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SFC Fluidics |
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January 23, 2017 Issue |
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CEOCFO MAGAZINE |
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Revolutionary Dermal Patch with Pump, Sensors and Microfluidic Technology that will Automatically Monitor and Administer Insulin for Diabetic Patients |
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Chief Executive Officer
SFC Fluidics
Contact: Anthony P. Cruz (479) 527-6810
Interview conducted by: Lynn Fosse, Senior Editor CEOCFO Magazine
CEOCFO: Mr. Cruz, would you tell us the idea behind SFC Fluidics? Mr. Cruz: We are trying to make it easier for anyone who has diabetes to live a normal lifestyle by developing a fully automated insulin delivery system.
CEOCFO: What is your approach to doing so? Mr. Cruz: For people with diabetes, specifically those who must take insulin on a daily basis, there may be several interruptions per day to in order to manage their disease. These interruptions consist of checking their blood glucose level through the use of a blood glucose monitor, and then self-injecting insulin to address the amount of carbs they eat, the exercise they conduct, or to counter other elements, such as stress level and/or overall health, that may impact their glucose levels.
SFC is utilizing its technologies to integrate and automate the steps to check glucose levels and inject insulin. The ideal form factor is a single device that automatically reads the blood glucose level and then administers the appropriate quantity of insulin with little to no management by the patient. People with diabetes should maintain a blood glucose level between roughly 102 to 130 milligrams per deciliter -- we are trying to automate this process of managing and maintaining the optimal glucose level.
CEOCFO: How does it work?
Mr. Cruz:
Our fundamental technology consists of a non-mechanical pump that can
administer insulin and that is better performing, less expensive, and less
burdensome to the patient. Our pump needs to be matched up with a blood
glucose sensor that automatically measures a patient’s blood glucose level.
The goal is to incorporate this glucose sensor with our drug pump into one
pod that a patient can wear discreetly. CEOCFO: Where does the pod go? Mr. Cruz: The pod would go on top of the skin, but will be hidden under the person’s clothing. The whole pod would be replaced every three days and we are targeting a form factor that will be small – about 1.5 inches square in footprint and about a half-inch thick.
CEOCFO: Why will this method be effective? Mr. Cruz: Our pod technology is a lot more accurate, and smaller than the standalone insulin pumps that are out there in the market. The small size will provide more convenience and discretion to the patient. Additionally, SFC can accomplish this at a lower cost than the pumping solutions currently available to patients. If you look at the clinical trials that have been conducted with this “artificial pancreas” set-up, that is a sensor integrated with an insulin pump controlled by special software - there is no question on the efficacy improvement possible when compared to the traditional, manual process. There is improved efficacy because patient intervention is minimized and the entire process is simplified.
What will prevent patients from adopting this technology will be a high cost and/or a form factor that is too bulky or is inconvenient to wear. There are several companies working on an artificial pancreas product. The sensor technology over the last decade has progressed to the point where it provides a sufficiently accurate result to dose insulin, but the base pump technologies have remained the same for twenty five years.
We believe that insulin pumps currently available are too bulky or too expensive to allow widespread adoption. Even if a “pile of studies” were to demonstrate that an artificial pancreas device unmistakably led to clinical improvement, the patient must still be convinced to use the device. SFC’s objective is to create an artificial pancreas that will be comfortable and transparent to the patient.
You see, current insulin pumps are based on a syringe model, nothing more than a plunger going through a cylinder and injecting insulin to the patient. This type of mechanism results in pumps that are bulky and expensive. SFC’s non-mechanical pump allows for a smaller size and improved performance. SFC’s pump has no moving parts except for an internal flexing diaphragm that administers the insulin. The non-mechanical mechanism is cheaper to produce and is more accurate because of the way it is designed.
CEOCFO: What is the sensor reading and how is it able to pick up the information? Mr. Cruz: In the early days of diabetes, people would use urine testing or go to the hospital to monitor their glucose levels, but sensor technologies have come a long way over the last few decades. Today glucose sensing is based on a small quantity of blood from a finger stick. This is a proven technology that produces reliable blood glucose readings at a single point in time. This is a $10 billion industry. Technology has progressed to providing continuous glucose readings --- a sensor can sit on top of the skin and continually monitor glucose. The sensor is able to take a reading every six seconds and those readings are then reported every five minutes on a hand held display. SFC will partner with a sensor technology company to incorporate their design to a SFC patch pump.
