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Digital Health MedTech

European MedTech Innovators: Pioneering the Future of Healthcare in 2025

I. Introduction: Europe’s Ascendance in MedTech Innovation

The landscape of healthcare is undergoing a profound transformation, driven by relentless innovation in medical technology. At the forefront of this evolution stands the MedTech Innovator (MTI) program, globally recognized as a premier accelerator for breakthrough medical device, digital health, and diagnostic companies. Its rigorous selection process, which identifies the top 4% of nearly 1,500 global applicants, underscores the high potential of the chosen cohort. Companies participating in this program benefit from invaluable mentorship, strategic guidance, and unparalleled access to an extensive ecosystem of industry leaders, all designed to de-risk innovation and accelerate market success.

Europe continues to solidify its position as a vibrant hub for MedTech innovation, with a significant presence in the 2025 MTI cohort. This robust ecosystem is fueled by world-class academic research, substantial grant programs such as Horizon Europe and the EIC Accelerator, and a burgeoning network of specialized investors and incubators. The groundbreaking technologies emerging from this region are not merely incremental advancements; they represent fundamental shifts in diagnostic and therapeutic paradigms, poised to address critical unmet medical needs across the globe.

This report delves into 15 European startups from the 2025 MedTech Innovator cohort. It offers a detailed examination of their pioneering technologies, introduces the visionary leaders driving their missions, and outlines their financial journeys. These companies are actively redefining patient care, from advanced diagnostics and regenerative therapies to AI-powered insights and minimally invasive solutions. Their collective efforts illuminate a future where healthcare is more precise, accessible, and effective.

II. The 2025 European MedTech Innovator Cohort: A Glimpse into Tomorrow’s Healthcare

The 2025 MedTech Innovator cohort showcases a diverse array of European startups, each poised to make a significant impact within their respective strategic interest areas. The following table provides an overview of these innovative companies:

Startup NameCountryStrategic Interest Area
ARTINESSItalyCardiovascular & Interventional
CathVisionDenmarkCardiovascular & Interventional
Kelvin HealthBulgariaCardiovascular & Interventional
MedLumicsSpainCardiovascular & Interventional
LightHearted AI HealthUKCardiovascular & Interventional
STENTiTNetherlandsCardiovascular & Interventional
Indigo DiabetesBelgiumDiagnostic & Monitoring
Microplate DxUnited KingdomDiagnostic & Monitoring
MiWEndo SolutionsSpainDiagnostic & Monitoring
IcometrixBelgiumNeurology
PrecisisGermanyNeurology
Connected ConsumablesGermanySurgical & Orthopedic
MOMM DiagnosticsSwitzerlandFemTech & Urology
Multi4 MedicalSwedenFemTech & Urology
The Flume Catheter CompanyUnited KingdomFemTech & Urology

ARTINESS (Milano, Italy)

ARTINESS is transforming medical imaging and surgical procedures, particularly in cardiovascular interventions, through innovative holographic solutions. Their flagship ARTICOR® software suite facilitates pre-procedural simulations on patient-specific 3D models using Mixed Reality (MR) reconstruction. This technology allows for shared holographic visualization among clinical teams, enabling more precise and targeted surgical planning. This represents a significant advancement from traditional 2D imaging, fostering improved communication and collaboration among surgical teams, which can lead to reduced errors and optimized patient outcomes. The ability to overlay digital information onto the real world offers a fundamentally new way for surgeons to understand complex anatomies and rehearse procedures, potentially setting a new standard for complex interventions.

The company’s leadership team includes:

  • Filippo Piatti (CEO & Co-founder): Holds a PhD in Biomedical Engineering from Politecnico di Milano.
  • Giovanni Rossini (COO & Co-founder): Also holds a PhD in Biomedical Engineering from Politecnico di Milano.
  • Omar Pappalardo (CTO & Co-founder): Holds a PhD in Cardiovascular Sciences from Università di Verona.
  • X handle is @artinessreality.

ARTINESS has secured total funding of €2.1 million. This includes a spin-out from Polytechnic University of Milan (Jan 2018), a €1.0M seed round from Vodafone (Apr 2020), support from EIT Health (Jan 2022), and a €1.1M seed round (May 2024). They have also participated in accelerators such as UniCredit Start Lab FinTech Accelerator, Berkeley SkyDeck, and the 2025 MedTech Innovator cohort. The company’s journey from a university spin-off and its engagement with multiple accelerators indicates a deliberate strategy to de-risk its technology and accelerate commercialization. This broad engagement suggests a strong network of early supporters and a commitment to structured growth. While specific 2024 revenue figures are not detailed, ARTINESS activated its membership in the Bio4Dreams Ecosystem in March 2024, signaling continued growth and engagement within the innovation community. Historical data up to 2022 shows revenues and EBITDA below €1M, but with a notable 131% growth in 2022. Main shareholders include Vodafone, UniCredit Start Lab FinTech Accelerator, Polytechnic University of Milan, Berkeley SkyDeck, EIT Health, MedTech Innovator, nVue Surgical, and B Heroes.

CathVision (Copenhagen, Denmark)

CathVision is advancing electrophysiology (EP) technology with its ECGenius™ System and CARDIALYTICS™ suite, designed to enhance cardiac signal recording and patient care for heart rhythm disorders. The company’s mission is to empower physicians to cure cardiac arrhythmia by providing high-fidelity EP systems and AI-based analytic tools for automated analysis during the diagnosis and treatment of complex atrial arrhythmias. The focus on improving signal clarity directly addresses a core challenge in electrophysiology, where precise signal acquisition is paramount for accurate diagnosis and effective ablation. By delivering clear signals, CathVision’s system enables more informed decisions, potentially leading to better treatment efficacy and reduced recurrence rates for conditions like atrial fibrillation.

The leadership team includes:

  • Mads Emil Matthiesen (Co-Founder & CEO): Co-founded CathVision in 2010. He possesses extensive experience in cardiology as both a business leader and biomedical engineer, with over a decade in medical device development and research in Europe and the U.S. He graduated from the Technical University of Denmark in biomedical engineering and received additional training at MIT and Harvard in medical device and implant design. He previously worked as a management consultant at the Boston Consulting Group.
    X: @MadsMatthiesen.
  • Rune Ørndrup (Co-Founder & CFO): Helped co-found CathVision in 2010. He brings a diverse background in corporate organizations and agile startups, with extensive experience in finance and global operations. He has successfully steered multiple funding rounds for CathVision, totaling over €20 million, and has also secured over $30 million in funding for the tech startup Labster. He is active in the Danish startup ecosystem.

CathVision has raised a total of $36.1 million over 11 funding rounds. Key investments include a $7.2 million round from existing investors in August 2022, and a $9 million round in May 2023. The largest round was a Series B for $14M in March 2020, led by Vaekstfonden. The company has also received a €2.2M grant from Horizon 2020 in 2019. In 2024, CathVision highlighted its PFAnalyzer at HRS 2024 in May, and its strategic focus for the year was to accelerate commercial adoption. The consistent investment from existing shareholders and the achievement of FDA clearance for the ECGenius™ System demonstrate strong investor confidence and a clear path towards commercialization. Main shareholders include Vaekstfonden, Borean Innovation, Innovation Fund Denmark, EIC Fund, and Lumine Capital.

Kelvin Health (Sofia, Bulgaria)

Kelvin Health is dedicated to preventing suffering for millions globally through its Thermography AI, offering accessible and rapid non-invasive vascular diagnostics. The company leverages advanced machine learning and a unique dataset, developed with R&D partners, to deliver personalized healthcare and telemedicine solutions. The technology’s ability to provide non-invasive, potentially low-cost, and rapid screening democratizes access to early detection, shifting diagnostics from reactive hospital settings to proactive community or even home-based care. This approach has the potential to significantly alleviate pressure on healthcare systems.

The founding team includes:

  • Georgi Kadrev (CEO & Co-founder): Recognized as a Visual AI API pioneer, an IDC Innovator in 2016, and featured in Forbes’ “30 under 30” in 2013. He co-founded Imagga, an image recognition AI company, in 2008, and subsequently co-founded Kelvin Health in March 2020.
    X: @GeorgiKadrev.
  • Georgi Kostadinov (CTO & Co-founder): Credited with a “130K+ categories ML model” and a “30B+ images API,” highlighting his deep expertise in image processing and AI. He was recognized in Forbes’ “30 under 30” in 2020 and has a strong background in AI, machine learning, and software engineering, including leadership roles at Imagga.
    X: @GeorgiKostadinov.
  • Pavel Andreev (CPO & Co-founder): Brings over 15 years of experience in building digital products. He co-founded Imagga in 2009 and Sticky Creative in 2011, before assuming his role as Head of Product and Design at Kelvin Health.

Kelvin Health has raised a total of $5.38 million through a single Series A funding round, which closed on June 11, 2024. This round saw Racine² as the lead investor, alongside Seedcamp and three other institutional investors. In 2024, Kelvin Health was a finalist in the EIT Health InnoStars Awards and was selected as one of seven companies for Medtronic’s MedLim program, indicating strong industry validation and potential for strategic collaborations. The company also prepared for new features in 2025 by renaming its “Kelvin-Clinic” app to “Kelvin-Clinic 2024 (Legacy)” in October 2024. The company’s ambitious vision to “positively touch the lives of billions of people” underscores the vast scalability of their non-invasive diagnostic approach.

