(AOF) – Affluent Medical announced positive clinical results from a pivotal study with its Kalios mitral ring. The medtech specialist in cardiology specifies that this ring for repairing the mitral valve of the heart “has demonstrated effectiveness and an excellent safety profile at 1 year” and that these results “have led to a strategic evolution towards the American market in order to ‘ensure optimal access to marketing’. “By adjusting the catheter, mitral regurgitation was optimized or corrected without additional open heart surgery. »
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Biotechs put to the test
These companies are suffering from a much less favorable economic cycle, which is reflected in particular by a drop in venture capital financing of start-ups. These companies are therefore obliged to carry out layoff plans. Added to this is a much more restrictive regulatory framework. First, in the United States, measures linked to the Inflation Reduction Act (IRA) could have a strong impact on the margins of stakeholders. Indeed, from 2026, the federal Medicare program will be able to renegotiate the price of drugs marketed for nine years (chemical) or 13 years (biological), with discounts that could range from 35 to 60% for biotechs. Likewise, in Europe, with the new drug regulations presented in Brussels in April, the duration of patent protection will be reduced if the innovative treatment is not marketed in all member countries within two years.