• 2

    Backer(s)
  • $ 5,100

    pledged of $ 20,000 goal
  • 2197

    days ago
  • Campaign Ended!

    This project was expired.

  • This project was expired on 2013-07-14

About our project



Diabetes is the Problem.
Better diabetes management, with improved Detection, Monitoring, and Therapy is the solution.

We have a clear path to the Artificial Pancreas which will enable the solution to diabetes, the “Diabetic’s Dream” and we would love to share it with you today. We hope you will be inspired to back our project and share it with the people you care about and who care about improving diabetes care.

Hi,
My name is Dr. Albert Kretz. I have been working on medical devices for 50 years. The Artificial Pancreas is the Holy Grail of diabetes management and it is the next medical device I intend to make, the culmination of a career making specialized biomedical devices. You can read about me on linkedin but a few of the devices I created were the ‘Roving Probe’ tester for HEPA filters, used by NASA; a Petri Dish filler that processes over 1,800 plates per hour and is used by the U.S. Army; and a high precision insulin infusion pump that was FDA cleared in 46 days.

To get there, we need a Continuous Glucose Monitor (“CGM”) that works better, is less painful, costs less, and is easier to maintain. We have made great progress and have filed a Provisional Patent for the key, new component of the CGM, a micro-needle. The micro-needle is integral to the design and is critical to minimize negative side effects such as pain, scarring, and infection risk. As you can see from the video, this is a solid monitoring needle that is revolutionary in design and will have many applications. We chose to address diabetes and the development of the next-generation CGM to enable the creation of an artificial pancreas because we believe we can have the most impact fastest leading to better quality of life, longer life, and lower health costs in the not too distant future.

I am going to go through much of what we said in the video because my friend, Alex Fair, tells me it is important for Crowdfunding to explain things well, in black and white. Please forgive me if I repeat myself. I will include handy headers so you can skip to what interests you most. We look forward to your support for this very important project. You are welcome to ask questions or make suggestions in the ‘comments’ tab and I will be happy to respond.

Thank You for your interest.
Yours Truly,
Al Kretz, Ph.D.

Just the Facts about Diabetes

The Scope of Diabetes

Globally: Over 366 Million people, around the world, have Diabetes, about half of whom are unaware of this fact.

In the US: More than 25.8 MM people have Diabetes, of whom one third Do Not Know it!

Additionally, in the U.S., there are over 79 Million people with Pre-diabetes, over 89% of whom are completely unaware of their grave RISK.

The Cost of Diabetes Care

Over 550 billion dollars, Globally, and 245 billion dollars in the US, are spent on managing and treating diabetes every year. In the US that is about 9% of all healthcare costs.

This is particularly bad for Americans who spend over $9,000 per patient per year on diabetes care, more than six times the global average. This cost is among the many that are crippling the American healthcare system and increasing the cost of care for everyone.

The greatest cost though, is in human lives. Diabetes is considered the 4th leading cause of death today. Many can not afford to even monitor their diabetes using the available technology.

In addition to saving lives, our technology will cut the cost of care, we anticipate, by a factor of five or more.

Diabetes isn’t just for humans

Our Companion Animals also are also suffering with Diabetes. Over 580,000 Cats & Dogs in the United States and the United Kingdom are estimated to have Diabetes. Indeed, one of the early markets we expect to be able to offer our new technology to are the animals we all know and love, our constant companions.

Our Plan

Just as the artificial limbs or hearts gives hope to millions suffering from injury or heart disease, we believe the most efficacious way to address diabetes is to develop an Artificial Pancreas. Fortunately, a pancreas is far easier to make than a heart or a fully functional hand. To replace the insulin production function, we only need instantaneous, “real time” monitoring of blood glucose levels, a supply of insulin in a pump, an algorithm for control, and iron clad software to run it. This is the function of the pancreas that is lost in diabetes and the existing systems that perform this function help millions live every day. The problem is that the detection and continuous monitoring of blood glucose in these systems is not fast enough and fails in many ways. This project is about field testing our solution to this engineering challenge, which we believe we have. While the Artificial Pancreas is still about two years away, the micro-needle that will enable our next generation Continuous Glucose Monitor, the key component, is here today and ready to be tested.

