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Cadrenal Therapeutics Partners with Abbott to Advance Novel Anticoagulant Trial for LVAD Patients

• Cadrenal Therapeutics and Abbott have formed a strategic collaboration to evaluate tecarfarin, a new oral Vitamin K antagonist, in patients with HeartMate 3 left ventricular assist devices.

• Abbott will provide crucial support for the TECH-LVAD trial, including trial design expertise, site identification, and insights from recent HeartMate 3 trials.

• The partnership aims to develop the first innovation in vitamin K-targeted anticoagulation in over 70 years, addressing the limitations of warfarin in LVAD patients.

Cadrenal Therapeutics (Nasdaq: CVKD) has announced a significant collaboration agreement with Abbott (NYSE: ABT) to advance the clinical development of tecarfarin, a novel oral Vitamin K antagonist (VKA), for patients with left ventricular assist devices (LVADs). The partnership focuses on supporting Cadrenal's pivotal TECarfarin Anticoagulation and Hemocompatibility with Left Ventricular Assist Devices (TECH-LVAD) trial.

Strategic Collaboration Details

Under the collaboration agreement, Abbott will provide comprehensive support for the TECH-LVAD trial, leveraging its expertise with the HeartMate 3 LVAD system. The partnership encompasses critical areas including trial design optimization, clinical site identification, trial awareness initiatives, and specialized HeartMate 3 expertise.
Quang X. Pham, Chief Executive Officer of Cadrenal Therapeutics, emphasized the significance of the collaboration: "We are pleased to have the support of Abbott, a global healthcare leader, which further validates the advancement into late-stage clinical development of tecarfarin. This partnership strengthens our access to key clinical trial sites and enhances patient enrollment efforts."

Addressing Unmet Medical Needs

The development of tecarfarin represents the first major innovation in vitamin K-targeted anticoagulation in more than seven decades. While warfarin is currently used off-label for various rare cardiovascular conditions, its significant side effects have highlighted the need for safer alternatives.
Tecarfarin has already received Orphan Drug designation for advanced heart failure patients with implanted LVADs, as well as for end-stage kidney disease with atrial fibrillation (ESKD+AFib). The drug has also been granted fast-track status for the latter indication.

Market Potential and Device Innovation

Abbott's HeartMate 3 LVAD, currently the only device of its kind available in the United States, represents the most advanced mechanical circulatory support system for patients with advanced heart failure. The LVAD market shows significant growth potential, with projections indicating an increase from $1.1 billion in 2023 to $2.4 billion by 2032, according to Business Research Insights.

Clinical Development Strategy

The TECH-LVAD trial will evaluate tecarfarin's efficacy and safety profile specifically in patients with LVADs. By combining Cadrenal's innovative anticoagulant with Abbott's HeartMate 3 expertise, the collaboration aims to improve anticoagulation quality and enhance hemocompatibility in LVAD patients.
This partnership marks a significant step forward in addressing the complex anticoagulation needs of patients with mechanical circulatory support devices, potentially offering a safer and more effective alternative to current treatment options.
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