Latest news with #EarlyFeasibility
Yahoo
13-05-2025
- Health
- Yahoo
GE HealthCare and Raydiant Oximetry accelerate innovation in fetal oxygen saturation technology
The companies plan to co-develop solutions that support the integration of Raydiant Oximetry's fetal pulse oximetry technology into GE HealthCare's fetal monitoring and digital perinatal surveillance platforms that have a 60-year history of innovation and industry firsts. Fetal pulse oximetry technology aims to provide real-time insights to clinicians during labor and delivery and improve the detection of fetal distress, potentially reducing newborn neurological injuries, emergency cesarean sections and improving healthcare costs. Expanding fetal monitoring to include oxygen saturation could support clinicians in improving the standard of care by providing a more comprehensive view of fetal well-being. CHICAGO & SAN RAMON, Calif., May 13, 2025--(BUSINESS WIRE)--GE HealthCare (Nasdaq: GEHC) and Raydiant Oximetry, Inc. today announced a joint development initiative to enhance fetal monitoring capabilities that could strengthen the support of clinical decision-making during labor. This effort leverages the combined expertise and technology of the two companies to advance fetal oxygen saturation monitoring technology with the goal of enhancing the detection of fetal distress during childbirth. Incorporating oxygen saturation into fetal monitoring can help improve measurements of fetal distress and enhance clinician confidence when making critical decisions during labor by providing a more comprehensive view of fetal well-being. Additionally, improving clinicians' evaluation of fetal status may help reduce emergency cesarean section rates, which have been steadily increasing worldwide over the last few decades beyond levels considered medically necessary.i "We are enthusiastic about the potential of our fetal pulse oximetry technology to improve the identification of fetal distress and the opportunity to improve outcomes for mothers and babies during childbirth," said Neil P. Ray, MD, Founder and CEO of Raydiant Oximetry. "GE HealthCare's deep knowledge of the fetal monitoring space will help us advance this technology that aims to transform the standard of care in fetal monitoring." Raydiant Oximetry has developed fetal pulse oximetry solutions to improve the detection of fetal distress during childbirth by measuring fetal blood oxygen saturation. In initial preclinical and clinical studies, Raydiant Oximetry has demonstrated that fetal pulse oximetry could improve the sensitivity and specificity for detecting fetal distress during labor and delivery, and potentially reduce newborn neurological injury rates, emergency cesarean section delivery rates and healthcare costs associated with Raydiant Oximetry has received United States Food and Drug Administration (FDA) Breakthrough Device Designation for expedited review by the FDA, and FDA approval for an Investigational Device Exemption (IDE) to conduct an Early Feasibility Study (EFS) of 30 pregnant women during labor and delivery. The initiation of the GE HealthCare and Raydiant Oximetry effort follows the completion of the EFS IDE clinical study. "Together with Raydiant Oximetry, we are proud to be at the forefront of this technology to help clinicians better manage the complexities of perinatal care," said Larry Boyd, general manager, maternal infant care, GE HealthCare. "We are excited about the potential of this technology to complement our current perinatal portfolio and help us enable care that can support every pivotal moment in labor and delivery, for every family and baby." Through this initiative, the companies plan to co-develop solutions that support the integration of Raydiant Oximetry's fetal pulse oximetry technology into GE HealthCare's fetal monitoring and digital perinatal surveillance platforms. The terms of the agreement have not been disclosed. About GE HealthCare Technologies Inc. GE HealthCare is a trusted partner and leading global healthcare solutions provider, innovating medical technology, pharmaceutical diagnostics, and integrated, cloud-first AI-enabled solutions, services and data analytics. We aim to make hospitals and health systems more efficient, clinicians more effective, therapies more precise, and patients healthier and happier. Serving patients and providers for more than 125 years, GE HealthCare is advancing personalized, connected and compassionate care, while simplifying the patient's journey across care pathways. Together, our Imaging, Advanced Visualization Solutions, Patient Care Solutions and Pharmaceutical Diagnostics