1. High Intensity Focused Ultrasound Sonablate® HIFU
A Non Invasive Way to Treat Prostate Cancer
David M. Spellberg, M.D., FACS

2. Localized Prostate Cancer
Effective treatment
Safe treatment
Minimal lifestyle changes

3. Non-Invasive not tending to infiltrate and destroy healthy tissue
Non-surgical
No side effects
Minimal discomfort

4. High Intensity Focused Ultrasound
What is HIFU?
HIFU stands for
High Intensity Focused Ultrasound
Non-Invasive therapy that focuses sound waves to create heat
Similar to light traveling
through a magnifying
glass to create heat
Raises the temperature of the target tissue to almost 195 degrees Fahrenheit (90 degrees Celsius)
Destroys the targeted tissues where sound waves cross
2000 W/cm2
Transducer
Focal Point

5. HIFU with the Sonablate® 500
The Sonablate® 500 is a medical device that uses HIFU to thermally ablate the prostate.

6. Brief History of HIFU
HIFU research began in the 1950s in Indianapolis, IN.
Over the years HIFU has evolved to the applications we have today which include treating various types of cancer and diseases.
In 2004, the first International HIFU Centers opened in the Americas.

7. Status of HIFU in the US
The Sonablate® 500 is being studied in clinical trials for use in the treatment of prostate cancer in the United States and is not approved for use by the U.S. Food and Drug Administration.
HIFU with the Sonablate® 500 is authorized for use for the treatment of prostate cancer in Canada, Argentina and the Dominican Republic. It is also available in the Bahamas and Mexico.  

8. HIFU featured in Men’s Vogue

9. Sonablate® HIFU Today
Over 100 International HIFU Centers in North & South America, Europe, Asia, and other countries where the device is approved
Over 3,500 prostate cancer patients treated with the Sonablate® 500
Over 6,000 patients treated with prostate disease (BPH and Cancer)
Over 180 credentialed Sonablate® users worldwide

10. Who Qualifies for HIFU? Ideal HIFU candidate:
Localized prostate cancer
PSA < 10
Gleason < 7
Prostate Volume 50 cc or less
Patients who don’t fit this criteria may still qualify; discuss case with physician for final qualification

11. Who else Qualifies for HIFU?
HIFU can also treat recurrent prostate cancer.
This includes:
Radiation failures
Cryotherapy failures
Surgical failures
Brachytherapy failures (seeds)
HIFU failures
Benign prostatic hyperplasia (BPH)

12. The Sonablate® HIFU Procedure
1-4 hour outpatient procedure, depending on size of prostate
Spinal/epidural anesthesia with light sedative
Therapy is delivered through a transrectal probe after patient is numbed from the waist down
1-2 hour recovery at HIFU treatment facility
After procedure, most patients resume normal lifestyle within a few days
In most cases, HIFU is a one time procedure. It is non-surgical, radiation free and has minimal blood loss.

13. Recovery & Follow Up
Patients have a catheter that is removed days after HIFU. Office visit with doctor required for removal.
Check PSA at 3, 6, 9 and 12 months then yearly thereafter.

14. Side Effects & Complications
HIFU results from a study done in Japan show low rates of both
Impotence (<20%)
Incontinence (<0.6%)
Minimal Complications
Discomfort associated with catheter
Tissue passing
Most are temporary and mild

15. MRI Pre and Post HIFU MRI Image of prostate 2 weeks
MRI Image of prostate Pre-HIFU

16. USHIFU Results & Data
Physicians have treated more than 700 patients in Mexico, the Dominican Republic and Canada.
According to a Japanese study, the disease free rate after 6 years is 97% for low risk patients (PSA < 10; Gleason < 6)
Another small study from the UK showed that 92% of men had Nadir PSA of 0.2 ng/ml or lower after 3 months.

17. # of SB Treatments worldwide # of HIFU cases in North & South America
Results and Data
# of SB Treatments worldwide
# of SB Centers in world
# of SB500 Users
# of HIFU cases in North & South America
Over 6,000
Nearly 100
Nearly 200
Over 700
Efficacy
KEY FINDING
Length of Follow-Up
Percentage
Physician
Presentation/Study
Negative Biopsy Rate
1 year
91%
Sumitomo, Hayakawa, Nagakura
One Year outcomes following HIFU Japan Endourology & ESWL Conference 2005
Biochemical Disease-Free Rate
6 years
97% (low risk group: pre-HIFU PSA <10)
Uchida, Shoi ,Nagata
HIFU for Localized Prostate Cancer 6 year Experience Japan Endourology & ESWL Conference 2004
Nadir PSA after HIFU
3 months
92% (PSA of 0.2ng/ml or lower)
Emberton, illing, Dawkins, Ogden
British Prostate Group- Autumn Meeting 2005

18. Now that we know what Sonablate® HIFU is…
If you are interested in HIFU, you will need to know the following:
PSA
Gleason
Prostate Volume (very important)
Other therapies/treatments and any relevant medical history

19. Where is HIFU Available now?
International HIFU Centers
Canada
Mexico
The Bahamas
Dominican Republic
FDA approved Phase III Clinical Trial
All trial sites are currently full
Trial is not accepting additional subject applicants
Additional trial sites may open in the future

20. Where can I get more information?
Online:
Read patient testimonials, watch videos and more
Call USHIFU Office to speak with a HIFU representative:
Patient Booklet and DVD
Speak with men who have already had HIFU

21. -Thank You- Questions?