About our project

The problem we solve: Untreated Sleep Apnea and chronic snoring can: Increase the risk of High Blood Pressure, Heart Attack , Stroke, Obesity, Diabetes, Atrial Fibrillation, Motor Vehicles Accidents, Join Arthroplasty, Metabolic Syndrome, Gastroenterology, Hepatology, Parkinson's Disease Alzheimer's disease.

About our solution: The PIVOT SOLUTION™ is an acrylic oral device featuring a tongue depressor that pivots to allow occasional swallowing at night. The tongue depressor returns to its position and retains the tongue forward preventing it from falling to the back of the throat. Hence, allowing the wearer to breath freely with an open and clear airway without waking. Obstructive Sleep Apnea (OSA) and snoring are a serious, potentially life-threatening conditions and caused by the repetitive collapse of the upper airway during sleep, resulting in either partial or complete airflow obstruction. PIVOT SOLUTION was designed to treat the more serious condition of Sleep Apnea, (OSA), as well as snoring. It is a one piece simple acrylic retainer with a soft inner surface that comfortably engages the upper and lower teeth in the wears mouth and natural bite position. It does not project the lower jaw forward.

About Our Company

How We Help Patients

PIVOT SOLUTION™ provides a new and effective SOLUTION for treating Obstructive Sleep Apnea, (OSA) AND CHRONIC SNORING.  This oral device does not require surgery nor does it tether the wearer to an obtrusive and unattractive face mask.  PIVOT SOLUTION™ can be worn comfortably by the wearer for the entire night.  Once commercialized, it is our intension to institute a program for people who are on low fixed income, disabled or living close to the poverty level to be able to have access to PIVOT SOLUTION™ at a price they can qualify for and afford.  Everyone has the human right to better health.

PIVOT SOLUTION™ does not trigger the gag reflex because it never touches any part of the throat. The tongue retaining mechanism is mounted on a pivot, allowing the wearer to swallow during the night and return to its stationary position keeping the air way open without waking the patient.  This is a big advantage over other tongue retaining devices.

PIVOT SOLUTION™ does not project the jaw forward, eliminating the associated joint pain common to such devices.

The advantages of PIVOT SOLUTION™, a simple oral retainer over invasive surgery, & being tethered to a machine and mask, (CPAP) are obvious.

How We Help Physicians

Show the world you care about this problem and want it solved.  In return we will do our best to solve it and know we are doing it for you.  Here and on our website, in perpetuity, we will list you and your practice as INSTITUTIONAL SPONSORS with our sincere thanks.

How We Help Hospitals

Show the world you care about this problem and want it solved.  In return we will do our best to solve it and know we are doing it for you.  Here and on our website, in perpetuity, we will list you and your practice as INSTITUTIONAL SPONSORS with our sincere thanks.

How We Help Partners

FOR PARTNERS OR INVESTORS: We will come to you anywhere in southern California to talk about this project, our plans, and how we might collaborate.  For non-local partners we can set up a teleconference.  Additionally, here and on our website, we will list you or your firm as FOUNDING SPONSORS.

Innovation Details

Intellectual Property Summary

I filed for a utility patent on September 23, 2010, was denied and appealed it.  I was granted the utility patent US 8,302,609 B2, (Secretary of State # 201319710105), on November 6, 2012 with protection in the U.S.A. only.   I assigned the patent to Lubin Martinez, LLC, dba Pivot Solution on April 30, 2015.  I will file additional patents to incorporate the new mechanical mechanism design, when they are completed, that will include international protection.

Patent Link
http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=8302609.PN.&OS=PN/8302609&RS=PN/8302609

Clinical Information

1.     We believe that the Pivot SolutionTM will prove to be more effective than the mandibular advancement devices because it directly retains the tongue from collapsing against the back of the throat.  Early results look very promising.

Table 1:  Overnight sleep study results using the Pivot SolutionTM

Table 2:  Clinical Results of COMPETITOR Mandibular Advancement Devices

2.     Currently, mandibular advancement devices are only approved for mild to moderate OSA.   We believe the Pivot SolutionTM will prove to be effective for severe OSA.  This will allow the device to compete with CPAP.

3.     The tongue retaining mechanism is mounted on a pivot which allows the user to swallow during the night.  This is a big advantage over other tongue retaining devices.

4.     The Pivot SolutionTM respects the natural position of the jaw so it is comfortable and does not cause joint pain.  The lower jaw is not projected forward eliminating problems encountered by projecting the lower jaw forward over night.

[i] Marijke Dieltjens, M.B.S. et al, “Prevalence and Clinical Signifi cance of Supine-Dependent Obstructive Sleep Apnea in Patients Using Oral Appliance Therapy” Journal of Clinical Sleep Medicine, Vol. 10, No. 9, 2014

[ii] Michael Friedman, MD; et al, “Mandibular Advancement for Obstructive Sleep Apnea Relating Outcomes to Anatomy”, JAMA Otolaryngol Head Neck Surg. 2014;140(1):46-51. doi:10.1001/jamaoto.2013.5746 Published online November 21, 2013

Regulatory Status

Regulatory Strategy

·         Prescription oral appliance for the treatment of OSA

·         IRB process for clinical studies

·         510k pathway for commercialization

Since there are over 100 oral appliances approved by the FDA the risk of 510k pathway is minimal.  There are several oral appliances which specifically target retaining the tongue.  These appliances will be sited as the predicate devices.

How we will use the funds raised

Marketing / Financials

·         The Pivot SolutionTM device will be sold through dentist offices, ENT doctors, pulmonologists, and other doctors specializing in sleep disorders.  Clinical studies and initial product launch will be done in the US only.  Commercialization outside US will be phased in after product launch.  We are in the process of considering reimbursement with Medicare and health insurance providers.  A financial analysis under these circumstances is pending.  After product launch, we would like to institute a reduced cost program for low / fixed income individuals.

Table 3:  Financial Analysis

*Consultations with a leading Prosthetic & Oncology Dentist indicate that he charges around $4,000 for mandibular advancement devices he prescribes.  He suggested once design improvements to our appliance are implemented he would be interested in coming on board our team of Experts, saying, “You have a premium device . . . . people will line up to pay $6,000.00 for it”

Thank You

Studies have shown that Untreated Sleep Apnea, (OSA), can: Increase the risk of High Blood Pressure, Heart Attack, Stroke, Obesity, Diabetes, Atrial Fibrillation, Motor Vehicles Accidents, Join Arthroplasty, Metabolic Syndrome, Gastroenterology, Hepatology, Parkinson's disease, Alzheimer's disease.

Sleep studies have proven the remarkable effectiveness of The Pivot Solution in the oxygenation to the brain- almost twice as much as the leading mandibular advancement devices.  I want help make a positive impact on the health and lives of people millions of people who suffer from these health risks.  I believe in this product and I want to share this innovative solution with the world.   

Believe in it with me and make a tax deductible contribution, so you and I can share in the satisfaction of having effected the health and the lives of millions of people here in the USA.  Then, the world. 

Supporters

• 
  Ephraim Zagelbaum, Master’s Degree in Business Administration from Seton Hall University
  10/06/2017 - Followed the project.
• 
  Ephraim Zagelbaum, Master’s Degree in Business Administration from Seton Hall University
  10/06/2017 - Liked the project.
• 
  Mr. Alex Fair, MS
  10/20/2016 - Liked the project.

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