Dushyanth Surakanti Founder & CEO of Sparta Biomedical Testimonial

Sparta Biomedical and bioaccess®: Advancing Osteoarthritis Treatment Through Innovation

Osteoarthritis affects millions of people worldwide, limiting mobility and quality of life. Enter Sparta Biomedical, a company founded in 2019 with a mission to transform osteoarthritis treatment by commercializing an innovative technology developed at Duke University. This groundbreaking solution replicates native hyaline cartilage, offering new hope to patients suffering from this debilitating condition.

Sparta Biomedical has navigated a complex path of regulatory and manufacturing challenges to bring its technology to market. Now, the company is on the brink of a major milestone—filing for regulatory approval to conduct clinical studies in both the United States and Colombia.

To achieve this, Sparta Biomedical chose to partner with bioaccess®, a trusted contract research organization (CRO) with deep expertise in managing first-in-human medical device studies, particularly in countries like Colombia. bioaccess’s robust infrastructure, experienced medical staff, and commitment to transparent communication made them the ideal partner to support Sparta’s ambitious goals.

The partnership has exceeded expectations. The bioaccess® team has been praised for their strong medical expertise, proactive approach, and ability to anticipate Sparta’s needs—qualities that are rare among CROs. This collaboration has positioned Sparta Biomedical to advance its mission of revolutionizing osteoarthritis treatment.

Want to know more about this exciting collaboration and the technology behind it? Watch the full testimonial and learn how bioaccess® is playing a vital role in supporting medical innovation and improving patient outcomes in Colombia and beyond.

Transcript

Dushyanth Surakanti:
My name is Dushyanth Surakanti, co-founder and CEO of Sparta Biomedical. We have been working on helping those who have osteoarthritis, which is a significant disease that affects hundreds of millions across the globe. It's been our mission to help those with OA live pain-free.

My background is in the life science space. I've spent about two decades more in product development, strategy, portfolio management, and then sales and marketing. Over that course of time, I had an opportunity to work in multi-therapeutic areas and those where a lot of individuals are afflicted with the big conditions such as osteoarthritis. I wanted to help those with this condition and started to look for technologies that had the potential to address osteoarthritis, specifically within the knee.

Sparta Biomedical was formed in 2019 on the basis of us accessing a technology that came out of Duke University where this platform was replicating native hyaline cartilage. It had all the properties of human cartilage. It was just as smooth. It had the strength and the potential to help millions. We were really excited to be able to partner with the university.

When you are working with device like this, there are many components that the regulators, in our case, the FDA, wanted to make sure that we had addressed. One of them is making sure that the device itself hits all of what we call user requirements, that those who are surgeons have specific needs. We have to incorporate those needs and build them into the technology or the device. In addition, we have to make sure that all of the components are characterized so that they're considered to be safe to, ultimately, put into people. We have to work with manufacturers. We have to actually first find the right manufacturer, from raw material to those who assemble the product. After we build the products and [inaudible 00:02:52] the design, we have to test it. We have to do a series of mechanical tests. Then, we have to do animal tests all to make sure that it's safe enough to then be tested in humans.

There were multiple roadblocks. There were multiple challenges throughout each of those pieces that we had to work through. That journey took us a few years. But we're really excited about the fact that we've been able to be very capital efficient and get to this very significant place, which is we're on the verge of filing for regulatory permission to study this in patients in the US and in Colombia.

I think I was looking for partners who were experienced in medical device and, number two, who did medical device first in human feasibility studies in overseas countries within the Western Hemisphere. Those were the general criteria. Honestly, I think I just was doing internet searching. They actually came to the top. But for me, they rose to the top because it was the amount of information that the management had put out there. They were very open with their experience. They were very open with the countries that they had worked in and all of the requirements for given countries such as Colombia. What is the regulatory process? What is the ethics review experience like? What have other sponsors done? Why have other sponsors gone there? So very extensive, frequently asked questions.

