UroMems Receives Clearance from the FDA and the French ANSM for Initiating Landmark Pivotal Clinical Study of UroActive® Smart Implant to Treat Male Stress Urinary Incontinence
DE approval in both countries follows strong feasibility clinical results in France
GRENOBLE, France and MINNEAPOLIS, July 17, 2025 /PRNewswire/ -- UroMems, a global company developing innovative, mechatronics technology to treat stress urinary incontinence (SUI), received investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) and French National Agency for the Safety of Medicines and Health Products (ANSM) clearance, enabling the company to begin a first-of-its-kind pivotal clinical trial of the UroActive smart implant to treat stress urinary incontinence (SUI) in men.
This prospective, multicenter trial, called the SOPHIA2 study, will evaluate the safety and efficacy of the UroActive System, the first smart automated artificial urinary sphincter (AUS) for the treatment of SUI. The FDA IDE approval and ANSM clearance follow strong feasibility study results for both women and men in France.
"This marks a key milestone that has been more than a decade in the making, and brings us a significant step closer to delivering the relief from symptoms and return to life that UroActive has the potential to provide patients suffering from SUI," says Hamid Lamraoui, UroMems chief executive officer and co-founder. "UroActive is the first and only smart automated AUS to reach this critical milestone, indicating a new era for millions of people suffering from SUI, while signaling an exciting transition for surgeons treating SUI across the U.S. and Europe."
UroActive is powered by a MyoElectroMechanical System (MEMS). This innovative system is placed around the urethral duct and is controlled based on the patient's activity, without the need for complex manipulation, intending to provide patients with ease of use and a better quality of life than current options.
Co-principal US investigators include Dr. Melissa Kaufman, FPMRS, professor and chief reconstructive surgery at Vanderbilt University in Nashville and Dr. Drew Peterson, FPMRS, professor at Duke University in Durham, NC. "We have seen first-hand the shortcomings of current SUI treatment options for our male and female patients," said Dr. Kaufman on behalf of both co-principal investigators. "That's why we're so excited to be leading the SOPHIA2 trial, as it's showing promise to provide significant improvements in addressing these issues. Based on the feasibility study data we've seen, UroActive has the potential to be a transformational technology."
"We've seen exceptionally strong results for both men and women in France as part of the feasibility clinical study, including over one year with no need for revision nor explant and extremely high praise from patients who had been suffering from SUI for years," said Professor Emmanuel Chartier-Kastler, Urology Chair, Sorbonne University and Pitié-Salpêtrière Hospital in Paris. "We look forward to conducting the pivotal SOPHIA2 study in France in lock step with the U.S. sites."
SUI, or involuntary urinary leakage, affects an estimated 40 million Americans and 90 million Europeans. SUI significantly impacts quality of life, as it can be debilitating, and often leads to depression, low self-esteem and social stigma.
SOPHIA2 study will serve as the basis for UroMems' regulatory submission to the FDA and supports its broader strategy to commercialize UroActive in the U.S. and European markets.
About UroActive
The UroMems technology platform is protected by more than 180 granted patents and is designed to overcome the limitations of current solutions by optimizing safety and performance, patient experience and surgeon convenience. UroActive is the first active implantable electronic artificial urinary sphincter (AUS) that is being developed to compensate for sphincter insufficiency in patients, both men and women, with SUI. It is based on a unique mechatronic platform using embedded smart, digital and robotic systems. UroActive has not received marketing authorization from the FDA and is not available for sale in the United States or in the EU. This project is financially supported by the European Innovation Council and France 2030.
For more information, please visit www.uromems.com.
Media Contact:
Shelli Lissick
651-276-6922
Wellington Partners Co-Leads €84 Million Series B Financing of Nuclidium to advance its Copper-based Radiopharmaceutical Platform
NUCLIDIUM Closes CHF 79 Million (EUR 84 Million) Series B Financing to Advance Clinical Development of its Copper-based Radiopharmaceutical Platform
- Proceeds will fund further clinical development of the company’s true theranostic pipeline and expansion of the global production and manufacturing network for copper-based radiopharmaceuticals.
- Initial clinical data presented at SNMMI 2025 by Dr. Gary Ulaner, MD, PhD show a solid safety profile and potentially improved performance of 61Cu-NuriPro in metastatic prostate cancer imaging.
- The financing round was led by Kurma Growth Opportunities Fund, Angelini Ventures, Wellington Partners, and Neva SGR (Intesa Sanpaolo Group), with participation from DeepTech & Climate Fonds (DTCF), Bayern Kapital, Eurazeo, Vives Partners, NRW.BANK and HighLight Capital, with existing investors.
