Funding was obtained from:

• the Canadian Institutes of Health Research (CIHR)
• the Canada Research Chairs (CRC) Program
• the University of Toronto’s strategic hub Medicine by Design, and
• the Ontario Research Fund.

Total funding of approximately $1.8M over six years supported this published research project.

Replacing missing or damaged cells to treat degenerative diseases has been a long-standing goal of medicine since the discovery of human stem cells. Stem cells have the ability to renew themselves indefinitely as well as turn into specialized cells in the body, which is why they are being harnessed to replace cells lost to disease or injury. Despite advances in stem cell technologies, the challenge of rejection of tissue and cell grafts, as well as the need for risky immune suppression persists. Dr. Nagy’s solution is to generate universal stem cells that can evade detection by the immune system, avoid rejection and address cell therapy safety concerns by ensuring immune-evading cells are unable to form tumors, regardless of any potential changes they may undergo.

Dr. Nagy expects in the next few years these technologies will become standard in cell replacement therapies, offering safe, off-the-shelf, economical treatments or cures for diseases such as blindness, arthritis, diabetes, neurological disorders, cardiovascular, and lung diseases, among others.

This research project also supported the successful completion of two full PhDs, helping train the next generation of Canadian researchers and innovators.

The generally insufficient funding available to support investigator-led health research and for the full continuum of health research and innovation, is the key barrier to advancing Dr. Nagy’s work.

While funding for the initial stages of this research project was secured, continuing to move this research forward, including into preclinical studies and commercialization, will require further, sustained investment.

Dr. Nagy notes that governments and funding agencies should acknowledge the significance of generously supporting research that carries both high risks and high potential impact. Such investments could result in transformative changes to current paradigms or even lead to ground-breaking discoveries.

2013 to 2015: Origin of the concept of the “Safe Cell” and “Immune Cloaking” technologies, respectively.

2014-2022: Research project conducted.

2018-2023: Publication of research findings in peer-reviewed journals, including Nature and Nature Biomedical Engineering, which is renowned for its high impact factor in the scientific community.

2024: These technologies are now ready to progress to the next phase, which involves preclinical studies and commercialization within the healthcare industry.

Stem cell-based therapies are advancing toward clinical trials, with some already in Phase 1 targeting conditions like diabetes, Parkinson’s disease, and blindness. Ongoing clinical trials aim to establish proof-of-principle data, demonstrating the potential safety and effectiveness of laboratory-made therapeutic cells to provide treatment or cures for currently incurable degenerative diseases.

“We have successfully developed these technologies addressing key challenges and now the question is will we receive adequate support to take the vital next steps,” said Dr. Nagy.

The research and commercialization journey of the Radialis LD-PEM system received $3.85M in funding from diverse sources, including:

• $450,000 from the Canadian Breast Cancer Foundation;
• $500,000 from the Canadian Cancer Society grant;
• $2M from the Ontario Research Fund-Research Excellence (ORF-RE) program;
• $460,000 from the Natural Sciences and Engineering Research Council of Canada (NSERC); and
• $440,000 from MITACS.

Clinical trials of Radialis LD-PEM demonstrate the technology can detect breast cancer at a low radiation dose similar to mammography, while decreasing false-negative rates associated with x-ray digital mammography and false-positive rates associated with MRI. This has multiple benefits to patients and the health system.

The Radialis LD-PEM system can help mitigate the risk of overdiagnosis with breast MRI and unnecessary interventions, including mastectomies. This in turn can help reduce patient anxiety and discomfort and result in time savings for patients and the health system.

The use of LD-PEM can also lead to cost savings for the health system and the freeing up of resources for other patients. The LD-PEM system costs $500,000, a fraction of the expenses associated with both MRI and PET/CT machines. Additionally, the average scanning time with Radialis LD-PEM is 5 minutes, in contrast to the 30 to 45 minutes required for breast MRI and approximately 40 minutes for whole-body PET/CT scanning. This efficiency translates to increased patient throughput, representing an additional avenue for cost savings.

The LD-PEM approach aligns with the growing trend of personalized or precision medical imaging, prioritizing women’s well-being in the pursuit of optimal outcomes in breast cancer screening and diagnosis.

The real-world impact of this research is illustrated through the stories of patients. For instance, a patient initially burdened with a misdiagnosis found relief through Radialis’ LD-PEM system, which provided a reliable diagnosis and lifted the heavy weight of uncertainty.

