Led · Equity · Jul 2024

The supplied articles do not contain information about Affluent Medical. Instead, they detail Carvolix, a medical-technology company that is deploying a robotic platform called Tavipilot and other products (Kalios, Artus, Artedrone, Mitrapilot). Carvolix used the €10.0M strategic placement to bolster cash to €20.0M, fund product development and repay bridge financing, and it plans regulatory submissions and clinical milestones through late 2026. If you intended a memo on Affluent Medical, please provide the articles or sources about Affluent Medical and I will prepare the requested deal memo.

Participated · Equity · Jun 2022

Corvia Medical develops the Corvia Atrial Shunt, a transcatheter device designed to reduce elevated left atrial pressure in patients with HFpEF or HFmrEF. The shunt is placed via catheter between the left and right atria to allow blood flow from the higher-pressure left atrium to the lower-pressure right atrium. The device was granted Breakthrough Device designation by the FDA in 2019. Corvia says the shunt aims to reduce heart-failure symptoms and events and improve quality of life. The company is led by CEO George Fazio and is based in Tewksbury, MA. Corvia recently raised USD54M to support a confirmatory trial building on data and learnings from the REDUCE LAP-HF II clinical trial. DC Devices develops the proprietary, minimally invasive InterAtrial Shunt Device (IASD) System, the world’s first transcatheter implant intended to treat diastolic heart failure (HFpEF) by reducing elevated left atrial pressure. The IASD is designed to be implanted in the atrial septum via standard interventional cardiology techniques, avoiding open‑heart surgery. The company positions the device to relieve symptoms, improve quality of life, and reduce heart failure hospitalizations. DC Devices says the IASD System is intended to be cost‑effective and is aimed at a roughly $5 billion global market opportunity. Current plans for the new capital focus on completing clinical evaluation of the IASD System. The IASD is an investigational device and is not currently available for commercial distribution. DC Devices develops a proprietary, minimally invasive InterAtrial Shunt Device (IASD) system to treat diastolic heart failure (DHF), also known as HFpEF. The IASD is designed to relieve increased left atrial pressure by placing a permanent implant in the atrial septum. The system enables physicians to perform a controlled trans-catheter treatment without open-heart surgery using standard interventional cardiology techniques. Led by president and CEO George Fazio with co-founder David Celermajer, M.D., the company focuses on structural heart solutions. The company said it will use the financing to accelerate development and ongoing clinical evaluation of its first trans-catheter device for DHF/HFpEF.

Participated · Series B · Jul 2020

Caption Health develops Caption AI, an AI-guided medical imaging acquisition system that helps healthcare providers perform ultrasound and obtain diagnostic-quality images. The platform includes Caption Guidance, which provides 90-plus types of real-time feedback to emulate an expert sonographer and perform automated quality assessment, and Caption Interpretation, which produces automated ejection fraction calculations from common cardiac ultrasound views. Caption AI is available fully integrated with a Terason uSmart 3200T Plus portable ultrasound system and supports a range of clinical applications including lung, vascular, and abdominal scanning. Led by CEO Charles Cadieu, the company intends to scale commercial operations, continue developing its AI technology platform, and form new partnerships to expand use of Caption AI in additional care settings. The company closed a $53M Series B funding round to support those efforts. Bay Labs is a San Francisco–based medical technology company founded in 2013 that applies deep learning to cardiovascular imaging. Its core product uses AI algorithms to help medical professionals of all skill levels perform and interpret echocardiograms. The company has partnered with Minneapolis Heart Institute and Allina Health, Northwestern Medicine, Duke University School of Medicine, and Stanford cardiologists to develop, test and validate its algorithms. Bay Labs says its products are for investigational use only and are not currently for sale. The company plans to continue clinical validation, accelerate technological development, and bring its products to the U.S. market. Recently it completed a financing to support those efforts.

