Medical device company profile

Procyrion

Clinical-stage Aortix mechanical circulatory-support system targeting heart failure with cardiorenal dysfunction.

Medical Device DeveloperCardiovascular & VascularUrology & Renal CareHeart Failure & Circulatory SupportRenal CareClinical development

Headquarters🇺🇸Houston, Texas, United States

FoundedNot confirmed

Commercial statusIn developmentInvestigational device; not available for routine commercial sale.

EmployeesNot confirmed

Estimated revenueNot confirmed

Disclosed fundingUS$57.7 million ^[13]Series E incl. conversion · Feb 2024

Official websitewww.procyrion.com ↗

Company overview

Procyrion develops Aortix, a catheter-delivered pump placed in the descending aorta to augment blood flow and support renal perfusion while reducing cardiac workload. The Houston company focuses on patients with acute decompensated heart failure, persistent congestion and inadequate response to diuretics.

The company identifies DRAIN-HF as its pivotal study and also describes completed pilot programs in cardiorenal syndrome and perioperative kidney-injury prevention. Enrollment descriptions are attributed to the company’s trial page; they are not a substitute for a fresh registry status review.

Aortix is investigational and not available for sale in any country according to the company. Eric Fain is President and CEO, with Andrew Davis as Chief Commercial Officer. The relevant business story is clinical execution and preparation for potential commercialization, rather than current device sales.

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Leadership

4 people

Eric S. FainPresident & Chief Executive Officer ^[15]

Reynolds M. Delgado IIIFounder & Chief Medical Officer ^[15]

Andrew DavisChief Commercial Officer ^[15]

Jason HeuringChief Scientific Officer ^[15]

Products & regulatory status How does MedTechIndex get this information?

Summary

Aortix remains investigational and is not approved for commercial sale in any geography according to Procyrion. The DRAIN-HF program and earlier clinical studies concern research use; no matching published FDA marketing authorization was found. ^{[14][11][15][12][1]}

No matching FDA recall event was identified in the completed company/applicant, linked-identifier and product-name searches. ^[5][3]

Regulatory snapshot How to read this snapshot

U.S. FDA

0
510(k) clearances: 0
De Novo grants: 0
PMA approvals: 0
Recall events

Latest recorded source review: 2026-10-20.

Commercial portfolio snapshot

No routinely marketed devices established in the reviewed scope.

Commercial development

NCT05677100: registry status recruiting in the 2026-08-25 update; 320 participants (estimated). Study completion is estimated for 2028-08; this is not an FDA decision or commercial launch date. ^[7]

Investigational percutaneous circulatory-support system