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Development of a microperforated nanocomposite balloon for intravascular anti restenotic drug delivery

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 6R44HL129870-03
Agency Tracking Number: R44HL129870
Amount: $602,197.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NHLBI
Solicitation Number: PA14-071
Timeline
Solicitation Year: 2014
Award Year: 2017
Award Start Date (Proposal Award Date): 2017-03-06
Award End Date (Contract End Date): 2019-02-28
Small Business Information
1708 JAGGIE FOX WAY, STE 120
Lexington, KY 40511-1162
United States
DUNS: 079829394
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 MARK BATES
 (844) 919-9990
 mark@pulsusmed.com
Business Contact
 WILLIAM ROSELLINI
Phone: (972) 883-2111
Email: will@roselliniscientific.com
Research Institution
N/A
Abstract

Hemodialysis is the most common treatment for kidney failure requiring the passing of blood out of the body
through a filter and back into the body Almost of hemodialysis patients undergo arteriovenous graft
procedures involving the insertion of prosthetic shunts i e synthetic tubes between artery and vein
particularly in the forearm With the hemodialysis patient population estimated to reach over by
the number of patients requiring grafts will reach over of and most of these grafts will
eventually clot Clotting occurs in these grafts due to blockages that occur in the blood vessel at the outflow
site of the graft As a result many hemodialysis patients require intervention to open up the narrowing or
stenosis of the blood vessel
Currently interventions for clotted grafts involve removal of the clot with a device followed by angioplasty of the
vein Once angioplasty is needed the lesion will keep restenosing and often the patients need additional declot
procedures and repeat angioplasty While stents are routinely used to open up narrowed arteries they cannot
be implemented in this case A more mechanically compliant structure is needed Relatively new drug coated
balloons DCBs are a possible solution However DCBs inherently exhibit sporadic and unpredictable drug
delivery Furthermore DCB drug delivery is currently quite inefficient with much of the drug being lost
downstream This increases the potential for systemic toxicity In addition chemical agents excipients are
needed to control diffusion of the drug coating These excipients pose a risk of downstream embolism for the
patient A more efficient safer method of intravascular anti restenotic drug delivery is needed to improve
efficacy and reduce risk of embolism
We propose to develop a nanocomposite based polymer balloon with microperforations to enable pulsed flow
drug delivery to the lesion Using our approach drugs can be efficiently delivered directly to the diseased site
reducing the potential for systemic toxicity Our intravascular drug delivery system is capable of delivering
drugs of almost any form from lipophilic drugs to hydrophilic drugs and even combinations thereof
Project Narrative
The major challenge for hemodialysis patients is the eventual blockage of arteries occurring near the site in the
forearm where the dialysis tubing is inserted We propose to develop a drug delivery system that will eliminate
these blockages Our drug delivery system will lower the added care costs currently required to manage
hemodialysis patients and reduce their mortality risk

* Information listed above is at the time of submission. *

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