Premier iomedical stock is traded on the OT under the ......Antibody/Antigen Therapy Extracorporeal...

Premier Biomedical stock is traded on the OTC under the symbol “BIEI” Visit us at www.premierbiomedical.com

© 2018, Premier Biomedical, Inc. 1

http://www.premierbiomedical.com/


Biologics Group • In Vivo • Extracorporeal

Pain Management Group

Cancer/Leukemia

Alzheimer’s

Atherosclerosis

Traumatic Brain Injury

Topical Pain Patch

Ointment

Roll-ons

Sprays

Anti-Aging

• Extracorporeal Treatment

• Immunotherapy (in vivo)


Premier Biomedical, Inc. Biologics Group

Antibody/Antigen Therapy Extracorporeal Sequential Dialysis Method (ESDM)

– Patented Treatment Process • US Patents No. 9,216,386 and No. 8,758,287

– Elimination of Disease Antigens

– Applicable To Many Blood-/CSF-borne Diseases • Cancer • Aging • Alzheimer’s • PTSD/TBI/CTE • Parkinson’s • MRSA (Sepsis) • Atherosclerosis • Dengue/Zika

– Eliminates Drug Side-Effects

– Funding Required To Complete Development

– See “A Scientific Roadmap to Cure Cancer” video https://youtu.be/BGdZqHH6oew


https://youtu.be/BGdZqHH6oew

https://youtu.be/BGdZqHH6oew

PBI Extracorporeal Treatment

© 2012-2018, Premier Biomedical Inc.

Processed Blood/CSF returned to the patient

Patient

PBI Patented Antibody/ Antigen Trap

Patented method for the removal of specific and unique molecules utilizing antibody-coated surface in disease antigen trap. Unique antibody coating for each disease application.

Outgoing Blood/Cerebral

Spinal Fluid

Pump

For neurological conditions (diseases or concussions) cerebrospinal fluid

is processed and returned to the body.

Pressure Monitor

5

FDA HUD #15-0346

Pressure Monitor

Pressure Monitor

PBI Extracorporeal Advantages

• Patented Process • Can Be used in Conjunction With Other Cancer

Treatments (i.e., CAR-T, Chemotherapy and Kanzius)

• Uses Common Dialysis Equipment – Chemicals NOT Introduced Into The Body – Eliminates Drug Side-effects – Enables Use Of High Concentration Antibiotics

• Treatment Cartridges For Specific Diseases • Applicable to Blood- and CSF-Borne Diseases


Immunotherapy – In Vivo Immunotherapy Products

– Developing Antibodies vs the Principal Cancer Antigens: CTLA-4, PD-1, BTLA at UTEP

– Patent-Pending Antibody – Laboratory Testing In-Process – Projected Launch – 2020

Breast Cancer Antibody – Completed Duplicated Mouse Studies

• Patent-Pending Monoclonal Antibody

• 98.8% Effective In Blocking CTLA-4 Antigens

– Research On PD-1 And BTLA In Initial Phases


PBI Product Advantages

Immunotherapy Cancer Antibodies (in vivo)

– Uses Body’s Immune System

– Effective In Reducing Tumor Volume In Mice

• PBI Antibody Treated Mice Demonstrated Immunity to Subsequent Breast Cancer Implantation

– Outperformed Yervoy® Anti-Cancer Drug (Bristol-

Meyers-Squibb) in Initial Mouse Tests

• BMS Projects $14 Billion in Yervoy ® sales in 2018

– Effective vs Melanoma Cells (In Test Tube)


PBI Product Advantages


Day 15 (Treatment Day 10)

Control Chemotherapy

Day 24 (Treatment Day 19)

Control PBI Treatment

PBI Treatment

Chemotherapy

Cancer Immunotherapy

Blood-Borne Disease Treatment

• Patent Pending Procedure to treat blood extra-corporeally with compounds which fluorescently tag infectious antigens/ cytokines targeting them for exposure to high energy emissive radiation (e.g., laser).

