Undoubtedly, one of the leading suppliers of obstructive sleep apnea (OSA) oral appliance therapy (OAT) devices in the world is SomnoMed out of Australia. In 2007, SomnoMed began to emerge from Australia to conquer the rest of the dental sleep world with their “patented” OAT, SomnoDent MAS.

As far back as July 31, 2004, the Sydney-based SomnoMed owned the rights to an oral device to treat snoring and obstructive sleep apnea.  The original Australian patent (“Inventor” – Richard George Palmisano, filed on 7/6/1999) was an upper and lower “winged” appliance without adjustment screws. This appliance was already known in the USA as the Nor-Snor.  The original “winged” appliance was develop in the 1980’s by Dr. Darek A. Nordstrom.  Patents granted in other countries do not necessarily take into account other people’s ideas and discoveries from around the world, especially in the pre-internet boom 1990’s.

Darek A. Nordstrom DDS is also the inventor of the A.L.F. appliance. Dr. Nordstrom graduated from BYU and USC Dental School and has presented courses in orthodontics and dental sleep medicine techniques since the 1980’s around the world (including Australia).  Working in conjunction with cranial osteopaths, he developed the A.L.F. and the Nor-Snor dental sleep appliance.  Dr. Nordstrom never applied for a US Patent for the Nor-Snor appliance because he was only interested in sharing his knowledge and teaching other practitioners how to treat patients with breathing disorders.

The Nor-Snor design uses upper and lower wings angle to prevent the lower jaw from dropping back during deep sleep which is exactly what the SomnoMed Australian patent claims.  So, SomnoMed does and does not have a US Patent.  Yes, SomnoMed has a US patent (6,604,527) for the dual winged device in the United States, but this design is not the same design that they fabricate today as the SomnoDent MAS.  The device that is fabricated by SomnoMedDynaFlex and Murdock Laboratory consists of a single lower winged design along with an upper buccal advancement acrylic block and screw for titration.  This design does not have a US patent and can be made by anyone in the dental field.  However, SomnoMed’s second Australian patent (2005201456) is a direct “knock-off” of the North American Nor-Snor 2 design and is a wonder how it was ever approved in the first place down under in 2005.  You would think that a quick internet search would have told the Australian investigators it was not an original idea of the person(s) filing the application.  I wonder if I could get an Australian patent on a wheel borrow?  But I digress.

In 2007, SomnoMed launched a 12 million dollar campaign to commercialized their “patented” OSA/OAT around the world, including the USA, underwritten by EG Capital.  SomnoMed had 74.9 million shares of stock issued and the device’s “inventor”, Richard Palmisano, held 30.9 million of them.

 

American dental labs that currently manufacture this product for the US market are:

  • SomnoMed’s SomnoDent MAS – The only difference in it’s design and the others is that it has a shorter 5mm adjustment screw.  In 2007, they expected to produce 5000 units a year and to sell them for between $390 and $490 each. Currently, the Flex model is $575 and the Classic is $525.
  • DynaFlex’s Dorsal– DynaFlex currently offers 8 different FDA approved OSA/OAT devices. The Dorsal device is $349 and includes free digital model storage, free 3D acrylic models and a free AM Aligner for morning wear.  It has a 7mm adjustment screw.  They also accept iTero OrthoCAD scans with a mailed in bite.  This is an excellent way to keep a permanent record of the patient’s occlusion.
  • Murdock Laboratory’s Nor-Snor 2 – It is the original design that is identical to the one patented in Australia and currently sells for around $283.50 plus $18.50 to mount it on an Accu-Liner articulator.  The differences between it and the others is in the angle of the wings and they use vacuum-formed material for the base rather than cold-cured acrylic.
I attended the 2012 Orlando meeting of the AADSM and spoke with both the Somnomed and DynalFlex representatives who were showing identical products and asked them to tell me the differences in their products.  The Somnomed representative said that they give a 3 year warrantee and their competitor only a one year.  When confronted with this the DynaFlex rep quickly counter that he would be glad to give a an additional two year warrantee for the additional $200 dollars it would cost to purchase from someone else (Somnomed), but that the appliance didn’t break that often nor cost that much to repair and would be a waste of money.
In the rapidly growing world of Sleep Dentistry the cost of doing business is a very important factor when deciding which appliance to use in your practice.  Current reimbursements for sleep appliances by insurance companies are going down, down, down and in some instances are below the cost of the appliance itself.  For example, Anthem (Blue Cross/Blue Shield) reimburses doctors for an OAT only $510.  At that rate, if you were to provide your patient with a Somnodent MAS, you would have to pay the the patient to make the appliance for them!  United Health currently reimburses at $1050 and Medicare is believed to settle somewhere around $1290.  Of course, you can always make your patient’s pay the difference.

References:

1.  Sleep Med. 2012 Mar;13(3):314-6. Epub 2012 Jan 18. Effects of vertical opening on pharyngeal dimensions in patients with obstructive sleep apnea. Vroegop AVVanderveken OMVan de Heyning PHBraem MJ Department of ENT, Head and Neck Surgery, Antwerp University Hospital, University of Antwerp, Antwerp, Belgium.

2.  ISRN Dent. 2011;2011:581692. Epub 2011 Jun 9. Comparison of titratable oral appliance and mandibular advancement splint in the treatment of patients with obstructive sleep apnea. Sari EMenillo S. Kasimpasa Military Hospital, Istanbul, Turkey.