Ostiio: A Smart, Fully-Implantable CMF Distractor

Each year >200K newborns suffer from conditions that restrict growth of the skull or jawbone. Left untreated, these can have life threatening outcomes in an otherwise healthy child. However, treatments are complex and traumatic. Distraction is a gentler therapy that uses a device to slowly expand abnormal bone, but distractors are semi-buried, increasing complication risk; manual expansion is performed by parents, leading to noncompliance; and surgeons are blinded to treatment, forcing weekly X-rays and exams. 

Ostiio’s therapy uniquely solves pain points of distraction to improve patient outcomes and experience. The fully buried implant is expanded magnetically, removing the complication risk of semi-buried devices. The automated driver simplifies expansion, reducing parental noncompliance. The remote monitoring platform allows surgeons to track treatment progress, reducing post-op follow-up. 

Distraction is the segment within the CMF device market that offers opportunity to differentiate, but technology advancement has been iterative with competitors focused on providing greater flexibility to the surgeon in the OR. Since treatment is home-based, Ostiio instead will transform how distraction is provided by parents and monitored by surgeons to improve patient outcomes and experience. 

At entry to the ITP program, the project had early proof-of-concept prototypes. The ITP program has enabled Ostiio to advance its integrated therapy from product conceptualization to design freeze for the implant and production intent for the driver. This, in turn, has allowed the company to begin animal studies to support regulatory filings. Early in vivo data have demonstrated the implant operation throughout a full distraction protocol and subsequent bone regeneration. 

• Awarded a Phase II SBIR grant from the NIH for a total of $1.74M 
• Awarded a Phase II SBIR grant from a the NSF for a total of $1M 

• 510(k) to be filed Q2 2027 

• Investment opportunity: The company will be raising a Series Seed financing of $2-3M in Q2 2026 to complete product development verification and validation activities and submit its regulatory filings. 

•  Kalmar et al. Forces exerted in craniofacial distraction osteogenesis. J Craniofac Surg 2022 
• US18/149,846 Systems and Processes for Distraction Control via Torque Sensing