CLINICAL STUDY
INITIAL STAGE COMPLETE · SUBSEQUENT STAGE IN PREP
Evaluating Crownio
where it matters: in the clinic.
Crownio™ is being evaluated in a prospective clinical study at Carmel Medical Center, assessing the safety and performance of the device directly in clinical use.
This page will be updated directly as the trial progresses.
12
Ministry of Health enrollment cap
Infants Authorized for Enrollment
Single-Arm
Prospective, open-label design
Feasibility Study
Carmel MC
Haifa, Israel
Study Site
Dec 2024
Initial stage complete
Study Start
CLINICAL STUDY
INITIAL STAGE COMPLETE · SUBSEQUENT STAGE IN PREP
Evaluating Crownio
where it matters: in the clinic.
Crownio™ is being evaluated in a prospective clinical study at Carmel Medical Center, assessing the safety and performance of the device directly in clinical use.
This page will be updated directly as the trial progresses.
12
Infants Authorized for Enrollment
Ministry of Health enrollment cap
Single-Arm
Feasibility Study
Prospective, open-label design
Carmel MC
Study Site
Haifa, Israel
Dec 2024
Study Start
Intial stage complete
STUDY SNAPSHOT
The trial, as registered.
STUDY TITLE
Evaluation of safety and performance of the Occipo band¹ in infants with positional skull deformity
Design
Prospective, open-label, single-arm feasibility study
OBJECTIVE
To evaluate the safety and performance of the device
SITE
Carmel Medical Center, Haifa, Israel
START DATE
December 18, 2024
ENROLLMENT
Up to 12 infants (Ministry of Health approved)
¹ The study protocol refers to the device as “Occipo band.” The device is now marketed as Crownio™.
INITIAL STAGE
Feasibility Study
Complete
UPCOMING STAGE
Expanded Evaluation
Expected to begin in 2026
FINDINGS
Publication & Updates
To follow
TRIAL STATUS
Where the trial stands today.
The trial, as registered.
STUDY SNAPSHOT
STUDY TITLE
Evaluation of safety and performance of the Occipo band¹ in infants with positional skull deformity
DESIGN
Prospective, open-label, single-arm feasibility study
OBJECTIVE
To evaluate the safety and performance of the device
SITE
Carmel Medical Center, Haifa, Israel
START DATE
December 18, 2024
ENROLLMENT
Up to 12 infants (Ministry of Health approved)
¹ The study protocol refers to the device as “Occipo band.” The device is now marketed as Crownio™.
TRIAL STATUS
Where the trial stands today.
INITIAL STAGE
Feasibility Study
Complete
UPCOMING STAGE
Expanded Evaluation
Expected to begin in 2026
FINDINGS
Publication & Updates
To follow
Principal INvestigator
Led by a specialist in
pediatric development
Dr. Lilach Shemer-Meiri
Director, Pediatric Neurology Unit
Principal Investigator
Dr. Shemer-Meiri serves as Principal Investigator for the Crownio clinical study.
She is Director of the Pediatric Neurology Unit and the Institute for Child Development at Carmel Medical Center and Clalit Health Services, Haifa and Western Galilee District.
Regulatory & Ethics
Conducted under formal oversight.
Helsinki Approval
0052-24-CMC
Carmel Medical Center Helsinki Committee
Ministry of Health
Enrollment Approved
December 2024
CLINICAL OVERSIGHT
Crownio’s clinical evaluation is being conducted at Carmel Medical Center under Helsinki Committee approval and Ministry of Health enrollment authorization. Following completion of the initial clinical stage, preparations are underway for the subsequent stage, pending Ministry of Health approval.
Principal INvestigator
Led by a specialist in pediatric development
Dr. Lilach Shemer-Meiri
Director, Pediatric Neurology Unit
Principal Investigator
Dr. Shemer-Meiri serves as Principal Investigator for the Crownio clinical study.
She is Director of the Pediatric Neurology Unit and the Institute for Child Development at Carmel Medical Center and Clalit Health Services, Haifa and Western Galilee District.
Regulatory & Ethics
Conducted under formal oversight.
Helsinki Approval
0052-24-CMC
Carmel Medical Center Helsinki Committee
Ministry of Health
Enrollment Approved
December 2024
CLINICAL OVERSIGHT
Crownio’s clinical evaluation is being conducted at Carmel Medical Center under Helsinki Committee approval and Ministry of Health enrollment authorization. Following completion of the initial clinical stage, preparations are underway for the subsequent stage, pending Ministry of Health approval.
Stay in touch
We’ll share meaningful updates as expanded evaluation progresses, including relevant study milestones and published findings when available.
A modern, scalable approach to cranial care built for clinicians, healthcare systems, and the families they serve.
Crownio is not yet available for sale in the United States.
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Crownio™ is a trademark of Occipo Ltd.