Cautionary Note on Forward-Looking Statements and Disclaimers This presentation includes statements that constitute “forward-looking statements” within the meaning of the U.S. federal securities laws. These statements relate to future events or to our future performance, and involve significant known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied in these forward-looking statements. These statements include, but are not limited to, information or assumptions about our ability to formulate, implement and gain market acceptance of our business plan and our products and services, the viability of our intellectual property, our financing needs and plans, and our management’s plans, goals and objectives for future operations and growth. In some cases, you can identify forward-looking statements by the use of words such as “may,” “could,” “expect,” “intend,” “plan,” “seek,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “continue,” or the negative of these terms or other comparable terminology. You should not place undue reliance on forward-looking statement since they involve significant known and unknown risks, uncertainties and other factors which are, in some cases, beyond our control and which could cause actual performance or results to differ materially from those expressed in or suggested by forward-looking statements. Important factors that could cause such differences include, but are not limited to: (i) risks and uncertainties associated with the development and implementation of our VIP Program; (ii) our dependence on key members of our management team; (iii) the risk that we may be unable raise capital when needed; (iv) risks associated with the timing of, and our ability to achieve, predictable revenue growth and ultimately profitability, if at all; (v) the risk that we may be unable to gain market acceptance for the Stimcore,Inc.; and (Si) risks associated with maintaining or protecting the validity of patents and other intellectual property. Should one or more of these risks or uncertainties materialize, or should any of our assumptions prove incorrect, actual results may vary in material or even significant respects from those projected in these forward-looking statements. We do not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. Sales, revenue and other economic estimates have been determined on-the-basis-of market research and comparable product analysis, but no assurances can be given that such results will be achieved, if at all. This presentation contains trademarks, trade names and service marks of other companies, which are the property of their respective owners. We do not intend to use or display other parties’ trademarks, trade names or service marks to imply, and such use or display should not be construed to imply, a relationship with, or endorsement or sponsorship of us by, these other parties. All references herein to the “Company,” “we,” “us,” “our” and similar terminology refer to Stimcore,Inc. Healio.com; OSA may affect nearly 1 billion adults worldwide/ www. Healio.com 2. American Academy of Dental Sleep Medicine/ www.aadsm.org 3. Frost & Sullivan; Hidden Health Crisis Costing America Billions ©2021 Stimcore, Inc. ALL RIGHTS RESERVED. CONFIDENTIAL | NOT FOR REDISTRIBUTION
Harnessing The Power - Bioregulatory Signals 2021 Stimcore, Inc. ALL RIGHTS RESERVED. CONFIDENTIAL | NOT FOR REDISTRIBUTION
Who We Are Stimcore is an early stage bioregulatory medical device company focused on the development of a non-surgical, non-invasive, non-pharmaceutical, regenerative and preventive, early intervention airway patency device suite. Sinus-Stim, Oropharyngeal-Stim, Tongue-Stim, are used to correct breathing disorders including sleep apnea, and reverse the chronic disease conditions they cause.
TEAM
Stimcore, Inc
Howard Leonhardt, President of Stimcore – CEO of Leonhardt Ventures. Leonhardt is an inventor and serial entrepreneur. He has more than 20 U.S. patents with over 100 patent claims for products for treating cardiovascular disease and has over 40 new patent claims pending. His TALENT (Taheri-Leonhardt) stent graft developed in the early 1990’s holds a leading world market share for repairing aortic aneurysms without surgery. His inventions have treated over 500,000 patients in 60 countries. In early 1999 Leonhardt founded Bioheart, Inc. www.bioheartinc.com a leader in applying adult muscle stem cells to treat heart failure. Leonhardt holds a Diploma in International Trade from Anoka Technical College. He attended the University of Minnesota, Anoka Ramsey College and UCLA Extension. He holds an honorary Doctorate in Biomedical Engineering from the University of Northern California and is an honorary alumnus of the University of Florida and Florida International University. He is co-leader of Startup California and Founder and Chairman of
CEO
exchange currently operating the Cal-X 30 Social Good Impact fund powered by Motif Investing (www.calstockexchange.com). He founded Cal-X Crowdfund Connect (www.calxcrowdfund.com), a crowdfunding campaign management co. and Cal-X Stars Business Accelerator, Inc. (www.calxstars.com), a business incubator and accelerator focused on cardiovascular life sciences and social good impact innovations. There are 30 regenerative medtech and regenerative economy startups in the current portfolio class. His Leonhardt Ventures angels network has raised and put to work over $145 million in 32 companies to date, most of them founded by Leonhardt.