When you think about someone who's coming to this for the first time and is not being referred, it was great to have such a wealth of information in one place that I could really read through. In addition, Julio and his responsiveness was very quick. I said, "I'm interested. Here's what I understand." Immediately, we scheduled a call, and then I started asking many questions from the most, I guess, technical on the regulatory side to the most... What have been other sponsors that you've worked with or who have they been? Orthopedics? Cardiovascular? And what's your focus area?

It wasn't immediate that I wanted to partner. But it was, I would say, after a number of conversations from my side, from clinical consultants on the US side, those who had done the overseas studies, advisors, that it was a fair amount of diligence that we went through before we said that, "Okay. Let's at least do the diligence and understand what is the Colombia context all about. Let's partner with bioaccess®, Monica, and the team, I realized, Monica, to help us understand that better." That's how we began the partnership. I would say a very motivated group who was very open. Any questions I would ask, they would give me the response. It was good in that way.

Coming into this, again, based on reading through all I had read on the website and then talking to Julio, and Monica, and the team, that a lot of it was confirmed. In other words, the infrastructure... What I mean by that is the facility, what equipment existed, the different functions that help a research study get off the ground and then follow it after surgery happens, and then the certification that folks have gone through to make sure that they follow good clinical practices because that's very important for a company like ours because we have to then speak to our board members. We have to speak to investors. Sometimes, we have to speak to regulators. To be able to have an infrastructure that's very similar to the US... You have surgeons who've actually trained in the US or surgeons who may not have trained in the US, but they have a lot of experience. They're very open and willing to partner with a US surgeon. That also gives us greater comfort.

I would say, so far, the experience has been really great. I have to speak about the team. The team, unlike many CROs, has a lot of experience from a medical perspective. They may not have a lot of industry experience, but they certainly make up for that in their medical education. I'm working with those who went to medical school. It's really great because I'm able to immediately talk about physiology, human anatomy, clinical study protocol requirements, exclusion/inclusion. They're very quick. They understand it because this is what they've been doing for at least their medical education background.

That is not common among CROs. When you're thinking about a clinical trial manager/clinical trial associate, to have folks who have such a educational background, I think, is hugely beneficial. The experience I've had with the team over the last several weeks and then, in particular, these two days have been fantastic.

Everyone's been, first of all, very accommodating. They've been really open to share as much as possible and address my concern. It's been very hospitable, in general. That's been tremendous. We've had a lot of very transparent conversations and had a lot of back and forth about site A, site B, site C, pros, and cons.

I also found them to at least need thinking about... "How do we prepare ourselves to initiate a study here? What are all the things we need to think about?" The checklist. Monica has been very much thinking about, "Okay, here are all the things we need to think about. Here are the things we need to follow up on." The team is always anticipating. I was very surprised coming in, and I continue to be surprised. It's been really great. It's been really great so far. I think time will tell in terms of... How's the regulatory experience? How's the ethics review board experience and so on?

Then, of course, we have to do our part to make sure that we give BioAccess the information it needs/the support it needs. I said that we're going to have a surgeon come down. That's, I think, also part of, from a sponsor perspective, bringing the support to the table, so to speak.

I think that there's always a reluctance sometimes when it comes to new geographies. For example, in the medical device arena, Australia is a very well-known country to go to for medical device studies, preliminary first-in-human. I think Latin America... It doesn't get viewed the same way. I think that folks, if they read up, for example, all the information that BioAccess put out there, if they spent on getting to know the BioAccess management combined with the team, and then they actually do their own visit... They actually are here. I think they'll be very pleasantly surprised that it's a place that has all the things that one would need, I believe. I can speak to the orthopedics piece, that you can at least get a good experience with first-in-human, again, if regulatory approvals are there and do it in a very efficient way and cost-effective way, too.

I would say that folks should really look and dig into geographies such as Colombia, but I would also say partnership, partnering with the right team who's been there, done that because to do it on your own... I think that some people can do it on their own. But I would say that most of us probably need some help. Language, relationship, being able to identify.