Applications

Focused first. Extensible by design.

RetinaTek is concentrating its commercial development on objective longitudinal measurement for concussion recovery while building a platform that can expand into adjacent research and clinical markets.

Paid research and sponsored observational pilots are available now under protocol. RT-Focus is the planned first 510(k) submission, and RT-TRACE is the condition-specific product being developed for the concussion market.

Discuss a sponsored pilot Explore RT-TRACE
A patient completes a headset-based cognitive assessment in a supervised clinical setting.

Applications by maturity

Not every application is at the same stage. RetinaTek separates sponsored investigational use, its first-clearance plan, RT-TRACE's condition-specific development, and future platform expansion.

Available now under protocol

Paid research and sponsored pilots

Research and sponsor-funded, clinic-delivered observational pilots can use RETINA to evaluate objective neurocognitive endpoints, usability, workflow feasibility, longitudinal protocols, and validation questions alongside usual care.

Examples

  • Academic research
  • Clinical-development studies
  • Concussion and mTBI observational protocols
  • Rehabilitation and recovery-tracking research studies
  • Clinical trial endpoints
  • Defense and human performance research

Pilot outputs are investigational and are not used for diagnosis, treatment, or return-to-activity decisions.

First clearance plan

RT-Focus general assessment aid

RetinaTek plans RT-Focus as its first 510(k) submission, using the completed FDA Q-Submission feedback to guide a focused general cognitive-assessment pathway.

Examples

  • General cognitive assessment
  • Supervised administration
  • Baseline performance profile
  • Repeat assessment
  • Clinician-interpreted output

RT-Focus is in development and is not FDA-cleared or available for clinical decision-making.

Commercial market focus

RT-TRACE concussion recovery

RT-TRACE is RetinaTek's focused commercial and fundraising story: objective longitudinal measurement for concussion recovery programs, developed first through sponsored evidence-generation pilots and later through a condition-specific regulatory pathway.

Examples

  • Longitudinal recovery research
  • Repeat-measurement feasibility
  • Treatment-response research
  • Pediatric return-to-learn research
  • Rehabilitation outcome research

RT-TRACE is investigational and is not FDA-cleared for diagnosis, monitoring, or return-to-activity decisions.

Future platform expansion

Broader platform opportunities

As evidence, datasets, partnerships, and regulatory pathways mature, RETINA may support broader applications across safety-sensitive work, sports, biopharma, digital health, international markets, and AI/data partnerships.

These are potential future applications, not current diagnostic claims.

Primary application areas

RETINA's value is strongest where objective, repeatable measurement under cognitive load can support research and future validated decisions about performance, recovery, treatment response, or readiness.

Available now: research

Research and Clinical Trials

RETINA can support research teams that need objective, repeatable neurocognitive endpoints across attention, processing speed, cognitive control, effort, and performance consistency. Potential uses include endpoint development, longitudinal research measurement, treatment-response studies, and clinical trial protocols.

Discuss research deployment
Commercial market focus

RT-TRACE Concussion Recovery

RT-TRACE is being developed for specialty concussion programs that need practical, repeatable objective measurement across recovery. Sponsored pilots are designed to generate workflow, usability, and longitudinal evidence in the settings where the product is intended to operate.

RT-TRACE is investigational and is not FDA-cleared for diagnosis, monitoring, or clinical decision-making.

Explore RT-TRACE
Available now under protocol

Sponsored Observational Pilots

Clinics, researchers, and sponsors can work with RetinaTek on paid observational pilots that test assessment workflows and generate evidence alongside usual care. These engagements are the near-term bridge from research platform to regulated product development.

Pilot results are investigational and are not used to direct diagnosis, treatment, or return-to-activity decisions.

Discuss a sponsored pilot
Regulatory sequencing

RT-Focus First-Clearance Plan

RetinaTek plans to pursue RT-Focus first as a general computerized cognitive-assessment aid. This narrower initial pathway is intended to establish the regulatory and quality foundation for later condition-specific RT-TRACE development.

RT-Focus is in development and does not carry a concussion-specific claim.

Review the staged pathway
Research / clinical development

Rehabilitation and Recovery Tracking

Rehabilitation is inherently longitudinal. RETINA may support research and future clinical-development work focused on cognitive-performance change over time in neurorehabilitation, vestibular rehab, stroke, acquired brain injury, and recovery-focused workflows.

