BIOFEST INVEST APPLICANT

Steradian Technologies, Inc.

Company Contact:

Legal Entity Type: C-Corp

Company Type: Medical Device

Company Stage: Development

No. of Employees: 5

Desired Financial Amount: $3,500,000

Background

Company Background

Backed by the Bill and Melinda Gates Foundation grants, Steradian Technologies’ mission is “high-tech healthcare accessibility for all.” The RUMI is the first equitable, one-step, non-invasive diagnostic device that is rapid, cheap, easy, and accurate. This no-lab platform-based diagnostic can be leveraged across environments to detect and monitor diseases globally, driving accessibility in even the most remote areas. The photon-based, hand-held device has high sensitivity (10^5 more than a plate reader) and can detect and quantify the presence of SARS-CoV-2 virus-specific proteins from a breathprint in real-time. The RUMI SARS-CoV-2 results are available within 30 seconds or less because there is no need for sample manipulation (i.e. dilution etc) or for target amplification (takes time and labor). With our biosensor’s high specificity for SARS-CoV-2 and variants, the RUMI’s accuracy is equivalent to a PCR test. The device is being expanded into lung cancer detection in conjunction with Johnson & Johnson Innovation’s Lung Cancer Initiative. Lastly, the cost of our test is a little less than a latte, coming in at less than $3! This technology was developed independently by the founders.

Management

BIPOC Female-Founded & Led Asma Mirza, MSc-GH | CEO & Founder Global Health Practitioner Global Health Equity Task Force Previous Duke University Jerry Aguren, M.S | CTO Electro-Optical Engineer > 40 years experience, 60+ Patents, Previous HP/Compaq John Marino | Chief of Product Dev Mechanical Engineer 30 years+ experience in product, Previous HP/Compaq Ingrid Stuiver, PhD | CSO Translational Medicine, Healthcare, pharma expert Prev. La Jolla Institute Sr. Dir. John Bruno, PhD | Lead Aptamer Scientist Biotechnology Expert in Protein Binding in Infectious Diseases The University of Texas Yang Liu, PhD | Lead Biophotonics Scientist Biomedical Engineer, Expert in Molecular Simulation Previous Duke University

Board of directors

Product / Service

disease area / application

Deep-tech platform diagnostic, infectious disease, respiratory disease, healthcare setting-agnostic, no-lab, portable

product / Service

Harnessing the power of photonics for breath imaging detection, Steradian Technologies is developing the RUMI, a noninvasive, portable diagnostic device for respiratory disease detection that will create significant accessibility to rapid diagnosis. The device is the first human bio-aerosol specimen collector to convert breath into a fully-enclosed liquid sample. The RUMI uses novel photon-based detection to detect biomarkers and pathogens in the collected breath sample within 30-seconds. The device consists of a laser-based optical system, an photonic bioprobes for detection, and the collection of the biological specimen through breath. The diagnostic can be used for direct pathogen detection in the case of infectious diseases (COVID-19, RSV, H1N1), and can be quickly adapted for use in the detection of non-communicable lung diseases such as lung cancer or COPD. Because of its size and how fast it works (30 seconds) the RUMI can be easily integrated during vital signs monitoring in any emergency, triage, or hospital setting. The RUMI’s accuracy approaches that of PCR plate reader and is as easy as a temperature check. The device’s platform capabilities allow us to expand it into multiplexing for several diseases simultaneously, allowing us to be one-step ahead of the next inevitable pandemic. PCR lab tests are too expensive and time-intensive, while rapid tests are inaccurate. Current diagnostics are costly and inefficient, costing hospitals and payers an average of $3M loss per week. Current testing is inaccurate (>16% false negative rates for rapid tests), uncomfortable (nasopharygeal, sputum, and blood samples are invasive and cause patient discomfort), and expensive (80% of providers pay >$150 per test). Lastly, labor-intensive and inefficient testing creates backlogs in the hospital system; rapid tests require a 15 min minimum wait time, while PCR testing ranges from 2 hours to 3 days wait time due to backlogs in labs.

technology / ip

As described previously, nothing like the RUMI platform device currently exists. The device uses user breathprints to detect and diagnose using photonics, in a contained cell-phone size, portable device. The device does not require a lab and does not need any sample manipulation for amplification. The device is under a filed provisional patent. Steradian currently has two patents and we have most recently filed for country designation.