MedLumics (Madrid, Spain)

MedLumics, founded in 2011 (with roots dating back to 2009) , develops medical devices for the treatment of Atrial Fibrillation (AF). Their flagship product, the Ablaview® system, is a unique, real-time, photonically guided radiofrequency (RF) irrigated ablation catheter system. It integrates photonics and miniaturized optics to guide device placement and directly assess ablation lesions in real time. This technology directly addresses the high recurrence rate in AF ablation, a significant unmet need in a multi-billion dollar market. By enabling precise guidance and real-time confirmation of therapy success, MedLumics aims to ensure complete and continuous lesions, thereby improving patient outcomes and reducing the need for repeat procedures.

The leadership team includes:

  • Peter Hinchliffe (CEO): He has over 40 years of extensive engineering and operational experience in medical device design, development, and commercialization. His background includes leadership roles at companies such as Jarvik Heart, Getinge, DataScope, Rex Medical, and Medtronic. He holds over 110 issued US medical device patents and more than 100 pending.
  • Eduardo Margallo (Co-founder): Holds M.Sc. degrees in Telecommunication Engineering, Electrical Engineering, and Physics, and a Ph.D. in Photonics. He has over ten years of experience founding and managing photonics technology firms.

MedLumics has raised approximately €18.99 million in total funding. This includes an initial €18 million in total financing as of October 2020, with a €14 million Series E round co-led by Asabys Partners, VI Partners, and CDTI Innvierte, joined by existing investors Andera Partners, Caixa Capital Risc, and Innogest. In February 2024, the company secured an additional €0.99 million in venture funding from Center for Technological & Industrial Development and Asabys Partners. While specific revenue performance for 2024 is not detailed, the company continued to secure funding, indicating ongoing investor confidence. Main shareholders include Asabys Partners, VI Partners, CDTI Innvierte, Andera Partners, Seroba Life Sciences, Innogest, and Caixa Capital Risc.

LightHearted AI Health (London, UK)

LightHearted AI Health is developing a precision cardiology platform that utilizes laser-based technology and AI to diagnose heart disease. Their device is designed for home use, capable of gathering essential data, including unique biomarkers, through clothing and at a distance in less than a minute. The aim is to make heart disease diagnostics affordable, accessible, and timely, significantly reducing the burden on healthcare systems by enabling earlier intervention. This advanced, laser-based digital stethoscope can diagnose valve diseases in primary care settings in just 10 seconds, with the AI platform generating a diagnostic report in one minute.

The co-founders are:

  • Lucrezia Cester (CEO & Co-founder): An AI Engineer and Clinical Scientist, she holds a PhD in Signal Processing. Her experience includes working as an AI Clinical Scientist within the UK National Health Service (NHS) and as a Clinical Entrepreneur, where she gained deep expertise in the challenges facing healthcare systems and how to navigate them.
    X: @CesterLucrezia.
  • Dilip Rajeswari (CTO & Co-founder): A Machine Learning engineer and DeepTech Entrepreneur. He has led R&D teams in building, developing, and clinically deploying regulatory-compliant precision medicine platforms.

LightHearted AI Health has raised $3 million in funding. This includes joint investment from Entrepreneur First and SOSV HAX in Autumn 2023. The company also secured grants and closed “a million in proceeds” prior to LSI Europe ’24, with plans to raise an additional $3 million for FDA submission and market expansion. In 2024, the company was actively piloting its technology with the NHS in the UK and conducting clinical trials in Dorset. While specific 2024 revenue figures are not provided, the company projects a 100k Monthly Recurring Revenue (MRR) with its first customer in an emerging market. The company is seeking Class IIa approval by the end of 2025. Main shareholders include Entrepreneur First and SOSV HAX.

STENTiT (Eindhoven, Netherlands)

STENTiT is introducing a novel class of regenerative endovascular implants, the Resorbable Fibrillated Scaffold (RFS), for cardiovascular diseases. This temporary vascular support structure is designed to reconstruct the artery from the inside out by triggering a natural healing response from circulating blood cells. The implant is eventually replaced by new vascular tissue and fully resorbs within 12 months, leaving nothing behind. This regenerative approach represents a significant paradigm shift from traditional stents, which merely provide mechanical support or elute drugs. The RFS aims to provide a “lifelong solution” by restoring arterial health, offering a distinct competitive advantage.

The company’s founder is:

  • Bart Sanders (CEO & Co-founder): An engineer from TU/e, his work on heart valves inspired the idea for regenerative endovascular implants. He holds a Doctor (dr) in Biomedical Engineering (2016) and a Master of Science in Biomedical Engineering (2011) from Eindhoven University of Technology. Despite initially lacking a business background, he has built a strong, complementary team to drive the company forward.

STENTiT has raised $1.98 million in total funding. This includes a university spin-out (Jan 2015), accelerator/incubator rounds (Sep 2016, Apr 2025), and grants (June 2019, Aug 2019, March 2023). A significant seed round of €1.8 million was secured on April 15, 2022, from NextGen Ventures, Brabant Development Agency (BOM), and Ten Cate Investment Company. A later-stage VC round also occurred on July 17, 2024. In 2024, the company focused on further product development and clinical trials, having proven the technology’s regenerative nature in pre-clinical studies. While no sales have been generated yet due to the long approval process inherent in MedTech, the company aims for its first clinical trials in 2025. Main shareholders include NextGen Ventures, Brabant Development Agency (BOM), Ten Cate Investment Company, and Horizon Europe.

Indigo Diabetes (Gent, Belgium)

Indigo Diabetes CMM. Source: https://indigomed.com/our-product/

Indigo Diabetes is developing the world’s first continuous multi-metabolite monitoring (CMM®) system, designed for individuals with chronic diseases. Initially, the system focuses on diabetes, providing continuous glucose, ketone, and lactate monitoring. The core of Indigo’s technology is an integrated sensor based on silicon photonics, enabling the miniaturization of established spectroscopic analysis techniques into a small, implantable device. This innovative approach allows for real-time data delivery to a smartphone app, offering a significant user experience improvement over external wearables or frequent finger pricks. The ability to continuously monitor multiple metabolites offers a holistic approach to managing complex chronic conditions, which can lead to improved patient outcomes and reduced healthcare costs.

The company’s founder is:

  • Danaë Delbeke (CTO, Managing Director, Inventor, & Co-founder): She has a proven track record in business management and entrepreneurship, having founded or co-founded seven high-tech photonics companies over the past 12 years. She holds a Ph.D. in Applied Sciences from Ghent University (2002) and degrees in Economics and Photonics.

Indigo Diabetes has raised over €45 million in total funding since 2016. This includes a €38 million Series B round concluded in July 2020, led by Fund+, with participation from Ackermans & van Haaren, imec.xpand, Capricorn Digital Growth Fund, QBIC II, Titan Baratto, and Series A investors. The company was founded in 2016 as a spin-off of Ghent University and imec. In 2024, Indigo Diabetes was recognized as a Key Innovator by the European Commission’s Innovation Radar (April 2025) and completed the SHINE Study, validating its breakthrough in continuous multi-metabolite monitoring (March 2025). The company was also selected for the 2025 MedTech Innovator Accelerator Cohort in June 2025. Main shareholders include Fund+, Ackermans & van Haaren, Thuja Capital, PMV, Capricorn Partners, imec.xpand, Qbic, and private investors.

Microplate Dx (Glasgow, United Kingdom)

Microplate Dx is developing RapidPlate Technology, a rapid antibiotic susceptibility testing (AST) platform designed to combat drug-resistant infections. This technology combines groundbreaking hardware with novel data processing algorithms to perform rapid AST on patient samples. A pre-clinical study focusing on urinary tract infections (UTIs) demonstrated 96% accuracy in detecting bacterial growth with results available in just 30 minutes. This rapid turnaround time is crucial for combating antimicrobial resistance (AMR), a growing global health threat that delays effective treatment and contributes to the spread of resistance.

The founding team includes:

  • Damion Corrigan (Co-founder & Chief Technology Officer): Brings over 10 years of academic and industrial experience in biosensors and assay development. He is a Professor of Chemistry at the University of Strathclyde, a founder of two spinout companies (AureumDx, Aureum), holds four patents, and is a Longitude Prize Discovery Award Recipient (2017).
  • Paul Hoskisson (Co-founder & Chief Scientific Advisor): Possesses over 15 years of experience in molecular microbiology. He is a Professor of Molecular Microbiology and Royal Academy of Engineering Research Chair at the University of Strathclyde, and previously licensed intellectual property to GSK.
  • Poonam Malik (Co-founder & Chair of the Board): An entrepreneurial business and commercial strategy leader with extensive experience as a board member, non-executive director, and advisor in life sciences, biotech, health, digital, and MedTech.
  • Stuart Hannah (Co-founder & CEO): Has over 10 years of academic and industrial experience in biotechnology, medical devices, and diagnostics development. He holds a PhD in Electronic & Electrical Engineering from the University of Strathclyde and is a former Royal Society of Edinburgh Enterprise Fellow.

Microplate Dx has raised a total of $3.73 million over two funding rounds. The first round, a $610K Seed round, closed on December 9, 2022. The latest, a $3.12 million Seed round, closed on September 11, 2023, with SIS Ventures as the lead investor. The company’s annual revenue was £35K as of April 30, 2022. However, for the legal entity Microplate DX Limited, turnover significantly increased by 92% to £901.29K for the period ending April 30, 2024, indicating strong early commercial traction and market validation. Main shareholders include Deepbridge Capital, SIS Ventures, Scottish Enterprise, Kin Capital, and the University of Strathclyde.

