FDA Clears Avenda’s Laser Technology for Urology Treatments

0

Santa Monica-based Avenda Health Inc., a software and medical device company that spun out of UCLA, has received clearance for its laser ablation technology from the Food and Drug Administration.

Avenda Health’s image-guided focal laser ablation system is designed to destroy soft tissue in an outpatient setting. It uses a laser needle and thermal optical sensor to precisely target and treat soft tissue while minimizing the impact on surrounding healthy tissues.  


In its Dec. 16 announcement, Avenda said it will focus its commercialization efforts to urology applications.
“We purposely designed our therapy system to be simple and intuitive to use in a physician’s office,” Avenda co-founder and Chief Operating Officer Brittany Berry-Pusey said in the announcement. “Given the current strain on the health care system due to Covid-19, we believe it is vital for more therapies to move from the hospital setting to an office-based procedure.”


Avenda Health was started by three UCLA faculty colleagues in June 2017. Two of the co-founders — Berry-Pusey and Chief Executive Shyam Natarajan — were co-founders of the UCLA Business of Science Center launched by the late businessman and innovator Roy Doumani. The third co-founder, Chief Medical Officer Leonard Marks, is a urology professor at the UCLA David Geffen School of Medicine.


The trio sought to develop laser ablation technology to treat prostate cancer that could be applied in an outpatient setting. The precision nature of laser technology would minimize urinary incontinence and sexual dysfunction, two common outcomes of conventional radiation or chemotherapy treatments for prostate cancer.


Within a year, they had raised $3.3 million from several angel investors.


The FDA clearance will allow Avenda to pursue an intermediate step: treating patients with urology conditions. The ultimate goal remains treating prostate cancer.


In its announcement, Avenda said it is continuing to develop laser tissue ablation technology that can be applied to treat the disease. The company is also participating in clinical trials of its laser technology on prostate cancer patients.


“With our first FDA clearance, we are now able to offer this revolutionary technology to patients and will quickly be following up with additional technologies from our pipeline including an investigational version that is being used in clinical trials for the treatment of intermediate-risk prostate cancer,” Avenda Health CEO Natarajan said in the announcement.

No posts to display