Man could have been saved by early PSA testing

Commentary by Dr. George Suarez, founder Sonacare Medical, and the worlds’ leading expert on HIFU for the treatment of prostate cancer:

The lost of life of any kind pf life is tragic and sad. However, in today’s medical environment early PSA screening, detection and treatment has been proven to save life’s. Traditionally, men opted for radiation therapy as best option for non-invasive treatment for localized prostate cancer. Today, FDA approved High Intensity Focus Ultrasound (HIFU) offers an effective non-invasive alternatives with less potential secondary toxic side effects than radiation therapy. As the reporter indicates, “HIFU was not available in the U.S. at time of the patients diagnosis. No longer, it is available in the U.S. with the most experience HIFU center in Miami, Florida.

– George M. Suarez, M.P. FACS, FAAP.

Pictured left to right:

Barry Rassin, President, Doctors Hospital; Dr. George M. Suarez, F.A.C.S., F.A A.P. Medical Director, USHIFU, International HIFU, Board Certified Urologist; James Roth, HIFU patient in the Bahamas

High Intensity Focused Ultrasound (HIFU) Treatment for Prostate Cancer Now Available in Bermuda

US HIFU Selects Bermuda for Easy Access to Treatment for Patients and Physicians in the Northeast PR Newswire

CHARLOTTE, N.C., May 17 2010 /PRNewswire/ — US HIFU, a worldwide leader in the development, distribution and use of minimally invasive high intensity focused ultrasound (“HIFU”) technologies, is pleased to announce that its HIFU treatment for prostate cancer is now available in Bermuda. King Edward VII Memorial Hospital in Bermuda joins more than 100 centers in 30-plus countries to offer the innovative treatment with the Sonablate® 500 medical device.

Bermuda is the newest location to become part of US HIFU’s international treatment program, which provides patients from the U.S. access to the Sonablate technology (“Sonablate HIFU”) in international facilities where it is approved or authorized, since Sonablate HIFU is in the final phase of the FDA clinical trials and not approved for use in the U.S. As part of the US HIFU international treatment program, which began in 2004, patients and physicians travel to the Bahamas, Mexico, Canada and other jurisdictions outside the U.S. for the procedure. HIFU has been approved in Europe and Asia for the past 20 years. Under the leadership of medical director, Dr. George Suarez, Miami based board certified urologist, FDA approved Sonablate HIFU for the treatment of localized prostate cancer in 2015.

“We were strategic in our selection of Bermuda so we could open up access to Sonablate HIFU for interested patients and physicians in the northeast,” said US HIFU’s CEO Steve Puckett, Jr. regarding the company’s decision to introduce Sonablate HIFU in Bermuda at this time. “For ease of transportation, we expect to see a good number of patients and doctors from that area and eastern seaboard in general, but Bermuda’s King Edward VII Memorial Hospital is just one more high-caliber choice open to any patients and doctors throughout the country.”

Dr. Donald Thomas, the hospital’s chief of staff, said, “We are very pleased to be able to offer this treatment. As we are only about a two-hour flight from the eastern U.S., we can offer this high-tech procedure very close to home for some U.S. patients in a stunningly beautiful island setting.”

The first two patients were treated at the beginning of May by Dr. Stephen Scionti, NYU clinical associate professor of urology, who has been involved with Sonablate HIFU since 2006.

“The hospital is a modern, first-rate organization staffed by world-class physicians. As with the other US HIFU facilities, I believe patients can feel as confident in traveling offshore for the treatment as they can in going to their local hospital for an already approved procedure,” said Scionti. “As a physician working away from my regular office, I am able to focus on my patients and their treatment when everything in the venue is in perfect order; King Edward VII Memorial Hospital was no exception.”

Sonablate HIFU is designed as a minimally invasive prostate cancer treatment. International, 10-year data shows that men who choose Sonablate HIFU may be able to treat their disease while also minimizing risk for significant side effects common with prostate cancer therapies such as surgery or radiation. The technology allows physicians to ablate prostatic tissue with extreme heat generated from focused ultrasound waves. The ultrasound energy is delivered in rapid-fire succession to targeted tissue throughout the gland. The tissue at each target is destroyed while surrounding tissue remains unharmed.

