FDA-Cleared Lotus Catheter Accelerates Global Expansion, Backed by Peer-Reviewed Zero-UTI Study and 500,000+ Uses

Non-balloon catheter observed zero UTIs in a 50-patient study at the University of South Florida; >500,000 uses worldwide; company selectively finalizing distributor partnerships and scaling manufacturing to meet demand

LARGO, Fla., Oct. 2, 2025 /PRNewswire/ -- Lotus Medical Technologies LLC today announced the next phase of global expansion for the Lotus® Catheter, an FDA-cleared urinary catheter that replaces the traditional Foley balloon with soft, collapsible wings engineered to minimize trauma and promote near-complete bladder emptying, the primary risk factor for Catheter-associated Urinary Tract Infections (CAUTIs). The company is actively engaged with multiple qualified distributors and is selectively finalizing partnerships across North America, MENA, Europe, and Asia, while advancing manufacturing scale-up with top-tier partners.

Why hospitals and distributors are reevaluating the Foley catheter. The Foley catheter has undergone little change since its invention in 1933 and remains the standard, despite well-documented complications. According to guidance from the International Society for Infectious Diseases (ISID), ~70% of ward UTIs and ~95% of ICU UTIs are linked to indwelling catheters¹. CAUTIs are among the most common hospital-acquired infections and can result in unreimbursed costs of $4,000–$10,000 per case, as well as an extended length of stay and quality penalties.

The CDC notes that CAUTI-related complications drive patient discomfort, prolonged hospitalization, higher costs, and increased mortality². Researchers estimate that even a 50% CAUTI reduction via better catheter design could save ~£500 million annually in the UK and ~$18 billion in the US, preventing 1,000+ and 5,000 deaths respectively each year³.

How Lotus is different. The Lotus Catheter addresses root causes of CAUTI by eliminating the balloon—a frequent source of residual urine, irritation, and injury—and using soft, compressible wings for atraumatic retention. In a peer-reviewed, 50-patient prospective study at the University of South Florida, clinicians observed 0 catheter-associated UTIs, a mean post-void residual of ~4.8 mL, no gross hematuria on insertion, and insertion/removal times measured in seconds⁴. To date, over 500,000 Lotus catheters have been used worldwide, reinforcing performance in real-world practice. Key highlights include:

• Residual urine (infection risk): Lotus ~4.8 mL mean residual vs. Foley ~50–100 mL commonly trapped by the balloon—less pooling means fewer bacterial growth opportunities.
• Infections: Lotus: 0 CAUTIs observed in a 50-patient study vs. Foley: symptomatic UTIs commonly reported even in short-term use; indwelling use is a major driver of ward/ICU UTIs.
• Trauma & comfort: Lotus:no gross hematuria on insertion; removal discomfort ~2/10; soft wings compress if tugged to reduce injury risk. Foley: balloon/shaft irritation is associated with pain, bleeding on removal, and bladder spasms.
• Workflow: Lotus: insert/remove in seconds, no balloon inflation/deflation step. Foley: adds balloon steps and potential error/delay.

The device is FDA‑cleared for continuous drainage (including continuous bladder irrigation) and intermittent catheterization via urethral, suprapubic, or nephrostomy access, in 8–26 Fr sizes (patients ≥5 years), allowing it to replace Foley, straight, and Malecot use cases with a single platform.

"It's been nearly a century since the Foley set the standard," said Said I. Hakki, MD, PhD, Founder & CEO. "By replacing the balloon with soft wings, Lotus addresses residual urine and balloon-related trauma while keeping clinical workflow familiar. Our focus is scaling with the right partners to deliver consistently improved outcomes globally."

Dr. Hakki is a globally recognized urologist, former professor, and inventor known for groundbreaking clinical innovations and public service. As a 27-year-old urology resident, he invented the modern-day inflatable penile implant. Since its acquisition by American Medical Systems (AMS)(owned by Pfizer in 1983), the device has generated more than $2 billion in global sales.

To support growing demand, Lotus is expanding production capacity with leading manufacturing partners, ensuring quality, supply redundancy, and timely availability for large health systems and tenders.

"Hospitals want a safer, simpler alternative to balloon-based catheters," said Khalid Raoof, Chief Operating Officer. "Lotus delivers fast, straightforward use, compressible wings that are gentle if tugged, and near-complete bladder emptying, exactly the factors tied to lower infection and injury risk. We're now selectively partnering with distributors positioned to support clinical education and scale responsibly."

The Lotus Catheter addresses longstanding pain points of urinary catheterization—infection, discomfort, and injury—with a design that improves core functionality while eliminating the Foley's flaws. By virtually eradicating residual urine and doing away with the injurious balloon, Lotus offers safer and more comfortable care. The Lotus Catheter is a long-awaited leap forward, "not just an improvement, but a revolution" in urinary care.

About Lotus Medical Technologies LLC

Lotus Medical Technologies LLC develops the Lotus® Catheter, a non-balloon urinary catheter designed for simple insertion/removal, minimal trauma, and near-complete bladder emptying. Learn more at www.lotus-catheter.com.

Media & Partnerships: [email protected]

Forward-Looking Statements: This release contains forward-looking statements regarding manufacturing scale-up and distribution plans. Actual results may differ due to regulatory, operational, or commercial factors.

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¹ https://isid.org/guide/hospital/urinary-tract-infections/#:~:text=
²https://www.cdc.gov/nhsn/pdfs/pscmanual/7psccauticurrent.pdf#:~:text=meningitis%20in%20patients,5
³https://www.tandfonline.com/doi/full/10.3109/03091902.2015.1085600
⁴https://www.gavinpublishers.com/article/view/the-lotus-catheter-a-non-balloon-novel-urethral-catheter-a-prospective-study#

SOURCE Lotus Medical Technologies LLC