Life support system for children with Cystic Fibro

Problem statement

Enhance efficiencies in research by providing Cystic Fibrosis patients with an alternative to lung transplant.
Enhance efficiencies in clinical trials and research and to move forward on the Life Support System development, we must increase our Technological Readiness Level to advance to a pilot plant testing stage and involve Venture Capital Investment.

 Helping patients with acute respiratory failure to breath:

Cystic fibrosis is one the most common genetic disorders that causes among other illness, difficulty to breathe. It affects more than 30,000 children in USA and there is no cure yet. More than 70,000 worldwide. (Cystic Fibrosis Foundation)

Lung cancer affects more than 130,000 patients in USA and life expectancy is severely reduced due lung failure. It is the main cause of death among cancers in the world representing 1.44 million cases worldwide. (World Cancer Research Fund)

Pneumonia is an infection that inflames the air sacs in one or both lungs. It accounts for 14% of all deaths of children under 5 years old, killing 740 180 children in 2019 (WHO, 2019)

Severe COVID. Pandemic has proven the great vulnerability on the Intensive Care Units. Mechanical ventilators will help but only as long as there still be a functioning part of lung tissue. Beyond that, patient’s prognosis will be severe detrimental.

A life support system which works like an artificial lung device would bring a glimpse of hope to increase the patients’ prognosis for all severe diseases.

“For Solve Use Only”

What it is?

Our solution is a Life Support System for patients with acute respiratory failure: Cystic Fibrosis, Lung Cancer, Pneumonia, COVID and EPOCs.

What does it do?

It completely replaces the pulmonary function named “Hematosis” consisting on the interchange of oxygen from the venous blood.

Currently we have implemented the open loop plant diagram.

But we aim, after proper testing and FDA approval to be implement the close loop, dialysis like system in Cystic Fibrosis patients that rely on lung transplant to survive.

Main statement

We will serve patients with acute respiratory failure by increasing the Technology Readiness Level of our device. It mainly will benefit Cystic Fibrosis young children whom last alternative relies on lung transplant availability. By doing so, we will attract, develop and retain scientific minded students and professionals to accelerate the Time to Market. Link to our Web Page

Regarding the device development

Cystic fibrosis is one the most common genetic disorders that causes among other illness, difficulty to breathe. It affects more than 30,000 children in USA and there is no cure yet. More than 70,000 worldwide. (Cystic Fibrosis Foundation)

Lung cancer affects more than 130,000 patients in USA and life expectancy is severely reduced due lung failure. It is the main cause of death among cancers in the world representing 1.44 million cases worldwide. (World Cancer Research Fund)

Pneumonia is an infection that inflames the air sacs in one or both lungs. It accounts for 14% of all deaths of children under 5 years old, killing 740 180 children in 2019 (WHO, 2019)

Severe COVID. Pandemic has proven the great vulnerability on the Intensive Care Units. Mechanical ventilators will help but as long as there still be a functioning lung. Beyond that patient’s prognosis is severe detrimental.

An artificial lung device would bring a glimpse of hope to increase favorable the patients prognosis for all these severe diseases allowing them to breathe.

“For Solve Use Only”

Regarding our project

Our consultancy like project-oriented structure, allow us to conform a team of experts from the main research centers and universities that set the study protocol frame and lead the quality control assurance in terms of experimental execution in the engineering and biomedical areas.

Which is conformed by more than 20 universities and research centers natin wide.

Top professors from the academia and external consultants.

We singed collaboration agreements with universities nationwide to involve experienced professors, consultants and professionals to guide our research & development efforts through the Technology Institutes Network, the Mexico’s National University academia (UNAM) and the Monterrey’s Superior Studies Technology Institute (ITESM) professors. 

A medical group of specialized medical doctors, assess regulatory compliance and biocompatibility versus golden standards.

An execution team conformed by students execute the engineering and biomedical tasks and biochemical evaluation is performed by a subcontractor.

“For Solve Use Only”

We have successfully tested the prototype, ensuring remarkable performance results under controlled lab conditions. We must perform the test under most severe conditions to assess its performance, biocompatibility and blood cell stress. The correlational data obtained will pave the way for venture capital firms involvement to leverage our technology development and request FDA approval for animal trials.

We have secured $431,131 USD. However, the more mature the technology becomes the more sophisticated personnel and testing is required to generate data driven evidence of its reliability.

