# Treatment of GERD Using Biodegradable Materials to Enhance Gastric Yield Pressure and GEJ Compliance Dynamics

> **NIH NIH R43** · ESCHARA MEDICAL, LLC · 2021 · $399,628

## Abstract

PROJECT SUMMARY
Gastroesophageal reflux disease (GERD) affects 8-33% of the global population. GERD can lead to esophagitis, strictures,
ulcerations and Barrett's esophagus (BE). Patients with BE have up to an 125-fold increased risk of developing esophageal
adenocarcinoma—a devastating outcome which is fatal in roughly 80-90% of cases. Currently, the gold standard treatment
for GERD remains long-term proton pump inhibitors, i.e. PPI therapy, or laparoscopic Nissen fundoplication (LNF).
However, PPI therapy fails to control GERD symptoms in 25%-42% of patients, and the chronic use of PPIs is associated
with serious adverse effects. Moreover,
LNF is technically exacting, and currently fewer than 1% of the eligible GERD
population pursue surgery due to concerns of postoperative complications and surgical failure. Thus, an alternative surgical
treatment is needed to close the “therapy gap”. Re
cently, LINX magnetic sphincter augmentation surgery (MSA) has become
an alternative surgical option to address the therapy gap (FDA-approved, January, 2012; Torax Medical, MN), The LINX
device is a ring of magnets permanently placed laparoscopically around the gastroesophageal junction (GEJ). Although the
side-effect profile of MSA is somewhat superior to LNF, unfortunately,
high rates of postoperative dysphagia
are routinely
seen after LINX placement along with low rates of device erosion.
To address these issues and improve GERD therapy, we have developed an entirely new class of GERD treatment: a novel
biodegradable device. Our device is called the Eschara suture collar and consists of a dense, tubular matrix of bioabsorbable
suture material that will create a ring of collagen around the lower esophageal sphincter, in the region of the GEJ. As the
material biodegrades within a matter of days, it loses tensile strength, thus avoiding any dysphagia. Within a matter of
weeks, the suture collar material totally absorbs and, via a foreign body reaction, leaves behind a collar of collagen that
supplies the appropriate amount of LES augmentation to demonstrably improve LES effacement characteristics, increase
yield pressure, decrease compliance at the GEJ, and increase functional LES length, thereby preventing pathologic acid
reflux. We developed the Eschara device in order to provide an ideal GERD solution with the following advantages over
LNF and LINX: 1) Correct GERD pathophysiology, 2) preserve natural physiological swallowing, belching, and vomiting,
minimize dysphagia, 3) cause minimal risk to the vagus nerve, 4) no risk of erosion, 5) MRI, and all imaging, compatible,
6) simple manufacturing, 7) Enable simplified Hiatal Hernia repair, and 8) eliminate the need for continued PPI use.
To ensure adequate performance of the Eschara suture collar prototype, we will 1) fabricate and develop the design; then 2)
test and validate it in an in vivo swine model. Based on the results of initial experiments, we will: 3) Fabricate and develop
the second round of design...

## Key facts

- **NIH application ID:** 10256155
- **Project number:** 1R43DK127535-01A1
- **Recipient organization:** ESCHARA MEDICAL, LLC
- **Principal Investigator:** Ryan Balko
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $399,628
- **Award type:** 1
- **Project period:** 2021-06-01 → 2022-09-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10256155

## Citation

> US National Institutes of Health, RePORTER application 10256155, Treatment of GERD Using Biodegradable Materials to Enhance Gastric Yield Pressure and GEJ Compliance Dynamics (1R43DK127535-01A1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10256155. Licensed CC0.

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