Rivermark Medical Raises $20 Million Series D for FloStent Pivotal Trial

Rivermark Medical, a urology device company developing a removable stent for enlarged prostate, has raised $20 million in a Series D financing led by Andera Partners, the European venture capital and private equity firm said on May 13. Existing investors and an unnamed strategic investor also took part. The size of Andera's own contribution was not disclosed.

Rivermark plans to use the proceeds to support its ongoing RAPID III pivotal clinical trial, achieve regulatory approval in the United States and prepare for the commercial launch of its FloStent System, the release said. FloStent is an investigational device, limited by US federal law to investigational use.

A stent instead of tissue removal

FloStent is designed as a non-surgical, fully reversible, first-line device therapy for men with lower urinary tract symptoms caused by benign prostatic hyperplasia (BPH), the companies said. It is placed in an outpatient setting during a routine cystoscopy using standard urological tools and can be retrieved or adjusted after implantation.

The device is a self-expanding, nitinol-based prostatic stent that holds the prostatic urethra open to help urine flow from the bladder, Medical Device Network reported, describing Rivermark as Wisconsin-based. The publication contrasted it with BPH devices that use laser, thermal microwave or aquablation-based approaches to remove or reduce prostate tissue.

RAPID III (NCT06849258) is comparing FloStent's safety and efficacy with a sham procedure, and around 215 patients at 20 locations in the US and Australia are enrolled, according to Medical Device Network, citing ClinicalTrials.gov. The Series D follows results from the earlier multicenter RAPID II study, which Andera said showed rapid recovery and a durable treatment effect through 24 months of follow-up. The release did not give the RAPID II figures.

Investor joins the board

"We welcome Andera Partners as we continue working to bring a simple, non-surgical, reversible option to the millions of men seeking treatment for BPH," said Adam Kadlec, Rivermark's CEO and co-founder. "Andera's support strengthens our ability to execute on RAPID III and prepare FloStent for a successful commercial launch."

Aneta Sottil, a partner at Andera, joined Rivermark's board of directors in conjunction with the financing. "We are excited to support the company as they advance FloStent toward FDA approval and widespread adoption," she said.

Medical Device Network noted that other companies are also pursuing stent-based BPH treatments, including ProVerum, which it said had closed an $80 million financing round to commercialise its ProVee system.

Neither company gave a timeline for completing RAPID III or for an FDA submission.