The iPill offering is now closed and is no longer accepting investments.

iPill

Remote Monitoring Technology to Combat the Opioid Crisis

iPill

Remote Monitoring Technology to Combat the Opioid Crisis

Rowland Heights, CA
Health Tech
Software & Services
iPill is a pill dispenser with a smartphone application, designed to directly address and combat the opioid crisis.

$0.00

raised
0
Investors
$7.5M
Valuation
$1.50
Price per Share
$399.00
Min. Investment
Common
Shares Offered
Equity
Offering Type
$1.07M
Offering Max
0
Days Left

$0.00

raised
0
Investors
$7.5M
Valuation
$1.50
Price per Share
$399.00
Min. Investment
Common
Shares Offered
Equity
Offering Type
$1.07M
Offering Max
0
Days Left
This offering ended on May 22, 2021 and is no longer accepting investments.

Reasons to Invest

iPill has won numerous competitions, has been designated by the FDA as a “breakthrough” medical device, and received FDA Class I Registration.
iPill’s serviceable addressable market is $10 billion annually.
iPill has been granted 3 patents and is the only pill dispenser on the market that is completely tamper-resistant and has insurance coverage.

Overview


Breakthrough technology for secure opioid dispensing

CEO John Hsu, MD, has practiced anesthesia and chronic pain management for 28 years, and one of the most common problems he’s had is monitoring the use of opioids by patients at home. The uncontrolled access to these substances has only served to perpetuate the rise of the 20-year-old opioid crisis (Source), which now accounts for 50,042 deaths per year.

The last breakthrough in technology invented to control the use of opioids was the child resistant cap, in 1969 (Source), so Dr. Hsu set out to create a more advanced, modern solution. The iPill combines smartphone technology with a secure dispenser that uses cognitive behavioral therapy to treat patients.


Development Stage:  The iPill platform is currently in development and not yet available on the market. It consists of a mobile app and dispenser, they are functional together and can wirelessly dispense a pill.  We have FDA class I registration and can sell the iPill today to the market once they are manufactured.  We are in the process of design for manufacturing of the dispenser for mass production. We are in the midst of upgrading the tamper detection method. The mobile app has been written and connects to the dispenser to dispense pills when instructed after registration and authentication by a patient. We are in the midst of upgrading the frontend and backend build. We have ongoing discussions with 2 customers and plan on fulfilling order by delivering prototype products to them at the end Q1/early Q2. We can gather pilot data with them, determine needed improvements, then upgrade for a full market launch.

*Images are computer generated demo versions. Product is still currently under development.

The Problem


Death rates due to opioid usage are seeing a double-digit year-over-year increase

The opioid crisis is 20 years old and will continue to worsen. Each year, there's a double-digit increase in death rates for opioid users, and the COVID 19 pandemic has only intensified this problem. In March, the overdose death rate increased 18%, in April  29% and in May 42%.(Source).

Many patients who use opioids keep them stored in unsecured medicine cabinets, where anyone can have access to them. 73% of teens get started on opioids by raiding the medicine cabinets at home (Source)  and 1 in 4 overdoses now involve children and teens (Source).

The Solution


A solution designed to save lives, reduce medical expenses and improve care

The iPill solution actively controls opioid dispensing from a secure dispenser and uses cognitive behavioral therapy to treat patients. To ensure prescription adherence, we created a smartphone mobile application that acts as a key to access the iPill dispenser. The mobile app ensures that only the person prescribed has access to the opioids, and only at the prescribed dose and time, thus reducing abuse. Unused pills within the dispenser are destroyed if tampered with and are safely disposed of after 90 days, thus reducing diversion. Through the mobile app, patients can also access cognitive behavioral therapy apps to support mental health, such as PearTherapeutics, and other anti-anxiety, anti depression, and wellness apps.

*Images are computer generated demo versions. Product is still currently under development.

