Item 1. Business
Company’s History
Wearable Health Solutions,
Inc. (Formerly known as Medical Alarm Concepts Holding, Inc.) (the "Company" or "Wearable Health") was formed
in June 2008 and, on June 24, 2008. The Company acquired 100% of the membership interests in Medical Alarm Concepts, LLC, a Delaware
limited liability corporation.
The principal executive
offices of the Company are located at 200 West Church Road, Suite B, King of Prussia, PA 19406.
Company Overview
The Company manufactures
medical alarm devices that are used to summon help in the event of an emergency. While these devices are primarily designed for
the elderly, there is also a market for those who are physically disabled, as well as for persons living alone.
The Company was organized
in mid-2008. The operation was financed with a considerable amount of toxic convertible debt. This type of financing, along with
several other issues, prevented the Company from realizing a robust growth rate for its first few years of operation. Since that
time, considerable management time has been spent and investor money utilized to turn the Company's operation around.
Our flagship product
is called the MediPendant®, which is a personal emergency alarm that is used to summon help in the event of an emergency at
home. Currently, approximately 60% of all medical alarms being sold in the United States are first-generation technologies that
require the user to speak and listen through a central base station unit. The MediPendant®, however, offers a product that
has the speaker in the pendant, enabling the user to simply speak and listen directly through the pendant in the event of an emergency.
The Company also manufacture
the iHelp™ mobile medical alarm device. The iHelp™ is a next- generation medical alarm that utilizes T-Mobile's 2G
network. Users of the iHelp™ mobile medical alarm can take the device with them wherever there is cellular service. There
is no base station and the iHelp™ only requires a cellular signal in order to work.
The company has invested
time, manpower, and money into the development of this product. On September 30, 2014, the company signed an agreement for a $300,000
line of credit to enable it to launch the iHelp™, and to build the infrastructure that allowed the Company to buy and track
air time from T-Mobile for cellular operation of this unit. The credit line was increased to $500,000 in January 2015. The iHelp™
has enhanced features and functions including an advanced GPS system, the ability to remotely locate a loved one, and a dealer
portal that enables dealers to manage their own iHelp™ customer base. A significant amount of time was spent on the backend
systems, including the dealer portal. iHelp™ dealers have significant benefits, most importantly the ease of use in ordering
product, activating and deactivating customers, tracking their customer usage, and creating and printing a variety of reports
to assist in billing and collecting revenues. The iHelp™ dealer program is a turn-key program that offers the dealer the
opportunity to provide his/her customers with the latest products without having to change his/her own backend.
We are in the process
of discontinuing the iHelp™ and implementing a new product called the iHelp+ 3G™. The iHelp+ 3G™ is a cellular
medical alert system that operates on a 3G network. In March 2016 and May 2016 the company raised an additional $612,500 and $425,000
to further develop the 3G product. Initially, it will be operating on the AT&T network (GSM - Global), and ultimately it will
be able to operate on the Verizon (CDMA - USA) network as well. It is Bluetooth and Wi-Fi enabled. It has a much broader reach
than the iHelp™, as well as additional functions, such as fall detection and geo-fencing (ability to pre-set an area and
alert loved ones if the user leaves or enters the pre-set area). As of this date we have gained FCC, CE, and PTCRB approval. Expected
product launch date is now Dec 2016.
It is planned
that by the end of 2017 the iHelp+3G™ will be used as the communication device for Low Energy Bluetooth 4.0-enabled
devices, and used for collecting and sending vital sign data, in any requested manner, to encrypted HIPAA-compliant cloud
servers for access by proper parties.
New Product
Development
The design and development
of wearable 'biosensor' devices, such as the iHelp+3G™ for health and wellness, has garnered much attention in the public
and healthcare community during the last few years. This is primarily motivated by increasing healthcare costs and propelled by
recent technology advances in miniature bio-sensing devices, micro-computing technology, and wireless communications. The advance
of wearable sensor-based systems will potentially transform the future of "telehealth", personal emergency response
(PERS, mPERS) and remote monitoring, by enabling ubiquitous, convenient-to-use, cost-effective and proactive personal health management
with real and near real-time monitoring and archiving of personal safety, health, and environmental conditions.
