Infection risk in PROM/PPROM

Clinical guidance advises limiting repeated digital exams with ruptured membranes. Objective, non-digital assessment aligns with this standard of care.

Economic tail risk

U.S. delivery episode spend is ~$53.6B/year. Complications and NICU stays add disproportionate costs that better triage and timing can help avoid.

CerviLite (device)

Handheld objective cervical measurement designed for repeatability, comfort, and infection-aware workflows.

• Quantified dilation & effacement
• Fast, standardized capture
• EHR-ready outputs

Maternal dataset (platform)

De-identified, schema-controlled dataset linking objective measures with outcomes—foundation for research and payer evidence.

• IRB-ready data model
• Governance & quality controls
• Multi-site harmonization

AI modules (roadmap)

Explainable prediction tools (time-to-delivery, C-section likelihood, complication risk) built with GMLP and PCCP in mind.

• Start with interpretable ML
• PCCP for model updates
• Auditability for regulators & payers

$53.6B delivery spend (U.S.)

Based on national birth counts, allowed amounts, and C-section rate blend. Even small improvements in decision accuracy move real dollars.

Downstream cost drivers

NICU days, readmissions, and litigation amplify total cost of care. Earlier, objective decisions help avoid the tail-risk cases.

Reimbursement path

Policy momentum suggests clearer Medicare and payer pathways for AI-enabled services and SaMD aligned with evidence standards.

Clinical interest

Provider interviews and clinical shadowing indicate strong demand for objective, infection-aware intrapartum assessment.

Regulatory prep

Pathway mapped; development docs and verification plan aligned to GMLP and SaMD expectations.

Partnership pipeline

Target sites identified for pilot data capture and EHR integration testing.

Kamola Mir — CEO

OB-GYN nursing background, biotech research. Focus: clinical workflow, data standards, partnerships.

Simon Lin, MD, MBA — CTO

Physician-informaticist & health system data leader. Focus: data governance, integration, evidence generation.

Advisors

Medtech commercialization, regulatory strategy, and hospital procurement expertise across U.S. and APAC.

Use of proceeds

• Clinical pilots & data capture (multi-site)
• Device verification / validation & human factors
• Dataset buildout, governance, and labeling
• Explainable ML V1 + PCCP package
• EHR integration & payer evidence

12–14 month plan

• M0–M6: pilots, data model lock, V&V
• M6–M10: SaMD file prep, payer evidence
• M10–M14: scale pilots, AI V1, procurement readiness