Empowered Patient Podcast

Greg Mayes, President and CEO of Reunion Neuroscience, is developing a psychedelic therapy for the treatment of postpartum depression. This serious acute, non-chronic mental health condition affects an estimated 20% of women after giving birth.  A phase two trial is underway to evaluate how RE-104, a rapid-acting psilocybin-like novel molecule, can help women with moderate to severe postpartum depression get faster relief compared to existing treatments. Greg explains, "The course of our psychedelic administration is significant because we believe it can be shorter in time period than other psilocybin-like treatments. In our case, we were able to establish it as 3.7 hours. Because it's a psychedelic and it is for an acute and non-chronic indication, we believe that women who take our product will see a rapid uptake and potentially day of administration benefit of the psychedelic therapy. Our phase two study is called the RECONNECT study because it's named for women reconnecting with themselves, their families, their children, and the world around them." "Postpartum depression is considered to be a subset depressive of major depressive disorder, major depressive order that's not put into remission after two treatments becomes treatment-resistant depression. There's also generalized anxiety disorder. We believe that RE104 and our lead product have a lot of legs to potentially go in this area. But as the CEO of the company, we want to stay focused. We know what we need to do first and foremost is we need to get our RECONNECT phase two proof of concept study and women with moderate to severe postpartum depression recruited. And we need to show that we can work there. Once we show that, we'll pivot to other indications. One is adjustment disorder in patients with cancer and with other major medical illnesses like Parkinson's disease, ALS, MS, or pulmonary fibrosis." #ReunionNeuro #PostPartumDepression #PPD #Psychedelics #Mothers #MentalHealth #Depression #RECONNECTStudy reunionneuro.com PPDReconnectstudy.com   Download the transcript here

Tyrone Lam, is Chief Business Development Officer at GATC Health, a company that has developed a predictive AI model to derisk and accelerate drug discovery and development. A significant partnership with Lloyd's of London to use this technology to underwrite insurance for clinical trials enables the insurer to base financing decisions on objective reports that predict a drug's safety and efficacy with high accuracy. There is potential for this technology to become a standard for biotech investment, reducing reliance on animal testing and enabling more efficient development of drugs for smaller patient populations.  Tyrone explains, "GATC Health is a technology company that is de-risking and accelerating the drug discovery and drug development process. So at a higher level, our mission is to take as much of the financial and scientific risk out of the drug discovery business as possible, which would enable better, safer, and more available drugs to be available for humans."   "Our overall platform is called Operon that has literally hundreds of AI models built in that basically do three things. One is that we're able to discover and validate in silico the targets in the body associated with a particular disease. And then the second piece of our platform broadly is the ability to generate novel compounds to treat those diseases. And then we created off of Operon an independent validation that would run in silico, like an AI-generated clinical trial to understand how those novel drugs would perform against those targets in human physiology."   "That third part of the platform is where we created a product called Derisq, and that is an independent, objective report that we can run on other people's drugs, biotech pharma's drug candidates, to give them a very rapid indication of how that drug's going to perform in a human clinical trial."  #GATCHealth #DrugDiscovery #AIinHealthcare #PharmaInnovation #ClinicalTrials #HealthTech #MedicalAI #Biotechnology #PrecisionMedicine #HealthcareInnovation #FutureOfMedicine #DrugDevelopment #AIplatform #DueDiligence  #DeriskingBiotech #Derisq #CapitalEfficiency #RiskIntelligence #BiotechInvesting  GATCHealth.com Download the transcript here

Kristin Ashcraft, Co-Founder and CEO of OncoRx Insights, is determined to bring current information to community-based oncologists to help them identify precision therapies for their patients. The AI platform is designed to augment the oncologist's expertise by analyzing molecular diagnostics, pathology reports, and patient history to identify appropriate FDA-approved drugs and possible clinical trials. The aim is to democratize access to advanced treatment information, bringing the capabilities of academic medical centers to the community setting. Kristin explains, "Our goal is to increase the lifespan of cancer patients by enabling community oncologists to more efficiently identify precision therapies for their patients. We do this through a unique, comprehensive analysis of the molecular diagnostics, patient history, and pathology reports. The reason that we are here is that it can be summed up really well in a study that was recently published in the Journal of Clinical Oncology, in which they found that only 36% of eligible lung cancer patients receive precision medicine therapies. And so OncoRX Insights is focused on bringing greater access to precision medicine for cancer patients."   "Cancer results from genetic mutations from external or inherited causes, and it presents in over a hundred different forms. So as you pointed out, understanding the best possible treatment really is a challenge. But using the molecular diagnostic report and additional information like pathology reports, patient history, understanding those details can really help drive the most targeted treatment to have the best chance of the best outcomes for those patients." #OncoRxInsights #PrecisionMedicine #CancerCare #AIInHealthcare #Oncology #CommunityOncology #HealthTech #MedTech #CancerTreatment #DigitalHealth #PersonalizedMedicine #HealthcareInnovation #CancerResearch #HealthcareInnovation #RealWorldData OncoRxInsights.com Download the transcript here

