Development Pathway

Our Pipeline

A strategic approach to bringing CiRPCs technology to patients, starting with orphan diseases and expanding to address the global burden of retinal degeneration.

Strategic Development Pathway

Our pipeline prioritizes rapid clinical translation while building a platform for addressing multiple retinal degenerative diseases.

LEAD PROGRAM

Retinitis Pigmentosa (RP)

Orphan Drug Designation: Targeting this rare but devastating inherited condition provides regulatory advantages and accelerated development pathways.

RP affects approximately 2 million people worldwide with no current cure. Our CiRPCs technology offers the first potential treatment to restore lost vision.

2027
IND Filing Target
FOLLOW-ON

Dry Age-Related Macular Degeneration (AMD)

Largest Market: The leading cause of blindness in patients over 60, affecting over 200 million people worldwide with no current treatment for the dry form.

Our RP clinical data will support expansion into this massive underserved population, leveraging established safety and efficacy profiles.

2028+
Development Timeline
FOLLOW-ON

Diabetic Retinopathy (DR)

Global Health Priority: Affecting 93 million people worldwide, disproportionately impacting underserved populations in developing countries.

Advanced diabetic retinopathy leads to irreversible vision loss when current treatments fail. Our technology offers hope for restoration even in advanced cases.

2029+
Development Timeline

Development Milestones (2025-2030)

A clear roadmap from preclinical success to patient treatment, with key regulatory and clinical milestones.

2025

IND-Enabling Studies

Complete GMP manufacturing, toxicology studies, and regulatory preparations for RP clinical trial authorization.

2026

Regulatory Submissions

Submit IND application for RP program. Leverage orphan drug designation for expedited review and development incentives.

2027

First-in-Human Clinical Trial

Initiate Phase I/II clinical trial for RP patients. Focus on safety, tolerability, and preliminary efficacy signals.

2028

Pipeline Expansion

Initiate IND-enabling studies for dry AMD program. Begin planning for diabetic retinopathy development pathway.

2030

Platform Validation

Multiple programs in clinical development, establishing CiRPCs as the leading platform for retinal regeneration therapy.

Regulatory Strategy

Leveraging orphan drug advantages and established regulatory pathways for cell therapy development.

Orphan Drug Advantages

  • • 7-year market exclusivity upon approval
  • • Tax credits for clinical development costs
  • • Expedited regulatory review timelines
  • • Protocol assistance and guidance from regulators
  • • Reduced regulatory filing fees

Development Pathway

  • • IND submission with comprehensive safety package
  • • Phase I/II adaptive trial design for efficiency
  • • Regular FDA communication and guidance meetings
  • • Potential for accelerated approval pathways
  • • Global regulatory strategy for key markets

Join Us on the Journey to Restore Sight

Our pipeline represents more than scientific milestones—it's a roadmap to transforming millions of lives. Partner with us to make vision restoration a reality.