MiWEndo Solutions (Barcelona, Spain)

MiWEndo Solutions, a spin-off founded in 2019 from multiple Spanish universities and a hospital, is developing microwave medical diagnostic systems primarily for early colorectal cancer (CRC) detection. Their innovative endoscopy accessory uses low-cost, safe microwave imaging technology. It attaches to a standard endoscope, providing a 360° field of view, emitting an alarm upon polyp detection, and differentiating between malignant and benign polyps. This technology directly addresses the limitations of current colonoscopy methods, which can miss a significant percentage of polyps, and has the potential to dramatically increase early diagnosis and prevention of CRC.

The management team includes:

  • Tomàs Escuin (CEO): An Industrial Engineer with a Master’s degree and a postgraduate degree in Financial Management. He possesses extensive experience in technology transfer, finance, and business development.
  • Glòria Fernàndez Esparrach (Co-Founder & CMO): A Medical Doctor (MD, PhD), gastroenterologist, and endoscopy specialist at Hospital Clínic de Barcelona, and a professor at Universitat de Barcelona. She co-founded MiWEndo in 2019, focusing on developing smart systems to improve endoscope diagnostic capabilities.
  • Marta Guardiola (Co-Founder & CTO): Holds M.Sc. and PhD degrees in telecommunications. She is an associate professor at the International University of Catalonia and Universitat Pompeu Fabra. Co-founded MiWEndo in 2019, she holds two patents and has received over 10 awards.

MiWEndo Solutions has received substantial funding through numerous grants from various Spanish and European bodies, including the EIC Accelerator (Grant Agreement No. 960251 in 2020). Its investors include GENESIS Ventures, AVANÇSA, FI Group, and CDTI Innovación. In 2024, David Ruiz joined as RAQA Manager, responsible for managing the quality management system and ensuring MDR 2017/745 compliance for CE marking, indicating a mature approach to commercialization. Marta Guardiola also received the Premio Salvà i Campillo al Emprendimiento in October 2024. Main shareholders include Glòria Fernández-Esparrach, Marta Guardiola, Miriam Cuatrecases, and Ignasi Belda.

Icometrix (Leuven, Belgium)

Icometrix develops AI-driven software solutions for brain imaging, transforming MRI and CT scans into actionable data for a wide range of neurological conditions, including Alzheimer’s, multiple sclerosis (MS), Parkinson’s disease, stroke, traumatic brain injury, and epilepsy. Their core technology, icobrain, has specialized modules like icobrain aria for monitoring Amyloid-Related Imaging Abnormalities (ARIA) in Alzheimer’s care. The company also launched icolung for AI lung analyses during the COVID-19 pandemic and icompanion, a patient-oriented care platform for MS patients. The broad application of icobrain across multiple neurological conditions addresses significant global health burdens, providing objective data for early diagnosis, differential diagnosis, and monitoring treatment efficacy.

The leadership team includes:

  • Wim Van Hecke (CEO & Co-founder): An academic engineer with two Master’s degrees in applied biomedical engineering and neuroimaging, and a PhD in diffusion MRI analysis. He is the author or co-author of over 150 scientific publications and the editor of a clinical neuroimaging handbook. He founded icometrix in 2011 as a spin-off from Belgian universities and hospitals.
  • Dirk Smeets (CTO & Co-founder): Heads the R&D team and serves as product manager for icobrain and icolung, as well as information security manager. He holds a Ph.D.

Icometrix has raised a total of $20.2 million over 10 funding rounds. The largest round was a Series A for $18M in May 2019, co-led by Optum Ventures, Forestay Capital, and Capricorn Venture Partners. The company was founded in 2011 as a spin-off from two Belgian universities and hospitals. In 2024, icobrain aria became the only FDA-cleared CADe/CADx solution in neuroradiology for ARIA monitoring in Alzheimer’s care. Icometrix was also named a finalist for the Scale-Up of the Year 2024 Award in October 2024. The company collaborated with the American College of Radiology (ACR) and the International Registry for Alzheimer’s Disease (InRAD) to improve standardization of care and real-world evidence generation in Alzheimer’s disease. Main shareholders include Optum Ventures, Forestay Capital, Capricorn Venture Partners, Heran Partners, EIT Digital, European Union, KU Leuven, University of Antwerp, Antwerp University Hospital, and Biover II.

Precisis (Heidelberg, Germany)

Precisis EASEE (R) - Source: https://precisis.de/en/

Precisis GmbH specializes in innovative medical devices for device-controlled brain therapies. Their flagship product, EASEE®, is an implantable bioelectric brain stimulation system for treating epilepsy. This minimally invasive device is positioned beneath the scalp, directly over the epileptic origin, without requiring the cranial bone to be opened or the brain to be touched. EASEE® offers individualized brain stimulation with two modes of action: a high-frequency pulse for interrupting upcoming seizures and a DC-like mode for seizure prevention. This represents a significant advancement over highly invasive surgical alternatives for drug-refractory epilepsy, offering a low-risk and highly effective treatment option.

The leadership team includes:

  • Angela Liedler (CEO & Main Shareholder): A medical doctor and serial entrepreneur. She founded and led a healthcare agency before transitioning to the MedTech sector and taking over a majority stake in Precisis in 2011. She is also one of the inventors of EASEE®.
  • Karl Stoklosa (Managing Director, CEO): Has extensive experience in global marketing and sales leadership from his time at Abbott (Cardiac Rhythm Management, Neuromodulation) and St. Jude Medical. He holds a BA from the University of Minnesota and an MBA from the University of Chicago Booth School of Business.
  • Michael Tittelbach (Managing Director, CTO): His experience includes R&D for interventional cardiology at Biotronik AG. He studied Physics.

Precisis has secured substantial funding, including a €20 million Series A round in 2015 from private investors and grants from the German Federal Ministry for Research and Education. In October 2021, the company concluded another €20 million funding round with Cochlear Ltd, a global leader in implantable hearing solutions and a strategic partner. Additionally, Precisis received €2.4 million from the EIC Accelerator in December 2022. In 2024, Precisis began generating revenue and projected €6 million in revenues for 2025, with market launch anticipated for early 2022. EASEE® has seen successful implantations in Germany, Austria, and Switzerland, and was expected to be available in the UK from Q2 2024. The company also commenced a pediatric study in May 2023. Main shareholders include Angela Liedler and Cochlear Ltd.

Connected Consumables (Dresden, Germany)

Connectd Consumables. Source: https://conncons.com/

Connected Consumables is revolutionizing medical fluid consumables by integrating data and power capabilities, transforming what were once simple plastic conduits into intelligent system-solutions. Their patented technology embeds a data line directly into medical consumables, enabling digital end-to-end control and automated fluid management. The primary focus is on enhancing the precision and safety of oncological infusion therapy. This innovation directly addresses critical issues such as medication errors and the significant burden on medical staff due to repetitive manual tasks, ultimately leading to substantial cost savings and improved patient safety through continuous ID checks and direct translation of therapy plans into fluid control.

Founders of Connected Consumables are:
Jochen Hampe – CEO, Speaker at Else Kröner Fresenius Center for Digital Health, Professor for Internal Medicine and Gastroenterology at TU Dresden.

Marika Geißler – CFO and Co-founder, CEO of Synagen AI,

Nora Herzog – CEO, Clinician Scientists at Universitätsklinikum Carl Gustav Carus. Founder of Clinicum Digitale, a program bridging medicine and technology. Winner of the Female Transformers in Healthcare Award for her work in interdisciplinary medical education

Connected Consumables has participated in several funding rounds, including Accelerator/Incubator rounds in January 2021 and June 2025, and a Seed Round in August 2023. While specific revenue or performance figures for 2024 are not detailed, the company’s continued participation in accelerator programs indicates ongoing development and investor interest. Main shareholders include MedTech Innovator, Cellex Cell Professionals, Murrplastik Medizintechnik, TUDAG, and Thuringian Regional Innovation Program. The company’s technology, which introduces the “first wire” into medical consumables, represents a foundational innovation with broad potential across various medical fields beyond oncology where precise fluid management is critical.

MOMM Diagnostics (Basel, Switzerland)

MOMM Diagnostics is a privately held Swiss startup poised to revolutionize diagnostics with its rapid diagnostic test technology. The company’s primary focus is the development of the préXclude rapid preeclampsia test, a high-sensitivity diagnostic tool capable of identifying or ruling out preeclampsia in minutes from a single drop of the mother’s blood via a finger prick. Preeclampsia is a life-threatening pregnancy condition affecting 3-8% of all pregnancies, making a rapid and accurate diagnostic tool critically important for preventing severe complications for both mother and baby.

The company’s founder is:

  • Mathias Wipf (Founder & CEO): His background is in nanoscience and physics, with a focus on biosensor technologies. His work at Yale University on simplifying biosensor manufacturing laid the groundwork for MOMM Diagnostics. He is recognized as an innovation-driven scientist and entrepreneur.

MOMM Diagnostics has raised CHF 1.2 million in funding. This includes an $80.6K Grant (prize money) round in May 2019 from the European Union and Venture Kick. The company’s first interaction with Venturelab was in 2018 through Venture Kick. While specific performance figures for 2024 are not detailed, the company’s technology aligns perfectly with the increased demand for sensitive and accurate rapid diagnostic tests, a need highlighted by the COVID-19 pandemic. Main shareholders include the European Union and Venture Kick.

