Zenflow, led by CEO Shreya Mehta, is a South San Francisco-based medical device company developing a minimally invasive treatment for urinary obstruction caused by benign prostatic hyperplasia (BPH). Its core product, the investigational Spring® System, uses a small spring-like coil to gently prop open the urethra while preserving natural anatomy. The Spring® System is an investigational device and is not approved for commercial sale. Zenflow intends to use the funds from its recent financing for a Pre-Market Approval (PMA) submission and to prepare for commercialization upon FDA approval. The company’s clinical research program covers over 300 patients across multiple studies, including the pivotal BREEZE™ prospective, multicenter, controlled study of more than 200 patients. Financially, Zenflow closed a $24M Series C financing to support its regulatory and commercialization efforts. Zenflow, Inc. is a South San Francisco-based medical device company developing a minimally invasive treatment for urinary obstruction caused by enlarged prostate (BPH). Its lead product, the Spring® System, is intended as a minimally invasive treatment option for patients with debilitating BPH symptoms. The company plans to use the new funding to support a pivotal clinical trial and pursue FDA clearance of the Spring® System. Zenflow is led by Co-Founder and CEO Nick Damiano. The company announced the appointment of Susan Stimson as President; she brings over 25 years of experience in development and commercialization of medical devices, including senior roles at Intersect ENT. The recent financing positions Zenflow to advance its clinical and regulatory pathway toward commercialization. Zenflow develops the Spring® System, an implantable device intended to treat benign prostatic hyperplasia (BPH). The Spring Implant is composed of super-elastic shape-memory material and is deployed through a small, flexible catheter to enable a less invasive, less painful in-office procedure. The device is currently undergoing clinical trials with leading global urologists and is available for investigational use only in select countries. The company received a $5M credit facility from Square 1 Bank to support short-term and long-term growth initiatives. Founded in 2014 and based in South San Francisco, Zenflow is backed by F-Prime Capital Partners, Invus Opportunities, Medical Technology Venture Partners, Y Combinator and the Stanford-StartX Fund. Zenflow develops the Spring System, a minimally invasive technology that delivers a low-profile superelastic implant into the prostatic urethra to permanently relieve BPH symptoms in a single procedure with fast recovery and minimal side effects. Founded in 2014 out of the Stanford Biodesign Innovation Fellowship and based in San Francisco, the company initiated a first-in-human ZEST safety and feasibility study in 2016. Zenflow has received grant funding from the NIH and NSF and was one of the first medical device companies funded by Y Combinator; it has also been supported by StartX and the Rosenman Institute. The company closed a $31.4M Series A equity financing led by Invus Opportunities, F-Prime Capital Partners, and Medical Technology Venture Partners. Proceeds will be used to perform additional clinical studies to further validate safety and effectiveness and to prepare for commercial launch. Zenflow anticipates enrolling patients in the UK, Australia, New Zealand, and Mexico in 2018 while pursuing an IDE from the FDA to initiate a pivotal U.S. trial.

Total raised

$84M

Funding rounds

4

Latest round

Series C

Latest activity

Nov 2024