Ian Crosbie, CEO of Sequana Medical, identifies the incidence of liver cirrhosis and the complication of liver ascites, which causes significant fluid buildup in the belly that severely impacts a patient's quality of life. Standard treatment requires repeated hospital visits to drain the fluid. The alfapump developed by Sequana is a fully implanted device that continuously drains ascites into the bladder for natural excretion, eliminating the need for drainage procedures. Ian explains, "Liver ascites is a complication of liver cirrhosis, a serious condition where the liver becomes badly scarred. As a result, the fluid accumulates in the belly, often five to ten liters of fluid. And as you can imagine, this causes huge swelling of the belly and major clinical problems, and obviously dramatically impacts the quality of life of these patients. Problems can include instability and falling. You can imagine with all that weight out front. The swelling of the belly causes difficulty eating, breathing, sleeping, and functioning."   "So we're in an era of AI and targeted cancer therapies, CAR-T, and things like that. But the standard of care for these patients is to let them build up five to ten liters of fluid in their bellies, then bring them into hospital, stick a big needle in them, drain them over the course of five to seven hours, send them away, and then the moment they leave hospital, they start to reaccumulate that fluid again, and the process starts all over. That is a procedure known as paracentesis. Not only is it, as you can imagine, a painful, burdensome, and traumatic procedure, but in the days leading up to the procedure, the days and weeks as the fluid starts to accumulate, all those impacts on quality of life and clinical complications occur. And so that is why we developed alfapump to stop the buildup of fluid in the belly and to stop all of those problems and to stop those regular visits to the hospital." #SequanaMedical #MedicalDevices #LiverDisease #HealthcareInnovation #PatientCare #MedTech #Alfapump #DigitalHealth #ChronicDisease #QualityOfLife #HealthTech #MedicalBreakthrough sequanamedical.com Download the transcript here

Andria Parks, Head of Commercial Operations at First Ascent Biomedical, highlights the value of using a biopsy to grow cancer cells in a lab to determine which drugs are most likely to be effective against a specific cancer. This functional medicine approach combines lab data, genomic data, and AI to produce a report that identifies which drugs might work and which are unlikely to be effective for that individual patient. This perspective is particularly effective for rare cancers, which often lack established treatment guidelines.  Andria explains, "First Ascent Biomedical is a functional precision medicine company. And what that means is we've put together three very unique and advanced technologies to produce something very specific, and I'll explain what that means. What we do is we take a fresh biopsy from a patient, and we will grow those cells in our lab in a medium very similar to the human body. We will test or validate more than 150 drugs and drug combinations on those cells to see what works on those cells and what kills them. We will combine that with a patient's genomic information using our advanced AI. And then a report is produced that stack ranks the drugs that work, but most importantly, the drugs that don't work for that patient's cancer. And when a physician sees that report, they know exactly what to start with before initiating treatment. So everything we do is outside the body."   "If you are testing 150 drugs and combinations on your unique cancer cells, you will be able to know what works and doesn't ahead of time. Usually, most patients who don't follow this approach go through a standard-of-care protocol. And what that means is these protocols or ways of treating patients are based on hundreds of thousands of patients that may look like you and me, but are not you and me. So it's based on evidence of many, many, many patients with a similar type of profile. But the uniqueness of getting a drug to work for your specific cancers is based on your unique cells. So that's what makes a big difference. You may see 20% - 40% that works, but without knowing if they were tested on your cancer cells, and that's what makes a big difference with what functional precision medicine in oncology delivers." #FirstAscentBiomedical #PrecisionMedicine #CancerResearch #Oncology #PersonalizedMedicine #HealthTech #RareCancer #Innovation #FunctionalMedicine #AI #Biotech #PatientCare firstascentbiomedical.com Download the transcript here