Dr. Blair’s background:
CSO
Graduate of University of the Pacific Arthur A. Dugoni School of Dentistry, one of the most prestigious dental schools in the world. (She is the fifth member of her family to graduate from there.) Graduate of LVI, the top CE based dental system in the US. Studied full mouth reconstruction, neuromuscular, myofunctional and aesthetic dentistry. This extensive and ongoing training and post dental degree allowed her to study under and maintain relationships with some of the most elite minds in dentistry. Founder Exceptional Professionals First dentist to work for Align Technology, Invisalign Innovator Award recipient, Launched certification program to the general dentist population and supported product “roll out.” Developed the healthcare vertical of Drop Thought, an instantaneous patient feedback system, developed by a Stanford think tank. One of 10 doctors/dentists worldwide chosen to be a part of the San Diego based Resmed clinical team, as a specialist in sleep. Fotona Laser Company speaker and consultant. Clinical Advisor and inventor for Cal-X-Stars Dental Division Co-founder of The Children’s Dental Healthcare League. (Kids in the Klinic) American College of integrative Medicine and Dentistry, Naturopathic Doctorate Continuum Co-founder Stimcore
PAIN
SBD SLEEP APNEA OBSTRUCTIVE SLEEP APNEA POOR BREATHING
An Obstructed Airway
Obstructive Sleep Apnea & Sleep Apnea are Serious Cronic Diseaes. OSA is Caused by a Blocked or Partially Blocked Airway Typical Obstructive Sleep Apnea Expat
Blockage prevents airflow to the lungs Results in repeated arousals and oxygen desaturations Severity of sleep apnea is measured by frequency of apnea or hypopnea events per hour, which is reffered to as the Apnea-Hypopnea Index (AHI)
Normal range: AHI < 5 events per hour Airway obstruction during breathing Most Patients are unaware of there condition. High risk patients: obese, male and of advanced age Common first indicator: heavy snoring Other indicators: Lack of energy Headaches Depression Nightime gasping Dry mouth
Memory or concentration Problems Excessive daytime sleepiness
Mild sleep apnea: AHI 5 - 15 events per hour
Moderate sleep apnea: AHI 15- 30 events per hour
Severe sleep apnea: AHI 30 > events per hour
... and unattended OSA multiplies serious health risks
2x
The risk for stroke
2x
The risk for sudden cardiac death
5x
The risk cardiovascular mortality
57%
Increased risk for recurrence of atrial fibrillation
Current treatment options, such as CPAP, MRD and Surgeries, have significant limitations.
MRD Non-Compliance
Arthritis TMD TMJ
Inspire Surgical Implant / 1 Muscle
Uvula / Lase / Surgery
CPAP
Uvulopalatopharyngoplasty (UPPP)
Continuous Positive Airway Pressure (CPAP) is the Leading Therapy for OSA Delivered through a mask that connects through a hose to a bedside air pump
Highly Invasive Surgery Success rates vary widely Irreversible anatomy alteration Inpatient surgery with extended recovery
Demonstrated improvements in patient-reported sleep quality and reductions in daytime sleepiness Long term limitations as a therapeutic option, primarily due to low patient compliance approximately (35% - 65%) Low patient compliance as many patients find the mask or treatment cumbersome, uncomfortable and loud
Drivers of Non-Compliance Mask Discomfort Mask Leakage Pressure Intollerance Skin Irritation Nasal Congestion Nasal Drying Nosebleeds Claustrophobia Lack of Intimacy Relapse
Americans spent an estimated $48 billion on sleep aids and remedies in 2020
Market Opportunity
Strong Market Opportunity for a Potentially Permanent Solution to OSA/SBD Obstructive Sleep Apnea 1 2
Sleep Apnea Affects nearly 1 Billion People Worldwide Approximately 54 Million people in the U.S. with OSA
3
Costs Associated with OSA in United States in 2016 = $149.6 Billion
4
Over 54 million people suffer from chronic sinusitus. Sinus-Stim.
