The Heart Valve Treatment That Doesn't Touch the Patient with Carine Schorochoff

In this episode, host Jordan Burgin sits down with Carine Schorochoff, CEO of Cardiawave, to explore Valvosoft the world's first CE-marked non-invasive ultrasound therapy for severe symptomatic aortic stenosis.With 30-plus years in structural heart across J&J, Medtronic, Edwards Lifesciences, and two startup CEO roles, Carine breaks down why the technology has delivered 0% stroke rates across 125 procedures, what it actually means to treat a calcified aortic valve without entering the body, and how Cardiawave is now navigating the FDA pathway with a €55M raise on the horizon.Key TopicsThe two patient populations Valvosoft was designed for and why neither could be helped beforeHow non-invasive ultrasound fragments calcification without damaging the leaflet tissue (the chocolate plate analogy)Safety data from 125 procedures: 0% stroke, 0% pacemaker implantation, 0% procedural mortalityCardiawave's path to CE mark under EU MDR and why their technical file passed first reviewThe FDA IDE study plan and early dialogue with CMS on reimbursementUsing Valvosoft to prep the valve before TAVR and the pull effect on patient referralsRelated InsightsWhy Valvosoft positions alongside drugs rather than against surgical or transcatheter valvesThe "lifetime management" model for aortic stenosis and why replacing a valve too early creates compounding problemsHow to attract senior talent in a cash-constrained startup: stock option pools, equity, and the pitchThe pull effect in action: why Valvosoft's presence in a centre brings in patients who were never even referredCore ChallengesFrail aortic stenosis patients too sick for TAVR, too sick for surgery have historically had no treatment option. Valvosoft was designed specifically to serve this population, with a non-invasive procedure requiring no anaesthesia, no incision, and no entry into the body.Early-stage moderate aortic stenosis is diagnosed but untreatable under current guidelines. The goal for this population is slowing disease progression not valve replacement placing Valvosoft in direct competition with drugs, where it offers comparable non-invasiveness with no side effects.Raising €55M for an FDA IDE study in a tighter VC environment requires extending runway, maintaining investor confidence, and managing burn rate without compromising the pace of regulatory execution across two continents simultaneously.🎧 Tune in now to hear why one of Europe's most experienced interventional cardiologists said he'd choose Valvosoft for his own heart and what that means for the future of aortic stenosis care.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&⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠KUKA⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ is a global leader in robotics with over 25 years of experience partnering with medtech companies on their journey to market. Their reputation is built on robust technology, reliability and long term collaboration and being more than just a supplier.KUKA provides trusted support throughout the product life cycle, from development to integration and beyond. Find out more at ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠kuka.com/healthcare⁠⁠⁠⁠⁠⁠⁠