Advertisement
"I speak for the combined USHIFU and Focus Surgery team when I say we arethrilled to announce the acquisition of Focus Surgery. Watching thetechnological innovation that Focus Surgery scientists and engineers haveconsistently achieved over the last several years with limited resources hasbeen nothing short of amazing," said Steve Puckett, Jr., CEO USHIFU. "As amuch stronger combined entity we are more encouraged than ever about ourability to positively affect healthcare delivery around the world."
Advertisement
"A great milestone in the history of Focus Surgery, Inc. is achieved todayas it combines all its technological strength with USHIFU, LLC. The combinedCompany will make HIFU rapidly available in approved markets worldwide for thetreatment of a most deadly disease - cancer, which is very important," saidNarendra Sanghvi, President, FSI. "In addition, this is also an extraordinaryopportunity to quickly commercialize many of the advanced HIFU applications tocreate a medical revolution with bloodless surgery while maintaining highquality of life."
About USHIFU, LLC
USHIFU is a healthcare development company and medical device distributorcommitted to creating a new standard for prostate cancer treatment with highintensity focused ultrasound (HIFU) therapy. USHIFU works with hospitals andmedical centers in countries where HIFU is authorized for treating prostatecancer, including Canada, Mexico, the Dominican Republic and the Bahamas, tomake the non invasive therapy available. USHIFU is also funding FDA-approvedclinical trials in the United States to gather data important for analysis ofthe technology by the FDA. The first is a pivotal trial for the treatment ofprimary organ confined prostate cancer that will enroll 466 participants at 24different centers. A second pivotal trial will begin for the treatment ofrecurrent prostate cancer in men who have failed external beam radiationtherapy. This single arm study will enroll 202 participants at 10 differentsites.
About the Sonablate(R) 500
The Sonablate(R) 500 is a non-invasive medical device that utilizesultrasound energy to destroy tissue within the body. It was developed by FSIand is manufactured by Misonix, Inc. (Nasdaq: MSON) who also holdsdistribution rights in Europe. Takai Hospital Supply Ltd. and THSInternational distribute the Sonablate(R) 500 in Southeast Asia and the MiddleEast.
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 treatmentof prostate cancer in clinical trials in the U.S. FDA has made no decision asto the safety or efficacy of the Sonablate(R) 500 for the treatment ofprostate cancer.
SOURCE USHIFU, LLC
