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US HIFU Acquires European Distribution Rights of the Sonablate® 500 Medical Device

Global News - Europe

CHARLOTTE, NC USHIFU, LLC (US HIFU), a world leader in minimally invasive high intensity focused ultrasound (HIFU) technologies and manufacturer of the Sonablate® 500 (Sonablate) medical device, announces the acquisition of certain Misonix (Nasdaq: MSON) HIFU assets and European distribution rights. In addition, through its transaction with Misonix, US HIFU acquires the Sonatherm® 600 medical device, a laparoscopic HIFU system used to ablate certain soft tissues.

The acquisition of the Sonatherm 600 is a major step for US HIFU: it represents the company's first device with FDA clearance for commercialization in the U.S.

"Our intent has always been to continue building the HIFU device product pipeline, and acquiring the Sonatherm is a significant milestone in that process," said US HIFU's chief executive officer Steve Puckett, Jr. "The device has two FDA 510(k) clearances for soft tissue ablation. Post-market surveillance trials have already begun in Europe, and we plan to add clinical sites in the U.S. to study the Sonatherm 600 later this year."

In addition to US HIFU's plans for clinical evaluation of the Sonatherm 600 in Europe and the U.S., its plans for growing the Sonablate HIFU technology in Europe include rolling out state-of-the-art Sonablate 500 machines; infusing both capital and human resources to significantly increase access to Sonablate HIFU; expanding the base of European Sonablate users; and increasing the existing clinical data registry.

Sonablate HIFU for prostate cancer is a minimally invasive, targeted approach to treating the disease with precision-focused ultrasound energy that, when delivered, raises the temperature of the tissue in a matter of seconds, resulting in its destruction. The tissue throughout the prostate is ablated while structures outside the gland remain unharmed. Members of US HIFU's management team are making preparations for a European road show whereby they will showcase the innovative feature upgrades to the Sonablate by giving a then-versus-now comparison. The team will also strategize with clinicians to tailor flexible, market-specific roll-out plans.

"We are confident that this initial push will have a big impact considering that much of the European user base has been exposed exclusively to older Sonablate technology, and we have made a number of technical upgrades," said Puckett. "We also want to convey to the European clinical community our commitment to substantially increase the monetary and human resources dedicated to physician training, patient education, technician support and data collection through our International HIFU Registry."

UK HIFU, one of US HIFU's subsidiaries, will conduct day-to-day European operations. The first European headquarters will be in the UK, with a satellite office in Berlin scheduled to open over the next three months. In collaboration with UK HIFU employees, US HIFU staff will launch and continue to conduct business operations in Europe to guarantee rapid proliferation of the technology and physician training.

"This transaction brings Sonablate manufacturing and research and development together again under one roof
Focus Surgery – allowing for increased efficiency operationally and an expansion of our HIFU product portfolio," said Puckett.

Sonablate HIFU is under clinical investigation by the FDA in the U.S. but approved or authorized and commercially available in more than 30 other countries. Through International HIFU, one of US HIFU's subsidiaries, patients and physicians from the U.S. are traveling regularly for the procedure to locations where it is approved and available, such as Mexico, Bermuda, the Bahamas and Canada.

About USHIFU, LLC
USHIFU, LLC (US HIFU), a privately held healthcare company, is a world leader in minimally invasive high intensity focused ultrasound (HIFU) technologies. US 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. US HIFU was founded in 2004 and is headquartered in Charlotte, N.C. Additional information can be found at
www.ushifu.com.

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. 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.

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