1. David Spellberg, MD Naples Urological Associates High Intensity Focused Ultrasound Sonablate ® HIFU A Minimally Invasive Way to Treat Prostate Cancer

3. Prostate Cancer Statistics  Prostate Cancer is the most common cancer among men and is the 2 nd leading cause of cancer deaths.  1:6 men will get Prostate Cancer.  African American men are more likely to get Prostate Cancer.  If you have a family history of Prostate Cancer, your risk of getting Prostate Cancer doubles.

4.  Approximately 220,000 men will be diagnosed with Prostate Cancer this year.  That means that 1,048 men per work/clinic day will be diagnosed with the disease.  Every minute of each work day, 2.18 men are told they have Prostate Cancer.  That is one man every 28 seconds!

5.  Approximately 30,000 men will die from prostate cancer each year.  1:8 men with Prostate Cancer will die from it.  Each day, 82 men will die from Prostate Cancer.  Every hour, 3.42 men die form Prostate Cancer.  A Prostate Cancer death occurs every 17:31.

6.  Incidence increases with age:  Between the ages of 40-59, 1 in 55 men will develop prostate cancer  Between the ages of 60-79, 1 in 7 men will develop clinically significant disease.

7.  Prostate Cancer can be treated.  Prostate Cancer can be cured.  Men diagnosed with Prostate Cancer can live a normal life time.  Most men with Prostate Cancer die from heart related diseases

8. Prostate Cancer Screening Prostate Exam Prostate Specific Antigen (PSA) Digital Rectal Examination (DRE) Transrectal Ultrasound Prostate Needle Biopsy (TRUS PNBx) Bone Scan CT Scan MRI/ Prostascint, etc

9. Treatment Options Radical prostatectomy (open or robotic) External beam radiation (IMRT) Seeds implantation (brachytherapy) Combination beam and seed implant Cryotherapy (total or focal) Hormone therapy Chemotherapy HIFU

11. COMPLICATIONS OF TREATMENT INCONTINENCE IMPOTENCE EJACULATION DYSFUNCTION BOWEL PROBLEMS WORSENING OF OVERALL HEALTH

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

14. Cost of Treatment Open Radical Prostatectomy: $26,000-$47,000 Robotic Radical Prostatectomy: $35,000-$104,000 External Beam Radiation: $80,000-$150,000 Interstitial Radiation: $60,000-$80,000 Cryotherapy: $24,000-$36,000 HIFU: $25,000 **Ranges shown above account for both regional differences and differences in patient outcomes and technologies but do not account for complications resulting from these treatments, which are an additional 50-75% of the original treatment

19. 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 TransducerFocal Point

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

21. 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, outside of the United States.

22. Who Qualifies for HIFU? Ideal HIFU candidate: Localized prostate cancer PSA < 10 Gleason < 7 Prostate Volume 40 cc Other patients may also qualify and should discuss their specific case with a physician.

23. Who else Qualifies for HIFU? HIFU can also treat recurrent prostate cancer. This includes: Radiation failures Cryotherapy failures Prostatectomy failures Brachytherapy failures (seeds) HIFU failures

24. Sonablate ® HIFU Today Over 100 HIFU Centers, outside of the U.S., in North & South America, Europe, Asia, and other countries where the device is approved. Over 7,000 patients treated with prostate disease (BPH and Cancer), outside the U.S. Over 250 trained Sonablate ® users worldwide.

25. The Sonablate ® HIFU Procedure 1-4 hour outpatient procedure, depending on size of prostate 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.

26. Recovery & Follow Up Patients have a catheter that is removed 2-4 weeks after HIFU. Office visit with doctor required for removal. Check PSA at 3, 6, 9 and 12 months then yearly thereafter.

27. Side Effects & Complications All treatments for prostate cancer carry some risk for potential side effects and complications. Side effects include frequency, urgency, mild discomfort or discharge in urinary stream. Studies performed outside the US report that less common side effects (these may be more severe) may also include urinary stricture, retention, incontinence, impotence and rectal fistula. As with any medical procedure, all potential side effects and complications should be discussed with a physician before undergoing therapy. For a complete list of all possible risks associated with HIFU please refer to www.InternationalHIFU.com

28. Results & Data TreatmentDescription Selected RisksRecoverySelected Outcomes High Intensity Focused Ultrasound (HIFU) as approved and used outside the US Minimally invasive use of intersecting, precision-focused ultrasound waves to ablate diseased tissue In approved countries Incontinence: 0-2% Impotence: 20-30% Temporary catheter worn for approximately 2-4 weeks; resume normal lifestyle almost immediately 94% biochemical disease-free survival rate at 4 years 87% negative biopsy rate at 6 months Cryotherapy Minimally invasive procedure using controlled freeze and thaw cycles to destroy cancerous cells Incontinence: 4-27% Impotence: 40-100% 2-3 hour procedure with possible overnight stay; return to normal activities within a few days 78% biochemical disease-free survival at 1 year; 60% at 5-7 years; 88% negative biopsy rate at 5 years Radical Prostatectomy Major surgery to remove prostate; can be open retropubic, laparoscopic or robotic Incontinence: 4-34% Impotence: 51-80% 1-3 day hospital stay; catheter for 2-3 weeks for open surgery; shorter hospitalization and fewer postoperative complications for robotic procedures 85-91% biochemical disease-free survival at 2 years; 68-72% biochemical disease-free survival at 10 years External Beam Radiation 6 to 8 week treatment, beaming radiation through healthy tissues Incontinence: 4-7% Impotence : 41-62% Bowel problems more common than with other treatments Five treatments per week for 6 to 8 weeks, up to 2 months fatigue after full course of treatment 78% survival rate at 5 years 55-65% biochemical disease-free survival rate at 5 years; 49% at 10 years Internal Radiation Seeds (Brachytherapy) Minimally invasive implants of radiation seeds in the prostate Incontinence: 3-18% Impotence: 44-58% 1-2 hour procedure with possible overnight stay; return to normal activities within a few days 85-91% biochemical disease-free survival at 10-12 years Data presented are for clinically localized, low-risk primary prostate cancer, generally defined as PSA ≤10ng.mL, Gleason score ≤6, clinical stage T1 or T2a. Chart was researched and compiled by Synteract, a third party CRO. The information provided in the chart may not included all potential risk, recovery and outcome information. *For a complete list of general reference for all treatment modalities see end of presentation.

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

30. 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

31. Where is HIFU Available now? International HIFU Centers Toronto, Ontario, Canada Brampton, Ontario, Canada Niagara Falls, Ontario, Canada Winnipeg, Manitoba, Canada Montréal, Québec, Canada Puerto Vallarta, Mexico Cancun, Mexico Nassau, Bahamas

32. Status of HIFU in the US HIFU with Sonablate ® 500 is not approved for use in the U.S. The Sonablate ® 500 remains investigational in the U.S. and is being studied for the treatment of prostate cancer in clinical trials in the U.S. The FDA has made no decision as to the safety or efficacy of the Sonablate® 500 for the treatment of prostate cancer. Currently the device is approved for use in Canada and the Dominican Republic, authorized in Argentina, and available in the Bahamas and Mexico.

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

34. -Thank You- Questions?