Levee Medical's Innovative Device Receives FDA Green Light
Levee Medical's FDA Approval for Pivotal Study
Levee Medical has exciting news to share regarding the development of a groundbreaking solution for patients experiencing post-radical prostatectomy stress urinary incontinence. The U.S. Food and Drug Administration (FDA) has granted approval for the initiation of the ARID II study. This pivotal study will investigate the efficacy of the Voro Urologic Scaffold, a novel device that aims to improve the quality of life for those impacted by this challenging condition.
Understanding the ARID II Study
The ARID II trial is designed as a multicenter, single-blind, randomized controlled study. Its primary objective is to assess the safety and effectiveness of the Voro Urologic Scaffold among adult men who undergo robotic-assisted radical prostatectomy. This innovative approach seeks not only to address incontinence but also to enhance patient recovery and overall satisfaction.
Leadership Behind the Innovation
Bruce Choi, the founder and CTO of Levee Medical, expressed his pride in attaining this critical milestone. He emphasized that such progress is a testament to the dedication of the Levee Medical team and the ongoing support from investors. Choi believes that the Voro Urologic Scaffold has transformative potential, reducing both the severity of post-prostatectomy incontinence and helping individuals regain their previous quality of life.
Expert Collaboration for Success
In an exciting development, Dr. Arvin K. George, a recognized authority in prostate cancer treatment and affiliated with a leading medical institution, will serve as the national principal investigator for the ARID II trial. His extensive experience in the field lends credibility to the study and raises expectations for the outcomes.
Financial Support and Future Prospects
On February 11, 2025, Levee Medical announced the successful closing of its Series B financing, which raised over $14 million. This critical funding will facilitate ongoing clinical trials and support the advancement of their innovative solution aimed at addressing post-prostatectomy incontinence. The interest from investors highlights the confidence in the solution being developed and its potential impact on patient care.
The Voro Urologic Scaffold
Levee Medical is dedicated to creating innovative solutions focused on minimizing complications associated with prostate cancer treatment. The Voro Urologic Scaffold is the first product slated for market introduction. Though currently limited to investigational use, this device represents a significant step forward in managing post-surgical incontinence.
Frequently Asked Questions
What is the ARID II study?
The ARID II study is a pivotal clinical trial investigating the safety and effectiveness of the Voro Urologic Scaffold in treating post-radical prostatectomy urinary incontinence.
Who is leading the ARID II trial?
Dr. Arvin K. George, a recognized expert in the field of prostate cancer, serves as the national principal investigator for the ARID II trial.
What is the purpose of the Voro Urologic Scaffold?
This innovative device aims to minimize the severity of incontinence following radical prostatectomy, enhancing patient recovery and quality of life.
How much funding has Levee Medical secured recently?
Levee Medical recently closed its Series B financing, raising over $14 million to support its clinical trials, including the ARID II study.
Is the Voro Urologic Scaffold commercially available?
No, the Voro Urologic Scaffold is currently for investigational use only and is not approved for commercial sale in the U.S. or elsewhere.
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