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.
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%.
Cardialen, Inc. was formed in 2008 to develop and commercialize pain-free cardioversion therapy, with a primary focus on atrial fibrillation (AF). The company is developing implantable low-energy (low voltage) pain-free atrial cardioverters to help address the major unmet needs of this condition. AF is the most common cardiac arrhythmia worldwide and has been recently estimated to affect over 3.0 million people in the United States. AF, unlike ventricular fibrillation (VF), is not immediately life threatening. However, AF greatly increases the risk of stroke and premature death, impairs quality of life and generates high healthcare costs. Current therapies (drugs, external cardioversion, catheter ablation and surgery of various types) do not fully meet AF patient needs.
CardiAQ Valve Technologies (CVT) is developing the world’s first self-conforming and self-anchoring technology for transcatheter mitral valve implantation. The initial indication for this percutaneous valve will be treating functional mitral regurgitation to prevent heart failure. CVT is located in Irvine, California and is led by CEO Rob Michiels, formerly of CoreValve. Three years after our initial investment CVT had attracted over $40M in follow on funding from angels and venture capital firms.
CVT was acquired by Edwards Lifesciences in 2015.
Portfolio Name: CellAegis
CellAegis Devices (Toronto, Canada) has patented and developed the non-invasive autoRIC Device, which delivers Remote Ischemic Conditioning (RIC) therapy to patients with acute and chronic cardiovascular conditions. RIC therapy is based on the principle of adaptive physiology, where short, deliberate occlusion of blood flow to the arm activates the cellular survival network against ischemia. This medical procedure protects the heart as well as other organs from ischemia and reperfusion injury.
The autoRIC Device has CE Mark and Health Canada approval for adjunct treatment during heart attacks, cardiothoracic or surgical procedures, and is being developed for chronic conditions such as heart failure and stroke. The autoRIC Device was developed from the clinical work of Dr. Andrew Redington and colleagues, who are part of the Fondation Leducq TransAtlantic network.
EP Sciences, LLC is a New York-based company founded in 2011 by the Coridea medical device incubator. The company is developing a novel waveform to reduce the severe pain associated with implantable cardioverter defibrillator (ICD) shocks in patients at risk of sudden cardiac arrest. While roughly 800,000 Americans have an implanted defibrillator, the fear of an initial shock, post-traumatic stress from having experienced a shock, and the risk of receiving inappropriate shocks greatly limit the patient and physician acceptance of ICD therapy. EP Sciences aims to improve the tolerance of ICD shocks to better assist patients suffering from ventricular fibrillation and other life-threatening cardiac arrhythmias.
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).
GI Windows is a clinical-stage medical device company developing a non-surgical approach to create anastomoses in the GI tract. Their patented self-assembling magnets are designed to enable an incision-less and durable intestinal bypass to treat chronic diseases, such as Type-2 Diabetes and Obesity, without the cost and invasiveness of surgical interventions.
Adient’s mission is the development of absorbable medical devices with the premise that implants should be safe and efficacious during their useful lifetime, and then simply vanish without intervention, alleviating costly removal procedures and downstream complications.
Aggamin is an early-stage biotechnology company founded in early 2010 to develop and commercialize therapies for a variety of vascular diseases. The lead program is focused on preeclampsia — a currently untreatable disease affecting 5% of pregnancies with an annual cost to the U.S health care system of $10 billion. Lead product is an extracorporeal device for preeclampsia that reduces circulating pathogenic proteins to improve maternal and fetal health. The company objectives are to manufacture and commercialize the preeclampsia device as a safe first-in-class treatment for preeclampsia that will control maternal symptoms and extend pregnancy, thus improving both maternal and neonatal outcomes.
Apama Medical, founded in 2009 by serial entrepreneur Amr Salahieh, is a medical device company committed to improving patient outcomes by developing a novel catheter ablation system for the underpenetrated and rapidly growing atrial fibrillation (AF) market. Recognizing the need for a more effective means of treating AF.
Apama developed a unique multipoint RF balloon catheter system designed to improve procedural efficiency and versatility, addressing fundamental obstacles to the more widespread adoption of atrial ablation therapy. AF remains the most common clinically significant cardiac arrhythmia affecting an estimated 12.9 million patients globally.
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.
NIDO is a medical device company developing SEPIA, an innovative device to improve epicardial ablation for ventricular tachycardia (VT), based on technology developed at Boston Children’s Hospital. SEPIA will enable real-time visualization of the epicardial surface and provide angle and force control to ablation catheters, resulting in improved ablation efficiency, decreased VT recurrence and fewer complications.
The company was co-founded by Dr. Pedro del Nido, Chairman of Cardiovascular Surgery and Professor at Harvard Medical School, and Dr. Nikolay Vasilyev, former Assistant Professor of Surgery at Harvard Medical School, currently Medical Director for the Surgicals Portfolio at Pfizer.
NuPulse, Inc is a clinical-stage medical device company that is developing novel technology to treat patients with heart failure, one of the leading causes of death worldwide. The device, which requires minimally invasive surgery, provides patients an alternative to medical therapy. NuPulse’s founders have extensive clinical, engineering and life science experience, which will allow them to alter the paradigm for the treatment of heart failure.
Vectorious Medical Technologies, a Tel-Aviv based company, has developed the V-LAP™, a miniature wireless pressure sensor implanted into the heart’s left atrium. The V-LAP™ enables patients to take a direct daily measurement of the heart’s left atrial pressure (LAP), the earliest and most accurate indicator of heart function, and therefore to optimize treatment at an early enough stage to prevent decompensation. As a result, patients will enjoy an enhanced quality of life, physicians will be able to provide superior care and hospitals will see fewer readmissions, saving the healthcare system billions per annum.
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.
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.