High Intensity Focused Ultrasound Sonablate HIFU A Non

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

Localized Prostate Cancer • Effective treatment • Safe treatment • Minimal lifestyle changes

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

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/cm 2 Transducer Focal Point

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

Brief History of HIFU • HIFU research began in the 1950 s 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.

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.

HIFU featured in Men’s Vogue

® 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

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

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)

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.

Recovery & Follow Up • Patients have a catheter that is removed 1421 days after HIFU. Office visit with doctor required for removal. • Check PSA at 3, 6, 9 and 12 months then yearly thereafter.

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

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

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.

Results and Data # of SB Treatments worldwide # of SB Centers in world # of SB 500 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. 2 ng/ml or lower) Emberton, illing, Dawkins, Ogden British Prostate Group- Autumn Meeting 2005

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) • Otherapies/treatments and any relevant medical history

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

Where can I get more information? • Online: www. International. HIFU. com – Read patient testimonials, watch videos and more • Call USHIFU Office to speak with a HIFU representative: 1 -888 -874 -4384 • Patient Booklet and DVD • Speak with men who have already had HIFU

-Thank You. Questions?