Localized Prostate Cancer Therapy: Interview with Shyam Natarajan, CEO of Avenda Health

0
240


Avenda Health, a medical technology company based in Santa Monica, California, has developed the focal therapy system. It provides AI-driven prostate cancer therapy with the goal of treating only tumor tissues, while reducing side effects compared to conventional therapies. The system has recently received the innovative designation from the FDA.

Currently, there are limited treatment options for men with prostate cancer, with surgery and radiation therapy the most widely used approaches. However, these techniques pose significant risks to patients, including urinary and sexual dysfunctions. The Avenda focal therapy system uses AI to design a personalized treatment plan for each patient that aims to treat only the tumor and preserve the surrounding tissues.

The treatment itself is performed under local anesthesia in a urologist’s office and involves minimally invasive laser ablation. The company compares the treatment to a lumpectomy for the treatment of breast cancer and claims it represents a significant advance in the current level of care.

To explore the technology a little more, Medgadget spoke with Shyam Natarajan, co-founder and CEO of Avenda Health

Conn Hastings, Medgadget: Please give us an overview of prostate cancer and affected men.

Shyam Natarajan, Avenda Health: Prostate cancer is one of the most common cancers, and one in eight men develop it in life. According to the National Cancer Institute, 248,530 men will be diagnosed with prostate cancer by 2021. Of these men, about half have intermediate-risk prostate cancer that has not spread beyond the prostate (clinical stage of T2b, score Gleason of 7 and PSA that is greater than 10 but less than 20). Despite advances in many areas of oncology, no localized prostate cancer treatment has been approved for decades.

Medgadget: How is prostate cancer currently treated? What are the limitations of these approaches?

Shyam Natarajan: Currently, men with intermediate-risk prostate cancer face limited options and treatment: patients have their entire prostate treated with radiation or complete elimination, or receive no treatment, and instead choose a “careful wait.” or “active surveillance”. Both options can leave men with significant quality of life problems. In fact, about 50 percent of men with prostate cancer who undergo surgery or radiation are at risk for sexual, urinary, and / or intestinal dysfunction. This is why many men and their doctors choose active surveillance and careful waiting, which is a way to monitor the progression of prostate cancer through periodic tests and biopsies.

Medgadget: Please give us an overview of the Avenda Health Focal Therapy System. What inspired you to design this system?

Shyam Natarajan: Avenda Health was founded, with support from a grant from the National Cancer Institute, to initiate the future of prostate cancer treatment. The company’s technology and device system, which is being developed to treat only the prostate tumor (an approach similar to a lumpectomy for breast cancer), uses imaging, artificial intelligence (AI) and ablation. laser. Using a large database of cancer imaging and pathology, along with the patient’s own clinical information, a cancer probability map and treatment plan is created to accurately calculate where the treatment should be applied, preserving the nerves around the prostate and urethra.

Unlike other similar options under development, this approach will offer patients a personalized treatment plan through the use of AI-based software and will allow treatment to be performed in the office using local anesthesia. This minimally invasive and local treatment will not affect the possibility of future additional treatment options, if necessary, for specific patients.

The company was inspired by the design of the system to offer sophisticated and personalized treatment to men with prostate cancer even outside the leading academic centers and to allow men to treat their prostate cancer with lower risk of side effects. life-changing side effects and underestimate current treatment. including sexual, urinary and / or intestinal dysfunctions. The system allows urologists to monitor both diagnosis and treatment pathways and collects the learnings of hundreds of urologists, allowing for the most advanced treatment of prostate cancer. Avenda Health wants to advance the treatment of prostate cancer just as breast cancer treatment was revolutionized decades ago with lumpectomy.

The FDA has designated the Avenda Health focal therapy system as an advanced device for prostate tissue ablation in patients with localized and favorable intermediate-risk prostate cancer. Avenda Health is currently joining sites to conduct a controlled, randomized, multicenter clinical trial in search of a PMA for system technology and devices as a Class III medical device for the treatment of prostate cancer.

Medgadget: What role does AI play in the system and how does it help improve patient outcomes?

Shyam Natarajan: Pending FDA approval, Avenda Health’s focal therapy system is the only treatment platform for prostate cancer that uses artificial intelligence to predict and help guide the most accurate treatment. Using a large database of cancer imaging and pathology, along with the patient’s own clinical information, a cancer probability map and a treatment plan are created to accurately calculate where the treatment should be applied, preserving the nerves around the prostate and urethra. Along with imaging to locate the tumor, it uses a proprietary optical laser and thermal sensor to accurately target and treat only the prostate tumor, not the entire prostate. The goal is for this targeted ablation to minimize the impact on healthy tissues, without compromising urinary or sexual function.

Unlike other similar options under development, this approach will offer patients a personalized treatment plan through the use of AI-based software and will allow treatment to be performed in the office using local anesthesia. This minimally invasive and local treatment will not affect the possibility of future additional treatment options, if necessary, for specific patients.

Medgadget: How do you want the system to compare to other prostate cancer treatments in terms of safety, side effects, and effectiveness?

Shyam Natarajan: Although we conducted a controlled, randomized, multicenter clinical trial in work where we will learn more about safety and efficacy, we completed two studies that have produced encouraging data.

In the most recent study, data from 6-month outcomes are still being analyzed. In the previous development study conducted at UCLA (published in 2017), a device prototype was used and we did not have our AI algorithms built into our device; however, this study provided two key learnings.

1.) Additional support is needed to identify cancer margins, as MRI underestimates the actual extent of the disease. Several patients in the first study had residual cancer as the cancer margins were not properly identified. This key vision is what drove us to develop a large database and form AI algorithms to predict the margins of prostate cancer. We retrospectively applied our algorithms and demonstrated that the algorithms correctly predicted where cancer was found in all patients from this first study.

2.) Long-term results seem lasting. For patients who did not have csPCa (clinically significant prostate cancer) on the 12-month follow-up biopsy, these results have been maintained for up to five years.

We hope to analyze the results of our latest study and continue to leverage clinical data to support our “lumpectomy” approach as an alternative therapy option to preserve the quality of life of men with favorable intermediate-risk prostate cancer.

Medgadget: Congratulations on receiving the innovative FDA device designation. What does this mean for the system and how will it help you develop it further?

Shyam Natarajan: The FDA’s advanced device designation is reserved for potentially transformative devices, which offer treatment for serious illnesses that may be more effective than currently available treatments. Under the FDA’s Advanced Devices Program, the FDA will provide Avenda Health with a priority review of clinical trial protocols and marketing decisions. The designation may also facilitate Medicare reimbursement after the technology is approved by the FDA. The designation of innovative device is significant because it serves for a specific indication of prostate cancer. A treatment device has not advanced in FDA approval for prostate cancer in more than 40 years.

Link: Avenda Health homepage …

Flashback: Avenda Health uses artificial intelligence to improve prostate cancer treatment





Source link