Rytek Medical Inc

Impedance-based Bone Health Characterization for Predictive Osseointegration and Patient-specific Treatment - Project Summary/abstract Clinical Importance: Almost 15 Million Dental Implants Were Placed Worldwide in 2021, With 3 Million of These Procedures Taking Place in the United States. Implants Have Been Linked to Maintaining Proper Nutrition Intake, Chewing Ability, and Quality of Life, Particularly Essential for a Rapidly Aging Population. the Demand for Implants Is Projected to Increase Up to 23% by 2026, With the Largest Rise Expected Among Those Aged 65-74 Years – Patients With the Highest Bone Quality Variability. While Bone Quality and Conditions Such as Periodontal Disease Can Complicate Treatment in Older Patients, Recent Studies Emphasize That Age Is Not a Contraindication for Implants. Instead, Successful Outcomes Rely More on the Quality of Bone at the Implant Site Than on Age Alone, Underlining the Need for Accurate and Effective Implant-site Bone Assessment. Patient Bone Integrity Is Key to Planning Treatment, Selecting the Right Implant, and Using Adjunctive Procedures and Postoperative Loading Protocols to Ensure Successful Osseointegration and Long-term Stability. Clinical Limitations: Despite the Widespread Use of Cone Beam CT (CBCT) for Preoperative Anatomic Assessment, Significant Challenges Remain in Accurately Quantifying Bone Quality From Hounsfield (HU) Measurements. Specifically, CBCT Struggles to Visualize Boney Microstructures, Particularly in Trabecular Cancellous Bone Which Has Increasingly Been Recognized as Critical for Implant Loading, Stability and Overall Osseointegration. While Dental Implants Have a High Overall Success Rate, Early Loading and Instability Can Lead to Failure in 5-10% of Cases, With Increasing Risks in Those Aged Over 50. Specific Objectives: This Proposal Aims to Design and Evaluate an Impedance-based Bone Assessment Technology for Characterizing Key Trabecular Bone Microarchitecture. Specifically, We Aim to 1) Manufacture and Validate Custom Impedance Sensing Drill Bit-based Hardware for Implant Site Assessment (aim 1), 2) Characterize Trabecular Bone Microarchitecture to Investigate Correlations Between Each Individual Micro-ct Bone Parameters (BV/TV, TBTH, TBN, TBSP, Smi) and Impedance Features Ex Vivo Using the New Hardware From Aim 1 (aim 2), and 3) Evaluate Feasibility of the Device and Impedance Correlations in a Cadaver Model to Inform a Larger Phase Ii Study, as Well as Quantify Classification Performance of the Aim 2 Optimized Impedance and Trabecular Architectural Features (aim 3). Such a Capability Could Be Transformative for Delivering Personalized Treatment Plans Improve Osseointegration Predictability, Ultimately Maximizing Outcomes While Expanding Treatment Accessibility for Aging Patients. Career Development: Successfully Leading This Project as a First-time Pi Will Enable DR. Everitt to Transition Into Full-time Entrepreneurship and Executive Leadership Under the Guidance of a Multidisciplinary Mentorship Team. Her Unique Combination of Expertise in Bioimpedance, Patient-centered Design, and Entrepreneurial Ambition Makes Her an Ideal Candidate for This Opportunity. the Program Will Be a Crucial Catalyst in Her Transition From Postdoctoral Researcher to Full-time Business Leader. With This Support, She Aims to Lead the Technology Through Fda Approval Within Five Years, Ultimately Enhancing Quality of Life for Geriatric Patients.