The Market


A multibillion dollar serviceable market

Our total available market is worth $9.5 Billion, with 191 billion pills prescribed in the US (Source) and nearly 200 million opioid prescriptions written per year. TAM Estimate is $9.5 Billion = 191 million opioid RX times $50/unit

The iPill costs $50, so our serviceable addressable market is an estimate of about $1.5 Billion with a 16% early adoption. 16% of $9.5 billion = $1.5 Billion (Source). 

*Images are computer generated demo versions. Product is still currently under development.

Our Traction


We’ve received FDA registration, along with numerous awards and patents

In 3 years, we have had fast traction because we have bootstrapped and invested $500K of our own money. In 2018, we were the FDA Innovation Challenge Winner: “Devices to Prevent and Treat Opioid Use Disorder” and the UCLA 2018 Opioid Hack-A-Thon winner. In 2019, we were the Hartford Insurtech Hub Competition winner, and in 2020, we won the American College of Cardiology Digital Health Innovation Challenge.

The FDA designated iPill as a “breakthrough” medical device and in May 2020, we received FDA Class I Registration. We have been granted 3 patents so far, and have had pilot studies done at Rutgers School of Dental Medicine, and UConn/Hartford Healthcare.

So far, we are in conversations with 2 different behavioral treatment centers.

What We Do


An advanced, tamper-proof solution designed to save lives

The pharmacist fills the iPill dispenser and affixes a QR code containing the APP, prescription and the serial number of the iPill dispenser. The patient takes a picture of the QR code, which downloads the iPill APP and the other information onto the APP. The patient registers their fingerprint or face and a personal code for two-point biometric authorization to access the iPill APP. Only one phone, one APP and one dispenser will complete the unique connection allowing dispensing of opioids. 

*Images are computer generated demo versions. Product is still currently under development.

Only the patient can access opioids from the iPill dispenser via the iPill App, which only works according to the prescription dosage and schedule . Should tampering occur, our patented detection method releases a DEA approved solution to dissolve the pills. A second solution creates a hard resin to act as a second barrier. The device is single use in accordance with the  FDA/DEA Drug Supply Chain Security Act.

*Images are computer generated demo versions. Product is still currently under development.

The Business Model


A B2B model focused on 3 major markets

The iPill costs about $15 to produce and will sell for $50. Our business model will concurrently focus on 3 market segments: dental offices (the second highest prescribers of opioids), addiction treatment centers (ATCs) and clinical research organizations (CROs), and finally pharmacy-insurers.

The first 2 segments are fast adopters and will allow us to generate revenue to support market penetrance and dominance. The sales cycle to pharmacy-insurers will be longer but well worth the endeavor, as there is an average of nearly 200 million opioid prescriptions written per year. 


We have already discussed the iPill solution with a consortium of 320 dental practices that  would like to pilot 100 units to scale up to 320 practices. We also have 2 ongoing discussions from 2 addiction centers.

How We Are Different


Tamper-resistant and the only pill dispenser with insurance coverage!

In August of 2020, the Centers for MediCare and MediCaid Services (CMS) announced that they will cover reimbursement for FDA designated breakthrough products. This gives iPill an incredible competitive advantage as the only pill dispenser with insurance coverage.


We are patented and FDA Class I Registered. Unlike our competitors whose products are not completely tamper-resistant, iPill actively controls dispensing with 2-point authentication, and destroys pills if tampered with. 

*Images are computer generated demo versions. Product is still currently under development.

We have 3 CBT apps and 1 Telehealth module to monitor and support the mental health of patients. We collect HIPAA-compliant data on opioid use, CBT use, and near-death 911 calls for predictive analytics and population health management.

The Vision


Making opioid usage just as safe at home, as in the hospital

Our mission is to save lives, improve care, and reduce healthcare costs. The goal of our product is to make it just as safe for patients to access their medication at home as if they were in the hospital. In addition, we are actively collecting HIPAA-compliant data on opioid usage, CBT interventions, and near-death events from the iPill app in order to prevent abuse and addiction by using predictive analytics and population health management.