Dr. Steven St. Peter, Co-Founder and Managing Director of Vie Ventures, discusses his firm's unique hybrid model that combines venture capital with disease philanthropy to accelerate the development of new therapies for autoimmune diseases.  While philanthropies have excelled at funding basic research, a gap exists in translating those findings into FDA-approved drugs. Steven points out that the autoimmune field is entering a golden age, driven by insights from immuno-oncology and by AI's potential to analyze data across autoimmune diseases. Steven explains, "I've been doing venture capital for the last 30 years. I'm also a physician, but I'm very interested in how venture capital is helping bring new therapies to patients, and that's really the core of what venture capital does. So I've been doing that and am comfortable with that for a long time, as well as my co-founders. About five years ago, I joined an effort working with the disease philanthropy to help create a hybrid model. And I thought that was very interesting because these disease philanthropies are really the voice of the patient. So to the extent that you can bring disease, philanthropy, and venture capital to mix, I just think that's an incredible model, and that really is what Vie Ventures is all about." "The large disease-focused philanthropies have done a phenomenal job in funding basic science research coming out of academics and helping really define, well, what is autoimmune disease and what are the biological systems and why does that matter? And in fact, just taking the case of type 1 diabetes until the 1980s, we didn't even know that that was an autoimmune disease. And in an autoimmune disease, it's the body's immune system attacking a tissue that it shouldn't. And the consequence is that it manifests as a sort of disease. So a lot of the research foundation spent a good amount of time teasing out all that basic science, and that led to insights that then allow us to create new therapies to actually change the course of these diseases. And so as you roll the clock forward to where we are in 2026, that biology has been defined." "So what Vie Ventures does is it really allows a way for these disease foundations to reach into the translation of that fundamental discovery research to actually fund drugs that are going into patients to hopefully result in an FDA approval. And that just hasn't been done in the past because the science hadn't been defined yet, but now we're at this very exciting time, and that's the next frontier." #VieVentures #AutoimmuneDisease #VentureCapital #CARTTherapy #Immunology #PatientAdvocacy #Biotech #HealthcareInnovation #Type1Diabetes #MultipleSclerosis #Lupus #EmpoweredPatient #HealthcarePodcast #MedicalResearch #PatientCentricity #DiseasePhilanthropy #AutoimmuneDisorders #ImmuneOncology #VentureImpact vieventures.com Download the transcript here

Ed Ahn, CEO of MEDIPOST, is developing next-generation stem cell therapies for inflammation-driven degenerative diseases with a primary focus on knee osteoarthritis. Using umbilical cord-derived stem cells, which have higher proliferation capacity than adult-derived stem cells, allows MEDIPOST to scale cell manufacturing and provide broader access to care. The company's lead program, Cartistem, has been approved in Korea for over 10 years, and new funding will accelerate US clinical trials. Ed explains, "We are focused on treating inflammation-driven degenerative diseases. So all these diseases that you commonly associate with the aging process. Those are some of the things that we're very interested in slowing the progression of." "We're actually going back to the source for neonatal stem cells from the cord blood. One of the primary advantages of going for a neonatal source of stem cells versus an adult source is that these are the most naive stem cells that one can obtain. And what I mean by naive is that they've been in a protected environment in the mother's womb. They have not been exposed to a lot of the different antigens that adults have been exposed to. So they're very immune-privileged compared to adult stem cells." "I think this idea or the concern about cost can be applied to all sorts of regenerative medicines, whether or not they're gene therapies or cell therapies, they're amongst the most expensive therapies to manufacture for a company, primarily because we're building a process around an inherently biological process. One of the advantages we have at MEDIPOST is that this product has been approved in Korea for over 10 years. So we have a tremendous amount of manufacturing experience and know-how from our parent company in Korea that we're able to apply to our manufacturing process in North America. And that really advances and matures our program far beyond other people in the field."    #MEDIPOST #CARTISTEM #StemCellTherapy #KneeOsteoarthritis #RegenerativeMedicine #Innovation #Healthcare #Biotech #ClinicalTrials #JointHealth #AntiAging #MedicalBreakthrough #BiotechInnovation medipost.com Download the transcript here

