Avenda Health, a medtech company based in Santa Monica, California has developed the FocalPoint ablation system, an AI-powered prostate cancer therapy. The system is designed to provide localized prostate cancer treatment and its AI system equips clinicians with a map of a patient’s cancer, along with treatment simulations to help them chose the best course of action. The goal behind the system is to effectively treat the tumor, but preserve as much of the healthy tissue as possible, thereby maximizing patient chances at retaining full urinary and sexual function. The ablation technology itself is laser-based, and the system is intended for use with just a local anesthetic and as an out-patient procedure in a clinician’s office. Medgadget spoke with Shyam Natarajan, CEO of Avenda Health in June 2021. Now, we catch up with the company about its latest developments and speak with Brittany Berry-Pusey, Co-Founder and COO. Conn Hastings, Medgadget: Please give us a basic overview of current approaches to treat prostate cancer, and their shortcomings. Brittany Berry-Pusey, Avenda Health: The current standard of care for prostate cancer treatment is a one-size-fits-all approach, which can include invasive surgery, radiation or active surveillance (i.e. annual biopsies/monitoring). Typically, providers treat prostate cancer like a whole-gland disease and these existing whole-gland therapies significantly impact the urethra and nerves surrounding the prostate which are critical to sexual and urinary function. This often discourages patients from seeking necessary treatment for the disease. Medgadget: Why has there been limited technological development in this disease space over the last 40 years? Brittany Berry-Pusey: Prostate cancer is a slow growing disease which makes designing clinical trials for new technologies for this disease challenging. The FDA and the American Urological Association (AUA) over the last few years have held several workshops to determine new trial designs and trial endpoints that can be used to encourage technological development for prostate cancer. The new guidance from the FDA and AUA will help spur new advancements in a field that has continued to struggle with high morbidity rates and low technical advancements. Medgadget: How did the idea for the system come about? Please give us a quick overview of how it works. Brittany Berry-Pusey: The Avenda Health technology is based on over a decade of research from the UCLA labs of my co-founders Dr. Natarajan and Dr. Marks. They hypothesized that if we can identify where the cancer is, we can treat just the cancerous lesions and leave the healthy tissue intact and preserve quality of life. Avenda Health’s two main products are iQuest and FocalPoint. iQuest was created to help identify where cancer is in an individual’s prostate. It is an AI-based software system that uses a patient’s clinical data to map the extent of the disease and simulate treatment options. Prostate cancer remains a challenging disease to image. Using AI, we have a much better understanding of where cancer is than ever before. FocalPoint is a laser-based ablation system. It can be used in an office-based setting with just local anesthesia. By using FocalPoint powered by iQuest, our goal is to provide a cancer control treatment option that preserves quality of life. Medgadget: How have things progressed since the last time we spoke to Avenda Health in terms of the regulatory pathway and clinical trials? Brittany Berry-Pusey: We recently received IDE approval for a randomized control trial where we will show that FocalPoint powered by iQuest is a superior form of treatment compared to the standard of care. We are extremely excited for this trial to begin and for the data that it will produce. Medgadget: Please give us an overview of iQuest, the patient management AI software that accompanies the system. Brittany Berry-Pusey: When someone is first diagnosed with prostate cancer, it’s not yet known the extent of the disease and where it is in the prostate. iQuest provides a cancer probability map that displays the probability of cancer within each area of the prostate. This information is used to understand the extent of the disease and to identify a cancer margin to target. iQuest can then simulate where to place tools, like FocalPoint, to fully ablate the tumor. Medgadget: Assuming the technology is approved and enters the market, how do you envisage that this will change how prostate cancer patients receive treatment? Brittany Berry-Pusey: Our mission is to personalize prostate cancer care to the patient and their specific case. By using AI mapping and focal therapy, it will improve precision targeting and overall control over tumor removal–ultimately, giving prostate cancer patients a better quality of life and clearer path to being cancer-free. Source