Portfolio News

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

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.

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.”

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BEVERLY, Mass., Nov. 4, 2024 /PRNewswire/ — Award-winning medical technology innovator, Quanta Dialysis Technologies®, has confirmed the US Food and Drug Administration (FDA) has given 510(k) clearance for the use of its Quanta Dialysis System in the home setting. With this clearance, Quanta becomes the only company to offer a high dialysate flow (500 mL/min) system across the entire care continuum for end stage renal disease (ESRD) patients.

This significant step in Quanta’s US commercialization efforts follows another recent milestone in which the company received clearance for the first, and only, FDA-cleared device able to perform intermittent hemodialysis (IHD), sustained low efficiency dialysis (SLED), and CRRT (CVVHD and SCUF) without any need for bags.

Based on 2022 data from the United States Renal Data System, of the 550,000 prevalent ESRD patients in the country on dialysis therapy, just 2.4% receive home hemodialysis (HHD). The Quanta Dialysis System (previously known as the SC+ Hemodialysis System) addresses this gap by providing patients access to a high-flow system in the home, the same offering as routinely provided in hospitals, post-acute facilities and in-center clinics.

“The 510(k) clearance embodies the hard work and determination of our exceptional team at Quanta,” said Quanta Chief Executive Officer Alejandro Galindo. “We recruited and executed this pivotal trial during the height of COVID-19 and have now achieved an FDA clearance few other products have obtained. As the US continues to evolve towards value-based care models, the focus for patients with chronic diseases is on minimizing complications and re-admissions.

“Our product is designed to help those patients seamlessly transition to the home and remain there as long as possible. We are currently planning our home launch with customers who have successfully implemented Quanta into acute and sub-acute settings first.”

Decades-Long Troubles with HHD Adoption

Across the US more than 70% of dialysis facilities are currently not certified to offer HHD, and almost half of those with certification have no active HHD patients. Much of this is attributed to the lack of FDA-cleared technologies, alongside challenges associated with the cost-of-therapy and patient ‘burnout’, caused by dialyzing with low flow technologies requiring frequent treatments.

“Many patients prefer the flexibility of home hemodialysis – a flexible schedule, no commute, and with more frequent therapies they feel better and need less medication,” said Quanta Chief Medical Officer Dr. Paul Komenda, MHA, FRCPC, FASN. “Expanding treatment into the home is something we are constantly asked about by clinicians, advocacy groups, providers and patients. One of our major commitments as a business is to make kidney care more accessible, and with an easy-to-train, easy-to-maintain device that accommodates a high-flow HD prescription, Quanta is poised to become the best option for the home.”

Encouraging Clinical Trial Results

An FDA Investigational Device Exemption (IDE) trial of the Quanta Dialysis System was completed in October 2023, including a multi-center, open-label assessment of efficacy and safety. The trial saw 32 patients receive standard in-center hemodialysis while training to use the Quanta Dialysis System, before transitioning to perform HHD four times per week for eight weeks. The study demonstrated the device to be safe and effective, with more than 90% of patients electing to continue using the device after completing the trial.

Study results were presented at the American Society of Nephrology meeting in 2023 and the manuscript is now under review at the Clinical Journal of the American Society of Nephrology.

“Our IDE study has clearly demonstrated best in class dialysis adequacy and high patient satisfaction. Our device gives sufficient dialysis in 3x per week therapy and the option of better outcomes with higher frequency,” added Dr. Komenda.

BERLIN, GERMANY and NEW YORK, NY (October 29, 2024) – Aignostics, a global artificial intelligence (AI) company that turns complex multi-modal pathology data into transformative insights, announced today that it has raised $34 million in Series B financing. This additional funding will be used to build new product offerings for biopharmaceutical clients, fuel growth within the United States (US), and develop leading foundation models for pathology in collaboration with Mayo Clinic. The oversubscribed funding round was led by ATHOS, with investments from Mayo Clinic and growth financing from HTGF, alongside support from existing investors Wellington Partners, Boehringer Ingelheim Venture Fund, CARMA Fund, and VC Fonds Technologie managed by IBB Ventures. In total, Aignostics has now raised over $55 million, reflecting investors’ confidence in its differentiated AI models and clear commercial strategy.