businesses help improve patient care from screening and diagnosis to therapy and monitoring. We are a $19.7 billion business with approximately 53,000 colleagues working to create a world where healthcare has no limits. GE HealthCare is proud to be among 2025 Fortune World's Most Admired Companies™. Follow us on LinkedIn, X, Facebook, Instagram, and Insights for the latest news, or visit our website for more information. About Raydiant Oximetry, Inc. Raydiant Oximetry is a venture-backed, clinical-stage medical technology company dedicated to improving outcomes for mothers and babies during childbirth. The company was founded by Neil P. Ray, MD, a pediatric anesthesiologist, to address large unmet clinical needs in labor & delivery and improve outcomes for both mother and baby. Raydiant Oximetry has been supported by the Bill & Melinda Gates Foundation, March of Dimes, National Institutes of Health, National Science Foundation, and leading venture capital funds dedicated to improving women's health. iWorld Health Organization. Infographic: Unnecessary Caesarean Section. Accessed April 23, 2025. iiRaydiant Oximetry data on file. View source version on Contacts GE HealthCare Media Contact: Kimberly SchmohlM +1 929 289 Raydiant Oximetry Media Contact: Denise MalvehyM +1 650 822 Sign in to access your portfolio
Yahoo
14-04-2025
- Business
- Yahoo
CARMAT Receives FDA Conditional Approval to Initiate the Second Cohort of the EFS Study in the United States
Recruitment of the second cohort expected to begin in H2 2025 PARIS, April 14, 2025--(BUSINESS WIRE)--Regulatory News: CARMAT (FR0010907956, ALCAR), designer and developer of the world's most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from advanced biventricular heart failure (the "Company" or "CARMAT"), today announces that it has received conditional approval from the U.S. Food and Drug Administration (FDA) to initiate the second cohort of its Early Feasibility Study (EFS) with Aeson® artificial heart in the United States. Stéphane Piat, Chief Executive Officer of CARMAT, stated: "The authorization to initiate the second cohort of our Early Feasibility Study (EFS) in the United States, received from the FDA, marks a very important milestone in CARMAT's journey. It reflects Aeson® artificial heart's quality and performance and its potential to address the unmet need expressed by healthcare professionals and patients around the world. This authorization will allow U.S. patients to benefit from our therapy as early as the second half of 2025. It also represents a key step towards a potential commercial launch of Aeson® in the United States, which—subject to factors including the quality of our clinical results—could occur from 2028. I would like to thank all our team for their contribution to this key achievement." Conditional approval to initiate the second cohort of the EFS study in the United States The EFS study in the United States is a feasibility study involving a total of 10 patients eligible for heart transplant. The study's primary endpoint is patient survival at 6 months post-Aeson® implant, or a successful transplant within this timeframe. The study design includes two successive cohorts. The first cohort of 3 patients was completed in Q3 2021. Following the completion of this initial cohort, CARMAT implemented enhancements to Aeson®, which were submitted to the FDA. All of these changes have now been reviewed and approved by the FDA, allowing CARMAT to start recruiting patients in the second cohort1. This second cohort will include a total of 7 patients, with an interim report on the first 3 implants. Initiation of the second cohort expected in H2 2025 CARMAT will now take all necessary steps - including obtaining approvals from ethics committees2 and refreshing the training of participating hospitals - with the objective to initiate implants in the second half of 2025. Meanwhile, CARMAT will seek the FDA to approve Aeson®'s most recent version, currently used in Europe, in order to be able to use it in the EFS study. This second part of the EFS study represents an important step in the Company's US market access strategy, the United States being the largest market in the world in the field of implantable cardiac devices. About CARMAT CARMAT is a French MedTech that designs, manufactures and markets the Aeson® artificial heart. The Company's ambition is to make Aeson® the first alternative to a heart transplant, and thus provide a therapeutic solution to people suffering from end-stage biventricular heart failure, who are facing a well-known shortfall in available human grafts. The world's first physiological