Two Important Customers — FDA and CMS

Key Learnings From Eric’s Experience

• To attract investors, develop a compelling story outlining your company's unique value proposition and path to success. If you want to build relationships with potential capital investors and strategic partners well in advance of needing immediate funding, start the conversation early. Focus spending on critical areas while you outsource non-core functions to conserve resources and extend your runway. 

• Put yourself in the acquirer’s shoes. Evaluate your company from their perspective to identify areas of value and potential concerns. Robust clinical evidence for early-stage startups is a must. Also, don’t underestimate the importance of a well-developed and documented quality management system, as the lack of it can be a real barrier to your venture’s ability to scale in the future.

• Your target market needs to be defined before you can properly develop your regulatory and reimbursement plans. Address coverage challenges early on and engage CMS. Explore partnerships with private payers for both learning and clinical trial opportunities.

Dr. Eric Fain has a background in applied math and medicine. An innovator at heart, during medical school, he worked on early implantable defibrillator research with his advisor Dr. Roger Winkle, a cardiovascular disease and electrophysiology specialist. After graduating in 1987, Eric took a one-year hiatus from medicine and joined Ventritex, a device startup specializing in implantable defibrillators, to help with fundamental research. 

Although he planned to return to clinical medicine after a year, Eric became enamored with medical devices and decided to stay in the space. After 10 years at Ventritex  and 20 years in various leadership roles at large strategics, he decided to rejoin the startup world as the CEO of Procyrion. 

Founded in 2005, Procyrion has been focused on overcoming engineering challenges to develop its flagship product, Aortix — a percutaneous mechanical circulatory support (pMCS) device designed to treat heart failure patients admitted to the hospital who are unable to be successfully treated with medication alone and make up about 25% of heart failure admissions. These patients experience severe symptoms and complications like shortness of breath and swelling of the lower limbs and feet due to excess fluid accumulation. The standard of care today primarily relies on high doses of intravenous diuretics and cardiac medications. 

Because of its placement in the descending aorta, Aortix reduces the risk of strokes and other complications that are associated with devices placed directly in the heart. After its placement, Aortix facilitates blood flow from the aortic arch to the lower aorta, decreasing the heart's workload. This helps improve cardiac efficiency while boosting renal function by directly increasing blood flow to the kidneys, which increases urine output and results in decongesting these diuretic-resistant patients. 

Procyrion was able to enroll its first patients in a pivotal trial called DRAIN-HF Trial in November 2023, a critical step in demonstrating Aortix’s efficacy in decongesting patients, enhancing their survival chances, and reducing hospital readmissions. Today, the team is focused on activating new trial sites and accelerating patient enrollment with the mission of completing enrollment in the trial in the second quarter of 2025, with the goal of ultimately obtaining a PMA from FDA.