CroíValve Announces Funding from Horizon Europe EIC Accelerator
Innovating a better way to help more patients suffering from tricuspid regurgitation
Share
Part of the EU's Horizon Europe 2021-2027 Research and Innovation Programme, the EIC Accelerator Programme provides transformational funding to high-potential, high-risk start-ups, scale-ups and subject matter experts. This award includes grant funding of €2.5 million, combined with an equity investment of €10 million in CroiValve's next financing. The latest competition included 959 applications, with only 40 awards across 16 countries. Almost one third of the selected companies are led by a woman and CroiValve are incredibly proud to be one of this group.
'Securing European Innovation Council (EIC) funding is instrumental in expanding clinical validation of the DUO™ System, a novel minimally invasive, transcatheter device to treat severe+ tricuspid regurgitation. There is a significant unmet clinical need to treat the heterogeneous patient population who are not suitable for first generation transcatheter tricuspid devices. It is CroiValve's mission to innovate a better way to help more patients suffering with this disease and we are honoured to have EIC support for this journey,' said Lucy O'Keeffe, CEO of CroíValve.
More than 4 million people in Europe and the US suffer from tricuspid regurgitation, a severe heart condition that occurs when the tricuspid valve in the right side of the heart fails to close properly. This results in blood being pumped backwards into the heart causing debilitating symptoms. It affects over 4 million people in Europe and the U.S. and is associated with significant morbidity and reduced life expectancy.
The DUO TM System is a novel transcatheter heart valve that preserves the patient's native anatomy while treating tricuspid regurgitation. It works in tandem with the native tricuspid valve to restore valve function while leaving the patient's right heart and native valve apparatus untouched through an innovative anchoring mechanism. Designed to treat a broad patient population, the DUO TM System accommodates the heterogeneity of patient anatomies while avoiding contact with critical structures in the right heart which could lead to complications.
The DUO TM System is also designed to enable a straightforward procedure and reduce the procedural complexity seen with other devices. The procedure is less reliant on expert intraprocedural imaging, enabling a short learning curve with predictable and stable outcomes. The DUO™ System is currently under clinical investigation through the TANDEM II Study, a multicenter, prospective early feasibility study including centers in Poland and the US.
About CroíValve
CroíValve is a clinical stage medical device company focused on the development of a novel transcatheter device for the treatment of tricuspid regurgitation with Research, Development and Operations based in Ireland and Clinical, Regulatory and Marketing based in the United States.
Caution: The DUO TM System is an investigational device and not for sale in any geography.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
a day ago
- Yahoo
Intuitive Surgical, Inc. (ISRG): 'I Really Like' It, Says Jim Cramer
We recently published . Intuitive Surgical, Inc. (NASDAQ:ISRG) is one of the stocks Jim Cramer recently discussed. Intuitive Surgical, Inc. (NASDAQ:ISRG) is a market leader in the hot global medical robotics industry. Its shares have lost 5.5% year-to-date primarily due to weaker margin forecasts, the firm's warning that US trade tensions could lower global sales of its Da Vinci medical robots, and bearish analyst sentiments. Cramer's previous remarks about Intuitive Surgical, Inc. (NASDAQ:ISRG) have expressed optimism about the firm and its business prospects. He believes that the company has a global presence and continues to expand its product expertise by adding more procedures. This time, he continued to have faith in Intuitive Surgical, Inc. (NASDAQ:ISRG): 'ISRG I really like Intuitive.' Cramer discussed Intuitive Surgical, Inc. (NASDAQ:ISRG) in detail in April. Here's what he said: 'Eighth best performer of the Mad Money era is Intuitive Surgical, ISRG, the creator of the minimally invasive Da Vinci Robotic Surgical System. This is another name that we found early on. I first interviewed someone from the company back in July of 2005 when the stock was trading at a split-adjusted price of $5 and change. Copyright: nimon / 123RF Stock Photo Since then, we've watched this Intuitive Robotic Surgical system… spread across the globe, constantly improving along the way and adding more types of procedures that it could do. The company's now [a] $184 billion behemoth, and this stock has given you more than 10,000% gain since the show got started. I think this is as relevant as ever. Company just reported an excellent set of numbers last Tuesday. I'm proud to be a huge supporter of this.' While we acknowledge the potential of ISRG as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an extremely cheap AI stock that is also a major beneficiary of Trump tariffs and onshoring, see our free report on the . READ NEXT: 30 Stocks That Should Double in 3 Years and 11 Hidden AI Stocks to Buy Right Now. Disclosure: None. This article is originally published at Insider Monkey.