Yael Elish, Founder of StuffThatWorks, was part of the Waze founding team that brought crowdsourcing to maps and traffic. She is now bringing her insights into the power of the crowd to build a patient-generated real-world database to support patients and medical research, accelerating drug development, and improving the efficiency of clinical trials. Their OpenStuff platform is an AI-powered search tool that makes patient experience data accessible to patients, doctors, and researchers, and validates the patient experience. Yael explains, "As background, I was part of the Waze founding team, and this is where I got acquainted firsthand with the power of crowdsourcing. Waze does crowdsourcing of traffic and the building of maps. And this is where people are joining based on a common vision that if everyone shares information in an organized form. If there's a platform that can collect all the data in a structured format, it can deliver everything in a way that's much more useful and solves a very big problem that otherwise couldn't be solved." "So the idea here is people have a ton of experience, especially when we're talking about a chronic condition someone has been living with for years and years and years. They've tried many things. Some went out and researched the information that everyone else has. How they experienced the condition, what they tried, what worked, what didn't work, what are the aggravating factors, what are the comorbidities? All this information that people have, if collected in an organized form as data at scale, can be transformed into very powerful data that doesn't exist today. That's the premise behind StuffThatWorks. And the way it works is that anyone can join their condition community. So if you have a chronic condition, you will search for your condition, you will join your condition, and you will share information that becomes data, consistent data across everyone who joins the platform. And today, with AI, it's really transformative. It's amazing, unique data that doesn't exist anywhere else." #StuffThatWorks #OpenStuff #HealthTech #PatientEmpowerment #AIHealthcare #CrowdsourcingHealth #DigitalHealth #ChronicDisease #HealthcareInnovation #PatientData #ClinicalTrials #PersonalizedMedicine #HealthAI #MedicalResearch #PatientVoice #HealthcareTransformation #RealWorldEvidence stuffthatworks.health Download the transcript here

Jesse Lipson, Founder and CEO of Levitate, focuses on using AI to help providers enhance patient-provider communication and develop and maintain personal, authentic connections with patients. Patient expectations are changing due to AI, and patients now expect more responsive, personalized messaging from doctors. This service-as-software can support busy providers in developing and executing a communication strategy at scale to build their practices and strengthen relationships with patients. Jesse explains, "My vision was to help what I call relationship-based businesses. I would consider many types of healthcare practices to fall into that category, and to do a better job of keeping in touch with their patients in a more personal, authentic way at scale. And so I think the challenge is we all know the value of the simple things like remembering kids' names, pets' names, spouse names, hobbies, and reaching out and keeping in touch in a thoughtful way on a regular basis. But it's very hard to do that at scale, and things kind of slip through the cracks." "When it comes to patient care itself, you want to be that person who, when you do get to spend a little bit of time with a patient, you are remembering things about them more on a human level rather than just in and out on the clinical level. Both because that provides a good patient experience, and I think that's what a lot of providers are motivated to do when they get into the field. But that context can also be helpful in providing a high level of care, in knowing and remembering things, and in deepening that personal relationship. So that was our goal: not to use AI as an automated replacement for that communication between providers and patients, but to use it to help them do a better job of that personal, authentic communication."   #Levitate #PatientEmpowerment #PatientExperience #PatientCenteredCare #HealthTech #HealthcareTechnology #RelationshipMarketing #PersonalizationAtScale #AIinHealthcare #CustomerExperience #ServiceAsSoftware #HealthTech #PatientCommunication #AIinHealthcare #HealthcareInnovation #DigitalHealth #PatientEngagement #HIPAA #PatientCare Levitate.ai Download the transcript here

Dr. Justin Schrager, Founder and Chief Medical Officer at Vital, aims to address poor communication in acute care settings such as hospitals and urgent care centers. Vital's software platform provides patients with real-time, understandable information on their own devices via a secure website. This AI-powered system is designed to provide updates on lab results and educational content, and to augment clinical care without adding to the workload of doctors and nurses. Justin explains, "We make software for the hospital, urgent care, and inpatient settings. The problem is that communication suffers when you get busier. So the busier you are, the less communication happens. It's a bit of a catch-22. And it's sort of treated as an expendable action when things are really critical. I'm an ER doctor. I understand that. And so we're trying to solve that problem by essentially communicating to patients, keeping them up to date, and helping the clinical staff out when they frankly don't have a lot of time to share a lot of the kinds of information that we're able to show patients."   "Access is at such a deficit right now that the vast majority of the healthcare we provide in the hospital and the ER specifically is for patients who are wide awake, thinking clearly, have family members there with them, and they just have an urgency. Sore throat, can't swallow, broken arm, things that aren't necessarily life-threatening or even limb-threatening, but they're urgent, and they need to be dealt with in a timely fashion. And so I think that's really where our software plays best."   #Vitalio #HealthcareInnovation #PatientEngagement #AIinHealthcare #DigitalHealth #HealthTech #PatientExperience #HealthcareCommunication #MedicalAI #HospitalTechnology #PatientCare #PatientSafety vital.io Download the transcript here