• Initial applications envisioned for treatment of targeted pathogen antigen complex, including bacteria, viruses, parasites, fungi, and prions.


Anti-Aging Treatment


• Patent Pending Procedure which extra-corporeally removes compounds associated with the aging process.

• A complexing agent causes target antigens to bind together for easy removal from the blood or cerebral spinal fluid.

• This process targets select known aging antigens, such as mTOR (mammalian target of rapamycin), interleukin-6, TGF-beta, oxygen free radicals, Progerin, lipofuscin, etc.

Technology Partner - Biologics

• University Of Texas at El Paso


Pain Management

Group


Overview

• What Are Cannabinoids?

• Hemp vs. Marijuana

• What Are Hemp Derived Cannabinoids?

• How Do Cannabinoids Work?

– What is the Endocannabinoid System?

– Interactions Between the Body and Cannabinoids

• Legal Issues

• Premier Biomedical’s Products

• Testimonials


What are Cannabinoids?

• Naturally occurring compounds found in Cannabis plants (Hemp, Marijuana) and certain other plants.

• Cannabis contains over 480 natural compounds – 66 have been classified as “cannabinoids” – Over 100 Terpenes (also found in essential oils) – A multitude of Flavonoids add to the healing properties of the plant

• “entourage effect” (whole plant/full spectrum therapeutic agents).

• Cannabidiol (CBD) accounts for up to 40% of the resin. • THC (delta-9-tetrahydrocannabinol,or Δ9-THC) is the psychoactive

component of the tetrahydrocannabinol subclass. • Cannabinoids and terpenes interact and modulate each other’s

effects. This synergy produces more powerful, and sometimes gentler, effects than single molecule substances.


Hemp vs. Marijuana

• Hemp and Marijuana are both members of the cannabis plant family (genus), and same species (Cannabis Sativa).

• Cannabis Sativa bred for high THC content is referred to as Marijuana

• Cannabis Sativa bred for industrial uses (paper, clothing, oils, topical ointments, etc.) is called hemp.

• Hemp contains CBD along with ~ 0.3 to 1.5% THC

• Marijuana is typically 5 to 10%THC. Medical marijuana may contain upwards of 20%THC, with prize strains going up to 30% THC.


What Are Hemp-Derived Cannabinoids?

• Cannabinoids derived from plants are referred to in general as phytocannabinoids.

• Cannabinoids (particularly CBD) derived from Industrial Hemp are: – Non-psychoactive – Non-euphoric – Non-habit Forming – Drug Test Safe – Legal throughout the USA, and virtually the world – Contain the same medicinal properties of marijuana

derived CBD (but at lower concentrations)


What is the Endocannabinoid System?

• A physiologic system in every human and almost every animal • Involved in establishing and maintaining human health • Cannabinoids produced inside the body are referred to as

endogenous cannabinoids or endocannabinoids. • Endocannabinoids and their receptors are found throughout the

body – Brain − Glands − Connective tissues – Organs − Immune cells

• In each tissue, the cannabinoid system performs different tasks, but the goal is always the same: homeostasis, the maintenance of a stable internal environment despite fluctuations in the external environment.


http://www.harmreductionjournal.com/content/2/1/17

Interactions Between the Body and Cannabinoids

• Cannabinoid receptors are present throughout the body, embedded in cell membranes

• Researchers have identified two cannabinoid receptors: – CB1, predominantly present in the nervous system,

connective tissues, gonads, glands, and organs

– CB2, predominantly found in the immune system and its associated structures.

• Many tissues contain both CB1 and CB2 receptors, each linked to a different action




CB1 Receptors work in the Nervous System

• CB1 receptors can slow down the release of neurotransmitters at the molecular level

• Changing the amount of neurotransmitters crossing the synaptic cleft has therapeutic implications for pain, mood, seizure activity, memory , etc.



CB2 Receptors work in the Immune System.

