FDA De Novo Clearance: Aurie becomes the first reusable intermittent catheter system ever cleared $14.24M raised - Lakehouse Ventures leads latest round Souvik Paul: "I never wanted to be an entrepreneur, but I'm here because I believe in the product" Harvard President's Innovation Challenge Grand Prize Winner 2024 MedTech Innovator 2024 - one of six companies selected globally VHA spinal cord injury hospitals: Aurie's first deployment target 120+ catheter users co-designed this product - community-driven from day one FDA De Novo Clearance: Aurie becomes the first reusable intermittent catheter system ever cleared $14.24M raised - Lakehouse Ventures leads latest round Souvik Paul: "I never wanted to be an entrepreneur, but I'm here because I believe in the product" Harvard President's Innovation Challenge Grand Prize Winner 2024 MedTech Innovator 2024 - one of six companies selected globally VHA spinal cord injury hospitals: Aurie's first deployment target 120+ catheter users co-designed this product - community-driven from day one
Souvik Paul, CEO and Founder of Aurie
CEO & Founder - Aurie

Souvik
Paul

Equity trader. MFA designer. FDA rule-breaker.
Building the catheter nobody thought could exist.

Medical Devices Harvard FDA Cleared Oakland, CA
$14M Total Raised
120+ Users Co-Designed
#1 FDA First-of-Kind
22 Team Members

JP Morgan to Johnson & Johnson to a 36-Minute Clean Cycle

Souvik Paul is building something that didn't exist in 2019. Before Aurie, there was no reusable intermittent catheter on the market - anywhere. Every catheter was single-use. Every device was wrapped in plastic, used once, thrown away. For 600,000 Americans who require intermittent catheterization, that meant roughly 2,400 disposables a year. And still, a 50% risk of a complicated UTI.

Paul didn't land in medtech through a straight line. He graduated from Harvard with a BA in Social Studies, then spent three years trading equities at JP Morgan. The pivot to design came later - he enrolled at the School of Visual Arts in New York, earning an MFA whose thesis project on designing for spinal cord injury and disability was good enough to display at the Cooper Hewitt Smithsonian Design Museum. Johnson & J&J hired him directly out of that work. He became Healthcare Solutions Lead for J&J Design, working on consumer medical devices before deciding the problem he most wanted to solve wasn't inside a corporation.

That problem had a face. In 2014, Paul's sister-in-law Carina sustained a T2/T3 complete spinal cord injury in a car accident that killed her mother and left her step-father in a weeks-long coma. Paul spent two weeks at the hospital. He watched Carina learn, in the middle of the worst moment of her life, that she would need to self-catheterize multiple times per day for the rest of it. He watched her insurance fall short of covering the full monthly supply. He watched her reuse catheters that weren't designed for reuse. He watched the UTIs follow.

It's been the hardest thing that I've ever done in my professional and personal life.

- Souvik Paul, CEO & Founder, Aurie

Years later, with a design degree and a J&J pedigree, Paul started asking a different question: not why catheter users get infections, but why nobody had ever built a reusable system that worked. The answer wasn't technical. It was economic. The single-use catheter market is highly profitable. Manufacturers had no incentive to cannibalize it. Paul did.

He incorporated Aurie, left J&J roughly six months later, and spent the next several years doing what product designers trained to do: talk to users. Over 120 of them, in depth, about current usage patterns, pain points, workarounds, and what a better system would need to look like. The product that emerged - a reusable no-touch catheter paired with a portable automated disinfection device - reduces annual catheter consumption from approximately 2,400 units to 24. The disinfection cycle runs 36 minutes. No hospital required.

In 2025, the FDA granted Aurie De Novo clearance, creating an entirely new device classification in the process. No reusable intermittent catheter system had ever existed in the FDA's classification framework. Now one does. The agency labeled the Aurie system a "Safer Technology." The company's next stop: the Veterans Health Administration's spinal cord injury hospitals.

Fast Facts

  • Role CEO & Founder, Aurie
  • Education Harvard BA, SVA MFA
  • Prior J&J Design, JP Morgan
  • Location Oakland, California
  • HQ Syracuse, New York
  • Founded Aurie ~2020
  • Raised $14.24M
  • Team 22 employees
  • Status FDA De Novo Cleared

Career Path

  • 2011 Harvard BA - Social Studies (Honors)
  • 2011-14 Equity Finance Trader, JP Morgan
  • ~2017-19 MFA, School of Visual Arts
  • ~2019-20 Healthcare Solutions Lead, J&J Design
  • 2020 Founded Aurie
  • 2022 FDA Safer Technology designation
  • 2024 Harvard Innovation Grand Prize
  • 2025 FDA De Novo Clearance
2,400 Single-use catheters per user per year (before)
24 With Aurie - a 99% reduction
600K Americans using intermittent catheters
50% UTI risk with sterile single-use catheters

"Our competitors are pretty firmly wedded to the single-use catheter model since it's very profitable."

- Souvik Paul

A No-Touch System for a Contact-Critical Problem

The Aurie system has two components. The catheter itself is engineered for up to 100 uses - polished eyelets to prevent trauma, a no-touch design with an insertion sleeve and introducer tip that protect the sterile surface during use, an articulating support handle. Free of phthalates and BPA. Built for someone whose hands may have limited dexterity.

The second component is a portable disinfector - essentially a washer-disinfector compact enough to travel with. It cleans, disinfects, and lubricates the catheter automatically using tap water and pre-packaged supply pods. Each cycle: 36 minutes. The system is single-user, designed to eliminate cross-contamination.