Dr. Charlotte McKee, Chief Medical Officer at Sionna, describes the nature of cystic fibrosis (CF, a genetic disease caused by a mutation in the single CFTR gene. While current CFTR modulator therapies do not address the most common mutation, Sionna's novel oral medicine is designed to target the previously undruggable NBDI domain of the CFTR protein. This new therapy aims to lead to better lung function and prevent the accumulation of permanent damage to other organs like the pancreas, gut, and liver.  Charlotte explains, "Cystic fibrosis is a genetic disease. The gene was actually discovered in 1989 for cystic fibrosis. It's considered a rare disease, but it's a relatively large rare disease. And one of those rare diseases that is potentially fatal, as you mentioned, it's thought of as a lung disease. And most patients, if their life is shortened, it's typically because of lung disease, because the lungs can be very severely affected. But the protein is caused by a genetic mutation in a gene called CFTR, and the protein is made from that gene. The CFTR protein is present on every epithelial cell of the body."   "Sionna is focused on a novel target in the CFTR protein. So you may know that, actually, there are approved medicines that have been developed over the last couple of decades that improve the function of the CFTR protein. And they've really advanced the clinical field, and there have been tremendous advances for people with CF. But this protein, this CFTR protein that goes wrong in CF, is a big, complicated, multi-part channel."   "Another unusual thing about CF is that there's one mutation that's so common around the world, and the part of CFTR that goes most wrong with F508del. This mutation is in a part of CFTR that was previously considered undruggable. It's that part that is called NBD1, and Sionna has been working for over a decade and a half of research, actually starting with Genzyme and then continuing through the company, Sanofi, has actually figured out how to develop potential medicines against this part of the CFTR protein that goes most wrong. And so we are working on these, they're called modulators, CFTR modulators, or we are working on NBD1-focused potential medicines that can directly bind to and stabilize this specific part of the CFTR protein."   #Sionna #CysticFibrosis #NBD1Stabilizers #CFTRModulators #RareDisease #Biotechnology #MedicalInnovation #PrecisionMedicine #GeneticDisease #PulmonaryHealth sionnatx.com Download the transcript here

Mark Bertagnolli, Chief Operating Officer at ViroMissile, has developed a modified vaccinia virus that can be delivered intravenously to seek out and destroy solid tumors throughout the body and is not dependent on a specific genetic driver of a cancer. The virus has been engineered to be resistant to the body's complement system, allowing it to survive in the bloodstream longer to infect the tumor. This action also turns the tumor microenvironment from cold to hot, signaling the immune system to attack the tumor and potentially working in combination with other treatments like PD-1 inhibitors to make them more effective. Mark explains, "ViroMissile has a modified vaccinia virus, and viruses tend to like to infect tumor cells. So the trick has been how to harness this. And we're on our third generation of virus, and we have a virus that you can inject intravenously that searches for tumors throughout the body, infects them, the body clears the rest of the virus, and the virus embeds itself in the tumors, replicates, spreads, activates the immune system, and destroys the tumors."   "So, the vaccinia virus itself, nobody knows really where it came from, but it ended up being the foundation of the smallpox vaccine, and we get the word vaccine from the vaccinia virus. Our founder was the first to sequence the genome of the vaccinia virus over 30 years ago. For the last 20 years, he's been working on it as an oncolytic agent. And in this particular case, within vaccinia, there are different strains. And he was able to isolate a very specific, never before isolated strain of virus that is resistant to complement attack, and also replicates very quickly in infected cells. So it has two embedded features within it, naturally, that we're able to capitalize on."   #ViroMissile #CancerResearch #Immunotherapy #OncolyticVirus #Biotechnology #MedicalInnovation #CancerTreatment #PrecisionMedicine #HealthcareInnovation #CancerCare #VacciniaVirus viromissile.com Download the transcript here

Dr. Ronald Lane, Founder of HOPE-Neuron Therapeutx, is developing an approach to treating ALS by rebalancing the body's immune system, which becomes dysfunctional in neurodegenerative diseases. The mechanism involves treating a patient's blood outside the body to activate the immune system and then infusing it back into the patient. The theory is that traditional drugs often fail because they target static genetic mutations and symptoms, while the source of the disease lies in the ongoing immune imbalance.  Ronald explains, "Well, in a broad sense, the goal of HOPE Neuron is based on the fact that our challenge here is to bring hope. And we use a neuronal basis to do that. We're not about drugs. There are no chemicals involved. We don't go that direction. But basically, it cuts across. We deal with memory, we deal with dementia and Alzheimer's, but our target initially is ALS."   "As I mentioned a moment ago, we're not doing drugs, we're not using chemicals. So what are you doing? Well, we're using the cell's immune system, and the problem with disease is that the immune system gets out of balance. When it's out of balance, you become ill. It can be in many different diseases. And there are certain indicators, and we know what to look for and what compounds the body generates."   #HOPENeuron #ALS #Neurology #ImmuneTherapy #MedicalInnovation #ALSResearch #Biotechnology #NeurodegenerativeDisease #MedicalBreakthrough #ClinicalTrials #Healthcare #Innovation #Neurodegeneration #Neuroplasticity #MedicalDevices #Immunotherapy #NeuroscienceInnovation #FutureOfMedicine #NonPharmaTherapies hopeneuron.com Download the transcript here