0.  Gasometer, testing cartiges A20190715_144141

Each sample has an approximated cost of $50 USD.  One hundred samples were assessed. 

1. Preparing the protocol for revision 20190713_002255

2. Calibration and testing A20190713_234414 Taking control samples. 

3. Promising first results A20190716_221327  Eureka moment. Performance results are promising.

4. Eureka moment. 

Promising first results 20190715_231427

5. More testing A20190716_224456 and data recording.

6. More testing A20190716_224516

7. More testing and observations recording A20190716_224529

8. A trend became evident. The device work! A20190719_205020

• The first and most important barrier is to get the acknowledgement that Latin American scientists can also produce high impact innovations for the America region. This acknowledgement will serve as a reference for gathering further support.
• Secondly and equally important, is to secure funding as a way to increase the Technology Readiness Level to present the project to Venture Capital Firms.
• It is well known than in the Latin American region, investments on Research & Development are limited or nonexistent.  We must pursue to take the produced know-how abroad to enable and accelerate its time to market.

Community’s children

We promote free 3D printing education for low-income youngsters as a way to dissuade them from joining drug cartels and pursue a career development path on engineering, design or manufacturing.

Regional students

With the support from the Science & Technology National Council, we promote scientific based projects in the region as a way to attract, develop and support scientific minded engineering students.

National Universities / professors

We singed collaboration agreements with universities nationwide to involve experienced professors, consultants and professionals to guide our research & development efforts through the Technology Institutes Network, the Mexico’s National University academia (UNAM) and the Monterrey’s Superior Studies Technology Institute (ITESM) professors. 

“For Solve Use Only”

Our device provides a life support service for patients with degenerative or acute respiratory failure.

Our innovation allows a high blood flow while reducing the clot formation risk that could derive on a thrombosis as side effect.

Our main focus are children with Cystic Fibrosis due its life spam is considerably reduced due the illness. Same case for lung cancer patients that succumb primarily by the lung capacity degradation.

There are no high blood flow respiratory support systems on the market that can be used in the long term.

We expect it to be a disruptive solution among the existing devices on the market due its high blood flow and clot formation prevention.

Next year:

• We aim to conform an ethics committee to prepare a protocol for test on humans as a requirement for the humans’ trial FDA approval.
• To have successfully performed the animal trials test.
• To enhance our facilities for next stages of testing.

Next five years:

• We aim to be already deploying our service, in Latin America, USA, UK, Europe and Australia.

“For Solve Use Only”

There are many factors we are considering in order to properly asses our progress and achieve our goals.

The technology indicator:

The measurement is based on the Technology Readiness Level developed by the NASA.

The finance indicator:

It is based on the amount on funding we are securing.

So far we have been granted with $431,131 USD in funding from the King Baudouin Foundation through the Ernest Solvay Fund, the National Entrepreneur Fund and the Science & Technology National Council. 

Synergies indicator:

It is based on the number of institutions internationally with whom we have signed a collaboration agreement.

Talent reach indicator:

It is based on the number of talented, scientific minded students and/or professionals we are able to reach.

All these indicators are based on a strategy for securing proper execution which is based on the Balanced Score Card.

Our activities are guided by the NASA Scale for assessing the Technology Readiness Level for a new technological development.

The main problem for children with Cystic Fibrosis, patients with lung cancer, pneumonia and COVID-19 has been not the disease itself but the progressive or acute respiratory failure from the lungs. A lung transplant is complicated, prohibitively expensive and most of the times unavailable.

Having a device that could support the lung function in the long term to an affordable cost is a remarkable improvement in the prognosis and life expectancy for the patients with progressive or acute respiratory failure.

The potential of patients to serve come from the 30,000 children with Cystic Fibrosis and 130,000 with lung cancer alone in the USA; however, there are 70,000 ill children and 1.44 million patients respectively, worldwide.

What would you do if you knew you have the capabilities to improve the life of at least 160,000 people in USA?

“For Solve Use Only”

Multi-systemic, multi-disciplinary biochemical control of the hematosis phenomena

To properly address this question, we must first make it clear what we are aiming to achieve.

An artificial lung replacement device is not an easy project. It is full of many complexities that go through many fields from the medical like hemodynamics, pneumology, cardiology, intensivism, critical medicine, urgenciology, to technical fields like biomedics, electronics, mechatronics, mechanics, systems.

