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OrthodontiCell Secures Capital to Complete Testing for Planned U.S. Phase II Pivotal Study

By Advos•
OrthodontiCell has secured sufficient capital to complete the remaining testing needed to support its application for a planned Phase II pivotal clinical study in the U.S., advancing its bioelectric technology to accelerate orthodontic tooth movement.
OrthodontiCell Secures Capital to Complete Testing for Planned U.S. Phase II Pivotal Study

OrthodontiCell, Inc. announced today that it has secured sufficient capital to complete the remaining testing needed to support its application to begin a planned Phase II pivotal clinical study in the United States. The funding marks a significant milestone in the company's development of bioelectric technology designed to accelerate tooth movement during orthodontic treatment. OrthodontiCell's approach aims to shorten treatment time and improve the patient experience when used alongside orthodontic care.

With funding in place for this stage, the company can now focus on completing the testing and prepare its regulatory submission seeking authorization to initiate the planned final pivotal U.S. study. The proposed study is intended to evaluate the technology's safety and effectiveness, including its potential to reduce the time required to straighten teeth. Final study design, participating centers, and enrollment timing will be announced in the near future, as the program advances.

"For patients and families, a shorter path to a healthy, confident smile can make a meaningful difference," said Mark Terrill, CEO. "Securing the capital to complete this testing moves OrthodontiCell closer to its next clinical milestone and gives our team the resources to advance the application process." The capital secured covers the remaining testing supporting the planned application. Funding for conducting the pivotal study will be addressed separately.

The news matters because it signals progress in a field where treatment duration remains a major pain point. Traditional orthodontic treatment often takes two years or more, requiring frequent visits and extended discomfort. A technology that safely accelerates tooth movement could reduce both the time and burden on patients, potentially lowering overall costs and improving adherence. For the orthodontic industry, which serves millions of patients annually, such an innovation could disrupt standard practice and create new competitive dynamics.

However, OrthodontiCell's technology remains investigational. Initiation of the planned U.S. study is subject to completion of testing and applicable regulatory and ethics approvals. Statements concerning development plans, treatment benefits, and future milestones reflect current expectations; actual results and timing may differ. The company's progress will depend on regulatory clearance and clinical outcomes.

For now, the secured capital allows OrthodontiCell to advance its regulatory submission and prepare for a pivotal study that, if successful, could bring a faster orthodontic option to market. Further details on the study will be shared as the program advances. More information about the company is available at OrthodontiCell.

Advos

Advos

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