A medical device company in Durham recently closed a $4.3 million raise as it begins its first clinical studies.
The funding will support Levee Medical's clinical and regulatory efforts as the company advances a device intended to reduce complications associated with surgical treatment for prostate cancer.
Levee Medical announced the close on Sept. 6, a few months after filing paperwork with the U.S. Securities and Exchange Commission. According to the filing, as of July 7 the company had raised about $3.4 million from 34 investors.
The new investment follows the company closing a $6.6 million Series A round last year.
Funding for the new raise came from angel and early-stage investors and friends and family, rather than institutional investors, said CEO Adam Irving. The raise included a combination of existing and new investors who support what Levee is trying to accomplish despite a difficult financial environment throughout the life sciences industry.
"It was seamless," Irving said. "I suspect it's a result of our story. The solution we're bringing to market and the problem we're solving."
Levee is a developing a bioresorbable device, called the Voro Urologic Scaffold. It's implanted in patients during a prostatectomy procedure to treat urinary incontinence. Prostate cancer is one of the most common types among men, and the primary surgery for these patients is radical prostatectomy.
"If we can address this side effect, we believe we can make a big difference," Irving said.
Levee has begun treating study participants in its first in-human study to evaluate the safety and performance of its Voro Urologic Scaffold.
This study, which the company started in the second quarter, is an early feasibility study that's intended to set up Levee to advance into a pivotal study based in the U.S. This pivotal study, the timing of which has not yet been determined, would support Levee's efforts to move forward in the regulatory process.
"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," said Bruce Choi, company founder and chief technical officer, in a statement.
To support its development plans, Levee has expanded its leadership team, bringing in Tessa Yamut to serve as the firm's executive vice president of clinical and regulatory affairs. Yamut has spent nearly 30 years in the medical device industry, including more than two decades in senior management roles.
With the appointment of Yamut, Levee is up to four full-time employees. A number that's likely to grow as Yamut brings on additional talent to support Levee's clinical and regulatory plans, Irving said.