CEOCFO: Where are you in the process? Mr. Cruz: We are in the early stages of the artificial pancreas development and still about three to four years away from a commercial launch. Medical device development takes time especially when you are dealing with innovative technologies like this. Multiple product tests and clinical studies have to be completed. SFC is raising money to complete a final design prototype that can be utilized for clinical studies. Our core technology is validated, but there is still a bit of design work to be done, mostly in order to further miniaturize the product. Unless this technology is reduced to a small form factor, to account for the patient’s need for convenience and discretion, the artificial pancreas will not be as widely adopted as it needs to be. The product must be as small and cost effective as possible so that patients can lead normal, active lifestyles.
CEOCFO:
What have you learned from your previous experience with early-stage biotech
that is helping with SFC?
CEOCFO: What has been the reaction from the investment community? Mr. Cruz: I look at the amount of money and the funding that goes into a huge problem like diabetes and it is not nearly where it needs to be. I think the investment community is looking at the space and thinking there are a lot of technologies being developed to better treat the disease and they could wait it out. There have been changes in the VC (Venture Capital) community over the last decade or so and they have gotten a lot more risk averse. It has forced companies like SFC to pursue funding through angels, high net-worth individuals as well as strategic partners rather than from the VC community.
CEOCFO: How do you spend your time as CEO? Mr. Cruz: On a daily basis, there are two critical activities. One is to continually understand and track the market. We need to understand our target customers and the competition that we will face in reaching our target customers. The second activity has to do with ensuring that our technology and product are being developed to create value. My day is spent talking to people - sitting down and chatting with my team, looking for partners, and searching for sources of funding.
CEOCFO: How do you ensure that it will work the way you plan? Mr. Cruz: There are two parts to that. We need to be confident that we are addressing the right problems that exist in the market and that we are applying our technology to address those problems in a way that is clear and with a high probability of success. We are going to go out there with a product that we know addresses the need. The second part is making sure the product is as easy as possible to use.
Medical devices are inherently risky because you are trying to intervene with a person that has a disease or an issue. The way I look at this is there are a lot of guidelines out there from the regulatory agencies. There are many mistakes that have been made by other companies that we can avoid. It is a matter of having a team that has the same type of passion about solving the problems.
What we are trying to do is help people and by making sure we have that goal, we are looking out for dangers along the way, looking at other people’s mistakes, listening to the regulatory guidelines, etc. I think the neat thing about the diabetes community is that people tend to be very passionate about this space. If you look around our company and other diabetes companies, many of the employees have personal experience with the disease or know someone who has diabetes. I do not personally, but I have a lot of family members that suffer from Type II. You understand what they go through and it is what drives you and the rest of your team. You have to focus on this passion. What we are trying to achieve is to make their lives better. It is a matter of trusting that passion and making sure we learn from other companies’ mistakes and going out there and learning as much as we can.
CEOCFO: Why should our readers pay attention to SFC Fluidics? Mr. Cruz: If you look at what is needed in the market place, the doctors, patients and insurance companies are all trying to find a better solution for patients of diabetes. If you look at the trajectory of improving the lives of diabetics, it clearly is going towards a more automated, hands-free system that provides the best outcomes. SFC is positioned right in the middle of that solution. SFC has a better performing insulin dosing system that is more accurate, is smaller, and provides convenience/discretion. Our aim is to make this system in a way that is cheaper and thereby more conducive to wide adoption by patients, physicians, and the insurance companies. We hope to provide a solution so that people with diabetes will lead a normal and less encumbered lifestyle. We are going to achieve this because we have folks who are passionate about this cause and we have technology that works. |
“If you look at the trajectory of improving the lives of diabetics, it clearly is going towards a more automated, hands-free system that provides the best outcomes. SFC is positioned right in the middle of that solution. SFC has a better performing insulin dosing system that is more accurate, is smaller, and provides convenience/discretion. Our aim is to make this system in a way that is cheaper and thereby more conducive to wide adoption by patients, physicians, and the insurance companies. We hope to provide a solution so that people with diabetes will lead a normal and less encumbered lifestyle. We are going to achieve this because we have folks who are passionate about this cause and we have technology that works.”- Anthony Cruz
SFC Fluidics
Contact: Anthony P. Cruz (479) 527-6810
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Anthony
Cruz