by Marc Rippen
The problem we solve: Over 20 million people in the United States have Diabetes, determined by CDC as of 2012. The number is growing. Most rely on intrusive blood sugar measurement methods requiring self measurement of blood from blood pricks multiple times every day (SMBG). If they are suffering from a low blood sugar attack they may not be able to be cognitive enough to do anything and could lapse into a coma. If they are living alone this could be deadly. Other continuous glucose monitors (CGM) are invasive requiring probes to be inserted into the skin that must be replaced and that can only measure interstitial glucose, which typically lags 10 minutes or more behind actual blood glucose measurements making it difficult for diabetics to make the right decisions real time to properly maintain their blood glucose levels real time.
About our solution: Our device continually measures actual blood sugar levels using a non intrusive sensor embedded in a wrist band worn by the diabetic. The data collected by the sensor is used to calibrate the system through the Alertgy Proprietary IoT cloud driven AI analytics system and to continuously optimize its accuracy. If blood sugars start to go too high or too low the smartphone which is monitoring the wrist band using wireless technology notifies the user of the situation. If the user ignores or is unable to respond to their smart phone alert it will call the alert contacts that the user programs into his phone app. The phone will then text or call those contacts with an alert and a location where the phone is located so they can follow up to insure the user is OK. This allows the USER the freedom of not having to prick themselves, and insures that all measurements are being done so that the users physician can get an accurate assessment of that individuals blood sugar levels real time.Progress to date:
We have a fully equipped systems development facility, A prototype system that has demonstrated equivalent performance to the hand held glucometers used to measure the blood from a users finger prick with a thumb based sensor. We also have 15 employees including a Chief Medical Officer MD (UF), PhD (in Biomedical Engineering Duke) and MPH (John Hopkins) with medical device public health experience. Check out our video on the technology page of our website www.alertgy.com.
Creator: Marc Rippen
Education: Degrees in Analytical Chemistry, Microbiology
Bio: Entrepreneur, Scientist, Engineer and Leader. Established Alertgy to provide diabetics a real time non intrusive wrist band based blood sugar monitor enabled with a smart phone app to give people freedom from having to prick themselves to measure their blood sugar, to alert them and their loved ones if levels are too high or low and give them real time trend analysis.
Hospital Affiliation: Former Director of Engineering SRI International Adjunt Professor at Embry Riddle Aeronautical Univ
Advanced Degree(s): MS
Alertgy will provide a means for diabetics not to have to prick themselves to know what their blood sugar level is. It will allow for a means to continuously moniter their blood sugar levels improving the ability for their doctors to monitor their continous history. It will allow for them to be alerted real time if their blood sugars are getting too high too low and if they are incapacitated by their blood sugar levels notify their loved ones doctors automatically. All this for less than what the blood strip finger prick glucomter system cost to use today.
The Alertgy non invasive blood glucose monitering system will provide them with continous blood sugar data on their patients that can be sent / downloaded by cell phone at what ever frequency is required for proper diabetic patent monitering. Most people hate to prick themselves so by nonivassive real time monitoring doctorswill be able to get all the data they need, with no dependancy on the patient to do what they should do.
The Alertgy device allows for non invasive blood glucose monitering during ICU stays to improve recovery time from traumatic injuries oroperations. The data it generates can also be used to better monitor diabetics to better manage their disease and reduce the costs associated with poor management of diabetics. Reducing costs for amputation, vision and other long term health issues.
Alertgys non obtrusive blood glucose monitering will help employers and insurance providers with a means to empower their employees and their doctors with critical continous blood sugar data that can be used to improve the treatment of the employee and give the employee a means to optimize their behaviors based on instant feed back ability of the device. This will reduce sick time, health care costs as well as minimze incidents were employees pass out from low blood sugar at work and have to have emergency services rendered.
Our Global Market is the 422 million people that suffer from diabetics worldwide1 (8.5% of the world population). 21.1 million are Americans that are diagnosed with diabetes. An additional 8.1 million Americans have diabetes but are not aware of it. So a total of 29 million Americans are affected2 (9.3%). Of the three types of diabetes (Type 1, Type 2, and gestational), type 2 accounts for over 90% of the cases of diabetes.
The increased prevalence of diabetes and obesity (a risk factor for type 2 diabetes) has increased dramatically from 1994 to 2014 and is expected to grow. There are 86 million Americans with pre-diabetes (1/3rd of the population) of which 15% to 30% will develop type 2 diabetes in five years. Diabetes is the seventh leading cause of death in the US and accounts for significant morbidity. People with diabetes are at risk for health complications including blindness, kidney failure, increased risk of heart attacks (1.8 times higher, death 1.7 times higher), strokes (hospitalization 1.5 times higher), and non-traumatic lower limb amputations5. In addition to the human costs, there are economic ones as well. The total medical costs and lost work and wages for people diagnosed with diabetes is $245 billion6. It has been estimated that the lifetime additional healthcare cost of one patient with diabetes is between $55,000 and $130,000.7 It is clear that diabetes has a significant impact on an individual’s health and our healthcare costs.