Hamilton Spectator
2 days ago
- Hamilton Spectator
PharmAla Issues Q3 Financial Statements
TORONTO, July 25, 2025 (GLOBE NEWSWIRE) — PharmAla Biotech Holdings Inc. ('PharmAla' or the 'Company') (CSE: MDMA) (OTC: MDXXF), a biotechnology company focused on the research, development, and manufacturing of LaNeo™ MDMA and novel derivatives of MDMA (MDXX class molecules), is pleased to have publicly filed its financial and operational results for the period ended May 31, 2025. All figures are reported in Canadian dollars. The Company's full set of unaudited condensed interim consolidated financial statements for the quarter and accompanying management's discussion and analysis can be accessed by visiting the Company's website at and its profile page on SEDAR+ at . 'The re-opening of PharmAla's domestic Canadian distribution has allowed us to execute as much volume in Q2 and Q3 as we did in all of the last fiscal year. The creation of our Prescriber's Portal has also allowed us to build a much closer relationship with our doctor customers, which we believe will serve us well moving forward,' said Nick Kadysh, CEO, PharmAla Biotech. 'As we move into the last quarter of Fiscal '24-25, we are incredibly pleased that a large shipment of LaNeo MDMA has arrived at our US distribution partner for delivery to a considerable group of clinical trial customers, most previously announced. PharmAla is also pleased to announce the completion of a manufacturing run in Australia for our 40mg LaNeo Capsules. These capsules were jointly manufactured for both Cortexa's use within Australia and PharmAla's use worldwide, and our improved manufacturing process should yield operational benefits well into the future.' Financial Highlights: 'Over the past quarter, our team has made exciting progress to ensure a reliable supply of pharmaceutical product for both researchers in clinical trials and patients in need of treatment,' said Will Avery, CFO, PharmAla Biotech. 'Our Prescriber Platform continues to empower physicians to access the MDMA and provide treatment for their patients and we look forward to additional clinical trial fulfillment to US and international customers in the near term, unburdened by cross-border trade issues.' About PharmAla PharmAla Biotech Holdings Inc. (CSE: MDMA) (OTCQB: MDXXF) is a biotechnology company focused on the research, development, and manufacturing of MDXX class molecules, including MDMA. PharmAla was founded with a dual focus: alleviating the global backlog of generic, clinical-grade MDMA to enable clinical trials as well as commercial sales in selected jurisdictions, and to develop novel drugs in the same class. PharmAla is the only company currently provisioning clinical-grade MDMA for patient treatments outside of clinical trials. PharmAla's research and development unit has completed proof-of-concept research into several IP families, including ALA-002, its lead drug candidate. PharmAla is a 'regulatory first' organization, formed under the principle that true success in the psychedelics industry will only be achieved through excellent relationships with regulators. For more information, please contact: Nicholas Kadysh Chief Executive Officer PharmAla Biotech Holdings Inc. Email: press@ Phone: 1-855-444-6362 Website: Neither the CSE nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release. Cautionary Note Regarding Forward-Looking Statements This press release contains 'forward-looking statements' within the meaning of applicable securities laws. All statements contained herein that are not clearly historical in nature may constitute forward-looking statements. Generally, such forward-looking information or forward-looking statements can be identified by the use of forward-looking terminology such as 'plans', 'strategy', 'expects' or 'does not expect', 'intends', 'continues', 'anticipates' or 'does not anticipate', or 'believes', or variations of such words and phrases or may contain statements that certain actions, events or results 'will be taken', 'will launch' or 'will be launching', 'will include', 'will allow', 'will be made' 'will continue', 'will occur' or 'will be achieved'. We direct readers to refer to the 'Caution Regarding Forward-Looking Statements' contained within the Company's management's discussion and analysis for the period ended May 31, 2025, as filed on Sedar+ . Readers are cautioned to not place undue reliance on forward-looking information. Actual results and developments may differ materially from those contemplated by these statements. Although the Company believes that the expectations reflected in these statements are reasonable, such statements are based on expectations, factors, and assumptions concerning future events which may prove to be inaccurate and are subject to numerous risks and uncertainties, certain of which are beyond the Company's control, including but not limited to the risk factors discussed in the Company's management's discussion and analysis, and elsewhere in this press release, as such factors may be further updated from time to time in our periodic filings, available at , which factors are incorporated herein by reference. Forward-looking statements contained in this press release are expressly qualified by this cautionary statement and reflect the Company's expectations as of the date hereof and are subject to change thereafter. The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, estimates or opinions, future events or results, or otherwise, or to explain any material difference between subsequent actual events and such forward-looking information, except as required by applicable law. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful. The securities being offered have not been, nor will they be, registered under the United States Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the United States Securities Act of 1933, as amended, and applicable state securities laws.
Hamilton Spectator
2 days ago
- Hamilton Spectator
Imperial Reports the Safe Return of Workers to Surface at Red Chris Mine
VANCOUVER, British Columbia, July 25, 2025 (GLOBE NEWSWIRE) — Imperial Metals Corporation ('Imperial' or the 'Company') (TSX:III) provides an update on the fall of ground incident that had isolated three workers underground at the 30% owned Red Chris mine in northwest British Columbia. Mine operator Newmont announced that at approximately 10:40 pm PST, Kevin Coumbs, Darien Maduke and Jesse Chubaty, three Hy-Tech Drilling workers at the Red Chris Mine, were safely brought to surface following a fall of ground incident. Newmont stated their relief to share that all three individuals are safe, and in good health and spirits. They had consistent access to food, water, and ventilation whilst they remained in place in a refuge chamber underground over the last two days. They are now being supported by medical and wellness teams. Their families have been notified. Imperial is grateful for the safe outcome of the incident and extends it thanks to Newmont and the rescue teams. Background on Rescue Effort from the mine operator At 8:30 pm PST on Thursday, July 24, following around-the-clock efforts, our specialized line-of-sight scoop successfully cleared the fallen debris from the access tunnel. With the area stabilized, the Emergency Response Team advanced across the impacted zone using equipment with an engineered Falling Object Protective System. Upon reaching the refuge chamber, the team found Kevin, Darien, and Jesse in stable condition. Together with the Emergency Response Team, they returned to surface using the same protected equipment. This outcome is the result of tireless collaboration, technical expertise, and above all, safety and care. We extend our heartfelt gratitude to the rescue teams and all those involved, and to Kevin, Darien, and Jesse as they recover from this experience. About Imperial Imperial is a Vancouver based exploration, mine development and operating company with holdings that include the Mount Polley mine (100%), the Huckleberry mine (100%), and the Red Chris mine (30%). Imperial also holds a portfolio of 23 exploration properties in British Columbia. Company Contacts Brian Kynoch | President | 604.669.8959 Darb S. Dhillon | Chief Financial Officer | 604.669.8959
