About our project

The problem we solve: Medication Adherence is a global crisis according to the WHO. It costs the US alone 125,000 lives, 380,000 avoidable hospitalizations, and $300 billion in financial losses, every year. The number one reason seniors lose their independence is because of poor adherence. It causes untold pain and suffering for users and is a major source of stress for concerned family members. Inaccurate adherence data also incurs additional time and expense for clinical trials. The problem impacts the complete health care eco-system.

About our solution: CertAlert Wearables are easy-to-use and reliable. The wearer can't turn the alarm off independently. The only way to disable the alarm is to swipe it across a small sensor. That small sensor is strategically placed inside to pill containers lid. The user's open medication is in their hands. The process self-verifies meds were taken. A color-coded system for multiple meds means no reading or mix-ups. The wearables also collect compliance and health data. The device can be integrated into telehealth platforms.

We have been granted a utility patent and have made a proof-of-concept prototype.

About Our Company

How We Help Patients

CertAlerts are empowering tools that allow patients to independently manage their medications. A low tech solution with high tech capabilities gives patients the ability to control their health outcomes. It reduces stress between concerned family members, providers, and the patient. It also keeps accurate, easily accessible logs on medication usage so patients can course correct on their own. Patients can choose the level of engagement they want providers to have, from real time monitoring to being off the grid, and still be protected against medicaiton errors, 

How We Help Physicians

Medication errors account for 25% of hospital admissions. Improving medication adherence will reduce their work load. Accessing new data streams will improve the providers ability to engage in their mission of protecting the health of the public.

How We Help Partners

We help our partners by delivering a reliable product. If you perform clinical studies, research, or work on a telehealth platform, or hardware will provide the data that leads to results.

Innovation Details

Intellectual Property Summary

We have been issued a utility patent.

Patent Link
https://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=5&f=G&l=50&co1=AND&d=PTXT&s1=8963707&OS=8963707&RS=8963707

Clinical Information

Upon completion of the device build, an efficacy and usability study will be conducted. CertAlert is a class 1 medical device and avoids the rigorous regulation approvals. Our estimated timeline is less than 18 months to build and test the device.

Regulatory Status

CertAlert is a class 1 medical device. It is exempt from the regulatory process.

How we will use the funds raised

The funds will primarily be used for the materials and personnel needed to construct the device and/or versions of the device and conducting a pilot to document the efficacy of the device. Funds will also be used for legal services, office space, utilities, equipment, and operating expenses incurred conducting the company's business. The remaining funds will be used for promotional materials.

Thank You

Ever since my son lost his transplanted kidney to this problem, I have made it my life's work to prevent another family experiencing what my family went through. One of the things about med adherence that really gets to me is that it is completely avoidable. This is an important problem and an important device. I am going to need your help to accomplish this. Hardware solutions are expensive. But this needs to be done. I am convinced this device will save lives. It will benefit everyone in the health care system. Maybe it will save or protect someone close to you. Not only are the people we love very vulnerable to fall victim to medication errors, our health care workers are under tremendous strain. Anything that can lighten their burden cannot come too soon. I hope you can see how this product will help you or a family member. I hope you realize what a big problem this is we are solving. This is a product that seniors, children, and everyone in-between can afford and use easily. It will bring health and peace of mind to medication users and the people that love and care for them.

Investor Info

Market Size

Georgetown University has said the 66% of adults in the US use prescribed medicaiton. About 14% of children do as well. The numbers for adult rounds to 140 million. 20% of those prescriptions are never filled. Many are hospitalized or have a caregiver. But over 100 million adult are med users. 

Business Wire reports this: "The global medication adherence market reached a value of nearly $2,438.2 million in 2020, having increased at a compound annual growth rate (CAGR) of 10.0% since 2015. The market is expected to decline from $2,529.6 million in 2019 to $2,438.2 million in 2020 at a rate of -3.6%. The market is then expected to recover and grow at a CAGR of 11.4% from 2021 and reach $4,181.3 million in 2025.

It is expected reach $6,497.0 million in 2030, at a CAGR of 9.2%."

Projected 3 Year Growth

Apologies but I hesitate to make these kind of projections at this stage of the products development. 

Revenue Model

A direct to consumers strategy using a mass marketing campaign is just one of the many options available. We can also access the market through government agencies (VA, Dept. of Aging), and health care institutions like the National Kidney Foundation, the National Heart Association, and the World Health Organization. We will attend industry events for the medical and health community to raise awareness of our products. Working with payers, providers, end-user clinicians with a team dedicated to reimbursement is how we will generate income from the wider US health care community. The fully-functional device with safety features will require a subscription. Our wearable is also a premier clinical trial tool. CertAlert Wearables can integrate into adherence, monitoring, and telehealth platforms. An online store where customers can buy accesories, (pendant shells, pill boxes, etc.) find support, and participate in incentivized games will generate revenue.  We also have the option of licensing the IP to other businesses who make wearables or adherence devices. There a eager market for the data these wearables can collect. Contract Research Organizations and pharmaceitical companies are also porential customers. A reliable solution to this problem will find many open arms and many willing payers.

Competitors

There is no product easier to use in this space. Full stop. No reading, no numbers, no hassle. The devices can be adapted to manage numerous drug delivery methods, such as creams, eye-drops, nebulizers, and glucose tests. The devices can manage these different delivery systems in any combination. CertAlerts can be adapted to work with, and enhance other adherence systems like pill dispensers that are immobile and easily left out of audible range. CertAlert can offer important safety features such as a fall detector and GPS location. The device can work stand alone or with web-enabled features. But the most unique quality that sets it apart is that it looks great! It can be designed to appeal to each individual user. A child can have their favorite cartoon character, a teen can have their favorite singer, Mom can have beautiful stylish jewelry, Grandpa can have his army unit's insignia. This is a very special feature of this device and not to be underestimated. A design or photo the user chooses can create a personal attachment and enhance customer engagement. CertAlert really stands out from the other devices. CertAlerts Wearables is the only medication adherence device that can be promoted with stunning jewelry designs and runway models. 

Traction

We do not have a finished product as yet and cannot supply sales information. We have conducted numerous interviews and focus groups and have found tremendous interest from medication users and their family members. After learning about CertAlert, the most common question is, "Where can I get one!"

Due Diligence Docs

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