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.
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