Executive Summary Overview

InStim is designed to read real time inflammatory and anti-inflammatory cytokines in the body and organs. Then adjust real time up or down cytokine levels to get inflammation in balance and under control to promote optimal healing and long-term organ health and function.

We believe proper inflammation management is served best by bioelectric energy management that in turn controls release of the right cytokines in the right sequence at the right time for healthy recovery, especially when combined with proper diet and exercise.

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Vision

Our vision for InStim is to provide a better alternative to treatment for a wide range of Inflammatory disorders. We want to help people reach a better quality of life free of chronic inflammation.

Product

The InStim therapy is designed to get inflammation under control via real time monitoring and real time adjustments to both bioelectric signaling and biologics therapies. The first line of therapy is 100% bioelectric, preferably non-invasive, and only if this is not successful a second wave of biologics therapy via a re-fillable micro infusion pump is included. Biologics therapy may include stem cells, exosomes, PRF, PRP, Micro RNAs, nutrient hydrogel, organ specific matrix, oxygenated nanoparticles and selected alkaloids.

Facilities

We have two research labs in Salt Lake City, Utah. Our first facility is at BioInnovations Gateway, and our second facility at the Center of Medical Innovation in Research Park. We have access to animal labs at UCLA, LABioMed and University of Utah. As well as research offices in Los Angeles and Salt Lake City.

Market

In an article published to Allied Market Research titled “Anti-Inflammatory Therapeutics Market by Indication (Arthritis, Respiratory diseases, Multiple sclerosis, Psoriasis, Inflammatory bowel disease) and Drug Class (Anti-inflammatory Biologics, Non-Steroidal Anti-inflammatory drugs (NSAIDs), Corticosteroids) – Global Opportunity Analysis and Industry Forecast, 2014 – 2020.”

In the first paragraph, it states “The Anti-Inflammatory Therapeutics Market is expected to garner $106.1 billion by 2020, registering a CAGR of 5.9% during the forecast period 2015-2020.”
https://www.alliedmarketresearch.com/anti-inflammatory-therapeutics-market

Suspected Chronic Inflammation Caused Disease States Include:

• Cancer
• Coronary and peripheral artery disease
• Heart failure
• Asthma
• High blood pressure
• Alzheimers
• Bowel syndromes
• Lupus
• Abdominal aortic aneurysms
• Cerebral aneurysms

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Problem

Inflammation has long been a well-known symptom of many infectious diseases, but new molecular and epidemiological research increasingly suggests that it is also intimately linked with a broad range of non-infectious diseases, perhaps even all of them.
Inflammation is a response of the immune system to injury, irritation, or infection caused by invading pathogens, radiation exposure, very high or low temperatures, or autoimmune processes. Therefore, inflammation is a mechanism for removing damaged cells, irritants, or pathogens. Inflammation is considered to be beneficial when it is short term and under control within the immune system (acute inflammation). Inflammation that persists longer is known as chronic inflammation. This inflammation is characterized by the simultaneous destruction and healing of tissue.

The various factors known to induce chronic inflammatory responses also cause numerous chronic diseases. These factors include bacterial, viral, and parasitic infections (eg, Helicobacter pylori, Epstein-Barr virus, human immunodeficiency virus, flukes, schistosomes); chemical irritants (eg, tumor promoters such as phorbol ester 12-O-tetradecanoylphorbol-13-acetate, also known as phorbolmyristate acetate); andnondigestible particles (eg, asbestos, silica). Inflammation produces reactive oxygen species and reactive nitrogen species, which cause oxidative damage and further lead to chronic diseases.. Inflammation also recruits leukocytes that secrete inflammatory cytokines and angiogenic factors to the site of tissue insult. These cytokines are required for proper wound healing and to stimulate epithelial cell proliferation; however, if uncontrolled these cytokines can lead to inflammatory disorders. All these inflammatory products have shown to be regulated by the nuclear transcription factor NF-κB, which is considered the master molecule of inflammation.

