Posts tagged Profound Medical
Profound makes leap to platform company from prostate product

With its recent acquisition of Royal Philips’ (NYSE:PHG; AEX:PHIA) Sonalleve business, Profound Medical (OTCQX:PRFMF; TSXV:PRN) is making the leap from a medical device company focused on prostate cancer ablation to a platform company, offering real-time magnetic resonance (MR)-guidance as the imaging platform and ultrasound as the energy source for the delivery of non-invasive ablative technology to clinicians.

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Profound Medical readies pivotal clinical trial of TULSA-PRO

After receiving CE Mark approval last month of its minimally invasive transurethral ultrasound technology for the ablation of benign and malignant prostate tissue, known as TULSA-PRO, Profound Medical (TSX-V:PRN) plans to enroll 14 sites in the U.S., Canada and Europe in a pivotal trial for U.S. regulatory approval.

“We have discussions ongoing with the FDA to file an IDE in the first half of this year in order to start a pivotal trial in the summer,” CEO, Steve Plymale, says in an interview with BioTuesdays.com.

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Profound Medical seeking CE Mark for TULSA-PRO this year

Profound Medical, which is going public next week, figures that data from a 30-patient safety and feasibility study of its transurethral ultrasound ablation (TULSA) technology for minimally invasive treatment of prostrate cancer will be sufficient to file for CE Mark approval in Europe before the end of 2015.

“We hope to launch TULSA-PRO in Germany during 2016 with a direct sales force in order to develop close relationships with early adopters and control our reimbursement strategy,” CEO, Steven Plymale, says in an interview with BioTuesdays.com.

“Our strategy is to seek high volume sites treating prostate cancer as a way to boost revenue,” he suggests. “We’re not selling high-cost capital equipment, but rather the disposables used in each treatment.”

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