*Images are computer generated demo versions. Product is still currently under development.

Our next milestones will include transitioning from pre-revenue to revenue and launching our product to the market. After that, we will start a clinical study for registration as a FDA class II de novo iPill product.


We aim to achieve manufacturing growth in the dental and addiction treatment center markets and partner with pharmacy-Insurer-PBMs.

OUR LEADERSHIP


Experienced and skilled serial entrepreneurs with a passion for making an impact

John Hsu, MD is a serial entrepreneur and has practiced anesthesia and chronic pain management for the last 28 years. Since the beginning stages of creating iPill, Dr. Hsu has put together a strong team of senior entrepreneurs, who have all had successful exits of their own.

Each of us has combined our skills and come together for the purpose of social impact and saving lives. We have identified a problem, created a solution, recognized a huge market opportunity, and we are now well-positioned for major future growth.

Why Invest


Help us make a major social impact with iPill’s life-saving first-to-market technology!

It is rare that a social impact business can create a win-win situation for all stakeholders, but at iPill we are doing just that. Today, one in three people know someone who has an opioid use disorder (Source). Our FDA-designated “breakthrough” product is the first tamper-resistant solution on the market with 2-point authentication that destroys pills if tampered with and is legally covered by insurance.

*Images are computer generated demo versions. Product is still currently under development.

We know that this is just the beginning for us and we hope you’ll join forces with us as we bring this life-saving product to the people who need it most!

Offering Summary


Company

:

iPill inc

Corporate Address

:

17532 Marengo Dr, Rowland Heights, CA 91748

Offering Minimum

:

$9,999.00

Offering Maximum

:

$1,069,999.50

Minimum Investment Amount

(per investor)

:

$399.00











Terms


Offering Type

:

Equity

Security Name

:

Common Stock

Minimum Number of Shares Offered

:

6,666

Maximum Number of Shares Offered

:

713,333

Price per Share

:

$1.50

Pre-Money Valuation

:

$7,500,000.00











COVID Relief

This offering is being conducted on an expedited basis due to circumstances relating to COVID-19 and pursuant to the SEC’s temporary COVID-19 regulatory relief set out in Regulation Crowdfunding §227.201(z).

Expedited closing sooner than 21 days.

Further, in reliance on Regulation Crowdfunding §227.303(g)(2) A funding portal that is an intermediary in a transaction involving the offer or sale of securities initiated beginning May 4, 2020 in reliance on section 4(a)(6) of the Securities Act (15 U.S.C. 77d(a)(6)) by an issuer that is conducting an offering on an expedited basis due to circumstances relating to COVID-19 shall not be required to comply with the requirement in paragraph (e)(3)(i) of this section that a funding portal not direct a transmission of funds earlier than 21 days after the date on which the intermediary makes publicly available on its platform the information required to be provided by the issuer under §§227.201 and 227.203(a).

Voting Rights of Securities Sold in this Offering

Voting Proxy. Each Subscriber shall appoint the Chief Executive Officer of the Company (the “CEO”), or his or her successor, as the Subscriber’s true and lawful proxy and attorney, with the power to act alone and with full power of substitution, to, consistent with this instrument and on behalf of the Subscriber, (i) vote all Securities, (ii) give and receive notices and communications, (iii) execute any instrument or document that the CEO determines is necessary or appropriate in the exercise of its authority under this instrument, and (iv) take all actions necessary or appropriate in the judgment of the CEO for the accomplishment of the foregoing. The proxy and power granted by the Subscriber pursuant to this Section are coupled with an interest. Such proxy and power will be irrevocable. The proxy and power, so long as the Subscriber is an individual, will survive the death, incompetency and disability of the Subscriber and, so long as the Subscriber is an entity, will survive the merger or reorganization of the Subscriber or any other entity holding the Securities. However, the Proxy will terminate upon the closing of a firm-commitment underwritten public offering pursuant to an effective registration statement under the Securities Act of 1933 covering the offer and sale of Common Stock or the effectiveness of a registration statement under the Securities Exchange Act of 1934 covering the Common Stock.

