Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
you clearly do not come from a scientific background....the pressure can easily be manipulated by a variety of components between the CPAP machine and a humans lungs....
Complete hogwash. The mask is just an interface between the CPAP machine and the airway, and there is no mask/interface that will change the pressure that is required to keep the airway open. Think of the airway as a balloon, pressure holds it open, and that pressure will be the same regardless of what you use at its nozzle to get the air in.
lol i dont have OSA, just insanely bad year round allergies that severely limit my ability to breath freely so i am usually breathing through my mouth...i go for weekly shots, hopefully biweekly soon....its a pain in the ass getting stuck in each shoulder once a week and the nurses are so hit or miss, some i hardly feel and others jab you right in the muscle...
DeltaWave allowed me not to be a mouth breather! ????
i know your pain, hence my name haha! goodluck moving forward
I remember before I got the Deltawave and had covid the pressure mad me feel like I was being choked… my wife said I was awful to sleep in bed with
Allergies are still kicking my butt, but yes much better broke it multiple times back in college football and so for the last 10+ years I haven’t known what breathing normal has been like
TY Mouthbreather!
I had that surgery as well. Plus tonsilectomy and uvula removed as log shots of helping with the OSA. No joy. When the pressure is high I rip the mask off my face while I'm sleeping and wake up gasping for air like I was suffocating. The mask usually stays on for 45 minutes to 1.25 hours. I am wearing this mask all night on most nights. GLTU
bet you feel much better now though....my allergies are so bad its like having a deviated septum myself
I just recently had severe deviation correction surgery to help with my nose so for a few weeks i had to use full face one and pressure was around 10 using auto sense.
Yeh I got two with mine one smaller pillow and one larger pillow so technically two of them.
My resmed has auto pressure sense and I am at 5.0-6.5 range and hardly ever use any extra moisture even in winter
ASCENDING!!!!!!!..........
TRIANGLE!!!!!!!............
UNITE!!!!!!!!
happy to hear your positive review of the product, best of luck to you, your health and your financial health!!
Nice picture! I have two Deltawave masks the first one had a different angle on the elbow piece that connects the tube to the mask. Tom sent me the better angled one once he got the part produced. Did you lower you pressure? Mine went from 11-12 to 5.0-5.5. That helps me wear the the mask much longer than I have ever worn any other mask. This make me more compliant and my Sleep Dr was very happy about that. Good luck to you with your OSA and with RMSL!
I don’t pay for IHub so I don’t believe I can. Feel free to use my photo though if you can
thank you, can you post the pic here? i dont have ST
I posted a brand new photo taken this morning hooked up to my resmed airsense 11.
https://stocktwits.com/Tz3sports/message/463509189
I would be happy to post a brand new picture for you tomorrow morning hooked up to the actual machine.
Sample pics of the DeltaWave by pumpers claiming to have sleep apnea are always suspect. Funny that they never show a picture of the mask actually hooked up to a cpap machine.
Great. Could be Monday till the following week that we hear
correct, hoping they worked their kinks out
Not sure where you got that info from but that is how long uplisting to otcqb takes once application is accepted and fee paid
They said approximately 30 days FDA decision would be made. That puts it at June 6th. FDA gives themselves a 10 day window on decisions so it could happen as late as June 16th… either way it’s out of RMSLs hands and they like everybody else are simply waiting on FDA
30 days from may 6th
Wasn’t it two weeks ago they said 2 -4 weeks?
woooooooooooooooo!!!! waiting for some PR
Will explode with approval…
would love to see that, will make nice gains from such move
Will hit the skids hard with another delay.
Every day that passes we are one day closer. Loving the action on the stock in the meantime. Once we break .047, which finishes the handle of the cup and handle formation currently forming, should breakout nicely to the .06-.08+ area on news.
Won’t be long!!$$$$$$
lolzzzzzzzzzzz maybe like a month but still new
You are legit arguing with yourself… I stated the 510k application as in 1 application does not take longer then a year.