artificial heart that is highly hemocompatible, pulsatile and self-regulated, Aeson® could save, every year, the lives of thousands of patients waiting for a heart transplant. The device offers patients quality of life and mobility thanks to its ergonomic and portable external power supply system that is continuously connected to the implanted prosthesis. Aeson® is commercially available as a bridge to transplant in the European Union and other countries that recognize CE marking. Aeson® is also currently being assessed within the framework of an Early Feasibility Study (EFS) in the United States. Founded in 2008, CARMAT is based in the Paris region, with its head offices located in Vélizy-Villacoublay and its production site in Bois-d'Arcy. The Company can rely on the talent and expertise of a multidisciplinary team of circa 200 highly specialized people. CARMAT is listed on the Euronext Growth market in Paris (Ticker: ALCAR / ISIN code: FR0010907956). For more information, please go to and follow us on LinkedIn. Name: CARMATISIN code: FR0010907956Ticker: ALCAR Disclaimer This press release and the information contained herein do not constitute an offer to sell or subscribe, nor a solicitation of an order to buy or subscribe to CARMAT shares in any country. This press release may contain forward-looking statements by the Company regarding its objectives and prospects. These forward-looking statements are based on the current estimates and anticipations of the Company's management and are subject to risk factors and uncertainties, including those described in its universal registration document filed with the French Financial Markets Authority (Autorité des marchés financiers) (the "AMF") under number D.24-0374, as updated by the amendment to the 2023 universal registration document filed with the AMF on September 17, 2024 under number D.24-0374-A01 (together, the "2023 Universal Registration Document"), which are available free of charge on the websites of CARMAT ( and the AMF ( Readers' attention is particularly drawn to the fact that the Company's current cash runway is limited to the end of May 2025 (excluding the flexible equity financing line entered into with IRIS, which was announced on March 27, 2025). The Company is also subject to other risks and uncertainties, such as its ability to implement its strategy, the pace of development of its production and sales, the pace and results of ongoing or planned clinical trials, technological evolution and competitive environment, regulatory changes, industrial risks, and all risks associated with the Company's growth management. The Company's forward-looking statements mentioned in this press release may not be achieved due to these elements or other risk factors and uncertainties, whether unknown or not considered material and specific by the Company as of today. Aeson® is an active implantable medical device commercially available in the European Union and other countries recognising the CE mark. The Aeson® total artificial heart is intended to replace the ventricles of the native heart and is indicated as a bridge to transplant in patients with end-stage biventricular heart failure (Intermacs classes 1-4) who cannot benefit from maximal medical therapy or a left ventricular assist device (LVAD) and who are likely to benefit from a heart transplant within 180 days of implantation. The decision to implant and the surgical procedure must be carried out by healthcare professionals trained by the manufacturer. The documentation (clinician's manual, patient's manual and alarm booklet) must be read carefully to learn about the characteristics of Aeson® and the information required for patient selection and proper use (contraindications, precautions, side effects) of Aeson®. In the United States, Aeson® is currently only available as part of a feasibility clinical trial approved by the Food & Drug Administration (FDA). 1 In view of this, CARMAT is required, with no suspensive effect, to provide the FDA with a limited number of clarifications within 45 days.2 IRB – Institutional Review Board. View source version on Contacts CARMAT Stéphane Piat Chief Executive OfficerPascale d'Arbonneau Deputy Chief Executive Officer & Chief Financial OfficerTel.: +33 1 39 45 64 50contact@ NewCap Press RelationsNicolas Merigeau Arthur Rouillé Tel.: +33 1 44 71 94 98carmat@ NewCap Financial Communication& Investor RelationsDusan Oresansky Jérémy Digel Tel.: +33 1 44 71 94 92carmat@ Sign in to access your portfolio
Associated Press
16-03-2025
- Business
- Associated Press
Laplace Interventional Inc. Announces Series C Financing of $22M for its Transcatheter Tricuspid Valve Technology