As precision medicine becomes more nuanced and complex, biopharmaceutical companies are increasingly turning to AI to enhance the utility, performance, and scalability of computational pathology analyses for drug development and diagnostics. In parallel, machine learning technologies are rapidly evolving, producing AI models with record accuracy and robustness, opening new avenues for biopharmaceutical research and diagnostics.

“At its core, Aignostics is a world-class machine learning company,” said Julian Zachmann from ATHOS. “The field is advancing so quickly that, in order to succeed, AI companies need to avoid flashy distractions, stay laser focused on the highest-quality science, and relentlessly innovate. Aignostics is doing just that and bringing a level of transparency and rigor to its biopharmaceutical clients that we think is truly unique.”

“We know that digital pathology, paired with the vast capabilities of AI, has immense potential to impact diagnosis and treatment for patients. Mayo Clinic is actively charting the new frontier of predictive and personalized care,” shared Jim Rogers, CEO of Mayo Clinic Digital Pathology.

The new funding will strengthen Aignostics’ offerings for target ID, translational research, and companion diagnostics (CDx), and support several strategic initiatives, including:

• Launch of scaled “plug-and-play” products for a range of indications and tasks, including tumor microenvironment and biomarker profiling.
• Continued expansion into the US with additional headcount and support for US partners.
• Collaborative development of foundation models and biopharma product offerings with Mayo Clinic.

“2024 has been a pivotal year for us that has included a major strategic collaboration with Bayer and the launch of our first foundation model, RudolfV,” said Viktor Matyas, CEO and Co-Founder of Aignostics. “With RudolfV, we’ve gained the ability to quickly develop cost-efficient algorithms that generalize to the real-world. Now with this new round of funding, we’re turning our most popular algorithms into products that will help usher in an era of truly generalizable AI for computational pathology.”

Hennigsdorf/Berlin, Germany, October 9, 2024 – Diagnostic company SphingoTec GmbH (“SphingoTec”) today announced a new partnership with Beckman Coulter Diagnostics Inc. (“Beckman Coulter”). Through this collaboration, the companies will bring an assay for SphingoTec’s innovative kidney function biomarker, Proenkephalin 119-159 (penKid), to Beckman Coulter’s extensive test menu for use on the Access Family of Immunoassay Analyzers. This alliance marks the first central laboratory license for a penKid assay and aims to significantly enhance the diagnostic capabilities for acute kidney injury (AKI) globally, by leveraging Beckman Coulter’s global installed base of instruments.

PenKid is a real-time biomarker in plasma designed to address critical gaps in the standard diagnostic practices for AKI, particularly in critical care environments. Specifically, scientific evidence shows that, unlike current methods, a penKid assay offers early detection of kidney function decline, unaffected by inflammation, potentially enabling earlier intervention and improved patient outcomes (1,2,3). The incidence of AKI is increasing in both hospital and community settings; it is estimated that more than 13 million people are affected by AKI annually worldwide (4, 5).

Under the terms of the agreement, Beckman Coulter will develop and validate a fully automated diagnostic test for penKid, leveraging SphingoTec’s IVD certified assay. This assay has already been implemented as a routine test in the first university hospitals. This collaborative effort will facilitate high-throughput availability of penKid assays in central laboratories, supporting critical care physicians with the ability for timely and precise kidney health assessment.

“Acute kidney injury exerts a profound impact on patients globally, complicates acute and chronic illnesses frequently resulting in poor outcomes, and rivals many other critical diseases in its severity and consequences,” said Kevin O’Reilly, President, at Beckman Coulter Diagnostics. “The published evidence for penKid testing combined with SphingoTec’s scientific expertise provides an exciting opportunity to improve kidney health management. Working with SphingoTec, our goal is to expand access to and improve workflow from this important kidney health innovation underscoring our commitment to enhancing patient care worldwide.”

Deborah Bergmann, Managing Director and CEO of SphingoTec, emphasized, “The development of a penKid-based assay for use on Beckman Coulter’s globally installed immunoassay platforms represents a significant step toward realizing our vision of transforming diagnostic innovation into tangible patient benefits. This partnership accelerates our mission to deliver precise, actionable insights to clinicians worldwide, ultimately improving outcomes for patients suffering from acute kidney injury.”