The clinical translation and commercialization of the Radialis LD-PEM system requires the validation of the researchers’ observations regarding its superior diagnostic capabilities through multi-centre studies with larger participant samples.

To facilitate this crucial phase, additional funding and resources are needed for early production, specifically for the manufacture of several (up to five) demo units intended for use in these multi-centre studies. The absence of these funds poses a substantial barrier to the integration of the Radialis LD-PEM system into the health system for the benefit of patients across Canada.

2010-2015: Research and development undertaken at Lakehead University and the TBRHRI, including research and development of the novel solid-state sensor arrays for Positron Emission Tomography (PET) detectors, the concept of the PEM system with increased detector sensitivity, and the conducting of a feasibility study.

2016: Incorporation of Radialis to commercialize the LD-PEM system.

2016-2019: Laboratory prototypes developed and tested.

2017-2020: Global patents obtained by Radialis.

2020-2021: First clinical LD-PEM prototype developed and tested in lab settings.

2021: Conducted breast cancer imaging at the University Health Network’s (UHN) Princess Margaret Cancer Centre.

2022: First results are published in Sensors journal.

2022: Radialis LD-PEM system receives ISO 13485 certification, the medical industry’s optimal medical device standard, which ensures that all medical devices meet the proper regulatory compliance laws and customer needs.

2022: Received FDA approval to sell Radialis LD-PEM system in the United States.

2023: Market-ready prototype production.

Approximately $3M in funding over five years was obtained from the Fonds de partenariat pour un Québec innovant et en santé (FPQIS) (Government of Quebec), Emovi, and Sanofi.

Osteoarthritis is the most common form of arthritis and affects one in six people in Canada. In the specific case of knee osteoarthritis, hundreds of thousands of Canadians could benefit from this new diagnostic tool, which would considerably improve their quality of life.

Knee biomechanics can be accurately assessed in real time by the Knee kinesiography test (KneeKG™), enabling doctors to prescribe the right series of exercises for each patient, thus correcting their movements and delaying or even avoiding unnecessary surgery.

Published in 2019, the clinical study involving 449 patients followed for 6 months demonstrated that this technology, combined with a personalized management program, significantly reduced patients’ symptoms and pain. Patients treated with KneeKG™ were more satisfied with their treatment, performed better on objective functional tests, and reported a greater overall impression of change in pain, function, quality of life and overall condition.

This research is also contributing to Quebec’s and Canada’s economy. Since its creation in 2007, Montreal-based Emovi has grown from one to thirty employees. In September 2019, it finalized a $20 million financing round, including $4.8 million from the Quebec government as part of the BioMed Propulsion program administered by Investissement Québec. This financing supports the launch of the KneeKG™ on the US market. In May 2020, Emovi was selected by the Canadian Consulate General in Boston to join the 2020 cohort of the Canadian Technology Accelerator, an incubator program that stimulates the growth of Canadian small and midsize enterprises (SMEs).

The introduction of a disruptive technology, such as the KneeKG™, is often met with reluctance, requiring a change management process to be put in place. Researchers had to demonstrate that the technology was useful not only from a clinical point of view, but also that it does not increase costs for the healthcare system. This rigorous process of demonstrating value has required a number of studies to be carried out, and is proving time-consuming and costly. Ultimately, it is hoped that the evidence will support the reimbursement of this technology as part of the public health system so that as many patients as possible can benefit from it.

1996: Publication of two research papers. The first research paper on the irregularities created by the movement of skin relative to bone when measuring knee kinematics. The second paper was published showing that an early version of the design for the KneeKG™ harness reduced these irregularities by 6 to 10 times.

2005-2011: Research focused on validating the concept, developing a new user-friendly design, and demonstrating the validity of its use for populations suffering from various knee problems (ligament injuries, osteoarthritis). This led to the publication of several more research papers on the knee kinesiography diagnostic tool.

2007: In partnership with the Quebec university research community (CRCHUM, ÉTS, TÉLUQ), established the Montreal-based Emovi.

2012: Pre-marketing phase of the knee kinesiography diagnostic tool.

2019: The knee kinesiography diagnostic tool was launched commercially under the name KneeKG™.