Dr. Galia Schwarz, CEO and Co-Founder of C8 Health, has developed a platform that addresses the gap between hospital best practices and their implementation across all departments. This approach consolidates medical knowledge from numerous disconnected systems and uses AI to proactively deliver relevant information to a clinician. C8 Health does not create best practices; it ensures that a hospital's vetted standards are communicated consistently to provide optimal patient care. Galia explains, "Hospitals are struggling to implement their best practices effectively, or in other words, control the quality and cost of care delivery. And let me explain this. There is tons of medical knowledge out there, and now with AI coming into our lives, there is even more. And hospitals create this knowledge through clinical trials, or they license this knowledge through platforms like Open Evidence or UpToDate. And every hospital takes these global best practices and turns them into local best practices, things like protocols, guidelines, procedures, and educational content. Any type of knowledge whose purpose is to ensure that standards of care are met. But I haven't met one hospital that knows how to take these best practices and turn them into actual practice, and this is what we allow them to do."   "So first of all, on a conceptual level, our platform consolidates fragmented knowledge across departments or sites into a single source and uses AI to surface the right guidance at the right moment based on the clinician's role, schedule, and patient context. So, for example, we can create an experience where we say, "Hi, Dr. X. Tomorrow you are scheduled for OR number eight. You have these four procedures. At 8:00 AM, you have a CABG procedure. These are the best practices of your hospital for this procedure. This is what changed since the last time you did this procedure. These are the people who are going to be with you in the OR."   #C8Health #HealthTech #AIinHealthcare #MedicalInnovation #PatientSafety #DigitalHealth #HealthcareTransformation #MedicalErrors #BestPractices #ClinicalExcellence #HealthcareAI #ArtificialIntelligence #AI #OpenAI C8health.com Download the transcript here

David Klein, a longtime healthcare innovator and Founder and CEO of Click Therapeutics, is a pioneer in the field of prescription digital therapeutics, PDT, which are defined as software as medicine. Click has received FDA authorization for an app to treat depression and migraine and had a successful pivotal trial for an app treating negative symptoms of schizophrenia. These digital therapeutics are designed to fill significant gaps in current care and there are opportunities to combine software with drugs and biometric data from wearables to determine personalized treatment plans. David explains, "Click's approach towards digital therapeutics is, I would say, probably the most rigorous from a clinical evidence perspective in the industry. So we really take a drug-like clinical approach to these programs where we discover and then validate these programs in multiple randomized control trials, all culminating usually in a pivotal trial. And on top of that, you'll often see in some other areas of the world or even in this country, to some degree, folks might say randomized control trial, but they're really using standard of care as the control or wait list control, and so on and so forth. We actually test our interventions against sham active control, so against other apps that control for time on task, expectation of benefit, and so on and so forth."   "Just a few months ago, we announced with Behringer Ingelheim, our partner in schizophrenia, that we hit our primary endpoint in our pivotal trial for our app that's designed to be a treatment of negative symptoms of schizophrenia. So, the holy grail, in serious mental illness altogether, but certainly in schizophrenia, is trying to mitigate negative symptoms of schizophrenia. This is such a huge patient issue and frankly an economic issue that none of the drugs have been successful at actually hitting it. So that's a unique one because we showed that an app can actually effectively and safely treat a disease that even a drug can't."   #ClickTherapeutics #DigitalTherapeutics #DigitalHealth #FDA #MedicalDevices #SoftwareAsMedicine #HealthTech #Innovation #Migraine #Depression #Schizophrenia #PrescriptionApps #PDT #PrescriptionDigitalTherapeutics #ClinicalTrials #HealthcareInnovation clicktherapeutics.com Download the transcript here

