Clinical Results of a Study in Chronic Ischemic Heart...

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Restoring Vascular Health … Naturally

Clinical Results of a Study in Chronic

Ischemic Heart Disease

CIRCULAT®

22180 Calumet Street, Clearwater, Florida 33735

www.circuforte.com


Chronic Ischemic Heart Disease

A common serious complication is damage to blood vessels in patients with diabetes, leading to decreased blood flow to the heart and results in pain of angina pectoris and heart attacks.

Cardiac ischemia (angina chronic complications of diabetes) occurs (only in USA) at 6.6 million patients a year, despite the use of established drugs for angina pectoris and some modern surgical procedures - stents, angioplast, etc.

Obviously, the overall disease burden reflects the many limitations of current therapy, as medication for angina pectoris are only partially effective, with a high morbidity and mortality from invasive procedures.

Almost 2 million people each year continue to suffer from cardiac ischemia and angina attacks, even with current interventions and therapies to optimize revascularization. The American Hearth Association in its statistics published in USA there are 8.5 million heart patients and 10.2 million suffer from angina.

According to the WHO World Atlas, heart disease and strokes kill 17 million people each year, approximately 29.3% of deaths worldwide. Nearly 40% is specifically for ischemic heart disease.


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CIRCULAT®Study

in Chronic Ischemic Heart

Disease


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Background: Endothelial Damage

Normal Artery Artery Narrowed byAtherosclerotic Plaque

Endothelium

Smooth Muscle

Smooth Muscle Cells

MacrophagesChanged inFoam Cells

Lipids, Calciumand Cellular Debris

Fibrous Layer

Endothelial Damage

EndothelialDisfunction

Mechanical Stress

Hypertension

Vasoconstriction

Peripheral-Vascular Resistance


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GSPECT Cardio-Diagnostic Imaging

Sorce: www.yale.edu/imaging


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Treatment study of chronic ischemic heart disease with complex herbal formulation

CIRCULAT®

- Researchers: Roberto Guzmán, José Olalde, Francis Améndola, Oswaldo del Castillo -

Results: There was good response to therapy in 85% of the sample (p ≤ 6.104 e-05,% = 99.9999, determined by Wilcoxon). No patients suffered adverse effects or died

during the study period.

Examples of Case StudiesIncluding GSPECT Image Evidence


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Case Study # 1

GSPECT image

Chronic Ischemic Heart Disease1 year treatment

68 years old male patient, with significant three vessel coronary artery obstruction disease. Indications of surgical myocardium revascularization were rejected. Entered study protocol on 04/29/2009 due to clinical symptoms (FC II Dyspnea on exertion). On such date a Cardiac SPECT is performed and patient commences CIRCULAT®

treatment. Patient presents satisfactory clinical evolution, remaining cardiovascularlyasymptomatic from the second month of treatment. Cardiac SPECT control,

performed on 09/26/2009, showed improvements of the anterior-apical perfusion, while showing the ventriculography study revealed a left ventricle ejection fraction increase (34% to 45%). Left Ventricle Perfusion Defect (PD) during studied period

with CIRCULAT® treatment dropped from 40% to 35%.


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Case Study # 2

Functional Capacity Time (sec.)Functional Capacity Test not done

due physical limitations

GSPECT Image


78 years old female patient, diagnosed with chronic ischemic cardiopathy(previous non ‘Q’ wave lateral myocardial infarction.) with stable FC II (NYHA)

exertion angina diagnosis; cardiac SPECT was performed under pharmacological stress and CIRCULAT® treatment was started on 05/13/2009. A satisfactory clinical evolution was observed; with disappearance of angina 90

days after treatment’s beginning. Control Cardiac SPECT’s were performed 10/28/2009 and 07/07/2010, showing myocardial perfusion improvements in lateral and inferior walls. Left Ventricle Perfusion Defect (PD) during studied period with CIRCULAT® treatment dropped from 45% to 30% (10/28/2009) to

15% (07/07/2010).


