Mimicking elusive bacteria to cloak medical devices from the immune system.
CEO: Richard Boyd
CTO: Andy Herbert
Based: Edinburgh, Scotland
The scoop: Picture life as the blood cells of a patient undergoing dialysis: Every few days, you find yourselves surrounded by a completely alien, artificial environment. This triggers a chain reaction that calls on the body’s immune system to attack, attack, attack. Rid it of everything that shouldn’t be there.
“Normally, this is exactly what you want—except when it comes to medical devices, implants and transplants that require something foreign to go into the body, or be in contact with the blood in order for it to work,” says Andy Herbert, Invizius’ chief technology officer.
That system-wide inflammatory response—the constant rebelling as the blood passes through the dialysis machine, across its tubes and filters, and back again—is part of the reason cardiovascular diseases are major causes of mortality among patients with end-stage renal disease, with one-year death rates reaching 20% to 30% and overall reduced life expectancy.
“These are enormous foreign bodies, as far as the immune system is concerned,” adds CEO Richard Boyd. “You’re taking the patient's entire blood supply and passing it through a foreign body with a surface area of about two square meters, and you're doing that for a few hours at a time. It's no surprise that the foreign-body response is particularly hazardous for patients.”
Invizius aims to cloak the machine from the body and have the blood pass through unawares, by stealing a trick from the bacteria Streptococcus pneumoniae, the main cause of pneumonia and meningitis. By coating the insides of the machine with a layer of proteins similar to the skin of the disease, they hope to mimic the microbe’s ability to hide from the human immune system and shield itself from attack.
What makes Invizius fierce: The company’s H-Guard priming solution is designed to serve as a consumable accessory in the normal dialysis process. After being flushed and cleaned, Invizius’ somewhat-sticky liquid mixture is fed into the machine before it is connected to the patient.
“Immediately upon contact with the blood, H-Guard recruits the body's own immune regulators by binding them to the surface of the device,” Herbert tells FierceMedTech. “Then you have a surface that looks less foreign, because it's coated in one of the patient's own human proteins. And by virtue of the fact that it is an immune regulator, any inflammatory response is then dampened down.”
In addition, recruitment of the complement immune system also helps cut back on blood-clotting events. The body’s two systems work together in something of a feedback loop: when you cut your finger, the immune system aims to clear invading bacteria, while the thrombotic system seals the cut from the outside and stop the bleeding.
And because H-Guard’s proteins are tethered to the surface of the machine, pretty much all of the effects take place locally, and ex vivo. “You don’t need to systematically inhibit the complement system to achieve the result that we do, because what we’re doing is hiding the device in the first place,” Herbert says.
That also allows Invizius to complete a lot of testing outside of human subjects. But when it begins human clinical testing, it plans to start with those whose immune systems react the strongest to dialysis, and have the highest rates of complications and mortality.
“The cost of dialysis in the U.S. is about $30,000 a year, but for patients who are intolerant, the hospitalization cost annually adds about $100,000 on top,” says Boyd.
In the future, Invizius believes its mixture could be tailored to coat a number of different devices where biocompatibility is lacking, such as ventricular assist devices and cardiopulmonary bypass machines, as well as grafts, stents and long-term catheters and ports.