CardiaCare, a clinical stage digital therapeutic company developing the world’s first non-invasive, personalized neuromodulation wearable for atrial fibrillation treatment, announced today the execution of a strategic licensing agreement with Dr. Reddy’s Laboratories, a leading multinational pharmaceutical company based in India.
Under terms of the agreement, which include undisclosed upfront and royalty payments to CardiaCare, Dr. Reddy’s Laboratories will lead the necessary clinical studies to secure regulatory clearance in India and will manage commercialization and distribution in India. This agreement will make India the first market to offer a home-care, digital therapeutic solution for atrial fibrillation patients and will reduce health inequities in cardiovascular care.
Atrial fibrillation (AF) is the most common sustained cardiac arrythmia, affecting tens of millions of patients worldwide. AF contributes to increased morbidity and mortality, mainly due to a 5-fold increased risk for stroke. Current standard of care includes pharmacological therapy or ablation, both of which have limited efficacy and various side effects, negatively impacting patients’ quality of life.
The CardiaCare wearable device adopts a closed loop approach, integrating therapy and monitoring. It utilizes proprietary AI based ECG analysis algorithms to allow optimized and personalized atrial fibrillation treatment. Initial clinical data suggests that this novel therapeutic approach has both acute and cumulative effects, decreasing atrial fibrillation precursors and overall disease burden.
Ofer Halbreich, CardiaCare’s CEO, commented: “Partnering with Dr. Reddy’s Laboratories accelerates CardiaCare's evidence generation and commercialization activity, externally validating the potential of our game-changing technology for the treatment of atrial fibrillation. Our device enables safe, drug-free, at-home treatment, that has been shown to increase AF treatment efficacy and decrease costs. Our closed loop approach integrating therapy and monitoring optimizes and personalizes care, providing clinicians and patients better AF management.”
Amos Ziv, CardiaCare's founder and CSO added: “We look forward to working closely with the Dr. Reddy’s Laboratories team to help improve patient outcomes worldwide. We will continue to execute on our clinical development plans in other regions for this initial as well as additional indications in our pipeline.”