USHIFU, a provider of minimally invasive high intensity focused ultrasound (HIFU) technologies and manufacturer of the Sonablate 500 (Sonablate) medical device, has acquired of certain Misonix HIFU assets and European distribution rights.
In addition, through its transaction with Misonix, USHIFU acquired 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 USHIFU. It represents the company’s first device with FDA clearance for commercialization in the US.
In addition to USHIFU’s plans for clinical evaluation of the Sonatherm 600 in Europe and the US, its plans for growing the Sonablate HIFU technology in Europe include rolling out Sonablate 500 machines; infusing both capital and human resources to 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 treat 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.
USHIFU said that the Sonablate HIFU is under clinical investigation by the FDA in the US but approved or authorized and commercially available in more than 30 other countries. Through International HIFU, one of USHIFU’s subsidiaries, patients and physicians from the US are traveling regularly for the procedure to locations where it is approved and available, such as Mexico, Bermuda, the Bahamas and Canada.
Steve Puckett, chief executive officer of USHIFU, said: “Our intent has always been to continue building the HIFU device product pipeline, and acquiring the Sonatherm is a significant milestone in that process. 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 US to study the Sonatherm 600 later this year.”