HighLife has achieved significant regulatory and clinical milestones this year. In January, the company received CE Mark approval for its Transcatheter Mitral Valve Replacement (TMVR) system, enabling the start of a limited market release in Europe while also initiating its US pivotal clinical study. In July, HighLife received CE Mark approval for the Clarity Valve, HighLife\u2019s next-generation valve, purpose-built to further mitigate LVOT obstruction risk, the primary barrier to adoption for TMVR. Together these milestones strengthen HighLife\u2019s ability to expand treatment access for patients who have limited therapeutic options.<\/p>\n
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“This financing represents an important milestone as HighLife continues to build momentum toward establishing its technology as a new treatment option for patients suffering from mitral regurgitation who have limited therapeutic alternatives. It will support HighLife\u2019s strategic roadmap, by accelerating commercial expansion across Europe, advancing its pivotal clinical study and strengthening the organization to support long-term growth<\/em>\u201d, said Stefan Pilz, Chief Executive Officer of HighLife.<\/strong><\/p>\n \u201cWe believe transcatheter mitral valve replacement is reaching a critical inflection point. With differentiated technology, a highly experienced team and a strong financial foundation, we believe HighLife is particularly well positioned to establish itself as a global leader in this new therapeutic approach.\u201d \u00a0<\/em>said R\u00e9mi Spagnol, Partner Supernova Invest, <\/strong>co-lead investor in the round.<\/p>\n