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.Read More
After nearly a decade of R&D, Profound Medical (OTCQX:PRFMF; TSXV:PRN) is now conducting a pilot commercial launch of its TULSA-PRO medical device to ablate tissue in localized prostate cancer in key European and other CE Mark jurisdictions ahead of full commercialization.Read More
In the more than 30 months since its startup, Knight Therapeutics (TSX:GUD) has shown an uncanny knack for raising equity at increasing valuations, building a portfolio of some 20 innovative products for its pipeline, expanding internationally and investing in life science funds to gain access to new pharmaceuticals.
“Over the next 30 months, we want to get real and demonstrate that we are good at commercializing and selling innovative pharmaceuticals that touch people's lives,” CEO, Jonathan Ross Goodman, says in an interview with BioTuesdays.com.
“In the highly competitive Canadian licensing landscape, we have been more creative and are adding more horsepower to our licensing capabilities,” he adds, noting that all of Knight’s products are sourced through partnerships and acquisitions.Read More
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.Read More
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.”Read More