A New Dawn of Cancer & Viral Disease Treatment and Brain Protection

Preliminary Prospectus by

Hypermeda Biomedical Technology Company

In La Jolla , Californiawww.hypermed.us

Hypermed, Inc A biomedical technology company in La Jolla, California, with U.S. patented (US patent number 6669661) and patent-pending devices and technology to achieve 4 product and service lines:

1. Hyperthermia technology to treat cancers and infections

2. Hypothermia Cool-Head Device to save injured or hypoxic brains

3. Advanced Ultra-Violet Germicidal Device to prevent hospital-acquired infections and spread of epidemics

4. O.A.S.I.S. protocol to stop opiate addiction instantly and safely without withdrawal

Corporate Mission

Become global leader in the technology and business of saving and extending meaningful human lives.

Science Team Chief of Clinical Research: Dr. Matthew Cooper, MD FACSformer Clinical asst Professor, Dpt. of Surgery University of Nevada School of Medicine

Chief of Basic Science Research: Dr. Bing Mei Fu, Ph.D.Assistant Professor, Department. of Mechanical Engineering, City College of New York

Chief of Medical and Animal Research: Dr. Kevin Murray, MDformer Chief of Cardiac Surgery, University of Nevada School of Medicine

Management TeamPresident: Thomas C. Yee, MD MBAformer chief cardiac anesthesiology, Univ. of Nevada School of Medicine

Vice President: Dr. Jason Yee, Ph.D. Electrical Engineering Ph.D., Princeton University

Patent on Brain Protection• “Method and Device for Central

Nervous System Protection During Whole Body Hyperthermia or Hypothermia”

• Includes novel use of pharmaceutical agents and the use of new devices to achieve safe profound whole-body hyperthermia in order to treat cancer patients and infectious disease patients, or alternatively, to achieve safe profound whole-body hypothermia in order to preserve the lives of critically ill patients.

• Invention can be viewed at www.uspto.gov by searching for the patent number 6669661

• View patent at http://www.google.com/patents?id=Co4NAAAAEBAJ&dq=6669661

Market and Revenue Projections for Treating Cancers with Hyperthermia

Approximately 500,000 persons die annually in the US due to cancer. Three times that number die in affluent societies outside US. Hyperthermia treatment warrants compensations at least similar to heart bypass surgeries or to bone marrow transplant procedures, costing between $40,000 and $100,000. It is reasonable to price the Hyperthermia treatment at $60,000. Assuming only 33% of persons dying of cancer in affluent societies (500,000 people) seek Hyperthermia treatment, the annual revenue will be thirty billion dollars. ($30,000,000,000)

Market and Revenue Projection for Treating Viral Diseases

In the US alone, there are more than two million people with HIV infection. Including all the affluent societies in the world, more than five million people have the same infection. Tens of millions of people are infected with Hepatitis B and C that are otherwise incurable. Every year, tens of thousands of people die in the US from the flu. Around the world, as the recent SARS epidemic reminded us, influenza has the potential of killing hundreds of thousands of people every year.

Assuming 300,000 seek the Hyperthermia and Anti-Viral Combination treatment, annual revenue of eighteen billion dollars. ($18,000,000,000)

Market and Revenue Projection for Cool-Head hypothermia Device

• In the US over 1.5 million patients suffer head trauma or anoxic brain injury. Every unconscious patient presenting to the emergency room or trauma center optimally require brain cooling and monitoring to increase chance of recovery. Global market is at least twice the size of the US market.

• Priced at $2,000 per patient, assuming only 50% of the eligible 1.5 million unconscious patients get the brain-cooling treatment offered by Cool-Head Device, the annual revenue in the US alone is $1,500,000,000.

Market and Revenue Projection for Advanced Ultra-Violet Germicidal Device

• Hospital-acquired infection costs the hospitals in the US an average of $90,000 per case. There are over 3,500 healthcare facilities with over 150,000 cases of serious hospital-acquired infections. Global market is at least twice that of US market.

• Priced at $3,000 per device monthly rental rate, with over 35,000 facilities in the US and additional 10,000 facilities outside the U.S. requiring infection control offered by the Advanced UVG Device, at 4 devices per facility, the annual rental revenue is $500,000,000.

