# AlloBrace: Pure Collagen Augment to Improve Performance and Integration of Allografts

> **NIH NIH R43** · COLLAMEDIX INC. · 2024 · $300,000

## Abstract

Summary
 An estimated 225,000 anterior cruciate ligament (ACL) tears are reported annually in the US, equating to
~$7B in medical costs. Tears of the ACL lead to instability of the knee and reduce mobility, if left untreated, it
can lead to chronic knee issues. Tears are typically treated by ACL reconstruction (ACLR) using either an
autograft or an allograft. Allografts only account for 22-44% of ACLR in the U.S. because autografts have a low
failure rate (5%). Harvesting an autograft causes donor-site morbidity (DSM) which leads to muscle weakness
of the ipsilateral leg, risk of infection, longer recovery time (9-12 months), chronic knee pain, and higher risk of
contralateral ACL tears. Use of allografts prevents DSM. Unfortunately, allografts have an ~14% failure rate and
are usually recommended for older and less active patients. Specifically, soft tissue allografts (STA) have poor
ligamentization and fail to form a true boney junction between the bone-graft interface. There is a need to improve
the biological integration of STAs to increase graft biomechanics, which will lead to lower failure rates. Therefore,
CollaMedix Inc. has developed AlloBrace to increase the biological integration of the allograft by stimulating and
guiding ligamentization throughout the STA and inducing true bony growth at the bone-graft interface. CollaMedix
is in the business of developing medical grade biotextiles using high-strength pure-collagen type I threads
produced by its patented high-throughput electrochemical compaction process. The collagen molecules in the
thread are unidirectionally aligned within threads, mimicking the native topography of ligaments and tendons,
which we have found makes the implant regenerative. Extensive in vivo research has found that new host
collagen is templated parallel to these threads, resulting in an ordered tissue deposition. Collagen threads also
impart a tenoinductive effect on stem cells topographically. The crosslinking agent genipin, which is used to
stabilize threads, polarizes macrophages to the pro-regenerative phenotype. A hydroxyapatite (HA) coating can
be added to impregnant the threads to be osteoconductive. Therefore, we have braided spooled collagen thread
with industrial braiding machines and coated each end with HA to create AlloBrace, a pure collagen sheath with
tenoinductive and osteoinductive potential. AlloBrace is simply deployed by sliding over the allograft and
prepared with traditional ACLR techniques and equipment. To validate AlloBrace, CollaMedix aims to confirm
the feasibility of AlloBrace as an enhancement for STA used in ACLR using a porcine model. We hypothesize
that AlloBrace will 1) guide cellular infiltration and tissue production throughout the allograft, and 2) stimulate
bone growth at the bone-graft interface within the bone tunnels. Specific Aim 1. Refine AlloBrace design to
improve graft conformity and to ease surgical deployment. Fabricate AlloBrace with varying diameters (6,
8, 10mm) ...

## Key facts

- **NIH application ID:** 10919715
- **Project number:** 1R43AR083784-01A1
- **Recipient organization:** COLLAMEDIX INC.
- **Principal Investigator:** Christian T. Denny
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $300,000
- **Award type:** 1
- **Project period:** 2024-06-01 → 2026-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10919715

## Citation

> US National Institutes of Health, RePORTER application 10919715, AlloBrace: Pure Collagen Augment to Improve Performance and Integration of Allografts (1R43AR083784-01A1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10919715. Licensed CC0.

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