Bill Niland CEO at ReGelTec Testimonial

ReGelTec, a U.S.-based company specializing in degenerative disc disease, is gearing up to launch an early feasibility trial for its innovative injectable polymer in Barranquilla, Colombia. Scheduled to begin in late April or early May 2020, the trial highlights the advantages of conducting studies outside the United States, including faster timelines and reduced costs.

CEO Bill Niland, who has extensive experience managing clinical trials in Europe, chose Colombia for its high-quality hospitals, skilled surgeons, and experienced investigators. His collaboration with bioaccess® has been a pivotal part of the process. Niland first connected with bioaccess® six years ago through LinkedIn during a previous venture. When the time came to set up this trial, he reestablished the partnership, relying on their expertise to navigate the regulatory and logistical challenges.

Niland has praised the professionalism and efficiency of the bioaccess® team, particularly Monica and Julio, who played key roles in getting the trial approved and operational. Reflecting on his experience, he recommends bioaccess® to any medical device company seeking to conduct early feasibility studies in Colombia or other South American countries.

Want to learn more about this success story? Hear directly from Bill Niland as he shares his experience working with bioaccess® and why Colombia is becoming a prime destination for medical innovation.

Transcript

William (Bill) Niland (00:06):

So my name's Bill Niland. I'm the CEO of ReGelTec Incorporated. ReGelTec is a US company working in the degenerative disc disease area. We have an injectable polymer to inject into a lumbar disc to give you your spacing and provide the spacing in a lumbar disc, in the nucleus. This would be for patients with degenerative disc disease, and we plan to do our first early feasibility trial in Barranquilla, Columbia, hopefully starting the end of April or early May of 2020.

(00:46):

We're looking for a place to run our clinical trial out of the United States. I have experience running clinical trials in Europe, and so we were trying to look for a place outside of the US because we felt we could get started quicker and the cost would be less expensive to start and do our early feasibility outside of the US. My first experience with BioAccess was through LinkedIn back when I was running a company called Harpoon Medical in the cardiac space, probably about six years ago.

(01:14):

And I met Julio. At the time, talked to him about potentially adding Columbia for another place in our trial. We had started in Europe. We were looking for more sites, so I took a trip and went down to Bogota and we met some hospitals that I was impressed with. I was impressed with the surgeons and doctors at the hospitals. But we decided to keep on going in Europe at the time. It would've been a little bit more disruptive to run back and forth in Columbia at the time, so we decided to stay in Europe.

(01:45):

But when we sold Harpoon Medical and I started ReGelTec, I decided to reach back out to Julio because we were looking for places outside of the US. So I reached out to my connections in Europe and talked to them about potentially going back and doing this in Europe, but I reached back out to Julio, who quickly jumped right in and made some contacts in Barranquilla and Medellín and quickly had some interest from spine and interventional radiologists in Columbia.

(02:24):

So we did some early screening of those potential principal investigators' resumes. We liked what we saw. Julio set up a trip. I went down last summer for our first visit and liked the principal investigator in Barranquilla that I met, Dr. Spath and we decided to move forward with setting up our early feasibility trial, with Barranquilla being the primary site or first site in the trial.

(02:54):

So far, everything's gone smooth. I've made a couple more trips down and back, getting everything set up, meeting more people, meeting the administration at the hospital. And I've been pretty satisfied so far with the way things are going. The trial was approved by NVMA and we are at the present time working to start to recruit patients. So the patient recruiting process has started. We've been happy with the amount of patients that are in the flow right now and hope to get everything started soon.

(03:27):

I've had a good experience with both Julio and Monica. Monica is very attentive to moving you through the process of getting approved in Columbia. Monica has done a great job working with the site and moving the paperwork and working with my regulatory quality person to make sure we had all the appropriate paperwork together. Helped us put it together, set up the whole trial, and it was really good. So far, I think we've moved through it, good timing, and again, ready to get started and ready to go. But couldn't say enough about Monica and her work in helping us get through this, making sure we had the documentation in place and everything necessary to go through the approval processes.

(04:10):

And yes, I would recommend that any medical device company in the United States or anywhere in the world that's looking for outside the US startup, talk to Julio or Monica about getting started with BioAccess and looking at the option of working with BioAccess in Colombia and other countries in South America for early feasibility work. I think we're confident we're going to have a successful clinical trial and looking to get started and move forward.