PERTH, Australia – Stem cell therapy company Mesoblast Ltd. provided new subgroup analyses from its phase III advanced chronic heart failure trial showing a greater treatment benefit from rexlemestrocel-L in high-risk patients with chronic heart failure and low ejection fraction (HFrEF) with diabetes or ischemia. The company had reported in December 2020 that the allogeneic mesenchymal cell therapy failed to meet the primary endpoint of a reduction in hospitalizations in its DREAM-HF phase III trial.
In the Dec. 3, 2021, issue of Science, researchers reported that a missense variant that is highly enriched in the Amish population was associated with reduced levels of both LDL cholesterol and fibrinogen. To date, very few variants have been identified that affect more than one risk factor for cardiovascular disease.
Longeveron Inc.’s share price (NASDAQ:LGVN) jumped 11.7% on Dec. 3 after the FDA awarded orphan designation to Lomecel-B, allogeneic bone marrow-derived mesenchymal stem cells, for treating hypoplastic left heart syndrome. The designation came two weeks after the FDA granted rare pediatric disease designation for Lomecel-B to treat the life-threatening congenital heart defect in infants.
In the December 3, 2021, issue of Science, researchers reported that a missense variant that is highly enriched in the Amish population was associated with reduced levels of both LDL cholesterol and fibrinogen. To date, very few variants have been identified that affect more than one risk factor for cardiovascular disease.
Restore Medical Ltd. is implanting the first patients with its Contraband technology for congestive heart failure (CHF). The minimally invasive, catheter-delivered implant is being assessed in patients with chronic left ventricular failure. The Or Yehuda, Israel-based startup is carrying out the trial at the ZNA medical center in Antwerp, Belgium, followed by the Kaplan medical center in Israel. The goal of the implant is to enable the right ventricle to strengthen the left ventricle and improve ejection fraction, reduce mitral regurgitation and restore a favorable ventricular geometry.
PERTH, Australia – Medtech newcomer Artrya Ltd. listed on the Australian Securities Exchange (ASX) in an AU$40 million (US$28.6 million) initial public offering to commercialize its software that analyzes heart computed tomography (CT) scans via artificial intelligence (AI) to better diagnose coronary artery disease.
The U.K. National Institute of Health and Care Excellence (NICE) issued two health technology assessments dated Nov. 24, including one that gives a guarded recommendation for devices used to narrow the coronary sinus as a treatment for refractory angina. Neovasc Inc., of Richmond, British Columbia, touted the news as a positive for its Reducer device, given that this is the first instance in which NICE has lent any support for a device to treat the condition.
The European Investment Bank (EIB) pumped €15 million (US$17 million) into Xeltis BV to accelerate clinical programs for its polymer-based technology platform for cardiovascular restoration. The Eindhoven, Netherlands-based company is developing three types of cardiovascular implants. These are a pulmonary heart valve, coronary artery bypass graft and hemodialysis access grafts. The devices use a therapeutic approach called endogenous tissue restoration (ETR), which causes the patient’s own body to naturally restore a new blood valve. As the patient’s healing system develops a functional valve, Xeltis’ implant is gradually absorbed by the body.
PERTH, Australia – Cardiovascular medical device company EBR Systems Inc. announced a planned AU$110 million (US$79.7 million) initial public offering (IPO) on Australia’s Securities Exchange to bring its wireless cardiac pacing system for heart failure to market. The IPO is planned for Nov. 24, 2021, and the funds raised will allow the company to complete pivotal trials for its wireless, inside-the-left-ventricle-of-the-heart pacing system called WiSE (wireless stimulation endocardially).
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