- Alongside Tony Rosenberg, who recently joined as the Chairman of the Board of Directors, David Meek joins as an additional new Independent Director; Oliver Sartor, MD and Bela Denes, MD join as additional Scientific Advisors.
Basel, Switzerland / Munich, Germany, July 10, 2025 – NUCLIDIUM AG, a clinical-stage radiopharmaceutical company developing a proprietary copper-based theranostic platform, today announced the successful closing of its Series B financing round, raising CHF 79 million (EUR 84 million). The round was led by Kurma Growth Opportunities Fund, Angelini Ventures, Wellington Partners, and Neva SGR (Intesa Sanpaolo Group), with participation from DeepTech & Climate Fonds (DTCF), Bayern Kapital, Vives Partners, Eurazeo, NRW.BANK and HighLight Capital, as well as existing investors. The proceeds will be used to advance the clinical development of NUCLIDIUM’s Copper-61/Copper-67 (61Cu/67Cu) theranostic pipeline across multiple oncology indications. In parallel, the company will expand its production and manufacturing capabilities through a global production network.
NUCLIDIUM’s differentiated platform links tumor-targeting molecules with copper isotopes – Copper-61 for diagnostics and Copper-67 for therapeutics – to address current limitations in radiotheranostics, such as suboptimal clinical efficacy and complex manufacturing. Diagnostic results from initial clinical trials in these indications show superior lesion detection and higher tumor-to-background ratios compared with clinically approved tracers. Initial data were recently presented at SNMMI 2025 by Dr. Gary Ulaner, MD, PhD highlighting a favorable safety profile and potentially improved imaging performance of 61Cu-NuriPro™ compared to current PET imaging standards, suggesting strong clinical promise and broader potential for 61Cu/67Cu theranostic pairing. Early therapeutic data from the two lead compounds, NuriPro™ and TraceNET™, show strong tumor-to-background ratios in metastatic prostate cancer and neuroendocrine tumors including breast cancer.
“NUCLIDIUM is entering the next clinical phases with its lead compounds to diagnose and treat metastatic prostate, neuroendocrine tumors and breast cancer,” said Leila Jaafar, PhD, CEO and Co-Founder of NUCLIDIUM. “Our copper-based radiotheranostics are developed for seamless use in hospital workflows, care delivery and waste management, making these therapies more accessible worldwide. Our groundbreaking next generation copper theranostic platform also allows us to rapidly develop new targets across a wider range of cancers, particularly those highly relevant to women’s health.”
With this financing, NUCLIDIUM will continue expanding its worldwide production and manufacturing network for diagnostics and therapeutics, growing its international team, and strengthening strategic collaborations with hospitals and academic centers, initially across Europe and North America.
In conjunction with the financing round, Daniel Parera, MD, Partner at Kurma Partners, Regina Hodits, PhD, Managing Director at Angelini Ventures, and Liliana Nordbakk, Partner Life Sciences at Neva SGR, will join NUCLIDIUM’s Board of Directors.
“This significant Series B financing reflects the confidence of our investors in NUCLIDIUM’s vision and the transformative potential for the diagnostic and therapeutic industry in oncology and nuclear medicine,” said Tony Rosenberg, Chairman of the NUCLIDIUM Board. “With this backing, we are positioned to accelerate clinical development, broaden patient access globally, and reinforce our commitment to innovation in precision oncology. I am delighted to welcome our new Board and advisory members, whose deep expertise will further strengthen NUCLIDIUM’s leadership in radiopharmaceuticals.”
“NUCLIDIUM’s platform stands out in a rapidly evolving field and will change how radiotheranostic care is delivered. This investment reflects our strong conviction in the future of precision medicine and our belief in NUCLIDIUM’s potential to scale as a next-generation company — an ambition shared across a strong European syndicate,” added Daniel Parera, MD, Partner at Kurma Partners, Regina Hodits, PhD, Managing Director at Angelini Ventures, and Liliana Nordbakk, Partner Life Sciences at Neva SGR for all participating investors.
The Series B financing transaction was advised by VISCHER AG, and Walder Wyss, Switzerland as legal counsels.
About NUCLIDIUM
NUCLIDIUM AG is a clinical-stage biotechnology company pioneering the development of next-generation copper-based radiopharmaceuticals for the diagnosis and treatment of cancer. Leveraging copper isotopes – Copper-61 for diagnostics and Copper-67 for therapeutics – NUCLIDIUM is creating a differentiated platform with the potential to overcome existing limitations in radiotheranostics. The company's operations in Switzerland and Germany combine innovative chemistry, deep clinical expertise, and strategic manufacturing capabilities to deliver scalable, accessible, and clinically superior theranostic solutions to patients worldwide. NUCLIDIUM is committed to expanding the reach and efficacy of radiotheranostics, including addressing critical unmet medical needs in oncology and women’s health.
