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In this episode, Henry Norton sits down with Karun Naga, CEO of Apreo Health, to talk about one of the most underserved patient populations in respiratory medicine and why everything the industry tried before was heading in the wrong direction. Karun takes us inside the 25-year journey from the original Emphasys Medical valve device through to Apreo's BREATHE Airway Scaffold, a fundamentally different, non-destructive approach to treating severe emphysema.He explains how a June 2021 cadaver lab session in Minnesota confirmed the science, how the team raised $130 million despite most investors wanting to wait, and why a mechanical engineer turned patent lawyer ended up leading a clinical-stage medtech company.Key TopicsWhy the original emphysema valve approach was answering the wrong questionHow Apreo's BREATHE Airway Scaffold works differently to every predecessorThe Foundry's venture studio model and what "maniacal focus" actually looks likeIP strategy for medtech founders: filing early, going broad, and securing global optionsRaising $130M when most investors wanted to wait for the dataRelated InsightsThe career path from mechanical engineering to patent law to medtech CEOWhy "publish or perish" and intellectual property protection go hand in handHow The Foundry turns clinical curiosity into venture-backed companiesWhat Inari and Penumbra prove about building an entire market through focused executionCore ChallengesSevere emphysema leaves patients with as little as 60-70% of their functional lung tissue, and the diseased tissue hyperinflates to two to three times its size, compressing healthy lung and making every breath a struggle. Every prior interventional approach, from valves to coils to vapour, has been destructive to the lung, limiting treatment to a narrow subset of patients.Apreo Health's BREATHE Airway Scaffold takes a collaborative, tissue-sparing approach: a minimally invasive implant that releases trapped air without sacrificing lung tissue, designed to reach the majority of severe emphysema patients who current treatments cannot help.🎧 Tune in now to hear how Karun Naga and Apreo Health are rewriting the playbook on emphysema treatment after 25 years of unfinished business.
In this episode of Crux of Cardio, Jordan Burgin sits down with Arnaud Mascarell, CEO and Co-Founder of FineHeart, the Bordeaux-based company behind the FlowMaker, a fully implantable cardiac assist device that works in synchrony with the heart's natural contraction rather than replacing it.Arnaud shares the full journey: 18 years at Medtronic pioneering CRT pacemakers, the origin story that started with a child's toy boat, why the current approach to heart failure is fundamentally broken, and what it takes to spend a decade building a device that nobody else has been able to replicate. He also opens up on fundraising in European medtech, securing a €48M EU grant, and why he measures success in patients saved rather than acquisition price.Key Topics:Why the heart failure industry is failing patients between medication and late-stage devicesThe FlowMaker: a fully implantable, wireless, synchronized cardiac assist deviceThe origin story behind FineHeart and the CRT pacemaker connectionEliminating the driveline and what that means for patient quality of lifeWireless energy transfer as a platform technology for all active implantablesFundraising a €100M+ medtech startup with VCs, industrialists, and cardiologists as investorsRelated Insights:The IPCEI Tech4Cure programme and European sovereignty in active implantable devices5P medicine: preventive, predictable, proof-based, personalised, participativeWhy disruptive medtech innovation now comes almost entirely from startups, not corporatesBuilding digital twins and surgical planning tools to de-risk implantationCore Challenges:Current MCS devices arrive too late in the disease progression, require invasive surgery and external drivelines, and carry significant infection risk. This limits cardiologist referrals and keeps the therapy niche.FineHeart's FlowMaker is designed to intervene earlier with a minimally invasive, fully implantable device that accelerates native blood flow rather than bypassing the heart, with the ambition of promoting cardiac recovery rather than lifelong device dependence.Scaling from feasibility trials to a commercial product serving 100,000+ patients per year demands parallel investment in manufacturing, regulatory approval, and clinical demonstration, all while maintaining fundraising momentum in a risk-heavy European medtech landscape.Tune in now to hear how a Playmobil toy boat sparked a device that could transform heart failure treatment for hundreds of thousands of patients.
Liam Burns, CEO of Qaelon Medical, joins Henry Norton to talk about one of surgery's most dangerous and overlooked complications: the anastomotic leak.With leak rates in colorectal surgery now estimated at 18-20% and the standard detection method dating back to 1910, Liam explains how Qaelon is digitizing leak detection to give surgeons real-time, objective data in the OR.He also shares the personal motivation driving the mission, his son Colin's battle with Crohn's disease, the leadership lessons he carried from the US Navy into medtech startups, and why he believes your device's data belongs to the surgical community.Key Topics:Why surgical leak rates are far higher than the community historically believedHow Qaelon's gas-monitoring platform detects leaks in under 30 secondsThe case for constant flow insufflation in robotic surgeryBuilding a GI data ecosystem from pre-op through post-opCareer lessons from J&J/Ethicon, Power Medical, and ConMedWhy medtech founders should watch the full procedure, not just their product's momentRelated Insights:How capitated CMS payments are shifting the financial burden of complications back onto US hospitalsThe combination of insufflation and perfusion imaging for detecting subtler post-operative defectsWhy "give me what I want, not what I ask for" should guide every medtech product roadmapCore Challenges:The air bubble test, surgery's standard leak detection method since 1910, is a visual analog inspection that misses defects invisible to the naked eye. Yet it remains the only tool most surgeons have.Surgeons have never been able to objectively measure leak size, meaning there is no data-driven way to assess which defects are clinically significant and which are not.Tune in now to hear how Qaelon Medical is replacing a century-old test with real-time digital leak detection, and what it takes to build a medtech startup around a problem this personal.
