US HIFU Acquires European Distribution Rights Of The SonablateÂ® 500 Medical Device And Ownership Of The SonathermÂ® 600 Medical Device
CHARLOTTE, N.C., May 28 /PRNewswire/ -- 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.
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