QUANTUM Hemodiafiltration Conversion system

Quantum Medical is a company incorporated in Ecuador, whose may goal is to deliver solutions to health disparities in the world, especially for Chronic Kidney Disease patients.

We have developed an adaptation that can be used in hemodialysis machines to achieve the function of hemodiafiltration. This treatment has been shown to provide advantages over conventional hemodialysis, including various clinical advantages and overall improvement of chronic kidney patient survival.

The Scale of the problem:

Chronic kidney disease (CKD) is a progressive condition that affects >10% of the general population worldwide, amounting to >800 million individuals, >37 million of them in the United States.

Chronic kidney disease is more prevalent in older individuals, women, racial minorities, and in people experiencing diabetes mellitus and hypertension. CKD patients are categorized in 5 stages, the most critical are 3 to 5. These patients will need dialysis and eventually a transplant. 

In the long term, hemodialysis will continue to be the main treatment for CKD patients. The percentage of these patients receiving a transplant, is currently less than 6%. Moreover, future innovations such as bionic kidneys, are in exploratory stages and they will be available in more than a decade. 

Furthermore, little progress has been made for stage 3-5 CKD patients in regards to treatment; one being hemodiafiltration. However, the cost of equipment compared to traditional dialysis makes it unaffordable to patients, and costly for providers.

Moreover, access to hemodiafiltration is very limited. Not only in low- and middle-income countries, but also in the USA where the FDA has recentlyapproved its use, with limited access.

What we do:

We place a “replacement” filter between the machine and the blood dialysis filter.  This allows the machine to provide fluid substitution to the blood (one of the main characteristics of hemodialfiltration), and provide additional filtering which prevents unnecessary contamination and fouling.

There are more than 1 million dialysis machines in the world, from different generations, that can profit from our QUANTUM CONVERSION SYSTEM. Without reconfiguring (hardware or software) in these machines, we allow them to perform hemodiafiltration.

Thus, our innovation allows CKD patients to have access to a better treatment, improve their wellbeing at affordable prices, as well as benefiting health providers by extending their service portfolio without having to invest large sums of money in new equipment. 

The performance of hemodialysis machines has improved over the past few decades, with newer machines offering more precise flow control from simple extracorporeal circulation devices without volumetric control, with low blood flow and low-flux dialyzers to precisely controlling devices. Thus, the clearence efficiency of older machines becomes less accurate, impacting their dialysis performance. Moreover, hemodialysis machines are costly pieces of equipment. In under-resourced geographical regions and societies, purchasing a new set of machines at each dialysis clinic is not always economically viable or environmentally responsible. Therefore, cost-effective methods to alter older but fully functional machines to achieve performance comparable to that of newer machines are highly desirable.
We have created a convertion system for reconfiguring existing hemodialysis machines to perform hemodiafiltration, as hemodiafiltration has been shown to provide advantages over conventional hemodialysis, including various clinical advantages and overall improvement of patient survival.
As mentioned before, older hemodialysis machines cannot be used for these purposes as they do not have any included functionality to provide fluid substitution to the blood. The QUANTUM CONVERSION SYSTEM strives to make use of the existing functionalities of the hemodialysis machine to achieve this, by using an additional dialysis filter, termed the “replacement
filter.” The primary purpose of this filter is to separate the dialysate inflow into two streams – one for dialysis, and the other for fluid substitution. There is a minor secondary purpose of this filter, which is to filter the dialysate prior to entering the hemodialysis filter which prevents any unnecessary contamination and fouling.
An average hemodialysis machine controls the inflow and outflow of the dialysate to maintain the ultrafiltration rate specified via user input. The QUANTUM CONVERSION SYSTEM takes advantage of this control to achieve more ultrafiltration than possible in a typical hemodialysis configuration. By partitioning a portion of the dialysate inflow for substitution, the actual dialysate outflow is lower than the dialysate outflow expected by the machine. As such, the dialysate is pumped out at a flow rate higher than anticipated, resulting in a higher actual ultrafiltration rate. While it is possible to increase the ultrafiltration rate manually in conventional hemodialysis, this may result in dehydration in the patient if increased excessively. With substitution of dialysate to the patient as found in hemodiafiltration, this would not be an issue.
An in-vitro perfomance test, carried out by the CBB-University of Waterloo, concluded that the QUANTUM CONVERSION SYSTEM appears to yield a better performance as compared to conventional hemodialysis when using the same parameters, such as blood and dialysate flow rate due to the increased ultrafiltration generated from the hemodialysis machine. The QUANTUM CONVERSION SYSTEM resulted in increased urea clearance, there does not seem to be any significant effect of albumin loss or increase in hemolysis. 
Overall, our CONVERSION SYSTEM aligns with the United Nations’ objective of promoting equitable access to healthcare, which seeks to ensure that all individuals have access to high-quality healthcare services regardless of their economic or social status.

