# Novel Guidewire Design and Coating for Adenosine Delivery

> **NIH NIH SB1** · ADENOPAINT, LLC · 2024 · $249,999

## Abstract

Coronary artery disease (CAD) effects 14 million Americans resulting in approximately 900,000 myocardial
infarction’s (MI) and 650,000 deaths annually. Percutaneous intervention (PCI) is the most frequently performed
procedure to treat CAD. Microvascular obstruction (MVO) and “no reflow phenomenon” (NRF) are major
barriers that preclude optimal outcomes and are independent risk factors for mortality and heart failure. Current
devices are only partially effective in mitigating MVO and NRF following PCI for MI. The mechanisms responsible
for MVO are complex and multifactorial. Adenosine, an endogenous nucleoside, attenuates many of the
mechanisms responsible for MVO. Seminal studies in our laboratory demonstrated that intravenous adenosine
resulted in striking myocardial protection, a finding confirmed in large clinical trials. Adenosine’s full therapeutic
potential is compromised due to its ultrashort half-life (approximately 1 second) in human blood. By combining
guidewire design, surface chemistry, jet milling of adenosine and creation of novel hydrophilic drug-loading and
diffusion barrier coatings, we developed a guidewire platform (Adenowire) which allows for continuous delivery
of adenosine throughout a PCI procedure. In vitro studies confirmed an ideal elution profile for adenosine that
was verified in large animal models where robust vasodilatation and rapid reversal of vasoconstriction was
identified. The novel inert coating also provides antiplatelet effects that are amplified with the addition of
adenosine in the coating. Bench studies reveal that wire performance and coating quality are comparable to inert
hydrophilic commercially available guidewires. While our phase 2 SBIR grant and subsequent development
resulted in a safe and functional product, a significant funding gap remains before the device can be
commercialized. Manufacturing and coating of Adenowires were not subjected to rigorous FDA regulatory
requirements and utilized a non-sterilized product. Adenowire is classified as a combination product and both
adenosine and guidewires are already FDA approved. A pre-IND submission by a regulatory consultant
determined that approval would occur via CDRH (device) division utilizing a “de novo“ pathway. In order to
proceed with clinical trials, the following assistance is needed: 1) Late Stage Research and Development on
guidewire manufacturing and application of coating utilizing good manufacturing practice (GMP) and evaluation
of biocompatibility and functional parameters on a sterilized product; 2) Regulatory Assistance to include
strategy, documentation, submission of IDE application and determination of size of requirements for clinical
trials. Results obtained from these studies would be invaluable since such data would result in finalization of the
product allowing issuance of an IDE and initiation of a First in Man (FIM) clinical trial. This will greatly enhance
our ability to obtain additional funding and strategic partnersh...

## Key facts

- **NIH application ID:** 10828429
- **Project number:** 5SB1HL136233-04
- **Recipient organization:** ADENOPAINT, LLC
- **Principal Investigator:** Mervyn B. Forman
- **Activity code:** SB1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $249,999
- **Award type:** 5
- **Project period:** 2017-08-10 → 2025-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10828429

## Citation

> US National Institutes of Health, RePORTER application 10828429, Novel Guidewire Design and Coating for Adenosine Delivery (5SB1HL136233-04). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10828429. Licensed CC0.

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