Tony Baldassarre, President and CEO of UniDoc Health, has a mission to provide accessible healthcare through remote technology and a Health Cube that can be deployed in a wide range of settings. This approach integrates into existing EMR/EHR platforms and includes a healthcare professional who works with the patient in the Cube to interact with medical devices and consult remotely with a doctor. There have been successful deployments in Ukraine, Italy, and Alaska, showing a significant reduction in emergency room visits and demonstrating capabilities for specialized care and management of chronic conditions.  Tony explains, "With the UniDoc solution, what we do is not just enable a conversation between a doctor and patient - it is not just a phone or video call. We actually provide real diagnostic medical devices for doctors to conduct a comprehensive medical visit remotely, just as if the patient were in their office. The important thing is that number one, we only use real medical devices. These are medical devices that are approved by Health Canada, the FDA, and the European Union. They are the exact same medical devices that you find at a doctor's office or a hospital. So the doctors are actually conducting the visit, and the data that they're receiving is exactly the same as it would be if they were together in the office."   "So, simply what happens first and foremost is that the patient, either through the browser, the UniDoc website, or through our app, chooses a doctor, be it male, female, different races, languages, etc. Once they have the appointment confirmed by the doctor, the patient just shows up at the Health Cube at the time that they requested the appointment, and they walk in. Once inside the Cube, there's a chair and a nurse, I'll call them a nurse for generality. There's a nurse on site, and the doctor is the only person who is remote. At that point, the nurse connects the doctor to the visit, and the medical visit starts."   "We have two Cubes in Ukraine right now, actually in Kyiv and at the border of Romania and Ukraine. That's been set up there since April of this year. We've already seen over 3000 patients, and a lot of it is actually being used by people in the town and for chronic diseases. On top of that, by law in Ukraine, we had to place these Cubes by the hospitals. That's a requirement. And the hospital is actually seeing a 35% decline in people going to the emergency room."  #UniDocHealth #HealthTech #RemoteHealthcare #MedicalInnovation #Telehealth #HealthcareAccess #Telemedicine #MedicalDevices #HealthEquity #DigitalHealth #RuralHealthcare #HealthcareInnovation  UniDocHealth.com Download the transcript here

Dr. Jennifer Perusini, CEO and Founder of Neurovation Labs, is developing a precision medicine platform to create targeted therapeutics and diagnostic tools that treat specific brain regions to address central nervous system diseases. For the treatment of PTSD, the approach focuses on the overactive amygdala due to dysregulated glutamate signaling. This objective, brain-based approach of treating a discrete part of the brain rather than the whole brain moves mental health treatment beyond the current one-size-fits-all approach, reducing side effects and improving outcomes. Jennifer explains, "What we are doing is really taking an objective, precision approach to treating mental health disorders, something like an oncology model. So what we really care about is that mental health disorders and psychiatric disorders are rooted in brain dysfunction, yes, but critically that dysfunction occurs in very discreet brain regions and circuits, not necessarily uniformly across the entire brain. So we have really developed a platform designed to identify compounds with dual potential. Precision therapeutics that act on specific brain regions, as well as diagnostic imaging agents that can reveal receptor-level dysfunction and circuit activity in the brain. And so our lead asset and main indication right now is for PTSD, post-traumatic stress disorder." "I think that academics like to focus on this research in very specific brain regions, but that therapeutic angle really hasn't caught up yet. And so, really more specifically, what we're doing is focusing on a very particular signal, an excitatory neurotransmitter in the brain called glutamate, which is a key regulator of neural activity and cell firing. And so there are many disorders, including PTSD, that are affected by dysregulated glutamate signaling. However, the glutamate drugs that are on the market today really bind to the whole brain. So that's just something that hasn't caught up yet, and that's what we're trying to do." #NeurovationLabs #PrecisionMedicine #PTSD #Neuroscience #MentalHealthInnovation #Biomarkers #DrugDiscovery #Glutamate #BrainHealth #DigitalHealth #HealthTech NeurovationLabs.com Download the transcript here

