# A Biosynthetic Degradable Textile for Soft Tissue Reconstruction

> **NIH NIH R44** · DEEP BLUE MEDICAL ADVANCES, INC. · 2021 · $1,063,767

## Abstract

ABSTRACT
Laparotomy patients are plagued with ventral hernias occurring and recurring in up to 30% of cases. Hernia
occurrence and recurrence is caused by anchor point failure of both permanent and degradable mesh (i.e.
suture, tacks, and screws cheese-wire through mesh and tissue, resulting in mesh migration and/or
contraction). Simply, hernias occur or recur where mesh is not adequately anchored to tissue and migrates or
contracts. It is rare for moderate to heavy weight meshes to rip allowing hernias to occur through the torn mesh
or for hernias to occur between intact mesh anchor points. Biosynthetic hernia mesh (i.e. a synthetic hernia
mesh made from a biodegradable polymer) is the fastest growing segment of the hernia mesh market with
~$95M in sales in 2017. Moreover, several recent long-term occurrence (prevention) and recurrence
(treatment) outcome studies have illustrated that newer degradable biosynthetic meshes, including Bio-A,
Phasix, and TIGR mesh, promote tissue regeneration and are equivalent in performance and safety to
permanent mesh and superior to xenografts and allografts. However, despite emerging data in support of
biosynthetic mesh over permanent mesh and the gradual growth of biosynthetic mesh in the market place,
biosynthetic meshes suffer from the same occurrence and recurrence problems as permanent mesh – both
types of meshes lack an adequate soft tissue anchoring system. While anchor point failure has unquestionably
been recognized for decades as the most common cause of ventral hernia recurrence, there are no mesh
anchoring systems on the market designed to address this problem. Sutures (or tacks, screws, or glue) are
simply insufficient. A better anchoring system is sorely needed. To meet this need, Deep Blue Medical
Advances, Inc. (DBMA) has engineered a patented T-Line® Hernia Mesh anchoring system for use in open and
laparoscopic repair and demonstrated the benefits with a permanent polypropylene mesh. DBMA has
successfully completed Phase I goals selecting a biodegradable copolymer with appropriate mechanical
properties and degradation rate to promote healing. The novel biosynthetic T-line Hernia Mesh design has
>250% greater anchoring strength compared to leading products on the market. In this Phase II SBIR grant,
we will complete major milestones for FDA 510(k) clearance of the class II biosynthetic T-Line Hernia Mesh. It
is evident from the medical literature, market reports, online webinars and podcasts, corpus of recent
presentations at hernia meetings, and guidance from our world-class scientific advisory board that biosynthetic
hernia meshes are rapidly gaining favor in the marketplace and that the biosynthetic T-Line Hernia Mesh, with
its surgeon-friendly, physiologically designed, superior anchoring system will have a transformative impact in
surgical care.

## Key facts

- **NIH application ID:** 10325360
- **Project number:** 2R44GM134778-02A1
- **Recipient organization:** DEEP BLUE MEDICAL ADVANCES, INC.
- **Principal Investigator:** David Ruppert
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $1,063,767
- **Award type:** 2
- **Project period:** 2019-08-12 → 2023-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10325360

## Citation

> US National Institutes of Health, RePORTER application 10325360, A Biosynthetic Degradable Textile for Soft Tissue Reconstruction (2R44GM134778-02A1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10325360. Licensed CC0.

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