For more information, please contact:
NUCLIDIUM
Leila Jaafar, PhD, CEO
Email:
Investor/Media Contact NUCLIDIUM
Trophic Communications
Stephanie May
Email:
Phone: +49 171 1855682
CorFlow Therapeutics Announces FDA Approval of the MOCA-II IDE Pivotal Trial to Validate a Novel Heart Attack Care Technology
CorFlow Therapeutics Announces FDA Approval of the MOCA-II IDE Pivotal Trial to Validate a Novel Heart Attack Care Technology
BAAR, Switzerland--(BUSINESS WIRE)-- CorFlow Therapeutics AG (CorFlow), a pioneering company in the field of cardiac care targeting microvascular disease, today announced that the U.S. Food & Drug Administration (FDA) has approved the company’s technology for investigational device exemption (IDE), which allows the pivotal clinical trial to begin at U.S. hospitals. CorFlow will now prepare these clinical trial sites to receive CorFlow systems, undergo training and begin enrolling patients being treated for heart attacks.
The IDE Pivotal Trial, MOCA-II, is intended to prospectively validate the diagnostic accuracy of the proprietary CorFlow CoFl system in determining the presence or absence of microvsacular obstruction (MVO) during a primary PCI procedure. The primary endpoint compares the CoFI diagnostic reading to a reference standard of diagnosis by a cardiac MRI scan. The trial is approved to enroll over 200 STEMI patients at prestigious research institutions in both the United States and Europe.
Having successfully completed the first-in-human MOCA-I trial in 2024, the MOCA-II study is the next critical step to bringing this unique technology into the hands of interventional cardiologists globally for the rapid diagnosis of MVO in heart attack patients. This in turn can enable new treatments and care pathways to the large MVO patient population with high rates of adverse clinical outcomes today. The CorFlow technology is designed to both diagnose MVO, plus serve as a localized drug delivery system for diagnostic and therapeutic agents, which is being researched independently.
According to the US government Centers for Disease Control and Prevention, someone has a heart attack every 30 seconds in the USA, with about 800,000 cases reported annually in the country. Incidence and prevalence are similarly high in Europe. More than half of STEMI heart attack patients are shown to have MVO, and previous research has demonstrated that the presence of MVO is a major driver of adverse events. Currently, there are no technologies approved to diagnose MVO during an acute coronary intervention, and there are no approved therapeutic devices that specifically address MVO in the United States or Europe. Heart attacks and related heart disease remains a leading cause of death and disability worldwide.
Paul Mead, CEO of CorFlow, said “The long history of interventional cardiology and heart attack care breakthroughs - going back over 100 years – is one of the great success stories of medical care progress, but the pioneers and luminaries of the field all agree that the work is unfinished. The majority of acute STEMI survivors have MVO, and current outcomes for these patients are shockingly poor. We aim to bring this issue to light and show you can do something about it. This milestone brings us all one step closer to delivering on the promise to improving care for these people where we know we can do better.”
MOCA-II is being led by world-renowned experts in heart attack care, Dr. Timothy Henry at The Christ Hospital in Cincinnati, Ohio (United States) and Professor Marco Valgimigli at Cardiocentro Ticino Institute, Lugano (Switzerland), who collectively have been published in over 1000 peer-reviewed manuscripts in cardiovascular research.
Dr. Tim Henry said “As an interventional cardiologist involved for decades in managing and researching STEMI patients, I am excited to get going on this pivotal trial with technology that could make such a significant impact to the outcome of our patients. I believe strongly that knowing with high confidence who has MVO at the point of care during a primary PCI procedure can make an immediate difference in how we manage our patients”. Professor Valgimigli added “Having played a significant part in MOCA-I first in human trial, I am thrilled to see the second-generation technology now available for the pivotal trial and am looking forward to contributing further to the scientific understanding of MVO in real time. While the medical community has diverse opinions on how to treat these patients, there is no question that proper diagnosis is the first step we need. I am optimistic that getting the CorFlow technology approved for everyday use by our peer interventional cardiologists can help move the field forward.”