I’ve never stated that if FDA doesn’t pass it would take longer…
So again FDA decision on this particular application is due in June 6th with the 10 day FDA self imposed grace period…
Its not complex, i had to submit PMA for my companies IMD. I know precisely how it works, for a single device, it can take years for 510k approval, doesn't matter if it is one being submitted or several, its not like they're starting over. Took 7 years for our device to be PMA approved and now we have sales in 5 continents.
Not sure what you just said… this specific 510k application is at the end point.
A 510k application from start to finish does not take longer then a year and that’s with an extension granted.
If a device were to be denied and entirely new 510k application would need to be submitted.
It’s not complex.
exactly what i said, it can take longer than a year to have a device PMA, takes years of research and trials to get to that submission point, then they can come back with amendments etc, just because you think the 510k submission process starts over, it doesnt, its still all apart of the same device, so maybe you are confused
FDA decision getting closer and closer. Can't be more than a couple weeks away at this point.
If you claim to have been doing it for years you know that the fda 510k has set time limits. There is no scenario that a 510k takes longer then a year without needing to be refilled
CEO didn't file a PMA until 2021 which is why it's been seven years with no cleared 510k and the company diluted into the ground.
He didn't disclose he was trying to pass off the 2008 510k from the Laminair modified as the DeltaWave when any fool could see they look nothing alike and no way in hell passable with the FDA.
PMA is a much more in depth process. Shortcut and non-disclosure cost folks a lot of time and money.
Looks like a knock-off of Resmed's Airfit P10. Not exactly revolutionary.
The fact that their patent was initially rejected tells you the patent office didn't think it was all that original.
i know the process, i work for a cardiac device company and our device took 5 years to be approved through PMA, so, yes a 510k can take several years. Maybe RMSLs is different because of the information FDA was requesting but stay in your lane buddy because ive been doing this as my job for years and yearsssssssssss
Inventory of masks? First of this is a revolutionary design… second off the machines are the shortage not the masks…
Well actually the 510k cannot take several years. There is a well defined process and RMSL got an extension on the Additional Information request. Had there not been a lab error the AI response would have been submitted back to FDA in January and final approval would have been completed already.
They are at the point of pass or fail… if fail they will need to submit a new 510k application
a 510k submission can take multiple years, as many years as it needs to.
I heard from some other chats MMs will run this to .25-.50 running into FDA.
Whoever is forecasting that crap deserves to be ignored forever. This company has one mask they've been touting to sell stock for years and years, and even if the FDA were to approve it, it won't sell. One mask, all that anybody needs to do is look through the inventory of masks from real companies on CPAP.com or other online vendors to know that this has only been a stock sale.
Followers
|
312
|
Posters
|
|
Posts (Today)
|
0
|
Posts (Total)
|
31325
|
Created
|
11/14/08
|
Type
|
Free
|
Moderators |
REMSleep Holdings, Inc. is engaged in the business of developing and distributing sleep apnea products. The Company focuses on offering optimum compliance and comfort for continuous positive airway pressure (CPAP) patients. Its DeltaWave CPAP interface (the DeltaWave) is a device to treat patients with sleep apnea. Its DeltaWave product is a nasal-pillows type interface that is designed with airflow characteristics to enable patients with sleep apnea to breathe normally. Its product is manufactured by mold makers. Its target market includes home care dealers, private sleep labs, product end users, sleep physicians, medical groups, sleep product distributors, hospitals, medical associations, such as the American academy of sleep medicine and the American sleep association. REMSleep LLC is its wholly owned subsidiary.
INDUSTRY
Medical Equipment & Supplies
CONTACT INFO
2202 N. WEST SHORE BLVD SUITE 200
TAMPA, FL
33607
United States
+1.912.5902001
https://www.remsleep.com/EXECUTIVE LEADERSHIP
Russell Finlay Bird
Chairman of the Board
Thomas J. Wood
Chief Executive Officer, Director
Jonathan B Lane
Chief Technology Officer, Vice President
https://www.fundable.com/remsleep
Share Structure
Volume | |
Day Range: | |
Bid Price | |
Ask Price | |
Last Trade Time: |