Video Transcription
David Bogart 00:00
Dave, I've been given nine minutes to tell you about 10 Minute Tissue and the 10 years it was developed. So I'm Dave Bogart. I'm a director and founder of Conexeu. We're a Canadian-based company, and we were started to commercialize this technology out of the University of British Columbia. The question we most get asked is, how are we in wound care and aesthetics? Well, whether it's repairing damaged skin or enhancing someone's aesthetic look, the ultimate goal is to promote healthy, natural tissue regeneration beyond the visible scars. The human cost of burns is immeasurable, and our technology came from the research at the Professional Firefighters Burn Lab at the University. So it's why we focus on innovative solutions for burns that don't just hope for a better, faster, and complete recovery, but work to solve it in the most rapid way possible. In aesthetics, the risks are hidden; in aesthetics, the quest is to fix the signs of aging or enhance our features. We turn to synthetic injectables to work as fillers, but these treatments can offer temporary improvements. They come with hidden risks. At the heart of tissue regeneration in wound care and aesthetics lies the extracellular matrix necessary to grow, migrate, and repair tissue. Conexeu is seeking to repair cellular tissue and growth in a way that works with the body, not as a temporary filler or a short fix.
So what's being used to support cellular growth and repair in scaffolds in wound care is a class of scaffolds or ECM powders, collagens, gels—these flowables. You can see the way that they're applied. Most noticeably, there is a lack of uniformity and integration with surrounding tissue. And if you look really closely, these skin substitutes don't form a smooth or stable surface, which is essential for cell migration. Dr. Hartwell has the best line: cells don't jump. So if you look at these models, cells have to migrate through these environments, and it's not easy, which leads to limitations in healing and outcomes.
10 Minute Tissue is optimized for tissue integration. Our unique delivery method is mechanically superior. It's liquid at room temperature, and it flows evenly into complex wounds and at full depth for precise placement. It creates a smooth and uniform environment, and it supports rapid cellular growth. In head-to-head studies with other collagen flowables, the market leader, we're more than 250% faster in wound closure in the first 14 days with a 96% closure rate. Our biologic advantage is superior transitioning throughout the healing process, fibroblast proliferation, reductions in inflammation, new vascularization, faster rates of tissue regeneration, and it's non-fibrotic, so there's less scarring. Our collagen-based substitute has a unique temperature-sensitive formula that gels in place. It sets at 34 degrees, or just under the body's temperature, ensuring that the filler remains in place. It's a simple, elegant, and effective solution for the world's most complex wounds.
So where are we at? We've begun the 510(k) process. We've received our pre-submission with the FDA, and we have an approved substantially equivalent predicate. We've selected a contract manufacturer to begin production and scale up, and we're targeting Q3 2025 for FDA submission. We have strong IP and proven science. We have 10 years of translational research at the University of British Columbia, so our science has been significantly de-risked. And we have a strong IP position, with patents granted in five jurisdictions, including the EU, which were only granted in 2023. We're focused on commercialization, so we understand wound care.
What you may not know about aesthetics is the aesthetic industry wants collagen IP. The foundation of our technology is collagen. The original aesthetic fillers are collagen; our aesthetic predicates are based on FDA-approved collagen fillers. So let's look at the aesthetic market. Dermal fillers we know are used in the face and hands and the creases around the eyes, nose, and mouth, and regenerative aesthetics has always been a focus of the aesthetics industry, and collagen, with its bio-stimulatory properties, makes it a desirable ingredient. And so we'll see where the industry is heading and why dermal fillers have limitations. The market is dominated by products that are made with hyaluronic acid. They have limitations with toxicity, like BV cross-linkers, and they have durability limitations with fillers breaking down in six to 12 months, and they have dosage limitations of 20 cc's of filler per year per patient.
It's because these issues—this class of filler doesn't work for large volume indications—a key market limitation for this class of filler. Large volume procedures are a very desirable market, but this market also has limitations. It's invasive and expensive. It's dominated by implants and fat grafting, and fat grafting is used in procedures like hip dips, butt lifts, and these contouring procedures need 200 cc's to 500 cc's, and since hyaluronic acid fillers are limited to 20 cc's, they're not suitable. The industry is looking for products. Fat grafting is a product of the human body. It is not a scalable, transferable product for distribution. Conexeu has a large volume indication by replacing fat with collagen as breast, butt, and hip fillers. This represents a significant opportunity for whoever gets to this market first.
There are three things driving this market: the consumer, new technology, and aesthetic pharma. Consumer demand for collagen replacements has never been higher. Collagen beauty products is a $2 billion market in the US and the EU alone. It's grown 50% in the last five years, and it's not stopping. There are technology breakthroughs; recent advancements in human collagen technology and production mean that scalable human collagen is coming. This will bring a brand new class of fillers and treatments in regenerative aesthetics, like new fillers. There's deal-making. The large aesthetic companies are spending hundreds of millions of dollars to license human collagen IP, whether that's manufacturing IP or licensing rights to that filler material. The signal is that large aesthetic companies are placing a high value on human collagen IP.
Conexeu offers the potential to be a first mover in human collagen. We're a collagen-based technology. As the industry seeks newer, safer soft tissue fillers and large volume alternatives, our IP puts us three to five years ahead, potentially saving millions of dollars in R&D, with the potential of even earlier market entry. So as the industry begins to formulate with human collagen, we hold the patents to our unique mechanical functions. We gel at 34 degrees for precise placement in situ. We don't have to develop a formula; we have one today.
So a quick summary: we're pursuing a 510(k) for our 10 Minute Tissue and expect to submit in Q3 2025, and as the world moves into human collagen, it's given us an accelerated global path with indications and predicates. We're a seed stage investment company seeking investment, and as an investment, we're backstopped and de-risked by our wound care device. But we have significant global opportunity in aesthetics with human collagen fillers, with each filler indication potentially valued in hundreds of millions of dollars.
So in nine minutes, that's 10 Minute Tissue. I appreciate you coming at the end of the day, and I look forward to speaking with you more. Thank you.
