This is Cruxx

This is Cruxx

This is Cruxx is a podcast network for founders, CEOs, investors, and operators building the next generation of MedTech. On this channel: Crux of MedTech (long-form interviews across the medical device landscape) Crux of Cardio (cardiovascular innovation) Crux of Neuro (neurotechnology and neuro devices) YouTube Shorts with punchy insights on MedTech, fundraising, commercialisation, and leadership We cover topics like surgical robotics, neurotechnology, cardiovascular devices, AI in healthcare, regulatory strategy, reimbursement, go-to-market, clinical adoption, and venture capital.

  1. 2d ago

    3,000 TAVRs and the Questions We Haven’t Answered With Dr Michael Reardon

    In this episode of The Crux of Cardio, Jordan is joined by Dr. Michael Reardon, Professor and Chief of Cardiac Surgery at Houston Methodist Hospital, to explore the evolution of transcatheter aortic valve replacement (TAVR), the lessons learned from more than 3,000 procedures, and the critical questions that remain unanswered in structural heart disease. With more than four decades of experience in cardiac surgery, Dr. Reardon shares how a once-radical idea has transformed the treatment of aortic stenosis, allowing many patients to return home the day after treatment. From the importance of patient selection and long-term valve durability to the future of transcatheter technology, he explains why the biggest decisions often happen long before a patient enters the cath lab. The conversation also explores the realities of designing and running pivotal clinical trials, the role of the multidisciplinary heart team, and how emerging technologies such as the Dura-AVR valve could reshape the future of aortic valve replacement. Key Topics How TAVR evolved from a controversial concept into one of the biggest advances in cardiac surgery What more than 3,000 TAVR procedures have taught Dr. Reardon about patient selection, procedural decision-making and achieving the best outcomes Why understanding the populations studied in pivotal trials is essential before applying their results to real-world patients The unanswered questions surrounding long-term valve durability and lifetime management How valve haemodynamics, effective orifice area (EOA) and laminar flow influence cardiac workload and patient outcomes What the Dura-AVR valve and the PARADIGM trial could reveal about the next generation of transcatheter aortic valves Related Insights Why collaboration between cardiac surgeons and interventional cardiologists remains critical to choosing the right treatment How TAVR has influenced surgical practice, patient referrals and the development of research-focused cardiac programmes Why younger, lower-risk patients raise important questions about valve durability and future reintervention The challenges smaller medical technology companies face when financing large-scale clinical trials How advances in mitral valve interventions could address patients who currently have few viable treatment options What complex cardiac procedures, including cardiac autotransplantation for rare tumours, reveal about innovation, surgical experience and giving patients more time Core Challenges The success of TAVR has transformed the treatment of aortic stenosis, but important questions remain. How long will these valves last? Which patients benefit most from transcatheter treatment versus surgery? And how can clinicians ensure that promising trial results translate into better outcomes for the wider patient population? For Dr. Reardon, the answers depend on more than technological innovation. Careful patient selection, robust clinical evidence, long-term follow-up and collaboration across the heart team are essential to making the right decisions. As the field moves towards younger and lower-risk patients, understanding lifetime management becomes increasingly important. Beyond aortic valve replacement, challenges such as mitral annular calcification and the treatment of complex structural heart disease highlight the need for continued innovation, better devices and new approaches to patients who have historically had limited options. Tune in now to hear Dr. Michael Reardon reflect on more than 3,000 TAVR procedures, the questions the field still needs to answer, and what the next decade of structural heart innovation could mean for patients, clinicians and the future of cardiac surgery.

    3,000 TAVRs and the Questions We Haven’t Answered With Dr Michael Reardon
  2. Oct 7

    How Cala Built The Most Personalised Wearable Neurostim Device For Essential Tremor