The Road to a new generation of Continuous Glucose Monitoring devices

The state of the art, represented in this chart on DiabetesNet leaves much to be desired. The current devices need constant calibration, have ¼ to ½ inch needles, and mostly only last 3-7 days. They also cost thousands of dollars.

So here is our plan and how we expect to get there, with projected completion time frames:

2012-2013 – Stage 1, Invent – Design, Develop, and “table top” test the required biosensor micro needle (Done!)
Q4, 2013 – Stage 2, Test – Prove the micro-needle is effective with a pilot study using existing CGM hardware and software – hardwired. To be funded by this Crowdfunding campaign.
(note: all stages after this point will require follow-on funding which, if Stage 2 is successful, is actually easier to get.)
Q2, 2014 – Stage 3, Next Generation CGM Building – Integrate Real Time CGM with wireless telemetry and conduct pilot study
Q3, 2014 – Stage 4, Clinical Trial – Submit data for FDA Approved Clinical Trial and Start Professional Veterinary sales
Q4, 2014 – Stage 5, FDA – Present application for FDA Approval

We expect a minimum of 90 days for FDA approval, bringing product to market by Q2 2015, optimistically. This is pretty fast for a medical device, largely due to the fact that many of the elements pre-exist and are just being updated with a better sensor and new capabilities.

Upon completion of this plan, our device will be ready for market and ready to help millions. It will require significant additional funding beyond which we will raise here, but there is a clear path and our team and partners are capable and familiar with it.

Details Regarding Stage 2: Needle Pilot

The goal of the needle test is to prove that our design can reliably detect blood sugar levels very fast, extremely accurately, and for over one week at a time in a continuous use scenario in a lab animal testing environment. To do this we will perform what is known as an “animal study” in conjunction with our cadre of partners and a qualified animal laboratory testing center in accordance with Institutional Review Board approval and ASPCA guidelines. No Animals will be harmed in this testing. I repeat, NO Animals will be harmed in this testing. In fact, many might become healthier.

Stage 2 Steps

The Micro-needle, feasibility study will proceed in the steps below:
1. Fabricate the Micro-needle with electronic layers.
2. Laser cut micro-needles.
3. Process to apply the sensitive enzyme and protective layers & test for continuity and in-vitro.
4. Package for distribution.
5. Sterilize.
6. Test with animals.
7. Analyze data and document results.

Clinical Applications of the Micro Needle CGM

In addition to the ultimate goal of creating the artificial pancreas, the first clinical application of a reliable, affordable biosensor like we describe is to detect and characterize diabetes in people and animals. Whether the treatment choice is diet, metformin, insulin pump, or combinations thereof, knowing is half the battle. In diabetes, it isn’t just a single test, you need a great deal of information on a daily basis to understand your disease. A pancreas does not fail all at once and there are many nuances to the progression of the disease that patients living with diabetes must learn in order to live a normal, healthy life. The alternative is a state of unhealthiness, increased risk of heart disease, blindness, dental problems, amputations, and even sudden hypoglycemic shock that can cause people to lose consciousness while driving, walking, or operating heavy machinery, leading to even more problems. There is a great deal at stake and detecting and understanding diabetes is the key to treatment.

One of the great challenges we hope to solve is to create a way to identify ALL the people and animals ‘At Risk’. Too many people and animals do not know they have pre-diabetes or diabetes. By the time the manifestations of diabetes are obvious, the disease has become well-established and irreversible. It has been proven that early detection and proper treatment can delay and even reverse the course of the disease. One of the benefits of the micro-needle test is that it will make detection of diabetes far easier.

What is the current “State of the Art” for detection of Diabetes?

