Companies / Kilele Health

Medical device company profile

Kilele Health

Ohio medical device developer creating wearable aptamer biosensors for continuous monitoring of blood biomarkers beyond glucose.

Medical Device DeveloperDiagnostics & ImagingPhysiological Assessment

Headquarters🇺🇸Oakwood, Ohio, United States

Founded2021

Commercial statusIn developmentPre-market wearable biosensor platform; company reported animal-model validation and preparation for human studies.

Employees2–10 ^[5]LinkedIn company-size range · Checked 2026-11-02

Estimated revenueNot confirmed

Disclosed funding$999,758 ^[9]2024 award for in-vivo validation of a volume-manufacturable, factory-calibrated wearable NT-proBNP monitoring system. This is one grant award, not cumulative company funding or disbursements.

Official websitewww.kilelehealth.com ↗

Company overview

Kilele Health is an Ohio medical wearables company developing the SunVida biosensing platform. Its aptamer-based sensors are designed to measure molecular biomarkers over extended wear periods and provide information to patients and clinical care teams.

Its current programs include phenylalanine monitoring for phenylketonuria and metabolic management, alongside work on heart-failure biomarkers. The platform uses a glucose-monitor-style device format to translate biochemical measurements into longitudinal monitoring data.

In March 2025, Kilele reported a ten-day sensor-performance demonstration in a porcine model and described itself as a pre-market company preparing for human studies. Its development has received support from the National Science Foundation and National Institutes of Health.

^{[1][2][4][5][9]}

Leadership

3 people

Andrew CothrelChief Executive Officer and Co-Founder ^[4][6]

Jason HeikenfeldChief Technology Officer and Co-Founder ^[4][7]

Sven SchreiberChief Product Officer ^[4][8]

Products & regulatory status How does MedTechIndex get this information?

Summary

SunVida is a pre-market wearable biosensor platform. Kilele's March 2025 announcement described animal-model validation and preparation for human studies. ^[2]

Regulatory snapshot How to read this snapshot

U.S. FDA

—
510(k) clearances: —
De Novo grants: —
PMA approvals: —
Recall events

Latest recorded source review: 2026-11-02.

Scope: selected product families.

Commercial portfolio snapshot

No commercially marketed product portfolio has been established in the reviewed material.

Commercial development

Kilele Health SunVida wearable biosensor concept rendering — Image: Kilele Health · official platform rendering

SunVida wearable biosensor platform ↗

Development-stage wearable aptamer biosensing platform intended to monitor molecular biomarkers beyond glucose. Programs include phenylalanine measurement and monitoring of biomarkers relevant to heart-failure management. ^[1][3][2][9]

Development-stage / pre-market