Activating them will: • Decrease cell response lowering

inflammation • Facilitate lots of enzymatic activity

Legal Issues

• 2014 Farm Bill legalized growing hemp in US (Sec. 7606)

• The Government recognized the medicinal value of cannabinoids in April, 1999 when it filed the patent “Cannabinoids as Antioxidants and Neuroprotectants” (US#6,630,507 B1)


• DEA wrongfully issues statement classifying hemp derived products as Schedule 1 drugs in Dec-16.

• This action puts entire industry in chaos.

• In April, 2017, DEA retracts its re-classification – “The new drug code (7350) established in [the Rule] does not include materials or products that are

excluded from the definition of marijuana set forth in the Controlled Substances Act (CSA). The new drug code includes only those extracts that fall within the CSA definition of marijuana. If a product consisted solely of parts of the cannabis plant excluded from the CSA definition of marijuana, such product would not be included in the new drug code (7350) or in the drug code for marijuana (7360).”

• Confusion persists, but Hemp Oil CBD is legal!


Legal Issues

Legal Opinions Source: Compliance Advisor – A Law Firm, Mission Hills, CA, S. Singh, Esq.

• “The 2014 Farm Bill which defined and permitted the growth of Industrial Hemp establishes Congress’s intent to prevent making Industrial Hemp subject to the CSA.” {Controlled Substance Act}

• “The Spending Bill prevents the DEA from enforcement acts that would be contrary to the Farm Bill. The Spending Bill is a clear indication that Congress intended to exclude certain parts of the Cannabis Sativa L. plant from federal enforcement agencies, including the DEA.”

• “The 2014 Spending Bill states: – ‘None of the funds made available by this Act or any other Act may be

used 1) in contravention of section 7607 of the Farm Bill of 2014 (7 USC 5940); or 2) to prohibit the transportation, processing, sale or use of industrial hemp

that is grown or cultivated in accordance with the subsection 7606 of the Farm Bill 2014, within or outside of the State in which the industrial hemp is grown or cultivated.”


Legal Opinions Source: Hoban Law Group, 14-Dec-16

• “In Hemp Indus. Ass'n. v. DEA, supra, the court held that the DEA could regulate products containing natural THC if it is contained within marijuana, and can regulate synthetic THC of any kind. But they cannot regulate naturally-occurring THC not contained within or derived from marijuana, i.e., non-psychoactive hemp products, because non-psychoactive hemp from the stalks and fibers of such a plant is not included in Schedule I. The Court concluded that the “DEA has no authority to regulate drugs that are not schedule….” Id. at 1018.”

• The Farm Bill renders the entire industrial plant, including extracts, as lawful. On February 7, 2014, President Obama signed the Agricultural Act of 2014 into law.

• In Hemp Indus. Ass'n. v. DEA, 357 F.3d 1012 (9th Cir. 2004), the Ninth Circuit ruled that naturally occurring cannabinoids in industrial hemp foods, including oil, were never scheduled under the CSA; therefore, the DEA has no jurisdiction. This means that naturally occurring industrial hemp cannabinoids are federally legal in the view of the Ninth Circuit.

• In this case, the Court concluded: “[a]s in the case of poppy seeds commonly consumed on bagels and expressly exempted from the CSA, that come from a non-drug variety of, but the same species as, the opium poppy…non-psychoactive hemp seed products do not contain any controlled substance as defined by the CSA...” 357 F.2d at 1017.


Is CBD Legal in the USA?

You can legally purchase CBD Oil derived from industrial hemp in ALL 50 STATES!


Alaska Hawaii Massachusetts New Mexico South Dakota Alabama* Idaho Michigan New York Tennessee Arizona Illinois Minnesota North Carolina Texas Arkansas Indiana Mississippi North Dakota Utah California Iowa Missouri Ohio Vermont Colorado Kansas Montana Oklahoma Virginia Connecticut Kentucky Nebraska Oregon Washington Delaware Louisiana Nevada Pennsylvania West Virginia Florida Maine New Hampshire Rhode Island Wisconsin Georgia Maryland New Jersey South Carolina Wyoming Source: http://www.endocafoundation.org/is-cbd-legal/ *effective June 1, 2016

http://www.endocafoundation.org/is-cbd-legal/





Cultivation of Hemp


As of October, 2017, 33 states have passed legislation related to growing of industrial hemp. Colorado allows hemp cultivation for commercial and research purposes to be overseen by the Industrial Hemp Committee under the Department of Agriculture.

