Aria CV
A New Frontier in Pulmonary Arterial Hypertension Therapy

Pulmonary arterial hypertension (PAH), characterized by elevated blood pressure in the pulmonary artery, is a heart condition that disproportionately affects women in the prime of their lives between the ages of 35 and 55. In patients with PAH, the vessel walls thicken and narrow, which restricts blood flow and reduces vessel stretch during each heartbeat, resulting in increased pressure and workload on the right side of the heart. Without proper treatment, PAH is progressive and often fatal due to right heart failure. While there are approved therapies like vasodilator drugs that help patients with PAH live a normal life, these drugs are not curative and the disease typically progresses despite therapy. Besides, they also cause several side effects, including headache, nausea, pain in the arms, legs, and jaws, as well as serious implications such as systemic hypotension and desaturation.

The need of the hour is a solution that reduces right ventricle after load while increasing cardiac output by restoring blood flow. “This is precisely what our device does. Despite the availability of multiple drug therapies, PAH remains a disease with large, unmet needs. Our device-based solution has the potential to treat this disease more effectively and with fewer side effects,” avers Dan Gladney, president and CEO of Aria CV, a medical device firm that is improving the lives of patients suffering from PAH with its novel implantable medical device.

Aria was co-founded by Dr. John Scandurra and Dr. Karl Vollmers, who at the time were Fellows at the University of Minnesota. The duo studied the medical literature and developed a novel approach to treating the disease. They developed early protoypes, tested them in animals, and filed a patent application for the device. In 2010, Drs. Scandurra and Vollmers licensed the patent from the University and founded Aria CV, Inc. “The idea of having a medical device implant that could provide relief for patients suffering from the disease was very attractive to them,” reveals Gladney.

“I was, in fact, one of the very first investors who helped the two of them get the fledgling startup off the ground,” adds Gladney.

Aria’s device is made up of a balloon, catheter, anchor and gas-filled reservoir. The reservoir is implanted in the upper abdominal wall and the balloon resides in the main pulmonary artery. The gas in the balloon compresses and expands based on the blood pressure in the pulmonary artery. “During systole—when the blood is rushing out of the heart into the pulmonary artery—the balloon compresses, and during diastole—when the heart is filling with blood—the balloon re-expands. Essentially the device mimics the function of a healthy pulmonary artery, and helps push the blood downstream,” explains Gladney. In other words, the device imitates the function of the healthy blood vessels by restoring compliance to the pulmonary vessels. By doing so, it enables the heart to pump more blood for less energy. These effects have the potential to improve cardiac output while reducing the burden on the heart.

Aria CV, a medical device firm that is improving the lives of patients suffering from PAH with its novel implantable medical device

What’s more, the device is completely passive, i.e., it has no battery or electronics and is easy to use, which are vital factors when it comes to medical implants. Aria recently received the ‘Breakthrough Device Designation’ from the FDA and approval to start its EFS trial. Alongside, the company also completed a $31 million Series B round of financing to fund its first clinical study in the United States. “FDA’s Breakthrough Designation affords multiple potential benefits including flexible clinical trial design and facilitated patient access through CMS’ MCIT reimbursement pathway. Part of our series B financing was to also expand the potential of the product by conducting an acute study at the University of Vienna in Vienna, Austria, in patients with pulmonary hypertension caused by left heart failure and lung diseases,” states Gladney. The firm is looking forward to conducting its series C financing in the early Q1 of 2022 which will fund a full PMA trial and commercializing its product by 2024. “Our mission is to address the unmet clinical need for this lifethreatening disease with an effective treatment option and the FDA designation brings us one step closer to delivering on the mission,” wraps up Gladney.