    In this episode of the Crux of Neuro, Liz Moyles is joined by Deanna Harshman, CEO of Cala Health, to explore how non-invasive neurostimulation is changing the way we think about treating essential tremor and Parkinson’s disease.From her early career in chemical engineering and time working in deep brain stimulation to leading Cala Health, Deanna shares the journey behind Cala’s approach to treating hand tremor without surgery. She explains how the company’s watch-like device uses transcutaneous afferent pattern stimulation (TAPS) to measure each patient’s tremor and deliver personalised stimulation designed to disrupt pathological oscillations in the brain.The conversation also explores what it takes to move a new neurological therapy from an interesting scientific concept to a treatment that patients can actually use — from clinical evidence and physician adoption to FDA clearance, reimbursement and designing technology around real patient needs.Key TopicsHow Cala Health is using non-invasive neurostimulation to treat hand tremorWhat essential tremor is and how it differs from Parkinson’s diseaseHow TAPS therapy measures an individual patient’s tremor and personalises stimulationWhy patient-centred design matters when developing neurological technologyWhat clinical trials and real-world evidence are revealing about Cala therapyThe challenges patients face when medications become ineffective or cause intolerable side effectsHow non-invasive neurostimulation could provide an option between medication and more invasive treatments such as deep brain stimulationRelated InsightsWhy essential tremor can have a profound impact on independence, confidence and quality of lifeHow tremor can affect everyday activities such as eating, drinking, working, playing music and getting dressedWhy clinical data is critical for physician adoption and reimbursementWhat Cala has learned from following patients over the longer termHow objective data from stimulation sessions could support further personalisation of therapyWhat the launch of CALA kIQ Plus means for personalised stimulation and different therapy modesCore ChallengesDeveloping a new neurological therapy requires more than promising technology. It requires clinical evidence, patient-centred design, physician confidence, regulatory progress and a pathway to reimbursement.For people living with essential tremor, the challenge is also deeply personal. As tremor progresses, patients can lose independence and begin avoiding everyday activities and social situations. Cala’s approach is focused on making neurostimulation easier to use, personalised to the individual and integrated into everyday life.Tune in now to hear how Deanna Harshman and the Cala Health team are working to expand the role of non-invasive neurostimulation, what it takes to build clinical evidence for a new category of therapy, and why the future of neurological treatment may involve increasingly personalised approaches to brain stimulation.

    How Cala Built The Most Personalised Wearable Neurostim Device For Essential Tremor
  3. Sep 29

    Your Brain Has Been Tired for Hours, You Just Don't Know It Yet with Dr. Ramses Alcaide

    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 Topics What brain-computer interfaces actually are and why the comparison to an Apple Watch matters How Neurable's EEG headphones track focus, cognitive fatigue, and brain age in real time The military, clinical, and consumer applications of scalable BCI technology Why Neurable licenses its technology rather than building its own headphone brand The concept of brain span and why it may be shorter than your lifespan Related Insights Why most people are 10 years into cognitive decline before they know it How Merck's venture arm is investing in brain data to transform pharmaceutical precision The neuroethics infrastructure being built to protect brain data before the market scales What a world with longitudinal brain data at scale means for AI development Core Challenges The 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.

    Your Brain Has Been Tired for Hours, You Just Don't Know It Yet with Dr. Ramses Alcaide
  4. Sep 24

    Don't Use The D Word With Christian Howell

    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 Topics How MIT research into 40Hz gamma activity led to a new approach to Alzheimer’s treatment How light and sound stimulation can induce and sustain 40Hz brain activity What researchers are learning about synapses, myelin, mitochondria, blood flow, and neuroinflammation What Cognito’s 673-person clinical study is designed to reveal How personalised, home-based brain stimulation could make neurological therapy more accessible Related Insights Why Alzheimer’s is a challenge affecting entire families and caregivers How EEG, proteomics, MRI, and cognitive testing can help measure the impact of a therapy Why partnerships with institutions such as Rockefeller Neuroscience Institute and Ochsner Health matter How the platform could eventually be explored across conditions including Parkinson’s, stroke, MS, and traumatic brain injury Core Challenges Turning 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.

    Don't Use The D Word With Christian Howell
  5. Sep 16

    Your Brain Is the Softest Thing in Your Body, that's Why All Implants Are Wrong with Dr. Nicolas Vachicouras

    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 TOPICS How soft, stretchable electrode materials unlock access to the brain's hidden 50% The minimally invasive deployment method that replaces large craniotomies Why Neurosoft chose epilepsy as its beachhead indication and what comes next Tinnitus as a neurological condition: 120 million severe cases, and no cure Building an objective biomarker for tinnitus and why pharma should be paying attention European vs. US investor mindset and why Nicolas is relocating to New York The Science Corporation partnership and the Max Hodak mentorship What it really means to de-risk a neurotechnology platform before going into humans RELATED INSIGHTS Why ECoG data collected in epilepsy patients can be used to decode motor intent for tetraplegic BCIs The regulatory and reimbursement divergence and why you have to design for both from day one Why US investors back vision and team, while European investors demand proof first How partnering with Science Corp accelerated Neurosoft's ASIC and wireless back-end without diluting their core IP The case for building your neurotechnology company in the US even if your tech and talent is European CORE CHALLENGES The 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.

