OcuRegen™
A topical bioelectric therapy for faster wound closure.
PCED beachhead. PD gated development. Lead nomination and ex vivo closure signal.
Persistent epithelial defects are conventionally defined at ~2+ weeks of non‑healing. When closure fails, patients escalate through successive interventions; each step increasing cost, morbidity, and time‑to‑closure.
Target indication: Persistent Epithelial Corneal Defects (PCED)
Product: OcuRegen™ topical bioelectric modulators
OcuRegen™ focuses on candidates that preserve barrier function, raise corneal wound ion flux, and accelerate closure. By modulating ion channels (Na⁺/Cl⁻ flux) and maintaining barrier integrity, the wound’s electric field is restored and directional epithelial migration accelerates toward the injury.
PCED enables short trials with objective epithelial closure endpoints. We plan to pursue Orphan Drug + Fast Track while building mechanistic PD→closure linkage and preparing IND‑enabling work post‑seed.
Clinical & regulatory path
PCED is the beachhead, followed by expansion into neurotrophic keratitis (NK) and broader impaired-healing surface indications, leveraging the same approach.
Wedge & expansion
Differentiation
What this Round Must Prove and How we Plan to Protect the Program
IP STRATEGY
File provisional patents around:
Analog families
Ocular-local formulation / combination / use claims
Assay and gating know-how
Differentiated chemistry as it emerges
FREEDOM-TO-OPERATE (FTO)
Formal FTO work begins pre-seed / early seed, focused on ion-channel small molecules, ocular-local formulation, and corneal-repair use claims.
REGULATORY STRATEGY
PCED has precedent for Orphan Drug and Fast Track designation. We plan to pursue designation, so orphan exclusivity would be a potential benefit after approval.
REPRODUCIBLE PD SHIFT
Can the lead generate a reproducible, decision-useful corneal PD shift in human-relevant tissue?
PD to EX VIVO CLOSURE TRANSLATION
Does the PD signal translate into directional improvement in ex vivo closure versus vehicle or comparator?
LOCAL TOLERABILITY / BARRIER PRESERVATION
Can the candidate preserve barrier function and local tolerability while increasing wound-associated ion flux?
SUFFICIENT DIFFERENTIATION
Do the chemistry, formulation, and early IP/FTO profile justify rabbit work and a seed round?
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