Urology medical device maker Zenflow said today it closed a $31.4 million Series A round of financing to support the development of minimally invasive devices designed to treat obstructive urinary symptoms related to benign prostatic hyperplasia.
The round was led by Invus Opportunities, F-Prime Capital Partners and Medical Technology Venture Partners and was joined by other new and existing investors, the San Francisco-based company said.
Zenflow said it has also received grant funding from the National Institutes of Health and the National Science Foundation.
The company’s first product is the Spring System device, which is designed to deliver a low-profile superelastic implant into the prostatic urethra. The system is intended to allow for a simple, physician-led procedure to relieve BPH symptoms with a fast recovery time and minimal side effects.
Financing from the current round will be used to support further clinical studies exploring the safety and effectiveness of the Spring System and preparations for a commercial launch.
Zenflow said it plans to begin enrolling patients in a trial of the device in the UK, Australia, New Zealand and Mexico this year as it pursues FDA Investigational Device Exemption approval to launch a pivotal trial in the US.
“The Zenflow Spring System is a promising new treatment option for men suffering from BPH symptoms. The device can be deployed in a simple procedure in the urologist’s office under direct visualization through a flexible delivery system, which should minimize patient discomfort. I look forward to seeing the results of the upcoming clinical trials,” Stanford University’s Dr. Harcharan Gill said in a press release.
Zenflow was founded in 2014 through a Stanford Biodesign Innovation Fellowship granted to Nick Damiano and Shreya Mehta, and was one of the first medical device companies funded out of the Y Combinator accelerator, the company said.
A first-in-human safety and feasibility has already been performed on the Spring System, with all patients in the trial having been followed for beyond 12 months. Results from the trial indicated “promising evidence of safety and lasting symptom relief,” according to a press release.
“Before founding this company, we interviewed a lot of BPH patients in the urology clinic and were astounded by the impact that the disease had on their quality of life. Since then, we’ve been able to build a talented and experienced team that is as motivated to help these patients as Shreya and I were when we founded Zenflow. The strong investor interest in this funding round validates the importance of this clinical need and the accomplishments of our team so far. We’re looking forward to the exciting next steps where we will see our technology have a real impact on patients’ lives,” co-founder & CEO Nick Damiano said in a prepared release.
Registration is open for DeviceTalks Boston! Join us on June 5-6, 2019, as we explore the trends and technology that are shaping the future of the medical device industry.