We aim to improve the lives of CKD patients around the world, who have limited access to better treatments because of economic constrains. There are 800 million patients worldwide and 1 million dialysis machines who can benefit directly from the QUANTUM CONVERSION SYSTEM. The majority of CKD Patients in stage 3 to 5, receive basic dialysis treatments. Hemodiafiltration is known to outperform conventional Hemodialysis, offering more effective waste clearance and better fluid balance to patients. However, the price difference between a HDF (Hemodiafiltration) and a HD (Hemodialysis) machine is 25,000 to 30,000 dollars. Therefore, the great majority of stage 3-5 CKD patients have no real possibility to receive HDF.

The QUANTUM CONVERSION SYSTEM has also been reported by CBB to shorten the time needed for HD sessions, allowing to increase the number of sessions (and patients) per machine in 25%. This means that an average dialysis machine that serves 4 patients per day, if they use the QUANTUM CONVERSION SYSTEM can increase its service by 1 patient per day.

Therefore, the QUANTUM CONVERSION SYSTEM improves the wellbeing of stage 3-5 CKD patients by increasing their urea and albumina clearance. Allows for health providers to strengthen the quality of care for CKD patients, as well as to increase the number of HD sessions per machine.

At the beginning, we were a team of three:

•Laura Torres, Ph.D. in Health Promotion from the University of Aarhus, Denmark; scientific advisor for the Inter American Global Change Institute.

•Bernardo Canizares, M. Phil from the University of Bergen, Norway; entrepreneur in health services.

•Cesar Vasconez, M.D. Nephrologist and inventor. Recently deceased. 

In 2020 Cesar Vasconez died of cancer, and after much soul searching we decided to continue developing THE QUANTUM CONVERSION SYSTEM on his memory. Dr. Vasconez created IARE, Institute of Nephrology Research based in Quito-Ecuador. In IARE he cared for thousands of CKD patients referred by the public heath system.

In Ecuador CKD is considered by law a catastrophic illness, whereby access to care is paid by the public system (Ministry of Health and Social Security), while delivered by private providers. Although the scheme provides for free health care for CKD patients, this has had some negative impact on care capacity. Providers receive a fixed price per patient, as well as a permanent number of patients. Therefore, there is little room for more patients although CKD increases 10% per year.

This leaves little room for providers to innovate or use updated technology. Thus, Dr. Vasconez looked for ways to improve patient care with limited budgets. He developed the earlier stage of the QUANTUM CONVERSION SYSTEM as well as other inventions.

He started using the CONVERSION SYSTEM in more than 40,000 treatments leaving a trail of critical data, that was lost after he died. Meanwhile, Dr. Torres and Bernardo Canizares partnered with Dr. Vasconez to further developed and patent the QUATUM CONVERSION SYSTEM, after they worked on an epidemiological and health system analysis of the CKD emerging public health crisis in Ecuador (https://www.medrxiv.org/content/10.1101/2021.02.19.21252087v1)

In order to further develop this and other treatments, the three members incorporated a limited liability company called QUANTUM MEDICAL SERVICES. Couple months before Cesar Vasconez died, we received funding from Ecuador’s National Science Secretariat to improve and introduce in markets the QUANTUM CONVERSION SYSTEM. We developed the next stage from the initial prototypes developed by Cesar, based on the date collected by in-vitro tests done by the CBB-University of Waterloo. 

We partnered with the Center of Bioengineering at the University of Waterloo, Canada, in order to carry out validation tests. The results have been promising and support Dr. Vasconez earlier work; the QUANTUM CONVERSION SYSTEM allows average dialysis machines (without reconfiguring their hardware or software) to provide hemodiafiltration. A pear-review paper has already been submitted to Hemodialysis International and we are expecting its publication by July 2023. 

In its earlier stager, it was proven in 40,000 treatments with stage 3-5 CKD patients.