Participated · Series C · Apr 2018

V-Wave develops the Ventura interatrial shunt, an hourglass-shaped tube that creates a small passageway between the heart’s upper chambers to relieve atrial pressure and reduce pulmonary congestion. The device has an FDA breakthrough designation and received a CE mark in Europe in early 2020. Ventura is being tested in an international, randomized trial of about 500 medicated heart failure patients with reduced or preserved ejection fraction. A secondary open-label arm of roughly 100 early participants has completed enrollment and is expected to deliver one-year follow-up data in 2022. CEO Neal Eigler said the open-label arm demonstrated ease and success of implantation, safety, shunt durability and patency, and improved quality-of-life metrics. The company is also developing a next-generation adjustable-size shunt to tailor shunting at implant and over time. V-Wave is a privately held medical device company based in Caesarea, Israel, led by CEO Dr. Neal Eigler. The company has developed a proprietary, minimally invasive implanted interatrial shunt device for treating patients with severe symptomatic heart failure. V-Wave has received FDA approval to initiate a pivotal IDE study and is launching the RELIEVE-HF global, randomized, controlled, double-blinded multicenter clinical trial. RELIEVE-HF will evaluate the safety and effectiveness of the device in HF patients with Class III or ambulatory Class IV symptoms with preserved or reduced ejection fraction already receiving optimal therapies. V-Wave closed a $70M Series C to fund ongoing development and trial activities. Strategic and corporate backers, including Johnson & Johnson Innovation and Edwards Lifesciences, participated in the financing, reflecting industry support. V-Wave Ltd. is a Caesarea, Israel-based medical device company developing a proprietary implantable, interatrial shunt for the treatment of heart failure. The device is implanted trans-venously and placed in the atrial septum where it remains, regulating left atrial pressure by shunting excess blood volume away from the left ventricle. The device is intended for use in patients with chronic symptomatic heart failure. The company completed a $28M Series B financing to support its programs. V-Wave plans to use the funds for clinical evaluation and development, addition of senior management, and manufacturing scale-up of its minimally invasive device. The company is led by Dr. Neal Eigler, MD, CEO.

Led · Equity · Dec 2014

CardioKinetix is a Menlo Park, Calif.–based medical device company pioneering the catheter-based Parachute® Ventricular Partitioning Device to treat heart failure. The Parachute implant is delivered via a femoral artery catheter to partition the left ventricle, exclude non-functional segments, reduce overall left-ventricular volume, and restore geometry and function in a minimally invasive procedure performed in the catheterization laboratory. The Parachute system received CE Mark in 2011 and is investigational in the U.S., limited to investigational use only. The company reports more than 300 patients treated, four clinical trials completed, and 23 publications on the Parachute therapy. CardioKinetix completed a $50 million financing that will fund the PARACHUTE IV randomized pivotal trial, support a U.S. pre-market approval (PMA) submission, and enable international market development efforts. The PARACHUTE IV study is currently enrolling patients in the United States and its data will form the basis of the company’s PMA submission to the FDA. CardioKinetix is a Menlo Park, CA-based medical device company developing the Parachute Ventricular Partitioning Device, a catheter-delivered, minimally invasive implant for patients with heart failure due to post‑MI damage. The Parachute implant is deployed via a catheter inserted in the femoral artery to partition the left ventricle, excluding non-functional myocardium to reduce LV volume and restore geometry and function. The procedure is performed in the catheterization laboratory under conscious sedation. The device has received CE Mark; in the U.S. it is an investigational device limited by federal law to investigational use only. The company is led by President and CEO Maria Sainz and is advancing its programs to bring the Parachute therapy to market. Recent financing activity supports further clinical and commercialization efforts. CardioKinetix is a Menlo Park, CA-based medical device company that developed the PARACHUTE™ Ventricular Partitioning Device, a transcatheter implant for the left ventricle. The Parachute device is intended to treat patients with heart failure resulting from a myocardial infarction and is implanted via a catheter lab procedure. The device recently received the CE Mark and the company is conducting clinical studies in Europe. The FDA has approved an IDE Pivotal Trial for Parachute based on results from a feasibility study. The company is led by President and CEO Wes Johnson. CardioKinetix completed a $44M two-tranche Series E financing, reflecting its ongoing clinical and regulatory progress.