The U.S. FDA sent a refuse to file letter to Nymox Pharmaceutical Corp. regarding its NDA for fexapotide triflutate, a pro-apoptotic protein intended for treating benign prostatic hyperplasia. The letter noted that more long-term safety data was needed for the application, the company said.

The FDA has delivered on a final guidance for non-clinical and clinical investigations of devices used for treatment of benign prostatic hyperplasia (BPH), needing only a year and a half to convert the draft guidance into a final version. The final guidance retains the draft’s recommendation that pivotal studies follow patients for at least a year, a provision some in the med-tech industry saw as unnecessary in some instances. The scope of the July 2020 draft included non-clinical testing, a novelty compared to previous guidance on the topic. The scope of this latest guidance includes four product codes, including KNS for endoscopic electrosurgical instruments, and the FDA included several specific suggestions for the use of thermotherapy and permanent prostatic stents as treatments for BPH.

The U.S. FDA draft guidance for select updates for premarket evaluation of class II atherectomy devices arrived with a lack of clarity that prompted device makers and clinicians alike to request the FDA address several sources of ambiguity. One of these is whether the agency should distinguish between particulate matter from the device vs. calcium particulates from the treated artery, while another is whether particulate evaluation is required only for devices with a coating.

Butterfly Medical Ltd. could be on the verge of metamorphosis into a major player in the benign prostatic hyperplasia treatment field. The Yokneam, Israel-based company just raised $7 million in a series B financing led by New Rhein Healthcare Investors LLC, of Philadelphia.