Multi4 Medical (Gothenburg, Sweden)

Multi4 Medical. Source: https://www.multi4.se/

Multi4 Medical has developed a unique and patented technology for automated endoscopic cancer diagnosis and treatment, specifically targeting urinary bladder cancer. Their handheld, multipurpose instrument integrates four key functions: applying local anesthesia, taking tissue samples in a novel way, automatically transporting samples through the instrument, and destroying cancer tissue or stopping bleeding. Designed for outpatient care, this technology eliminates the need for general anesthesia or operating rooms, allowing patients to go home immediately after treatment. This innovation significantly reduces the high costs and lengthy treatment times associated with traditional bladder cancer procedures, while improving patient quality of life.

The company’s founder is:

  • Miden Melle-Hannah (CEO & Founder): A urologist, surgeon, and entrepreneur. She founded Multi4 Medical in 2017, driven by her frustration with the inefficiencies in existing bladder cancer treatments. Her deep clinical insight has led to the development of a solution highly practical and relevant to clinical practice. She has received numerous awards for her innovative work.

Multi4 Medical has raised $2.7 million in total funding. This includes Accelerator/Incubator rounds in March 2024 and June 2025. A significant milestone in 2024 was securing a €2.5 million grant from the European Innovation Council in July. The company was also selected for the 2025 MedTech Innovator Cohort. In 2024, Multi4 Medical relocated to Gothenburg, leveraging the city’s thriving life science ecosystem for talent acquisition and partnerships. The first surgeries using their instrument are underway as part of a clinical study involving 25 bladder cancer patients in Gothenburg. The company submitted its Technical File for MDR/CE-mark and an Application to the FDA in 2025. Main shareholders include MedTech Innovator, European Innovation Council, and Science Park Jönköping.

The Flume Catheter Company (Farnham, United Kingdom)

The Flume Catheter Company is dedicated to developing an improved alternative to the traditional Foley indwelling urinary catheter, a device used by 100 million patients worldwide. Their FLUME catheter features a unique balloon configuration designed to envelop the tip of the catheter upon inflation, allowing the bladder to contact the compliant balloon rather than a rigid catheter tip. This innovative design directly addresses the significant patient discomfort, infections (CAUTI), and blockages commonly associated with existing catheters, aiming to enhance quality of life and reduce catheter-associated healthcare costs.

The founding team is composed of:

  • Dr. John Havard (Chairman & Founder): A Suffolk GP with a career-long interest in medical innovations. His inspiration for FLUME stemmed from community nurses’ feedback on the pervasive issues with the Foley catheter. He has been recognized as one of the UK’s Top 50 Innovators by the Health Service Journal.
  • Roger Holmes (Co-Founder & Chief Executive): A former CEO of M&S, an engineer, an accountant, and a private equity partner. He is a Partner at Change Capital Partners LLP and was drawn to FLUME’s potential for significant patient impact and healthcare financial benefits.

The Flume Catheter Company has raised a total of $6.19 million in funding. This includes seed funding of £450k (2016-2019), followed by three Angel rounds: £825k (March 2020), £2.1M (March 2022), and £1.4M (July 2024). The company also received grant support from an MRC-funded Elizabeth Blackwell ‘Proof of Concept’ award and an NIHR ‘Research for Patient Benefit’ award. In 2024, the company successfully completed its third Angel funding round and saw Kristian Olsen join as VP Engineering in January. The latest FLUME catheter was ready to ship in March 2025, with product arriving in the U.S. warehouse, marking a significant step in market expansion. The company is licensed to sell in 49 U.S. states and D.C., and the FLUME® catheter is covered under Medicare Part B. The company was also selected for the 2025 MedTech Innovator accelerator cohort in July 2025. Main shareholders include the founders, Angel investors, and MedTech Innovator.

III. Our Top Three Most Promising Startups

Identifying the “most promising” startups involves considering several factors: the disruptive potential of their technology, the size and urgency of the unmet medical need they address, their progress in clinical validation and regulatory approval, the strength and experience of their team, and their financial traction. Based on these criteria, the following three European startups from the 2025 MedTech Innovator cohort stand out for their potential to significantly transform healthcare:

1. Precisis (Heidelberg, Germany)

Precisis is a standout innovator due to its EASEE® system, which offers a minimally invasive bioelectric brain stimulation solution for drug-refractory epilepsy. This technology addresses a critical unmet need for millions of epilepsy patients who do not respond to medication, for whom current surgical options are highly invasive and carry significant risks. EASEE®’s unique design, placed beneath the scalp without opening the cranial bone or touching the brain, drastically reduces surgical complications and patient burden. The compelling clinical results, with 84% of severely ill study participants benefiting and 53% achieving a ≥50% seizure reduction (17% becoming completely seizure-free) , demonstrate a profound improvement in patient quality of life. This level of efficacy in a minimally invasive package positions EASEE® as a truly disruptive therapy.

Furthermore, Precisis’ strategic partnership with Cochlear Ltd, a global leader in implantable solutions, is a significant accelerator for its market penetration. This collaboration provides not only substantial funding but also invaluable access to Cochlear’s vast expertise in implantable devices and its established global market presence. The fact that Cochlear’s investment is tied to clinical and development milestones, including CE Mark certification , aligns incentives for rapid progress and de-risks the venture. The company’s achievement of CE Mark approval under the new MDR regulation as a small company in just seven years is a testament to its robust development and regulatory capabilities. The platform nature of EASEE®, with potential applications in other functional brain diseases like depression and cognitive dysfunctions , indicates a broader long-term vision and scalable market potential beyond epilepsy, making it a highly attractive investment.

2. Microplate Dx (Glasgow, United Kingdom)

Microplate Dx presents a compelling case for its disruptive potential by directly confronting the urgent global health crisis of antimicrobial resistance (AMR). Their RapidPlate Technology offers a rapid antibiotic susceptibility testing (AST) platform that can deliver results in just 30 minutes with 96% accuracy for urinary tract infections. This is a game-changer compared to current methods that can take days, often leading to “best guess” antibiotic prescriptions that contribute to resistance and delay effective treatment, especially in time-sensitive conditions like sepsis. The ability to provide immediate, targeted antibiotic guidance can significantly improve patient outcomes, reduce hospitalizations, and slow the progression of AMR.

The company’s strong academic foundation as a spin-out from the University of Strathclyde, with multiple founders holding professorships and extensive experience in biosensors and microbiology , provides a solid scientific and technical bedrock. This academic rigor, combined with the university’s commercialization support, enhances the credibility of their innovation. Financially, the significant increase in turnover for Microplate DX Limited, which saw a 92% growth to £901.29K in the fiscal year ending April 2024 , demonstrates strong early commercial traction and market validation. This rapid revenue growth, coupled with their direct impact on a major global health challenge and a clear path to market through their platform, positions Microplate Dx as a highly promising venture.

3. Multi4 Medical (Gothenburg, Sweden)

Multi4 Medical stands out for its innovative approach to cancer diagnosis and treatment, particularly for urinary bladder cancer, by shifting complex procedures to an outpatient setting. Their patented, handheld, multi-purpose instrument automates critical steps like local anesthesia, tissue sampling, sample transport, and tissue destruction, eliminating the need for general anesthesia, operating rooms, and catheters. This transformation addresses a significant pain point in bladder cancer care, which is often costly and time-consuming, with high recurrence rates. By enabling patients to go home immediately after a 20-minute procedure, Multi4 Medical promises substantial cost savings for healthcare systems (e.g., $140,000 per case in the US) and a dramatically improved patient experience.

The company’s innovation is driven by the direct clinical expertise of its founder and CEO, Miden Melle-Hannah, a urologist and surgeon. Her firsthand frustration with existing inefficiencies in bladder cancer treatment provided the impetus for developing a highly practical and clinically relevant solution. This “doctor-turned-entrepreneur” narrative lends significant credibility to the company’s mission. Furthermore, the technology’s generic nature, with potential applicability to other cancers of the esophagus, stomach, lungs, and intestines , indicates a broad market potential and scalability beyond its initial focus. The recent €2.5 million grant from the European Innovation Council and the strategic relocation to Gothenburg’s thriving life science ecosystem further underscore the company’s strong validation and ambitious growth plans.

IV. Conclusion

The 2025 MedTech Innovator cohort highlights Europe’s pivotal role in shaping the future of healthcare. The featured startups demonstrate a collective commitment to addressing critical unmet medical needs through groundbreaking technologies, ranging from AI-powered diagnostics and regenerative therapies to minimally invasive surgical solutions.

A recurring theme among these innovators is the strategic application of advanced technologies, such as AI, photonics, and mixed reality, to create solutions that are not only clinically effective but also enhance accessibility, reduce costs, and improve patient quality of life. Many of these companies originate from strong academic foundations, leveraging deep scientific expertise to develop robust, evidence-based products. Their ability to secure substantial funding from diverse sources, including venture capital, grants from European bodies, and strategic partnerships with industry giants, underscores the market’s confidence in their disruptive potential.

The progress demonstrated by these companies, including successful clinical studies, regulatory clearances (FDA, CE Mark), and early commercial traction, indicates a maturation of the European MedTech ecosystem. These ventures are not merely developing novel devices; they are actively working to integrate their solutions into existing healthcare workflows, streamline patient pathways, and ultimately redefine the standards of care. Their collective efforts forecast a future where healthcare is more proactive, personalized, and efficient, promising significant advancements for patients worldwide.