May support research and future validated use cases involving treatment-response tracking, recovery trajectory assessment, and identification of patients who are not progressing as expected.

Contact the team
Research / platform expansion

Defense and Human Performance

RETINA was shaped in military research environments and may support cognitive readiness, training readiness, blast exposure research, and human-performance studies. The platform is well suited to measuring cognitive performance under controlled demand.

Specific operational or medical claims require appropriate validation, use context, and regulatory treatment.

Contact the team
Research / future platform expansion

CNS Biopharma and Digital Endpoints

CNS trials often need objective, repeatable, low-burden measures of cognitive change. RETINA may support exploratory endpoints, secondary endpoints, trial enrichment, treatment-response studies, and decentralized or hybrid assessment workflows.

Use in clinical trials depends on protocol, endpoint strategy, validation requirements, and regulatory context.

Discuss research deployment
Future platform expansion

AI, Data, and Platform Partnerships

Task-evoked multimodal data may support future predictive models, longitudinal digital biomarkers, and integrations with hardware, clinical, research, and digital health platforms. These opportunities require appropriate consent, privacy controls, validation, and governance.

Contact the team

Additional future expansion areas

Additional opportunities may emerge as the platform, evidence base, hardware ecosystem, and data infrastructure mature.

Occupational and public safetySports and human performanceNeurodegenerative and chronic neurologic conditionsInternational research and clinical marketsPediatric return-to-learnADHD and attention-related researchLong COVID and post-viral cognitive dysfunctionSleep, fatigue, and alertness researchPTSD and stress-related cognitive performanceDepression-related cognitive slowingChemo-related cognitive changesMedication and treatment side-effect researchPost-anesthesia cognitive recoveryDigital therapeutics and cognitive trainingInsurance and medico-legal documentationWorkers' compensation and return-to-workConsumer brain-performance baseliningEmployer wellness and executive performanceRemote and hybrid clinical trials

These are potential future areas and do not represent current diagnostic claims.

Different applications, different claims boundaries

The same measurement architecture can be used in different contexts, but the claims are not the same. RetinaTek separates investigational pilots, first-clearance development, condition-specific development, and future regulated clinical indications.

Application type Current status Appropriate framing Not claimed
Research deployments Available now Objective neurocognitive endpoints and task-evoked cognitive-performance measurement. No clinical diagnosis unless part of an appropriately approved study and regulatory context.
RT-TRACE sponsored pilots Available now under approved protocols Investigational longitudinal measurement, workflow feasibility, and evidence generation alongside usual care. No diagnosis, treatment recommendation, monitoring, or return-to-activity decision.
RT-Focus clinical development First planned 510(k) submission A general computerized cognitive-assessment aid informed by completed FDA Q-Submission feedback. No current FDA-cleared, FDA-approved, diagnostic, or monitoring claim.
Platform expansion Future validation- and partnership-dependent Human performance, occupational safety, biopharma endpoints, AI/data, and international opportunities. No current employment, safety, diagnostic, or predictive claims without validation and compliance review.

Where should you start?

Pathway

I run a concussion program

Start with a sponsored observational pilot.

Discuss a pilot
Pathway

I am a researcher or clinical investigator

Start with a research deployment.

Contact the team
Pathway

I work in concussion, rehabilitation, or sports medicine

Start with clinical-development collaboration.

Review Clinical Development
Pathway

I represent a strategic partner or hardware platform

Start with platform partnership.

Contact the team
Pathway

I am an investor

Start with the platform thesis and evidence base.

Review Evidence

Application language depends on context

RetinaTek has completed an FDA Q-Submission and is using that feedback to plan a first 510(k) submission for RT-Focus. RT-TRACE and other RetinaTek products remain investigational and are not FDA-cleared or FDA-approved for diagnosis, monitoring, treatment decisions, or return-to-activity decisions.

Help build the evidence for objective concussion recovery measurement

RetinaTek is seeking concussion programs, research partners, and sponsors for paid observational pilots, along with strategic partners for clinical development and future platform applications.

Discuss a sponsored pilot Review Clinical Development