First let’s summarize the existing testing methods:

  • A Good test is the standard, Finger Stick – it provides only a Snapshot of the patient’s blood glucose level status. Each test costs about a dollar and typically patients are told to do them on their own 4 times a day, but people rarely do.
  • A Better test is the Hemoglobin A1c Blood test – it provides a 60 to 90-day average. These cost $25-$75 each and can be done with a home kit, but are typically done in a Doctor’s office or lab and sent to the physician for review.
  • A Better-yet test is the Glucose Tolerance test – it determines your body’s ability to handle sugar. These cost hundreds of dollars and need to be performed and interpreted by a trained clinician.
  • The BEST test is Continuous Glucose Monitoring or “CGM”. CGM provides real time data as well as meta data about trends and rates of change information. These are very expensive to install and maintain, but once installed, each test is not expensive and can be read by a patient themselves in real time.

We say CGM is the best because it provides the most data and more data is better data, especially in treating a stealth disease like diabetes. Having all this information doesn’t just give patients and clinicians the highs and the lows, but helps intelligent software systems find patterns and trends that can keep patients healthy. People talk about Big Data and Personalized medicine a great deal these days. This is a great example of how big data is being collected and used in medicine today, the “Gold Standard” as they say in healthcare.

Why the Advanced Biosensors Micro Needle CGM is better

There are several problematic aspects of the technology that is presently available as cleared by the FDA. Let us discuss each.

1. Less Pain
CURRENT TECHNOLOGY: Requires an insertion needle that is 6-10 hairs thick and needs to penetrate the skin ¼ to ½ inch – like a typical needle with which you get a shot.
OUR NEW TECHNOLOGY: Is only 1 hair thick and needs to penetrate only 1/16th of an inch, more like a splinter than a needle. Like many splinters, you don’t notice them going in and unlike splinters, they are very easy to remove.
ADVANTAGES: Painlessness, better adoption, less fear, reduced risk of infection, and no scarring.

2. Faster Data
CURRENT TECHNOLOGY: Existing sensors measure Glucose in the subcutaneous, fatty tissue, they capture data more slowly.
OUR NEW TECHNOLOGY: Advanced BioSensors’s technology senses glucose in the blood and oxygen-rich dermis, producing a much faster response.
ADVANTAGES: Faster data means that if connected directly to an insulin pump, it would be able to respond in physiologically relevant time frames. Current technology requires manual input and is insufficient for this purpose. Newer, ultra-fast acting insulins will work better with our CGM as well.

3. Ease of Use
CURRENT TECHNOLOGY: Existing sensors require a clinician or special training to perform an “insertion” using a complicated “introducer device” that penetrates up to half an inch into the skin.
OUR NEW TECHNOLOGY: There is NO insertion device. The patient merely pats it into place, penetrating less than 1/16 of an inch with no “introducer device” or specially trained clinician required. A patient-managed solution is critical for long term cost effectiveness and benefit.
ADVANTAGES: A Patient can do it, it does not require a clinician, permits increased privacy and is designed to reduce painful and dangerous errors.

4. Ready to Use Faster
CURRENT TECHNOLOGY: Existing sensors need 2-10 hours to be ready for use, needing to reach equilibrium.
OUR NEW TECHNOLOGY: Advanced Biosensors technology requires less than 1 hour to reach equilibrium which means faster results.
ADVANTAGES: Quicker installation means faster results and faster feedback if calibration is needed.

5. Less Expensive
CURRENT TECHNOLOGY: Requires expensive devices and clinical installation.
OUR NEW TECHNOLOGY: Does not.
ADVANTAGES: Could reduce the cost of care by an order of magnitude.

In summary, our sensor design will enable the development of a cost-effective critical element to solving the problem of insulin regulation. This new sensing technology is the last technical engineering challenge that prevents the development of a reliable artificial pancreas at a reasonable cost.

We Need Your Help

We invite you to become a Pioneer Sponsor and help bring this device to market. As you may know, the Food and Drug Administration has high standards and takes its important job of protecting the American people from medical devices, foods, and drugs that could be harmful, very seriously. We are familiar with the process and have been through it many times, sometimes in as little as 46 days. The burden of proof lies with us and to prove the effectiveness and safety of our sensor, we need to perform scientific and clinical studies. As is typical, we will do so in animals first, developing scientific proof that our micro needle and next generation Continuous Glucose Monitor works well in small mammals first. We have the technology ready, now we just need to prove it in a real world environment and begin to build a case for the FDA to review and approve. We ask for your help in supporting this first study to prove the utility of this needle that will lead, eventually, to the next generation CGM and one day to a true artificial pancreas.