This content has been enhanced with GenAI tools.

References:

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Categories
Digital Health MedTech

Mistakes to Avoid in MedTech Commercialization (and How to Fix Them)

Even with the right product, market, and team — many MedTech startups fail. And the reasons often come down to avoidable commercialization mistakes: misjudging the buyer, skipping regulatory nuance, or assuming your tech will sell itself.

This final post in the Scaling MedTech: From Product to Market series lays out the most common missteps in MedTech go-to-market and how to avoid them — with real-world examples and corrective actions.


1. Building Before Validating the Buyer

Mistake: Launching development without confirming who pays, who uses, and who benefits.

Too many founders build based on clinical need or innovation potential — without validating demand, budget holders, or economic value.

Fix: Use the JTBD (Jobs-To-Be-Done) framework + early payer interviews to design with reimbursement in mind.


2. Relying on Pilots Without a Conversion Plan

Mistake: Dozens of pilots, zero sales.

Pilots are easy to get — but unless there’s a conversion path, they drain resources and confuse investors.

Example: Many DTx startups in Germany listed under DiGA saw high downloads but failed to convert to revenue due to unclear therapeutic ownership.

Fix: Design pilots with: – Pre-negotiated success KPIs – Budget source for scale-up – Procurement-ready documentation


3. Ignoring Procurement and IT Requirements

Mistake: Gaining HCP interest, but failing at hospital onboarding.

Even if clinicians love your product, procurement, legal, and IT may reject it due to data compliance, MDR classification, or lack of integration.

Fix: – Include procurement in early demos – Prepare GDPR/Data Processing documentation – Get listed in hospital or GPO vendor systems (e.g., GHX)


4. Misunderstanding Regulatory Signals

Mistake: Confusing CE marking or FDA approval with market readiness.

Regulatory clearance allows sales, but doesn’t guarantee adoption or reimbursement.

Fix: Align your commercial roadmap with regulatory + access strategy (e.g., CE mark + DiGA listing or NICE submission).

Resource: See MDR timeline & guidance from the European Commission.


5. Over-Investing in the Wrong Channel Early

Mistake: Hiring a large sales team before validating CAC or message fit.

Burning capital on outbound reps without understanding the sales motion leads to churn and stalled traction.

Fix: Run test campaigns with fractional reps, digital outreach, or advisor-led selling before hiring full-time field force.


Summary Table: Mistakes & Fixes

MistakeFix
No buyer validationConduct payer & JTBD interviews
Pilot fatigueDesign conversion-ready pilots
Procurement blockersInvolve early, prep documentation
CE mark ≠ market fitLayer regulatory + access planning
Premature sales hiresValidate channels first

Final Word

Commercialization in MedTech is not just execution — it’s sequencing. Avoiding these five traps increases the odds of landing not just pilots or press — but scalable, reimbursed adoption.


Explore more: – Why Pear Therapeutics failed despite FDA clearanceHow Bigfoot Biomedical sequenced product + payer strategy

This wraps our series on Scaling MedTech — let us know what topic you want next.

This content has been enhanced with GenAI tools.

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Digital Health MedTech

Commercial Channels That Actually Work in MedTech

For MedTech startups, success hinges not only on product quality, but also on how you reach, convince, and support stakeholders. Whether selling to hospitals, doctors, or patients, early-stage companies must design a channel strategy that reflects the healthcare buying process — slow, risk-averse, and influence-driven.

This post breaks down the most effective commercial channels in MedTech, based on what’s actually working in 2025.


1. The MedTech Sales Funnel Is Nonlinear

In traditional B2B, a sales funnel moves from awareness → interest → consideration → purchase.

In MedTech, it looks more like:

Clinical KOL → Hospital Committee → Procurement → IT → Payer → Rollout

Each stage requires a different communication style and sometimes different messengers. Sales success is more about building internal champions than pure outbound volume.

Insight: On average, a hospital sale in Europe involves 5–7 decision-makers (McKinsey MedTech Commercial Benchmark).


2. Channels That Work in Early-Stage MedTech

a. Key Opinion Leaders (KOLs)

  • Clinical influencers who help validate product utility
  • Invite early as advisors or co-authors of case studies
  • Ideal for high-specialty tools (robotics, diagnostics, DTx)

Example: Impulse Dynamics used KOLs to validate its cardiac neuromodulation tech pre-launch.

b. Medical Science Liaisons (MSLs)

  • Hybrid of sales and education
  • Often paired with clinical trials or early access programs

c. Virtual Selling Platforms

  • Tools like Veeva Engage or Showpad support rep-driven or rep-less demos
  • Crucial for digital products, AI tools, and DTx

Statistic: 75% of HCPs in Europe now prefer hybrid or remote interactions (Accenture HCP Preferences)

d. Peer-to-Peer Learning & CME Platforms

  • Hosting webinars, masterclasses, or contributing to Univadis and Medscape
  • Builds credibility and engagement in clinical communities

3. Choosing the Right Channel by Product Type

Product TypePrimary ChannelSecondary
Surgical toolsKOLs + in-hospital demosProcurement-led tenders
DTx & SaMDVirtual platforms + payersPrimary care orgs
Diagnostics (AI)MSLs + evidence portalsRadiology or lab heads
Monitoring devicesPeer-to-peer pilotsDistributors

4. Global Commercial Trends in 2025

  • Digital-first detailing is mainstream. COVID catalyzed a shift to Zoom-based product detailing and asynchronous video walkthroughs.
  • Field force is shrinking. Reps are more specialized, often scientific or hybrid profiles.
  • Channel orchestration is key. Companies using Salesforce, HubSpot, or Aktana orchestration outperform on conversion.

5. Building a Channel Strategy: Questions to Ask

  1. Who influences vs decides vs pays?
  2. Can you pilot the sales motion before full deployment?
  3. Can one channel (e.g. KOLs or CME) drive multiple buyers?
  4. Can data from pilots be repurposed for access and pricing?

Tip: In early-stage MedTech, channel feedback is often better than user feedback — it tells you what blocks growth.


Up next in the series: 📌 Mistakes to Avoid in MedTech Commercialization (and How to Fix Them)

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Digital Health MedTech

Cracking Reimbursement — Value-Based Pricing for MedTech Startups

Pricing in MedTech isn’t just a number — it’s your business model. In the EU, where public payers dominate and health systems are increasingly value-driven, getting paid requires clinical validation, health economic proof, and a clear story about long-term cost savings.

This post breaks down how to approach reimbursement and pricing for MedTech startups, with examples from DTx, devices, and AI diagnostics. We focus on the frameworks that matter and what early-stage founders must do to prepare.


1. Understand What Payers Actually Buy

Public and private payers (like insurers and national health services) don’t buy tech — they buy outcomes. Successful pricing strategies show how your product: – Improves health outcomes (efficacy) – Saves money (cost avoidance) – Improves workflow or capacity

Tip: Frame pricing in terms of cost per QALY (quality-adjusted life year) or ROI within 12–24 months.


2. Pricing Models That Work in MedTech

ModelBest forNotes
One-time saleCapital equipment, implantablesRequire large budget cycles
SubscriptionDTx, RPM, AI toolsCommon for digital health; easier for payers to adopt
Outcome-basedDigital diagnostics, chronic careReimbursed only if outcome achieved; harder to negotiate
Bundled with servicesMonitoring devices + clinical servicesEnables multi-stakeholder value delivery

Example: Kaia Health offers MSK therapy via reimbursed app + coaching in Germany, priced as monthly license.


3. EU Reimbursement Pathways to Know

Germany: DiGA Pricing

  • Startups can set their own price in the first year post-listing.
  • After 12 months, price must be negotiated with the GKV-Spitzenverband (National Association of Statutory Health Insurance Funds).
  • Must show comparative evidence vs standard of care.

Caution: DiGA price averages dropped 30% post-negotiation in 2024 (IQVIA DiGA Report).

France: PECAN / LPPR

  • PECAN pilot covers early-stage pricing with proof-of-concept.
  • Long-term reimbursement requires HTA via HAS and inclusion on LPPR list.
  • Prices often benchmarked to existing therapies.

UK: NICE HTA and Value-Based Pricing

  • NICE uses cost-effectiveness models (e.g., ICER thresholds: ~£20k–£30k per QALY).
  • Pilots with NHS can inform real-world pricing.
  • Commercial frameworks like NHS England’s MIA allow negotiated price-volume deals.

4. Building Your Reimbursement Strategy Early

a. Collect Health Economics Evidence

  • Use budget impact models (BIMs)
  • Simulate payer scenarios: what happens if 1,000 patients adopt your solution?

b. Start Conversations With Payers

  • Germany: GKV associations
  • France: CNAM and HAS
  • UK: NICE and NHS regional leads

c. Use External Tools

  • Partner with health economics consultancies like Coreva Scientific
  • Validate models with HTA reviewers and KOLs

5. Common Pricing Mistakes to Avoid

  • Pricing too high without evidence → rejection by payers
  • Free pilots without contract conversion → unsustainable
  • Lack of cost comparator → HTA rejection
  • Misunderstanding budget holder (hospital vs insurer)

Insight: In France, even successful pilots stalled due to unclear budget responsibility between national and regional health bodies.


