# Improved Treatment of Vertebral Compression Fractures for Elderly Patients Using an Image-Guided, Percutaneous Delivery of a Novel Bone Adhesive

> **NIH NIH R43** · REVBIO, INC. · 2022 · $375,000

## Abstract

Project Abstract
Approximately 700,000 vertebral compression fractures (“VCF”) occur each year in the United States, costing
an estimated $250 million in Medicare-related expenses. Compression fractures are most common among
elderly individuals with osteoporosis, occurring in 20% of U.S. population over the age of 70. Eighty-four percent
of patients with radiographic evidence of compression fractures report severe associated back pain.
Historically, VCFs have been primarily treated using vertebroplasty and kyphoplasty, which are techniques
involving the injection of polymethylmethacrylate (PMMA) into the vertebral body through a transpedicular
approach under fluoroscopy. Significant pain relief is achieved in 70% to 90% of patients treated using these
procedures. However, more recent clinical evidence has shown that these procedures are extremely risky with
significant complications amplified by an underlying condition of osteoporosis, including graft dislodgement and
subsistence, loss of implant fixation, and junctional kyphosis. PMMA cement causes thermal necrosis of
adjacent bone tissue due to its high polymerization temperature. Its lack of biodegradability coupled with its
higher modulus of elasticity (i.e., stiffness) compared to cancellous bone has also led to fractures in adjacent
vertebrae. Most concerning is the risk of extravasation, or cement leakage, which has occurred in up to 75% of
all reported cases resulting in pulmonary embolisms occurring in up to 23% of patients tracked in published
literature. It is therefore not surprising that the prevalence of these procedures decreased by more than 70%
from their peak since this information has come to light. Unfortunately, however, this has left many patients in
chronic pain without a viable treatment option.
To address this issue RevBio, Inc., has developed Tetranite® (TN), a novel bone adhesive biomaterial that can
bond bone fragments together and fill bone voids. Over time this proprietary material acts as a scaffold, allowing
bone to grow through it and ultimately replace it with new, vital bone. Research indicates that the material is
also osteopromotive and accelerates bone healing and remodeling in osteoporotic patients. TN’s proven
injectability, low exothermal temperature, biodegradability, intrinsic mechanical strength, lack of toxicity, and
cohesive properties allowing it to infiltrate cancellous bone, make it a good candidate for replacing PMMA to
enable the treatment of patients with VCFs who suffer from chronic pain. As a result, this proposed research
seeks to achieve the following Aims: Aim 1: Optimization of the Percutaneous Delivery of TN for VCF
Procedures and Aim 2: Demonstration of the Safe and Effective Use of TN in a Large Animal Pilot Study.
The results from this pilot animal study (Aim 2), complemented with surgeon validated simulated use cadaver
testing (Aim 1A), will be used as the basis for developing a pivotal animal study to initiate regulatory discussions
...

## Key facts

- **NIH application ID:** 10547209
- **Project number:** 1R43AG079741-01A1
- **Recipient organization:** REVBIO, INC.
- **Principal Investigator:** Brian Hess
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $375,000
- **Award type:** 1
- **Project period:** 2022-08-15 → 2023-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10547209

## Citation

> US National Institutes of Health, RePORTER application 10547209, Improved Treatment of Vertebral Compression Fractures for Elderly Patients Using an Image-Guided, Percutaneous Delivery of a Novel Bone Adhesive (1R43AG079741-01A1). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10547209. Licensed CC0.

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