Market and Revenue Projection for OASIS protocol (Opiate Addiction Safely and Instantly Stopped)

In the US, 40,000 Americans die from opiate overdose per year. Currently Las Vegas Rapid Detox Medical Clinic, owned by Hypermed, Inc, charges $15,000 per procedure and performs 100 cases per year.

Assuming 20,000 cases performed per year, under license to Hypermed, at a licensing fee of $5,000 per case, the annual revenue is projected to be $100,000,000.

Financing and Timetable

Hypermed seeks investment of between $10 to $50 million USD to fund development and production of the patented method and devices with 4 revenue streams

Revenue generation begins at 12 months after funding.

Funding Stage 1 (6 months)

Cool-Head Device

Manufacturing cost $300,000

Marketing cost $200,000

Adv UVG Device

Manufacturing cost $300,000

Marketing cost $200,000

Hyperthermia Device

Animal Study$1,000,000

(at Utah Artificial Heart Center)

---------------------------------------------------------

Stage 1 funding need $2,000,000

 

Funding Stage 2 (6 months)Cool-Head Device

DEA app. cost $300,000

Manufacturing $300,000

Marketing $200,000

Adv. UVG Device

UL app cost $100,000

Manufacturing $300,000

Marketing $300,000

Hyperthermia Device

Animal Study $2,000,000

(at Utah Artificial Heart Center)

---------------------------------------------------------

Stage 2 total funding need

$3,500,000

Funding Stage 3 (9 months)

Cool-Head Device

Manufacturing $1,200,000

Marketing $ 500,000 

Adv. UVG Device

Manufacturing $1,800,000

Marketing $ 500,000 

Hyperthermia Device

Clinical Trial $1,000,000

--------------------------------------------------------Stage 3 total funding need

$5,000,000

Funding Stage 4 (9 months) Sales Revenue Starts

Cool-Head Device

Manufacturing $2,000,000

Marketing $1,000,000

Income from Sales ($2,500,000)

Net funding need $500,000

 

Adv. UVG Device

Manufacturing $2,000,000

Marketing $1,000,000

Income from Sales ($2,500,000)

Net funding need $500,000

Hyperthermia Device

Clinical Study $1,000,000

-----------------------------------------------------------

total funding need $2,000,000

Stage 5 (30 months after initial funding)

Annual Revenue

Cool-Head Device $200,000,000

Adv. UVG Device $100,000,000

Hyperthermia Tech $300,000,000

----------------------------------------

Stage 5 Projected Annual Revenue

$600,000,000

Company Valuation at twice annual revenue: $1,200,000,000

Stage 6 (60 months after initial funding)

Franchising and Licensing technology and direct sales

Annual Revenue

Cool-Head Device$400,000,000

Adv. UVG Device$300,000,000

Hyperthermia Tech$800,000,000

--------------------------------------------------------------

Stage 6 Projected Annual Revenue

$1,500,000,000

Company valuation at twice annual revenue

$3,000,000,000

S.W.O.T. Analysis (Strength, Weakness, Opportunity, Threat)

Strength: (1) Novelty of the concept (2) Patented technique (Patent already

granted)(3) Great potential demand for the medical

service(4) Highly respected animal research facility

and staff(5) International basis for human studies (6) Short duration of animal and human

studies(7) Early start up of commercially viable

clinics

S.W.O.T. Analysis

Weakness : (1) Insufficient Funding (2) Knowledge gap between lay person’s

grasp of basic science in this field and the breakthrough at hand

(3) Experience gap between the average investors’ prior exposure to tech and biomed start-ups and the magnitude of Hypermed’’s prospects

S.W.O.T. Analysis

Opportunity(1) Exclusive Cure of Cancer (2) Exclusive Cure of viral diseases(3) Life-extension hypothermia

hibernation (4) Patented exclusive technology can

dominate world market

S.W.O.T. Analysis

Threat:(1) Industrial Espionage(2) Weak protection of intellectual

rights in countries in Asia(3) Future competing technologies

Conclusion & Vision This is a new technology company that owns

patented key technology in the arena of cancer treatment, infection control, and brain protection.

