Periodic Reporting for period 1 - The Blue Box (THE BLUE BOX: A NEW AGE FOR BREAST CANCER DIAGNOSTICS)
Berichtszeitraum: 2022-06-01 bis 2023-05-31
1 in 8 women will have Breast cancer (BC) at least once. BC is the most commonly diagnosed cancer among women worldwide. BC is highly treatable, but only if detected early. However, mortality rates for women with breast cancer are higher than for any other cancer, except lung cancer. Despite that, of all 385M women in Europe, only 130M, (34%) take a mammogram biannually. This is because the mammogram does not provide clear visualization of small tumors in young women, who have dense breasts. Hence, most European healthcare systems only invite women aged 50-69 to mammogram-based screenings.
As a result, women aged 20-49 cannot get easily tested for breast cancer because existing solutions are unreliable. However, they want to and are ready to pay for it. Additionally, ~1/3 of BC happens in this age range. At The Blue Box, we have built a radiation-free, pain-free, low-cost, easy-to-operate device to detect breast cancer in urine with an accuracy of 78.57%, a sensitivity of 83.33%, and a specificity of 75.00%. In 2025, we’ll launch into the market, bringing The Blue Box to private gynecology clinics with a Diagnostics-as-a-Service subscription model, and a pay-per-test revenue stream that we’ll share with doctors.
As a result, women aged 20-49 cannot get easily tested for breast cancer because existing solutions are unreliable. However, they want to and are ready to pay for it. Additionally, ~1/3 of BC happens in this age range. At The Blue Box, we have built a radiation-free, pain-free, low-cost, easy-to-operate device to detect breast cancer in urine with an accuracy of 78.57%, a sensitivity of 83.33%, and a specificity of 75.00%. In 2025, we’ll launch into the market, bringing The Blue Box to private gynecology clinics with a Diagnostics-as-a-Service subscription model, and a pay-per-test revenue stream that we’ll share with doctors.
Women TechEU support has made possible the work performed in this project “The Blue Box: A New Age For Breast Cancer Diagnostics” during the last 12 months and the main achievements are described below:
1. Product Development
a. Prototype iteration.
We have been working on the 4th version of our prototype with more robust hardware (HW) that acquired less noise and higher-quality data from the sample, and improved software (SW) with pre-processing steps to reduce noise and sample variability not related to cancer.
b. AI algorithm training (Clinical observational studies).
To validate the performance of our 4th prototype, we organized a patient observational study at 7 hospitals. The Blue Box prototypes have been built and tested with +400 samples in a multicentre study, showing an accuracy for early-stage BC of 78.57%, a sensitivity of 83.33%, and a specificity of 75.00%.
c. Industrial partners
To start designing for the industrialization of our technology, we have started working with Perdigó Medical, a design and industrialization consultancy company for medical products, that operates under the ISO-13485 compliant Quality Management for Medical Device design and development activities.
The design of the UI/UX for the software that will operate The Blue Box will be done with the assistance of a medical software development company named Qualud. This company operates under ISO13485 and UNE-EN 62304 for medical device and medical software development, respectively.
2. Regulatory affairs
We have identified a consulting firm for the medical device industry (PS consulting) and started working on the definition of the strategy and pathway to achieve CE mark. The device is expected to fall under the In vitro Diagnostic Medical Device Regulation (IVDR) 2017/746, class (c).
3. IP
We are now past the riskiest piece of our intellectual property protection strategy, since last summer we received a favorable reply from the European Patent Office after filing the International Search Report. We will enter National Phase in July 2023.
4. Go-to-Market activities
We have prepared a sound business plan that includes a market and competitive landscape analysis, business model definition, commercial strategy plan, and financial projections. We have also well-planned the following steps to reach the market, including large-scale clinical trials, IP, and regulatory issues.
1. Product Development
a. Prototype iteration.
We have been working on the 4th version of our prototype with more robust hardware (HW) that acquired less noise and higher-quality data from the sample, and improved software (SW) with pre-processing steps to reduce noise and sample variability not related to cancer.
b. AI algorithm training (Clinical observational studies).
To validate the performance of our 4th prototype, we organized a patient observational study at 7 hospitals. The Blue Box prototypes have been built and tested with +400 samples in a multicentre study, showing an accuracy for early-stage BC of 78.57%, a sensitivity of 83.33%, and a specificity of 75.00%.
c. Industrial partners
To start designing for the industrialization of our technology, we have started working with Perdigó Medical, a design and industrialization consultancy company for medical products, that operates under the ISO-13485 compliant Quality Management for Medical Device design and development activities.
The design of the UI/UX for the software that will operate The Blue Box will be done with the assistance of a medical software development company named Qualud. This company operates under ISO13485 and UNE-EN 62304 for medical device and medical software development, respectively.
