Avenda Health, a medtech company based in Santa Monica, California has developed the Focal Therapy System. It provides AI-powered prostate cancer therapy with the aim of treating only tumorous tissues, while reducing side-effects compared with conventional therapies. The system recently received FDA breakthrough designation.
At present, there are limited treatment options for men with prostate cancer, with surgery and radiation therapy being the most commonly used approaches. However, these techniques pose significant risks for patients, including urinary and sexual dysfunction. 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 surrounding tissues.
The treatment itself occurs under local anesthesia at a urologist’s office, and involves minimally invasive laser ablation. The company compares the treatment to a lumpectomy for breast cancer treatment, and claims that it represents a significant advancement in the current standard 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 the men affected by it.
Shyam Natarajan, Avenda Health: Prostate cancer is one of the most common cancers, with one in eight men developing it in their lifetime. According to the National Cancer Institute, 248,530 men will be diagnosed with prostate cancer in 2021. Of those men, about half have intermediate-risk prostate cancer that has not spread beyond the prostate (clinical stage of T2b, Gleason score of 7 and a PSA that is greater than 10 but less than 20). Despite advances in many areas of oncology, no treatment of localized prostate cancer has been approved for decades.
Medgadget: How is prostate cancer currently treated? What are the limitations with these approaches?
Shyam Natarajan: Currently, men with intermediate-risk prostate cancer face limited choices and treatment — patients either have their entire prostate treated with radiation or complete removal, or receive no treatment at all and instead choose “watchful waiting” or “active surveillance.” Both of these options can leave men with significant quality-of-life issues. In fact, about 50 percent of men with prostate cancer who undergo surgery or radiation are at risk of sexual, urinary and/or bowel dysfunction. This is why many men and their physicians choose watchful waiting and active surveillance, which is a way to monitor the prostate cancer for progression through regular tests and biopsies.
Medgadget: Please give us an overview of the Avenda Health Focal Therapy system. What inspired you to design such a system?
Shyam Natarajan: Avenda Health was founded, with support from a National Cancer Institute grant, to usher in the future of prostate cancer treatment. The company’s technology and device system, which are being developed to treat only the tumor in the prostate – a similar approach to a lumpectomy for breast cancer – uses imaging, artificial intelligence (AI) and laser ablation. Using a large database of cancer imaging and pathology, in conjunction with a patient’s own clinical information, a cancer probability map and treatment plan is created to calculate precisely where treatment should be applied, preserving the nerves around the prostate and the urethra.
Unlike other similar options in development, this approach will offer patients a personalized treatment plan through the use of the AI-based software and allow treatment to be performed in-office using local anesthesia. This minimally invasive and local treatment will not impact the possibility for additional future treatment options, if needed, for particular patients.
The company was inspired to design the system to bring sophisticated, personalized treatment to men with prostate cancer even outside of the leading academic centers and to allow men to have their prostate cancer treated with lower risks of life-changing and demeaning side effects of current treatment including sexual, urinary and/or bowel dysfunction. The system allows urologists to control both the diagnosis and treatment pathways, and it compiles the learnings from hundreds of urologists, allowing delivery of the most advanced treatment for prostate cancer. Avenda Health wants to advance prostate cancer treatment just as breast cancer treatment was revolutionized decades ago with the lumpectomy.
The FDA has designated the Avenda Health Focal Therapy System a Breakthrough Device for the ablation of prostate tissue in patients with localized, favorable intermediate-risk prostate cancer. Avenda Health is currently onboarding sites for a pivotal, randomized controlled multi-center clinical trial in pursuit of a PMA for the technology and device system 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 to 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 precise treatment. Using a large database of cancer imaging and pathology, in conjunction with a patient’s own clinical information, a cancer probability map and treatment plan is created to calculate precisely where treatment should be applied, preserving the nerves around the prostate and the urethra. Along with imaging to locate the tumor, it uses a proprietary optical laser and thermal sensor to precisely target and treat just 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 in development, this approach will offer patients a personalized treatment plan through the use of the AI-based software and allow treatment to be performed in-office using local anesthesia. This minimally invasive and local treatment will not impact the possibility for additional future treatment options, if needed, for particular patients.
Medgadget: How do you expect the system will compare with other treatments for prostate cancer in terms of safety, side effects, and efficacy?
Shyam Natarajan: While we have a pivotal, randomized controlled multi-center clinical trial in the works where we will learn more about the safety and efficacy, we have completed two studies that have produced encouraging data.
In the most recent study, data from 6-month results are still being analyzed. In the prior developmental study conducted at UCLA (published in 2017), a prototype device was used and we did not have our AI algorithms incorporated into the device; however, this study provided two key learnings.
1.) Additional support for identifying the cancer margins is necessary as MRI underestimates the true extent of the disease. Several patients from the first study had residual cancer as the cancer margins were not properly identified. This key insight is what drove us to develop a large database and train AI algorithms to predict prostate cancer margins. We have retrospectively applied our algorithms and have shown that the algorithms correctly predicted where the cancer was in all patients from this first study.
2.) Long term results seem durable. For the patients that did not have csPCa (clinically significant prostate cancer) at 12-month follow-up biopsy, these results have held out to 5 years.
We look forward to analyzing the results of our latest study and to continue to build on the clinical data in support of our “lumpectomy” approach as an alternative therapy option to preserve quality of life for men with favorable intermediate risk prostate cancer.
Medgadget: Congratulations on receiving Breakthrough Device Designation from the FDA. What does this mean for the system, and how will it help you to develop it further?
Shyam Natarajan: Breakthrough Device Designation by FDA is reserved for devices that are potentially transformative, offering treatment for serious diseases that may be more effective than currently available treatments. Under the FDA Breakthrough Device Program, the FDA will provide Avenda Health with priority review for clinical trial protocols and commercialization decisions. The designation may also facilitate Medicare reimbursement following FDA approval of the technology. The Breakthrough Device Designation is significant because it is for a prostate cancer-specific indication. A treatment device has not advanced to FDA approval for prostate cancer in more than 40 years.
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