Source: http://www.ncsl.org/research/agriculture-and-rural-development/state-industrial-hemp-statutes.aspx

http://www.ncsl.org/research/agriculture-and-rural-development/state-industrial-hemp-statutes.aspx














Market and Drivers

• Pain Management Market – Size Estimates Up To $112 B Annually Worldwide – Fastest Growing Industry – Competitor To Lyrica®*, Cymbalta®*, Fentanyl*, etc.

• Topical Pain Reliever Market projected to be $5B by 2025

• Pressure To Find Opioid-free Alternatives – 71,000 Opioid-related drug overdose deaths projected in

2017 (US) – Government Action – Task Force – AMA, CDC, FDA, NIH -- Guidelines/Restrictions


* Major side effects have been reported with these competitor products

Premier Biomedical Product Advantages

• All of our products are supplied with third party certification for CBD purity (no THC), organic and non-GMO certifications.

• All of our products feature a proprietary blend of ingredients proven to effectively relieve various types of pain without adverse side-effects.

• PainEx-IITM line of new, extra strength topical pain relief products contain among the highest levels of CBD content in the industry.


CBD Analysis


Other Constituents


Other Constituents


Vitamin E Oil Essential Oils

Premier Biomedical’s Products

Topical application of hemp oil products provide absorption over a longer period of time resulting in more uniform and longer relief. Our Topical Patches are: • Made with a proprietary blend of

all-natural ingredients • 50 mg of certified hemp oil extract per patch • Contain no chemical enhancers • Hypoallergenic and water-resistant • Lab tested pesticide- and solvent-free • Latex-free pharmaceutical grade adhesive • Delivers relief for up to 96 hours • 2x2 Square patch with rounded corners • Tan colored patch for discrete use




• Made with a proprietary blend of all-natural ingredients

• 150 mg of certified hemp oil extracts • Infused with Essential Oils for a pleasant

sage aroma and antibacterial properties • Rich golden color • Quickly absorbed and easily applied

Premier Biomedical’s Pain Relieving Roll-On contains industrial hemp extracts which you can use discreetly, anywhere on your body.



• 30 ml size spray bottle • Made with a proprietary blend of all-natural

ingredients • 150 mg of certified pure hemp extracts • Infused with Wintergreen Oil for a natural

cooling sensation. • Rich golden color • Quickly absorbed and easily applied

Premier Biomedical’s Pain Relieving Spray contains industrial hemp extracts which you can use discreetly, anywhere on your body.

Premier Biomedical’s Pain Relieving Hemp Extract Roll-On is easily applied directly to the skin, for relief of minor aches and pains.



• 120 mg of water soluble hemp isolates in each 10 ml bottle

• Proprietary blend • Infused with essential oils for pain relief,

stress relief and reducing inflammation • Easily applied anywhere on the body • Gentle lavender aroma • Creamy and quick drying • Water based; dries clear; no oily residue

Premier Biomedical’s Pain Relieving Cream contains industrial hemp extracts. Apply to painful areas and massage gently into skin. Mild, pleasant wintergreen aroma.



• Infused with Wintergreen Oil for a natural cooling sensation. • Made with a proprietary blend of all-natural ingredients • 150 mg of certified pure hemp extracts • Quickly absorbed and easily applied • Rich creamy texture • Available in 2 oz. Jar

Introducing Premier Biomedical’s Pain-Ex II

TM Extra Strength Topical

Pain Relief Products


Pain-Ex IITM Extra Strength Pain Relieving Ointment contains industrial hemp extracts. Ideal for sore muscles and joints. Mild, pleasant sage aroma.



