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Salvage focal ablative therapy for radio-recurrent prostate cancer is safe and provides good short to medium-term oncological control.

New study shows focal ablative salvage therapy after radio-recurrent prostate cancer is safe and provides good cancer control over 6 years.

Charlotte, NC (PRNewswire) June 2, 2020 – SonaCare Medical, the leading developer and manufacturer of high intensity focused ultrasound (HIFU) technologies, is pleased to report a new study that has shown that targeted treatment to areas of cancer inside a prostate previously treated for cancer using radiotherapy is effective and has low risk of side effects. The study was carried out in men in whom prostate cancer had recurred following radiotherapy. The study is to be presented at the international ASCO (American Society of Clinical Oncology) cancer meeting on 29th May 2020.

Every year, about 30,000 to 50,000 men with prostate cancer in the U.S. are treated with radiotherapy. This is an effective treatment for prostate cancer but about 30% of men will have evidence of recurrent disease within five years. Patients who have a cancer recurrence contained within the prostate are traditionally offered anti- testosterone hormone treatment. While effective at limiting the disease, it does not eliminate the disease and must be taken for life in lieu of another intervention. Courses of hormone treatment can cause side effects such as obesity, tiredness, and bone thinning, and can also increase the risk for diabetes and heart disease. An alternative is radical salvage surgery (called salvage prostatectomy) which removes what is left of the prostate after radiation. This procedure is difficult to perform after radiation therapy because the tissues surrounding the prostate are scarred and stuck down secondary to the radiation. Among men who receive a salvage prostatectomy, 50-100% get urine leakage needing daily pads and 5-10% get rectal injury that may require a colostomy or other major reconstructive surgery.

Focal therapy uses different forms of energy, noninvasively or minimally invasively, to target and treat selectively only those regions of the prostate where cancer has recurred. The form of energy used by Sonablate is high intensity focused ultrasound (HIFU). Unlike prostatectomy surgery, HIFU is delivered without incisions. Most men go home the same day pain free and are back to work within several days; this is weeks to months sooner than what is seen with a salvage prostatectomy.

At 356 patients, this current study is the largest ever and with the longest follow-up to come out of the UK. At six years, 3 out of 4 patients treated with focal therapy had their cancer controlled and did not need hormones or surgery. Cancer specific survival was 97.2%. The procedure is also safe; less than1 in 100 patients had a significant complication. Rectal injury was 0.3% while the researchers have shown in another study that urine leakage needing pads after salvage HIFU was only 12.5%.

Professor Hashim Ahmed, senior researcher for this study, which was performed at Imperial College NHS Foundation Trust and Imperial College London, said that “Radiotherapy is effective in most men but for the thousands of men with recurrent prostate cancer after radiotherapy, the options are very limited. Focal therapy for these patients offers a treatment for their cancer that does not carry the high risk of side-effects from traditional hormones or major surgery.”

Dr. Deepika Reddy, a urology research doctor, and lead author on the study, based at Imperial College NHS Foundation Trust and Imperial College London, said, “This study provides more evidence that focal therapy should be considered in men whose cancer is suitable for a minimally-invasive approach. Such evidence in combination with well-structured clinical trials will help patients, in partnership with their doctors, work out the most suitable option for them.”

Dr. Mark Carol, SonaCare Medical CEO and President, said, “One of the first clinical uses for Sonablate HIFU in the U.S. was for the treatment of recurrent prostate cancer status post radiation therapy. The U.K. has taken the lead in developing and demonstrating the value of HIFU for many stages of prostate cancer. This paper continues the amazing track record Professor Ahmed and his team have established in proving and promoting the value of HIFU.”

Please click here to view the:
Focal Ablative Salvage Therapy for Radio Recurrent Prostate Cancer Poster
Focal Ablative Salvage Therapy for Radio-Recurrent Prostate Cancer Infographic

Since Sonablate® received FDA clearance on October 9, 2015, thousands of patients have had a Sonablate HIFU prostate procedure across the 60+ locations in the U.S., including top-tier academic institutions in California, Indiana, Oklahoma, Maryland, New York, Arizona and Texas. Over 70 U.S. physicians now offer HIFU prostate tissue ablation to their patients as a minimally invasive alternative to surgery or radiation. Sonablate is also used in more than 30 countries worldwide, and is the de facto standard for delivering HIFU to men in the U.K.

