Using AI to diagnose and treat anastomotic leaks 

FluidAI Medical, a postoperative medical technology company, recently invested $25 million in manufacturing its Origin™ medical device, a component of its Stream™ Platform that enables monitoring after digestive tract surgery, in Kitchener, Ontario. 

This investment was supported by a $1.4 million grant from the Government of Ontario’s Advanced Manufacturing and Innovation Competitiveness stream of the Regional Development Program.

After placing second in Innovation Factory’s Synapse Life Science Competition in 2019, FluidAI raised a pre-seed round from angel investors later that year and followed it up with a $2.65 million USD seed round in early 2021. 

“We started thinking about how we are going to deliver those devices into the hands of our clinical partners and customers. So, we began setting up our own manufacturing where we got some government funding to support us,” shares Amr Abdelgawad, the COO and Co-founder of FluidAI Medical, formerly NERv Technology Inc.

The team gained momentum in Canada and soon started expanding their reach globally. After receiving Health Canada approval in early 2022, FluidAI acquired a competitor company in the United States and secured regulatory clearance in Saudi Arabia. The team also closed a successful Series A round and received approval to enter the UAE and other Gulf markets.

“We’re in a position where we’re doing a limited market release in the Gulf region and Canada. And all of that wouldn’t have been possible just with our team alone,” shared Abdelgawad. 

How did FluidAI develop its postoperative monitoring solution?

FluidAI was founded in 2014 by Youssef Helwa when he developed a postoperative monitoring solution to address post-surgery complications that can occur during recovery. Often developing unnoticed after the surgery, these complications can lead to delayed treatment and sometimes even severe consequences. Helwa’s solution, FluidAI’s Stream Platform™, aimed to address these complications.

After researching and speaking to clinicians, the team decided to focus on general and abdominal surgeries. Specifically, anastomotic leaks, which occur in roughly 8-10% of those surgical procedures. These leaks can lead to infections and severe complications if not diagnosed in time. And diagnosis can take up to a week. This is where FluidAI’s postoperative monitoring solution bridges that gap and improves patient recovery.

In 2019, searching to iterate and validate their design, FluidAI turned to Innovation Factory (iF). The same year the team participated and won second place in the Synapse Competition, taking home $15,000 in non-dilutive funding and prizes. 

“Innovation Factory’s Synapse Life Science Competition was actually a key moment for us. It was when we were going through a major pivot and a major transition in terms of product design,” added Abdelgawad.

The company also received advisory services and early R&D funding through the National Research Council of Canada Industrial Research Assistance Program (NRC IRAP) to support feasibility studies and the development of its biosensor device, as well as assistance to help build its Intellectual Property capacity.

Tapping into key support to accelerate commercialization

Working with Innovation Factory, the team developed their investment pitch, gained support in validating their commercialization plan, and received several strategic introductions to funders, partners and industry leaders within the life sciences ecosystem, like Ontario Centre of Innovation (OCI) and Ontario Bioscience Innovation Organization (OBIO). 

After multiple iterations, the FluidAI team designed Origin™, a non-invasive postoperative medical device and part of Stream™ Platform. Origin attaches to existing drains and catheters, and monitors for fluid as it leaves the body, identifying whether the patient is recovering, or potentially suffering from a leak. Using AI, Stream™ Platform uses and analyzes data from Origin™ and the Electronic Medical Records (EMRs), and leverages it to effectively produce a diagnosis.

In 2021, as FluidAI was looking to test its product for safety and validity, the team learned of the Southern Ontario Pharmaceutical and Health Innovation Ecosystem (SOPHIE) program. Delivered by Innovation Factory, in collaboration with the Synapse Life Science Consortium, the SOPHIE program launched in 2021 with a $7-million investment from the Government of Canada through the Federal Economic Development Agency for Southern Ontario (FedDev Ontario). The SOPHIE program supports high-potential life science companies and enables them to accelerate their path to market. To date, the program has supported over 70 commercialization projects, enabled $15 million in commercialization investment and helped emerging companies create new jobs and raise capital.

Through the SOPHIE program, FluidAI was able to partner with Hamilton Health Sciences to utilize trial data to create a diagnosis model and improve their platform’s functionality. This commercialization project formed the basis for an FDA breakthrough designation submission, and a Saudi FDA submission, which will serve as the first steps to commercialization in the USA and Saudi Arabia.

FluidAI went on to also complete a project through Innovation Factory’s Hamilton Ecosystem to Accelerate and Leverage Trials of Health Innovation Program (HEALTHI) program. Supported in part by funding from NRC IRAP, the program helped FluidAI develop a clinical strategy and establish essential protocols for clinical investigations.

“HEALTHI gave us the chance to collaborate with clinicians to design our trials with precise end-points. It also facilitated the creation of solutions tailored to our users’ needs and the achievement of critical patient care outcomes.”

Now with 42 full-time employees, FluidAI’s journey shows that collaboration is key in turning ideas into solutions that can benefit patients everywhere. With support from ecosystem members, the company is set to expand around the world and help patients heal better with its postoperative monitoring solution.

“We’re truly grateful for the support of everyone. And it really does take a village in order to take a company in a start-up from an idea all the way to market,” shared Abdelgawad.

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