# Crosslinkable Tissue Particles for Regenerating Craniofacial Bone in an Ovine Model

> **NIH NIH R43** · LEEFA BIOTECH, LLC · 2021 · $249,315

## Abstract

PROJECT SUMMARY
The overall goal of this application is the translation of a new crosslinkable bone void filler that will allow surgeons
to better heal patients after craniofacial bone loss. The bone void filler designed is unique in that it can be
implanted as a paste then quickly transition to a solid after initiation with blue light. The ability to transition into a
solid after placement is unique to bone fillers that regenerate bone rather than filling the defect with a synthetic
material such as bone cement. The motivation to improve upon the current state of the art was inspired by a
clear gap identified by plastic surgeons and neurosurgeons, to be filled by an off-the-shelf material that can be
molded to a patient’s contours, crosslink or “set” after placement to retain material, quickly transition to a solid
when desired by the user (i.e., no working time restriction), and be completely biodegradable so the material will
be replaced with the patient’s bone over time. To create the exact craniofacial bone void filler to meet the needs
of surgeons, multiple material designs were evaluated in over 200 rats to develop the photocrosslinking bone
void filler, BoneLink, proposed in the SBIR Phase I project.
 Our team is uniquely positioned to accomplish the goals set forth in the project and have multiple years of
cumulative experience working together. The team is comprised of a plastic surgeon, craniomaxillofacial
surgeon, pathologist, regulatory consultant, biostatistician, and biomedical engineers providing the necessary
skills to successfully complete the translational large animal (sheep) model testing proposed. The project is
highly focused with a single Specific Aim: To demonstrate improved bone regeneration in critical-size cranial
bone defects using a crosslinkable tissue particle implant. We will test the hypothesis that BoneLink will lead to
improved bone regeneration in a large defect compared to DBX®. Successful completion of this SBIR Phase I
project will pave the way for an FDA Q-Submissions meeting, which will in turn shape a future Phase II project
to bring BoneLink closer to the clinic.
 Compared to clinically available bone products, BoneLink offers surgeons a new option for craniofacial bone
defect repair by combining the moldability of current products with the ability to set after placement, creating a
solid structure to regenerate bone. For multiple reasons, the current focus is on translation of the technology to
the craniofacial space where the material’s inherent capabilities will be the most advantageous and marketable.
The desired initial indication for use will be a craniofacial bone void filler with the intention to expand indications
later after 510(k) clearance to the extremities, pelvis, and spine. Successful translation of BoneLink offers a
paradigm shift for the treatment of large size craniofacial bone defects by potentially replacing the need for bone
autografts since commercially available products cannot. ...

## Key facts

- **NIH application ID:** 10140445
- **Project number:** 1R43DE029738-01A1
- **Recipient organization:** LEEFA BIOTECH, LLC
- **Principal Investigator:** Jakob Townsend
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $249,315
- **Award type:** 1
- **Project period:** 2021-03-01 → 2022-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10140445

## Citation

> US National Institutes of Health, RePORTER application 10140445, Crosslinkable Tissue Particles for Regenerating Craniofacial Bone in an Ovine Model (1R43DE029738-01A1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10140445. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*