ULTROID TECHNOLOGIES, INC.

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What are Hemorrhoids?What are Hemorrhoids?Hemorrhoids are swollen veinsHemorrhoids are swollen veins

• Internal – Veins inside the rectal canal• External- Veins under the skin around the anus• Mixed- Both internal and external

Etiology•Constipation

•Diarrhea•Straining at stool

•Low fiber diet•High in refined foods

•Pregnancy

Clinical Symptoms•Bright red bleeding

•Sense of fullness in anal area•Prolapse

•Pain or discomfort•Soiling

•Mucous discharge

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THE MARKETTHE MARKETHemorrhoid FACTSHemorrhoid FACTS

• The MOST COMMON AILMENT KNOWN TO MEN AND WOMEN!The MOST COMMON AILMENT KNOWN TO MEN AND WOMEN! • 80% of Americans will acquire some level of hemorrhoids

in their life time.• 33% of pregnant women develop hemorrhoids.• About HALF of all Americans will have hemorrhoids by the

age of 50.• 80% of Americans over the age of 50 will acquire

hemorrhoids• Onset usually occurs after the age of 30.• Common causes: prolonged sitting/standing,

pregnancy, poor diets, constipation, straining, etc. • Over-the-counter remedies at drug retail stores,

ranking it as one of it’s most strategic products.

SOURCE: United States Agency for Healthcare Research & Quality

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THE MARKETTHE MARKET

Total Cost: $1.2 Billion +174%

The US Agency for Health Care Research and Quality ranked hemorrhoids as the third fastest growing disease in a recent survey

   

• The recorded cost of patients treated for symptomatic hemorrhoids increased by 23% to 1.2 Billion.

• Approximately 45 million Americans above the age of 45 have symptomatic hemorrhoid disease.

• Most Americans suffer in silence, delaying medical treatment an average of 9 years.

• The vast majority of Americans are unaware of painless, non-surgical, safe and effective treatments for hemorrhoid disease.

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Treatment Modalities

Hemorrhoidectomy

Rubber Band Ligation

Laser

Direct Current (Ultroid)

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Hemorrhoidectomy

• Applicable Grades: 3, 4• Percent Success?• Advantages

- Useful in severe cases• Disadvantages

- Costly $12,000 to $15,000 +- Requires hospital stay 2-5 days- Extreme Pain associated- Takes 20-50 days to fully recover- Procedure related complications . include: Death, bleeding,

recurrence, incontinence, sepsis- Patient frequently out of work for 2-3 weeks.

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JAMIE THOMPSONPublished August 21, 2005

“Erin Flatley told friends she was having mouth

surgery. The truth was too embarrassing. She

didn't like to talk about it, not even with her father,

who already had the procedure done twice:

a hemorrhoidectomy. Doctors said it wasn't

essential, but Erin, 23, had been having pain.”

“Everyone had told her: It was minor surgery,

with major pain. They weren't worried.

What could go wrong?”

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Rubber-Band Ligation• Applicable Grades: 1, 2, 3• Percent Success:

– 90%• Advantages:

– Outpatient– No Anesthesia– Economic– Easy to Perform– High Risk Patient

• Disadvantages:– Local Pain– Rare Hemorrhage– Thrombosis (Blood Clot)– Complications including sepsis,

death– Questionable Value on Grade 3

and 4

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Laser• Applicable Grades: 1, 2, (3?)• Percent Success:

– 85 - 95% for grades 1 & 2• Advantages:

– Outpatient– No Anesthesia– Economic– Quick

• Disadvantages:– Some Pain associated– Bleeding– Thrombosis– Questionable efficacy on Higher

Grades– Possible Laser Burn

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Direct Current• Applicable Grades:

– 1, 2, 3, and 4• Percent Success:

– 85-95% grades 1 thru 3• Advantages:

– Outpatient– Effective– Safe (No reported complications)– Easy to Apply– No Bowel Preparation– Applicable to All Grades– Economic– No Anesthesia

• Disadvantages:– 8-12 minute procedure vs. 1-5 with

Banding & Laser

• Haynes began using Electrolytic Action to treat tissue in 1866• Baker then actually treated Hemorrhoids with Electricity in 1882• Webb used Electrolysis to destroy tissue in 1921• Wilbur Keesey used the Direct Current technology, referred to as Galvanism, to