2019: With 30 employees and an annual budget of $4 million, Emovi has implemented this technology for 60 customers (hospitals and clinics) in eight countries, including Canada, the US, the UK and France. The company holds worldwide marketing rights for the device, as well as regulatory approvals from Health Canada and the FDA, CE mark and several patents.

2019: Quebec’s Ministry of Health and Social Services and the National Institute of Excellence in Health and Social Services (INESSS) approved the implementation of two pilot projects to assess the cost and feasibility of integrating this management model into the public network.

2019: The Federation of General Practitioners of Quebec (FMOQ) updated its continuing education training on osteoarthritis management to incorporate KneeKG™ as a diagnostic aid and information on the biomechanical factors to be taken into account in therapeutic management.

2022: The results of the project to analyse the implementation of the KneeKG system with a view to scaling it up in the public health system, carried out by Emovi and the Centre intégré et de services sociaux de la Montérégie-Centre (Hôpital Charles-Le Moyne), have confirmed the positive impact on patients of the introduction of knee kinesiography.

A total of just under $5.9M in funding was secured from several sources, including:

• $2.4M from the Canadian Institutes of Health Research;
• $500,000 from the Newfoundland and Labrador Provincial Government’s Department of Industry, Energy, and Innovation;
• just over $2.3M from Newfoundland and Labrador Health Services (formerly Eastern Health);
• $532,000 from Memorial University of Newfoundland, and
• $100,000 from the Trinity Conception Placentia Health Foundation.

Preliminary results provide a strong indication of SurgeCon’s ability to improve wait times.

When compared to three other trial sites that were operating without SurgeCon during the first audit period, G.B. Cross Memorial Hospital, which experienced the largest year over year increase in patient volume of the four sites, was able to outperform the next best ED by:

• 23% for physician initial assessment (the duration between patient arrival and a provider’s first assessment);
• 14% for the length of stay of a patient in the ED (the duration between a patient’s arrival and their departure or transfer to an inpatient unit); and
• 18% for patients who leave without being seen.

The research team conducted telephone interviews with more than 1400 randomly selected patients from the four intervention sites. Initial results reveal that sites using SurgeCon have a higher probability of achieving patient satisfaction for both length of stay and time before being seen by a physician.

Through optimized patient flow and higher patient throughput, researchers see SurgeCon helping enhance the value of emergency healthcare spending by increasing the value of the fixed sessional rate that emergency physicians in the province are paid.

By streamlining emergency care and reducing wait times, the researchers also anticipate minimizing the economic burdens associated with delayed medical interventions, thereby benefiting the health system, patients, and the broader community.

The current restructuring of health services in Newfoundland and Labrador has caused the diversion of key personnel who can grant access to electronic health record (EHR) data feeds. This has resulted in the research team being unable to automate SurgeCon. The platform currently relies on nurses to manually enter department-level data every two hours. Despite the data entry process taking less than a minute, the pressures on staff due to ongoing health workforce shortages have led to inconsistent data capture, limiting the effectiveness of the SurgeCon app as a decision-support tool. Additional funding could enable the development of custom data capture tools for triage nurses and ED staff, which would replace generic and outdated solutions offered by EHR vendors.

Health workforce shortages and turnover are also affecting SurgeCon’s implementation and sustained use as its management platform relies on an organization having enough staff to effectively manage patient demand and appropriately flow patients. Despite these difficulties, SurgeCon has achieved wait time reductions, unlike other management frameworks that have shown yearly increases.

The limited availability of certain resources, such as long-term and inpatient beds, means patients who require admission or transfer to specialized units end up occupying ED beds, leading to prolonged wait times. This challenge hampers the effectiveness of SurgeCon as it becomes difficult to streamline patient flow and ensure timely access to appropriate care. Even though SurgeCon cannot solve these systemic issues on its own, it still enables frontline ED staff to control some aspects of ED operations, such as the flow of lower acuity patients.

The closure of EDs within the catchment areas of the four trial sites has increased patient demand, further burdening ED personnel and resources. This strain results in higher rates of staff burnout and turnover, impacting manual data entry and efficient patient flow. This poses a risk to the sustainability of gains made in ED performance and diminishes the value of SurgeCon as a decision-support tool.

Market research identified demand for additional automation and AI features among healthcare organizations in North America and Europe. An analysis of the commercial landscape confirms that SurgeCon’s approach to ED management is unique, even when compared to offerings by multinational organizations. Additional funding from the federal government is needed to automate SurgeCon’s app. This automation will open up opportunities to enhance its features so that it better aligns with its patient flow framework through patient pathway recommendations, allow patients to access information related to estimated wait times and factors impacting patient flow, and address priority areas identified by frontline staff and management.

