Crux of Medtech

In this episode of the Crux of Neuro, Liz Moyles is joined by Dr. Ramses Alcaide neuroscientist, inventor, and CEO of Neurable, to explore what happens when brain-computer interface technology leaves the lab and enters the headphones in your ears. From tracking cognitive fatigue in real time to detecting neurodegeneration before symptoms appear, Ramses sets out a vision of brain health that goes far beyond anything current wearables can offer and explains why 14 years of R&D was the only way to get there.Key TopicsWhat brain-computer interfaces actually are and why the comparison to an Apple Watch mattersHow Neurable's EEG headphones track focus, cognitive fatigue, and brain age in real timeThe military, clinical, and consumer applications of scalable BCI technologyWhy Neurable licenses its technology rather than building its own headphone brandThe concept of brain span and why it may be shorter than your lifespanRelated InsightsWhy most people are 10 years into cognitive decline before they know itHow Merck's venture arm is investing in brain data to transform pharmaceutical precisionThe neuroethics infrastructure being built to protect brain data before the market scalesWhat a world with longitudinal brain data at scale means for AI developmentCore ChallengesThe brain is perceived as more sacred than any other data source education and demonstrated ethics will be essential to adoption.14 years of R&D were required to get medical-grade EEG data out of a consumer headphone. Most companies cannot clear that bar.Fewer than 1% of consumers know that brain-sensing headphones exist. Distribution and awareness are the next frontier after product-market fit.Tune in now to hear why Dr. Ramses Alcaide believes your brain has been the most under-tracked organ in your body and what Neurable is doing to change that.

In this episode of the Crux of Neuro, Liz Moyles is joined by Christian Howell, CEO of Cognito Therapeutics, to explore what happens when neuroscience, light, sound, and clinical research come together to tackle one of the biggest challenges in brain health: Alzheimer’s disease. From MIT research on 40Hz gamma activity to a home-based therapy using light and sound, Christian explains the science behind Cognito’s approach and what it takes to translate breakthrough neuroscience into something patients can actually use.Key TopicsHow MIT research into 40Hz gamma activity led to a new approach to Alzheimer’s treatmentHow light and sound stimulation can induce and sustain 40Hz brain activityWhat researchers are learning about synapses, myelin, mitochondria, blood flow, and neuroinflammationWhat Cognito’s 673-person clinical study is designed to revealHow personalised, home-based brain stimulation could make neurological therapy more accessibleRelated InsightsWhy Alzheimer’s is a challenge affecting entire families and caregiversHow EEG, proteomics, MRI, and cognitive testing can help measure the impact of a therapyWhy partnerships with institutions such as Rockefeller Neuroscience Institute and Ochsner Health matterHow the platform could eventually be explored across conditions including Parkinson’s, stroke, MS, and traumatic brain injuryCore ChallengesTurning breakthrough neuroscience into a real therapy requires more than promising science, it requires clinical evidence, regulatory progress, patient trust, and accessibility.Making innovative neurological technology available to the people who need it most remains a major challenge.Cognito’s approach is grounded in balancing scientific rigor with the responsibility to take patients’ hopes seriously.Tune in now to hear how Christian believes 40Hz sensory stimulation could change the future of brain health, and what it takes to move breakthrough neuroscience from the lab into people’s homes.

In this episode of the Crux of Neuro, Liz Moyles sits down with Dr. Nicolas Vachicouras, PhD, CEO and Co-Founder of Neurosoft Bioelectronics, a Geneva and New York-based neurotechnology company spun out of EPFL, developing the world's softest, stretchable brain interfaces.Nicolas takes us through his journey from studying the bionic eye, to building brain interfaces for epilepsy, tetraplegics, and severe tinnitus and why the key to all of it starts with matching the mechanical properties of the brain itself.KEY TOPICSHow soft, stretchable electrode materials unlock access to the brain's hidden 50%The minimally invasive deployment method that replaces large craniotomiesWhy Neurosoft chose epilepsy as its beachhead indication and what comes nextTinnitus as a neurological condition: 120 million severe cases, and no cureBuilding an objective biomarker for tinnitus and why pharma should be paying attentionEuropean vs. US investor mindset and why Nicolas is relocating to New YorkThe Science Corporation partnership and the Max Hodak mentorshipWhat it really means to de-risk a neurotechnology platform before going into humansRELATED INSIGHTSWhy ECoG data collected in epilepsy patients can be used to decode motor intent for tetraplegic BCIsThe regulatory and reimbursement divergence and why you have to design for both from day oneWhy US investors back vision and team, while European investors demand proof firstHow partnering with Science Corp accelerated Neurosoft's ASIC and wireless back-end without diluting their core IPThe case for building your neurotechnology company in the US even if your tech and talent is EuropeanCORE CHALLENGESThe brain and spinal cord are extraordinarily soft and constantly in motion yet for decades, we have interfaced with them using rigid, static devices. The resulting mechanical mismatch causes foreign body reaction, device degradation, and limits long-term viability.More than 50% of the brain's cortex sits hidden within its sulci (folds). Existing surface electrode arrays miss most of it and reaching those areas historically requires invasive large-scale craniotomies.Severe tinnitus affects 120 million people worldwide, has no cure, and is almost completely misunderstood by the investor community. Objective biomarkers do not yet exist making it hard to measure, treat, or run efficient clinical trials.Neurotech is capital-intensive and long-cycle. Specialist venture capital with genuine risk tolerance for decade-long timelines is plentiful in the US but rare in Europe, forcing companies to move or fail.🎧 Tune in now to hear how Nicolas Vachicouras is rethinking the fundamental materials of brain surgery and why soft electrodes could be the unlock that takes BCIs from the lab to 120 million patients.