*Maximum Number of Shares Offered subject to adjustment for bonus shares. See Bonus info below.

Investment Incentives and Bonuses*

Early Bird

Friends and Family - First 6 days | 5% bonus shares


Early Bird Bonus - Next 7 days | 4% bonus shares


Volume


* Tier 1 perk - ($5,000+ 1% bonus shares)


* Tier 2 perk - ($10,000 + 2% bonus shares)


* Tier 3 perk - ($25,000+ 3% bonus shares)


* Tier 4 perk - ($50,000+ 5% bonus shares)


*All perks occur when the offering is completed.

Irregular Use of Proceeds

We will not incur any irregular use of proceeds.

Show More
Most recent fiscal year-end:
Prior fiscal year-end:
Total Assets
$2,546.00 USD
$1,500.00 USD
Cash And Cash Equivalents
$2,546.00 USD
$1,500.00 USD
Accounts Receivable
$0.00 USD
$0.00 USD
Short Term Debt
$2,546.00 USD
$0.00 USD
Long Term Debt
$0.00 USD
$0.00 USD
Revenues And Sales
$0.00 USD
$0.00 USD
Costs Of Goods Sold
$0.00 USD
$0.00 USD
Taxes Paid
$0.00 USD
$0.00 USD
Net Income
-$1,550.00 USD
$0.00 USD

Risks

A crowdfunding investment involves risk. You should not invest any funds in this offering unless you can afford to lose your entire investment. In making an investment decision, investors must rely on their own examination of the issuer and the terms of the offering, including the merits and risks involved. These securities have not been recommended or approved by any federal or state securities commission or regulatory authority. Furthermore, these authorities have not passed upon the accuracy or adequacy of this document. The U.S. Securities and Exchange Commission does not pass upon the merits of any securities offered or the terms of the offering, nor does it pass upon the accuracy or completeness of any offering document or literature. These securities are offered under an exemption from registration; however, the U.S. Securities and Exchange Commission has not made an independent determination that these securities are exempt from registration.


Updates

Drug Expert: U.S. Needs an 'Operation Warp Speed' for Opioid Epidemic

12 months ago

The opioid crisis is 20 years old.  Why do we continue to repeat the same thing over and over again and expect a different result?  Instead of treating the symptoms which prolongs disease and offers no cure.  iPill is on a different path.

iPill is in the final stages of planning our human factor trials at an OUD treatment center Aspire365 to collect data on feasibility, usability, and acceptance.  We have spoken to Ohio Governor Mike DeWine's office about collaborating on the study because Ohio has one of the highest opioid overdose death rate in the country.   We hope this leads to an introduction to Sen. Rob Portman, (R-OH), Author, Comprehensive Addiction and Recovery Act (CARA) and CARA 2.0 and potential Federal support for the iPill initiative.

With State and Federal support, and the support of the DEA (a called is planned next week), it is our hope to change the standard of care.  The same opioid triple locked in hospitals, will be given the same safety protocols in patients homes.  Secure storage, active control dispensing, and destruction of unused opioids on tampering and prescription end.

I have hope today with two bright spots

about 1 year ago

NSF & NIDA/NIH/HEAL initiative Grant submission

For the past 22 years I have been combating opioid over usage in my medical practice.  I was harshly criticized for adopting multimodal pain therapy just as “pain” was becoming the “5th vital sign” and the opioid crisis was beginning.  Multimodal pain therapy is now used as a measure of the quality of anesthesia and determine physician reimbursement.  My actions were 22 years too early.

Today I have hope.  

