James Clemmer15:19
We agree. You know, NanoKnife has a history here at AngioDynamics. What NanoKnife is, it's an ablation tool to ablate tumors. It uses energy that we deliver. So, it's a non-thermal approach, meaning it doesn't use heat or cold. No thermal energy is used to freeze or to burn the tissue. But energy is delivered through our probes. A small electrical field is created around the tumor which lets that tumor die naturally actually within the body and we don't damage surrounding tissue or vascular structure that supports the organ you're treating. So NanoKnife is an amazing product. The challenge we've had for years is we've had an FDA approval since 2012 to market the product with just a soft tissue indication. No specific organs that we could treat. So the company struggled and was challenged for a couple years to try to get an organ specific code. So when I arrived and others, we decided to focus our energy in those spaces. The first area that we thought we could treat was folks with stage three pancreatic cancer, which is a really difficult treatment. There's no real standard of care today for those people, but we thought our product could help there. So we launched a study called DIRECT four years ago and we're actually getting ready now to launch the results of the DIRECT study soon so people can see how our product works in that difficult disease. But along the way the FDA actually came out with a guidance document, a pathway for products like NanoKnife to become enabled to treat men with intermediate risk prostate cancer which is a really large market and men today need an alternative treatment if you have intermediate risk prostate cancer. Today, some men are told their prostate cancer isn't moving that rapidly. So, they take a watchful waiting approach to monitor the disease in their bodies. Then, men on the aggressive schedule are told that, 'Hey, we've got to get this out of your body. We're going to take your prostate out.' And unfortunately, with that come side effects of incontinence and impotence that affect many men who have that treatment. Well, in the middle, there's about 40% of the men diagnosed annually. Here in the US, 300,000 men are told annually they have some level of prostate cancer. We think about 40% of the men that we can help with NanoKnife. And NanoKnife again can deliver energy to the tissue, not going to harm the other structure around the tissue, hopefully treat that tumor and give men a chance to have that recovery period, have their prostate treated safely and not have those side effects of incontinence and impotence. We proved that in our PRESERVE study and the PRESERVE study had really favorable outcomes. We presented that data to the FDA last year and they gave us an approval in December. For the first time we can now market the product and educate people around this product. So we're really excited, Omar, to become a new part of what we think will be a treatment protocol over time, become a standard of care we believe and give men this option and also give the urology community a new treatment option they can offer to men today. So we're really excited about this. We think it'll help our company grow as well. Today we're early, only six or seven months into the approval phase. So, we're doing the early level education, talking to the urology community about our unique device, doing some awareness campaigns, so men can go online now and Google, you know, find out what they've just learned if they've been unfortunately told they have intermediate risk prostate cancer. They can learn about our device and learn about why it's different, maybe talk to a caregiver to see if we're a good option for them. But, we're really excited. Our healthcare economics team did a really good job working to get us a CPT1 code that'll kick in and become effective January 1 of 2026. So, we're excited. We look at the landscape, Omar, not that far into the future, even next calendar year, we're going to have a device that's approved. We're going to have a CPT1 code to get reimbursement for caregivers who deliver care and hopefully men who will become aware and educated about this new device and have a new treatment option. So we think NanoKnife can be a really important product for men in the healthcare community and for our company to grow over time.