Partnership Opportunities

Lotus®: Beyond the balloon

The first balloon-free urinary catheter FDA 510(k)-cleared for the same indications as the Foley, Malecot, and straight catheter — in a single device. We're building a global network of distribution partners who can move decisively.

$6B+
Global Catheter Market
500K+
Units Deployed
3-in-1
Foley · Straight · Malecot
2045
Patent Protection
Market Opportunity
A category-defining invention in a specialty that hasn't seen one in 90 years
The Foley catheter hasn't fundamentally changed since 1933. CAUTIs remain the most common device-associated infection in hospitals — an unaddressed cost burden across every health system globally.
6.6%
CAGR Through 2033
Global urinary catheter market projected from $6.17B to ~$11B by 2033.3 Lotus addresses ~100% of catheter indications in a single device.
Zero
Direct Competitors
No other balloon-free catheter has received FDA 510(k) clearance for the same indications. Patent protection through 2045 secures long-term exclusivity.
$18B
Est. U.S. Savings Potential
Independent researchers estimated that even 50% of a better catheter's potential would save ~$18B annually in the U.S.5


The Financial Case
The numbers your hospital contacts care about
Every hospital conversation comes down to clinical outcomes and financial impact. Here's the cost burden Lotus is designed to address — and the readmission cycle that compounds it.
$9,496
Median cost per CA-UTI episode — published from 2.5M patient encounters. CMS classifies CAUTI as a "never event"; hospitals absorb the full cost.9
2–4 extra days
Average extended length of stay per CAUTI — directly impacting bed availability and throughput.4
1% Medicare risk
CAUTI factors into CMS Hospital-Acquired Condition penalties — up to 1% of total Medicare reimbursement at risk.6
7–14 days antibiotics
Each CAUTI requires a full antimicrobial course7 — the leading risk factor for C. difficile, which costs ~$24,000/episode.8
42%
All-cause readmission rate for CA-UTI patients within one year — each readmission generating a new unreimbursed episode.9
62%
Higher odds of 60-day readmission for catheterized complicated UTI patients (OR 1.62, 95% CI 1.07–2.45).10

For Distributors
Why partners choose Lotus
Commercial advantages that matter to your business — not just clinical talking points.
Only FDA-cleared alternative
No direct competitor exists. Patent protection through 2045 secures long-term exclusivity for your territory.
3-in-1 SKU efficiency
One device replaces three catheter types — simplifying inventory, procurement, and clinical training for your hospital accounts.
CMS penalty tailwind
Hospital CFOs are actively seeking CAUTI solutions. CMS non-reimbursement creates urgency that makes your pitch easier.6
How It Works
1
Initial Inquiry
Submit your market, existing relationships, and distribution capabilities. We respond within 48 hours.
2
Evaluation & Alignment
Joint market opportunity review, regulatory pathway, and go-to-market plan. Clinical data packages and product samples provided.
3
Partnership Agreement
Defined territory, performance milestones, and ongoing commercial and regulatory support from Lotus.
What We Provide
Clinical Data Package
Study summaries, comparison charts, evidence briefs for procurement teams.
Spec Sheet →
Product Samples
Evaluation units for clinical demonstrations and hands-on assessment.
Training Materials
Insertion guides, video walkthroughs, clinical education for your team.
Regulatory Support
Dossier assistance for local submissions using FDA 510(k) K191512 documentation.
Supply Chain
ISO 13485 manufacturing with capacity for national and international distribution.
Co-Branding
Co-branded collateral, trade show assets, and digital marketing for your market.

For Skilled Nursing Facilities

Reduce readmissions at the source — not with another protocol.

SNF patients with catheter-associated UTI face the highest readmission rates of any care setting in the dataset. Current CAUTI bundles focus on duration, hygiene, and removal protocols. Lotus is the first FDA-cleared catheter designed to eliminate the structural causes of infection: residual urine pooling, sustained trigone pressure, and traumatic removal.
44%
SNF All-Cause Readmission
All-cause readmission for CA-UTI patients discharged from skilled nursing facilities — the highest of any care setting.9
26%
SNF UTI-Specific Readmission
SNF patients readmitted specifically with a UTI diagnosis within one year.9
0%
Lotus CAUTI Rate
Observed in 50-patient prospective clinical trial. Designed to eliminate the structural causes of catheter-associated infection.1
Same insertion technique as Foley — no additional staff training required
Reimbursed under existing HCPCS codes (A4338/A4340) — no new billing pathways
Wings collapse at ~3 lbs of pull-out force — designed to prevent urethral trauma in confused or agitated patients
Addresses CMS Hospital Readmissions Reduction Program exposure directly at the device level

