Evidence Pathway

Clinical Trials
& Validation
Plan

MastisGUARD™ is being positioned as an evidence-backed adjunct pathway. Our validation program is structured to demonstrate safety, real-world performance, and measurable dairy outcomes — from protocol to launch.

Production Ready Safety First Investor-Ready Evidence

Protocol-Led Trials

Clear design, defined endpoints, transparent reporting — built for adjunct credibility.

Safety First

Target-animal tolerability before efficacy trials — rigorous, auditable, and investor-ready.

Measurable Outcomes

SCC trends, clinical mastitis rates, recovery time, and farm economics.

Partnering & Investment Request Trial Brief

This page outlines a proposed validation pathway. Final protocols should be confirmed with veterinarians, trial partners, and applicable regulatory guidance for adjunct use.

Why Evidence Matters

Demonstrating measurable improvement requires structured studies

Mastitis impacts both visible clinical disease and silent subclinical cases tracked through SCC. A strong evidence package is also what enables serious partnering and investment discussions for adjunct positioning.

What We Must Prove

Four pillars of clinical credibility

Safety: cows tolerate the adjunct without adverse effects across a defined period.
Performance: measurable improvement in udder-health indicators including SCC trends.
Field practicality: dosing and protocol fit real farm workflows without friction.
Commercial relevance: adjunct benefits connect to farm economics and milk quality stability.

Evidence Expectations

What partners and buyers look for

Dairy partners and milk buyers use quality programs and screening indicators including SCC trends to monitor udder health. The best adjunct trials clearly define endpoints, measure them consistently, and report results transparently — creating a defensible, usable evidence package.

Proposed Program

Five-phase clinical validation structure

Safety first, then efficacy, then field validation — an execution-ready structure that investors recognize and veterinary partners can execute.

Phase 01 — Pre-Clinical

Formulation Readiness & Quality

Confirm formulation consistency, shelf stability, packaging suitability, and dosing format. This avoids trial failures caused by supply inconsistency and creates a reliable adjunct study foundation.

Stability testingDosing formatQuality controls

Phase 02 — Safety

Target-Animal Toxicology & Tolerability

A controlled safety study in healthy lactating animals confirming tolerability at the proposed dose and a defined safety margin — including monitoring of feed intake, behavior, blood parameters, and mineral safety markers.

Lactating animalsCopper safety markersBlood parametersBehavioral monitoring

Phase 03 — Efficacy A

Prevention & Recurrence Reduction Trial

A farm-based controlled trial measuring whether the adjunct program reduces mastitis burden over time — primarily through clinical mastitis incidence, recurrence rates, and SCC trend improvement.

Clinical incidenceRecurrence rateSCC trendPrevention focus

Phase 04 — Efficacy B

Adjunct Support During Active Mastitis Management

MastisGUARD™ evaluated as an adjunct alongside veterinarian-guided management — tracking time-to-recovery, recurrence, SCC stabilization, and milk yield recovery trend when used alongside conventional therapy.

Time-to-recoverySCC stabilizationYield recoveryAlongside antibiotics

Phase 05 — Field Validation

Multi-Farm Real-World Proof & Economics

Multi-farm validation confirming practicality and economics: fewer repeat cases, less discard pressure, better milk consistency, and a clear ROI narrative for investors and strategic distribution partners.

Multi-farmROI documentationDiscard reductionPartner-ready evidence

Note: Exact endpoints, sample sizes, and timelines should be finalized with veterinary investigators and trial sites for adjunct use. Full trial brief available under NDA.

What Investors Enable

Funding accelerates promising to clinically backed

Capital flows into trial sites, veterinary oversight, lab analysis, data collection, and reporting — the bridge from concept to evidence-backed commercial positioning.

Trial Site Onboarding

Investigator fees, site selection, and dairy farmer/veterinary partner agreements for structured trial execution.

Lab Testing & Data

Sample logistics, SCC analysis, blood panels, and data management infrastructure for clean, auditable results.

Trial Manufacturing

Product batches for trials with quality controls — ensuring consistent, reproducible adjunct supply throughout study phases.

Statistical Analysis & Reporting

Qualified statistician, reporting package, and summary documents designed for partner due diligence and regulatory review.

Proof → Partnership → Launch

Clinical evidence de-risks commercialization

Strong trial data supports partnering discussions, strengthens distribution readiness, and gives buyers and regulators the defensible evidence base needed for adjunct adoption at scale.

Fund the Trial Program MastisGUARD™

Request the trial brief
under NDA

If you are reviewing LactoVance as an investor or strategic partner, we can share the trial brief, target endpoints, execution plan, and financial model under NDA.

Disclaimer: Informational only. Not a substitute for veterinary diagnosis or treatment. Adjunct positioning requires appropriate professional guidance.

Contact the Team Partnering Page