# Commercialization of an Improved Treatment of Extremity Fractures Using a Regenerative Bone Adhesive to Accelerate Bone Healing in Aging Patients

> **NIH NIH SB1** · REVBIO, INC. · 2024 · $1,240,327

## Abstract

Project Abstract/Summary
In the U.S., about 2.1 million people experience a fragility fracture each year. This number is expected to double
or triple by 2040 as the population ages. Injuries in the upper and lower extremities equate to more than 40% of
fragility fractures, and experiencing a prior fracture is associated with an 86% increased risk of recurrence. Falls
from standing height and other low-energy trauma account for 87% of all orthopedic fractures among the elderly.
External fixation, percutaneous pinning, and open reduction internal fixation with locking plates are interventions
that are currently being used to treat extremity fractures. Despite advances in surgical technique and implant
design, nonunion, malunion, and hardware failure continue to remain a significant cause of revision surgery in
the elderly. Complication rates as high as 36% have been reported and involve onset of carpal tunnel syndrome,
complex regional pain syndrome, tendon irritation and rupture, and deep infection.
To address this problem, RevBio developed Tetranite® (TN), a novel bone adhesive that can fill gaps in bone,
fixate bone fragments, and accelerate healing through its osteoconductive effects. TN can be used as an adjunct
to traditional hardware fixation to provide immediate load sharing between the metal plate and screw systems,
and bone. It provides additional stability by enhancing fracture stabilization to achieve better healing and
prevents hardware failure. It can also be injected percutaneously a standalone method of fixation providing an
option to surgically treat fractures without the need for open reduction, metal hardware, or anesthesia.
Proposed work to treat extremity fractures in the elderly will bridge off existing late-stage development of TN
supported by a SBIR Phase II award from the National Institutes of Aging entitled, “Improved Treatment of Distal
Radius Fractures Using an Image-Guided, Percutaneous Delivery of a Novel Bone Adhesive” (R44 AG060881-
02). This grant enabled formulation optimization and conduction of user validation studies with surgeons (Aim 1)
and a pivotal animal study in sheep (Aim 2) to demonstrate safety and efficacy of TN. This project is focused on
a specific indication to treat distal radius fractures; however, based on discussions with FDA and surgeons, the
impact and value of the material could be expanded to a wider set of indications across all metaphyseal fractures
in the upper and lower extremities for this same patient population. Therefore, this grant would provide additional
funding to conduct market research and supplemental pre-clinical development costs to expand its use to these
additional anatomic regions. This funding would also enable completion of biocompatibility, sterilization,
packaging, and shelf-life validations to finish late-stage development, enabling RevBio to file an IDE, and execute
a clinical study with TN as an adjunct to hardware. The overarching goal of this program is to build...

## Key facts

- **NIH application ID:** 10934600
- **Project number:** 5SB1AG085803-02
- **Recipient organization:** REVBIO, INC.
- **Principal Investigator:** Brian Hess
- **Activity code:** SB1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $1,240,327
- **Award type:** 5
- **Project period:** 2023-09-30 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10934600

## Citation

> US National Institutes of Health, RePORTER application 10934600, Commercialization of an Improved Treatment of Extremity Fractures Using a Regenerative Bone Adhesive to Accelerate Bone Healing in Aging Patients (5SB1AG085803-02). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10934600. Licensed CC0.

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