David Larson

Carlsbad, CA (USA)
Role(s):
C-Level Executive (CEO, CFO, etc.)

True Diagnostics, Inc.

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Location: Carlsbad
Industry: Bio-Technology
Year Founded: 2010
Number Employees: 1-10 people
Business Stage: Growth (not profitable)
Entity Type: "C" Corporation
Description: True Diagnostics is changing medicine with its revolutionary TrueDX™Platform by providing immediate answers to the point-of-care, point-of-incidence and remote-of-care. Our simple, fast, portable and economical tests require only a drop of blood or small urine or saliva sample – and within minutes give answers which allow treatment to begin immediately – and in some cases, save lives. True Diagnostics creates simple, powerful and highly profitable diagnostic tests for the $21 billion point-of-care market. The TrueDX™Platform conducts quantitative tests for life-threatening and quality of life conditions which provide laboratory quality results in minutes. Dr. James Lee, the inventor of the pregnancy test over 30 years ago and holder of 18 patents for diagnostic solutions based around lateral flow immunoassay (LFIA) technology, created the TrueDX™Platform (with well protected IP) to bring lab quality tests and results to the doctor’s office. The Company is positioned to enter the global market quickly with: - CE Mark for TrueDX™MI3 Test (3-panel heart attack/myocardial infarction) allowing shipments to begin to Europe - sFDA clearance and CE Mark for the TrueDX Platform with TrueDX™ TSH Test allowing shipments to begin to China and Europe - CE Mark is expected within a few months for T4 and PSA - 47 TrueCX™ branded qualitative (yes/no) tests ready to ship globally - Its R&D team headed by Dr. James Lee - Decades of experience receiving 510(k) FDA clearances and CLIA-waivers - Over 60 tests in its product pipeline - ISO and GMP certified outsourced manufacturing in the U.S. and China - Global distribution, branding and marketing expertise The Company is looking for $10M million in Series A equity funding. Use of proceeds includes expansion of development activities, conducting simple clinical tests and regulatory clearances and launch of its products into the global market. This will bring the Company to profitability within 15 months. Projections see the Company reaching over $500M in sales within 5 years providing investors with significant ROI and an additional exit strategy (other than acquisition by a major global player or IPO) through multiple liquidity events. As an example, after the Company builds out the women’s health market with over 12 tests, we could sell off that market to a major player who has companion therapeutic products to offer.