Mercator MedSystems announced last week that it finished enrollment for a six-month trial of its Bullfrog micro-infusion device in patients with below-the-knee critical limb ischemia.
The Emeryville, Calif.-based company’s 120-patient trial was designed to evaluate if Mercator’s Bullfrog device can improve blood flow and reduce the occurrence of restenosis following atherectomy-based revascularization.
Mercator’s micro-infusion device delivers drugs directly through blood vessel walls and into adventital tissues. The Bullfrog device is tipped with a microneedle that is protected by a balloon as it is guided through the vasculature. When the device reaches its intended injection site, the balloon inflates and slides the microneedle through the vessel wall.
“This technology is so hyper-efficient,” CEO Trent Reutiman told Drug Delivery Business News. “It delivers the drug very locally and precisely to the tissue surrounding a blood vessel or an airway.”
The 16-person company has used its device in above-the-knee applications and is now applying Bullfrog for below-the-knee lesions. Reutiman said that the precise delivery that comes along with micro-infusion enables them to use a safer, less toxic drug – like dexamethasone – rather than paclitaxel, which is often used by companies developing drug-coated balloons for the same application.
In Mercator’s latest trial, patients are slated to be randomized either to a treatment group, where they will receive an atherectomy plus dexamethasone via the Bullfrog device, or to a control group, where they will receive an atherectomy-based intervention, the company’s chief executive explained.
After six months, investigators plan to assess if adding dexamethasone to an atherectomy helped keep a patients’ blood vessels open.
“In this category, probably half or more of the patients would be back for repeat intervention within six months, so there’s a really big unmet need to try to solve additional things that can provide more durability and better outcomes for these patients,” Reutiman said. “So we’re excited that if we do we have a benefit in the treatment versus control group, that we would go back to the FDA through the second half of ’18 and hopefully be in position to commercialize the technology for the below the knee market starting in 2019.”
The company is busy with other trials for its Bullfrog device as well, including a below-the-knee application with Pfizer’s temsirolimus drug.
“But there’s no questioning here that there’s a very large clinical development plan that could be executed faster with more cooperation and more resources applied, so I think the only thing that limits us from being bigger and going faster would be more financial resources,” he said. “Hopefully as we generate big data and we put micro-infusion kind of solidly on the map, we’ll attract partnership and resources so that we can continue to work on a broad range of applications and broad range of drugs and biologics.
“It’s not very often you have a true platform delivery technology. It’s peripheral, it’s coronary. We have a version of the product that goes through a bronchoscope for pulmonary. We’re trying to be very focused and deliver value right now, one study at a time.”