The always smiling and positive Chief Executive Officer of Chattanooga-based Advanced Catheter Therapies (ACT) was as upbeat as ever about his company and its recent progress when we checked-in with him recently.
“As with all start-ups, we are cautiously optimistic,” Paul Fitzpatrick told teknovation.biz. That optimism is based on several factors, ranging from progress with ACT’s initial technology to just receiving U.S. Food and Drug Administration (FDA) clearance for its patented Occlusion Perfusion Catheter TM (OPC), and a new institutional investor.
The FDA clearance came earlier this month, and ACT’s news release is available here.
ACT is an early stage research and development medical device company with a portfolio of innovative catheter technologies targeting vascular disease including thrombosis, inflammation, occlusions and restenosis. We originally profiled it in March. That article can be found here.
When we chatted with Fitzpatrick a few weeks ago, the company had just submitted responses to the latest set of questions from the FDA as it sought 510(k) approval for the inaugural catheter. It has taken an extra three months and estimated $100,000 to meet the requirements of an FDA application process, including guidance documents that were changed after ACT submitted its initial response.
Fitzpatrick was ecstatic about the approval when we chatted with him again last week. He had previously told us, “We know the catheter functions beautifully as designed. It clearly overcomes the major limitations we see of other drug delivery devices such as drug coated or eluting balloons and stents.”
With that clearance, he expects to be able to complete the raising of a $3 million Series B preferred equity round that will enable further development and progress of the OPC such as CE mark and a first in human trial along with other catheters in ACT’s pipeline and attract a strategic partner to commercialize the OPC.
ACT also secured another patent on the OPC a few months ago and recently received notice of allowability on a patent for one of its other catheters in the pipeline, the Neuronal Protection System (NPS) catheter for treatment of ischemic stroke.
As the company continues to make progress, Fitzpatrick noted that ACT has secured its first “true venture capital investor” in Memphis-based Innova. Ken Woody, the latter’s President.
“We’re thrilled Ken is involved,” Fitzpatrick said in describing the seasoned executive in healthcare, information technology, and medical device companies.
ACT was formerly known as Atlanta Catheter Therapies before relocating to Chattanooga.
“I left Georgia because we weren’t getting any help,” Fitzpatrick reminded us. “There are open arms for companies like us in Tennessee and Chattanooga.”
He cited “a lot of good programs” across the state such as accelerators, organizations (Launch Tennessee), Company Lab and the former Innovate Here program, both based in Chattanooga, associations (Life Science Tennessee), and TNInvestcos. Nevertheless, Fitzpatrick noted that there are still challenges for life science companies and other start-ups.
“Where Tennessee needs to bolster itself is in the B and C series round of investment,” he said. “That’s where we are missing. Getting a company from zero to exit is a continuum.”
With four platform technologies and two or three products using each, Fitzpatrick sees a bright future for the company.