I hope that with the changing attitude towards prevention of OUD,  the iPill will be funded by a grant.  In trying to get an update for the grant applications submitted to the National Science Foundation (NSF) for $256,000 and to the NIDA/NIH/HEAL Initiative SBIR Fast-Track Direct to Phase II for $2.3 million, I learned something that gave me hope.  The HHS Secretary announced that  prevention was the next frontier in opioid use disorder (OUD) because treatment is relapse rates and the costs are astronomical.  The Surgeon general made the same assessment.

I have hope in a lead investor who has committed to a seed of $2 million.  In my heart I know that the iPill has the potential reduce the risk potential for OUD, save live, reduce medical costs, and improve care.

Thank you for your support

Have you locked up your opioids today?

about 1 year ago

Have you locked up your opioids today?

1 in 4 opioid overdoses now involves children and teens. https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2719580

One of the biggest problems, no one really know what to do with unused pills. There are no universal recommendations for the proper disposable of unused opioids, and patients are rarely advised of what to do with unused opioids or expired medications. According to the Office of National Drug Council Policy, most medications that are no longer necessary or have expired should be removed from the containers, mixed with undesirable substances (i.e. cat litter, used coffee grounds) and put in an impermeable, nondescript container (possible container with a lid or a sealed bag) before throwing in the trash. The FDA recommends the most opioid medications, including OxyContin/acetaminophen (Percocet) and oxycodone (OxyContin tablets) and transdermal fentanyl (Duragesic transdermal system) be flush down the toilet instead of thrown in the trash. Disposal by flushing down the toilet proves immediate and definitive elimination of safety hazards from in intentional use or a accidental exposure of opioid products

Patient should be advised to flush prescription drugs down the toilet only if the label or accompanying patient information specifically instructed do so. Flashing on his medication has been the subject of controversy with some state governments and boards recommending against the practice due to pollution concerns and affects on waterways and wildlife.

The American medical Association recommends following three steps to promote the safe storage and disposal of opioids.
1. Educate patient about the safe use of opioids including not sharing prescriptions with others.
2. Remind patients that medication should be stored out of reach of children and in safe place - preferably locked to prevent other family members and visitors from taking them.
3. Talk to patients about the most appropriate way to dispose of unused expired, unwarranted, and unused medications. The preferred option is that unwanted or unused pills, liquid or other medication should be disposed of in a local “take back” or mail back program or medication dropbox at a police station, pharmacy, or unauthorized collection site. Contact your state law enforcement agency or visit HTTPS://takeback-day.DEA.GOV to determine if a program is in your area


A new use for the iPill, a new market segment

about 1 year ago

Recently, we were contacted by a company that treats depression with Ketamine.  They expressed interest in using iPill to save delivery costs and ensure medication adherence and reduce abuse.  The company currently overnight delivers a single dose of medications to the patient’s home and videoconference ingestion.  Their daily delivery costs are over $120 and see using the iPill to realize a 75% reduction in transportation expenses to $30 total. 

iPill provides secure storage, active control dispensing, and destruction of unused pills on tampering and prescription expiration.

We are demonstrating our specialized engineered solution to them tomorrow.

Once others understand the potential, we will become the new standard for delivery of medications to patients

A patient

about 1 year ago

This was a comment from the iPill website

I am having knee replacement surgery. I have been sober for 2 years and am looking for pain medication distribution options that are timed and locked: I have had issues with pain meds and alcohol. Thanks for any ideas or assistance you might have available.

My response

Thank you for the note.  Congrats on your sobriety and for reaching out.  This is impressesive because you are genuinely interested in your own well being and recovery.  

Substance use disorder (SUD) and opioid use disorder (OUD) are chronic diseases. Treatment unfortunately has focused on psychological and emotional support but leaves out the physical aspects of treatment, the pharmaceutical intervention.  You have identified the problem iPill is trying to solve. 

