Edwards Lifesciences Corp. set analysts a-spin ahead of its investor day activities with the revelation it plans to launch its critical care unit as a stand-alone public company next year. Edwards expects that dividing the business will allow it to focus on cardiovascular and surgical markets.
Omini SA hopes that the multiplexed blood testing platform it is developing will transform the lives of patients suffering from heart failure. With its multiplex, sensor-based testing strip that simultaneously measures four key biomarkers from a single drop of blood, the company’s technology should increase the chance of a patient’s survival and reduce pressure on health care systems, Joanne Kanaan, CEO and co-founder of Omini, told BioWorld.
Regenerative medicine company Mesoblast Ltd. plans to raise AU$97 million (US$64.5 million) to conduct additional phase III registration trials for its allogeneic stem cell treatment for steroid-refractory acute graft-vs.-host disease and for chronic back pain, as required by the U.S. FDA.
Regenerative medicine company Mesoblast Ltd. plans to raise AU$97 million (US$64.5 million) to conduct additional phase III registration trials for its allogeneic stem cell treatment for steroid-refractory acute graft-vs.-host disease and for chronic back pain, as required by the U.S. FDA.
“The FDA approval to begin the Bivacor Total Artificial Heart EFS is a critical milestone for Bivacor and is another validation of the remarkable work and accomplishments of the entire Bivacor team. This device will provide a unique approach to help patients currently with limited clinical options,” said William Cohn, heart surgeon at the Texas Heart Institute and Bivacor chief medical officer.
4-Hydroxynonenal (4-HNE) is a major byproduct of lipid peroxidation, a process exacerbated by mitochondrial dysfunction and oxidative stress. Accumulation of 4-HNE protein adducts has been reported in several cardiovascular diseases, such as myocardial infarction, hypertension and heart failure in both rodents and humans. Therefore, identifying critical 4-HNE targets relevant to cardiac pathophysiology could help develop better therapies to treat heart failure.
Ethris GmbH and Heqet Therapeutics srl, a company spun out last year from King’s College London, have entered into a collaboration agreement to harness the potential of non-coding RNA (ncRNA) for heart tissue regeneration following acute myocardial infarction and in heart failure.
Ventric Health Inc. received U.S. FDA 510(k) clearance for its Vivio system, a mobile, non-invasive medical device that can aid in the diagnosis of heart failure. With early diagnosis crucial for treating and managing the condition, Vivio uses advanced algorithms to detect elevated left ventricular end diastolic pressure (LVEDP) in less than five minutes and can therefore improve clinical and health outcomes.
As part of its quest to advance its three first-in-class heart failure drug candidates toward the clinic, Corteria Pharmaceuticals SAS has closed an oversubscribed €65 million (US$70.7 million) series A, co-led by investors Orbimed and Jeito Capital, companies based in the U.S. and Europe, respectively.
When the data and safety monitoring board (DSMB) for Biocardia Inc.’s phase III pivotal trial of its Cardiamp cell therapy for heart failure advised pausing the study in July to analyze the interim results, the company expressed confusion as there were no reported treatment-emergent safety issues and aggregated blinded data showed better than expected outcomes. With the recommended external analysis now complete, the company confirmed the study is unlikely to achieve its primary endpoint at one year. The trial has now been unblinded.