Atlanta-resident Robert Jenkins, who received his HIFU treatment on Saturday, May 1, said, “From my perspective—and my physician’s—everything ran like clockwork, from the procedure to the logistics involved with traveling to a different location. The staff was focused, friendly, caring and made sure I felt right before I left.”

Regarding the future of Sonablate HIFU in Bermuda, Puckett said, “The current therapy involves whole gland ablation but we are looking ahead to the focal treatment of prostate cancer, beginning with the upcoming UK clinical trials. Bermuda is slated to be the international specialty site for our focal HIFU procedure.”

About US HIFU US HIFU (USHIFU, LLC), a privately held healthcare company, is a world leader in minimally invasive high intensity focused ultrasound (HIFU) technologies. U S HIFU manufactures the Sonablate® 500 medical device and is focused currently on treating primary and recurrent prostate cancer using Sonablate® HIFU. The company is engaged in ongoing research for technological advancements for the Sonablate® system or other ultrasound applications.

About the Sonablate® 500 The Sonablate® 500 is a minimally invasive medical device that utilizes ultrasound energy to destroy tissue within the body. It was developed by Focus Surgery, Inc. and is manufactured in part by Misonix, Inc. (Nasdaq: MSON), which also holds distribution rights in Europe. Takai Hospital Supply Ltd. distributes the Sonablate® 500 in Southeast Asia. The 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. FDA has made no decision as to the safety or efficacy of the Sonablate® 500 for the treatment of prostate cancer.


Dr. George M. Suarez, founder and Medical Director, Emeritus of USHIFU and International HIFU, and recognized as the most experienced HIFU physician in North America, gave a presentation in Salt Lake City, Utah, on May 12, 2010, on High Intensity Focused Ultrasound (HIFU). The presentation was titled “Minimally Invasive Treatment Options for Localized Prostate Cancer: The Status of HIFU in 2010.”

The conference was attended by University of Utah Urology faculty and members of the local urologic community, as well as several medical and radiation oncologists, therapists, internists, and interventional radiologists. The evening seminar was hosted by Western Urological Clinic, spearheaded by their HIFU trained physicians, particularly, Dr. Steven Gange, the most experienced HIFU trained doctor in the region.

There was great interest and enthusiasm by the group, as well as recognition that HIFU with the Sonablate – 500 has become an integral treatment option for patients with localized prostate cancer. The Western Urological Group have all been trained, or exposed to the technology. Dr. Gange’s passion for HIFU is evident in when he states: “You can’t argue with the excellent cure of prostate cancer and preservation of quality of life after treatment with HIFU. It stands alone as the most promising therapy for urologic cancer of all times”. He further stated: “The patient is cured, he has no down time (same day recovery) and back to work the next day, but in addition, they remain sexually active and with full urinary control.”


Dr. Gange was recently featured in “Healthy Utah Magazine” and on ABC, Salt Lake City.

For further information on Western Urological Clinic, and Dr. Gange, please call (801) 993-1800.

Dr. George Suarez, a Miami-based urologist and founder of International HIFU Centers, has been awarded the 2016 Healthcare Visionary Award by the Miami Herald. This prestigious recognition is given to a medical pioneer who has made a major contribution to the advancement of healthcare that benefits the community.

Dr. Suarez was one of over 250 overall nominees and three finalists within the healthcare Visionary category. His dedication to finding a better treatment for prostate cancer that not only cures men of the disease, but also preserves their dignity, resulted in the FDA approval of HIFU (high intensity focused ultrasound) in October of 2015.

HIFU is a targeted, non-invasive therapy that uses ultrasound energy to heat and destroy specific areas of tissue without damage to surrounding areas. It is done in an outpatient setting and does not require surgery, chemotherapy or radiation. In 2003, Suarez first sought approval for the use of HIFU in the U.S. for prostate cancer –which had already been approved in Europe and Japan because of its positive results –but was denied and told further research was needed.