About CorFlow Therapeutics: Headquartered in Baar, Switzerland, with subsidiary operations in both Italy and the United States. The company is venture capital funded with an international VC firm syndicate, most recently with a Series B financing round announced in September 2024. CorFlow aspires to be the leader in diagnostic and therapeutic solutions for restoring healthy microvascular blood flow anywhere in the human body where a critical need exists. Working in close partnership with scientists from the University of Bern, ETH Zurich and the University Hospital Zurich, in a collaboration funded by the Swiss Innovation Agency (Innosuisse), CorFlow continues to explore applications for the unique patented technology.
Media and Scientific Contact
CorFlow Therapeutics AG
Aktiia secures $42 million in Series B funding round and rebrands to Hilo
Aktiia secures $42 million in Series B funding round and rebrands to Hilo
With fresh funding round, the health tech pioneer continues to work toward managing the world’s blood pressure.
LONDON, May 1, 2025 – Aktiia, a blood pressure intelligence platform, announces an oversubscribed $42 million (over CHF 34 million) Series B funding round, co-led by Earlybird Health and Wellington Partners, with new investors Kfund and naturalX Health Ventures, and participation from existing investors redalpine, Khosla Ventures, Molten Ventures, Translink Capital and Verve Ventures. The investment, which has brought the total financing to date above $100 million, will accelerate the company’s mission to manage the world’s blood pressure.
The latest investment builds on a period of significant momentum for the company during which it has achieved several major milestones, including securing CE marking for its innovative mobile phone camera blood pressure monitoring technology, securing regulatory approvals in Canada, Australia and Saudi Arabia, achieving 76% compounded annual revenue growth, and completing a pivotal clinical trial ahead of its U.S. FDA application submission. This Series B funding will fuel continued product innovation, expansion into new markets and the build out of its blood pressure intelligence platform to support enterprise use cases.
Alongside this funding, Aktiia is introducing its new brand identity: Hilo – a rebrand which reflects the company’s global ambition to make cuffless, clinically validated blood pressure monitoring universally accessible and effortless. The transition to Hilo marks an important milestone in the company’s journey, aligning with its vision of healthier blood pressure for all, while continuing to deliver the trusted technology and reports that have been central to its platform.
With more than 120,000 devices sold, Hilo has already established itself as a stand-out in the health tech space. The company has developed a foundation Machine Learning model specifically designed for blood pressure. The model has been trained on tens of billions of optical signals from real-world users and further refined with hundreds of millions of calibration points, strengthening its position as the leader in the emerging cuffless blood pressure monitoring (CBPM) category.
Raghav “Rags” Gupta, CEO of Hilo, commented:
“This funding round is a testament to the confidence our investors have in Hilo’s groundbreaking technology and our mission to manage the world’s blood pressure via more frequent, convenient and accurate measurements. With billions worldwide suffering from hypertension, only 20% of whom are in control of their blood pressure, the need for innovative, accessible blood pressure monitoring solutions has never been greater. Our rebrand to Hilo represents more than just a name change, it’s a commitment to empowering users around the world with smarter tools to optimise their health. We are grateful to early Aktiia customers for their support and to our investors, new and existing, for their faith.”
Christoph Massner, Principal at Earlybird Health, who will join Hilo’s Board of Directors, commented:
“ Hilo stands at the intersection of medical-grade precision and consumer-centric accessibility. By building on a validated medical device platform and an intuitive, user-friendly design, they bridge the gap between clinical reliability and everyday usability. It’s a rare combination that empowers users to take meaningful control of their health with minimal effort. This is especially critical given the enormous medical need: uncontrolled high blood pressure remains one of the leading risk factors for death worldwide .”
Johannes Fischer, Managing Partner at Wellington Partners, commented:
“We are excited to co-lead this financing and to be backing Hilo’s innovative technology, which provides groundbreaking advancements to the billions of people with elevated bloodpressure today. We believe that real-time and continuous access to blood pressure information will change the way we think about the monitoring and management of one of the most common risk factors to human health.”
ENDS
About Hilo
Aktiia, now trading under Hilo, was established in 2018 to transform how blood pressure is measured and therefore managed. By integrating advanced AI algorithms with extensive datasets, Hilo’s cuffless blood pressure monitoring (CBPM) products offer convenient, valuable reports to give both individuals and healthcare professionals a useful picture of their blood pressure. The company’s foundation model for blood pressure has been trained on billions of optical signals and hundreds of millions of readings across more than 120,000 users, underscoring its leadership in the CPBM category. The company’s multidisciplinary team, composed of experts with extensive experience in biomedical signal processing, has contributed to over 120 peer-reviewed publications and holds more than 35 patents. Headquartered in Switzerland, Hilo continues to expand its global presence, transforming how blood pressure is understood and managed.