In this episode of the Crux of Cardio, Jordan Burgin sits down with Tarik Pacuka, former Chief Commercial Officer of Terumo Aortic, who scaled the business from a niche textile graft company into a $400M+ global cardiovascular player. Tarik shares the commercial playbook behind his 15-year rise from territory manager to CCO, the mentorship that shaped his leadership, what product recalls really do to a brand, and why he believes aortic disease is the most suppressed opportunity in cardiovascular.Key Topics:Tarik’s career trajectory from pharma to Vascutek to Terumo Aortic CCOBuilding and retaining high-performing commercial teams across three time zonesThe commercial playbook behind Terumo Aortic’s growthManaging product recalls and protecting brand confidenceDirect vs. indirect vs. OEM commercial models and where execution falls shortWhat Tarik looks for in his next move and the red flags he’s watching forRelated Insights:Why reliability, not innovation, is the real differentiator in Class III medical devicesThe role of mentorship in fast-tracking executive careers in medtechHow pharma training gives commercial leaders a competitive edge in medtechThe generational shift from radical invasive surgery to digitally supported, minimally invasive careCore Challenges:Aortic disease remains suppressed in terms of the urgency and investment needed. Despite the aorta being formally recognised as an organ, innovation is not moving fast enough to address the full spectrum of aortic conditions with minimally invasive, digitally supported solutions.Scaling commercial culture across global teams while maintaining trust, purpose and execution discipline is one of the hardest leadership challenges in cardiovascular medtech, particularly when competing against significantly larger incumbents like Medtronic, W.L. Gore and Getinge.Tune in now to hear how Tarik Pacuka built one of cardiovascular’s most formidable commercial engines, and what he thinks the industry needs next.
In this episode, Henry Norton is joined by Neal Piper, Founder and CEO of Luminoah, the company behind the world’s smallest wearable enteral feeding pump. Neal shares the deeply personal story of how his son Noah’s cancer diagnosis exposed just how outdated tube feeding technology really is, and what he’s doing to change it.Key TopicsThe founding story behind Luminoah and Neal’s son Noah’s cancer journeyWhy enteral nutrition technology has barely changed in 20 yearsDesigning the Luminoah Flow: credit-card-sized, wearable, gravity-independentBuilding a full data ecosystem for real-time feed tracking and remote patient monitoringRaising capital and staying capital-efficient as a mission-driven medtech startupRelated InsightsHow malnourishment in chronic illness drives a 5x increase in mortalityThe role of personalised nutrition in improving drug therapy outcomesWhy early regulatory and reimbursement mapping de-risks medtech venturesHow children’s hospitals collaborate across institutions to improve paediatric careCore ChallengesCurrent enteral feeding pumps are bulky, IV-pole-based devices with six feet of tubing, no data tracking, and no mobility. Patients, including young children, are tethered for 8–10+ hours a day, impacting quality of life, socialisation, and nutritional compliance.Luminoah has built a wearable, credit-card-sized pump with a pouch-based feeding set, 360-degree nutrition delivery, and a connected data platform. Their goal: let patients live freely while giving clinicians real-time visibility into nutritional status to intervene before hospital readmission.Tune in now to hear how one father’s personal mission is reshaping the future of enteral nutrition.