We aim to be part of SOLVE, because we can greatly profit from a program that fosters diversity, equity and inclusion; three of our core values at QUANTUM MEDICAL. Our backgrounds, perspectives, and skills have allowed us to design and improve a HUMAN-CENTERED SOLUTION to a problem that affects millions of people around the world. Our talent and ingenuity has created a viable solution to a big problem, and it can develop even more in partnership with SOLVE and MIT’s resources and knowledge. Together with SOLVE we can further develop the QUANTUM CONVERSION SYSTEM by designing and conducting a clinical trial that will allow us to introduce our innovation in multiple regions and markets, and it will strengthen our vision and approach in those regions where we are already aiming to introduce our product. We will also be able to design a strategic approach towards its implementation in a diversity of health services and systems around the globe. Finally, we want to connect with partners that will be interested to try our solution in the US market, where care for CKD patients is similar to low and middle income countries. Also to learn about  and navigate regulatory and market barriers in the United States and Africa in order to introduce the QUANTUM CONVERSION SYSTEM in those markets and regions. 

We have created a solution that provides access to hemodiafiltration to 3-5 stage CKD patients, regardless of their economic status. Our product allows exiting dialysis machines (low and high flow) to deliver hemodiafiltration treatment at a much lower price, translating into a significant improvement in the wellbeing of these patients.  

This is a positive development for medical practice in regions where access to hemodialysis is limited, and hemodiafiltration is nonexistent (including the United States). The in-vitro validation test has also recorded a higher efficiency rate of our product compared to an average dialysis session. A dialysis machine services 4 patients per day, with our product they can attend to 5 patients per day. The QUATUM CONVERSION SYSTEM can improve the capacity of health providers by shortening the dialysis sessions by 25%, and increasing the number of patients treated per machine. However, this has to be tested on a clinical trial.

By improving the efficiency of machines and allowing access to better dialysis treatment, the QUANTUM CONVERSION SYSTEM is catalyst of change in regards to health equity in the world. If implemented, health systems can expand services and improve the lives of patients; two of the main problems related to Chronic Kidney Disease. 

In the coming year we expect to commercialize the QUANTUM CONVERSION SYSTEM in Ecuador, where there are about 50 dialysis clinics (franchised, public and independent) with a market projection of 800 to 1000 dialysis machines. We will also present our design patent and obtain our utility patent in Ecuador. In 2024 we expect to carry a clinical trial to validate the in-vitro results and introduce our conversion system in Peru, where there are about 60 dialysis clinics and 600 to 700 machines. We will also present our patent in Peru, Colombia, Mexico and Argentina. By 2025 we expect to introduce our system to the Colombian, Argentinian and Mexican markets, and convert by this year more than 2000 machines. By 2026, we expect to apply for FDA approval and introduce the QUATUM CONVERSION SYSTEM to the US market.

By 2028 we except to have impacted the lives of 50,000 stage 3-5 CKD patients in our target markets. And by that year we expect to introduce our solution to markets in southern Africa and South East Asia. 

Impact Indicators

Number of 3-5 stage CKD patients who access hemodiafiltration in target markets linked to the use of the QUANTUM CONVERSION SYSTEM.

Impact of the QUANTUM CONVERSION SYSTEM on the efficiency and coverage of hemodialysis sessions on 3-5 stage CKD patients in target markets.

Process indicators

Number of clinics that have adopted the QUANTUM CONVERSION SYSTEM in target markets per quarter and per year.

Number of machines that are using the QUANTUM CONVERSION SYSTEM in target markets per quarter and per year.

Activities:

• 1-Stage 3-5 CKD patients have access to hemodiafiltration treatments at a low cost
• 2-Health providers and clinics can offer hemodiafiltration treatments with low investment and without changing their existing hardware

Outputs:

1. Stage 3-5 CKD patients increase their urea clearance levels, improve their albumina and hemolysis loss thanks to the QUANTUM CONVERSION SYSTEM
2. Health providers and clinics improve their service portfolio by including hemodialfiltration treatments

Short Term Outcomes

1. Stage 3-5 CKD patients improve their health and wellbeing through access to the QUANTUM CONVERSION SYSTEM
2. Health providers and clinics improve their efficiency levels by incorporating the QUANTUM CONVERSION SYSTEM and have positive financial impact on their quarterly and yearly income.

