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PatenSee initiates clinical trial with Henry Ford Health to validate technology for safer and quicker dialysis care
We are pleased to share that PatenSee has initiated a clinical trial with Henry Ford Health – a key milestone in validating our rapid, non-contact vascular access monitoring technology for dialysis care and advancing toward FDA approval.
In hemodialysis, the vascular access (VA) site—where an artery and a vein are joined—is the patient’s lifeline and must be monitored regularly to prevent complications. However, routine monitoring is time-consuming and performed inconsistently, and VA-related complications remain a leading cause of morbidity and impaired quality of life.
PatenSee’s AI-driven optical monitoring system is the first to provide comprehensive touch-free physiological monitoring per KDOKI guidelines, designed to alleviate the clinical burden of VA monitoring, support early detection of stenosis, and establish a new standard of care in dialysis clinics.
We are excited to collaborate with lead investigators Dr. Lalathaksha Kumbar and Dr. Sandeep Soman on this study and are thankful to Henry Ford Innovations and Michigan Rise for their continued partnership.
Finally, we remain grateful to our syndicate of investors that provide the resources necessary to demonstrate PatenSee’s promise of improved patient outcomes and reduced costs.
Quoting Henry Ford Innovations:
𝗣𝗮𝘁𝗲𝗻𝗦𝗲𝗲 𝗠𝗮𝗸𝗲𝘀 𝗗𝗶𝗮𝗹𝘆𝘀𝗶𝘀 𝗦𝗮𝗳𝗲𝗿, 𝗦𝗺𝗮𝗿𝘁𝗲𝗿, 𝗮𝗻𝗱 𝗠𝗼𝗿𝗲 𝗣𝗮𝘁𝗶𝗲𝗻𝘁-𝗙𝗿𝗶𝗲𝗻𝗱𝗹𝘆
Clinical trials are underway as PatenSee moves toward FDA approval of a device designed to improve the dialysis experience through 𝗳𝗮𝘀𝘁𝗲𝗿, 𝗻𝗼𝗻-𝗰𝗼𝗻𝘁𝗮𝗰𝘁 𝘃𝗮𝘀𝗰𝘂𝗹𝗮𝗿 𝗮𝗰𝗰𝗲𝘀𝘀 𝗺𝗼𝗻𝗶𝘁𝗼𝗿𝗶𝗻𝗴.
Henry Ford Health has signed a clinical trial agreement with 𝗣𝗮𝘁𝗲𝗻𝗦𝗲𝗲, a company developing a 𝗻𝗼𝗻-𝗰𝗼𝗻𝘁𝗮𝗰𝘁 𝗶𝗺𝗮𝗴𝗶𝗻𝗴 𝗱𝗲𝘃𝗶𝗰𝗲 to rapidly monitor patients’ 𝘃𝗮𝘀𝗰𝘂𝗹𝗮𝗿 𝗮𝗰𝗰𝗲𝘀𝘀 (𝗩𝗔)—the critical connection point between the patient and the dialysis machine. This surgically created site, where an artery and a vein are joined, must remain clear and be monitored regularly to ensure safe and effective treatment.
𝗣𝗮𝘁𝗲𝗻𝗦𝗲𝗲 𝗮𝗱𝗱𝗿𝗲𝘀𝘀𝗲𝘀 𝘁𝗵𝗿𝗲𝗲 𝗺𝗮𝗷𝗼𝗿 𝗰𝗵𝗮𝗹𝗹𝗲𝗻𝗴𝗲𝘀 𝗶𝗻 𝘃𝗮𝘀𝗰𝘂𝗹𝗮𝗿 𝗮𝗰𝗰𝗲𝘀𝘀 𝗺𝗼𝗻𝗶𝘁𝗼𝗿𝗶𝗻𝗴:
𝟭. 𝗧𝗶𝗺𝗲 𝗰𝗼𝗻𝘀𝘁𝗿𝗮𝗶𝗻𝘁𝘀: Dialysis clinics are extremely busy. With PatenSee, clinical teams can assess a patient’s VA in one minute, compared to seven minutes using traditional methods.
𝟮. 𝗜𝗻𝗳𝗲𝗰𝘁𝗶𝗼𝗻 𝗿𝗶𝘀𝗸: Direct contact between the patient and the nurse increases the risk of infection. PatenSee is completely touch-free.
𝟯. 𝗜𝗻𝗰𝗼𝗻𝘀𝗶𝘀𝘁𝗲𝗻𝘁 𝗮𝗰𝗰𝗲𝘀𝘀 𝗲𝘅𝗮𝗺𝘀: Manual checks are often suboptimal due to varying clinician techniques and assessment variability.
PatenSee’s 𝗔𝗜-𝗱𝗿𝗶𝘃𝗲𝗻 𝗼𝗽𝘁𝗶𝗰𝗮𝗹 𝘀𝗰𝗮𝗻𝗻𝗶𝗻𝗴 𝗱𝗲𝘃𝗶𝗰𝗲 enables quick, non-invasive VA monitoring—either in the clinic or waiting room. It uses machine learning to analyze scanned data and detect early signs of stenosis, serving as a clinical decision support tool to help prevent complications.
𝗣𝗿𝗲𝗹𝗶𝗺𝗶𝗻𝗮𝗿𝘆 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝘃𝗮𝗹𝗶𝗱𝗮𝘁𝗶𝗼𝗻 in 60 patients over 1.5 years demonstrated results comparable to current standards of care. Building on this success, lead investigators Lalathaksha Kumbar, MD, and 𝗦𝗮𝗻𝗱𝗲𝗲𝗽 𝗦. 𝗦𝗼𝗺𝗮𝗻, 𝗠𝗗, are launching a 𝗽𝗿𝗼𝘀𝗽𝗲𝗰𝘁𝗶𝘃𝗲, 𝗶𝗻𝘁𝗲𝗿𝗻𝗮𝘁𝗶𝗼𝗻𝗮𝗹, 𝗺𝘂𝗹𝘁𝗶𝗰𝗲𝗻𝘁𝗲𝗿, 𝗻𝗼𝗻-𝗶𝗻𝘁𝗲𝗿𝘃𝗲𝗻𝘁𝗶𝗼𝗻𝗮𝗹, 𝘀𝗶𝗻𝗴𝗹𝗲-𝗮𝗿𝗺, 𝗯𝗹𝗶𝗻𝗱𝗲𝗱 𝗳𝗲𝗮𝘀𝗶𝗯𝗶𝗹𝗶𝘁𝘆 𝘀𝘁𝘂𝗱𝘆 with 40 patients at Henry Ford Health.
Henry Ford Innovations has been instrumental in bringing this clinical trial to Henry Ford Health. We’re proud of Dr. Kumbar and Dr. Soman, our partners at Michigan Rise, and the entire PatenSee team as this technology continues to move toward FDA approval and commercial use.
Vascular access–related complications in hemodialysis patients contribute to significant morbidity and reduced quality of life. Routine monitoring remains a challenge in busy dialysis clinics. The integration of PatenSee’s technology is expected to enable early detection and timely intervention, helping to reduce life-threatening complications and the associated financial burden.