In this episode of Crux of Neuro, host Liz Moyles is joined by Dr. Leo Petrossian, CEO of Kandu, Inc. the company formed from the merger of Neurolutions and Kandu Health. Leo has spent over 20 years at the intersection of neurotech and clinical care, and under his leadership, Neurolutions secured FDA breakthrough clearance for the IpsiHand®: the first non-invasive, at-home brain-computer interface for stroke rehabilitation. He also navigated the first BCI-specific CMS billing code and led a randomised controlled trial that was stopped early for efficacy. In this conversation, Leo and Liz cover the systemic failures in post-stroke care, the science behind the IpsiHand®, the brutal realities of getting novel devices covered by insurance, and what it will take to give 8 million stroke survivors in the US a real shot at recovery.Key TopicsThe "level 10 to zero" problem: why stroke survivors are abandoned at dischargeHow the IpsiHand® uses non-invasive EEG and ipsilateral brain signals to restore arm functionThe real cost of neurological disease and why most people underestimate itNavigating FDA breakthrough designation, de novo clearance, and the first BCI billing codeWhy the RCT was stopped early and what an NNT of 2.2 actually meansBuilding Kandu: why combining a clinical device with a virtual care platform changes outcomesThe barriers to adoption: awareness, insurance coverage, and clinician educationRelated InsightsWhy neurological disease spend is already approaching cardiovascular and still climbingThe indirect cost of stroke: pulling caregivers out of the workforce and what that costs the systemWhy "neurons that fire together, wire together" is more than a mantra, it's the therapeutic mechanismHow CMS's "reasonable and necessary" standard creates a maze that FDA's "safe and effective" never prepared you forThe case for collaboration over competition in neurotech and what Kandu is actively building towardCore ChallengesPost-stroke care is structurally broken: patients go from 24/7 hospital monitoring to zero follow-up overnight, with no systematised path back to function.The IpsiHand® has FDA clearance and a CMS billing code, but formal coverage policy remains the "final frontier," leaving most patients navigating reimbursement case by case.Novel device makers face a gap that drug companies don't: FDA has a clear pathway for innovation, but reimbursement bodies haven't built the equivalent and two attempts (MCIT and TCET) were both cancelled.🎧 Tune in now to hear why one in four people will suffer a neurological disease and how the IpsiHand® is giving stroke survivors a genuine shot at recovery, years after they were told rehab had run its course.The Crux of MedTech podcast is brought to you by Cruxx, a specialist surgical robotics recruitment agency. To learn more about Cruxx,⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ ⁠click here.⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠A big thank you to our sponsors on this season of the podcast; ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠TTP plc⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ With a 35-year track record, TTP excels in turning innovative ideas into market-ready solutions. Their team of 300+ experts deliver breakthrough solutions in areas ranging from endoluminal robotics and navigation systems to ultrasound imaging. Whether you're a startup or a multinational, ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠TTP plc⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ can accelerate your development with the latest technologies. Learn more at ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠TTP.com⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠

In this episode of the Crux of Neuro, Renee Ryan, co-founder and CEO of PinPrint and former CEO of Cala Health. Renee traces her path from Wall Street healthcare banker to one of medtech’s most prolific investors and operators. She explains why, in neurotech today, getting reimbursed is often harder than getting cleared and how data became the whole story.Key TopicsRenee’s path from healthcare investment banking to leading J&J’s medtech investing (JJDC)Founding Verb Surgical and investing across J&J’s surgical-robotics portfolio (Auris, Verb)Crossing from investor to operator as CEO of Cala HealthWinning Medicare coverage for wearable, at-home neuromodulationLaunching PinPrint and high-resolution 3D-printed microneedle patchesRelated InsightsWhy “if it’s not published, it doesn’t exist” to payersHow a connected device turns real-world data into reimbursement evidenceThe shift in medtech from “get FDA approval” to “prove you can get paid”Pharma and medtech converging around sensors, biomarkers and real-time dataCore ChallengesWearable, at-home neuromodulation didn’t fit existing reimbursement codes forcing Cala to build the clinical evidence and the payment pathway from scratch, through repeated appeals.Microneedle/microarray patches have existed for decades without FDA approval; PinPrint argues the real bottleneck has been manufacturing precision, which high-resolution 3D printing now addresses.🎧 Tune in now to hear how Renee Ryan turned data into dollars in neuromodulation and where she’s taking the body’s next interface with PinPrint.The Crux of MedTech podcast is brought to you by Cruxx, a specialist surgical robotics recruitment agency. To learn more about Cruxx,⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ ⁠click here.⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠A big thank you to our sponsors on this season of the podcast; ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠TTP plc⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ With a 35-year track record, TTP excels in turning innovative ideas into market-ready solutions. Their team of 300+ experts deliver breakthrough solutions in areas ranging from endoluminal robotics and navigation systems to ultrasound imaging. Whether you're a startup or a multinational, ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠TTP plc⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ can accelerate your development with the latest technologies. Learn more at ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠TTP.com⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