This data was obtained from 2 sources:
1) World Health Organization Website. “Diabetes Fact Sheet”. Updated November 2016. Obtained online 12/10/2016 at: http://www.who.int/mediacentre/factsheets/fs312/en/
2) CDC Website. “2014 National Diabetes Statistics Report” https://www.cdc.gov/diabetes/pubs/statsreport14/national-diabetes-report-web.pdf
Projected 3 Year Growth
We are looking to do preclinical trials in early 2019, followed by clinical trials 3 months later, fda certification by end of 2020, market launch 2021.We expect to generate over 1 billion dollars in recurring revenue by end of the first year to market, with just 10% of US Market.
How We Will Make Money
We are the only truly non-invasive wearable technology that we know of. We bring to market a disruptive technology that addresses a major unmeet need in the mature diabetes industry: a totally non invasive manner. We will make money by providing our wristbands undera subscription agreement. Our cost per wristband is under $33.75 this include BOM, assembly, packaging and delivery. We will charge $100.00 a month which is less than supplies cost for glucometers. We will use a fully scalable 3 prong approach to market. Direct to consumer through the Internet, Business to business through retailers, and Business to Health Care providers through outreach and pilot projects.
About our Competition
Alertgy currently has no direct competitor in the market. 90% of the completion consists of the current manufacturers of prick and test strip glucometer systems. There are no truly non-invasive systems available to provide real time blood sugar levels and trends. Competitors such as Dexcom use sensors embedded under the patient’s skin or on the eye to achieve continuous monitoring which is extremely invasive. Optical and other skin chemistry methods are not practical for continuous monitoring and lack adequate selectivity and or sensitivity to meet FDA requirements. The skin chemistry based systems cause rashes on many patients since they require abrasion or fluid exchange through the skin to work. In addition all of these technologies are significantly more expensive and are not as easy to use.
Progress with Customers to date
We have raised 2.2 million in equity funding to date. We are presently at 50% of current 2 million dollar raise at a 25 million dollar pre valaution.
New Orleans and Our Company
If funded we will continue preclinical and clinical studies, develop fabricate optimize our wristband gen 2 product, start FDA approval Process, file for additional Patents conduct key hires, pursue strategic partnerships, and move out of our present incubator. We also would support research at local universitieds to look at other medical applications for out technology in other preventative medicine applications.
The total market opportunity is 20 million type one diabetics in the US and the other 400 million around the world. With 10% of the US Market Alertgy will be generating over 3 billion dollars of revenue on an annual basis.
Projected 3 Year Growth
In Three years after FDA approval Alertgy will be generating over 3 billion dollars in revenue with 10% of the US Market share, our earnings will allow us to rapidly address the 400 other diabetics world wide and be penetrating those markets as we move forward.
Upon successful clinical validation of the accurate performance of our present clinical system which should be complete by early 2020, the company will enter into agreements with one or more strategic partners which have established sales and marketing resources. Our devices will be sold by those strategic partners “B to C” through the internet and “B to B” to health care organizations and drug store chains. Alertgy proposes a subscription pricing model at a monthly rate of $100 per unit to the end user. The monthly cost of providing that service is projected to be under $40, including the cost for manufacturing, packaging, and distributing a new wristband every month and providing an IoT cloud-based data analytics service. A ten percent market penetration of just the US market could generate $1 billion in recurring revenue to Alertgy and 2 billion to its partners. Alertgy plans to retain ownership and control of its proprietary sensor material fabrication and its cloud-based analytics software platform.
Alertgy currently has no direct competitor in the market. Over 90% of the existing competition consists of manufacturers of finger prick and blood test strip glucometer systems. Continuous monitoring competitors such as Dexcom and Abbott use chemical reaction-based sensors embedded under the patient’s skin, Notably, the Abbott Libre system which features an invasive patch worn on the patient’s upper arm does not measure blood glucose levels. Instead the Libre examines interstitial (body) fluid. Glucose levels in that fluid typically lag actual blood glucose levels by approximately 20 minutes, making the measurement much less useful. Libre is generally not accepted as a substitute for blood glucose monitoring. Instead it is a warning system prompting the patient to test their blood glucose with a proven testing method. Dexcom’s devices require the implant of a sensor in the abdomen and also test interstitial fluid, not blood.
Alertgy raised 1.2 million in equity capital their seed round in 2018. They have raised another 1 million in equity capital with another 1 million to go in the present round of funding that just recently opened. Alertgy has developed a functional NICMG clinical product that provides continuous blood glucose measurements and trend analysis enabled by a smart phone application. The accuracy of the system has been validated by inhouse studies comparing Alertgy blood glucose readings to those produced by a leading “finger prick” blood glucose meter and lab benchtop systems. In the fall of 2019 Alertgy will sponsor an independent study at a major medical center to further confirm the accuracy of its blood glucose measuring system.
Starting with a large proof of principle system approximately the size of a home refrigerator in 2017, Alertgy has reduced the size of the NICMG to approximately that of a blood pressure cuff. That format is appropriate for hospital and clinical use. During the next 12-18 months the system will be further reduced to a wearable wristband size – much like a Fitbit or a smartwatch
Alertgy has accomplished the following other significant achievements to date:
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