CardiaLen

CardiaLen, Inc., founded in 2008, operates as a clinical-stage medical device company focused on developing gentler and more effective treatments for cardiac arrhythmias. The company originated from the scientific work of Dr. Igor Efimov, who developed a novel method for defibrillating the heart using a sequence of low-energy electrical pulses instead of a single, high-voltage shock. This foundational technology, known as MultiPulse™ Therapy (MPT™), is designed to restore normal heart rhythm in patients suffering from atrial fibrillation (AFib) and ventricular tachycardia (VT).

The company’s primary market is patients with cardiac rhythm disorders, particularly the approximately 34 million people worldwide affected by AFib. CardiaLen's approach targets individuals who have or are likely to receive an implantable cardioverter-defibrillator (ICD) or a cardiac resynchronization therapy defibrillator (CRT-D). The core of its business is the development of an implantable, pacemaker-like device that utilizes MPT™. This therapy aims to provide a less painful and debilitating alternative to the high-energy shocks delivered by current defibrillators, which can cause significant patient anxiety and depression. The MPT system delivers a patented sequence of low-energy pulses, which have been shown in clinical studies to terminate AFib episodes at energy levels well-tolerated by patients. This represents a significant potential advancement over existing treatments like drugs, external cardioversion, and catheter ablation.

CardiaLen has navigated a path of venture capital financing and strategic development, securing a $17 million Series B funding round in 2018 to advance its clinical programs. The company also received substantial non-dilutive funding, including a $3 million grant from the National Institutes of Health (NIH) in 2021 to support the development of its therapy. A major milestone was achieved in late 2021 when the U.S. Food and Drug Administration (FDA) granted the company an Investigational Device Exemption (IDE) to begin a clinical trial for its MPT to treat paroxysmal and persistent AFib. In December 2022, the assets of CardiaLen were acquired by Maxwell Biomedical, a company also focused on innovative, pain-free treatments for AFib. This acquisition combines CardiaLen's MPT technology and clinical data with Maxwell's own Spatial Resynchronization™ Therapy (SR™T), aiming to accelerate the development of next-generation atrial fibrillation therapies.

Keywords: cardiac arrhythmia treatment, atrial fibrillation therapy, implantable cardioverter-defibrillator, low-energy cardioversion, MultiPulse Therapy, ventricular tachycardia, medical device, cardiac rhythm management, electrophysiology, investigational device exemption, pain-free defibrillation, heart failure, medtech, cardiovascular therapy, clinical trials, Maxwell Biomedical, Igor Efimov, implantable medical device, arrhythmia treatment, cardiac device technology