Quick Reference Table: National Pricing Characteristics

CountryNegotiation BodyModelNotes
GermanyGKVPost-listing price setDiGA pricing volatile post-year one
FranceHAS / CNAMCase-by-casePECAN pilots used for prep
UKNICE / ICSValue-basedUses QALY model and ROI thresholds

Final Takeaways for MedTech Startups

  • Start pricing strategy early — not after CE mark
  • Understand payer incentives and outcome expectations
  • Prepare BIMs and value dossiers during pilot phase

Up next in the series: 📌 Commercial Channels That Actually Work in MedTech

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Digital Health MedTech

Market Access in Europe — What Founders Need to Know

Getting into the hospital is no longer the endgame. For MedTech startups in Europe, getting reimbursed — and doing so consistently across fragmented markets — is what separates hobby projects from scalable businesses.

In this second post of our series, we dive into the European market access landscape for medical devices and digital health, with a founder-focused lens on systems in Germany, France, the UK, and Nordic/CEE markets.


1. Germany: DiGA and the Fast Track for Digital Health

Germany remains Europe’s most structured digital reimbursement market thanks to the DiGA Fast Track, launched in 2020 by the Federal Institute for Drugs and Medical Devices (BfArM).

What qualifies: Apps or software-based interventions classified as low-risk medical devices (Class I or IIa under MDR).
Who pays: Statutory health insurance (covers 73M+ Germans).

Key Steps: 1. CE Marking as a medical device 2. Apply for DiGA listing (provisional or permanent) 3. Submit evidence (clinical, economic, usability)

Success story: Selfapy — a digital mental health therapy platform — was listed in 2022 and now reimbursed nationally.

Caution: Only 55 apps were listed as of mid-2025, with >40% later withdrawn due to insufficient evidence or pricing issues.


2. France: PECAN Pathway and Public Evaluation

France doesn’t have a DiGA equivalent yet, but the new PECAN pilot launched in 2023 offers early funding for digital therapeutics.

Agencies involved:HAS (clinical evaluation) – CNAM (payer negotiations)

Key routes for market access: – PECAN for DTx and AI diagnostics (pilot program) – LPPR for physical devices (Listing for reimbursement)

Tip: Leverage French Tech Health20 status to speed up access via Bpifrance support.


3. United Kingdom: NICE, NHS Pathways, and DTAC

In the UK, access is driven by public health pilots and evidence-based appraisals.

Key frameworks:NICE DHT Evidence StandardsNHS DTAC (Digital Technology Assessment Criteria)

Best path for startups: 1. Pilot with NHS via accelerators like NHS Innovation Accelerator 2. Gather local data and enter NICE appraisal 3. Align with Integrated Care Systems for regional deployment

Example: Huma has scaled UK pilots into global expansion after evidence-driven adoption in NHS settings.


4. Nordics: Digital-First, But Decentralized

Sweden, Denmark, and Finland lead in digital infrastructure but lack a unified reimbursement track.

Approach: – Run local hospital pilots (funded by Vinnova, Business Finland) – Engage with regional procurement bodies

Tip: Nordic health systems value co-creation and evidence transparency over hype.


5. Central & Eastern Europe: EU-Backed Access with Cost Advantage

In Poland, Romania, and Czechia, adoption is slower but aided by EU structural funds.

Tactics that work: – Partner with local CROs or academic hospitals – Position for structural fund-backed pilots – Focus on affordability + clinical value

Note: EIT Health plays an active role in startup acceleration and validation across CEE.


Summary Table: Market Access Pathways by Country

CountryKey FrameworkEntry PointReimburses Digital?
GermanyDiGABfArM application✅ Yes
FrancePECAN / LPPRHAS + CNAM⚠️ In pilot
UKNICE / DTACNHS pilot + ICS✅ If evidence exists
SwedenLocal procurementRegional pilots❌ No central track
Poland/CEEEU-backed pilotsAcademic/hospital use❌ Not at scale

Takeaways for Founders

  • Don’t treat Europe as one market — the access frameworks are radically different.
  • Start with pilots and evidence in 1–2 strategic countries.
  • Use programs like DiGA and PECAN if applicable, but expect pricing pressure and compliance overhead.

Up next in the series: 📌 Cracking Reimbursement — Value-Based Pricing for MedTech Startups

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Digital Health MedTech

The MedTech Go-to-Market Playbook (2025 Edition)

Breaking into healthcare is hard. Breaking into MedTech is harder — thanks to complex regulations, long sales cycles, and conservative procurement paths. For early-stage medtech startups, choosing the right go-to-market (GTM) strategy can be the difference between scaling and stalling.

This guide breaks down the GTM playbook for MedTech in 2025, with a focus on startups launching in Europe and beyond. Based on real-world cases and regulatory insights, it’s built for those bringing medical devices, diagnostics, SaMD, or digital therapeutics (DTx) to market.


1. Choosing Your Commercial Model

Startups typically consider three primary go-to-market approaches:

1. Direct Sales (Field Reps, Clinical Liaisons)

  • Best for: High-margin products requiring clinician education (e.g. surgical robotics, diagnostics)
  • Challenges: Expensive ramp-up, long hiring timelines, regulatory training

2. Distributor & Channel Partnerships

  • Best for: Physical devices, CE-marked products in new geographies
  • Challenges: Less control over brand, data access, or customer experience

Example: Aidar Health used local channel partners to launch its multi-parameter diagnostic device in the EU before expanding direct.

3. Hybrid Model (Digital + Field, Centers of Excellence)

  • Best for: DTx, connected devices, AI-enabled diagnostics
  • Combine inbound marketing, centralized KOL outreach, virtual demos, and sales hubs

Example: Kaia Health built its GTM around remote clinical onboarding + digital HCP engagement, reducing cost-per-acquisition in Germany.


2. B2B vs B2C vs B2B2C in MedTech

MedTech isn’t one market — it’s multiple buyer archetypes:

ModelBuyerExampleRisk
B2BHospitals, GPOsSurgical robots, AI diagnosticsLong cycles, tender processes
B2CPatientsWearables, chronic disease appsAcquisition cost, compliance
B2B2CEmployers, insurersDTx, remote monitoringValue-based outcomes required

Key takeaway: Align GTM strategy to your reimbursement model and data capture capabilities.


3. Launch Sequence: What Comes First

Here’s a 4-step playbook most successful medtech startups follow:

Step 1: Identify Use Case + Early Adopter Segment

  • Focus on a narrow clinical pathway (e.g. remote respiratory monitoring in COPD)
  • Validate with 3–5 pilot sites

Step 2: Secure Certification or Reimbursement Milestone

  • EU: CE Mark under MDR, DiGA listing in Germany
  • UK: NICE DHT Evidence Standards
  • US: FDA 510(k) or De Novo

Step 3: Establish Clinical + Economic Credibility

  • Publish real-world evidence or observational data
  • Prepare short HTA dossiers (see EUnetHTA)

Step 4: Build Repeatable GTM Engine

  • Onboard 2–3 KOLs as advisors
  • Launch pilot-to-procurement playbook
  • Invest in sales enablement tools (e.g. Showpad, Veeva)

4. The Rise of Digital-First MedTech GTM

  • Virtual engagement is now table stakes. Over 70% of HCPs prefer virtual or hybrid touchpoints post-COVID (Accenture Life Sciences Report).
  • AI-powered reps, modular education, and asynchronous demos are outperforming live-only tactics.
  • Tools like ExplORer Surgical are now used in complex OR sales motions.

5. Budget Benchmarks for GTM Readiness

For pre-Series A startups, GTM budgets vary by model:

GTM ModelTypical Budget (Year 1)Headcount
Direct sales€300K–€1M3–5 reps
Distributor€100K–€250K1–2 BD FTEs
Hybrid/Digital€150K–€500KGrowth + Med affairs + digital comms

Up Next in the Series

📌 Post 2: Market Access in Europe — What Founders Need to Know
We’ll explore DiGA (Germany), PECAN (France), NICE (UK), and how early-stage companies can position for public system adoption.

Explore related reading: – Bigfoot Biomedical’s GTM modelPear Therapeutics: Why commercialization failed

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Digital Health MedTech

EU Digital Health Funding Landscape 2025: Where and How to Raise Capital in Europe

With over €20 billion in public and private capital flowing into digital health ventures since 2020, the European Union has become a strategic launchpad for healthtech founders. But where exactly does this capital come from? And what’s the smartest path for early-stage startups looking to digital health funding?

This in-depth guide breaks down the EU digital health funding landscape in 2025 — covering both EU-level grants (like Horizon Europe, EU4Health, and the EIC Accelerator) and national innovation programs (from France’s Bpifrance to Germany’s HTGF). We also map out the private funding scene, spotlighting active VCs and corporate funds, and show how EU regulations like MDR and GDPR influence access to capital.

Whether you’re applying for your first public grant, looking to raise a blended round, or building a scalable platform for regulated care — this guide is for you.

The Big Picture: Why EU Digital Health Funding Matters in 2025

In 2024 alone, startups in Europe raised $4.8 billion in digital health VC — a 27% YoY increase (Galen Growth). Mega-rounds like Alan (€193M), Ōura (€200M), and Flo Health ($200M) highlighted the growing maturity of the region.

Public funding is also expanding. The European Commission committed over €14 billion to digital health via Horizon Europe, EU4Health, and the Digital Europe Programme. Countries like France, Germany, and the Nordics doubled down on national programs for startups, especially those focused on regulated innovation (e.g. DTx, AI diagnostics, RPM).

But with increased capital comes increased complexity: understanding how to access the right programs, meet regulatory expectations, and position your startup for both grants and venture capital is essential.