• 500 mg of certified pure CBD Isolate • Made with a proprietary blend of all-

natural ingredients • Infused with sage essential oils • Quickly absorbed and easily applied • Rich creamy texture • Available in 1 oz. Jar

Premier Biomedical’s Pain-Ex IITM Extra Strength Pain Relieving Spray contains hemp extract CBD Isolate which you can use discreetly, anywhere on your body.



• 500 mg of certified pure CBD isolate • Made with a proprietary blend of all-natural

ingredients • Infused with sage essential oil • Rich golden color • Quickly absorbed and easily applied • 30 ml size spray bottle

Premier Biomedical’s Pain-Ex IITM Extra Strength Pain Relieving Roll-on.



• 200 mg of certified hemp oil extracts • Made with a proprietary blend of all-

natural ingredients • Infused with Essential Oils for a pleasant

sage aroma and antibacterial properties • Rich golden color • Quickly absorbed and easily applied • Convenient 10 ml pocket/purse size

Premier Biomedical’s Planned Products

Opioid-Free / 50-State Legal Oral Medication – Pain-ExTM Natural And Synthetic Compounds

– Synthetic Compound US Patent 8,865,733, 2014 • Naltrexone and Cyclobenzaprine • For treating Fibromyalgia, and Chemical/Drug Addiction • Potential $300 Million Annual Market

– Provisional Patent Application - August, 2016 • Addition of Patented Synthetics to Base Hemp Oil Capsule

– Available by Prescription Only – Requires FDA Approval


Distribution Network

In addition to internet sales outlets, we are in the process of attempting to build a network of distributors throughout the world.

– North America

– Europe

– Asia

– South America

– Australia


Testimonials

“I’ve used the Hemp Oil roll-on for some leg tendon strain/pain and the oil

relieved the pain within minutes and the relief lasted overnight. I had an

upper toothache and applied the roll-on oil to my cheek. The pain went away

within a couple of minutes and the relief lasted all day. I gave a roll-on to a co-

worker, who had upper back pain, and the hemp oil relieved the pain

overnight. She let her father use the oil on his arthritic fingers and the oil

relieved the pain for hours and he was able to use this fingers without any

associated pain. The hemp oil roll-on is great to have handy around the

home.”

John M.

Colorado


“I bought a pain patch some time ago when they first came out on this

website. I hadn’t had an opportunity to use the patch until recently. I must

say, the patch worked well while I had it on. I left the patch on for only 2 days

because the extent of my pain was not too bad. As an average consumer, this

patch is a bit much. I don’t need pain relief for 4 days. I’m feeling like I’m not

getting the full value if I don’t use the patch for its full duration. The company

has said that pain patches with shorter duration are in the works. I would be

more inclined to buy those.”

Mitchell N.

California


Testimonials (cont)

“My mom suffers with daily migraines and MS – we have tried everything – including

drug addiction – not pretty for a 75 year old woman. She went through treatment and

now we have tried these patches – I am not going to say that it miraculous takes ALL

the pain away – but it works very similar to all the meds she use to take without all the

awful side effects of narcotics. She is peaceful, comfortable and able to tolerate the

pain level she has with bulging discs, plate in neck, bone loss in lower back and MS.

This has been a god send. I started out buying the stock and then thought to try the

product. I am so glad someone had told me about this – we seriously have tried

EVERYTHING. She has severe allergies to many medications including Fentanyl – truly

if you suffer from pain please try this you will be happy you did.”

Jodi L.

Georgia


Testimonials (cont)

“I have had severe polymyalgia throughout my body, but predominantly in my shoulders and arms. I have been unable to sleep through the night without pain for the past ten years. The only relief up until now has been through the use of opioids (Oxycodone/OxyContin). My husband, Bud, has severe arthritis in his fingers and has been unable to make a tight fist due to the severe arthritic pain.

We got some of your roll-on, and Bud applied it to my shoulders, back and arms. Immediately after rubbing the oil in, Bud experienced relief of pain in his fingers and was able to clench his fist without pain, and I was able to sleep soundly all night without pain. A real two-fer!