The Hilo system by itself is not intended to make diagnoses. Data should always be used in consultation with your healthcare provider.
Website: www.hilo.com
For more information on Hilo, please contact or call 07585 294566
HepaRegeniX completes €21.5 million financing to support clinical advancement of HRX-215 for liver regeneration
HepaRegeniX completes €21.5 million financing to support clinical advancement of HRX-215 for liver regeneration
Tuebingen, Germany, April 15, 2025 – HepaRegeniX GmbH (“HepaRegeniX”), a clinical-stage company advancing novel therapies to treat acute and chronic liver diseases, today announced the second closing and completion of a €21.5 million financing round with the addition of Wellington Partners to its investor syndicate. HepaRegeniX plans to use the proceeds to complete its ongoing Phase Ib trial and to advance the Phase IIa clinical trial for HRX-215, the company’s lead clinical candidate in liver regeneration.
“We continue to make significant progress in the clinical evaluation of our lead candidate, HRX 215, and the additional investment is a strong acknowledgment of our achievements and the impressive safety results of HRX-215 in the completed Phase I trials,” said Elias Papatheodorou, Chief Executive Officer at HepaRegeniX. “HepaRegeniX has brought to light the significant therapeutic potential of Mitogen-Activated Protein (MAP) Kinase Kinase 4 (MKK4) in multiple indications of high medical need, and we remain committed to making a real difference in the lives of patients that need liver resections due to tumors, for patients in need of a liver transplant, and for patients with chronic and acute liver diseases. As we gain momentum in our clinical development strategy, we appreciate the continued support of our existing investors and the support of Wellington Partners at this important stage in our journey.”
“Wellington Partners is very excited to join and further strengthen the HepaRegeniX investor base in this financing round,” commented Dr. Rainer Strohmenger, Managing Partner at the Munich based life science venture capital fund. “HepaRegeniX’ approach is highly differentiated and has demonstrated efficacy in several in vivo models for liver diseases with extraordinarily high unmet medical need. We look forward to supporting the generation of meaningful clinical efficacy data in human patients in the near future.”
HRX-215 is a first-in-class, orally available small molecule inhibitor designed to target Mitogen Activated Protein (MAP) Kinase Kinase 4 (MKK4), a master regulator of liver regeneration. By selectively inhibiting MKK4, HRX-215 enhances the liver’s natural ability to regenerate. Extensive preclinical studies in mice and pigs have demonstrated that HRX-215 enhances liver regeneration of healthy and diseased livers. Impressively, HRX-215 helps prevent liver failure after extended liver resection. A Phase I clinical trial in healthy participants has further validated its favorable safety and pharmacokinetic profile. HRX-215 represents a new therapeutic approach for indications requiring rapid liver repair, offering a new possibility beyond conventional treatments.
About HepaRegeniX GmbH
HepaRegeniX is advancing therapies to treat acute and chronic liver diseases based on the groundbreaking discoveries of a novel cellular target and small molecules that enable the liver to regenerate rapidly. They do so by harnessing the liver’s inherent regenerative power not only in healthy but also in diseased livers. The company’s lead candidate, HRX-215, an orally available small molecule currently in a Phase Ib/IIa trial, selectively inhibits Mitogen-Activated Protein (MAP) Kinase Kinase 4 (MKK4), a master regulator of liver regeneration. Building on demonstrated safety in clinical trials, HepaRegeniX is progressing HRX-215 to prevent post-hepatectomy liver failure, facilitate transplantation of smaller living donor liver grafts, and treat severe alcohol associated hepatitis. Beyond liver diseases, the company is also developing HRX-233 to target kinase inhibitor treatment resistance in KRAS-driven tumors.
HepaRegeniX is backed by experienced life science investors, including Vesalius Biocapital IV, Novo Holdings A/S, Boehringer Ingelheim Venture Fund (BIVF), Coparion, High-Tech Gründerfonds, Ascenion GmbH and Wellington Partners.
Visit our website at www.heparegenix.com to learn more about the company.
For further information, please contact:
HepaRegeniX GmbH
Elias Papatheodorou
Chief Executive Officer
Media Inquiries
Trophic Communications
Charlotte Spitz or Jacob Verghese
Tel: +49 171 351 2733
Email:
AMBOSS closes €240M financing round and expands its position as the leading co-pilot for physicians worldwide
AMBOSS closes €240M financing round and expands its position as the leading co-pilot for physicians worldwide
Berlin / New York – March 25, 2025 – AMBOSS, the leading resource for medical education and clinical decision-making in Germany and the US, closes a €240M fi nancing round with new long-term investors, supporting the exploration of additional international markets and the expansion of its offering to nurses and other health care professionals.
