# SBIR Direct Phase II: Nature Inspired Biphasic Glue for Dura Repair

> **NIH NIH R44** · ALEO BME, INC. · 2022 · $895,594

## Abstract

Project Summary
The global market for surgical adhesives and sealants was valued at USD 4.09 billion in 2018 and projected to
reach USD 7.89 billion in 2026 at a CAGR of 9.7%. Surgeries in central nervous system (CNS) accounted for
the largest market share in the year 2016, owing to a high prevalence of neural disorders globally. To name a
few numbers, there are 600K cranial surgeries, 1.2 million lumbar surgeries, and 1.7 million traumatic brain
injuries in the U.S. alone. Sealants are the number one choice in CNS surgeries, such as CSF leak prevention
and dura repair in brain surgeries, over traditional tissue closure methods such as wires, sutures, and staples.
However, traditional sealants such as DuraSeal® and Tisseel® are far from satisfactory in brain surgeries due to
their weak wet tissue adhesion strength and rapid degradation and even when used as adjuvants to other tissue
grafts or duraplasty devices. As a result, demand for surgical sealants and adhesives for brain surgeries has
risen exponentially, giving Aleo BME’s BP Glue product a huge opportunity to penetrate this ever-increasing
niche market. Aleo BME has made significant progress in discovering an interesting tissue adhesion mechanism
for the development of BP Glue and established the feasibility of using BP Glue for cerebrospinal fluid (CSF)
leak prevention and dura repair in rat and pig craniotomy models. BP Glue is an A-B formulation composed of
fully synthetic and degradable water-borne polyurethane (WPU) nanoparticle dispersion solutions with
counterions. BP Glue adhesion mechanism is a unique combination of English-Ivy adhesion mechanism through
which WPU (+) and WPU (-) nanoparticles penetrate and permeate onto tissue surfaces and then ionically
crosslinked to form a mechanical interlocking at the material/tissue interface for tissue adhesion and particle
packing theory through which particle size mismatch (large WPU (+) and small WPU (-)) plays a significant role
in enhancing particle packing and interfusion for improving adhesive and cohesive strengths of the adhesive
(Fig. 1). BP Glue is the first aqueous, super-strong, and elastic tissue adhesive demonstrating equivalent lap
shear strengths to Dermabond® (cyanoacrylate) without using toxic chemical crosslinking. It is expected that the
use of BP Glue may eliminate the use of other tissue grafts or duraplasty devices in brain surgeries and may
also eliminate the revisional surgeries to fix the post-surgical CSF leaks. The objectives of this SBIR Direct
Phase II are to scale-up the manufacturing processes of BP Glue, develop BP Glue delivery tool, validate the
scale-up productions, understand the impact of sterilization on BP Glue functions, evaluate its efficacy for dura
repair in a canine craniotomy, and further rigorously validate the biocompatibility of BP Glue following ISO 10993
toward FDA submissions. The success of this Phase II will help Aleo BME secure further investments and
develop business partnerships and...

## Key facts

- **NIH application ID:** 10489915
- **Project number:** 1R44GM146574-01
- **Recipient organization:** ALEO BME, INC.
- **Principal Investigator:** Chao Liu
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $895,594
- **Award type:** 1
- **Project period:** 2022-09-20 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10489915

## Citation

> US National Institutes of Health, RePORTER application 10489915, SBIR Direct Phase II: Nature Inspired Biphasic Glue for Dura Repair (1R44GM146574-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10489915. Licensed CC0.

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