Sbir phase II: miniaturization of a magnetic craniofacial distraction system

This National Science Foundation (NSF) Cooperative Agreement award, provided through the NSF Technology, Innovation, and Partnerships (CFDA #47.084) program, funds the development of a novel, fully implantable craniofacial distraction system by Ostiio LLC, a medical device company based in Philadelphia, PA. The $1,000,000 award aims to produce a magnetic, subcutaneous distraction device capable of gradually correcting skeletal abnormalities affecting craniomaxillofacial functions such as breathing, speech, and mastication. The innovative design eliminates the need for an external component, reducing risks of infection, dislodgement, and noncompliance associated with current distraction devices. Through this project, Ostiio LLC will advance the device's usability, manufacturability, and preclinical validation prior to pursuing regulatory clearances and commercialization. The project builds upon Ostiio's prior federally funded research in craniofacial distraction technologies.

Abstract

The broader impact/commercial potential of this small business innovation research (sbir) phase II project is the first fully implantable, subcutaneous system for treating 200,000 infants born with congenital conditions causing impaired growth of the skull or mandible. These abnormalities affect basic functions including breathing, hearing, speech, visual function, neurologic development, and mastication. Distraction osteogenesis (do) is a widely recognized clinical treatment for craniofacial abnormalities that applies controlled mechanical forces to correct skeletal deficiencies and defects by leveraging the natural ability of the body to regenerate bone. Current semi-externalized mechanical design systems restore functional discrepancies but result in issues with patient comfort and adverse events that rely on caregivers to follow precise treatment protocols that hinder widespread adoption. This project aims to develop the first fully subcutaneous, automated do system for the craniomaxillofacial (CMF) skeleton. Applications include surgical correction of obstructive sleep apnea and temporomandibular joint (TMJ) disorder in the adult population, representing potential markets exceeding $10 billion. This small business innovation research (sbir) phase II project will produce a novel, fully implantable craniofacial distraction system comprised of an implantable, magnetically driven mechanism and an external controller driver. The system aims to significantly improve upon existing distraction osteogenesis surgical designs by removing an external component that protrudes through the patient?s skin using a novel implantable magnetic driver design. The novel design enables manual mechanical device adjustment capable of providing the necessary distraction forces in a safe and reliable manner, while eliminating the principal path of complications and treatment noncompliance. The proposed benefits would reduce the risks of infection, device dislodgement, analgesic use, patient stigma, required manual operation, and treatment noncompliance. This project aims to reduce the key critical remaining engineering design risks including system usability issues prior to clinical use and manufacturability. Upon completion of the project, the prototypes will undergo in vivo testing in preclinical models prior to human use. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the foundation's intellectual merit and broader impacts review criteria.- subawards are not planned for this award.