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
As president and CEO of upstart Repare Therapeutics, Lloyd Segal was instrumental is arranging the initial funding to create Repare while he served as an entrepreneur-in-residence at Versant Ventures, a leading healthcare investment firm with a hands-on approach to company building. Repare is developing precision oncology drugs that target specific vulnerabilities of tumor cells...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
3D Signatures (TSX-V:DXD) which has developed proprietary software with the potential to analyze a patient’s chromosomal arrangement, or signature, is seeking collaborations to advance its TeloView platform in the areas of Hodgkin’s lymphoma, prostrate cancer, multiple myeloma and Alzheimer’s disease.Read More
With approvals in Europe and Israel for its CellDetect non-invasive test for recurrence of bladder cancer, Micromedic Technologies (TASE:MCTC) is seeking FDA approval for a pivotal trial expected to begin in the first quarter next year with bladder cancer patients.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
Can-Fite BioPharma (NYSE MKT:CANF; TASE:CFBI) is preparing the protocol for its next advanced psoriasis trial with its CF101 oral drug candidate, even though an earlier Phase 2/3 study did not meet its primary endpoint.
The earlier trial was designed to show a statistically significant improvement in the Psoriasis Area Severity Index (PASI) 75 score, relative to placebo, after 12 weeks of treatment. PASI 75 refers to 75% clearing of a patient’s lesions.
However, further analysis of the entire study period revealed that by 32 weeks of treatment with CF101, 35% of patients with moderate-to-severe plaque psoriasis achieved PASI 75 scores, while the mean percent improvement in PASI score was 57%.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