AI laser probe for prostate cancer enters clinical trials • The Register

AI software capable of more accurately imaging tumor tissue to help surgeons treat and shrink prostate cancer with a laser-powered needle will soon be tested in clinical trials on real patients.

The National Cancer Institute estimates that about 12.6 percent of men will be diagnosed with prostate cancer at some point in their lives. The risk of developing the disease increases over time men over 50. It is one of the most curable forms of cancer considering that most cases are caught in the early stages due to regular screening tests.

Treatment for prostate cancer depends on the severity of the disease. Patients may undergo hormone therapy, chemotherapy, or surgery to remove tissue. Avenda Health, a medical startup founded in 2017, is developing a new type of treatment that is less invasive. The U.S. Food and Drug Administration (FDA) this week granted the company’s invention an investigational medicinal product exemption (IDE), meaning it can now be used in a clinical trial.

Patients must first have an MRI scan and a targeted fusion biopsy. The data is processed by Avenda’s AI algorithms in its iQuest software to map where the cancer cells are located in the prostate. Next, the computerized model simulates where FocalPoint, a laser-armed probe, can best be inserted to assist surgeons in treating the patient’s tumor. The heat from the laser gently heats and kills the cancer cells with the goal of shrinking and removing the entire tumor.

focal point_iquest_avenda

MRI images where cancer was mapped before and after treatment using iQuest software. Photo credit: Avenda Health

“Historically, prostate cancer treatments through surgery or radiation affect critical structures such as the urethra and the nerves that control sexual and urinary function,” said Shyam Natarajan, CEO and co-founder of Avenda The registry. “Our FocalPoint focal laser ablation system, powered by our AI-driven cancer margin software iQuest, specifically targets tumor tissue while avoiding healthy tissue. This means patients no longer lose control of these functions that are so common with traditional treatments. this significantly improves the quality of life.”

The treatment is only effective in men who have been diagnosed as having an intermediate risk of prostate cancer, a classification that describes tumors that are only limited to the prostate. Patients are considered high-risk when the cancer has spread beyond the prostate.

“This is one of the advantages of the iQuest software. Not only can it map the cancer, but it also helps the doctor make decisions when determining the best course of treatment for an individual patient. Not every patient is a candidate for focal therapy, and it is important for the physician to distinguish between good candidates for focal therapy and those who are not. iQuest provides useful insights for this decision-making process,” said Natarajan.

Avenda receive FDA clearance for its FocalPoint device in 2020. IDE clearance brings the company one step closer to bringing its product to market following clinical trials, Brittany Berry-Pusey, co-founder and COO of Avenda, said in an opinion.

“This clinical study will play a key role in advancing our breakthrough technology to improve the treatment of prostate cancer. With no new FDA approvals for the treatment of localized prostate cancer in more than four decades, we look forward to working with our clinical sites to gather the data needed to bring iQuest and FocalPoint to market and into to bring patient care.”

Natarajan informed us that the company aims to start clinical trials in 2023. ® AI laser probe for prostate cancer enters clinical trials • The Register

Laura Coffey

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