Milestone Achieved as Company Announces Successful Enrollment of First Patients in its First-in-Human (FIH) Study
DURHAM, NC – Sept. 6, 2023 – Levee Medical, a clinical-stage medical device company designing solutions to improve surgical outcomes following prostate cancer, announced today it has raised a total of $4.3 million in oversubscribed funds. Additionally, Levee Medical successfully treated the first study participants in its first-in-human (FIH) study, demonstrating initial safety data for the Voro™ Urologic Scaffold. The trial will evaluate the safety and performance of the Voro Urologic Scaffold as a prophylactic treatment for post-prostatectomy stress urinary incontinence.
“Today we celebrate two incredible accomplishments for Levee Medical and the Voro Urologic Scaffold,” says Bruce Choi, Founder and CTO of Levee Medical. “This latest funding will serve as a powerful catalyst, propelling our clinical and regulatory efforts forward, expediting the path to commercialization, and facilitating the development and execution of a robust clinical strategy for our groundbreaking technology. With the support of our valued investors and dedicated team, we are poised to make a profound impact on patients undergoing surgical treatment for prostate cancer.”
The Voro Urologic Scaffold is the first and only bioresorbable device designed to be placed during the robotic prostatectomy procedure for the treatment of urinary incontinence. It is designed to reduce the stress on the urinary sphincter by managing the geometry of the bladder neck and maintaining urethral length, which is the best predictor of post-op incontinence.
“I am thrilled to say the first implant of the Voro Urologic Scaffold in the ARID study was a success,” states Michael Ferrandino, M.D., urologist at Colorado Urology in Westminster, CO. “The resorbable scaffold integrated into the robotic procedure and we were able to increase the urethral length. I firmly believe this approach can provide patients with the invaluable benefit of early continence after undergoing a robotic prostatectomy. The Voro Urologic Scaffold has the potential to significantly expedite the recovery process and enhance outcomes.”
In addition to these significant milestones, Levee Medical has also expanded its leadership team with the recent hire of Tessa Yamut, as Executive Vice President of Clinical and Regulatory Affairs. Tessa is a seasoned veteran in the medical device industry, with a remarkable track record spanning nearly 30 years, including 24 years in senior management roles. Her expertise shines through in her ability to navigate the complex landscape of regulatory, clinical, and reimbursement challenges for emerging companies. Her innovative and creative approach, combined with her unique skills, has proven instrumental in successfully de-risking, and expediting the approval process for Class I, II, and III medical devices both domestically and internationally.
About Levee Medical
Levee Medical is committed to designing solutions that aim to reduce complications associated with surgical treatment for prostate cancer. The Voro Urologic Scaffold is the first product Levee Medical plans to bring to market. The device is not currently available for sale.
For more information, please visit leveemedical.com