Advanced Catheter Therapies, Inc. has announced that it has signed a worldwide license agreement with Toray Industries, Inc. to manufacture, market and sell the patented and FDA-cleared Occlusion Perfusion Catheter® (OPC), a targeted therapeutic agent delivery system for the exclusive field of peripheral vascular stenosis and restenosis.
ACT is a research and development medical device company with a portfolio of innovative catheter technologies addressing vascular disease and targeted endovascular drug delivery. The company began manufacturing the OPC approximately one year ago to support clinical trials and a targeted test market release.
“Our first-in-human clinical trials have been very encouraging, and we have successfully met our milestones for safety and efficacy,” said Paul J. Fitzpatrick, CEO of ACT. “We look forward to working closely with Toray to address a worldwide market for the treatment of peripheral arterial disease (PAD) and targeted drug delivery estimated at about $3 billion by 2020.”
“At Toray, we are continually seeking new and innovative ways to treat the most pressing medical needs, such as arterial stenosis and restenosis,” said Shigeo Fujimori, Director of TAM Ventures, Limited (TAMV), a subsidiary and a corporate venturing arm of Toray. “We believe the OPC is truly ‘generation skipping’ and offers innovative features that overcome the limitations of current technologies to offer a substantial patient benefit.”
The OPC is a multi‐lumen balloon catheter designed to temporarily occlude a specific region from blood flow to allow the targeted delivery of various therapeutic and diagnostic agents to the peripheral vasculature. The OPC, which is disease and agent agnostic, has the ability to create a localized treatment chamber and place the agent circumferentially into the vasculature of the treatment chamber. Inflow and outflow ports allow for chamber filling, evacuation and flushing.
The OPC is unique in being able to measure pressure applied inside the treatment chamber. It affords clinicians substantial procedural control along with the ability to select the agent and volume, as well as limiting systemic release of the agent. Terms of the licensing agreement were not disclosed. The OPC remains available for licensing within other fields such as coronary stenosis and restenosis, oncology, dialysis, venous insufficiency and lytic therapy.