    Your Brain Is the Softest Thing in Your Body, that's Why All Implants Are Wrong with Dr. Nicolas Vachicouras
  6. Sep 2

    The Brain Knows How to Heal, Medicine Just Hasn't Caught Up with Dr. Leo Petrossian

    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 Topics The "level 10 to zero" problem: why stroke survivors are abandoned at discharge How the IpsiHand® uses non-invasive EEG and ipsilateral brain signals to restore arm function The real cost of neurological disease and why most people underestimate it Navigating FDA breakthrough designation, de novo clearance, and the first BCI billing code Why the RCT was stopped early and what an NNT of 2.2 actually means Building Kandu: why combining a clinical device with a virtual care platform changes outcomes The barriers to adoption: awareness, insurance coverage, and clinician education Related Insights Why neurological disease spend is already approaching cardiovascular and still climbing The indirect cost of stroke: pulling caregivers out of the workforce and what that costs the system Why "neurons that fire together, wire together" is more than a mantra, it's the therapeutic mechanism How CMS's "reasonable and necessary" standard creates a maze that FDA's "safe and effective" never prepared you for The case for collaboration over competition in neurotech and what Kandu is actively building toward Core Challenges Post-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

    The Brain Knows How to Heal, Medicine Just Hasn't Caught Up with Dr. Leo Petrossian
  7. Aug 19

    The Bravest Thing a CEO Can Say Is "I Don't Know" with Renee Ryan

    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 Topics Renee’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 Health Winning Medicare coverage for wearable, at-home neuromodulation Launching PinPrint and high-resolution 3D-printed microneedle patches Related Insights Why “if it’s not published, it doesn’t exist” to payers How a connected device turns real-world data into reimbursement evidence The shift in medtech from “get FDA approval” to “prove you can get paid” Pharma and medtech converging around sensors, biomarkers and real-time data Core Challenges Wearable, 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

    The Bravest Thing a CEO Can Say Is "I Don't Know" with Renee Ryan
  8. Aug 7

    The Tricuspid Valve Was Forgotten for Decades. TRiCares Is Changing That with Ahmed Elmouelhi

    In this episode, Jordan is joined by Ahmed Elmouelhi, President & CEO of TRiCares, the company behind Topaz, a purpose-built transcatheter tricuspid valve replacement system now in head-to-head pivotal trial against Edwards EVOQUE in the US. Ahmed brings over 20 years of structural heart experience, including nearly a decade building TAVR and LAA therapies at AtriCure and Medtronic, and explains exactly why he crossed to the right side of the heart and what it took to build a valve that doesn't behave like anything the field has seen before. Key Topics: Why the tricuspid valve was "the forgotten valve" for decades and what changed The design philosophy behind Topaz: building a soft, flexible valve purpose-built for the right side of the heart Going head-to-head with Edwards EVOQUE in the TRICURE US IDE pivotal trial What the first 20 patients taught TRiCares the good, the bad, and the ugly Running dual CE mark and US pivotal studies simultaneously, and what that demands from leadership and board The three things TRiCares hires for: hungry, humble, and smart Related Insights: Why more than 25% pacemaker rates in current TTVR systems are clinically and economically untenable How ICE-based (intracardiac echo) guidance is reducing procedural imaging burden and removing the need for general anaesthesia The "smooth is fast, slow is smooth" operating philosophy borrowed from Formula One What physicians should look for when choosing which TTVR pivotal study to join Core Challenges: The tricuspid annulus is highly variable in anatomy and extremely low-pressure, everything that works in aortic and mitral valve replacement has to be unlearned when building for the right side of the heart. The current commercial standard (Edwards EVOQUE) carries a pacemaker implant rate exceeding 25%, often appearing after discharge, a clinical, economic, and patient safety problem that TRiCares is targeting with a reported 0% rate from its soft outer shell design. Running two concurrent pivotal trials across the US and Europe while building out a team, infrastructure, and physician network is a resource and execution challenge that demands an experienced, aligned board. Tune in now to hear why Ahmed believes the tricuspid space has the potential to outgrow TAVR and what it will take to get there. 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

    The Tricuspid Valve Was Forgotten for Decades. TRiCares Is Changing That with Ahmed Elmouelhi

Ratings & Reviews

5
out of 5
2 Ratings

About

This is Cruxx is a podcast network for founders, CEOs, investors, and operators building the next generation of MedTech. On this channel: Crux of MedTech (long-form interviews across the medical device landscape) Crux of Cardio (cardiovascular innovation) Crux of Neuro (neurotechnology and neuro devices) YouTube Shorts with punchy insights on MedTech, fundraising, commercialisation, and leadership We cover topics like surgical robotics, neurotechnology, cardiovascular devices, AI in healthcare, regulatory strategy, reimbursement, go-to-market, clinical adoption, and venture capital.

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