IRegained, a Digital Neurotherapeutics (DTx) company, is changing how stroke and brain injury survivors regain lost hand function. Their flagship product, the MyHand® System, is a precision rehabilitation device that helps patients restore function through active neuroplasticity. It allows users to retrain their brains by repeating real-world tasks with their own effort, leading to more effective recovery.

After years of dedicated clinical research, early design iterations, and valuable feedback from patients and therapists, IRegained launched the MyHand® System in December 2024 and quickly gained traction. In a short period, the company has generated $250,000 in sales. With strong sales momentum, they are now collaborating with clinics and hospitals across the country and are set to surpass $1-million in revenue by the end of 2025.

How does The MyHand® System work?

The MyHand® System by IRegained uses the human sensory system and motor apparatus to aid in development of alternative neural pathways using the principles of neuroplasticity. It uniquely personalizes the finger movement patterns, force, and placement elements of exercises, combining it with the MyHand® digital app that gamifies the rehabilitation process with its highly engaging and interactive interface.

Understanding that each user engages their hand muscles uniquely for the same tasks, IRegained’s founder, Vineet Johnson, ensured the MyHand® System offers a highly customizable experience. This personalized approach actively supports the redevelopment of neural pathways, restoring hand mobility.

“We’ve really made sure that every element of the device is specific to the patient using it,” says Johnson. “From the amount of force used for each finger to the distance between the fingers, you can adjust and personalize it to fit your level of capability.”

The commercialization journey

The IRegained team was well into their commercialization journey when they encountered a crucial challenge: securing a product that fits the established industry safety standards and compliant to medical device manufacturing systems to enter the market. This is where Innovation Factory‘s CAMEDA (Canadian MedTech Alliance) program provided essential support.

The CAMEDA program, backed by Innovation Factory’s Southern Ontario Pharmaceutical & Health Innovation Ecosystem (SOPHIE) program, supports collaborative initiatives for Ontario-based life science firms in the later stages of commercialization. SOPHIE is funded by a Government of Canada investment through the Federal Economic Development Agency for Southern Ontario (FedDev Ontario), to help technology companies develop, test, and commercialize innovative healthcare solutions.

Through the CAMEDA program, IRegained successfully completed its product safety testing and initial-batch manufacturing, by collaborating with Megalab Group Inc. and Engineering CPR. This journey to the final product took some time, requiring multiple iterations and a commitment to listening to their target market to refine the MyHand® System.

“Working with the CAMEDA partners has been amazing, and leveraging their expertise has been advantageous for us. They are in this space and really understand the nuances of manufacturing medical devices. They are very meticulous about everything, and that’s what we really appreciate about this collaboration,” says Johnson.

Scaling IRegained from Ontario to Singapore and beyond

Not only is IRegained on a path of significant growth, but they’re also expanding globally. The MyHand® System has already received FDA and Health Canada approval, making it available in both Canada and the U.S. The team has also secured approval to enter the market in Singapore.

“We have regulatory approvals for the U.S., Canada, and Singapore, and we’re in the process of getting approvals from India,” adds Johnson. “We’ve seen a lot of interest from universities and healthcare organizations from Singapore, and we are planning on hosting demonstrations for them. After we’ve established a market there, we’re looking to expand into Southeast Asia.”

As it grows, IRegained is strategically targeting the Asian and Middle-Eastern markets—regions experiencing high stroke rates and a growing demand for advanced rehabilitation tools.

The IRegained team is working on laying the groundwork for a potential acquisition or IPO in the future, all while maintaining a sharp focus on measurable patient outcomes. To support this expansion, the company is raising a $2-million round, with more than half already secured. These funds will directly support expanded manufacturing and sales efforts.

IRegained’s journey demonstrates how deeply rooted clinical knowledge, patient-centered design, and strategic ecosystem support from programs like CAMEDA can lead to innovation with real-world impact.

Interested in learning more about the CAMEDA program? Connect with us to find out more.