BT945680

This company represents an outstanding investment opportunity, bringing groundbreaking AI-driven diagnostics to address critical gaps in healthcare. With a unique yeast-based platform that delivers rapid, cost-effective tests for metabolic disorders, chronic pain, and toxicology, it’s positioned to lead an under-served yet expanding market.

The diagnostic solutions it offers are designed to minimize regulatory burdens, reduce healthcare costs, and provide scalable testing options for high-demand areas like drug impairment and pain management. Already at the MVP stage with early partnerships, the company is primed for growth. Raising $5M to accelerate commercialization, expand its assay portfolio, and deepen partnerships, this venture offers investors a rare chance to enter at a pivotal phase in a high-impact, multi-billion dollar industry.

Overview

Industry: Diagnostics, Personalized Medicine, Toxicology
Founded: 2016
Mission: To deliver rapid, cost-effective diagnostic solutions for metabolic disorders, chronic pain, and drug impairment, leveraging innovative biosensor technology.

Problem & Solution

Problem: Many diagnostic tools lack sensitivity and are unable to accurately measure drug response or impairment, especially in areas such as GLP-1 therapy for diabetes, cannabis impairment, and neuropathic pain.
Solution: The platform uses gene-edited yeast cells to analyze and quantify drug efficacy and metabolic response biomarkers directly from patient samples. It supports both high-throughput lab settings and point-of-care environments, providing accurate, on-the-spot diagnostics without complex storage needs.

Market Potential

Target Market: Diagnostic labs, toxicology centers, and healthcare providers addressing metabolic health, chronic pain, and drug impairment.
Market Size:
Metabolic Diagnostics: $30.8B market, with 8.6% CAGR.
Toxicology Testing: $7.3B, fueled by legislative changes around cannabis impairment testing (16.1% CAGR).
Chronic Pain Management: $9.4B, with a need for improved diagnostic precision (2.9% CAGR).
SAM:

→ Metabolic diagnostics (U.S.): $11.7B
→ Toxicology: $2B
→ Chronic Pain TDM and Dx: $5.7B

Product / Service

Product Description: Multi-well plates and point-of-care devices for testing; adaptable to a wide range of analytes and therapeutic areas.
Core Features:

→ Broad detection range across active metabolites.
→ High sensitivity with minimized cross-reactivity.
→ Fast response time (<1 hour) and extended shelf life.
Technology Stack: CRISPR-Cas edited yeast, AI-guided receptor design, portable analysis devices.
Development Stage: MVP stage for cannabinoid toxicology screen; toxicology and pain diagnostics slated for clinical validation in upcoming months.

Business Model

Revenue Model:

→ Lab Fees: $50 per toxicology test.
→ Clinical Testing Fees: Targeting insurance reimbursements.
→ Partnering Opportunities: Royalty agreements with labs and potential for biopharma collaborations on companion diagnostics.
Sales Channels: Direct sales to labs and clinical send-outs from physicians, with partner labs marketing directly to their own customers.

Financials

Current Financials:

→ Revenue: Pre-revenue, with launch expected within 12 months.
→ Burn Rate: $12K/month with runway through Q1 2025.
→ Funding to Date: $1.4M invested in platform development and IP.
Funding Requirements: $5M to complete product development, launch toxicology assays, and expand partnerships.
Financial Projections:

→ 1-Year: $0, pending product launch.
→ 3-Year: $78M revenue from expanded toxicology and pain management applications.
→ 5-Year: $300M+ revenue as additional assays and companion diagnostics are commercialized.

Team

CEO: Experienced biotech analyst with bioengineering expertise, focusing on diagnostic innovation.
CTO: 10+ years in industrial engineering and medical prototyping.
COO: Background in analytics, manufacturing integration, and healthcare data management.
Advisors: Seasoned advisors from Pfizer, Quest Diagnostics, and healthcare consulting firms with extensive industry expertise.

Competitive Analysis

USP: Consolidates multiple tests in a single well, reduces costs, and minimizes regulatory burdens by using stable, scalable yeast-based assays.
Barriers to Entry: Strong IP portfolio, unique yeast-cell technology, and early lab partnerships create a competitive moat.

Traction

Milestones: Secured term sheets with several labs, MVP stage with toxicology testing.
Customer Feedback: Positive early feedback; formal feedback pending wider commercial launch.

Risks and Mitigation

Market Risks: Dependency on regulatory changes around cannabis and drug testing.
→ Mitigation: Flexible deployment in high-demand states with supportive laws.
Operational Risks: Raw material availability.
→ Mitigation: Robust Quality Management System (QMS).
Financial Risks: Additional funding needs.
→ Mitigation: Strategic investor alignment to ensure sustainability.

Funding Requirements

Amount Being Raised: $5M
Use of Funds:
→ R&D and personnel hiring (60%)
→ IP management and legal fees (20%)
→ Sales and SG&A expenses (20%)
Runway: 24 months with new funding, supporting key product development milestones and early market penetration.

Exit Strategy

Potential Exit: Acquisition by diagnostics or pharmaceutical companies (e.g., Quest, Abbott) seeking innovative diagnostics for GLP-1 therapies and toxicology.
Timeline: 5 years, based on traction, product expansion, and increasing adoption rates.