Published study by international panel of leading researchers, reported that nearly one billion people worldwide have sleep apnea.
$
229
Number of adults suffering from obstructive sleep apnea in the United States is estimated to be 54 million (not including kids) The Stimcore protocol is estimated to be effective in approximately 98% of cases of obstructive sleep apnea
Stimcore will be the first treatment suite to treat children, young adults and teenagers. This will give doctors access to millions of kids at an early stage to treat poor airway and poor sleep. Children, teenagers and sinus sufferers are not included in our $229 Billion!
U.S. Stimcore
Market is approximately $229 Billion
60 million kids (organized sports)
Endless market for the future.
15% of this market equals 1 Billion dollars in sales per year.
The mouth guard industry globally is valued at 2.7 billion dollars. Most mouth guards do two things, they protect the teeth and the jaw. There are 60 million kids playing sports in the USA. The brain, teeth, hydration, balance and breathing are all connected. Parents are looking for that differentiator that give their sons and daughters the ability to perform at a higher level while being safe at the same time. Is Stimcore a game changer for these kids?... YES
Stimcore provides Oxygen to our kids. Oxygen provides better balance, better strength and endurance.
Proof of Concept
Total Volume: 9.4cc / Min Area: 38.0mm2 Before Treatment
Total Volume: 16.8cc / Min Area: 199.Smm2 After Treatment
Total Volume: 178% change / Min Area: 523% change Before Treatment
Total Volume: 10.9cc / Min Area: 108.4mm2 Before Treatment
Total Volume: 29.8cc / Min Area: 339.2mm2 After Treatment
Total Volume: 264% change / Min Area: 312% change Before Treatment
Before
After Front View
Side Piece
Sinus-Stim
Upper Dental Arch
T-STIM
Tongue-Stim
Lower Dental Arch
Oropharyngeal- Stim
Industry Leaders
Competitive Landscape Non-Surgical Treatment Options (Non-Invasive) Treatment Protocol Correct the Underlying Condition Treatment Time Nose, Palet & Tongue
STIMCORE*
CPAP
Oral Appliance Therapy
YES
NO
NO
30 min per day/ twice per wk
8 hrs per day Lifetime
8 hrs per day Lifetime
Surgical Treatment Options (Invasive) Inspire Medical
NO Surgery
YES
NO
NO
Pain Associated with Treatment
None
Minor or None
Minor or None
Potential Negative Side-Effects
Minor
Moderate
Moderate
Major
Lifetime
Only During Use
Only During Use
Only During Use
Cosmetic Benefits
YES
NO
NO
NO
Health Insurance Coverage
YES
YES
YES
In Most Cases
In Most Cases
Does Treatment Address the entire airway
Duration of Benefits
Est. Average Treatment Cost Accessibility Children and Adults
In Most Cases
$3,000 - $6000 Primary Care/Dentist YES
2021 2021 Stimcore, Stimcore, Inc. Inc. ALL ALL RIGHTS RIGHTS RESERVED. RESERVED. CONFIDENTIAL CONFIDENTIAL || NOT NOT FOR FOR REDISTRIBUTION REDISTRIBUTION
YES $2,500 Plus Consumables
Referral NO
$3,000 - $10,000 Referral NO
NO In Some Cases
$30,000 - $40,000
Uvulopalatopharygoplasty (UPPP Surgery)
NO
Maxillomandibular Advancement Surgery
YES
Surgery
Surgery
NO
NO
During Recovery
During Recovery
Major Limited Duration In Most Cases
Major Potentially Lifetime
NO
YES
YES
YES
$2,000 - $10,000
$70,000
Referral
Referral
NO
NO
Referral NO
Success in a Box WellbyMD Starter Kit Welcome Letter Dr Training Quick Start Guide Staff Training Guide Diagnostic Supplies Internal/External Marketing, Media Kit Website, Brochures, Posters
Patient Education Materials Patient Quick Start Guides Device models and disposable measuring tools Device Care Kits Doctor/Patient “Drop Thought” app 1-800 patient care, Training video, Patient Survey
New Branding
Case Studies, Medical Device Development, & Clinical Trials, Cost Projections
Stimcore Device Development and Cost Timeline
----
Funding Necessary to Reach Acquisition Point 1, $4,500,000
($428,555)
1
$850,000
$950,000
Device Lab Gen 1 Engineering
Rev 1 Wireless Engineering
Microfabrica stimulators,
51 Ok Pre-sub
Expand 51 Ok Clearance
Expanded Use Trials
,-S
s;""' & '""'o"I w;ced o.,;,., (>3)
IProd. Of 90 Clinical Trial Prototypes.
