Edap TMS SA signed a €36 million (US$42 million) multi-tranche credit facility with the European Investment Bank, with the first tranche of €11 million expected to be disbursed in early November. The funds will be used to strengthen the company’s balance sheet to support the continued expansion of its Focal One high-intensity focused ultrasound technology in focal therapy and accelerate the development of new clinical indications.

A management-led syndicate of prominent investors acquired a majority stake in Histosonics Inc. that values the company at approximately $2.25 billion. The funding will support expansion of the Edison Histotripsy system and therapy platform into new clinical indications and markets. Edison uses non-invasive focused ultrasound energy to destroy tumors.

Edap TMS SA recently published data showing that its Focal One high intensity focused ultrasound technology is non-inferior to radical prostatectomy as a first-line treatment for localized prostate cancer. The company is also working towards gaining approval for the technology as a therapy for endometriosis.

The U.S. FDA granted Edap Tms SA breakthrough device designation for its Focal One system to treat deep infiltrating rectal endometriosis. The company believes that the Focal One high intensity focused ultrasound technology can offer relief to the thousands of women suffering from the debilitating condition.

Medicare coverage does not necessarily mean appropriate reimbursement levels, a point pressed by Inspire Medical Systems Inc. at the Aug. 23 Medicare outpatient advisory panel hearing. The panel agreed that the company’s hypoglossal nerve stimulation (HNS) device for sleep apnea was subject to an inappropriate device offset figure, which could lead to a Medicare rate increase of more than $7,000 and a significant boost of sales of the company’s flagship Inspire HNS device.

TORONTO – Exact Imaging Inc. has secured C$5.1 million (US$4 million) from the Business Development Bank of Canada and federal Export Development Canada to drive adoption of its Exactvu micro-imaging platform for real-time imaging of the prostate. Company CEO Randy Aucoin said it’s been a slow process getting street cred for his prostate imager, investing “tens of millions of dollars” in a direct sales force that eventually installed 100 systems in the U.S., Europe and Canada.