27-01-2026
News
After one year in the VR Health Champions programme, Virtuleap has moved beyond isolated milestones to focus on something far more demanding: building a coherent pathway from technology to clinical validation, regulation and market readiness. We spoke with Amir Bozorgzadeh, Principal CEO of Virtuleap, and Hossein Jalali, Co-founder and CTO, about how Cogniclear VR has evolved — and what it really takes to prepare a healthcare VR solution for real-world deployment.
Building foundations instead of chasing milestones
Virtuleap develops virtual reality solutions for cognitive assessment, training and monitoring. Its flagship product, Cogniclear VR, delivers immersive cognitive assessment based on neuropsychologically validated tests.
Looking back on the first year of VR Health Champions, the team is clear: the biggest achievement was not a single breakthrough, but sustained, multidimensional progress.
“We would not point to one isolated accomplishment as our main achievement,” says Amir Bozorgzadeh, Principal CEO at Virtuleap.“The real value of VR Health Champions has been accelerating our progress across several interdependent dimensions — technology, regulation, market readiness and clinical validation — all of which are essential for the long-term success of Cogniclear VR.”
According to Bozorgzadeh, VRHC fundamentally changed how the company structured its roadmap.
“The programme enabled us to mature Cogniclear VR in a holistic and structured way. Instead of addressing usability, clinical development and regulatory requirements sequentially, we were able to work on them in parallel — which is critical in healthcare innovation.”
Technology as the backbone of clinical progress
From a technical perspective, the past year delivered tangible advances. Feedback gathered during a workshop at the Medical University of Lodz directly informed the development of Cogniclear VR Part B, an alternative version designed to minimise training effects during repeated assessments. At the same time, Virtuleap significantly expanded its Enterprise tools for clinicians, including dashboards for data visualisation, live streaming of patient experiences and guided interaction within VR.
For Hossein Jalali, Co-founder and CTO, this work was pivotal — but not without challenges.
“One of our main challenges was managing dependencies between workstreams,” Jalali explains. “Enhancing the Enterprise tools became a prerequisite for pre-clinical testing, which meant that technical development had to be tightly coordinated with usability studies, regulatory processes and technical documentation.”
Rather than slowing progress, this dependency reinforced an integrated development approach — where advancement in one area enabled progress across the entire project.
Usability, ethics and localisation
User-centred validation moved forward in parallel. Usability protocols and ethics approvals were finalised at Politechnika Łódzka and Fondazione Bruno Kessler – FBK , while Cogniclear VR Part A was successfully localised for both Polish and Italian users.
A usability study involving 40 participants, conducted by TUL, provided further evidence to refine the solution ahead of clinical trials — a necessary step before entering real healthcare environments.
Entering the clinical and regulatory phase
Clinical validation is now transitioning from preparation to execution. The trial protocol for ULS de Coimbra has been finalised, with ethics committee submission underway. The study will evaluate Cogniclear VR as a screening tool for mild cognitive impairment.
On the regulatory side, Virtuleap continues progressing towards medical certification through the implementation of a Quality Management System and the development of technical documentation, supported by close collaboration with Critical Catalyst.
“Critical Catalyst has been instrumental in shaping our regulatory pathway,” says Jalali. “Their expertise in software-based medical devices and CE marking has helped us make informed decisions around risk classification and technical documentation at exactly the right moment.”
Market access and value creation
Beyond technology and regulation, Virtuleap has advanced its market access strategy. A scoping review and reimbursement pathway report for Germany are nearing completion, while health-economic modelling and value frameworks are being developed with Syreon.
For Bozorgzadeh, this work is essential to ensuring Cogniclear VR is not only innovative, but viable.
“Innovation only matters if it fits real healthcare systems,” he notes. “Our focus has been on preparing Cogniclear VR for early adoption, particularly in the private sector, while building a solid case for long-term integration into clinical pathways.”
Priorities for year two
Looking ahead, the coming months will focus on execution. Usability testing at Fondazione Bruno Kessler will be completed, patient recruitment for the clinical trial in Coimbra will begin, and development of Cogniclear VR Part B and the updated Enterprise tools will be finalised.
Regulatory efforts will intensify, including software verification and validation, cybersecurity and GDPR compliance, supported by partners selected through the second cascade funding wave. A new onboarding experience for clinicians will also be introduced, clearly positioning Cogniclear VR as a medical device from the first interaction.
Why VR Health Champions is different
Asked what distinguishes VR Health Champions from other innovation initiatives, Virtuleap points to its practical, results-driven character.
“In one word, VR Health Champions is results-oriented,” Bozorgzadeh concludes. “It brings together partners who understand healthcare VR, focuses on real-world needs, and actively supports SMEs in completing the necessary steps towards market launch and market fit.”
After one year, Virtuleap’s journey illustrates what VR Health Champions was designed to do: turn complex innovation into a credible, structured pathway towards clinical deployment and commercial reality.
Pictured from left: Hossein Jalali, Co-founder & CTO, together with Amir Bozorgzadeh, Principal CEO at Virtuleap.
This article is part of a broader VR Health Champions campaign showcasing the progress of five Flagship SMEs and highlighting how each of them has evolved over the course of the project. Through this series, we take a closer look at where our flagship SMEs stand today, what they have achieved so far, and how the programme has supported their journey from innovation to market readiness.