Suarez spent a dozen years, and a large sum of personal funds, advocating for HIFU while conducting research to prove its benefits to patients. HIFU significantly decreases the risk of impotence, from 80% to 2%, and incontinence, from 20% to .4%, when compared to other prostate cancer treatments such as surgical removal of the organ or radiation. In addition, studies show a 95.4% decrease in PSA levels with 80% of patients remaining cancer-free for up to 10 years.

While waiting for the FDA to act and not wanting to deny men in need a better treatment option, Suarez offered HIFU in centers he established in the Caribbean, Mexico, South America and Canada. Thanks to Suarez, it is now no longer necessary for American men to travel overseas to obtain the life-altering treatment. Dr. Suarez has since performed over 2,300 HIFU treatments – more than any other doctor in the world – and has trained over 500 physicians in how to administer HIFU.

“Having changed the culture of how we treat the most common cancer in men and having the opportunity to impact the entire community of urologists around the world is deeply gratifying,” said Suarez. “But most importantly, we can now provide an effective treatment that offers a cure without compromising quality of life and dignity for men.”

The Miami Herald South Florida Visionary Awards recognizes 13 community leaders who have made a positive impact in their respective fields which include: architecture, arts/culture, business, civic leadership, education, environment, government, healthcare, next generation, philanthropy, real estate development, quality of life and the 305 award.

Nominations from Herald readers were provided for each category. A panel of community judges narrowed down the field to 3 nominees per category. Readers were once again given a voice with the opportunity to vote online while also factoring votes from a panel of community judges who looked at the vision, impact and inspiration of each finalist. Winners were announced on June 13, 2016.

For more information on Dr. George Suarez, visit or call 305-274-7144.

How we can have a positive impact in a man’s health: HIFU.

Featured on June 13, urologist George Suarez, MD was among thirteen Miami visionaries profiled by Cindy K. Goodman:

In the medical world, Suarez has devoted his career to finding a noninvasive option for men with prostate cancer. He pioneered a treatment – recently approved by the Food and Drug Administration – for prostate cancer known as high intensity focused ultrasound (HIFU). This treatment delivers energy converted to heat into the body without harming intervening tissue and without requiring surgery, radiation or chemotherapy.

For 13 years, while awaiting FDA approval in the United States, Suarez administered HIFU to prostate cancer patients overseas. Suarez’s relentless commitment contributed to the FDA’s decision to approve HIFU treatment in the U.S. for prostate cancer in October 2015.

Suarez said his dogged determination grew from seeing HIFU’s success in treating prostate cancer patients who experienced a much lower risk of impotence, incontinence and re-occurrence. He has performed more than 2,300 HIFU treatments, probably more than any other urologist worldwide, and has trained more than 500 physicians in how to administer the treatment.

Suarez says his reward is seeing men return to good health with their dignity intact and without the troublesome side effects of traditional invasive prostate cancer treatments. He now performs the treatment in South Florida as well as abroad.

HIFU Experts Discuss Focused Ultrasound for Prostate

We spoke with three experts – Dr. Cary Robertson, Dr. George Suarez, and Dr. John Ward – to get their take on the recent FDA approvals, their experience with the technology, and predictions for the future.

Dr. Robertson is a urologic oncologist and Associate Professor, Division of Urology, Department of Surgery, Duke University Medical Center. He was national Principal Investigator for the clinical trial assessing the safety and effectiveness of EDAP’s Ablatherm as the initial treatment in men with newly diagnosed localized prostate cancer, compared to cryotherapy.

Known as one of the world’s leading experts in the technology, Dr. Suarez has performed over 2,000 HIFU procedures and has trained more than 400 doctors. Dr. Suarez is a practicing urologist in Miami, and a former faculty member of the University of Miami department of Urology. He is Co-Founder and former Medical Director of SonaCare Medical.

Dr. Ward is Associate Professor of Surgery, Department of Urology, at the University of Texas M.D. Anderson Cancer Center. His center participated in all EDAP and SonaCare-sponsored FDA registration trials. He is interested in focal therapy for prostate cancer.

South Florida Visionary Awards

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