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USHIFU, LLC Completes Acquisition of Focus Surgery, Inc.

Combination Creates New Opportunities for Expansion of HIFU Technology

CHARLOTTE, N.C., July 2 /PRNewswire/ -- USHIFU, LLC (USHIFU), the distributor and provider of non-invasive high intensity focused ultrasound for prostate cancer, announced today that it has completed the acquisition of Focus Surgery, Inc. (FSI) of Indianapolis, IN, the creator and manufacturer of the Sonablate(R) 500, an image-guided acoustic ablation device. This acquisition will accelerate USHIFU's ability to expand the FSI HIFU technology platform, as well as gain access to new markets, such as India.

"I speak for the combined USHIFU and Focus Surgery team when I say we are thrilled to announce the acquisition of Focus Surgery. Watching the technological innovation that Focus Surgery scientists and engineers have consistently achieved over the last several years with limited resources has been nothing short of amazing," said Steve Puckett, Jr., CEO USHIFU. "As a much stronger combined entity we are more encouraged than ever about our ability to positively affect healthcare delivery around the world."

"A great milestone in the history of Focus Surgery, Inc. is achieved today as it combines all its technological strength with USHIFU, LLC. The combined Company will make HIFU rapidly available in approved markets worldwide for the treatment of a most deadly disease - cancer, which is very important," said Narendra Sanghvi, President, FSI. "In addition, this is also an extraordinary opportunity to quickly commercialize many of the advanced HIFU applications to create a medical revolution with bloodless surgery while maintaining high quality of life."


USHIFU is a healthcare development company and medical device distributor committed to creating a new standard for prostate cancer treatment with high intensity focused ultrasound (HIFU) therapy. USHIFU works with hospitals and medical centers in countries where HIFU is authorized for treating prostate cancer, including Canada, Mexico, the Dominican Republic and the Bahamas, to make the non invasive therapy available. USHIFU is also funding FDA-approved clinical trials in the United States to gather data important for analysis of the technology by the FDA. The first is a pivotal trial for the treatment of primary organ confined prostate cancer that will enroll 466 participants at 24 different centers. A second pivotal trial will begin for the treatment of recurrent prostate cancer in men who have failed external beam radiation therapy. This single arm study will enroll 202 participants at 10 different sites.

About the Sonablate(R) 500

The Sonablate(R) 500 is a non-invasive medical device that utilizes ultrasound energy to destroy tissue within the body. It was developed by FSI and is manufactured by Misonix, Inc. (Nasdaq: MSON) who also holds distribution rights in Europe. Takai Hospital Supply Ltd. and THS International distribute the Sonablate(R) 500 in Southeast Asia and the Middle East.

The Sonablate(R) 500 is not approved for use in the U.S. The Sonablate(R) 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(R) 500 for the treatment of prostate cancer.

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