This multidisciplinary project must properly choreograph the input signals from the instrumented sensors to filter in order to be converted to a digital signal that a microprocessor will analyze.

Once the acquired signal is in the secondary microprocessors, it is sent to the main control board so it can be evaluated to take the appropriate control action accordingly with its PID gain selected algorithm.

So far, we have talked about instrumentation, electronics, systems and control, however this is just a small part of the whole system.

There are many other areas to focus like the vital signs monitor, the out of range oximeters configuration, the oxygen sensors and calibrations that will be more in the area of biomedics.

Added to this, the clinical aspects also must be considered and translated to their equivalent electro o thermodynamic parameters.

With the implementation of all the previous cited parameters, now we can begin to control the biochemical phenomena.

Gasometry is the golden standard for testing oxygenation levels. Experts control and advice about these testings. A protocol is previously formulated and a manual followed.

Control tests are performed previous each round of measurements.

A statistical correlation analysis is performed with one hundred samples.

Performance is measured based on data analysis. Results are promising. In order to publish these results, we must get intellectual property protection to avoid releasing patentable know-how and deliver value on fund-rising rounds.

Full time staff: 3

Part time staff:7

Contractors or other workers:10

8 years

We select our team in terms of their moral values, their capabilities, and their commitment.

We procure to include women for gender equality. We include marginalized youngsters in other projects to prevent them from joining drug cartels.  However we are in the path of learning how to be more inclusive.

More about our social commitment can be found at www.proyeccion22.org and at https://kbs-frb.be/en/encourag...

Value proposition:

Our value proposition consists on a service for monitoring vital signs and providing a life support system for Intensive Care Unit patients with acute respiratory failure at a reduced cost.

Insurance companies will require it as it will reduce the cost of ICU care and will provide an additional coverture from which they may profit.

Segments (key customers and beneficiaries):

In USA alone Cystic Fibrosis affect more than 30,000 children with a median survival age of 14.2 years.

Lung Cancer is one of the deadliest cancers accounting for more than 130,000 deaths a year in USA alone. 

Pneumonia, EPOCs, Covid-19, all of them may degenerate to cause acute respiratory failure.

By succeeding on developing a life support system for acute respiratory failure Cystic Fibrosis children survival age may be increased; lung cancer patients can improve its overlife, pneumonica & COVID-19 patients’ prognosis can be greatly improved, saving lifes.

Channels

There are two main channel for service distribution. The private channel service will be provided through contracts with insurance companies or directly with large private hospitals. The public channel service will be provided on high specialization public hospitals.

Intervention

Consist on an Intensive Care Unit Service.

Key activities

Securing availability of devices. Training proper use. Providing maintenance. Procuring sterilization for components. Monitoring performance. Disposal of used supplies.

Key resources

Procuring 24/7 technical support. Securing sufficient stock of replacement materials.

Partners

Hospitals and medical personnel, insurances, suppliers.

Revenue

Device availability fixed revenue. Device rent, supplies consumption.

Cost structure

Preventive and corrective maintenance. Technicians, physicians training. Procurement logistics and machine distribution. Overheads. Supplies manufacturing.

At this stage:

To reach the development of these devices we have been awarded with $431,131 USD in funding from the King Baudouin Foundation through the Ernest Solvay Fund, the National Entrepreneur Fund and the Science & Technology National Council. 

The backup from these institutions are allowing us to increase our international institutional and talent reach which will accelerate our funding securing objectives.

On subsequent stages:

Main channel of revenue will come from capital investors.

Maturity stage:

Once the technology has reached its maturity, the revenue streams will come from the private sector through contracts with multinational insurance companies; and to from the public sector, through public health contracts with federal governments to serve high specialization hospitals.

“For Solve Use Only.”

At this stage:

To reach the development of these devices we have been awarded with $431,131 USD in funding from the King Baudouin Foundation through the Ernest Solvay Fund, the National Entrepreneur Fund and the Science & Technology National Council. 

At the next stage:

Once the device has reached enough TRL maturity our focus will move to secure capital investment, internationalization and high medical/tech talent through seed capital, equity interchange etc.

We are being advised by Abeona Capital and began conversations with the Wellcome Fund a specialized UK fund for bioengineering research.

This funding will allow us to begin human trials.

Finally, at the third stage:

We will be advised by the previous incorporated funds to reach mayor investment firms, request FDA and EMA approval for market growth in North America and Europe.