In hospitals, opioids are triple locked yet these same opioids are sent home with patients without similar safeguards.  Combining psychological/emotional support therapy with secure storage, active control dispensing, and destruction of unused pills on tampering and prescription end,extends the safety of opioid from the hospital to the home.

At this time iPill is not for sale to the general public.  We are conducting a feasibility, usability, and acceptance human factor study in Q3-4 2021.  We will likely be market launching shortly thereafter.

Regarding the surgery, talk to your orthopedic surgeon as soon as possible so he can contact the anesthesiologist to address your concerns.  There are predications that can be given to reduce postop pain and reduce the use of opioids.  Intraoperatively the orthopedic surgeon can inject long acting local anesthetics to the posterior capsule and the anesthesiologist can place a regional pain block (femoral + sciatic or adductor canal block).  Postop ice and a continuous passive motion (CPM) device can be used to encourage early ambulation which can improve pain and speed recovery.

The psychologic preparation for pain postop is in education.  I reassure patients that the knee replacement surgeries enable return to better function in the long run.  There will be pain, and possibly lots of pain.  It willl be for a short period of time for long term gain. Patients sometimes tell me that with this uderstanding, they were better able to tolerate the postop pain knowing what to expect preoperatively.

Again postoperatively it will hurt.   Early ambulation will reduce pain. Adhering to the physicial therapy regimen will not only reduce pain but improve range of motion to ensure a successful surgical outcome.  Elevation of the operative side combined with an activity to distract from the pain is extremely important emotionally. Watching movies is a great alternative.   Good nutrition is very important for healing. Good luck

Thank you 

John Hsu MD




The need for the iPill continues to grow

about 1 year ago

The need for the iPill continues to grow. Drug overdose deaths have surged during the Covid-19 pandemic, with provisional CDC data predicting over 88,000 overdose deaths from September 2019 through August 2020, a 27 percent increase from the prior 12-month period. https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm#dashboard

FDA approves higher dose naloxone nasal spray for treating opioid overdose.https://www.healio.com/news/psychiatry/20210430/fda-approves-higher-dose-naloxone-nasal-spray-for-treating-opioid-overdose

The opioid overdose is over 20 years old and if we continue to treat the symptoms and not one of the causes more people will continue to dies

"We lost 88,000 people in the 12-month period ending in August 2020," Regina LaBelle told reporters during a morning briefing. "Illicitly manufactured fentanyl and synthetic opioids are the primary drivers of this increase."

We must not forget the 41 people who die a day from prescription opioid overdoses. https://www.cdc.gov/drugoverdose/data/analysis.html

86% of Heroin addicts report 1st abusing prescription opioids as teens. https://www.drugabuse.gov/publications/research-reports/relationship-between-prescription-drug-heroin-abuse/prescription-opioid-use-risk-factor-heroin-use.

iPill is trying to reduce the risk of misuse.

if you don't believe me please see this message that was emailed to me:

I am having knee replacement surgery. I have been sober for 2 years and am looking for pain medication distribution options that are timed and locked: I have had issues with pain meds and alcohol. Thanks for any ideas or assistance you might have available.

Can the DEA mandate the iPill like the child resistant cap from 1967

about 1 year ago

We have reached out to the DEA and have a call next week to present the iPill.

9.8 million opioid units lost 2018and 6.8 million units lost 2019. https://www.dea.gov/sites/default/files/2018-11/DIR-032-18%202018%20NDTA%20final%20low%20resolution.pdf

iPill destroys unused pills after the prescription term ends so they can't be accidentally ingested or stolen.


Notice of Material Change in Offering

about 1 year ago

[The following is an automated notice from the StartEngine team].

Hello! Recently, a change was made to the iPill offering. Here's an excerpt describing the specifics of the change:


iPill has extended their campaign and updated their financials


When live offerings undergo changes like these on StartEngine, the SEC requires that certain investments be reconfirmed. If your investment requires reconfirmation, you will be contacted by StartEngine via email with further instructions.

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