distribution channels

The target customer is the health system and healthcare insurance companies. The device’s accuracy for respiratory diseases and lung cancer circumvents the need for multiple lab tests, chest x-rays, and scans, contributing to faster workflow and diagnostic efficiencies, as well as and lower costs for the providers (hospital systems) and the payer (insurance). The test removes multiple specialist consults and can be quickly administered for routine inpatient readings and before surgery to rule out viral respiratory infections. The test can easily be used in outpatient clinics to screen for early-stage lung cancer and other respiratory diseases. Our distribution channels include strong distribution partners such as Johnson & Johnson, with whom we have already established connections and a partnership.

market size

The U.S. in-vitro diagnostic market is a $58B recession-proof market. The infectious disease market within that amounts to $40B. Our first beachhead indication is SARS-CoV-2 and Influenza A/B testing for frontline and emergency services (approx. 700,000 devices), leading to a $2.2B obtainable market for Steradian. Furthermore, there are market expansion opportunities based on disease sector (TB, RSV, rhinovirus, lung cancer, COPD], customer sector (hospital departments, pharmacies), and global sector (25x larger than U.S. market).

competition

Owlstone, InspectIR, and Breathonix use volatile organic compounds (VOC) detection-based tests. These compounds are metabolites that are by-products of a cell and don’t give a diagnosis; they give a biochemical pattern present with the disease instead of direct disease detection (lateral flow test or a PCR test). The RUMI for infectious diseases is the only breath-based detection diagnostic that binds specifically to the infectious pathogen. The advantage of direct binding enables higher accuracy and specificity and direct quantification levels that cannot be achieved when using indirect detection methods. This enables disease detection before symptom manifestation. Our competitors are rapid testing companies who 1) have false positives/negatives and 2) do not have advanced data-sharing interfaces and capabilities in their tests.

Financials

Desired financial amount

$3,500,000

previous funding

Significant Sources of Funding: *The Bill and Melinda Gates Foundation ($125,000) – Grant *Johnson & Johnson’s Lung Cancer Initiative ($100,000) – Grant *Johnson & Johnson Medtech Center for Device Innovation – Grant *XPRIZE Foundation ($275,000) – Grant *JLABS @ The Texas Medical Center *Friends & Family Round ($100,000) – Convertible Note

current financials

We are an extremely lean startup; our average burn rate is about $12000 per month currently. Our available cash allows us to move forward with R&D and pilots while beginning fundraising efforts for our next steps.

financial use

This round will support management salaries, engineering efforts for miniaturization and development, regulatory pathway assessment and engaging with the FDA, setting up a clinical pilot with identified partner, bolstering our patent portfolio, and further R&D for the RUMI as a platform.

revenue

The retail price of the RUMI will be $500, and cartridges will be $5/each. The revenue model is a straightforward razor/razorblade model: buy the platform device (includes software interface and connectivity), and the disposable tests come bundled with it. We conducted 67 interviews with various stakeholders and purchasing-decision makers. We found that 87% of payers and providers were willing to pay for the RUMI, with 93% citing that it would cut current costs and create diagnostic efficiencies. Currently, there are revised CPT codes available for direct antigen detection in SARS-CoV-2 and Influenza. As we expand our disease repertoire, we aim to have a robust reimbursement strategy. Because we are at our development stage currently, we are not generating revenue.

exit strategy

510(k) devices’ most recent exits have yielded higher deal values and better returns for investors with less time and money spent. There is data that demonstrates high acquisition likelihood for medical device companies at the following milestones: FDA approval/clearance or early revenue. More recent Class II Diagnostic exits have yielded: Higher deals values (41% increase) and Better returns for investors (70% increase). Our exit strategies is two-pronged: we initially would like to have exclusive use licenses for different RUMI uses, and once we are at a significant valuation then we will consider being acquired by a larger player in the space, such as Johnson & Johnson, which has a large Cancer Initiative, as well as a viral pathogen branch. Furthermore, BD and Labcorp are already interested in our technology and are two companies that have had significant acquisition plays in the recent years.

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