# Commercialization Readiness for Bone Filler Scaffold Device to Aid in Dental Applications and Reconstruction

> **NIH NIH SB1** · NUSHORES BIOSCIENCES, LLC · 2022 · $39,732

## Abstract

Project Summary
Current bone grafting techniques for functional rehabilitation with dental implants have limitations
– high-cost, difficulties with fixation and stabilization, insufficient bone regeneration, high morbidity
using autogenous block grafts and prolonged healing of up to 9 months. Existing synthetic bone
fillers cannot match defect shape and volume, are weakly resorbed if at all, are not easily and
quickly modifiable in size and shape during surgery, cannot promote early and enhanced
neovascularization and osseointegration; and are poorly suited for advanced reconstruction.
Current technologies cannot be modulated to match existing bone architecture – a critical feature
for improved healing. Although pre-implant reconstructive surgeries are commonly performed, an
estimated 7% of patients are unable to receive dental implants due to these limitations. The
NuCress™ scaffold has shown in animal studies that it is a better alternative for these autografts,
due to its controllable shape and form, enhanced bone formation and early neovascularization,
shelf-life stability and tolerance over a range of storage conditions, and a composition that
includes only components that have received FDA clearance for use in other devices or are in
process of clearance. In situ, the scaffold swells to lock into place in the bone defect, eliminating
the need for special instruments to secure it. These scaffolds could reduce costs and
convalescent time, benefiting millions of patients. NIDCR-funded Fast Track SBIR results
demonstrate superior and fast bone regeneration by the NuCressTM bone filler scaffold for
craniomaxillofacial applications in pre-clinical animal studies, setting the stage for the next step
of commercialization to benefit patients. Integral to commercialization is FDA approval for the
NuCressTM scaffold as a dental medical device (required) and clinical trials (highly desirable).
These essential steps require implementing and finalizing manufacturing practices to meet FDA
manufacturing regulations (Aim 1), performing biocompatibility and chemical characterization/risk
assessment studies, as well as animal studies per FDA guidance to compare performance of the
NuCressTM scaffold to a predicate device and untreated control group in critical-sized alveolar
ridge defect model (Aim 2), transition from production for research to production for patient
treatment in clinics (Aim 3), and planning and preparing for clinical trials in the future (Aim 4). The
proposed team has the expertise and experience backed by academic and clinical leaders,
globally recognized Contract Research Organizations, and consultants successfully fulling FDA
studies and NIDCR-supported clinical study successes.

## Key facts

- **NIH application ID:** 10554541
- **Project number:** 3SB1DE028213-04S1
- **Recipient organization:** NUSHORES BIOSCIENCES, LLC
- **Principal Investigator:** Karrer Alghazali
- **Activity code:** SB1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $39,732
- **Award type:** 3
- **Project period:** 2022-03-01 → 2023-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10554541

## Citation

> US National Institutes of Health, RePORTER application 10554541, Commercialization Readiness for Bone Filler Scaffold Device to Aid in Dental Applications and Reconstruction (3SB1DE028213-04S1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10554541. Licensed CC0.

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