PIVOT SOLUTION: PIVOT SOLUTION STARTUP

by Lubin Martinez

Pivot Solution is a medical device startup company in Orange County California that is developing an innovative oral appliance for treating patients with obstructive sleep apnea & chronic snoring.
Orange , CA United States MedStartr Ventures challenge

All Team Company Patients Physicians Hospital Partners Mission Innovation Details Supporters Comments Updates

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.

Progress to date:I have been using a working prototype since 2006. Currently, we are redesigning the tension mechanism to incorporate the features suggested by the doctors and dentists we have consulted with. Once this is achieved we will file updated patents to protect our proprietary rights in the U.S and internationally.

About Our Team

Creator: Lubin Martinez

Location: California

Bio: I was diagnosed with severe Obstructive Sleep Apnea, (OSA) and snoring in 1987. I began using CPAP back in 2003 and tolerated it for approximately 3 yrs. I underwent three surgical procedures to treat my OSA. I invented a simple oral device that has been tested and stops Sleep Apnea and Chronic Snoring better than any prescription oral appliance to date. I want to share this innovative solution with the world because Snoring alone has been linked to several known health risks.

Hospital Affiliation: None

Title: Founder

About Team Members

Bill Brunnett
Director of R&D, B.S. Mechanical Engineering
Biography: 25 yrs in product development, with 17 years in medical devices, taking design concepts to product completion in implantable and disposable medical devices, diagnostic equipment, and computer peripherals.
Title: Director of R&D
Advanced Degree(s): B.S. Mechanical Engineering
LinkedIn: https://www.linkedin.com/in/bill-brunnett-491209b

Roger Crumley
Expert Consultant, M.D., MBA,
Biography: Professor & Chair, Emeritus, Department of Otolaryngology-Head & Neck Surgery, U.C. Irvine School of Medicine, Consulting Physician
Title: Expert Consultant
Advanced Degree(s): M.D., MBA,
LinkedIn: https://www.linkedin.com/in/roger-crumley-2a69aa17

George, K. Shahinian
Consulting Physician, M.D., FCCP,
Biography: Diplomat: American Board of Sleep Medicine, American Board of Pulmonary Medicine, American Board of Critical Care, American Board of Internal Medicine, and Director of Saddleback Sleep Centers, Consulting Physician
Title: Consulting Physician
Advanced Degree(s): M.D., FCCP,

Theotokis Kolovos
Consulting Dentist, D.D.S.
Biography: Variation and range of mandible and oral cavity sizes, patient tolerance of oral appliances, consulting on appliance materials and designs.
Title: Consulting Dentist
Advanced Degree(s): D.D.S.

Michael Pashley
Original Consulting Orthodontist, (Ret), D.D.S.
Biography: Retired Orthodontic Practice
Title: Original Consulting Orthodontist, (Ret)
Advanced Degree(s): D.D.S.

Randy Summers
Dental Laboratory Consultant,
Biography: Principal/Owner of Olympic Laboratories & Dental Lab Services.
Title: Dental Laboratory Consultant

Bo Lewis
Project Marketing Consultant,
Biography: Principal at B3 Precision Medical Technologies
Title: Project Marketing Consultant
LinkedIn: https://www.linkedin.com/in/bo-lewis

Judy Gordon
Regulatory Consultant,
Biography: DVM, Founder at ClinReg Consulting Services, Inc.
Title: Regulatory Consultant
LinkedIn: https://www.linkedin.com/in/judy-gordon-a2756922

About Our Company

Pivot Solution

Location: 624 E. La Veta Avenue
Orange , CA 92866

Founded: 4

Website: https://www.pivotsolution.website

Facebook: https://1. https://www.facebook.com/Pivot-Solution-1778113952427794/

Other link: https://www.linkedin.com/in/lubin-martinez-a4b97629

Product Stage: Prototype/MVP

YTD Sales: Working on it

Employees: 1-2

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.

 

AHI

Baseline

AHI

with Pivot SolutionTM

Percentage Improvement

Fully Treated

(AHI < 5)

Patient 1

19.9

2.4

88%

Yes

Patient 2

22.9

2.9

87%

Yes

Table 1:  Overnight sleep study results using the Pivot SolutionTM

Study

Number of Patients

AHI
Baseline

mean ± sd

AHI
with device

mean ± sd

% Fully Treated

(AHI < 5)

Mandibular Advancement Device  - Antwerp [i]

183

20.8 ± 14.1

9.9 ± 8.8

40%

Mandibular Advancement Device  - Chicago [ii]

75

30.6± 20.0

10.5

53%

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.

Component

Unit Cost

Custom fitted acrylic retainer

$300.00

Computerized Scan Imaging per device

$150.00

Injection Molding

$150.00

Misc. Dental Hardware

$5.75

Packaging

$3.00

Burdened Labor

$2.00

Tongue Depressor

$50.00

Silicone Bonding

$5.00

Total COG @

$665.75

Gross Margins

47%

Total COG if Computerized Scanning and Injection Molding costs can be reduced.

$565.75

Gross Margins

60%

Selling Price

$1265.75 approx.

Gross Profit per Device

$600.00 approx.

Doctor/Dentist Office
(includes 2 visits @ $350 ea.  & dental impressions)

$700

*Doctor/Dentist mark-up on device

$1,200 to $3,500 for Mandibular Advancement Device

(Assuming Insurance reimbursement $1000.00/device)

$1,200 to $3,500

Total Cost to Patient

$1,800 - $ 4,000

Gross sales at 2% market penetration
(assuming total market of 21M people)

$531,615.000

Gross profit at 2% market penetration
(assuming total market of 21M people)

$252,000,000.00

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. 

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