and get it pre-approved?
4. Any research trials or clinical trials of this appliance that I could get in on? That would mean a free appliance. No co-pay even. No insurance disapproval and getting stuck with the bill.
?????Would appreciate any information.
Thank you.
Vicki in Illinois
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Permalink Reply by Mike on
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Honestly, I don't know the answers to any of your excellent questions. That said, this is such a new development, not sure anyone here will know the answer. Vicki, here's an idea: how would you feel about calling ResMed's number - 1 (800) 424-0737 (toll free) - and tracking down the answers directly from the source, and report back to us on what you find? I'm sure many others are asking/ should be asking the same questions, and would benefit greatly from your efforts.
Vicki E Jones said:Mike -
Great information! I have a retrognathic jaw (jaw too far in, receding chin) and a big tongue and can only sleep on my back. This problem is causing much of my obstructive sleep apnea (or most of it). Have to look into getting a deviated septum fixed, too. I wear an oral appliance, but this one looks better.
So - a few questions:
1. How do I get one of the O.R.M. appliance?
2. From whom do I get it?
3. Will insurance pay for it - if I prove medical necessity and get it pre-approved?
4. Any research trials or clinical trials of this appliance that I could get in on? That would mean a free appliance. No co-pay even. No insurance disapproval and getting stuck with the bill.
?????Would appreciate any information.
Thank you.
Vicki in Illinois
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Permalink Reply by Adrian Karl Zacher on
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Good Morning from France!
My name is Adrian Zacher and I am the Export Manager for Laboratoires Narval (ResMed). I will attempt to answer your questions. Please remember that this is a very recent development!
First of all - the www.laboratoiresnarval.com site IS available in English here: http://www.laboratoiresnarval.com/index.php?newlang=en
You will note that the press release clearly stated that the ORM device will be commercialised in 'selected EUROPEAN' markets. I cannot comment on plans to distribute to the US at this stage.
Please do get in touch on the toll free number that Mike kindly listed for the US - 1 (800) 424-0737
Best wishes,
Adrian Zacher
http://www.adrianzacher.com
Mike said:Honestly, I don't know the answers to any of your excellent questions. That said, this is such a new development, not sure anyone here will know the answer. Vicki, here's an idea: how would you feel about calling ResMed's number - 1 (800) 424-0737 (toll free) - and tracking down the answers directly from the source, and report back to us on what you find? I'm sure many others are asking/ should be asking the same questions, and would benefit greatly from your efforts.
Vicki E Jones said:Mike -
Great information! I have a retrognathic jaw (jaw too far in, receding chin) and a big tongue and can only sleep on my back. This problem is causing much of my obstructive sleep apnea (or most of it). Have to look into getting a deviated septum fixed, too. I wear an oral appliance, but this one looks better.
So - a few questions:
1. How do I get one of the O.R.M. appliance?
2. From whom do I get it?
3. Will insurance pay for it - if I prove medical necessity and get it pre-approved?
4. Any research trials or clinical trials of this appliance that I could get in on? That would mean a free appliance. No co-pay even. No insurance disapproval and getting stuck with the bill.
?????Would appreciate any information.
Thank you.
Vicki in Illinois
-
Permalink Reply by Banyon on
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Vicki E Jones said:........ I have a retrognathic jaw (jaw too far in, receding chin) and a big tongue and can only sleep on my back. ..........
Vicki in Illinois
Just curious about why you can only sleep on your back?
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Mike -
I emailed Laboratoires Narval in France.
They replied that there are no plans to market the O.R.M. in the USA.
Here is their reply:
"Dear Mrs. Jones,
Thank you, for your email. You are correct in that ResMed has acquired Laboratoires Narval.
However, at this stage I am sorry to disappoint you, as at present there are no plans to commercialise the ORM device in the USA.
Should this situation change I will contact you again.
Sincerely,
Adrian ZACHER
Export Manager
Laboratoires NARVAL S.A
m: +33 (0) 6 16 98 32 27
t: +33 (0) 4 78 69 22 02
f: +33 (0) 4 78 66 23 94"
Sigh. We could sure use this in the USA. I will definitely try it if it is ever marketed here.
Anyway, my contact will email me if they eventually decide to offer it here, and I will post that information to this list.
Have a good day, everyone!
Vicki in Illinois
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Vicky, wonder whether you caught that Monsieur Zacher responded himself, below.
Adrian Karl Zacher said:Good Morning from France!
My name is Adrian Zacher and I am the Export Manager for Laboratoires Narval (ResMed). I will attempt to answer your questions. Please remember that this is a very recent development!
First of all - the www.laboratoiresnarval.com site IS available in English here: http://www.laboratoiresnarval.com/index.php?newlang=en
You will note that the press release clearly stated that the ORM device will be commercialised in 'selected EUROPEAN' markets. I cannot comment on plans to distribute to the US at this stage.
Please do get in touch on the toll free number that Mike kindly listed for the US - 1 (800) 424-0737
Best wishes,
Adrian Zacher
http://www.adrianzacher.com
Mike said:Honestly, I don't know the answers to any of your excellent questions. That said, this is such a new development, not sure anyone here will know the answer. Vicki, here's an idea: how would you feel about calling ResMed's number - 1 (800) 424-0737 (toll free) - and tracking down the answers directly from the source, and report back to us on what you find? I'm sure many others are asking/ should be asking the same questions, and would benefit greatly from your efforts.
Vicki E Jones said:Mike -
Great information! I have a retrognathic jaw (jaw too far in, receding chin) and a big tongue and can only sleep on my back. This problem is causing much of my obstructive sleep apnea (or most of it). Have to look into getting a deviated septum fixed, too. I wear an oral appliance, but this one looks better.
So - a few questions:
1. How do I get one of the O.R.M. appliance?
2. From whom do I get it?
3. Will insurance pay for it - if I prove medical necessity and get it pre-approved?
4. Any research trials or clinical trials of this appliance that I could get in on? That would mean a free appliance. No co-pay even. No insurance disapproval and getting stuck with the bill.
?????Would appreciate any information.
Thank you.
Vicki in Illinois
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