PatenSee

PatenSee is a clinical-stage MedTech company building a non-contact, AI-driven optical monitoring system to detect vascular access stenosis early in hemodialysis patients, with the goal of improving outcomes and reducing clinic burden while moving toward commercial launch after clinical trials and regulatory clearance[1][2].

High-Level Overview

• Mission: PatenSee aims to protect dialysis patients’ vascular access (“the fistula”) by delivering standardized, non-contact physiological monitoring that enables earlier detection of stenosis and timely intervention[1][5].
  - Investment philosophy / Key sectors / Impact on the startup ecosystem: Not an investment firm — PatenSee is a medical device company operating in renal care/medical devices, imaging, and AI for healthcare; its activities (seed funding, clinical pilots, and regulatory progress) attract MedTech investors and can accelerate innovation in dialysis monitoring and care pathways[1][3].
  - Product and customers: PatenSee builds a contactless multi‑modal imaging system combined with machine learning that delivers a standardized assessment of vascular access in roughly 1–2 minutes for dialysis clinics and care teams[2][5].
  - Problem solved: The system addresses variability, subjectivity, infection risk and time burden of manual fistula checks by nurses and aims to increase sensitivity/specificity for early stenosis detection to prevent complications and costly interventions[5][2].
  - Growth momentum: PatenSee has completed a $2M seed round led by Michigan Rise with participation from Spark Capital and others, established US headquarters in Michigan, initiated a clinical pilot with Fresenius Medical Care, and in Sept 2025 received FDA Breakthrough Device designation to accelerate development[1][3].

Origin Story

• Founding and background: PatenSee was founded at the MEDX Xelerator (an Israeli MedTech venture studio supported by the Israeli Innovation Authority) and operates out of Or Yehuda, Israel, and Detroit, Michigan[1][5].
  - Founders / leadership: Public materials highlight that PatenSee emerged from the MEDX Xelerator and in 2024–2025 appointed Paul Neeb, an early‑stage CEO and start‑up veteran, as CEO to lead U.S. clinical trials and commercialization[1].
  - How the idea emerged: The company was created to address persistent challenges in dialysis clinics—busy workflows, painful/contact-based checks, and subjective assessments—by using optical imaging plus AI to reproduce and standardize the “look, listen, feel” assessment non‑contact and faster[5][2].
  - Early traction / pivotal moments: Key early milestones include seed funding (~$2M), a clinical pilot with Fresenius Medical Care, establishment of U.S. headquarters, and FDA Breakthrough Device designation granted in Sept 2025 for their non‑contact vascular access management system[1][3].

Core Differentiators

• Multi‑modal, contactless imaging + AI: Combines advanced optical 3D imaging and machine learning to detect evolving “fingerprints” of stenosis over time rather than single subjective checks[2].
  - Speed and standardization: Designed to deliver an objective assessment in 1–2 minutes versus typical 7–8 minute manual checks, reducing clinic time per patient and variability between examiners[5][2].
  - Alignment with guidelines: The system is developed to provide comprehensive physiological monitoring aligned with KDOQI (kidney disease) guidance when used with its ML analytics[1][3].
  - Clinical partnerships and regulatory pathway: Active clinical pilots (including with Fresenius Medical Care) and an FDA Breakthrough Device designation position PatenSee for an accelerated regulatory pathway and early-adopter clinical validation[1][3].
  - Reduced infection/pain risk: Contactless approach eliminates direct touch during monitoring, addressing infection risk and patient discomfort inherent to manual palpation and auscultation[5].

Role in the Broader Tech Landscape

• Trend fit: PatenSee rides two converging trends — AI-enabled medical imaging and remote/automated monitoring in chronic care — which aim to shift diagnostics from subjective clinician-dependent processes to objective, repeatable, data-driven workflows[2].
  - Timing: Increasing focus on reducing hospitalizations and costs in chronic disease management, plus regulatory pathways that favor high‑impact innovations (e.g., FDA Breakthrough designation), make dialysis monitoring a receptive market for effective automated tools[3].
  - Market forces: Aging populations, rising dialysis prevalence, and the high morbidity/cost of vascular access failures create demand for tools that extend access life and reduce interventions; dialysis providers and large networks are potential early customers and trial partners[1][5].
  - Influence on ecosystem: If validated clinically and adopted, PatenSee could standardize vascular access surveillance, lower clinician workload, and stimulate further investment in contactless physiological monitoring and AI-driven point-of-care devices in nephrology and other specialties[2][1].

Quick Take & Future Outlook

• Near term (12–24 months): Expect expansion of clinical trials in the U.S. following the pilot with Fresenius, continued refinement of ML algorithms with longitudinal data, and regulatory milestones driven by the FDA Breakthrough Device pathway[1][3].
  - Medium term (2–4 years): Commercial launch (targeted by PatenSee for 2026 in prior communications) would center on deployment in dialysis clinics and integration into care workflows; reimbursement strategy and real‑world performance will determine adoption speed[1].
  - Key trends that will shape outcomes: Demonstrated clinical sensitivity/specificity versus existing surveillance methods, ease of integration into busy clinic workflows, cost-effectiveness (reduction in interventions/hospitalizations), and regulatory/reimbursement progress. FDA and large dialysis providers’ adoption decisions will be pivotal[3][1].
  - How influence might evolve: Success could position PatenSee as a category leader in contactless vascular access monitoring, catalyzing broader use of non‑contact AI imaging in other outpatient monitoring applications and strengthening ties between MedTech innovators and dialysis providers[2][5].

Quick reminder: The PatenSee system is investigational and not yet FDA‑approved for sale in the U.S.; current information is drawn from company materials, press releases and regulatory announcements cited above[5][1][3].