BIOSNS

Raising $1M for Product Development, Clinical Validation, and Commercialization

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Introduction - BIOSNS
BIOSNS is a Med-Tech startup based in Dallas TX.  Our team comprises seasoned business developers, physicians, biotech experts, engineers, mathematicians, and biostatisticians. 90% of our team members have PhD in their respective field.  BIOSNS is focused on developing non-invasive and non-contact screening/monitoring technologies for personalized medicine, virtual care, and mobile-health applications. Our mission is to create disruptive digital health technologies that will revolutionize the healthcare ecosystem and bridge the gap between patients and physicians.

We are currently developing two technologies that we believe will transform digital healthcare. 1. XTEMP - The first mobile based core body temperature monitor (currently in pilot testing phase), and 2. GHENET - Non-invasive and non-ionized breast cancer screening and monitoring technology (in the early stage of development). In this summary, we are presenting the executive summary for XTEMP. Information related to GHENET will be available upon request.
 

XTEMP
The Main Challenge
Current methods for measuring core body temperature such as rectal probes, gastro-intestinal (ingestible) sensors, and surgically inserted thermometers are invasive. Magnetic resonance imaging (MRI) can be used for measuring temperature distribution with high spatial resolution, but it is expensive and not portable. Bottomline, there is no accurate, affordable, non-invasive, and non-contact core body temperature monitoring system in the market. 

With the rapid growth of virtual care and personalized medicine, accurate monitoring of core body temperature will be critical in the success and expansion of preventive care and remote monitoring, as well as improve the quality of patient treatment and personalized medicine.

Our Solution
BIOSNS presents XTEMP, the first accurate, non-invasive, and non-contact core body temperature monitoring solution that takes measurement from the back of the eyes. XTEMP measures body temperature as accurately as the invasive core body temperature measurements used in hospitals and ICUs with much better convenience. It can provide continuous or intermittent measurement, and is not  influenced by environmental conditions, sweat, and skin type. Our patented  technology can be embedded in mobile devices and telemedicine with infrared sensors, turning them into unobtrusive continuous core body temperature monitoring devices. 

Key Features:
  • The capability of XTEMP to operate as part of the mobile devices will open the possibility of monitoring and tracking a wide range of healthcare applications, and collecting meaningful data that can potentially improve patient engagement and treatment. 
  • The proximity of the eyes to the hypothalamus (the thermal regulator in the brain) allows XTEMP to accurately capture real-time changes in the core body temperature.
  •  Additional features include:
    a)       Consistency of 99% (±0.2oC at 95% CI).
    b)       Very-Fast response times (<1.0 secs of runtime).
    c)       Operate as handheld or standalone.   
Important Application as part of mobile/tele-health technology. 
  • Use global connectivity to respond to global or local outbreaks like COVID-19, Ebola, H1N1 etc. 
  • Monitoring women’s hormonal change and fertility. Women’s core body temperature elevates days before the ovulation period, an essential indicator of fertility and hormonal changes.
  • Provide unobtrusive accurate core body temperature measurement of infants. For example, infants suffering from hypoxia-ischemia have an elevated brain temperature, and if detected can be effectively treated by hypothermic neural rescue.  
  • Fitness and wellness. Monitors hydration and recovery for athletes, field workers, fire fighters, and soldiers, preventing them from heat stroke, premature fatigue, and even death. 
Market Opportunity
The rapid growth of mobile health and telemedicine, and the widespread embedment of IR sensors in mobile devices and interactive monitors (as part of facial recognition and image enhancement tools) will create a huge marketing opportunity for XTEMPIR in patient remote care monitor, women’s fertility,  and predictive healthcare analytics.

Patient remote care monitor: Remote monitoring (body temperature, blood pressure, heart rate, weights, etc.)  are becoming commonplace in healthcare settings. In fact, research conducted by the American Medical Association earlier this year found that nearly 9 in 10 physicians see an advantage in using digital health tools. More than >80% of US consumers are interested in m-health solutions.  More than 90% of doctors would like their patients to monitor their health at home,  particularly their vital sign (including body temperature), weight, and blood sugar. The global remote patient monitoring market is projected to reach USD 117.1 billion by 2025 from USD 23.2 billion in 2020, at a CAGR of 38.2%. 

Patient Care Monitoring Systems accounted for $17.41 billion in 2017 and is expected to reach $33.95 billion by 2026 growing at a CAGR of 7.7% during the forecast period. The health and wellness apps market is expected to grow from $3.3 billion in 2019 to $13.0 billion by the end of 2025 at a compound annual growth rate (CAGR) of 25.61%.
 