Henry Norton sits down with Todd Dunn, CEO of Accuryn Medical, for a conversation that starts on an OR floor and ends with a question about what it really means to lead with integrity. Todd didn’t come to medtech through a lab or a VC fund, he came through a hospital in Charlotte, where a CRNA pointed under a bed and showed him that the kidney, medicine’s most sensitive organ, was still being monitored by a gravity-fed bag invented in 1936. A decade on from that moment, he’s now running the company trying to fix it.Key TopicsWhy kidney monitoring hasn’t meaningfully advanced since CR Bard’s 1936 Foley catheterWhat AKI (acute kidney injury) actually is and why CMS now classifies it as a hospital-acquired harmHow Accuryn’s SmartFoley detects kidney distress up to 12 hours before blood tests canThe ‘diagnosis before prescription’ framework Todd built at Atrium HealthTransitioning from health system innovator to medtech CEORelated InsightsWhy hospital financing explains why the kidney was the last vital organ to be digitisedThe real cost of AKI: 13 million cases annually, 300,000 deaths, and $10–24bn in US healthcare spendWhy serum creatinine is the wrong marker for kidney function and what replaces itHow clinical partnership rather than conventional sales tactics is breaking through hospital inertiaCore ChallengesThe standard of care for urinary output measurement hasn’t changed since 1936. While the heart, lungs, and brain are fully digitised in critical care settings, hospitals still rely on a gravity-dependent system prone to stagnation, back-pressure, and manual error. ICU nurses carry the cognitive burden and patients pay the price when outputs go unrecorded.Creatinine blood tests only flag kidney injury once function has already dropped to 60%. By the time the lab result returns, damage is done. Urine output is the real-time vital sign — and Accuryn is the only FDA-cleared platform that automates and digitises it, giving clinicians up to a 12-hour head start.Tune in now to find out why the most sensitive organ in the body has been flying blind for nearly a century and what one former hospital innovator is doing to fix it.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 Dr. Arun Menawat, Chairman and CEO of Profound Medical, the company behind the TULSA-PRO® system, an MRI-guided, incision-free platform that’s directly challenging robotic prostatectomy with head-to-head clinical data.Arun shares the clinical trial results that show step-change improvements in patient outcomes, the commercial lessons from building and exiting Novadaq (acquired by Stryker), and why he believes incision-free surgery isn’t just a product, it’s the next wave.Key Topics:Head-to-head clinical trial data: TULSA-PRO vs. robotic prostatectomyHow MRI-guided thermal ultrasound works and why it matters for patient outcomesThe Novadaq journey: from fluorescence imaging to a Stryker acquisitionBuilding a KOL strategy for a novel surgical platformWhy incision-free surgery is positioned to disrupt the next decade of surgical careRelated Insights:Why you can’t sell to surgeons by telling them they need to be betterThe role of AI in standardising MR imaging for surgical planningWhy CMS reimbursement for TULSA now exceeds robotic surgeryHow different KOL personas early adopters, visionaries, and conservatives each serve a commercialisation strategyCore Challenges:Robotic prostatectomy, despite being the current standard, carries a 75% risk of incontinence or erectile dysfunction. The robot mimics the surgeon’s hands with more reach, but it doesn’t address the precision problem the prostate sits in a highly congested area surrounded by nerve bundles and sphincter muscles.Profound Medical’s TULSA-PRO uses real-time MRI guidance and thermal ultrasound to ablate tissue at 57°C the lowest lethal temperature with AI-driven boundary mapping. The result: dramatically reduced side effects, no incision, and patients going home the same day.Tune in now to hear how Profound Medical is challenging the robotic surgery status quo with clinical data, MR-guided precision, and a vision for incision-free surgery across oncology and beyond.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, host Jordan Burgin is joined by Martin Herman, co-founder and CEO of Powerful Medical the AI-powered cardiac diagnostics company behind PM Cardio.Martin shares how a software engineering background, a medical student brother, and a search for a truly pioneering problem led him to build an AI platform that can now diagnose 46 cardiovascular conditions from a single 12-lead ECG with over 120,000 doctors already using it in clinical practice.They cover the journey from early scepticism to clinical proof, the brutal reality of MedTech fundraising, and what FDA breakthrough designation means for Powerful Medical's imminent US commercial launch.Key Topics:How Powerful Medical identified the ECG as cardiology's biggest unsolved problemBuilding AI that outperforms experienced cardiologists on the hardest casesThe clinical and commercial case for PM Cardio in US heart attack centresFDA breakthrough designation and the road to US approval this summerRaising €46M in non-dilutive EU grant funding and what comes nextWinning MedTech Innovator and what it means for partnerships and validationRelated Insights:Why starting with the biggest clinical sceptics is actually a growth strategyHow 64 American physician-investors validated the product with $3.5M in fundingThe difference between pre- and post-ChatGPT AI fundraising environmentsWhy young founders have a structural advantage in MedTech and how to use itCore Challenges:Beyond the cardiologist, almost no clinician can reliably read an ECG creating a critical diagnostic gap at the first point of patient contact that PM Cardio is designed to close.US hospitals chasing heart attack accreditation KPIs are generating false positive rates as high as 70–80%, costing up to $15,000 per unnecessary cath lab activation. PM Cardio reduces false positives by ~90% while maintaining diagnostic sensitivity.Regulatory fragmentation across 27 EU healthcare markets and the complexity of US FDA approval has been the single biggest bottleneck to commercial scale, despite overwhelming clinical evidence.Tune in now to hear how Martin Herman turned a software engineering background and a medical student brother into a platform already saving thousands of lives and why the biggest breakthrough may still be ahead.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
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Welcome to The Crux of Medtech, where we sit down with special guests from the medtech industry.We tell the stories of this incredible sector by looking inside businesses from across the trade. Our guests are leaders from companies at all levels, from pre-seed startups and scale-ups to global-scale players. We’re uncovering experiences from the whole medtech ecosystem.
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