One silicone urinary catheter with no balloon, cleared by the FDA through 510(k) for the same indications as Foley, Malecot and straight catheters. We are growing a worldwide network of distribution partners ready to act quickly.
Territory-based partnerships for medical device distributors who already have strong hospital relationships, in the U.S. or internationally.
Distributor partnershipFDA-cleared catheter technology ready for your formulary, in line with CAUTI reduction mandates and within existing CMS quality-program frameworks.
GPO & health system partnershipPatients in skilled nursing facilities have the highest catheter-associated readmission rates of any care setting. Lotus is designed to tackle the structural factors linked to infection.
SNF & long-term care partnershipThe Foley catheter’s basic design has stayed the same since 1933. CAUTIs are still the most frequent device-associated infection in hospitals, and a cost burden that no health system in the world has solved.
The global urinary catheter market is expected to grow from $6.17B to about $11B by 2033.3 One Lotus device covers around 100% of catheter indications.
The only FDA 510(k)-cleared silicone urinary catheter that holds itself in place with self-deploying wings rather than an inflatable balloon. Patents running to 2045 protect that exclusivity for the long term.
Independent researchers calculated that achieving even half of a better catheter’s potential would save around $18B a year in the U.S.5
Sizes, catalog numbers, materials, flow rates and ordering information.
Every hospital discussion ends up at the same two questions: clinical outcomes and financial impact. Below is the cost burden Lotus is designed to address, and the readmission cycle that makes it worse.
Median cost of a single CA-UTI episode, from 2.5M published patient encounters. CMS treats CAUTI as a “never event”, so hospitals carry the entire cost.9
Typical additional length of stay per CAUTI, which directly affects bed availability and patient throughput.4
CAUTI counts toward CMS Hospital-Acquired Condition penalties, putting up to 1% of total Medicare reimbursement at risk.6
Each CAUTI needs a full course of antimicrobials,7 the leading risk factor for C. difficile, at around $24,000 per episode.8
One-year all-cause readmission rate for CA-UTI patients. Every readmission opens a new episode that is not reimbursed.9
Higher odds of 60-day readmission for catheterized patients with complicated UTI (OR 1.62, 95% CI 1.07–2.45).10
Business advantages that count for your company, beyond the clinical talking points.
The only FDA 510(k)-cleared silicone urinary catheter that uses self-deploying wings instead of a balloon to stay in place. Patents running to 2045 protect your territory’s exclusivity for the long term.
One device replaces three types of catheter, which simplifies inventory, purchasing and clinical training for the hospitals you supply.
Hospital finance leaders are actively looking for CAUTI solutions. Because CMS does not reimburse CAUTI, the need is urgent, and your pitch gets easier.6
Tell us about your market, your existing relationships and your distribution capabilities. You will hear back within 48 hours.
Reply within 48 hours Send your inquiryTogether we review the market opportunity, the regulatory pathway and the go-to-market plan. We provide clinical data packages and product samples.
Clinical data & samples providedAn agreed territory, performance milestones, and continuing commercial and regulatory support from Lotus.
Territory & milestones agreedStudy summaries, comparison charts and evidence briefs for procurement teams.
Spec sheetEvaluation units for clinical demos and hands-on testing.
Insertion guides, video walkthroughs and clinical education for your team.
Help with dossiers for local submissions, based on the FDA 510(k) K191512 documentation.
ISO 13485 manufacturing with the capacity to supply national and international distribution.
Co-branded collateral, trade-show assets and digital marketing tailored to your market.
In the dataset, SNF patients with catheter-associated UTI have the highest readmission rates of any care setting. Today’s CAUTI bundles concentrate on duration, hygiene and removal protocols. Lotus is a silicone urinary catheter designed to tackle the structural factors linked to catheter-related infection: pooled residual urine, constant pressure on the trigone, and traumatic removal.
Seen in a 50-patient prospective clinical trial. Designed to tackle the structural factors linked to catheter-related infection.1
Each dot is one patient. Two separate studies shown side by side, not a head-to-head comparison.
The same insertion technique as a Foley, so staff need no extra training
Reimbursed under existing HCPCS codes (A4344/A4340), with no new billing pathway
Wings fold at about 1 lb of pull-out force, designed to limit urethral trauma in confused or agitated patients
Fits within the quality frameworks of the CMS Hospital Readmissions Reduction Program
Lotus supports the outcomes your member hospitals are already measured against: CAUTI rates, HAC penalties, antibiotic stewardship and patient safety scores.
A single device replaces Foley, straight and Malecot catheters, cutting SKU complexity, training variation and procurement overhead across member facilities.
CAUTI is a core metric of the HAC Reduction Program, and hospitals in the bottom quartile lose 1% of Medicare reimbursement. Lotus is designed to address a structural mechanism behind catheter-associated infection.6
Billed under CPT 51702, the same code as the Foley. Same insertion technique, same drainage bags, no new training, and peer-reviewed clinical data ready for value analysis committees.1
Whether you are a distributor bringing Lotus to your market, a GPO looking at CAUTI outcomes and cost exposure, or an SNF focused on catheter-associated readmissions, we would like to hear from you.