Echelon Wealth Partners initiated coverage of Profound Medical (OTCQX:PRFMF; TSXV:PRN) with a “buy” rating and one-year price target of $4. The stock closed at 78 cents on March 14.
Profound has developed MRI-guided localized prostate cancer-targeted ultrasound ablation technology, TULSA-PRO, which has been CE Marked in Europe.
Analyst Doug Loe writes that data demonstrating clinical efficacy for TULSA-PRO has already been generated and published, and the path to FDA approval is now clear with the design for a pivotal 110-patient IDE study established in June 2016.
He expects Profound to report one-year follow-up data by the second quarter of 2018, with a FDA 510(k) filing by the third quarter of 2018, “leading under best-case scenario to FDA approval/launch by the first half of 2019.”
Profound has established marketing partnership/collaborations with major global therapeutic device developers, including Royal Philips and Siemens Healthcare, which are incorporating TULSA-PRO in their MRI platforms.
“In addition to the CE Mark itself, which while positive does not really reflect the therapeutic benefit of medical devices as robustly as FDA approval conventionally does, we do have strong evidence that TULSA-PRO works as intended at ablating localized prostate tumors, and without the collateral damage to neighboring anatomical structures that other ablation technologies commonly confer,” Mr. Loe said.