Oral BioLife Announces First-in-Human Clinical Trial of Ambrilux™ Dental Gel for Periodontal Bone Regeneration
Breakthrough piezoelectric therapy enters clinical development, targeting the $30 billion periodontal disease market
DENVER, CO – [Month] [Day], 2026 – Oral BioLife, Inc., a regenerative medicine company developing piezoelectric therapies for bone regeneration, today announced the initiation of its first-in-human (FIH) clinical trial of Ambrilux™ Dental Gel for the treatment of periodontal bone loss.
Ambrilux is a first-in-class, injectable, light-curable gel that harnesses the body's natural mechanical forces to regenerate bone lost to periodontal disease. The proprietary piezoelectric scaffold converts everyday chewing motion into localized bioelectrical signals that activate physiological bone formation—without drugs, growth factors, or invasive surgery.
"This is a pivotal moment for Oral BioLife and for the millions of patients suffering from periodontal bone loss," said Gregory Ambra, CEO and Co-founder of Oral BioLife. "Ambrilux represents a fundamentally new approach to regeneration—one built on physics rather than pharmacology. We're excited to bring this technology to patients and demonstrate its potential to transform the standard of care."
Trial Design
The Phase 1 clinical trial is a prospective, randomized, controlled study designed to evaluate the safety and preliminary efficacy of Ambrilux Dental Gel in adults with moderate-to-severe periodontal bone defects. Key details include:
- Enrollment: Approximately 40 patients across multiple U.S. clinical sites
- Primary Endpoint: Safety and tolerability at 6 months
- Secondary Endpoints: Bone fill measured by radiographic assessment, clinical attachment level, and probing depth reduction
- Duration: 12-month follow-up period
"The unmet need in periodontal regeneration is significant," said Dr. Stella Vnook, President of Oral BioLife. "Current surgical approaches are invasive, expensive, and yield inconsistent results. Ambrilux offers the potential for in-office, non-surgical bone regeneration—a true paradigm shift for periodontists and their patients."
Mechanism of Action
Ambrilux leverages Oral BioLife's proprietary piezoelectric regenerative platform. When applied to a periodontal defect, the biocompatible scaffold converts ambient mechanical forces—generated by normal chewing, speaking, and jaw movement—into electrical microcurrents that mimic the body's natural bone-healing signals.
This approach is supported by decades of research demonstrating that mechanical loading and bioelectrical signaling are fundamental to bone homeostasis and repair. In pre-clinical studies, Oral BioLife's piezoelectric scaffolds achieved 100% bone regeneration response in validated canine models of periodontal disease.
Market Opportunity
Periodontal disease affects approximately 47% of American adults over age 30, with severe periodontitis impacting more than 1 billion people globally. The condition is the leading cause of tooth loss in adults and has been linked to systemic health issues including cardiovascular disease, diabetes, and cognitive decline.
The global periodontal therapeutics market exceeds $30 billion annually, yet no approved therapy predictably regenerates periodontal bone without surgery. Ambrilux is positioned to address this substantial unmet need.
Regulatory Pathway
Oral BioLife is pursuing FDA clearance for Ambrilux through the De Novo pathway, appropriate for novel devices with new mechanisms of action that do not have a valid predicate. The company expects to complete the FIH trial in 2027, with U.S. commercial launch targeted for the second half of 2027, pending regulatory approval.
About Oral BioLife
Oral BioLife is building the mechanical foundation for the next generation of regenerative medicine. The company's piezoelectric regenerative platform converts endogenous mechanical forces into localized bioelectric signaling that activates physiological bone formation. Oral BioLife's lead human product, Ambrilux™ Dental Gel, is in clinical development for periodontal bone regeneration. The company's veterinary product, Restoris™, launched in partnership with Phibro Animal Health Corporation in 2025. Oral BioLife is headquartered in Denver, Colorado.
For more information, visit www.oralbiolife.com.
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