Long Term Outcomes:

1. Stage 3-5 CKD patients have longer life expectancy by accessing a low cost hemodiafiltration treatment thanks to the QUANTUM CONVERSION SYSTEM
2. Health systems in low and middle income countries adopt the QUANTUM CONVERSION SYSTEM as a valid alternative to treat CKD patients.

The Hemodialysis process is based on an anatomic principle performed by kidneys. Their main job is to remove waste from the blood and return the cleaned blood back to the body. Each minute about one litre of blood – one-fifth of all the blood pumped by the heart – enters the kidneys through the renal arteries. After the blood is cleaned, it flows back into the body through the renal veins. Chronic Kidney Disease Patients have a gradual loss of kidney function. Advanced chronic kidney disease can cause dangerous levels of fluid, electrolytes and wastes to build up in your body, and for that reason 3-5 stage CKD patients need hemodialysis: an external machine powered process that mimics kidney functions. Developing on the evidence-based research done by Dr. Vasconez, we give dialysis filters a utilitarian alternative use, by assembling a conversion system that allows low and high flux dialysis machines to perform a higher and more accurate cleansing and filtering process that obtains a higher urea cleaning rate, a lower albumina and hemolisis loss. This prevents a lower morbidity rate in 3-5 stage CKD patients and a better health status than those receiving hemodialysis

We are a woman-led team whose solution serves underserved populations, Historically, 3-5 stage CKD patients have recieved fewer health care services; encountered economic, cultural, and/or linguistic barriers to accessing primary health care services, and have had a lack of familiarity with the health care delivery system.

For instance, in the United States Chronic kidney disease is more prevalent in older individuals, women, racial minorities, and in people experiencing diabetes mellitus and hypertension. 

Therefore, equity, inclusion and diversity are embedded in every aspect of our solution.

The QUANTUM CONVERSION SYSTEM, can eventually improve the efficiency of dialysis sessions by increasing the number of patients served by each machine in 25%. This is an important advancement for CKD treatments since in many regions one of the main burdens, is machine availability.

Our model relies on a conversion fee per machine and an annual license fee per machine per year. This allows for a steady cash flow that will translate in improvements to the system and development of alternative products targeting low and middle income markets.

The QUANTUM CONVERSION SYSTEM consists of a plastic container where two dialysis filters interconnect, with a maximum 60cm with and 50cm length. This presentation makes it efficient for shipping, handling and delivering in the majority of markets.

We provide a pre-sale induction, sales support, and post sale monitoring. In the first stage commercialization process, we need a technician for plugging in the module; but we except, as the product improves, customers to be able to access all technical information in an on-line platform in several languages. 

We have developed a business model that relies on a conversion fee per machine and an annual licensing fee per machine. Our financial projections are based on two price ranges: Low income markets, and medium and high income markets. You can find a more detailed cash flow explanation for the next five years:

2023 Target Markets: Ecuador Number of Machine Conversions: 150 Price per conversion: 3,000 USD Total Income: 450.000 Total expenses (including salaries and materials) 60,000

2024 Target Markets: Ecuador, Peru Number of Machine Conversions: 400 Price per conversion: 3,000 USD Price per annual licensing fee per machine: 1000 Total Income: 1.350.000 Total expenses (including salaries and materials) 250,000

2025 Target Markets: Ecuador, Peru, Colombia Number of Machine Conversions: 600 Price per conversion: 3,000 USD Price per annual licensing fee per machine: 1000 Total Income: 2.350.000 Total expenses (including salaries and materials) 450,000

2026 Target Markets: Ecuador, Peru, Colombia, Mexico Number of Machine Conversions: 300 Price per conversion: 3,000 USD Price per annual licensing fee per machine: 1000 Total Income: 2.000.000 Total expenses (including salaries and materials) 450,000

2026 Target Markets: United States, Mexico Number of Machine Conversions: 300 Price per conversion: 6,000 USD Price per annual licensing fee per machine: 1000 Total Income: 3.300.000 Total expenses (including salaries and materials) 450,000

We received $120,000 in funding from Ecuador’s National Secretariat for Innovation. This amount has allowed us to implement our production facility; file the patent in Ecuador, Perú and Colombia; pay for some of the expenses related to the in vitro validation test; develop communication strategies; received an ISO 9001 certification as well as good storage and distribution practices; and file for health permits in Ecuador.

We received in kind contribution from the Center of Bioengineering at the University of Waterloo, Canada for $29,000 that cover overhead, postdoctoral researchers, and PI fee.