Jean Pham presented Cellens at LSI USA ‘24

Jean Pham  0:04  
Hello, everyone, thanks so much for being here after, I would say delicious lunch today. My name is Jean Pham. I'm the co founder and CEO of Selland. At cell and we're developing a novel diagnostic modality and machine learning to detect cancer non invasively. So I would like to start by sharing with you an interesting fact about cancer cell that you may not know, which is the fact that cancer cells are actually feel softer lead adhesive than normal, healthy cell. So physically, it feels different if you can touch it with a mechanical tool. And that's what selon is doing. We using a mechanical probe that is 10,000 times thinner than the strand of human hair, and touching the cell surface and extracting biophysical property on a single cell level. And we use machine learning and AI to be able to train and validate our platform to differentiate cell coming from a tumor for this normal healthy cell. And this phenomenon applied to multiple saw that tumor, but I'm gonna zoom in on our first clinical opportunity here in bladder cancer. This is a common cancer, nearly a million people in the US right now has a prior history of bladder cancer 60 to 80% of the time, they would see a recurrent in their bladder, again, making this disease a very much like a chronic disease that requires constant monitoring of the bladder. And it's very costly. It costs the US healthcare system, an upwards of $11 billion. And this is what the patient is going through with bladder cancer. Again, after the initial diagnosis and treatment, they are now going through an endless visit to the urologist clinic where they're going to do a cystoscopy, basically putting an endoscope into the urethra to visually see where the tumor lesion. And I don't have to tell everybody that is painful and inconvenient. It's expensive procedure, which is why it has a very high, noncompliant rate, so patient don't really show up to do this procedure. And the most striking fact is, actually there's only 10% positive result, meaning that 90% of the patient just going through this endless cycle with cystoscopy, just to receive a negative test. So we asked the questions, what if we could develop an high performing non invasive test that could serve as a rule out and stratify the patient risks before they go into the urologist clinic? Right? So that would help the urologist not only be able to see more patients, but see them at the earliest stage where the surgical treatment is still the most effective therapy, and they actually spend more time doing our treatment and resection of the tumor than doing just an unnecessary cystoscopy, diagnostic Cystoscopy. And our process is super simple. All we need is avoided urine sample, so pee in a cup and then ship it out to a centralized lab, where we invented the whole method of collecting the cell from the urines scanning it with atomic force microscope, and our own machine learning algorithms software to differentiate the cell and give back a resolve to the urologist with a binary yes and no resale. We already conducted clinical study with two hospital U DUB Seattle and Dartmouth Medical Center and the first 68 patients for the same patient population that we're gonna launch the test for. We compared with standard of care, Cystoscopy and biopsy for the positive patient and we were able to show a 91% sensitivity and 82% specificity, which is a really good performance right now that we continue to improve. The commercial strategy is to launch this test as a lab develop a test product, this is the most capital efficient way to launch this technology will get me one sample from patient at home or in clinic, ship it out to our centralized lab, and then in the future, when we have more volume we're gonna go with the FDA clearance. There has been a A lot of devlopment for urine based diagnostic for bladder cancer. But just to be clear here, the you know, there are a few FDA clearance. urine tests are actually getting some traction. Eurovision fish by Abbott was approved in 2001 23 years ago. And then bladder epi check was approved last year in 2023. However you look at the sensitivity and specificity of these tests, it's basically still sensitivity in the 60%, which means that there's still a lot of false positive and actually lead to more unnecessary Cystoscopy. So we'll we'll see that this is a unmet clinical need that a novel and high performing urine based tests could solve. Looking at reimbursement, this is actually one of our core strengths. One of our independent Board member is a global head of reimbursement at cogent and we looking at the landscape really closely. There already been positive local coverage determinations for urine base tumor marker with the same intended use that we are going after, we would pursuing our own code and looking at the landscape, this there's going to be a pricing of between 700 to $1,000 tests, compared to a pretty good Dubai. And the market for oncology diagnostic space actually fast growing based on number of factor, just bladder cancer monitoring alone is a $1 billion. And if we expand it to other kinds of urologic oncology, it could be a one could be a 4 billion market. And then we have super excited to have the support from you ologists in different care setting, both from academic medical center where we create the technology to community practice, where majority of the patients are being seen at. So we're developing clinical guidelines with these neurologists and launching trial we have a trial of a 200 patients that is ongoing at Dana Farber and Brigham and women that have really promising readouts happy to follow up and up you with more interest. Looking at IP protections, cellent is their academic spin now so we license exclusive IP from Tufts University, that's where I met my technical co founder when I was in tough school of engineering, we already got IP, like secure in the US and Canada already have issue pattern, and we continue to persecute it in number of countries, number of countries as well. Again, going back to the first story that I tell you, this is a platform technology, bladder cancer, just the first product, but this could work on other types of epithelial cell where we could get the sample from non invasive manner such as cervical cancer or colorectal cancer, we had demonstrate some proof of concept data on cell ly, showing that this method could apply to other type of indication as well. And super excited that you know, Sal and had been able to attract both non diluted and diluted funding over the past two and a half year that we started this company 6.5 million from the NIH and NSF and the mass Life Science Center. Last year, we close about 1.5 million in convertible note from a lease that we see such as sosv CDL. And just very recently, the fund from the American Cancer Society had been one of our investor. And also next week, we're gonna announce our strategic r&d collaborations with poker. It's a publicly traded lifestyle and company that we are very excited about the ability to scale. Thanks so much for having me. We are teams that have what it takes to bring this product to the market. Thank you so much.