With an investment of between 10 to 50 million USD,

investors can own equity of a company that has potential of billion Dollar annual revenue in 5 years.

United States Patent 6669661

Granted to Dr. Thomas C. Yee

assigned by Dr. Yee to Hypermed

“Method and device for central nervous system protection during whole body hyperthermia or hypothermia”

View patent at: http://www.google.com/patents?id=Co4NAAAAEBAJ&dq=6669661

Background of the Invention The normal body temperature in a human

ranges between 36.1.degree C. and 37.2.degree C. An increase in body temperature is a normal response to a bacterial or viral infection.

Cancer cells, HIV, and hepatitis virus cannot survive extreme temperatures.

To take advantage of this susceptibility to temperature extremes, it is a well accepted medical practice to induce single limb hyperthermia to treat cancer isolated in limbs.

Whole Body Hyperthermia can cause serious side effects such as increased acidity in the blood and neurological damage.

Purpose of the Invention as Applied to Hypothermia (project 2)

Sometimes it is desirable to intentionally induce hypothermia for treatment purposes. For example, during cardiac surgery, the body temperature may be reduced to between 18 degrees. C. and 20 degrees. C. to allow complete circulatory arrest. However, so far, hypothermia is usually limited to less than sixty minutes to prevent neurological damage.

Hypothermia with appropriate neurological protection, as in this patented invention, may provide safe hibernation preservation of humans

Application of the Patented Invention

Therefore there is a need for a method and device for raising the body temperature above 45 degree C or lowering the body temperature below 20 degree C for extended periods of time to allow medical treatment without risking neurological damage.

Patent Abstract A method and device for intentionally inducing whole-body

hyperthermia or hypothermia in a patient for medical treatment while protecting the central nervous system from damage

A tub for immersing the patient's body in a solution with a temperature greater than or less than normal body temperature to thereby increase or decrease the patient's body temperature.

The patient's cerebral spinal fluid is circulated and maintained at temperatures less drastically altered from normal temperatures by a pump and a heater and cooler connected to the patient's spine through catheters.

The patient's central nervous system blood is separated from

the rest of the circulatory system and circulated and maintained at temperatures less drastically altered from normal temperatures by pumps and a heater and cooler. The remaining blood in the patient's body is circulated and temperature controlled through pumps and a heater and cooler.

Sites of Proposed Animal Research

UCSD Animal Research

FacilityUniversity of California, San Diego

La Jolla, California

Utah Artificial Heart CenterSalk Lake City, Utah

Development site of the Jarvik Artificial Heart

Supporting Scientific Studies:

Medical Journal: Annals of Oncology. 2002 Aug;13(8):1173-84. Heating the patient: a promising approach?van der Zee J.Erasmus Medical Center-Daniel den Hoed Cancer Center, Department of Radiation Oncology, Hyperthermia Unit, Rotterdam, The Netherlands

• The effects of both radiotherapy and many drugs are enhanced at an increased temperature

• These findings justify using hyperthermia as part of standard treatment in tumor sites for which its efficacy has been proven and, furthermore, to initiate new studies with other tumors. Hyperthermia is certainly a promising approach and deserves more attention than it has received until now.

Medical Journal:Perfusion. 2002 Jul;17(4):279-90.

Whole-body hyperthermia: a review of theory, design and application.

Vertree RA, Leeth A, Girouard M, Roach JD, Zwischenberger JB.Department of Surgery, The University of Texas Medical Branch, Galveston

• All patients were safely heated to 42 or 42.5 degrees C for 2 h and survived the 30-day study period

• Hyperthermia has been used successfully to treat isolated neoplastic lesions of the head and neck, regional tumors such as melanoma of the limb, and is under investigation as either an adjunct to, or therapy for, locally disseminated and systemic diseases

Critical Review of Oncology and Hematology. 2002 Jul;43(1):33-56. The cellular and molecular basis of

hyperthermia. Hildebrandt B, Wust P, Ahlers O, Dieing A, Sreenivasa G, Kerner T, Felix R, Medical Clinic, Department of Hematology and Oncology, Charite Medical School, Humboldt-University, Campus Virchow Clinic, D-13344 Berlin, Germany.