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Case Study # 3


70 years old male patient, diagnosed with chronic ischemic cardiopathy (stable FC II exertion angina). Cardiac SPECT performed on 05/20/2009 and CIRCULAT® treatment

was started. After 60 days of treatment disappearance of Exertion Angina was observed. Control Cardiac SPECT performed on 10/28/2009 showed improvement of

myocardium perfusion in inferior wall, which remains in control as per Cardiac SPECT performed on 06-16-2010 (one year after treatment’s initiation). Left Ventricle

Perfusion Defect (PD) with CIRCULAT® treatment dropped from 20% to 10 % (10/28/2009). Last SPECT control (06/16/2010) determined the same level of PD (10%).

GSPECT Image


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Case Study # 4

GSPECT Image

Chronic Ischemic Heart Disease6 month treatment

Male 68 yeasr old patient, chronic ischemic cardiopathy previously diagnosed, with two prior hospitalizations due to unstable angina and positive Resistance Test (++) for

myocardium ischemia. Enters clinical study on 06/23/2009 when control Cardiac SPECT is performed and CIRCULAT® treatment commences. After a month,

significant improvement of functional capacity for exercise and reduction in the frequency of angina episodes are reflected. Cardiac SPECT performed on 11/11/2009, showed global perfusion defect decrease, while an increase in ejection fraction (from 44% to 50%) is observed. Left Ventricle Perfusion Defect (PD) during studied period

with CIRCULAT® treatment dropped from 70% to 60% (11/11/2009) to 10% (06/16/2010).


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Case Study # 5

Male 68 yeasr old patient, with chronic ischemic cardiopathy (significant obtrusive artery damage in two vases), enters study with FC II Exertion Angina clinical

symptoms. Cardiac SPECT was performed at the start of treatment with CIRCULAT®(on 05/06/2009). Two months after the start of treatment a very satisfactory clinical

evolution is observed; with disappearance of exertion angina. Control Cardiac SPECT was performed on 10/07/2009, which evidenced important improvement of

myocardium perfusion in inferior and anterior-septal walls. Cardiac SPECT on 07/09/2010 reveals ‘without myocardium perfusion defects’. Patient remains

cardiovascularly asymptomatic. Left Ventricle Perfusion Defect (PD) during studied period with CIRCULAT® treatment dropped from 30% to 25% (07/09/2009) to 0

(07/09/2010).

GSPECT Image



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Case Study # 6

Male 42 years old patient diagnosed with chronic ischemic cardiopathy (previous heart attack in lower side) and Mellitus Diabetes type 2. Enters clinical study with

clinical symptoms of FC II Dyspnea on Exertion (NYHA). A Cardiac SPECT was performed and treatment with CIRCULAT® started on 05/06/2009. After two months of treatment disappearance of Dyspnea on Exertion is observed. Control Cardiac

SPECT was performed on 10/07/2009 revealing increase in myocardium perfusion in inferior lateral wall. Improvement is maintained as demonstrated with cardiac SPECT control performed on 06/09/2010. Patient is currently FC I (NYHA). Left

Ventricle Perfusion Defect (PD) during studied period with CIRCULAT® treatment dropped from 30% to 20%. PD is maintained at the same level (20%) on 06/09/2010.

GSPECT Image



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Case Study # 7

GSPECT Image


61 years old male patient, diagnosed with chronic ischemic cardiopathy (stable FC II Exertion Angina) and positive exertion test for ischemic cardiopathy.

Cardiac SPECT was performed and CIRCULAT®treatment started on 04-29-2009. Satisfactory clinical evolution with improvement

of functional capacity for exercise, in spite that Cardiac SPECT Control performed on 09-16-2009 revealed continuance of perfusion defect (15%) in left ventricle

inferior wall, with a post exertion ejection fraction within normalcy. Left Ventricle Perfusion Defect (PD) during studied period with CIRCULAT®

treatment remained at 15%.