2013-2017: Proof-of-concept study conducted.

Mar–Aug 2021: Baseline period during which baseline metrics were collected.

Sep–Dec 2021: SurgeCon implementation in first trial site, G.B. Cross Memorial Hospital.

2022-2023: SurgeCon implementation in last three trial sites, St. Clare’s Mercy Hospital, Health Sciences Centre, and Burin Peninsula Healthcare Centre.

2021-present: Sustainment phase which includes working with frontline ED staff and managers to resolve issues and barriers related to using SurgeCon to manage operations; ensuring staff are adhering to process improvement principles; and advocating for SurgeCon’s integration into hospital policy to ensure its long-term usage.

The final year of the project will include knowledge translation activities, finalizing data collection and analysis, and submitting final reports. The researchers will be applying for additional funding to enhance SurgeCon’s app and create commercial and academic opportunities.

Just under $1.2M in funding was secured from several sources, including:

• $273,663 from CIHR, and
• $900,000 from Alberta Innovates.

Getting patients back on their feet and home sooner, ERAS is also an effective way of helping to manage hospital capacity. Alberta researchers have found that among 6,773 patients across five surgery types in AHS, ERAS was associated with:

• 71 fewer days spent in hospital after surgery (patients get out of hospital sooner, which frees up beds so that more can come in to have surgery).
• 6 per cent fewer readmissions (fewer readmitted means more hospital beds are available for surgical patients to recover in).
• 7-day shorter length of stay in those patients that required readmission.
• Between 2013-2015, ERAS colorectal implementation demonstrated conservative realized net savings of $3.6 million, a gain four times greater than the implementation investment.
• Between 2013-2015, implementation of ERAS for gynecology cancer patients led to a cost savings of $956 per patient.
• Additionally, from 2013-2018, ERAS has saved the health system an estimated $34 million.

“ERAS decreases readmissions to hospital due to surgical complications. And when patients do need to be readmitted, they spend less time in hospital than do readmitted non-ERAS patients. Those improvements also mean more beds are available for surgery patients.” – Dr. Gregg Nelson, Surgeon, co-lead researcher for ERAS, and Physician Lead ERAS Alberta.

An economic analysis looking at the 2013 to 2018 period shows the net health system savings per patient ranged from $26.35 to $3606.44 and return on investment ranged from 1.05 to 7.31, meaning that every dollar invested in ERAS brought $1.05 to $7.31 in return.

Funding remains the primary obstacle for the research team. If additional funding were able to be secured, the research team would explore how to improve the experience for patients on an ERAS pathway, and how to amplify the benefits of ERAS to all patients undergoing surgery in the province of Alberta.

A secondary barrier is to continue to advance uptake of the pathways across the province, especially in smaller suburban and rural areas. The ERAS team is exploring how to overcome these challenges to better serve all Albertans who have surgery.

2013: ERAS pilot begins at Calgary’s Peter Lougheed Centre and Edmonton’s Grey Nuns Community Hospital, where clinical care teams, leaders, and patients adapted and implemented ERAS guidelines for patients undergoing colorectal surgeries.

2016: ERAS is piloted at the additional sites of Calgary’s Rockyview General Hospital, Red Deer Regional Hospital Centre, and Lethbridge’s Chinook Regional Hospital allowing more Albertans to benefit from this innovative approach to surgical care.

2018: The surgical units of an additional four large urban hospitals implemented the ERAS guidelines. ERAS is expanded to other types of elective surgeries, including gynecology, pancreas, liver, cystectomy, major head and neck, and breast reconstruction.

2023: Further expansion of ERAS by building on the system-wide implementation of an electronic medical record, reducing the need for manual data collection. This enables real-time quality improvement data and support to move toward ERAS for all patients undergoing surgery in Alberta.

Approximately $10M in funding over five years was secured from various sources, including:

• $5M from Genome Canada and CIHR,
• $2.5M from Genome BC,
• $1M from PHSA,
• $1M from the BC Children’s Hospital Foundation, and
• approximately $500,000 in in-kind contributions.