New Long-term Investors for the Next Decade of Continuous Growth
AMBOSS recently converted to a European stock corporation (SE) and completed a financing round with new primary investors KIRKBI, M&G Investments and Lightrock with participation from existing shareholders.
“We choose investors who are committed to our long-term vision and very flexible in the investment duration. Many of our new investors manage evergreen funds and plan to accompany us until a possible IPO and beyond,” commented Benedikt Hochkirchen, Co-Founder and Co-CEO of AMBOSS. “Additional funds will go into further investment in technology and new market segments. Selective acquisitions will also continue to be part of our strategy.” In 2024, AMBOSS acquired Novaheal, a start-up in the nursing field, and NEJM Knowledge+, a board exam prep product for residents in the US. The recent financing round significantly improves access to capital for AMBOSS.
Empowering the Next Generation of Health Care Professionals
AMBOSS leads the digital empowerment of physicians by keeping them at the center of the product so that they are tech-enabled to provide the best possible care. Doctors worldwide rely on AMBOSS to continuously combine the latest, trusted medical content with cutting-edge technology. “Technology will not replace health care professionals, but those who embrace it will lead the way,” said Dr. Madjid Salimi, Co-Founder and Co-CEO of AMBOSS.
Over 1 million users in more than 180 countries trust AMBOSS for clinical decision-making and medical education. Every second inpatient treatment in Germany is carried out by a physician supported by AMBOSS. In the US, the majority of medical students use AMBOSS to successfully prepare for exams, and score higher than with other question banks. 25% of first-year US residents depend on AMBOSS to help them provide excellent patient care. The concept is as simple as it is successful: Medical experts distill relevant medical knowledge, and AI-supported technology places it directly at users’ fingertips.
Trusted Partner for Medical Knowledge, With Over Half a Decade of AI Expertise
Key to this success is strong in-house collaboration between experienced medical experts and technology specialists. Providing precise and actionable recommendations on diagnostics and treatment based on the latest guidelines, AMBOSS is a digital co-pilot for everyday clinical practice, helping to save time and avoid treatment errors. Responsible use of AI technologies has long played a role in the AMBOSS experience that so many educators and clinicians have valued and trusted for years. AMBOSS will continue to lead the way through rigorous validation of outcomes and a value-first approach.
Peter Bason, Head of Private Capital at KIRKBI, says, “We have followed AMBOSS’ impressive growth journey, from its successful US expansion to its strong focus oninnovation. Its unique platform is becoming a vital tool for both medical students and health care professionals, supporting learning and decision-making at every stage. We are excited to partner with other experienced technology and growth investors to back AMBOSS’ visionary leadership team in their mission of empowering the next generation of health care professionals worldwide.”
About AMBOSS
Founded in 2012 by a team of physicians, AMBOSS is a global medical knowledge platform that has fundamentally changed the way medical know-how is acquired and utilized at the point of care. With an emphasis on precise, high-quality content, innovative AI-empowered technology, and a user-centered approach, the company has grown its international team to over 500 employees from more than 50 countries, including scientists, software engineers, and 150+ physicians. AMBOSS has more than 1 million professional users across 180 countries. For more information, visit www.amboss.com.
Aignostics Announces Results for Pathology Foundation Model Developed in Collaboration with Mayo Clinic
Aignostics Announces Results for Pathology Foundation Model Developed in Collaboration with Mayo Clinic
Model was generated in only two months and sets new industry standard for performance
BERLIN, GERMANY and NEW YORK, NY (January 14, 2025) –Today, Aignostics announced research results for a new pathology foundation model developed in collaboration with Mayo Clinic Digital Pathology. The model, built in two months using over one million diverse slide images from Mayo Clinic and Charité – Universitätsmedizin Berlin, establishes a new state-of-the-art for performance across more than twenty public benchmarks. In addition, the model is computationally efficient, enhancing its usability relative to existing image-based models. High performance and efficiency were enabled by Aignostics’ pathologist-curated development approach, which emphasizes the integration of expert medical knowledge throughout the model development process.
“These results represent an exciting achievement in our collaboration with Mayo Clinic,” said Maximilian Alber, CTO of Aignostics. “Aignostics and Mayo Clinic have direct access to millions of additional training images and new data modalities that will be integrated into the model over time, further enhancing its capabilities and accuracy.”
Healthcare and life sciences organizations will be able to use the new model for research and clinical development. Aignostics will also integrate the model into its expanding portfolio of AI-powered pathology products, enabling accurate, generalizable solutions for biomarker, cell, and tissue image analysis. This dual approach – direct licensing of foundational technology and offering purpose-built applications – will allow partner organizations to leverage the model’s capabilities in ways that best suit their specific needs.