t.:.\ ; M c,o-St'.m"l"o'. '"•;""';"• (,o-Jt,mo,) � Push Button, Pre-Programmed V-Bram' zy Gen 2 V-Bram Prototype Production � Gee 2 let,ao,al & s;"os-St;m oe,;ces
51 Ok FDA Pre-Sub, Airway/CSA 3 Devices (7/8) Lab Analysis Protocol
Continue Airway Patency Case Reports
Revise 51 Ok Submissions/Clearance
Filing of Additional Expanded use Patents
July'2�
July'2�
stimcore Facility, Clinical & Corporate Development
I
Clinical Trial Prep & C
n
nrl
""',.._
I
I
Phase 3 Expan�ed Ap lication and � Superiority Trials Gen 3 Devices Engineering
(Jan)'2�
Phase 2 Clinical Trials
Conduct Phase 2 Clinical Trials 90 Patients
I
According to IRB Parameters for Primary Device �......_ Early-Stage Discovery & Trial Center Prep�--... Airway & OSA Clinical Trial Protocol Dev .--. Applications Clinical Validation & Device Design
Concept and Partnership Development Patented Bioelectric Sig1nal Licenses
Filing of Airway Patency/CSA Specific Patents $175k Investment Capitol Raised
ftft
I
ft
Sterling IRB Site & Trial Approval
51 Ok Pre-Submission for Expanded Use
Baseline Data Collection, Lab Assays
Acquisition Point 1
Patient Screening, Trial Enrollment
Expanded Applications Case Reports
$450,000
Branding and Implementation Kits
$2,250,000
Applications
TBD
Stimcore Partners
Dropthought
2021 Letter to Stakeholders
A highly FOCUSED organization on the brink of major contributions to healthcare Dear Stakeholders, It is truly an honor to serve as Executive Chairman and CEO of Leonhardt Launchpads Inc by Cal-X Stars Business Accelerator, Inc. the innovation and startup accelerator arm of Leonhardt Ventures LLC. I feel blessed to be able to do work that I love every day, highly FOCUSED on developing breakthrough innovations with people I love working with as part of an amazing team. It is one of the great honors of my life to help lead this team with a long legacy of achievements in the medical industry. Our research team, board, and advisors have over 2000 peer-reviewed publications, over 2000 patent claims and have had leadership roles in over 500 pre-clinical and clinical studies. It is fair to say we have assembled an all-star team of industry veterans with proven track records, complemented by recruiting some of the brightest rising young stars. In any given month we may have more than 300 people working on our projects in one form or another. This incredible team of inspiring leaders shares a common vision of leading healthcare into a new era, driven by applying bioelectronics and biologics with advanced delivery systems towards regenerating and healing organs. Our team is highly focused on applying our core IP in bioelectronics, delivery systems, and biolog-ics to meaningful innovations in one single FOCUSED area – organ regeneration and recovery. The competitive advantage of our organization is rapid innovation FOCUSED on This is precisely where we dedicate the lion’s share of our resources and time. The business model of our organization is simple and focused.
bioelectronics, delivery systems, and biologics and then seek a strategic acquir-er/partner to take them through commercialization. We keep our FOCUS where we believe we are amongst the best in the world – rapid breakthrough innovations in organ regeneration and recovery at low cost.
Howard Leonhardt, CEO Stimcore, Inc.