BIOFEST INVEST APPLICANT

Steradian Technologies, Inc.

Company Contact:

Legal Entity Type: C-Corp

Company Type: Medical Device

Company Stage: Development

No. of Employees: 7

Desired Financial Amount: $2,000,000

Background

Company Background

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 the high specificity our biosensor has for SARS-CoV-2 and variants, the RUMI’s accuracy is equivalent to a PCR test. The device is currently 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

Our team consists of scientists, engineers, quality assurance specialists, product expertise, global health experts, and clinical and regulatory affairs specialists. We have a CEO, CTO (technology officer), CPDO (product officer), CSDO (strategy and development officer), a Director of Clinical Affairs, and a Lead Scientist. This is our immediate team structure. Asma Mirza – Asma Mirza is the CEO of Steradian Technologies, Inc, a Houston-based biotech startup that is bridging the gap of healthcare inaccessibility by developing high-tech medical platforms that cost the price of a latte! Asma received her graduate degree in Global Health and Human Rights from Duke University and has led extensive projects globally in the Caribbean, Middle East, and South Asia. Her background in data analytics drives much of the software interface and machine learning that Steradian’s technology incorporates. She was the original founder of Pheramor, Inc., a genetics-tech startup. She served as its CEO before transitioning to Steradian to pursue her passion for medicine, deep-tech, and global health. John Marino – John Marino is the Chief Product Officer. His role in this project is in research and development for hardware, program management, supplier management, and coordination between device engineering and bioengineering. I design and source hardware components, construct and assemble parts, and manage the materials budget. He also ensures that the device and bio developments move in parallel to ensure the overall solution functions as intended. He has managed many successful commercial products throughout their entire life cycle; from conception to launch/volume production, and finally to end of life and replacement in the market, but have never been more excited about a product than this one. Jerry Aguren – Jerry Aguren is the CTO for Steradian Technologies with a distinguished 40 years’ experience leading scientific and engineering teams in conducting research and development in diverse areas, such as robotics, software, optics, electronics, and medicine. In particular, as the CTO for Steradian Technologies, he developed the electronics, optics, software, and signal algorithms for the RUMI photonic diagnostic system. This system uses proprietary optics that result in discrete focal point manipulation for rapid amplification and detection of photons. The system’s field-of-view and resolution allow for gathering all emitted photons in one location, as well as indicating when enough sample has been collected. In addition, he has developed the optical and electrical architectures for Steradian Technologies. Ingrid Stuiver, PhD – Chief of Strategy and Development – In addition to her background in cell & molecular biology and biochemistry, Ingrid has 20 years of extensive experience in cross-functional operations and leading the successful translation of technologies from academia through the development stages in a corporate setting. Previously, as Sr. Director of Translational Research at the La Jolla Institute for Immunology, Ingrid supported the start of 4 spin-outs companies focused on neoantigen vaccines/T Cell receptor therapies for cancer, Anti-atherosclerosis vaccines and pharmaceuticals as well as bispecific antibodies for autoimmune disorders. Technologies licensed to for profit entities involved stabilized structures for use as infectious disease vaccines and research tools, therapeutic and research antibodies targeting aspects of the Spike and N proteins and peptides associated with T-cell specific SARS-CoV-2 responses. Perhaps most importantly, she brought diagnostic technologies to the institute which resulted in a significant focus on COPD, Cancer as well as a concentrated effort on COVID-19 methods for diagnosis. She has established a SARS-CoV-2 biorepository of blood components and saliva that is still in use today. Technologies on-boarded were saliva-based PCR testing, lateral flow diagnostics, LAMP assays and optical shadowing. Furthermore, Ingrid cultivates numerous relationships with external research reagent, drug screening, pharma, biotechnology and VC companies to foster interest in translating immunology-based technologies from academia to for profit development pathways. Tra Tran – Tra Tran is the Director of Business Development and Research Affairs at Steradian Technologies. She is an experienced qualitative researcher with experience in academia, multi-lateral non-governmental organizations, and nonprofits. Tra worked as the Program Director at The Kenan Institute for Ethics at Duke University, directing two human rights and health projects. Tra has a well-established research and quantitative data background with a Master’s of Science (MSc) in Global Health and a Bachelor of Arts (B.A.) focused in Psychology and Cultural Anthropology from Duke University.