I have experienced similar pain relief from using your skin patch. I have never felt so wonderful! Your products have allowed me to reduce my dependence on dangerous narcotic opioids for my pain relief.”

June DeRaud Hubbard, OH


Testimonials (cont)

“I just wanted to take a minute to thank you for helping my wife with her chronic pain. She has been dealing with chronic jaw pain (TMJ) for the better part of ten years. We have been to numerous doctors and spent thousands of dollars with little or no relief. She has dealt with jaw pain and debilitating migraines for years and held out little hope that anyone could help her.

The CBD pain patch you created has proven to be just what she needed. It helped alleviate her daily pain and reduced her intake of other pain medication, especially prescribed opioids. The patch lasted for four days and made a real difference in her life: it saved our marriage and gave her a new outlook on her daily life!

Thank you so much, Premier Biomedical, you helped us.”

Stephen Harder Construction Manager


Testimonials (cont)

“I am a 58-year-old white female, also an investor in your company. That is how I found out about the pain patch and when it became available for purchase. I was diagnosed with Fibromyalgia in the 1980’s. Since then I have gotten a bulging disc in my lower back and arthritis in my T-connectors in my spine. I have been taking some type of opioids since the 1980’s and more recently for the past 17 years I have been taking Methadone (14) 10 mg for pain and Oxycodone (4) 10 mg for breakthrough pain.

After putting the patch on, my pain completely disappeared! Read that again … my pain completely disappeared! The patch did come loose from my skin after 1-1/2 days so I put it back into the pouch it came in overnight and took a shower in the morning then put it back on with an additional bandage patch over the top and it stayed on. It continued working up until about 3-1/2 days (minus the time I had it off) then my pain came back. Unfortunately, I am on Social Security Disability and cannot afford to use the patches instead of the pain pills due to cost. I am anxiously awaiting the insurance companies to catch up and start letting us get these on our insurance. After all, it benefits them as well.”

Diane Knuckles Tennessee


Testimonials (cont)

“I am a white female, 58 years of age. I have been diagnosed with both chronic osteo-, and sero-negative arthritis. I also suffer from Facet’s disease, herniated and bulging discs spinal stenosis. I favored and guarded my L knee for over 30 years due to a traumatic injury sustained as a young teen. Because of this, I put undue pressure on the right foot causing trauma to the ankle area. The ankle is continually swollen, complicated by severe venous insufficiency. Pain is reported at a constant 8 to 9 on a scale of 10. I am currently using a 25 mg Fentanyl patch, with 7.5mg Hydrocodone used for breakthrough pain. I also utilize Meloxicam at a 15mg. dose each morning to help control inflammation.

My nephew provided me with a pain patch and I put it directly on the affected area, which remained relatively pain free for approximately 3-1/2 days, after which the patch came off on its own. I anticipate a day when I and others can utilize your product for both a safer and effective manner of pain relief, free of man-made opioids and similar pain relief methods.”

Kari Location Unknown


Testimonials (cont)

“This CBD roll on needs to be in every first aid kit and medicine cabinet in America. It helps sooth minor sunburn pain, headaches, back pain, sports related muscle pain, knee pain, bursitis and even calms my phantom limb pain. Opioids, Lyrica and Cymbalta could never even touch my phantom limb pain. I want to take a bath in this oil, that’s how good it works and smells.”

Raymond C. New York


Testimonials (cont)

A World Leader in New Biomedical Technology Research & Development

William A. Hartman President & CEO

P.O. Box 25 Jackson Center, PA 16133

Phone: (01)-814-786-8849 Skype name: w.a.hartman

Email: [email protected]

Visit us at www.premierbiomedical.com


http://www.premierbiomedical.com/

Premier iomedical stock is traded on the OT under the ......Antibody/Antigen Therapy Extracorporeal...

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Transcript of Premier iomedical stock is traded on the OT under the ......Antibody/Antigen Therapy Extracorporeal...