Innitius

While the days might be getting shorter, the LSI Alumni’s list of accomplishments keeps growing longer. This week the #LSIAlumni secured new funding, received FDA Breakthrough Device Designation, appointed new board members, and much more on the road to LSI USA ‘25. Your 60-second news recap: 4C Medical Technologies, Inc. — Saravana Kumar → Commenced enrollment in the A Transseptal Left Atrial System for Treatment of Mitral Regurgitation (ATLAS) trial in the United States and Europe. AccurKardia — Juan C Jimenez, Mohamed Sadeq Ali → Received FDA Breakthrough Device Designation for its ECG-based, AI-powered aortic valve stenosis screening software. CardiaCare — Amos Ziv → Enrolled the first patient in its NeuroPulse Post-Ablation clinical trial with Mount Sinai Health System. InspireMD — Shane Gleason → Announced IDE application approval from the FDA to initiate its CGUARDIANS II pivotal study. Innitius — Rubén Molina → Announced the latest results from its FB-CT1 clinical study assessing the usability and efficacy of its FineBirth device in predicting preterm labor risk. Lymphatica Medtech — Marco Pisano → Raised a €17.9M Series B funding round co-lead by LSI Alumni investor Panakes Partners, TechWald Next S.p.A, and CDP Venture Capital SGR's Digital Transition Fund. Reprieve Cardiovascular — Mark Pacyna → Completed enrollment in the Fluid Management of Acute Decompensated Health Failure Subjects Treated with Reprieve System (FASTR) trial. SymPhysis Medical — Tim Jones → Secured €2.2M in funding for developing its digital catheter-based device for treating fluid buildup in the body due to late-stage cancers. Vitestro — Toon Overbeeke → Appointed LSI Alumni Dave Hickey to its Board of Directors as an independent board member. Congratulations to all the LSI Alumni who made major milestones this week!

🤔 Curious what's been up in the world of femtech and women's health innovation this week? Here's the our run-down! 👇 🚀 Panasonic Well Launches $1 Million Family Wellness Challenge. https://lnkd.in/gJYKsRQU 💰 Maven Clinic raises $125M in Series F, becomes highest valued digital health company in women's and family health. https://lnkd.in/gcrQtMne 🔍 LEVY Health secures $4.5M seed funding to accelerate fertility diagnosis. https://lnkd.in/gNb_Apdu 👩👩👦 Rezilient Health raises $10M Series A to expand tech-enabled family healthcare model. https://lnkd.in/g8WMkveK 🔴 Canada-based Marlow secures $1.9M for novel lubricated tampon product. https://lnkd.in/e--zRp9P 🌱 FLORA (Flora Fertility) raises $1.5M to launch fertility insurance product. https://lnkd.in/g2Nehgvy 💰SimX secures $1.25M from AFWERX, DAF's innovation arm, for VR-based women's health training. https://lnkd.in/gRrui9NV 🚀 Sollis Health launches family membership for integrated emergency and everyday care. https://lnkd.in/gDz3u6hV 🔬 Consumer health startup Beli expands from supplements to at-home fertility testing for men and women. https://lnkd.in/gAXxECjE 🍼 Harbor introduces Remote Nanny Service for affordable overnight infant care. https://lnkd.in/gK9uMFsh 🤰 Innitius's Fine Birth Device shows promise in preterm labor diagnosis. https://lnkd.in/gDsCtHt5 🚀 RH Capital Team launches Foreground Capital; a new chapter in women's health investing. https://lnkd.in/gEixK9pn Want to learn more? We've collected the links to all stories (and more!) in the article below: 👇 https://lnkd.in/g2-spGbJ #femtech #womenshealth #womenshealthinnovation #health #healthcare #healthcareinnovation #femhealth #digitalhealth #healthtech #biotech #pharma #startup #scaleup #venturecapital #research #ecosystem

✨🚀 Exciting news! 🚀✨ We’re featured in Femtech Insider, where the results of our latest pilot study, Fine Birth Clinical Trial-1 (FB-CT1), are highlighted! 🎉 Our Fine Birth device, which uses torsional wave elastography to accurately measure cervical consistency, is a game-changer in diagnosing threatened preterm labor (TPTL). A huge thanks to our CEO, Rubén Molina, and the entire team for their dedication! Special shoutouts to our collaborators and partners—together, we are making strides in improving maternal health! 💪 Check out the full article here! #Femtech #MaternalHealth #PretermBirth #Innovation #Healthcare #WomenInScience #Innitius #StartupLife #MedicalTechnology