Board of directors

Our Board of Directors is currently the founding team, as listed above with their expertise. As we raise funding, we will begin expanding our BOD.

Product / Service

disease area / application

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

product / Service

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 the high specificity our biosensor has for SARS-CoV-2 and variants, the RUMI’s accuracy is equivalent to a PCR test. The device is currently 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 Fast and Easy: What makes the RUMI highly innovative is that the platform gives a qualitative (positive or negative) and quantitative (proportionate viral load concentration) result output in a record time of 30 seconds due to photonic amplification – our diagnostic system literally uses the speed of light! The RUMI can be administered by anyone, anywhere. A user blows into the cartridge that condenses their breath to condensate. The tube is inserted into the device. The device will detect if it is in the correct orientation, and the operator simply presses a trigger to begin the instantaneous sample analysis. Accurate: The RUMI system has demonstrated high accuracy with very small dissociation constants of (kD = 10^-8) with the SARS-CoV-2 biosensor, establishing that the biosensor remains tightly bound. Furthermore, the reaction takes place at a record speed of seconds due to very rapid association rates (ka=10^5) with our SARS-CoV-2 biosensor. Lastly, the detection sensitivity is 10^5 – 10^6 times more sensitive than other molecular detection systems currently on the market. Cheap and Frequent Testing: The cost of the RUMI (~3) allows for frequent testing, bolstering and driving a more equitable outcome for rapid diagnostics.

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. Fast and Easy: What makes the RUMI highly innovative is that the platform gives a qualitative (positive or negative) and quantitative (proportionate viral load concentration) result output in a record time of 30 seconds due to photonic amplification – our diagnostic system literally uses the speed of light! The RUMI can be administered by anyone, anywhere. A user blows into the cartridge that condenses their breath to condensate. The tube is inserted into the device. The device will detect if it is in the correct orientation, and the operator simply presses a trigger to begin the instantaneous sample analysis.

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

In the United States, nearly 15% of all primary care visits, or more than 125 million patient visits alone, are for respiratory-related conditions. The demand-supply gap for resources is expected to widen further with the increase in incidence rates of respiratory diseases. The overall respiratory disease management market is projected to reach $21.3 billion in 2022. The diagnostic portion of this market is about $15 billion. Through our modeling, Steradian aims to capture 10% of the diagnostics market. Though respiratory disease is one of the leading causes of morbidity and mortality among infectious and non-communicable diseases, most major respiratory conditions are preventable. Much of the respiratory conditions can be mitigated by improved screening and early diagnosis of patients/public.

competition

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. -Abbott -Roche -Owlstone -Helix -DNA Electronics Unlike other diagnostic tests that require multi-steps in their assays for detection, Steradian Technologies has opted for a single-step, direct detection approach using photonics for targeting surface proteins for respiratory diseases, such as COVID-19, and biomarkers for early-stage lung cancer detection. Furthermore, Steradian Technologies is the only company in the market that combines high-tech point-of-care capabilities with a sophisticated software system integrated for data-sharing and connectivity.

Financials

Desired financial amount

$2,000,000

previous funding

XPRIZE Rapid COVID-19 Testing Challenge Winners ($275,000 – ) – Grant Johnson & Johnson Lung Cancer Initiative Grant ($100,000) – Grant Friends & Family Round ($100,000) – Convertible Note

current financials

We are an extremely lean startup; our average burn rate is about $4000 per month currently. With that said, 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, regulatory pathway and engaging with the FDA, setting up a clinical trial with a Houston-based CRO, bolstering our patent portfolio, and further R&D for the RUMI as a platform.

revenue

The revenue model is a straightforward razor/razorblade model: buy the platform device (which includes its software interface and connectivity capabilities) and the disposable tests come bundled with it. The disposable tests are unique to specific diseases, and they can all be used in one platform RUMI device without compromising specificity to each disease. Because we are at our development stage currently, we are not generating revenue.

exit strategy

One of 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.

Pitch Video

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