Wisconsin-based medtech Rivermark Medical has secured $20m in a Series D financing round – supporting the company’s late-stage clinical activities being used for approval of its flagship device for patients with an enlarged prostate.
With cash in hand from this capital raise, which was led by Andera Partners, Rivermark will continue its pivotal RAPID III clinical study (NCT06849258) on its FloStent system. The study is evaluating the stent’s safety and efficacy versus a sham procedure in patients with benign prostatic hyperplasia (BPH). Around 215 patients across 20 locations in the US and Australia are enrolled onto this trial, as per ClinicalTrials.gov.
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In a statement, Rivermark’s CEO and co-founder, Adam Kadlec, added that the financing will also help the company prepare for FloStent’s successful commercial launch – provided it secures approval from the US Food and Drug Administration (FDA).
Unlike some devices for BPH treatment, which use laser, thermal microwave or aquablation-based approaches to remove or reduce excess prostate tissue, Rivermark designed the FloStent as a non-surgical and fully reversible alternative.
The device, which can be delivered in the outpatient setting during a routine cystoscopy, is a self-expanding, nitinol-based prostatic stent. It acts by holding the prostatic urethra open, helping to facilitate the flow of urine from the bladder.
In a 13 May statement, Aneta Sottil, partner at Andera Partners, noted that FloStent’s “smart yet simple” approach to BPH treatment could prove a compelling option for patients, as many remain “unsure [on] how to navigate the current treatment pathway.”
BPH market heats up
With a meta-analysis estimating the global prevalence of BPH stands at 26.2%, there is a clear need for treatment options that can relieve symptoms and improve patient quality of life. To meet the needs of individuals with BPH, several companies have commercialised devices for the condition – including stents and ablation systems.
Like Rivermark, ProVerum, is vying for a slice of the BPH device market through its stent-based approach, with the company recently closing an $80m financing round to commercialise its ProVee system. In a statement at the time of the raise, Steve Kaplan, professor of urology at the Icahn School of Medicine, touted the permanent prostatic urethral stent’s potential to be a “first-line interventional therapy for BPH that can be safely and reliably performed in the office setting.”
Meanwhile, Prodeon Medical recently secured FDA clearance for its non-permanent BPH implant, Urocross. The FDA’s decision came after the device prompted a mean improvement in International Prostate Symptom Scores (IPSS) at 12 months post-implant and six months post-retrieval in 48.1% of patients during the Expander-2 pivotal trial (NCT05400980).
GlobalData currently estimates that the nephrology and urology devices market – in which prostatic stents are a part of – will reach a value of $11.79bn in 2035.
