Aria CV, Inc.is developing a medical device that treats pulmonary hypertension, a life-threatening disease with few therapeutic options. Pulmonary hypertension, or high blood pressure in the vessels that carry blood from the heart to the lungs, increases the workload on the heart. The increased workload leads to right heart failure, the ultimate cause of mortality in this disease. Patients are currently treated with drugs that can cost over $100,000 per year but are generally considered to have limited efficacy. Even with optimal drug therapy, the average survival time is on the order of six years, making pulmonary hypertension a tremendous unmet medical need. Aria CV, Inc. is developing a medical device that reduces the workload on the heart. Preclinical testing suggests the device has the potential to enhance both survival and quality of life of those suffering from pulmonary hypertension.
AtaCor Medical is developing novel cardiac pacing and defibrillation systems that do not require any direct connections to the patient’s heart. Today, when patients require pacemaker or defibrillator therapy, hardware is inserted into the veins and attached to the inside of the heart, a process requiring extensive x-ray imaging. Once implanted, this hardware can lead to serious complications with challenging removal procedures, even for newer “leadless” pacemakers. AtaCor’s substernal pacing and defibrillation leads are inserted without any need for medical imaging, allowing for faster, less-invasive therapy delivery. The unique placement avoids the need to access the patient’s vascular system and leaves the heart completely untouched. AtaCor’s technology will offer a new treatment option for both transient and chronic bradycardia, including the escalating need for temporary pacing in conjunction with TAVR procedures, as well as ventricular fibrillation and tachycardia.
Cardiosense is building a physiological waveform AI platform to develop predictive biomarkers to detect and manage cardiovascular disease. The Company has developed a suite of novel digital tools, multi-sensor devices, and analysis algorithms to detect changes in cardiovascular disease non-invasively, inform personalized therapy, and improve patient outcomes. The Company is currently pursuing clinical development of its clinical-grade, multi-parameter, non-invasive monitoring device, CardioTag, with an initial focus on improving the monitoring and management of patients with congestive heart failure (CHF).
CorFlow is developing the first catheter-based technology designed to rapidly and accurately diagnose microvascular obstruction (MVO), and to deliver therapeutic agents targeted directly, at high local concentrations, to the site of the obstruction. The first indication will be in the setting of primary PCI for acute myocardial infarction (AMI) where the presence of MVO severely impacts patient outcomes – for every 1% increase in MVO there is a corresponding 14% increase in 1-year mortality risk and an 8% increase in hospitalizations due to heart failure. Beyond the heart, CorFlow aspires to lead in all disease states where diagnosing and treating microvascular obstruction is a critical need.
CroíValve (croí is Irish for heart) is a medical device company based in Ireland developing a novel device to treat tricuspid regurgitation (TR), a severe heart condition that occurs when the tricuspid valve fails to seal properly. TR results in blood flow retrograde from the right ventricle into the right atrium, with progressive symptoms including fatigue, fluid retention leading to abdominal and leg swelling, liver and kidney failure, and death. CroíValve’s solution is a coaptation valve which restores tricuspid valve function by supporting the native leaflets while preserving cardiac anatomy. CroíValve’s device promises to be safer, more effective, less traumatic, and easier to deliver than competing technologies.
FineHeartis a French medical device company focused on creating innovative technologies in the cardiovascular space.
FineHeart has developed the ICOMS (Implantable Cardiac Output Management System), a novel, wirelessly powered, fully implantable mechanical circulatory support device that is able to optimize cardiac output while preserving the heart’s innate contractility. It is a game changing therapy for long term circulatory assistance in severe heart failure patients. FineHeart was founded by a team of four internationally renowned cardiologists, led by Dr. Stéphane Garrigue (ICOMS Inventor) and Dr. Philippe Ritter, co-inventor of cardiac resynchronization therapy, with a vision of making a miniaturized, fully implantable, pulsatile circulatory support system that would overcome many of the challenges associated with left ventricular assist devices (LVADs) currently on market. The overarching goal is to restore normal cardiac output and allow heart failure patients to return to a normal quality of life. The founding scientists and clinicians have been joined by four managers with specific expertise in the medical device industry, led by Arnaud Mascarell (CEO).
NyraMedical, a spinout of Emory University, is developing a novel device to treat mitral regurgitation (MR), a severe heart condition in which the mitral valve between the left atrium and left ventricle does not seal properly, resulting in leakage of blood backward through the mitral valve each time the left ventricle contracts. MR can lead to enlargement of the atrium and ventricle, abnormal heart rhythms, pulmonary hypertension, and heart failure.Nyra’s cardiac leaflet enhancer (CARLEN) is a first-in-class device delivered percutaneously to correct MR while preserving the physiological valve geometry.
Puzzle Medical Devices Inc. is developing ModulHeart, a percutaneous heart pump for patients with advanced HF. The device’s modular design allows for hemodynamic support through multiple parallel endovascular pumps anchored in the descending aorta. This novel design results in low pump speeds, secure aortic anchoring, and positioning distal to the cerebral arteries. As a result, the device is expected to preserve blood integrity, reduce the risk of embolic events, enable ambulatory and outpatient use. These attributes will allow for safe long-term implantation, with minimal risk of bleeding, stroke, and pump thrombosis.
RapidPulse is developing a novel cyclic aspiration system enabling rapid and consistent mechanical thrombectomy of blood clots for the treatment of acute ischemic stroke.
Relief Cardiovascular is developing the Relief System, a novel transcatheter smart implant designed to improve long-term outcomes in diuretic-resistant heart failure (DRHF). DRHF impacts millions of patients globally, with significantly elevated rates of mortality and rehospitalization due to persistent and worsening congestion. To address this, the Relief System incorporates autonomous renal vein pressure monitoring paired with a flow-modulating implant to enhance renal perfusion and diuretic efficiency to reduce congestion in DRHF patients.
Vascular Graft Solutions (VGS) is a leading developer of innovative technologies to improve surgical revascularization, vascular reconstruction procedures, and arteriovenous fistula. VGS is improving the standard-of-care in cardiovascular surgery while focusing on patients’ quality-of-life, surgeons, and health economics.
XII Medical is developing an innovative, minimally invasive technology to address obstructive sleep apnea (OSA), a condition affecting approximately 45 million people in the US. OSA is characterized by recurrent, functional collapse of the upper airway during sleep, causing substantially reduced or complete cessation of airflow and leading to nocturnal hypoxemia. Untreated OSA is associated with long term negative health outcomes, including an increased risk of cardiovascular disease, poor neurocognitive performance, reduced quality of life, and increased all-cause mortality. Treating OSA has specifically been shown to improve disease markers across a range of cardiovascular conditions, yet many patients are unable to tolerate current therapeutic options, with adherence rates of roughly 50%.