The Series C financing was led by a global strategic investor along with participation from new investors Aphelion Cardeation and Unorthodox Ventures. Existing investors Engage Venture Partners, JWC Venture and Features Capital also participated in the round. Laplace Interventional plans to use the funds raised from this round towards completing their Early Feasibility Study (EFS) and work towards a pivotal study approval. MINNEAPOLIS, March 16, 2025 /PRNewswire/ -- Minnesota based Laplace Interventional, a medical device company developing a transcatheter tricuspid valve technology, announced today that it has completed its Series C financing led by a non-disclosed global strategic investor along with investments from Aphelion Capital, Engage Venture Partners, Unorthodox Ventures, JWC Venture and Features Capital. The company also announced the addition of Ned Scheetz, Founding Managing Partner at Aphelion Capital to its Board of Directors. Laplace Interventional's device aims to offer an improvement to the quality of life to patients worldwide diagnosed with Tricuspid Regurgitation (TR). Laplace Interventional is developing a prosthetic valve that is delivered through a minimally invasive procedure not requiring an open-heart surgery and thereby reducing future complications in patients. 'So far we have treated three patients in the Laplace EFS and all were discharged home within 1-2 days and are doing well. This was our first experience with a dedicated transcatheter tricuspid valve replacement platform and we are highly impressed with the intuitive deployment, imaging requirements, and overall ease of use of the Laplace system in a variety of challenging anatomies,' said Dr. Brandon Jones, Interventional Cardiologist and Medical Director of Structural Heart at Providence St. Vincent Medical Center, Portland, Oregon. Laplace has enrolled 22 patients in the United States largely as part of their US EFS Study (and 25 globally) with encouraging results. 'This round of financing marks a significant milestone for the company and further validates our progress over the past few years.' said Ramji Iyer, PhD, Founder and CEO of Laplace Interventional. 'We are grateful to our patients, physicians as well as new and existing investors for their continued support and look forward to working towards starting a pivotal trial.' Laplace Interventional plans to use the funds raised from this round towards completing their feasibility study (US EFS and OUS) and work towards a pivotal study. 'Aphelion Cardeation, a venture fund formed to invest in innovative health care products, services and technologies that align with the mission of the American Heart Association, is proud to participate in this round of financing,' said Ned Scheetz with Aphelion Capital. 'We are inspired by Laplace's innovative solution for TR and its potential to transform care for millions of patients worldwide.' Caution: Laplace Interventional's device is in its development phase and is NOT approved or cleared by the FDA or any other regulatory body in any region of the world.
Yahoo
16-03-2025
- Business
- Yahoo
Laplace Interventional Inc. Announces Series C Financing of $22M for its Transcatheter Tricuspid Valve Technology
The Series C financing was led by a global strategic investor along with participation from new investors Aphelion Cardeation and Unorthodox Ventures. Existing investors Engage Venture Partners, JWC Venture and Features Capital also participated in the round. Laplace Interventional plans to use the funds raised from this round towards completing their Early Feasibility Study (EFS) and work towards a pivotal study approval. MINNEAPOLIS, March 16, 2025 /PRNewswire/ -- Minnesota based Laplace Interventional, a medical device company developing a transcatheter tricuspid valve technology, announced today that it has completed its Series C financing led by a non-disclosed global strategic investor along with investments from Aphelion Capital, Engage Venture Partners, Unorthodox Ventures, JWC Venture and Features Capital. The company also announced the addition of Ned Scheetz, Founding Managing Partner at Aphelion Capital to its Board of Directors. Laplace Interventional's device aims to offer an improvement to the quality of life to patients worldwide diagnosed with Tricuspid Regurgitation (TR). Laplace Interventional is developing a prosthetic valve that is delivered through a minimally invasive procedure not requiring an open-heart surgery and thereby reducing future complications in patients. "So far we have treated three patients in the Laplace EFS and all