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Case Study # 8

GSPECT Image


57 years old female patient seeks consultation because of FC II (NYHA) exertion Dyspnea with positive (+) exertion test for myocardial ischemia. Enters clinical

study on 07/14/2009, when Cardiac SPECT is performed and CIRCULAT® treatment is started. Patient is cardiovascularly asymptomatic after 30 days of treatment.

Control Cardiac SPECT is performed on 11-11-2009, evidencing front wall (front-apical segment), perfusion improvement. This last is maintained in SPECT

performed after 12 months (07-28-2010). Currently cardiovascularly asymptomatic. Left Ventricle Perfusion Defect (PD) during studied period -with CIRCULAT®

treatment- dropped from 10% to 5%.


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Case Study # 9


GSPECT Image

58 years old male patient, diagnosed with chronic ischemic cardiopathy (previous infarction in inferior wall?). Patient is cardiovascularly asymptomatic when entering clinical study. Cardiac SPECT is performed and CIRCULAT® treatment is started on

07-14-2009. Control cardiac SPECT’s performed on 11-11-2009 and 08-04-2010 reporting continuance of myocardial perfusion defect (20%) in inferior and high lateral walls is reported. Patient remains asymptomatic. Left Ventricle Perfusion Defect (PD) during studied period -with CIRCULAT® treatment- remained at 20%.


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Case Study # 10

GSPECT Image


74 years old female patient, diagnosed with chronic ischemic cardiopathy (previous inferior myocardial infarction), enters study protocol with exertion angina (FC II)

clinical symptoms and recent hospitalization with unstable angina diagnosis. Cardiac SPECT performed and CIRCULAT® treatment started on 05-13-2009.

Cardiovascularly asymptomatic, after four month treatment. Control Cardiac SPECTperformed on 10-07-2009, where important myocardial perfusion defect

improvements were noticed, diminishing from 60% to 35%. Control SPECT performed on 06-02-2010 reveals further perfusion defect decrease to 20%. Currently

continues to be cardiovascularly asymptomatic (08/04/2010) with same PD (20%).


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Case Study # 11

GSPECT Image


75 years old female patient, diagnosed with chronic ischemic cardiopathy (stable angina, FC II Exertion); and positive exertion test (++) in inferior wall. Cardiac SPECT

was performed and treatment with CIRCULAT® started on 08-12-2009, showing a functional class clinical improvement one month after the start of treatment. After 4

months of treatment compliance there is absence of cardiovascular symptoms. Control Cardiac SPECT was performed on 12-08-2009, where Myocardium perfusion defect

improvement -in inferior and lateral walls- is reported. Post exertion ejection fraction stays normal. Left Ventricle Perfusion Defect (PD) during studied period with

CIRCULAT® treatment dropped from 25% to 15%.


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Case Study # 12

GSPECT Image


Female 53 years old patient enters study with clinical symptoms of exertion DyspneaFC II (NYHA) and positive myocardial ischemia exertion test (+). Cardiac SPECT

performed on 07-14-2009, date of CIRCULAT® treatment start. Initial perfusion defect was 10%. Cardiovascularly asymptomatic one month after start of pharmacological

treatment. Control SPECT performed on 12-02-2009, which reported status as ‘normal’and disappearance of perfusion defect (0%). Yearly control SPECT (08-04-2010)

remains within normal parameters with PD maintained at 0%.


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Conclusions

Results in the administration of CIRCULAT® have proven to be therapeutically effective, accessible and safe for the treatment of chronic ischemic heart disease

The evidence of the effectiveness of CIRCULAT® was determined by imaging product of the state of science through GSPECT (CT photon emission).

CIRCULAT® is the only known treatment capable of producing oral myocardial reperfusion in patients with chronic ischemic heart disease.

2180 Calumet Street, Clearwater, Florida 33735www.circuforte.com


For additional information about clinical trialsand CIRCULAT®, please contact us at

CIRCULAT BIOTECH, LLC

2180 Calumet St.

Clearwater, Florida 33735

Dr. José Angel Olalde Rangel, CEO & Founder

Phone: +727-214-1290 / +58-212-945-9925

[email protected]

Clinical Results of a Study in Chronic Ischemic Heart...

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