An improvement of both local control and survival rates have been demonstrated by adding local/regional hyperthermia to radiotherapy in patients with locally advanced or recurrent superficial and pelvic tumors

Surgery. 2002 Jan;131(1 Suppl):S121-7.

Hyperthermia for rectal cancer. Ohno S, Sumiyoshi Y, Mori M, Sugimachi K.

Department of Breast Surgery, National Kyushu Cancer Center, Fukuoka, Japan.

Hyperthermia combined with radiation or chemotherapy demonstrates great promise for the treatment of patients with carcinoma of the rectum.

European Journal of Cancer. 2001 Jul;37(11):1429-34.

Enhancement of the therapeutic outcome of radio-immunotherapy by combination with whole-body mild hyperthermia.

Saga T, Sakahara H, Nakamoto Y, Sato N, Ishimori T, Mamede M, Kobayashi H, Masunaga S, Sasai K, Kuroki M, Konishi J.

Department of Nuclear Medicine and Diagnostic Imaging, Graduate School of Medicine, Kyoto, Japan.

The addition of whole-body mild hyperthermia significantly enhanced the therapeutic effect of radio-immunotherapy by increasing the radiosensitivity of the tumor.

International Journal of Hyperthermia. 2003 Jul-Aug;19(4):444-60.

Heat- and 4-hydroperoxy-ifosfamide-induced apoptosis in B cell precursor leukaemias.

Mauz-Korholz C, Dietzsch S, Banning U, Trobs RB, Korholz D.Department of Pediatrics, University of Leipzig Medical Center, Oststr 21-25, D-04317 Leipzig, Germany

• Application of hyperthermia enhances efficacy of certain anti-neoplastic drugs such as ifosfamide

• whole body thermochemotherapy could be considered as a treatment option in relapsed leukaemic patients.

Cancer Immunology and Immunotherapy. 2002 Dec;51(11-12):603-13.

41.8 degrees C whole body hyperthermia as an adjunct to chemotherapy induces prolonged T cell activation in patients with various malignant diseases.

Atanackovic D, Nierhaus A, Neumeier M, Hossfeld DK, Hegewisch-Becker S Department of Oncology and Hematology, University Clinic Eppendorf, Hamburg, Germany

• This the first study to provide evidence for prolonged WBH-CT-induced activation of human T cells.

• Whole body hyperthermia (WBH) has been used as an adjunct to radio-/chemotherapy in patients with various malignant diseases

US National Cancer Institute Info

04/10/2023 38

The Cool-Head Device

Project 3

04/10/2023 39

Vision Statement

New Device capable of saving brains in distress and offering viable brain life extension in critically ill patients

04/10/2023 40

Goal and Objective

Incorporating Hydrogel, Rapid cooling circulation covering head, neck, chest, back, armpits, groins, abdomen skin areas. Monitoring with Somanetics, BIS EEG and nasopharyngeal temp probes.

Seeking partners in the manufacturing and marketing of Cool-Head device

04/10/2023 41

Today’s Situation

Brain death after 4 minutes of cardiac arrest or respiratory arrest

Emergency, trauma, ICU patients suffering brain death

04/10/2023 42

How Did We Get Here?

Not Dead Till Warm and DeadOriginal assumptions that are no longer

valid: Heart arrests always lead to immediate onset of brain death

04/10/2023 43

Available Options

Cool the brain rapidly or face brain-damaged survivor

Nothing more expensive to healthcare system than a brain-damaged survivor of cardiac arrest

Use Cool-Head to increase brain survival in cardiac/pulmonary arrest, head trauma, stroke, shock patients

04/10/2023 44

Next Steps

Manufacture the Cool-Head based on prototype

Build sales network or partner with distributors

Market it to all EMT, OR and ICU

Contact

Hypermed

5440 La Jolla Blvd, Suite 207, La Jolla, CA 92037

www.hypermed.us

drthomasyee@gmail.com

TEL: (702) 813-3888