Launching a technology-based start-up is never easy, but the task is particularly challenging in the life science sector. The timeframe is generally longer than other tech ventures and involves considerably more investment capital in addition to the federal approvals that are required.
That’s certainly been the experience of Paul Fitzpatrick, Chief Executive Officer (CEO) of Advanced Catheter Therapies Inc. (ACT) He’s held that role at the Chattanooga-based company since 2008, so his perspective on launching a life science company is clearly based on solid experience.
“We continue the same thing we’ve experienced for the last five or six years,” Fitzpatrick told us in a recent interview by phone. “We reach a key stage gate, then the goal posts move. It’s not getting easier.”
As he explained in our first interview that published more than seven years ago, “We are developing a universal therapeutic agent delivery device that is agnostic to the disease or agents.” Subsequent articles documented progress ranging from an oversubscribed Series B round to 510(K) clearances (now totaling three) from the U.S. Food and Drug Administration (FDA), 24 issued patents on three devices, and a major licensing agreement with Toray Industries Inc. that recently ended.
Today, there is both optimism on Fitzpatrick’s part and a recognition that more work remains as the company considers its best path forward.
ACT’s focus has been on its PRESSANA® OPC (Occlusion Perfusion Catheter), 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 catheter, 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.
Those who know Fitzpatrick are aware of his upbeat, energetic, always positive outlook, and that was clearly evident during our recent interview when he talked about a recently published study in a peer-reviewed journal. The study (click here) reported excellent clinical results on the safety and feasibility of treating infrapopliteal lesions using ACT’s PRESSANA® OPC to locally deliver liquid paclitaxel.
“The results of this multi‐center study demonstrated that infrapopliteal arteries can be safely and effectively treated with liquid paclitaxel using the occlusion perfusion catheter,” the study found. For Fitzpatrick, those results were clearly encouraging in light of the fact that ACT had previously focused on use of its catheter for diseases above the knee.
“It had become a crowded space, so we decided a couple of years ago to bifurcate the study to include both above and below the need usage,” Fitzpatrick said. “There were no DCBs (drug-coated balloon treatments) approved for below the knee. We saw it as a niche area.”
Armed with the study results, he sees several paths forward in what he hopes could be the final stage gate.
“We could find a strategic buyer to get in the market or a strategic partner who would help us commercialize the catheter by leveraging their sales force,” Fitzpatrick says. The third alternative would be to raise $20 to $30 million to develop a combo device where the physicians would have the catheter and whatever drug they wanted to deliver in a single box. That process would take two to three more years to secure FDA approvals.
“We have a great team and a great product,” Fitzpatrick says. “We just need capital to clear the final hurdles.”
In the interim, he ticked-off a series of actions ACT is taking. They include:
- Finalizing an agreement with a local Chattanooga company to be ACT’s sales/marketing/market development and logistics partner;
- Extending the shelf life of existing inventory and manufacturing additional BTK Pressana® OPCs so that an adequate supply is available as elective surgery rebounds; and
- Working with a 503(b) pharmacy to make the agent mixture that saw such great results in the COPPER A trial and make this available for physicians or cath labs or hospitals to buy it pre-mixed ready to go.
Regarding the latter point, Fitzpatrick says, “I believe this overcomes a hurdle on the drug side for delivering treatment for restenosis. This way, and before we have the ‘combo’ version of the Pressana®OPC, the doc or the doc’s pharmacy doesn’t have to mix-up the agent which takes time and has certain rules that need to be followed.”