Levee Medical has secured more than $12m in an additional financing round to support the premarket approval (PMA) process as the ARID II Trial of the Voro Urologic Scaffold progresses.
The funding round closed earlier than anticipated and was substantially oversubscribed.
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The proceeds will further extend the company’s financial runway and provide direct backing for the PMA after enrolment in the ARID II trial concludes.
Progress in the pivotal study is advancing alongside ongoing regulatory activities.
The multi-centre randomised trial is presently assessing the Voro Urologic Scaffold device to further evaluate its effectiveness and safety in men who are undergoing robotic-assisted radical prostatectomy.
The Voro Urologic Scaffold is designed for placement during a prostatectomy to preserve urethral length and support bladder neck geometry, which are regarded as essential in preventing incontinence after surgery.
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By GlobalDataThis absorbable device seeks to cut the rate of stress urinary incontinence and may provide an option for individuals undergoing radical prostatectomy.
Levee Medical CEO Adam Irving said: “We are grateful for the overwhelming investor support. The extended runway strengthens our position during the PMA process following ARID II enrolment. We are laser-focused on meaningful results for patients and stakeholders.”
The Voro Urologic Scaffold represents the company’s initial product intended for commercial launch.
It is currently available only for investigational purposes and has not received approval for commercial use in the US or in any other country.
In June 2024, Levee Medical announced the initiation of a $10m Series B financing round intended to expedite the development of its Voro Urologic Scaffold, designed to enhance recovery outcomes following prostatectomy.