What the FDA Clearance Actually Means

The De Novo pathway is reserved for novel, moderate-risk devices with no predicate - no existing cleared device to point to as a reference. Aurie had no predicate because nothing like it had ever been cleared before. The FDA designated the system a "Safer Technology," an additional classification that signals the agency views the device as meaningfully safer than existing alternatives. Getting that designation through an entirely new device class, without a comparable device to benchmark against, is the regulatory equivalent of writing the rulebook while taking the test.

The initial clearance covers adult males requiring intermittent bladder drainage. Expanded indications - broader patient populations - are the logical next step.

The Community-Design Model

Paul has been consistent on this point in every interview: Aurie is built with its users, not just for them. Over 120 individual catheter users were interviewed to understand current usage patterns before a product existed. Approximately 60 participated in human factors validation studies as prototypes developed. The company maintains a user advisory board. Aurie actively hires people with disabilities.

Paul calls this "authentic lived experience in design." For a category where every existing competitor has financial reasons to maintain the status quo, that orientation is genuinely differentiated - and functionally important when designing something that needs to work reliably for people with variable motor function, different catheter types, and daily routines built around a problem that doesn't stop on weekends.

Single-Use vs. Aurie - By the Numbers

Status Quo
2,400
catheters / year
vs
Aurie
24
catheters / year

Funding History
2020
$750K
2023
$6.23M
2024
$6M
Total
$14.24M

Key Milestones
2022 FDA Safer Technology Designation
2024 Harvard Innovation Grand Prize ($75K)
2024 MedTech Innovator Program + Remarkable Tech US
2025 FDA De Novo Clearance - Class II, new device category
2025+ VHA spinal cord injury hospital launch
Career Arc

From Trading Desk to Cooper Hewitt to FDA Filing

2011

Graduated Harvard University with BA in Social Studies, High Honors.

2011-14

Equity Finance Trader at JP Morgan Chase - a finance career that would be the first of two major pivots.

2014

Sister-in-law Carina sustains a T2/T3 complete spinal cord injury. Paul spends two weeks in hospital with her - an experience that plants the seed for Aurie six years later.

2017-19

Enrolls at School of Visual Arts for MFA in Products of Design. Thesis: "Unbound: Design for Paralysis and Disability." Selected for display at the Cooper Hewitt Smithsonian Design Museum. Recognized by Core77 and IDSA.

2019-20

Healthcare Solutions Lead at Johnson & Johnson Design, New York City. Works on consumer medical devices and innovation strategy.

2020

Incorporates Aurie. Raises $750K pre-seed led by Lakehouse Ventures. Leaves J&J roughly six months later to pursue it full-time.

2022

Accepted into NEMIC Foundation Accelerator. FDA awards Aurie "Safer Technology" designation. Harvard Launch Lab X GEO accelerator program.

2023

Raises $6.23M Series A. Delivers guest lecture at SVA Products of Design. Total users interviewed for co-design research exceeds 120.

2024

Raises $6M led by Lakehouse Ventures. Wins Harvard President's Innovation Challenge Grand Prize ($75K). Accepted into MedTech Innovator Program and Remarkable Tech US (one of six companies selected globally).

2025

Aurie receives FDA De Novo Clearance - first-ever reusable intermittent catheter system to achieve this classification. New board appointments and CTO promotion follow. VHA launch planned.

Achievements

Recognition Earned the Hard Way

🏛

Cooper Hewitt Smithsonian

MFA thesis "Unbound: Design for Paralysis and Disability" selected for display at the Cooper Hewitt Smithsonian Design Museum - a rare distinction for graduate work.

🏆

Harvard Innovation Grand Prize

Won the Harvard President's Innovation Challenge Grand Prize in 2024 - a $75K grant for Aurie's work on reusable catheter technology.

FDA De Novo Clearance

First-ever reusable intermittent catheter system to receive FDA De Novo clearance. Established a brand-new device classification and received "Safer Technology" designation.

MedTech Innovator 2024

Accepted into the 2024 MedTech Innovator Program - one of the most competitive medtech accelerators globally.

🌍

Remarkable Tech US

Selected as one of six companies globally for the Remarkable Tech US accelerator, focused on assistive and accessible technology.

🎓

IDSA + Core77 Recognition

Work recognized by both the Industrial Designers Society of America and Core77, two of the most prominent voices in industrial design.

Fun Facts

The Details That Don't Fit Anywhere Else

Paul started his career trading equities at JP Morgan before pivoting to get an MFA in industrial design. That's about as far as you can get from catheter systems - which may be exactly why he saw the gap.

Aurie was originally called CathBuddy before the rebrand. The product category is clinical. The original name was refreshingly blunt about what it does.

Paul interviewed over 120 catheter users before a final product existed. He says he obsesses over user research the way other founders obsess over pitch decks.

His LinkedIn bio reportedly references being "obsessed with urinary catheters and helping catheter users avoid urinary tract infections." In a world of vague mission statements, that's specificity as a branding strategy.

Lives in Oakland, California while Aurie is headquartered in Syracuse, New York - two cities with roughly 2,800 miles between them. Remote-first before it was fashionable.

The Aurie system reduces a user's annual catheter count from ~2,400 to just 24 - a 99% reduction in plastic waste alongside the safety improvement. The sustainability angle wasn't the pitch, but it's a compelling side effect.

In His Own Words

What Souvik Paul Actually Says

"Essentially, what we're doing is we're increasing access to the safer life-saving technology by making it safely, automatically, and portably reusable."

"Our whole model is partnering with people living with disabilities to develop products that help improve quality of life, improve health in everyday contexts."

"I never wanted to be an entrepreneur, but I'm here because I believe in the product and the impact that it might have."

"Our competitors are pretty firmly wedded to the single-use catheter model since it's very profitable."

"It's been the hardest thing that I've ever done in my professional and personal life."

"Use design and authentic lived experience to create products that people with disabilities will choose to enhance their lives."

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