For GPOs & Health Systems
A CAUTI reduction tool that pays for itself
Lotus aligns with the metrics your member hospitals are already measured on — CAUTI rates, HAC penalties, antibiotic stewardship, and patient safety scores.
Formulary Consolidation
One device replaces Foley, straight, and Malecot catheters — reducing SKU complexity, training variance, and procurement overhead across member facilities.
CMS Penalty Mitigation
CAUTI is a core metric in the HAC Reduction Program. Hospitals in the bottom quartile lose 1% of Medicare reimbursement — Lotus addresses a structural root cause of catheter-associated infection.6
Antibiotic Stewardship Alignment
Every CAUTI prevented is 7–14 days of antibiotics avoided — reducing C. difficile risk and resistance pressure. Balloon-free retention is also designed to eliminate balloon-induced spasms and downstream anticholinergic prescriptions.7,8
Zero Adoption Friction
Billed under CPT 51702 — the same code as Foley. Same insertion technique, same drainage bags, no new training. Peer-reviewed clinical data packaged for value analysis committees.1
Partner Profile
Who we work with
Distributors
Established relationships with hospital procurement, urology, or ICU decision-makers
Medical device distribution infrastructure and logistics in your market
Regulatory registration experience for Class II medical devices
Track record introducing new medtech products — not just maintaining legacy portfolios
Interest in long-term category exclusivity with patent protection through 2045
GPOs & Health Systems
Active CAUTI reduction initiative or quality improvement program
Member hospitals with HAC penalty exposure or high catheter utilization
Value analysis committee open to evaluating new technology
Interest in formulary standardization across member facilities
SNFs & Long-Term Care
Residents with indwelling catheters and recurring UTI-related readmissions
Exposure to CMS Hospital Readmissions Reduction Program penalties
Infection prevention leadership open to device-level interventions beyond bundled protocols
Interest in evaluating a pilot program with clinical outcome tracking
Get Started
Ready to partner with Lotus?
Whether you're a distributor bringing Lotus to your market, a GPO evaluating a CAUTI reduction solution, or an SNF looking to reduce catheter-associated readmissions — we'd like to hear from you.
Start a Partnership Conversation
Or reach us directly at
Distribution territories are actively being assigned — early partners gain priority market access.
References
  1. Lockhart J, Boyle A, Kidd LC, et al. The Lotus Catheter: a Non-Balloon Novel Urethral Catheter — a Prospective Study. J Urol Ren Dis. 2017;125. View study →
  2. Saint S, Trautner BW, Fowler KE, et al. A Multicenter Study of Patient-Reported Infectious and Noninfectious Complications Associated With Indwelling Urethral Catheters. JAMA Intern Med. 2018;178(8):1078-1085. View study →
  3. Urinary Catheter Market Report, 2024–2033. Market research estimates; $6.17B (2024) to ~$11B (2033), 6.6% CAGR.
  4. Agency for Healthcare Research and Quality (AHRQ). CAUTI Toolkit for Reducing CAUTI in Hospitals. ahrq.gov →
  5. Feneley RCL, Hopley IB, Wells PNT. Urinary catheters: history, current status, adverse events and research agenda. J Med Eng Technol. 2015;39(8):459–470.
  6. CMS Hospital-Acquired Condition (HAC) Reduction Program. 42 CFR §412.172.
  7. Hooton TM, Bradley SF, Cardenas DD, et al. Diagnosis, Prevention, and Treatment of CAUTI in Adults: 2009 International Clinical Practice Guidelines. Clin Infect Dis. 2010;50(5):625–663.
  8. Armstrong EP, Pham J, Lal LS, Jiang Y. A systematic review of real-world healthcare resource use and costs of Clostridioides difficile infections. Antimicrob Steward Healthc Epidemiol. 2023;3(1):e17.
  9. Judy MT, et al. Descriptive Analysis of Healthcare Resource Utilization and Costs Associated with Treatment of Urinary Tract Infections in U.S. Hospitals. Am J Infect Control. 2021;49(10):1281–1287. DOI: 10.1016/j.ajic.2021.04.009. Premier Healthcare Database, 2,516,936 patients (Jan 2013–Oct 2017). Figures used: 42% all-cause / 24% UTI-related 1-year readmission; SNF subgroup 44% / 26%; $9,496 median cost per CA-UTI episode.
  10. Babich T, Zusman O, Jeganathan N, et al. Risk factors for hospital readmission following complicated urinary tract infection. Scientific Reports. 2021;11:6926. DOI: 10.1038/s41598-021-86246-7. N=742 cUTI patients. Indwelling catheter insertion: OR 1.62 (95% CI 1.07–2.45) for 60-day readmission.
  11. Merchant S, Engel T, Engel-Nitz N, et al. Epidemiology, Microbiology and Outcomes of Catheter-Associated Urinary Tract Infection. Open Forum Infect Dis. 2017;4(suppl_1):S348. Premier Healthcare Database (2013–2015). Figures: 8.4-day mean LOS, 23.2% ICU admission, 3.6% vs 1.6% unadjusted mortality (>2-fold increase).