EU-Level Public Funding: Key Programs for Startups

1. Horizon Europe

The EU’s flagship R&D program with a €95.5 billion budget, Horizon Europe funds large-scale innovation consortia. While not startup-specific, early-stage digital health ventures can access funds by partnering in consortium projects (e.g. under Cluster 1: Health).

Pro tip: Join a consortium via national contact points or through platforms like CORDIS.

2. EIC Accelerator

For high-risk, high-impact innovation, the EIC Accelerator offers up to €2.5M in grant + €15M in equity. In 2024, only 71 out of 1,211 applicants (≈5.9%) were selected (EIC Results).

Eligible: single startups incorporated in the EU.
Selection: based on scalability, scientific merit, and impact.

3. EU4Health

A €4.4 billion program supporting digital infrastructure, health data, and cross-border health services. Includes funding for the upcoming European Health Data Space (EHDS).

Best fit: startups providing EHR, interoperability, cybersecurity, or public health software.

4. Digital Europe Programme

Targets adoption of digital capabilities like AI and cybersecurity. Useful for startups bridging research and deployment.

National-Level Public Funding: Country Breakdown

France – Bpifrance and France 2030

  • Over €2.3B deployed into health innovation via Bpifrance since 2021.
  • Grant programs: i-Lab, i-Nov, French Tech Emergence.
  • Digital Health Acceleration Strategy under France 2030.

Germany – High-Tech Gründerfonds (HTGF)

UK – Innovate UK

  • Smart Grants up to £2M.
  • Health-specific challenges (e.g. mental health, aging tech).
  • Access to NHS pilots via NIHR, NHS Innovation Accelerator.

Nordics (Finland, Sweden, Denmark, Norway)

  • Innovation agencies (e.g. Business Finland, Vinnova) offer R&D grants, public co-investment.
  • Highly digital healthcare systems ideal for pilots.

CEE (Poland, Estonia, Czechia, etc.)

  • Heavy use of EU structural funds via EIT Health and local programs.
  • Lower VC volumes but rising interest from pan-European funds.

Private Capital: VC and Corporate Investors in Digital Health

Top early-stage investors active in EU digital health (2024–2025):

VC/InvestorHQNotes
BpifranceFRPublic VC, top deal count in Europe
Octopus VenturesUKHealthtech-focused team, 7 deals in 2024
Heal CapitalDEBacked by German insurers
MTIPCHDigital health scale-up investor
Nina CapitalESSpecialized in early-stage health tech
Khosla VenturesUSActive in EU AI health rounds
Wellington PartnersDEKnown for Temedica, Kaia Health

EU Regulations and Their Impact on Fundraising

MDR (Medical Device Regulation)

If your product qualifies as a medical device (e.g. AI diagnostics, digital therapeutics), you must comply with MDR to enter the EU market.

Pro tip: CE-marked startups are more likely to receive both VC and public funding.

GDPR (General Data Protection Regulation)

Strong privacy and data governance are mandatory. Consider external audits, ISO27001 certification, and working with GDPR Sandboxes in countries like France or Spain.

EHDS (European Health Data Space)

Coming 2025, EHDS will define interoperability and data-sharing standards across Europe. Compliance could unlock access to new tenders and cross-border pilots.

2025 Outlook: Trends and Opportunities

  • AI dominance: ~60% of 2025 funding so far went to AI-driven health ventures (CB Insights).
  • Public-private blending: More startups combining EU grants + VC in same round.
  • Reimbursement as ROI: Germany (DiGA), France (PECAN), and Nordics offer clear digital reimbursement paths — critical for Series A+ readiness.
  • CEE Rising: Low costs + EU funds = surge of new startups in Poland, Romania, Hungary.

FAQs

What are the best EU digital health funding programs for early-stage startups?

Top options: EIC Accelerator, EU4Health, national innovation agencies (Bpifrance, HTGF), and Digital Europe grants for AI/infra.

How competitive are EU public grants?

Highly. For example, the EIC Accelerator had ~5.9% success in 2024 (source). “Seal of Excellence” can still unlock national funds.

Which EU country is best for starting a digital health company?

France (strong grants), Germany (DiGA reimbursement), UK (private VC and NHS pilots), Nordics (public adoption), and Poland (cost and EU access).

Want to go deeper into commercialization, regulatory strategy, or fundraising? Explore our insights on how Bigfoot Biomedical built a commercial model around a digital-first insulin delivery system and why Pear Therapeutics failed to secure sustainable revenue despite FDA-approved DTx.

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Categories
MedTech

What Is MedTech? A Beginner’s Guide to Medical Technology

The intersection of medicine and technology is rapidly transforming healthcare worldwide. If you’ve ever wondered, what is MedTech?, you’re not alone. This beginner’s guide explores the definition, industry scope, and the latest trends shaping medical technology today.

What Is MedTech?

MedTech—short for medical technology—refers to the vast range of products, services, and solutions that leverage technology to diagnose, monitor, treat, and improve patient health outcomes. MedTech encompasses everything from simple tools like thermometers and bandages to complex innovations such as MRI machines, surgical robots, and AI-powered diagnostic platforms.

“Medical technologies are products, services or solutions used to save and improve people’s lives.”
MedTech Europe

Key MedTech Categories

  • Medical Devices: Instruments and machines used in diagnosis, treatment, or monitoring (e.g., pacemakers, CT scanners, insulin pumps).
  • In Vitro Diagnostics (IVD): Laboratory tests and equipment for analyzing blood, tissue, or other samples.
  • Digital Health Solutions: Software and connected devices for remote monitoring, telehealth, and electronic health records.
  • Implantable Devices: Artificial joints, stents, and other devices placed inside the body.

Industry Scope

The MedTech industry is a cornerstone of modern healthcare, serving hospitals, clinics, laboratories, and home care settings. Its scope includes:

  • Patient Diagnostics: Tools for early and accurate disease detection (e.g., imaging systems, point-of-care diagnostics).
  • Therapeutic Devices: Equipment for surgical procedures, rehabilitation, and chronic disease management.
  • Monitoring & Wearables: Devices for continuous tracking of vital signs, glucose levels, or cardiac rhythms.
  • Connected Care: Integration of devices and data for seamless patient management and improved outcomes.

MedTech is distinct from HealthTech, which focuses more on consumer-facing digital health apps and telemedicine. MedTech primarily empowers healthcare professionals with advanced tools for clinical care.

Global Impact

The MedTech sector demonstrated resilience and growth in 2024, achieving a robust 5–7% annual growth rate despite global economic pressures. Demand is surging for wearable devices, AI-enabled diagnostics, and minimally invasive procedures, especially in emerging markets where access and affordability are critical priorities.

The MedTech landscape is evolving at an unprecedented pace. Here are the most influential trends shaping the industry:

1. Artificial Intelligence (AI) and Machine Learning

AI is revolutionizing diagnostics, imaging, and workflow automation. AI-powered tools help clinicians detect diseases earlier, improve diagnostic accuracy, and streamline administrative tasks. The adoption of AI in healthcare operations is projected to grow at an annual rate of over 30%.

2. Connected Devices and Home Healthcare

Wearable devices and remote monitoring solutions are empowering patients to manage their health at home. Edge computing and IoT-enabled devices provide real-time data to clinicians, supporting proactive care and reducing hospital visits.

3. Minimally Invasive and Patient-Centric Solutions

Technologies that reduce recovery times and improve patient comfort—such as robotic surgery and advanced imaging—are in high demand. The market for minimally invasive devices is expected to grow at a CAGR of 12-15% through 2025.

4. Data Security and Regulatory Compliance

With the expansion of digital health platforms, cybersecurity and regulatory oversight are top priorities. Investments in AI-powered threat detection and compliance tools are rising to safeguard sensitive medical data and meet evolving industry standards.

5. Global Expansion and Access

Emerging markets are driving growth through investments in healthcare infrastructure and affordable medical technologies. Companies are focusing on scalable, cost-effective solutions to reach underserved populations worldwide.

Conclusion

MedTech is at the forefront of healthcare innovation, blending advanced technology with clinical expertise to enhance patient care. From AI-driven diagnostics to connected home health devices, the industry is shaping a future where healthcare is more precise, accessible, and patient-centered than ever before.

Whether you’re a healthcare professional, industry stakeholder, or curious newcomer, understanding what is MedTech is essential for navigating the evolving landscape of modern medicine.

References

  1. MedTech Europe – What is Medical Technology?
  2. FDA – What Are Medical Devices?
  3. Mayo Clinic – Wearable Technology in Healthcare
  4. Deloitte – 2024 Global MedTech Industry Outlook
  5. McKinsey – MedTech in Emerging Markets
  6. Nature – Artificial Intelligence in Medical Devices
  7. Statista – AI in Healthcare Market Size
  8. Forbes – The Rise Of Connected Medical Devices
  9. MarketsandMarkets – Minimally Invasive Surgical Instruments Market
  10. Healthcare IT News – Cybersecurity in MedTech
  11. PwC – Medical Device Regulation
  12. WHO – Medical Devices: Managing the Mismatch

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MedTech

How to Build a Medtech Unicorn in Europe: The 2025 Founders Playbook

Introduction: Medtech Unicorns on the Rise in Europe

The medtech unicorn phenomenon is transforming healthcare in Europe. As one of the world’s largest industries—nearly 20% of U.S. GDP (about $5 trillion)—healthcare has long been ripe for disruption. Yet, medtech unicorns (startups valued at $1 billion or more) have historically represented only about 8% of all unicorns globally. This is changing rapidly: the European digital health market reached €64 billion in 2024 and is growing at over 20% CAGR, driven by medtech founders leveraging AI, digitalization, and urgent healthcare needs.