“Mayo Clinic Digital Pathology will work together with Aignostics to transform pathology for the benefit of patients everywhere,” said Jim Rogers, President and CEO, Mayo Clinic Digital Pathology. “These results show there is real potential in combining Mayo Clinic’s vast medical expertise and resources with Aignostics’ pioneering technologies,” added Viktor Matyas, CEO of Aignostics. “They underline our ambition and readiness to jointly lead in this space.”
About Aignostics
Aignostics is an artificial intelligence company that turns complex pathology data into transformative insights. By combining proprietary access to multimodal clinical data, industry-leading technologies, and rigorous science, Aignostics develops best-in-class products and services for the next generation of precision medicine. Through collaborations with its biopharma partners, Aignostics supports drug discovery, translational research, clinical trials, and CDx development. Established in 2018, Aignostics is a spin-off from Charité Berlin, one of the world’s largest and most esteemed university hospitals. Aignostics is funded by leading investors and has operations in Berlin and New York.
Find more information at: www.aignostics.com
Follow us on LinkedIn: www.linkedin.com/company/aignostics
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Contact
Lisa Zheng
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Carisma Therapeutics Presents Promising New Preclinical Data on Engineered Macrophages for the Treatment of Liver Fibrosis at AASLD The Liver Meeting® 2024
Carisma Therapeutics Presents Promising New Preclinical Data on Engineered Macrophages for the Treatment of Liver Fibrosis at AASLD The Liver Meeting® 2024
New preclinical results support the anti-fibrotic potential of engineered macrophages in multiple fibrosis models
Engineered TIM4-expressing macrophages correct defective efferocytosis in MASH, demonstrating potent anti-fibrotic activity
PHILADELPHIA, Nov. 17, 2024 /PRNewswire/ — Carisma Therapeutics Inc. (Nasdaq: CARM) (“Carisma” or the “Company”), a clinical-stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, today presented promising preclinical data on engineered macrophages for treating liver fibrosis at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® 2024. These results underscore the pre-clinical efficacy of Carisma’s engineered macrophages in multiple liver fibrosis models and offer a novel, off-the-shelf potential treatment option for patients with fibrotic liver disease including advanced metabolic dysfunction-associated steatohepatitis (MASH).
Liver fibrosis is a central late-stage pathway in multiple liver diseases, including MASH, acute liver injury, primary sclerosing cholangitis, primary biliary cholangitis, and others. Treatment options remain limited for advanced liver disease patients. Liver disease is characterized by defective efferocytosis (an anti-inflammatory process by which macrophages clear dead hepatocytes), activation of hepatic stellate cells which leads to collagen accumulation, and chronic inflammation.
New preclinical results demonstrate that macrophages can be genetically engineered to target specific key pathways underlying liver disease with factors including TIM4 (restores efferocytosis), relaxin (inhibits hepatic stellate cell activation), and IL10 (reduces inflammation). Notably, a single dose of macrophages expressing TIM4, alone or together with relaxin, significantly reduced liver fibrosis and hepatic stellate cell activation in the translationally relevant choline-deficient, L-amino acid-defined, high-fat diet (CDAHFD) MASH model. The engineered macrophages were well tolerated and outperformed non-engineered cells in all models.
“We are pleased to present compelling preclinical data supporting the therapeutic potential of our engineered macrophages to address a critical unmet need in liver fibrosis, which is found in advanced stages of MASH,” said Michael Klichinsky, PharmD, PhD, Co-founder and Chief Scientific Officer of Carisma. “These data underscore the efficacy of our engineered macrophages as a differentiated, off-the-shelf approach for treating advanced liver fibrosis. Based on these promising findings, we are committed to advancing our liver fibrosis program.”
Carisma expects to nominate a development candidate for its liver fibrosis program in the first quarter of 2025.