Sonablate® has 501(K) clearance in the U.S. and is indicated for the transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue. Caution: Federal (USA) law restricts this device to sale by or on the other of a physician

ABOUT SONACARE MEDICAL, LLC

SonaCare Medical is a world leader in minimally invasive focused ultrasound technologies. SonaCare Medical is committed to developing focused ultrasound related technologies that support precise and innovative procedures for the treatment of a range of medical conditions. SonaCare Medical, with its subsidiary Focus Surgery, Inc., designs and manufactures medical devices, including the following: Sonablate®, which has

501(K) clearance in the U.S.; Sonablate®500, which has CE Marking and has obtained regulatory authorization in more than 50 countries outside the U.S., Sonatherm® laparoscopic HIFU surgical ablation system, which has

510(K) clearance in the U.S., has CE Marking and has obtained regulatory authorization in more than 30 countries outside the U.S.

For additional information, visit http://www.SonaCareMedical.com

COMPANY CONTACT: SonaCare Medical, LLC

Karen Cornett This email address is being protected from spambots. You need JavaScript enabled to view it.This email address is being protected from spambots. You need JavaScript enabled to view it.

ABOUT IMPERIAL COLLEGE LONDON

Imperial College London is a world top ten university with an international reputation for excellence in teaching and research. Consistently rated amongst the world's best universities, Imperial is committed to developing the next generation of researchers, scientists and academics through collaboration across disciplines. Located in the heart of London, Imperial College is a multidisciplinary space for education, research,

translation and commercialisation, harnessing science and innovation to tackle global challenges.

ABOUT IMPERIAL PROSTATE

Imperial Prostate is a world-leading team of researcher-practitioners who work towards improving the lives of men who develop or are being investigated for prostate cancer and other prostate diseases. The group’s mission is to improve the speed, accuracy and safety of prostate disease diagnosis, and to evaluate new treatments

which have fewer side effects than standard techniques without losing treatment efficacy. It is partnered with scientists at Imperial College, who help us develop our research based on the latest scientific discoveries, techniques and technology.

Imperial College Healthcare NHS Trust is one of the largest hospital Trust’s in England, providing acute and specialist healthcare for a population of nearly two million people. The Trust has five hospitals – Charing Cross, Hammersmith, Queen Charlotte’s & Chelsea, St Mary’s and The Western Eye – as well as community services.

ABOUT PROST8 UK CHARITY

Prost8 UK charity: 1182590 is a UK charity concentrating on the major advances in minimally invasive prostate cancer treatment enabled through focal therapy. Among the important benefits this treatment pathway provides is low cost treatment at point of delivery with fast recovery times

and low lifestyle impacting outcomes over a long period. Focal therapy includes HIFU (high intensity focal therapy), which uses ultrasound to generate points of heat, and cryotherapy, which uses

extreme cold, to target and destroy cancer tumours with minimal damage to surrounding tissue and organs. Prost8 UK are campaigning to create awareness of the availability of focal therapy for prostate cancer as up to 12,000 men each year in the UK could benefit from this treatment, if they know to ask. More than 95% of men with a diagnosis will currently not be informed of this less invasive treatment option which will be the primary focus of Prost8’s ‘Prostate Cancer - Know Your Choices’ campaign launching in June 2020. The charity is currently also actively fundraising £5m to

buy, donate and deploy focal therapy equipment into the NHS across the UK to rapidly increase access to this treatment. Following the important outcomes of this trial Prost8 UK will also be

actively supporting Imperial Prostate to promote awareness among the general public, GP’s and urological practitioners of the potential for prostate lumpectomy treatment via focal therapy for men with recurrent cancer following earlier radiotherapy treatment.

Contact Details:

This email address is being protected from spambots. You need JavaScript enabled to view it.This email address is being protected from spambots. You need JavaScript enabled to view it. prost8.org.uk

IMPORTANT

Men who are concerned about prostate cancer should in the first instance discuss this with their family doctor (GP). Queries from patients, GPs and consultants This email address is being protected from spambots. You need JavaScript enabled to view it.This email address is being protected from spambots. You need JavaScript enabled to view it.;but GP or consultant referrals will be needed for those men who wish to discuss their eligibility for the treatment. The following websites have further information: http://www.imperialprostate.org.uk and https://www.prost8.org.uk

FOR FURTHER INFORMATION Contact Details:This email address is being protected from spambots. You need JavaScript enabled to view it.This email address is being protected from spambots. You need JavaScript enabled to view it.

SONACARE MEDICAL FORWARD LOOKING STATEMENTS

The Company's forward-looking statements are based on management's current expectations and assumptions regarding the Company's business and performance, the economy and other future conditions and forecasts of future events, circumstances and results. As with any projection or forecast, forward-looking statements are inherently susceptible to uncertainty and changes in circumstances. The Company's actual results may vary materially from those expressed or implied in its forward-looking statements. Any forward-looking statement made by the Company speaks only as of the date on which it is made. The Company is under no obligation to, and expressly disclaims any obligation to, update or alter its forward-looking statements, whether as a result of new information, subsequent events or other factors.

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