2. Regulatory affairs
We have identified a consulting firm for the medical device industry (PS consulting) and started working on the definition of the strategy and pathway to achieve CE mark. The device is expected to fall under the In vitro Diagnostic Medical Device Regulation (IVDR) 2017/746, class (c).
3. IP
We are now past the riskiest piece of our intellectual property protection strategy, since last summer we received a favorable reply from the European Patent Office after filing the International Search Report. We will enter National Phase in July 2023.
4. Go-to-Market activities
We have prepared a sound business plan that includes a market and competitive landscape analysis, business model definition, commercial strategy plan, and financial projections. We have also well-planned the following steps to reach the market, including large-scale clinical trials, IP, and regulatory issues.
Further steps:
1. Product development
We will work on reengineering the device with particular attention to the manufacturability and scalability of the design adds trust by reducing market entry barriers. The final product will be developed taking into consideration the design requirements to pass technical file tests and verification processes.
2. Regulatory affairs
We will apply for the Conformitè Europëenne (CE) mark clearance in 2024 as well as the United States Food and Drug Administration (FDA) approval later on. The device is expected to fall under the In vitro Diagnostic Medical Device Regulation (IVDR) 2017/746, class (c) "Devices intended to be used in screening, diagnosis or staging of cancer".
3. Business model validation
The business plan will be continuously revised and updated through cooperation with stakeholders. We will conduct the following activities:
- Stakeholder engagement with gynecologists/other physicians and key opinion leaders in the field.
- Validation of our pricing model and reimbursement strategy.
- In-depth analysis of the characteristics of each EU country of interest’s healthcare system, and design of a plan to penetrate it.
4. IP
We will work on the Freedom To Operate to ensure that our activities do not infringe upon existing patents in these markets. Our approach involves examining granted methodologies first, followed by scrutinizing the components of our product to ensure they are free for our use and commercialization.
5. Funding
a. Public grants/Non-dilutive funding
During the last 12 months, we have received non-dilutive funding from the following entities:
- Procter & Gamble grant “Womenalia”, 4,000€, Lump-sum + Mentorship
- Catalan government (dept of health, CIMTI), 20,000€, Mentorship + Services
- Catalan government: Startup Capital ACCIÓ, 100,000€, Reporting project
- MassChallenge Healthtech Sprint, 0€, Mentorship
- European Union, Cascade funding: StairwAI 2nd Open Call, 60,000€, Lump-sum + Mentorship
- NextGenerationEU funds: Kit Digital - Red.es 2,000€, Services
b. Private investment
We have raised 225,260.00€ in private equity rounds: pre-seed FFF investment of €75,282.00 in November 2021; and a seed investment round (from two business angels) of €149,978.00 in total, in November 2022. We are currently raising a 500k round, which will give us runaway until the end of the year. On June 7th, 2023 we received a term sheet and already have the first 300k compromised.
1. Product development
We will work on reengineering the device with particular attention to the manufacturability and scalability of the design adds trust by reducing market entry barriers. The final product will be developed taking into consideration the design requirements to pass technical file tests and verification processes.
2. Regulatory affairs
We will apply for the Conformitè Europëenne (CE) mark clearance in 2024 as well as the United States Food and Drug Administration (FDA) approval later on. The device is expected to fall under the In vitro Diagnostic Medical Device Regulation (IVDR) 2017/746, class (c) "Devices intended to be used in screening, diagnosis or staging of cancer".
3. Business model validation
The business plan will be continuously revised and updated through cooperation with stakeholders. We will conduct the following activities:
- Stakeholder engagement with gynecologists/other physicians and key opinion leaders in the field.
- Validation of our pricing model and reimbursement strategy.
- In-depth analysis of the characteristics of each EU country of interest’s healthcare system, and design of a plan to penetrate it.
4. IP
We will work on the Freedom To Operate to ensure that our activities do not infringe upon existing patents in these markets. Our approach involves examining granted methodologies first, followed by scrutinizing the components of our product to ensure they are free for our use and commercialization.
5. Funding
a. Public grants/Non-dilutive funding
During the last 12 months, we have received non-dilutive funding from the following entities:
- Procter & Gamble grant “Womenalia”, 4,000€, Lump-sum + Mentorship
- Catalan government (dept of health, CIMTI), 20,000€, Mentorship + Services
- Catalan government: Startup Capital ACCIÓ, 100,000€, Reporting project
- MassChallenge Healthtech Sprint, 0€, Mentorship
- European Union, Cascade funding: StairwAI 2nd Open Call, 60,000€, Lump-sum + Mentorship
- NextGenerationEU funds: Kit Digital - Red.es 2,000€, Services
b. Private investment
We have raised 225,260.00€ in private equity rounds: pre-seed FFF investment of €75,282.00 in November 2021; and a seed investment round (from two business angels) of €149,978.00 in total, in November 2022. We are currently raising a 500k round, which will give us runaway until the end of the year. On June 7th, 2023 we received a term sheet and already have the first 300k compromised.