Dr. Paul Testa, Chief Health Informatics Officer who helped create the About Me Initiative at NYU Langone Health, and Dr. Katherine Hochman, Director of Hospital Medicine at NYU Langone Health, who envisioned the initiative, discuss the benefits of encouraging patients to provide non-medical information. The goal is to help care teams see patients as whole people beyond their diagnoses and to give patients an opportunity to share interests, hobbies, and fun facts that can help build trust and meaningful human connections. This About Me Initiative is being expanded from inpatient care to outpatient settings, such as infusion centers. Paul explains, "The About Me section in our EHR Epic is something that NYU Langone developed with the inspiration of Dr. Hochman, and it's essentially a dedicated discreet space in the medical record to allow patients to declare themselves, allowing them to give them a space that is transparent to all the users of the electronic health record, which are many and vast in their rules. So let them articulate something beyond their disease process or their health. So often, we reduce records to pneumonia, a broken hip, or an infection. The patient is so much more than that, and patients want to share that with us. We know that from practicing for years, Kathy and I both know that the way you connect with patients is through a narrative. Our currency is narrative. This is a location where either a patient or, if they choose to defer, can have one of their nurses or care team members provide a small sample of who they are outside of the care environment."   Katherine elaborates, "So I'm a hospitalist. Every Tuesday, I come into 16 to 18 new patients. And at NYU Langone, our length of stay keeps getting shorter and shorter, which is fantastic for patients because we want to get them in and out of the hospital as quickly and as safely as possible. But by definition, if patients stay shorter and shorter, we don't have as much time to connect. So the About Me Initiative really kicks off that connection that Paul was talking about a second ago. So long ago, and this is how it started, I would tell my teams, slow down to speed up, get to know who this patient is before getting into the heart failure, the pneumonia, the COPD, and really try to establish a little bit of a connection and build trust." #NYULangone #PatientVoices #PatientCare #HealthcareInnovation #PatientExperience #HealthIT #EHR #EpicEHR #HumanConnection #HealthcareTransformation #PatientCentered #MedicalTechnology #DigitalHealth #EmpathyInMedicine  nyulangone.org Download the transcript here

Dr. David Kirk, Chief Medical Officer at Regard, discusses the role and benefits of real-time clinical AI to help clinicians navigate patient charts and find critical information to prevent medication management errors and misdiagnoses. The Regard platform can also generate proactive documentation, allowing physicians to complete their documentation more accurately and efficiently, reducing note-bloat and the need for after-hours charting. One key goal of using AI is to free physicians to spend more time on the art of medicine, directly working with patients.   David explains, "So, Regard with real-time clinical artificial intelligence software, is helping clinicians propose the right diagnosis and information while they're working in the chart. Our mission is to make patient care as clear as possible. At the same time, we make sure that the doctors are getting the support they need so they can better support the patient. The charts of patients are getting bigger and bigger every year because more and more data is going into the charts. And as that happens, the really important thing that we as physicians need to find is diluted." "Some research even suggests that maybe doctors are going to see 3% of the data that comes in in the chart when a patient comes into the hospital. As the physician, I'm trying to understand a patient's clinical story with only having access to three pages. Our goal is for artificial intelligence to find important information in that deep sea of data so the treatment team can make better decisions. Maybe you can correct the documentation. What that means is the physician is doing all the work in their natural workflow. We're not having to do prep work during downtime at home, and we're not trying to wrap up notes at night. We need the documentation to be done proactively in a way that is as accurate as possible for the patient at the time of care." #Regard #HealthcareAI #DigitalHealth #MedicalTechnology #PatientCare #HealthTech #AIinMedicine #ClinicalDocumentation #HealthcareInnovation #MedicalAI #PhysicianSupport Regard.com Download the transcript here

Daniel Hart, CEO of Sentact, describes the need to integrate technology, analytics, and services for hospitals and health systems to improve patient safety, patient outcomes, and regulatory readiness. One of Sentact's key goals is to help organizations gain insights from data to allow them to move from a reactive posture using lagging indicators to a proactive environment supported by AI and real-time data to generate early warning signals. Successful implementation of these insights also reduces operational costs and potentially eases clinician burnout. Daniel explains, "Sentact is a healthcare technology, services, and analytics company. Three core pillars of our business are across tech analytics and services. We serve the hospital and health system market primarily, although we do have all types of healthcare organizations in our customer base. But as an example, a representative example, we service 60% of the top 20 health systems in the market with our solutions. And we are focused on patient safety, quality, experience, and regulatory readiness or compliance. That's the corner of healthcare in which we play."  "We offer a range of services through the combination of several companies over the last 12 to 18 months. And we're really excited about the integrated platform that we have compiled. And that platform extends from the credentialing function at a hospital to comprehensive rounding to support safety experience and compliance initiatives. It also includes clinical analytics to help manage provider performance and patient safety, to provide the necessary protections of safety information, and promote continuous learning." #Sentact #HealthcareQuality #HealthcareTechnology #PatientSafety #HealthcareInnovation #DigitalHealth #HealthIT #PatientExperience #PatientOutcomes #HealthcareAnalytics #ClinicalOperations #RegulatoryCompliance #HealthSystemManagement #RiskManagement #QualityOutcomes Sentact.com  Download the transcript here