Women's health
At present, the development and use of smartphone-based and wearable devices for measuring fertility rates is trending in the market.  One of the key factors contributing to the growth of the global fertility testing devices market is the high adoption of basal body temperature monitors. Women’s core body temperature elevates days before the ovulation period, which can be used as an essential indicator of their fertility and hormonal changes.

The ovulation predictor kits segment held the largest market share in 2018, accounting for over 41% of the market. This product segment is expected to dominate the global market throughout the forecast period. The global fertility testing devices market was expected to grow at a CAGR of nearly 6% during the forecast period, 2019 - 2023.

Predictive healthcare
With the advent of IoT in healthcare and mobile health technology, people are more aware of the available health metrics monitoring platforms and choose to closely monitor health parameters. This phenomenon is generating a huge amount of patient data inclusive of diet habits, physiological parameters, and vital signs. Predictive modeling based on this data helps in understanding disease patterns using statistical tools to draw an analysis of key therapy trends and outcomes, and allowing healthcare companies to develop healthy lifestyle recommendations for their patients.

Global Predictive Analytics in Healthcare Market size is projected to grow from USD 2.3B in 2020 to USD 4.4B by 2026. According to a 2019 survey, 60% of healthcare executives were using patient data for predictive healthcare, and  nearly two-thirds of executives anticipate that predictive analytics tools will cut organizational costs by 15 percent or more over the next five years. This has significantly increased in 2020 and 2021 partly accelerated by COVID-19.

Revenue Model
BIOSNS is establishing strategic partnership with OEM and Mobile device manufacturers to gain a solid revenue streaming ground. Our main source of revenue for XTEMP will be through licensing model, where XTEMP can operate as an native application supporting existing mobile and telemedicine devices, including smartphone, tablet, interactive monitors, kiosk, smartwatches with embedded IR sensors.

XTEMP can be provided either as a backend, supporting the existing facial recognition application of the mobile and/or tele-health device,  or it can operate as a full-stack with our facial-SDK, API, and the thermal analyzer backend. As part of the XTEMP package, BIOSNS also offers a unique IR calibrator package, capable of detecting systematic bias and error being introduced by an IR camera. The XTEMP-IR calibrator is essential in upgrading the capability of an off-the-shelf IR camera (OEM)  to perform with a high degree of accuracy and reliability.   
 
Competitors

Since XTEMP is a software solution that turns IR imaging sensors into an accurate core body temperature monitors, we do not see the IR camera, mobile devices and kiosk manufacturers, as our competitors, rather we see them as our partners that can provide XTEMPIR a platform to advance the IR and biosensor technologies and expand their market segment. XTEMP is the first to provide an accurate, noncontact, and noninvasive core body temperature measurement capable of integrating in mobile and tele-health devices. for more info please visit our website https://biosns.us.
   
Next Steps in XTEMP developmental phase
XTEMP is currently in pilot testing phase, conducting measurement accuracy and reliability testing: 
  • Phase 1-1: Pre-clinical testing, Regulatory and Ethics Reviews
    • Comparing XTEMP with existing noninvasive measurement methods. (In progress)
    • Filing for an IRB approval. 
  • Phase 1-2: Adoption of XTEMP in mobile devices and telemedicine devices
    • Integration of XTEMP backend with existing smartphone and tablet devices with IR sensors. 
    • Integration of XTEMP with interactive monitors like Zoom Dten Me, Newline Interactive, Amwell (kiosk), etc. 
  • Phase 2: Pilot Testing - XTEMP Clinical Evaluation and Testing 
    • Upon IRB approval, test the performance of XTEMP against the current gold standard measurement methods. 
    • File for 510K FDA approval 
  • Phase 3: Commercialize XTEMP as  standard measurement,  

It has been said that healthcare is a team sport, as the system is unlikely to be dramatically transformed by one entity alone. BIOSNS is committed to doing its part to realize a shared vision for an evidence-based, digital health-enabled future. As Thomas Edison advised, “There is a way to do it better – let’s find it.” Our ask to join us in our journey of finding it. 

The funding BIOSNS is raising will be used for the following:
  • Approximately 70% of the funds will be dedicated to: 
    • Pilot testing and evaluation 
    • Development and testing of smartphone application
    • Cover the costs for third party product validation
    • Development IR Calibration and testing site
    • BIOSNS - GHENET Prototype development and pre-clinical testing (Information about GHENET will be provided upon request).
  • General Working Capital 
    • Marketing campaign for pilot testing and establishing strategic partnerships 
    • Additional IP filings and Operational Workforce
    • Administrative Costs, Legal Fees, Utilities, and Certifications

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