obliterate Hemorrhoids in 1934- Developed a crude machine to treat hemorrhoids

-The machines were cumbersome and difficult to use by Physician

SourcesHaynes, CM. Electrotherapeutics. W.T. Kenner Co., Chicago, 1896, p. 163.Webb, JC. Treatment of Hemorrhoids by Electrolysis. Br. Med. J. 1921, 1:457.Ogden, WE. Hemorrhoid Treatment by Galvanism. Research Dept., H. G. Fischer & Co., Inc., Chicago, 1932. Keesey, WE. Obliteration of Hemorrhoids with Inverse Galvanism. Am. J. Phys. Ther., May, 1933.Keesey, WE. Obliteration of Hemorrhoids with Negative Galvanism. Arch. Phys. Ther., 1934; 12:533-40.Norman, DA. Management of Hemorrhoidal Disease: An Effective, Safe, and Painless Outpatient Approach Utilizing D.C. Current. Gastrointestinal Endoscopy April, 1987. Norman, DA, et.al. Direct Current Electrotherapy of Internal Hemorrhoids. Am. J. Gastro. 1989; 5: 482-87.Zinberg, SS, et.al. A Personal Experience in Comparing Three Nonoperative Techniques for Treating Internal Hemorrhoids. Am. J. Gastro. 1989; 5: 488-92.Shackett, RA. Electric Treatment of Hemorrhoids. Hemorrhoid Care Medical Clinic, San Diego, 1989.Machicado, GA, et. Al. Resoltion of chronic anal fissures after treatment of contiguous internal hemorrhoids with direct current probe. Gastro. Endoscopy 1997, 45: 157-62.

History of the TechnologyHistory of the Technology

• 1986 - Ron Newton, Inventor & Dr. Dan Norman, MD, Gastroenterologist,redesigned, improved technology; applied for patent rights.

• 1987 – MicroVasive, Inc. purchased rights, filed FDA 510K and began marketing the device. Approximately 1,500 units sold in first year.

• 1988 – MicroVasive transferred Licensing rights to Boston Scientific.

• 1994 – Cabot Medical obtained technology from Boston Scientific.

• 1996 – Circon (now ACMI) acquired Cabot and displaced Ultroid in attempt to market their more expensive Bicap device. Bicap eventually was removed from the market due to patient

complications.

• 2002 – Dr. Norman and Mr. Newton eventually re-acquired the rights to the technology, updated the Ultroid Machine filing a new 510K and patents.

Chronology of Events for UltroidChronology of Events for UltroidWhy now? Where has the technology been for the last 10 years?

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Ultroid DeviceUltroid Device

• FDA - 510K filed and approved

• Technology with nearly 20 years of history, validation

• Clinical Trials showing high efficacy

• Proven in thousands of cases around the world

Mechanism of ActionMechanism of Action

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Comparative StudyNo. of Patients

Good Results * Fair Results **

Requiring

Surgery

Laser Coagulation

GRADE 1 152 97.4% 2.6% 0

GRADE 2 136 96.5 2.9 1

GRADE 3 13 23.1 69.2 1

GRADE 4 1 0 100.0 0

BICAP (Heater Probe)

GRADE 1 178 95.5 4.5 0

GRADE 2 69 88.4 11.6 0

GRADE 3 17 5.9 88.2 1

GRADE 4 0 0 0 0

ULTROID

GRADE 1 58 100.0 % 0.0 % 0

GRADE 2 109 92.7 7.3 0

GRADE 3 21 85.0 9.5 1

GRADE 4 4 0.0 75.0 1

* Good Results = Complete Resolution of the Symptoms

** Fair Results = Marked Improvement in Symptoms

(Amer. Journal of Gastroenterology, Vol. 84, No. 5, 1989)

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Comparative Study “Conclusion”

"….Ultroid therapy, which is also performed on an outpatient basis with little or

no sedation, appears to be associated with still less discomfort and complications

than either infrared photocoagulation therapy or heater probe coagulation therapy.

In addition, good results in the treatment of third-degree hemorrhoids and in some cases, fourth-degree hemorrhoids, can be achieved with Ultroid

Therapy.“

(American Journal Gastroenterology, Vol. 84, No. 5, 1989; Sheldon S. Zinber, MD, David H. Stern, MD, Donald S. Furman, MD, Joel M. Wittles, MD)

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What Doctors are saying about Ultroid…

• “My patients are very pleased. In fact, they are referring family and friends…” Dr. B. Theobold, Missouri

• “I had a BAD case of hemorrhoids myself and saw a colleague of mine. The experience was so good, I am now performing it.” Dr. D. Young, South Carolina

• “I may be one of the first Ultroid users in the world. I have been using this device since 1991 (over 15 years) with unparalleled results. I might have treated over 4 thousand patients… I have not had a single complication and patient satisfaction is over 95% or even higher. I can not understand, nor believe why this method is not the first line of treatment? Dr Joseph Georghy, Austrailia

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What Patients are saying…• “My rectal bleeding and itching are totally gone. I’m very

happy.” L.B. Brooklyn, NY

• “I feel like a new man.” D.N. Orlando, FL

• “Your treatment has allowed me to avoid a surgical operation.” E.T. Clermont, FL

• “During and after the treatment, I had no pain.” - Tony, Orlando, FL

• “I was a patient of Dr H. in the Salt Lake City Utah area.  The treatment was successful and exactly as advertised.  Suffice to say I am very satisfied.” – Col. J. T. (Retired)

STATISTICS INDICATE YOUR PATIENTS ARE SUFFERING!

HELP THEM WHILE GENERATING SIGNIFICANT PROCEDURE-BASED

INCOME!To sign up and reserve your location with Ultroid

please call Gary Schubach, Ed.D, A.C.S.

1-415 459-2801Email: DoctorG@DoctorG.com