🚀 ¡Buenas noticias en el ámbito de la salud! Un reciente estudio publicado en Nature destaca la fiabilidad y precisión de las ondas de torsión para evaluar amenazas y predecir partos pretérmino. Esta innovadora tecnología ha sido desarrollada por Innitius una empresa beneficiaria del programa #MindtheGap de la #FundaciónBotín. 💔 El parto prematuro antes de la semana 32 es la principal causa de muerte infantil, y la amenaza de parto pretérmino representa la razón más común de hospitalización durante el embarazo. Actualmente, INNITIUS está en fase de estudio clínico para su aprobación regulatoria, con la participación de hospitales de referencia en España, como HUSC de Granada y el Hospital Clínic de Barcelona, y en el Reino Unido, como el Hospital King's College de Londres. ¡Estamos un paso más cerca de mejorar la atención prenatal! 💪✨ https://lnkd.in/d5fHHNuA

🚀 Advancing Women's Health: FineBirth's Impact 🚀 We are proud to announce the latest results from our FB-CT1 clinical study, showcasing the innovation behind Innitius' FineBirth device. Our mission is to redefine diagnostics for preterm labor, a major challenge affecting nearly 500,000 families annually across the EU. Our Torsional Wave Elastography (TWE) technology brings a new level of accuracy to cervical consistency measurement, offering clear, objective insights that traditional methods struggle to provide. With a specificity rate of 95.38%, our approach is proving to be a reliable solution for assessing preterm birth risk in symptomatic patients within 7-14 days. 🌐 As we look ahead to our international trial in 2025, we're excited about the opportunity to expand our impact and bring this groundbreaking technology closer to women and healthcare providers across Europe. 🌍 Learn more about our journey and access the full white paper here: https://lnkd.in/d22kU3WQ #WomensHealth #Innovation #PretermLabor #FineBirth #Innitius #HealthcareTech #ClinicalResults

 🌟 The Impact of Premature Birth on Infant Health 🌟 Premature birth presents unique challenges that can impact an infant's health and development. Swipe through to learn more about these challenges and how specialized care can make a difference. At Innitius, we are committed to developing technologies that support healthcare providers in managing preterm birth risks for better outcomes. #PrematureBirth #InfantHealth #PretermInfants #SIDS #NICUCare #BreastfeedingChallenges #NeonatalHealth #Innitius

🚨 The September Newsletter is Here! 🚨 This month, we’re spotlighting Innitius' growth in exposure and brand-building efforts! 🌍💡 From key presentations at international conferences to the exciting addition of Prof. Lee Shulman to our Clinical Events Committee and Data Safety Monitoring Board, it’s been a remarkable month of expansion and innovation. Check out the full newsletter for all the latest updates on how Innitius is pushing boundaries in women’s health! 🚀 #healthcareinnovation #medtech #womenshealth #innitius #globalimpact #brandbuilding #exposure

Innitius Very excited that we have the opportunity to present Fine Birth at COGI with an oral presentation and a poster!! Teamwork makes the dream work! Rubén Molina Alberto Maroto Ferrer, PhD Francisca Sonia Molina García Guillermo Rus Callborg

✨ Exciting News ✨ We’re excited to welcome Prof. Lee Shulman to Innitius’ Clinical Events Committee (CEC) & Data Safety Monitoring Board (DSMB) for our upcoming pivotal study, FB-CT2! 🎉 Prof. Shulman, a faculty member at Northwestern University and a renowned expert in reproductive genetics and women’s health, brings over 30 years of experience in clinical practice and research. His expertise will be key in driving our mission to develop cutting-edge medical solutions and improve patient outcomes. 🩺 We’re thrilled to have him on board! 💡

🔍 The Role of Race in Preterm Birth Rates One significant factor influencing preterm births is racial disparity. According to the March of Dimes Report (2020-2022), African American women face a notably higher risk of preterm labor compared to other racial groups in the U.S.: 📊 Preterm Birth Rates: African American: 14.6%  American Indian/Alaska Natives: 12.2%  Hispanics: 10.0%  Whites: 9.4%  Asian/Pacific Islander: 9.2% These disparities highlight the need for targeted healthcare solutions and better access to maternal care for at-risk communities. At Innitius, we are committed to developing technologies that can support early diagnosis and management, helping improve outcomes for all mothers. #MaternalHealth #PretermBirth #HealthDisparities #Innitius #HealthcareInnovation