# Software for OCT Analysis of Vascular Stents

> **NIH NIH R44** · DYAD MEDICAL, INC. · 2020 · $1,085,076

## Abstract

Project Summary.
Dyad Medical, Inc. will create intravascular Optical Coherence Tomography (IVOCT) software for clinical, live
time determination of stent apposition and for offline analysis of stent implantation. Every year, 100s of
thousands of patients in the US are treated with intravascular stents creating an opportunity for both solutions.
Although advancements such as drug eluting metal stents hinder restenosis, there remains significant room for
improvement. Stent design parameters include drug, material (bioresorbable vs metal), polymer composition,
coatings to stimulate cell coverage, etc. To optimize designs, sensitive, in vivo assessments are needed for
preclinical and clinical evaluations. IVOCT is the lone imaging modality with the resolution and contrast to meet
this challenge. Dyad's automated software solution promises to drastically cut stent image analysis from 6-16
hrs of manual analysis to less than 2 minutes per single stent, as demonstrated in our Phase I feasibility
results. We also demonstrated stent strut detection accuracy >88%, classification accuracy >88%, and stent
and vessel areas with accuracy >90%. In addition to faster analysis, we will eliminate inter-analyst variability
and errors, which in turn have the potential to significantly improve clinicians' ability to accurately assess and
interpret stent position and integrity in real time. Cardiology analysts will be able to provide instant feedback to
physicians, presenting the number and location of malapposed struts in 3D, empowering their decision making
on the need for additional dilatation with a larger balloon or higher pressure, or whether patient needs to stay
on anti-platelet regimen or be taken off in order to minimize bleeding risk. For purposes of research, clinical
trials or stent design development, our software will improve reproducibility, increase accuracy, and harmonize
analysis. In this follow on Phase II study, we will develop enhanced algorithms, optimize software usability,
develop and test several user interfaces (UIs) in collaboration with the Core Lab at the University Hospitals.
We will test and validate the functionality and performance of software using image data sets from multiple
sources, increasing robustness of our approach. Phase II will enable us to develop a highly functional and
usable software ready for commercial deployment. It will facilitate the use of our software in the clinic as part of
an initial trial in the cath lab.

## Key facts

- **NIH application ID:** 9861264
- **Project number:** 5R44HL137500-03
- **Recipient organization:** DYAD MEDICAL, INC.
- **Principal Investigator:** Ronny Shalev
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1,085,076
- **Award type:** 5
- **Project period:** 2017-07-01 → 2022-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9861264

## Citation

> US National Institutes of Health, RePORTER application 9861264, Software for OCT Analysis of Vascular Stents (5R44HL137500-03). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/9861264. Licensed CC0.

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