Irish start-up company Sothic Bioscience Ltd is poised to break into a niche in the medical devices sector that in 2014 was worth $485 million. The company believes it has the product to do this and if successful will also deliver an environmental benefit: rescuing the horseshoe crab from extinction.
Few people know it but the horseshoe crab is the unsung hero when it comes to medical devices and pharmaceutical products. The blood of the crab has unique properties that make it ideal for giving an absolute guarantee that an injectable product or implantable medical device is absolutely sterile.
Proof of safety is good for humans but the crabs suffer the consequences. They are captured then bled to recover their blood and then returned to the sea, with a disputed percentage of losses that ranges from a few per cent up to 35 per cent.
Biosynthetic equivalent
Here is where Cork-based Sothic Bioscience comes in, to the delight of the horseshoe crabs. The company has developed a "biosynthetic" equivalent of the product derived from the crab blood that is "indistinguishable" from the crab version, says company chief executive Stephen Geary. "There is no other product like it, it is entirely novel," he says.
A move by the med tech industries to use the Sothic Bioscience product could remove a risky bottleneck. The Atlantic horseshoe crab is only found along the northeast coastline of North America and although the species is not under threat at the moment, demand for the product from its blood (LAL or limulus amebocyte lysate) is growing by 12 per cent year on year, something that could put the crab under pressure.
“The [med tech] industry depends on the product and is consuming more and more each year and people have been plugging that gap relying on an unsustainable source. It is a weak link, a single point of failure,” Geary says.
Sterility accuracy
The company’s LAL equivalent would take the crab out of the production line all together and it has been tested to show it is just as accurate about the sterility of an injectable, he says.
“Any time that an injectable or implantable medical device is used you have to be able to trust it. It must be verified as not just biologically sterile but pyrogen-free. A pyrogen is a byproduct of bacterial contamination and can cause high fever in a patient or even kill you,” he says. “It is not enough to prove something is sterile, global controllers demand the product must be pyrogen-free as one of the final quality-control steps.”
Sothic Bioscience is a traditional start-up. It was formed in April 2015 and currently employs two, its co-founders Geary and Dr Piotr Jakubowicz. Geary's background is in engineering and pharma biotech and Jakubowicz's is in materials and biochemistry, but both have been involved in a number of companies and have developed some business acumen.
Developing an alternative to crab-derived LAL was something Geary first considered in 2011 when he was going through some quality-control training. He felt it was “unusual” for an entire industry to be dependent on such a tenuous product source and started to look into alternatives.
The two founders finally made the leap last year after entering an IndieBio accelerator programme. “We were able to get running and got lab space at UCC to pursue this,” he says.
“It was a three-month sprint of R&D and we managed to discover how to make LAL in vitro without any crabs involved. We took them right out of the equation,” says Geary.
Patents
They filed patents to protect the intellectual property for their “novel biotech platform developed in-house here last summer,” he says. Tests have shown that their synthetic LAL is just as effective at detecting bacterial or pyrogen contamination and research has continued into this year to further refine the product and the manufacturing process.
They are now ready to take on the med tech world, with the undoubted support of the horseshoe crabs. “The next step is scaling for growth and actual manufacture,” says Geary.
“We are a small team at the moment but need to move to a bigger facility and develop it, going from bench scale to an actual manufacturing centre so we can supply in bulk and in meaningful quantities.”
They have been fundraising and he said they were coming towards the end of a seed fund raising round and have attracted venture capital.
The world market for LAL is expected to break $1 billion by 2020, but the more manageable Irish/UK market accounts for about 20 per cent of the total. There will be plenty of market for them to target when the time comes.