were discharged home within 1-2 days and are doing well. This was our first experience with a dedicated transcatheter tricuspid valve replacement platform and we are highly impressed with the intuitive deployment, imaging requirements, and overall ease of use of the Laplace system in a variety of challenging anatomies," said Dr. Brandon Jones, Interventional Cardiologist and Medical Director of Structural Heart at Providence St. Vincent Medical Center, Portland, Oregon. Laplace has enrolled 22 patients in the United States largely as part of their US EFS Study (and 25 globally) with encouraging results. "This round of financing marks a significant milestone for the company and further validates our progress over the past few years." said Ramji Iyer, PhD, Founder and CEO of Laplace Interventional. "We are grateful to our patients, physicians as well as new and existing investors for their continued support and look forward to working towards starting a pivotal trial." Laplace Interventional plans to use the funds raised from this round towards completing their feasibility study (US EFS and OUS) and work towards a pivotal study. "Aphelion Cardeation, a venture fund formed to invest in innovative health care products, services and technologies that align with the mission of the American Heart Association, is proud to participate in this round of financing," said Ned Scheetz with Aphelion Capital. "We are inspired by Laplace's innovative solution for TR and its potential to transform care for millions of patients worldwide." Caution: Laplace Interventional's device is in its development phase and is NOT approved or cleared by the FDA or any other regulatory body in any region of the world. For more information:Laplace Interventionalinfo@ View original content to download multimedia: SOURCE Laplace Interventional, Inc. Sign in to access your portfolio
Daily Tribune
14-03-2025
- Health
- Daily Tribune
Man Survives 100 Days with Artificial Titanium Heart in Groundbreaking Medical Trial
A groundbreaking medical trial in Australia has seen a man survive for 100 days with an artificial titanium heart, marking a significant milestone in cardiac technology. The patient, a man in his 40s who has chosen to remain anonymous, received the BiVACOR Total Artificial Heart (TAH) in November at St. Vincent's Hospital Sydney. In February, he became the first person to be discharged from the hospital while relying on the device. Earlier this month, he successfully underwent a donor heart transplant and is now recovering well, according to a joint statement from St Vincent's Hospital, Monash University, and BiVACOR, the company behind the artificial heart. The BiVACOR TAH is designed to replace both ventricles of a failing heart. It features a single moving part—a magnetically levitated rotor—constructed from titanium, eliminating the need for mechanical bearings or valves that could wear out over time. Australian bioengineer Daniel Timms, who founded BiVACOR after losing his father to heart disease, called the achievement a major step forward in heart failure treatment. "This milestone represents decades of hard work, and we are deeply grateful to the patient and his family for trusting our technology," Timms said. Professor Chris Hayward of the Victor Chang Cardiac Research Institute, who has been overseeing the patient's recovery, said the success of the device could transform the future of heart transplants. "Within the next decade, artificial hearts may become a viable alternative for patients who are unable to receive donor hearts in time," Hayward stated. The BiVACOR device has been undergoing trials in the United States as part of the FDA's Early Feasibility Study. Five patients have been implanted with the device so far, including a 58-year-old man in Texas last year, who survived for eight days before receiving a donor heart. Researchers hope the study will expand to 15 patients. The Australian trial is part of Monash University's Artificial Heart Frontiers Program, a AU$50 million ($31 million) initiative aimed at advancing artificial heart technology. Cardiovascular disease remains the leading cause of death worldwide, with around 18 million fatalities annually, according to the World Health Organization. Experts believe that artificial hearts like the BiVACOR TAH could help address the shortage of donor hearts and improve survival rates for patients with end-stage heart failure. Medical researchers say further trials will be needed before the BiVACOR heart can be considered for widespread use, but this latest development marks a promising step forward in the field of cardiac care.