Indigenous data governance principles require Indigenous control of the samples and their sequences. Before this project, there were no Indigenous developed governance structures, meaning there was no genomic reference data available to diagnose genetic disorders for Indigenous patients. Researchers and Indigenous partners created the Indigenous governance mechanisms required to enable sampling, sequencing, and storage of Indigenous data. The creation of genetic variation reference data for rare disease diagnosis will enable Indigenous populations to have increased access to genetic testing and diagnoses.

This project demonstrates that it is possible for Canadian health systems to work in partnership with Indigenous peoples to create governance structures based on Indigenous principles and perspectives. It also showcases that advancing equity and reconciliation in genomic medicine, and healthcare more broadly, is achievable and necessary.

It also highlights the importance of supporting and creating the conditions for Indigenous people to work in the health system. Having more Indigenous healthcare workers in a diversity of roles across the health system ensures that their perspectives are reflected in care delivery.

A major barrier to this work was the lack of governance mechanisms that take into account Indigenous data governance principles. From determining the Indigenous representation that should be involved in co-developing and informing this work to creating the data governance structure for the collection, use, and storage of the genome samples, the researchers and Indigenous partners had to forge a new path to take this project from idea to reality.

Another obstacle was finding First Nations, Inuit, and Métis people to do this work given the limited number of Indigenous healthcare workers. For example, the researchers had difficulty finding Indigenous data scientists to help carry out this work. This speaks to the need for federal government assistance to engage and support Indigenous peoples seeking roles in research and healthcare.

2016: Initial idea for the project.

2017: Extensive consultation on purpose and design of project.

2018: Funding secured.

2020-ongoing: Silent Genomes Indigenous Rare Diseases Diagnosis (SGIRDD) Steering Committee made up of Indigenous individuals and representatives is formed to provide cultural oversight and strategic advice in support of the collaborative creation, implementation, and utilization of the IBVL including respectful, culturally safe policies regarding access to data for clinical diagnoses and related research.

2020-2022: Project team develops software to store and process genomic samples once collected, refining based on SGIRDD Steering Committee feedback.

2023: The SGIRDD Steering Committee approves the proposed data uses and governance approach for the IBVL.

2023: Indigenous communities provide their approval of the governance approach, and four communities agree to participate in the initial launch of the IBVL.

2023-2024: Samples provided, sequenced, and input into the IBVL database.

Spring 2024: The IBVL will come online to support clinical diagnosis. Use will be extended to Indigenous peoples beyond Canada’s borders, as appropriate for diagnosis.

Adela, Inc. has raised US$108M through financing rounds from investors.

Adela’s technology can be used to accelerate the diagnosis and improve the management of cancer through a blood test. It will initially be applied for use in patients who have completed surgery for cancer, to direct use of additional treatment based on individual risk and to detect recurrences sooner than possible with today’s standard of care follow-up.

It will subsequently be developed for multi-cancer early detection. Routine screening to detect certain types of cancers in early stages has been shown to save lives; however, routine screening only exists today for a few cancers. Currently we don’t have tools to screen for many common cancers – such as pancreatic, ovarian, liver, and kidney cancers. These cancers are often not diagnosed until symptoms present, when the cancer is in later stages. To address the need for enhanced screening, Adela is developing a multi-cancer early detection (MCED) test.

Developing a blood test that can be used at population scale to screen for cancer requires large studies to evaluate the benefits and harms. Significant funding is needed to support these studies. In the case of Adela, UHN invested UHN Commercialization capital to launch the company’s efforts, and Adela subsequently raised capital from leading venture and strategic investors. Adela’s incubation at UHN was a success factor unique to UHN capacity and capability, and not all research institutions are in the same position. Government grants dedicated to translational research and commercialization projects could also help with such efforts.

Adela’s success also relies on the ability to attract highly-specialized talent in areas such as data science, software development biostatistics and clinical development.

2016: UHN internal gap funding awarded and CfMeDIP-seq technology discovered in Dr. De Carvalho’s lab.

2016: Initial Intellectual Property filed in the US

2018: Data demonstrating sensitive detection of multiple cancers with the research platform published in Nature

2021: Adela launches with US$60M in Series A funding.

2021: US Patent issued

2023: Data presented at the American Association for Cancer Research meeting demonstrating strong detection of multiple cancer types with Adela’s platform

2023: Adela secures US$48M in a second round of financing.

2025 (Planned): Adela plans to launch its first product for minimal residual disease (MRD) monitoring