How we will utilize your contributions

Within the Intended Use of Funds There will be NO Salaries
(Please note: an executive summary and additional exhibits are available upon request.)

Funds will be used for:
30% Micro-needle fabrication, processing, packaging, and sterilization
60% The Feasibility Study, and
10% Ongoing Operations such as patent preparation *

The Total cost anticipated is $60,000

This is only possible due to the generous support of partners like doctor Charles E. Wiedmeyer DVM, PhD, DACVP at the University of Missouri, College of Veterinary Medicine.

Partners

Overall, Advanced Biosensors has developed relationships with 20 Strategic Partners, all with extensive experience and expertise in Medical Device Development, Production, FDA applications, and Marketing. Most are local in the Medically Enriched, Northeast Ohio Region and have indicated that they will aid in the execution of this plan upon funding.

The Rewards

We can’t sell the devices through MedStartr, but we can let people support the idea and provide certificates of thanks and Coupons for future credit against the purchases of the devices as indicated in the Rewards section at the right. Note that the development of this device is not without risks. We may fail. If we fail, we cannot offer a refund.** You will be funding the fabrication and feasibility study, which may very well not work out. Do not support this project if you only are doing so for a material reward. Support this project because you want there to exist a better way to detect and treat diabetes.

If we succeed, we will succeed together. You also will be among the first to receive reports and data on the studies and receive information about follow-on rounds which will be for equity, perhaps even through MedStartr’s equity platform that they are building presently. Note, you cannot buy equity through MedStartr presently. This is not a solicitation for sale of stock in the company.

Thank you for your time, attention, and hopefully support. We have had great success in creating a whole family of devices that help people live longer better lives and look forward to bringing the Artificial Pancreas to market within 24 months.

Warm Regards,
Albert P. Kretz, Ph.D., MBA
Founder/Chairman
Advanced BioSensors-Ohio, LLC

Dr. Kretz has had over 50 years extensive experience bringing bio-mechanical systems to market and gathering successful teams for all aspects of FDA devices

Visit our site:
www.advancedbiosensors.com

* Note on Patent Status

To protect our Intellectual Property, a Provisional Patent has been filed, which covers the sensor technology that enables consistent function of the sensor for up to 7 days. Part of the use of the proceeds of this campaign will be to complete the patent application process.

** Note on Project Risk

It is possible that the project will fail. In this case, no refunds will be available. All data will be made available and options to continue the work will be among our alternatives. All reasonable attempts will be made by Advanced Biosensors to honor all Coupons, but there is no guarantee given, expressed, or implied. MedStartr maintains no responsibility for delivery or performance of this project.

Prescription May Be Required

In addition to FDA approval, a prescription may be required to obtain our advanced CGM. Backing this project, you do hereby acknowledge that you may not obtain our device without a prescription if this is required.

Note: This project was thoroughly reviewed by MedStartr clinical staff and was optimized as part of the MedStartr Partner Program. To learn more about this service, please visit their services page.

Rewards

For $ 100 or more

0 Backer(s)


Our Sincere thanks for your support, a certificate suitable for framing, and a numbers place in our Scroll of Support which will be published online and in print. Names will be listed in order of contribution date, so get your low scroll number now!

For $ 500 or more

0 Backer(s) Limited (100 left of 100 )


Inclusion on the Scroll of Support as above and a Coupon for $500 towards the purchase of the Next Generation CGM when and if it becomes available.**

For $ 1000 or more

0 Backer(s)


Inclusion on the Scroll of Support as above and a Coupon for $1000 towards the purchase of the Next Generation CGM as well as supplies including extra sensors when and if it becomes available. Pricing will be based upon Medicare Pricing at time of launch.**

For $ 5000 or more

1 Backer(s)


Inclusion on the Scroll of Support as above and a Coupon for $5000 towards the purchase of the Next Generation CGM and Artificial Pancreas as well as disposable supplies including extra sensors when and if it becomes available. Pricing will be based upon Medicare Pricing at time of launch.**

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