Why Medtech Unicorns Are Emerging Now

  • AI & Data Revolution: The AI healthcare market is projected to grow 40% in 2025, reaching over $208 billion by 2030. Medtech unicorns like Neko Health (Sweden) and Abridge (U.S.) are using AI for diagnostics, workflow automation, and drug discovery.
  • Systemic Pressures: Chronic disease, workforce shortages, and aging populations are driving demand for digital solutions and automation.
  • Market Growth: The European digital health sector is expanding rapidly, with innovation hubs in the Netherlands, Belgium, Switzerland, and the Nordics.

What Problems Do Medtech Unicorns Solve?

DomainExample CompaniesProblem Tackled
Access & ConvenienceDoctolibCeraOnline booking, telehealth, elder care
Chronic Disease MgmtDexcomSword HealthWearable monitoring, remote coaching
Data & DiagnosticsTempusBetter MedicineGenomics, AI-driven early diagnosis
Workflow & EfficiencyAbridgeDoctolibAutomated documentation, scheduling
New Therapies & R&DInsilico MedicineAI-driven drug discovery

Key Insight: Medtech unicorns in Europe address big, costly, and pervasive healthcare pain points, often reimagining processes with technology for a 10x improvement.

How Do Medtech Unicorns Make Money?

  • B2B SaaS: Selling software to hospitals, clinics, and pharma (e.g., DoctolibTempus).
  • B2B2C: Partnering with employers/insurers for broader coverage (e.g., Cera).
  • Direct-to-Consumer: Selling directly to patients (e.g., DexcomNeko Health).
  • Device Sales: Hardware, wearables, and consumables (e.g., Dexcom).
  • Data Licensing: Monetizing unique health data via partnerships (e.g., TempusInsilico Medicine).

Europe vs. US: Medtech Europe startups often face centralized payers and tougher regulatory hurdles but can access broad markets through national schemes, while U.S. startups may scale faster but face fragmented payers and state regulations.

The Founder Blueprint: Traits of Medtech Unicorn Leaders

  • Experience Matters: 70% of medtech unicorn founders have over 10 years of professional experience before launching their company.
  • Team Composition: Over 80% of unicorns are built by teams, not solo founders, and more than half of the founders hold advanced degrees.
  • Centaur Teams: Winning teams blend domain experts (clinicians, pharma, medtech) with tech-native outsiders (AI, software), creating “bilingual” cultures.
  • Mission-Driven: Medtech founders are deeply passionate about impact, often with personal stories fueling their drive.

Navigating European Medtech Hubs

CityStrengthsNotable Companies
LondonCapital, NHS, researchCMR SurgicalBenevolentAI
BarcelonaInvestment, clinical infrastructure, digital focusImpressAortyx
Zurich/BaselPharma proximity, deep tech, elite talentMindMazeSOPHiA GENETICS
BerlinDigital health, policy access, support networkAmbossDoctorly
WarsawAI talent, cost-effective, emerging VC sceneDocplannerJutro Medical

Medtech Europe clusters are thriving in Western and Northern Europe, with strong support in Switzerland, the Nordics, and key EU capitals.

Regulatory and Market Challenges for Medtech Unicorns

  • EU MDR/IVDR: New regulations have increased costs, extended approval times, and created higher complexity for startups. Small medtech companies are disproportionately affected, with some shifting focus to the U.S. market due to regulatory hurdles.
  • Fragmented Reimbursement: Each EU country has its own system; medtech founders must design trials and health-economic evidence for specific markets.
  • Data Privacy: GDPR and local laws require robust data protection and compliance from day one.
  • Long Sales Cycles: Hospitals and payers move slowly; founders must be prepared for up to 18-month sales processes.

Funding the Journey: Key Investors and Strategies

  • Venture Capital: Top European healthtech VC funds include V Health Investors, Calm/Storm, Index Ventures, Nina Capital, and Octopus Ventures. In 2024, digital health investments in Europe reached $3.5 billion, a 19% YoY increase.
  • Corporate VC: Pharma and medtech giants such as NovartisRoche, and Bayer provide capital, expertise, and access to distribution.
  • Public Funding: EU programs and national grants remain vital, with over €16 billion allocated to healthcare digitalization between 2014 and 2027.
  • Strategic Mix: Combining equity, grants, and partnerships is key for surviving long development cycles.

Actionable Steps: Your Medtech Unicorn Roadmap

  1. Identify a Painful, Funded Problem: Validate with clinicians, patients, and payers. Focus on “must-have” needs.
  2. Build a Bilingual Team: Combine domain (clinical, regulatory) and tech expertise.
  3. Leverage Your Ecosystem: Tap local accelerators, universities, and health systems for pilots and validation.
  4. Design for Regulation: Map out regulatory needs (e.g., CE mark, FDA) early; consult experts from the outset.
  5. Validate Clinically and Economically: Run pilots, publish results, and build a health economics model for each target market.
  6. Strategize Funding: Target VCs and public grants aligned with your market and stage; consider corporate partnerships.
  7. Plan Go-to-Market by Country: Tailor your approach for each market’s regulatory and reimbursement realities.
  8. Prepare for the Long Haul: Set milestones, cultivate resilience, and stay adaptable as regulations and markets evolve.

Conclusion: The Future of Medtech Unicorns in Europe

Building a medtech unicorn in Europe is challenging but increasingly achievable. Success demands a unique blend of technical and clinical excellence, regulatory savvy, and strategic ecosystem navigation. By focusing on real, validated problems, assembling a centaur team, leveraging Europe’s maturing hubs, and planning for regulatory and funding complexity, medtech founders can reach billion-dollar valuations and make a lasting impact on healthcare.

References

  1. SignalFire Health & Pharma Tech Unicorn Founders Analysis
  2. Vestbee: European Unicorns and Tech Hubs
  3. European Parliament: Digital Health Market in the EU
  4. Fortune Business Insights: Medical Devices Market

This text was enhanced with Generative AI models.

Categories
Digital Health MedTech

What Happened to 23andMe? The Rise, Fall, and Future of a Consumer Genetics Pioneer

Understanding the 23andMe Journey

23andMe was founded in 2006 by Anne Wojcicki, Linda Avey, and Paul Cusenza with a bold vision: to put the power of genetics directly into the hands of consumers. The startup pioneered the direct-to-consumer (DTC) genetic testing market, offering affordable at-home DNA test kits that could reveal ancestry roots, inherited traits, and potential health risks.

The company made headlines early on with its $999 saliva-based DNA test, which later dropped to $99—making it accessible to millions. For the first time, individuals could decode their DNA without going through a doctor or lab. This democratization of genetic data made 23andMe a household name and a Silicon Valley darling.

But with innovation came regulatory friction. In 2013, the U.S. Food and Drug Administration (FDA) halted the marketing of 23andMe’s health reports, citing concerns over accuracy and consumer safety. After years of negotiations, the company received FDA clearance in 2017 for specific health risk reports, such as predispositions to Parkinson’s and Alzheimer’s.

The Business Model Shift

23andMe wasn’t just selling DNA kits—it was building a data-driven biotech engine. Over time, it accumulated one of the largest genomic databases in the world. This treasure trove of anonymized genetic data became a valuable asset for pharmaceutical research.

Image: GSK’s 2018 partnership with 23andMe marked a major turning point for the company’s therapeutics ambitions.

In 2018, 23andMe announced a high-profile partnership with GlaxoSmithKline (GSK), aiming to develop new drugs using its consumer data. The move signaled a pivot from consumer health to therapeutics.

The company went public in 2021 via a SPAC merger, reaching a valuation of nearly $3.5 billion. It was a landmark moment, but also the peak of its trajectory.

Why Did 23andMe File for Bankruptcy?

In early 2025, 23andMe filed for Chapter 11 bankruptcy protection—a stunning development for one of health tech’s most iconic players.

The reasons behind the collapse are multifaceted:

  • Declining demand for consumer DNA tests as the novelty wore off
  • Privacy concerns and increased scrutiny over genetic data usage
  • Limited success from the GSK partnership, with no therapies reaching late-stage trials
  • Rising operational costs amid a tougher funding environment for biotech startups

The consumer genetics market matured and contracted. With fewer new customers and limited revenue from therapeutics, 23andMe faced an unsustainable business model.

The Chapter 11 filing offers a path to restructure. However, it remains unclear whether the company will recover, pivot again, or sell off its most valuable asset—its genomic database.

Who Is Anne Wojcicki?

Anne Wojcicki, born in 1973, is the co-founder and CEO of 23andMe. A biology graduate from Yale, Wojcicki began her career as a healthcare investment analyst before disrupting the world of genomics.

She envisioned a more transparent, consumer-centric healthcare model—one where individuals could access and understand their own genetic code. Her leadership helped push personalized medicine into the mainstream.

Wojcicki is a prominent advocate for digital health, women in STEM, and healthcare innovation. She was formerly married to Google co-founder Sergey Brin and is the sister of former YouTube CEO Susan Wojcicki.

Even as 23andMe faces restructuring, Anne Wojcicki remains a powerful voice in biotech, known for challenging traditional healthcare and betting on the future of data-driven medicine.


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