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 that OrthodontiCell’s bioelectric technology, which is being developed to accelerate orthodontic tooth movement and improve the treatment experience, is moving closer to a pivotal U.S. clinical trial. If successful, the technology could offer a new way to shorten orthodontic treatment time, a significant benefit for patients and families. However, the technology remains investigational, and 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. For more information, visit OrthodontiCell.
