Inanovate Inc

Inanovate has developed the world's first blood analysis platform (the Bio-ID) that can simultaneously process multiple tests (multiplex) as well as different types of tests (multimodal) in a single low-cost run; this improves reliability, accuracy and sensitivity of existing blood-based diagnostic tests for complex conditions such as cancer where analysis of multiple different biomarkers is essential.

 





Company name Inanovate, Inc. (www.inanovate.com)

Technology platform | The Bio-ID blood analysis platform
Entry application and market | Lyme Disease diagnosis: $840 Million
Growth application and market | Breast Cancer diagnosis and monitoring: $4 Billion

OverviewInanovate has developed the world’s first blood analysis platform that can simultaneously process multiple tests(multiplex) as well as different types of tests (multimodal) in a single low-cost run. We call this patented blood analysis system the Bio-ID, and its unique multiplex-multimodal capability improves the cost and reliability of existing blood-based diagnostic tests, while also opening the door to a new generation of more accurate and sensitive tests for complexconditions such as cancer (where analysis of multiple different biomarkers is essential).The Bio-ID has been extensively validated across multiple test cases. Beta systems are presently operating at our SiouxFalls facilities, with three new ‘commercial grade’ systems presently in production at our manufacturing partners (Blur PD). These new systems will be advanced through full Validation and Verification procedures through Q4 2022 and Q1/Q22023, in preparation for a 510k submission at the end of Q2/start of Q3 2023.

Market Entry and GrowthThe global Lyme disease diagnostics market was valued at $840 million in 2022 and is projected to reach $1,151 million by 2027 in the US alone.

Entry Plan: We plan to launch our first test (a low-cost Lyme Disease Diagnostic) into the clinic in Q3 2023 following510k approval. By combining the existing gold standard serology tests for Lyme Disease into one integrated multiplexed-multimodal test on the Bio-ID, we will deliver significant improvements in both cost and reliability.over 3.4 million Lyme disease tests are performed annually by commercial laboratories, at costsranging from $150 to $500 per test. Most cases occur in the Northeast, Mid-Atlantic states, and upper Midwest. We plan to initially launch our test into the Sanford Health clinical testing laboratory in Sioux Falls, South Dakota at a cost of ~$100 per test (we have a close ongoing alliance with Sanford Health, a major health network headquartered in Sioux Falls).Following this initial launch, in Q4 2023, we plan to expand to one additional testing laboratory, targeting monthlyrevenues of ~$70,000 by end 2023 (~700 tests per months across two clinical testing sites).

Growth Plan: In late 2023 we plan to secure investment of circa $20M to expand market penetration of our LymeDisease test, while also progressing our first cancer diagnostic test into clinical trials. Leading our diagnostics pipeline for cancer is a test to detect breast cancer recurrence at a stage when it may still be cured. Presently, over 40,000 women die every year from breast cancer in the US alone, the majority following a recurrence. Studies show that early detectionof recurrence can improve survival rates by up to 50%.Our inexpensive blood test tracks a patients’ response to multiple different blood-based protein biomarkers. The goal is to provide clinicians with information on the effectiveness of the chosen treatment regime, and most critically, to help identify recurrence at its earliest stage. At a target test price of $250,this represents a $1billion opportunity in the US alone and over $4billion world-wide.

Status & PlansWe are presently raising a new investment to scale our operating team, support our 510k clearance application preparations, launch our Lyme Disease test into two clinical sites (one is already secured – Sanford Health), and build a foundational revenue stream. From this strong foundation, we will either seek a strategic exit/sale, or raise further capital to both expand market penetration of the Bio-ID with our Lyme Disease test and progress our breast cancer recurrence diagnostic test through clinical trials. This second phase (if pursued) is anticipated to last ~18months and position our company for a strong exit via acquisition or IPO.To date, two 400 patient studies and one 1,500 patient study have been completed with our clinical partner SanfordHealth. These have correctly identified ~8 in 10 cases of breast cancer. We continue to work on optimizing test performance and are targeting entry into FDA Pre-Market Approval trials in late 2023/early 2024 following clinical launchof the Bio-ID and our Lyme Disease test.

Contact Info: Kamran Tahamtanzadeh (Inanovate’s President & CEO) at [email protected] Mobile: 925-518-3658