The Crux of Medtech

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, 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 changedThe design philosophy behind Topaz: building a soft, flexible valve purpose-built for the right side of the heartGoing head-to-head with Edwards EVOQUE in the TRICURE US IDE pivotal trialWhat the first 20 patients taught TRiCares the good, the bad, and the uglyRunning dual CE mark and US pivotal studies simultaneously, and what that demands from leadership and boardThe three things TRiCares hires for: hungry, humble, and smartRelated Insights:Why more than 25% pacemaker rates in current TTVR systems are clinically and economically untenableHow ICE-based (intracardiac echo) guidance is reducing procedural imaging burden and removing the need for general anaesthesiaThe "smooth is fast, slow is smooth" operating philosophy borrowed from Formula OneWhat physicians should look for when choosing which TTVR pivotal study to joinCore 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

In this episode of the Crux of MedTech, Henry Norton is joined by Tatiana Lobanov-Rostovsky, Investor at Oxford Science Enterprises, the independent, billion-pound investment company built in partnership with the University of Oxford. With a background in neuroscience, Healthcare M&A at Rothschild & Co, and hands-on experience inside a biotech startup, Tatiana brings a rare view across the full lifecycle of medtech company building.From the Europe vs US debate to why most companies fail not in R&D but in commercial and what the best founders do differently from day one, this is a candid conversation about what it actually takes to build something the strategics will want.Key TopicsEurope vs US: where medtech startups should build, raise, and scaleThe Oxford Science Enterprises model, patient capital, EIR programmes, and venture building from university spinoutsHow to spot the difference between a technology looking for a problem and a genuine clinical pullBuilding for a strategic acquisition from day one, what the buyers actually want to seeWhy commercial talent matters more than technical talent at the early stageThe EU/UK infrastructure gaps holding back medtech foundersRelated InsightsWhy hardware companies will outlast SaaS in a world of AI disruption and what that means for medtech investorsThe NHS as a data advantage: how UK founders can use patient data to build globally competitive productsStructural heart and neurovascular as active investment themes and what's driving OSE's thesis buildingCaristo Diagnostics and Ultromics as case studies in AI-powered cardiac diagnostics scaling for the US marketCore ChallengesThe majority of medtech companies that reach FDA approval still fail in commercial, making go-to-market strategy as important as clinical validation.European founders face a structural disadvantage in accessing the right commercial talent early enough, with risk aversion and brain drain compounding the problem.Investors are paralysed by AI disruption uncertainty, but hardware-first, highly regulated sectors like medtech remain defensible, if founders and investors are willing to think long-term.Tune in now to hear why the most valuable medtech companies are built from the commercial endpoint backwards and what the strategics are actually looking for when they acquire.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 Cardio, Jordan Burgin sits down with Dan Rose, CEO of Endovascular Engineering (E2), to talk about building, exiting, and doing it all over again this time in one of the hottest spaces in cardiovascular medicine.Dan joined LimFlow as its first employee, guided it through an FDA approval, a landmark New England Journal of Medicine publication, and ultimately its acquisition by Inari Medical. Weeks before that deal closed, E2 had seven days of cash in the bank.Key TopicsThe PE thrombectomy market and what the Stryker–Inari and Boston Scientific–Penumbra acquisitions signalBuilding LimFlow from the ground up as a first-time CEO and first employeeWhy changing physician behaviour is harder than building the technologyCultivating strategic relationships before you need themManaging strategics on your cap table without compromising board integrityWhat physicians actually want from the next generation of PE devicesClosing an oversubscribed $80M Series C when most of the market is starved for capitalThe role of chair seats in extending a CEO's impact and perspectiveRelated InsightsWhy market development, not efficacy is often the real barrier to adoptionThe emotional reality of exits: the post-acquisition dip no one talks aboutWhy CEOs should proactively build peer networks and ask for helpHow arriving second in a category can be a structural advantage if you have differentiated technologyThe value of transatlantic commercial experience in European medtechCore ChallengesPulmonary embolism is the third leading cause of cardiovascular death, yet the current category leaders are delivering incremental innovation rather than the low-profile, high-efficiency, blood-return-capable devices physicians are asking for.Medtech startups moving into unfamiliar physician behaviour, like foot-focused wound care for interventional cardiologists at LimFlow, require deep clinical education infrastructure, not just compelling data.Founder CEOs face a lonely role where they cannot be fully transparent with their own teams, and must actively build external peer networks to stay effective and grounded.🎧 Tune in now to hear what it really takes to build, exit, and rebuild in medtech and why Dan Rose had just seven days of cash left when the LimFlow deal finally closed.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