Patents

Over 400 patent claims issued, pending, licensed or optioned for organ regeneration and recovery. Patent claims cover over 20 regenerative proteins expressions including SDF-1 + PDGF for stem cell homing, a full suite of angiogenesis (blood vessel forming) protein expressions and bioelectric signaling sequences for managing inflammation, blood pressure, muscle formation and nerve regeneration. Important regeneration promoting controlled proteins expressions include klotho, tropoelastin (for increasing elasticity), follistatin and sonic hedgehog.

Pre-clinical

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Clinical

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Upcoming Milestones

InStim – www.instimcell.com – bioelectric inflammation management – planning clinical trials in China. Real time read and customized bioelectric inflammation management via anti-inflammatory cytokine expressions. The anti-inflammatory drugs market exceeds $106 billion annually but barely dents the potential total available market. InStim believes its real time bioelectric read and treat technology has the potential to provide superior results compared to currently available therapies.
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References

Supporting Related Pre-Clinical Studies & Reviews
by SC Payne – ‎2019 – ‎Cited by 2 – ‎Related articles
May 8, 2019 – In a subsequent colitis study, inflammatory markers were only modestly … A first, small clinical trial demonstrated efficacy cervical VNS in ileocecal …… or limiting the effectiveness of the bioelectric neuromodulation treatment.
 
by SC Payne – ‎2018 – ‎Cited by 1 – ‎Related articles
Feb 5, 2019 – Vagus nerve stimulation to treat inflammatory bowel disease: a chronic, preclinicalsafety study in sheep. Sophie C Payne; ,; Owen Burns …
 
by R Marshall – ‎2015 – ‎Cited by 14 – ‎Related articles
Dec 6, 2015 – Matteoli et al induced intestinal inflammation in mice devoid of splenic innervation. While stimulating the vagus nerve, they were able to …

by SEB Tyler – ‎2017 – ‎Cited by 8 – ‎Related articles
Sep 4, 2017 – Bioelectric mechanisms of wound healing and regenerative processes in …. For instance, amputated digits of mice express the developmental gene ….. by reducing inflammatorycytokines and facilitating tissue regeneration.

by A Kanashiro – ‎2018 – ‎Cited by 2 – ‎Related articles
These drugs decrease joint inflammation in RA, but they are very expensive and ….. An initial preclinical study demonstrated that cervical vagal stimulation with …
Clinical Studies Review
by JA French – ‎2017 – ‎Cited by 8 – ‎Related articles
These models have demonstrated that specific anti-inflammatory treatments can be … Some of these have already been evaluated in early phase clinical trials. ….. effect and comparable shifts in specific bacterial abundance seen in humans with autism. …. Discoveries in bioelectronic medicine, which is the convergence of .

Team

Howard Leonhardt, Executive Chairman and CEO, is an inventor and serial entrepreneur with over 21 issued U.S. patents and dozens more pending. He developed the leading endovascular stent graft system and the first percutaneous heart valve, both now a part of Medtronic. He has founded over 30 startups and has numerous successful exit.

Dr. Leslie Miller
Chief Medical Officer
Brittany Brown, CPA
Interim Chief Financial Officer
Alex Richardson
Vice President Engineering & Product Development
Dr. Stuart Williams
Vice President Biologics Research
Dr. Jorge Genovese
Vice President Bioelectrics Research
Jeremy Koff
Vice President Strategic Development
Ken Evans
Vice President Business Development Dr. Brett Burton
Director of R&D & Startup Launches
Dr. Robert Gelfand
Los Angeles Research Lab Manager
Dr. Alonso Moreno
Utah Research Lab Manager
Ben Boytor
Lead Quality Management Advisor
Larry Stevens
Lead Regulatory Affairs Advisor
Michael Angerbauer
Senior Bioengineer #1
Sejal Chaudhari
Senior Bioengineer #2 and Utah Lab Assistant Manager
Kapil Sharma
Senior Bioengineer #3
Paul Norman
Managing Partner Accelerator
Nick Kearley
Executive & Research Assistant #1 Los Angeles
Madyson McDaniel
Executive & Research Assistant #2 Utah