‘Race against the clock’: iiShield raises $1m for ‘kidney pyjamas’ to boost transplant outcomes

Sydney-based medtech iiShield has raised just over $1 million to fund clinical trials of an innovative device, colloquially known as “kidney pyjamas”, to enhance the success rates for transplant surgery, with the startup planning to take the technology to a global market by the end of next year.

The iiShield technology, developed by biomedical engineer Dr Jeremy Kwarcinski and Westmead Clinal School’s Professor Henry Pleass and Associate Professor Tony Pang, is described as a single-use, cost-effective medical device that aims to increase the available time for surgeons to undertake kidney transplants.

The seed round has been backed by the third Sydney Angels Sidecar Fund, which is among a series of venture capital funds that co-invest alongside members of Sydney Angels.

The $200,000 investment is the first for the Sidecar Fund III which aims to build a diversified portfolio of early-stage investment opportunities that have been selected, screened and invested in by members of Sydney Angels.

The iiShield technology has been developed by a core team of biomedical engineers and transplant surgeons, including Pleass who is chief of surgery at Westmead Hospital.

Kwarcinski says the Kidney Protective Jacket solves a direct need for surgeons by giving transplant surgeries a greater chance of success.

“Right now, there is no commercially available solution to address this problem,” Kwarcinski tells Business News Australia.

“Our device is centred on minimising the risks and dangers of kidney transplant surgery.

“When you think about keeping organs safe for transplantation it’s all about keeping organs on ice from point A to point B.

“But the big problem when you get to the surgery itself is to take the organ off the ice and put it into a warm 37-degree body without a blood supply. Essentially, as that organ heats up it starts to die.”

Kwarcinski points out this is a major issue in the operating theatre as the average surgeon takes about 40 minutes to complete the transplantation, whereas the kidney reaches that dangerous temperature after only about 10 to 15 minutes.

“It makes transplantation a race against the clock,” he says.

“Our device, the Kidney Protective Jacket or the kidney pyjamas, is a single-use consumable device that goes onto the kidney as it goes into the body that insulates it from the heat of the body.

“This means that it doesn’t reach a dangerous temperature until after the surgeon has reconnected all the blood vessels to minimise the risk of rewarming injury.”

Kwarcinski says the success of the kidney pyjamas rests with its development as a medical device that is designed by surgeons for surgeons.

“My co-founders would love to attest that surgeons don’t like things that annoy them,” says.

“They like it to be easy and like it to work, so we have built it the way kidney transplantation is done.

“Surgeons don’t need to change the way they do it. The only difference is the kidneys are in a nice comfortable set of pyjamas that keep them at a safe temperature.

“As soon as the surgeon is finished the transplant, the pyjama is removed and disposed of.”

While production costs of the device are relatively low, iiShield expects the product to be sold at a premium price point of aboutUS$4,500, or less than 1 per cent of a typical US kidney transplant cost.

Founded in 2020, iiShield was previously supported by non-dilutable government grants and founder capital with the startup receiving its first funding in 2021 through the NSW Medical Devices Fund.

The first capital raise by iiShield will be used to largely fund clinical trials of the medical device, due to start in December at Westmead Hospital.

“We have previously tested the device with human kidneys that were not used for surgery in a simulated environment,” says Kwarcinski.

“That was able to show that we can reduce the core temperature by 50 per cent at the average surgical time, which means that the kidney is only half as warm and has not crossed into that danger zone until well after the global average surgical time.”

The iiShield co-founder points out that getting the temperature right is critical for kidney transplantations.

“The kidney being too warm causes damage, but at the same time if the kidney is too cold, that temperature change can also cause damage,” he says. “It’s about finding that Goldilocks zone to give the kidney the best chance of life.”

The startup anticipates the clinical trials will be completed in March next year, paving the way to apply for US Food and Drug Administration approvals.

The founders are initially looking to scale the business in the lucrative US market, where 30,000 transplants were performed in 2023.

The kidney pyjama also has secured a patent from the Japanese Patent Office and is at the Patent Cooperation Treaty stage in several countries.

The founders anticipate they could be in a position to officially launch the product by the end of 2026 or early 2027.

Sydney Angels Sidecar Fund investment committee member Adrian Bunter says iiShield has enormous potential to solve “a really big problem in a very large market”.

“We liked the team and what they are trying to do,” he says.

“It’s a simple solution, but the logic is quite sound and through the quality of the surgeons involved they have come at it in a way that works really well for them.”

While Bunter says this is the first investment for the third Sidecar Fund, the committee currently has other opportunities under review.

Sydney Angels jointly operates the Sidecar Funds in partnership with VentureCrowd.

“The sidecar fund is attached to the Sydney Angels group, which invests in every single deal that goes through the Sydney Angels that passes through the criteria including the due diligence,” says Bunter.

“The reason Sydney Angels has partnered with Venture Crowd is to democratise access to the fund, which is genuine.

“The minimum investment is $25,000, whereas with most other funds you have to commit $250,000.

“Even as a high-net-worth investor that can be a really big investment requirement. We still require people to be sophisticated investors is a much easier one and gives more people access to these kinds of investments.”