The poster presented at AASLD 2024 is now available online in the “Publications” section of Carisma’s website at https://carismatx.com/technology/publications/
About Carisma Therapeutics
Carisma Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on utilizing our proprietary macrophage and monocyte cell engineering platform to develop transformative immunotherapies to treat cancer and other serious diseases. We have created a comprehensive, differentiated proprietary cell therapy platform focused on engineered macrophages and monocytes, cells that play a crucial role in both the innate and adaptive immune response. Carisma is headquartered in Philadelphia, PA. For more information, please visit www.carismatx.com.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, anticipated discovery, preclinical and clinical development activities for Carisma’s product candidates, the potential safety, efficacy, benefits and addressable market for Carisma’s product candidates, and clinical trial results for Carisma’s product candidates. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The words “believes,” “anticipates,” “estimates,” “plans,” “expects,” “intends,” “may,” “could,” “should,” “potential,” “likely,” “projects,” “continue,” “will,” “schedule,” and “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are predictions based on the Company’s current expectations and projections about future events and various assumptions. Although Carisma believes that the expectations reflected in such forward-looking statements are reasonable, Carisma cannot guarantee future events, results, actions, levels of activity, performance or achievements, and the timing and results of biotechnology development and potential regulatory approval is inherently uncertain. Forward-looking statements are subject to risks and uncertainties that may cause Carisma’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to Carisma’s ability to advance its product candidates, the receipt and timing of potential regulatory designations, approvals and commercialization of product candidates, clinical trial sites and our ability to enroll eligible patients, supply chain and manufacturing facilities, Carisma’s ability to maintain and recognize the benefits of certain designations received by product candidates, the timing and results of preclinical and clinical trials, Carisma’s ability to fund development activities and achieve development goals, Carisma’s ability to protect intellectual property, and other risks and uncertainties described under the heading “Risk Factors” in Carisma’s Annual Report on Form 10-K for the year ended December 31, 2023, its Quarterly Reports on Form 10-Q and other documents that Carisma files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and Carisma undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof, except as may be required by law.
Carisma Unveils Promising Pre-Clinical Data on Anti-GPC3 In Vivo CAR-M Therapy for Hepatocellular Carcinoma
Carisma Unveils Promising Pre-Clinical Data on Anti-GPC3 In Vivo CAR-M Therapy for Hepatocellular Carcinoma
New findings showcase the potential of in vivo CAR-M technology as an effective, off-the-shelf treatment for hepatocellular carcinoma (HCC)
“The data demonstrate our ability to generate anti-GPC3 CAR-M cells directly in vivo using mRNA/LNP technology, leading to significant tumor reduction in translationally relevant pre-clinical models,” said Michael Klichinsky, PharmD, PhD, Co-Founder and Chief Scientific Officer at Carisma. “This novel off-the-shelf approach offers a promising new strategy for treating hepatocellular carcinoma, and we are eager to advance it toward clinical development.”
“These preclinical data highlights the successful application of our mRNA/LNP platform in enabling in vivo cell therapy,” said Lin Guey, PhD, CSO of Therapeutic Research Ventures, Moderna. “We look forward to further advancing the anti-GPC3 in vivo CAR-M therapy for HCC patients and continuing our collaboration with Carisma to bring innovative treatments to those patients with solid tumors.”
About Carisma Therapeutics
Carisma Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on utilizing our proprietary macrophage and monocyte cell engineering platform to develop transformative immunotherapies to treat cancer and other serious diseases. We have created a comprehensive, differentiated proprietary cell therapy platform focused on engineered macrophages and monocytes, cells that play a crucial role in both the innate and adaptive immune response. Carisma is headquartered in Philadelphia, PA. For more information, please visit www.carismatx.com.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, anticipated discovery, preclinical and clinical development activities for Carisma’s product candidates, the potential safety, efficacy, benefits and addressable market for Carisma’s product candidates, and clinical trial results for Carisma’s product candidates. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The words “believes,” “anticipates,” “estimates,” “plans,” “expects,” “intends,” “may,” “could,” “should,” “potential,” “likely,” “projects,” “continue,” “will,” “schedule,” and “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are predictions based on the Company’s current expectations and projections about future events and various assumptions. Although Carisma believes that the expectations reflected in such forward-looking statements are reasonable, Carisma cannot guarantee future events, results, actions, levels of activity, performance or achievements, and the timing and results of biotechnology development and potential regulatory approval is inherently uncertain. Forward-looking statements are subject to risks and uncertainties that may cause Carisma’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to Carisma’s ability to advance its product candidates, the receipt and timing of potential regulatory designations, approvals and commercialization of product candidates, clinical trial sites and our ability to enroll eligible patients, supply chain and manufacturing facilities, Carisma’s ability to maintain and recognize the benefits of certain designations received by product candidates, the timing and results of preclinical and clinical trials, Carisma’s ability to fund development activities and achieve development goals, Carisma’s ability to protect intellectual property, and other risks and uncertainties described under the heading “Risk Factors” in Carisma’s Annual Report on Form 10-K for the year ended December 31, 2023, its Quarterly Reports on Form 10-Q and other documents that Carisma files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and Carisma undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof, except as may be required by law.
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