Beyond the recent emergence
of smart mobile wireless and geographic location solutions, these systems will integrate via Bluetooth low energy 4.0 and other
technologies with FDA approved medical devices and biosensors. The Company will be able to collect data on vital signs, send this
data to HIPAA compliant servers in the cloud, and allow access by caregivers, nurses, doctors, hospitals, and other health organizations.
This process can facilitate low- monthly-cost wearable solutions for the implementation of monitoring of users, all day and anywhere,
for emergency, health, and activity status changes. This evolution will change the face of the traditional PERS device into a
WHAM (Wearable Health& Alarm Monitoring) market.
Market Background
Living arrangements
have changed greatly in the United States among older people and other potentially vulnerable segments of the population, including
those with physical disabilities and/or medical conditions. During the 20th century, one of the most dramatic changes in the lives
of the aging in the United States was the rise of the number of aging people living at home alone. In 1910, for example, only
12% of widows age 65 or older lived alone. In 1970, this figure was 70% and today it is estimated to be impressively higher.
In the 21st century,
this trend has gained momentum and become stronger than ever, with more of the aging and medically at risk population living alone
at present than at any other time in the past, especially with the rise of the aging Baby Boomer population. The Baby Boomers,
those born between 1946 and 1964, started turning 65 years old in 2011, with the number of older people set to increase dramatically
during the 2010 to 2030 time period. According to a 2009 analysis of U.S. Current Population Survey data, "between 2010 and
2030, the number of people age 65 and older is projected to grow by 31.7 million or 79.2%." Thus, the older population in
2030 is projected to be twice as large as in 2000, growing from 35 million to 71.5 million, representing 20% of the total U.S.
population around the year 2030.
This social dynamic
of a rising older population is true in both the United States as well as in many developed nations worldwide. Likewise, social
change, technological advancements, and general lifestyle choices have promoted increased independence and the ability to live
alone among other potentially vulnerable segments of the population such as those with physical disabilities or medical conditions.
These groups can be especially susceptible to health problems and concerns for their physical wellbeing. Experts and even common
sense agree that in order to help facilitate independence and safety, more help is needed to provide these people with a point
of contact in case of emergency, or the benefit of support in a time of need. It was in response to this situation that the personal
emergency response systems (PERS) industry emerged in the United States and developed the first personal medical alarm. The most
obvious and common use for personal medical alarms is as a safeguard for the aged and persons with certain medical conditions,
in case of an age or health related incident that requires immediate attention, and in which the victim is unable to reach out
for assistance via traditional means, including the ability to make a telephone call.
Effective personal
emergency response systems with their emergency alert capabilities, are a key technology solution that can greatly help the vulnerable
segment of the population live a more free and active life while maintaining the security of being able to access immediate assistance
as needed. In fact, there has been a boom in the PERS market in recent years because of the growing aging population worldwide.
According to Forrester Research, Inc., the PERS market in the United States has grown at double digit rates, from approximately
$350 million in 2004 to $2 billion in 2012 and increasing every year thereafter.
Today, however, while
the PERS industry has been around for a long time, much of the technology within the industry has unfortunately remained stagnant.
Many of the original PERS solutions are still designed today to provide alerts whereby a push of a button simply triggers a call
center operator to respond by calling the device user at home, with two-way voice communication done through a centralized speaker
box and not the actual device itself. Thus, traditional PERS solutions currently on the market offer communication between user
and a call center only through a speaker box. This greatly inhibits the user's freedom and limits their mobility to an area near
the speaker box.
Mobile medical alerts
have recently been introduced to the market. They are designed for the younger and more active person with medical issues, and
also the active elderly adult.
And with the emergence
of telehealth and biosensor technology, the market is changing again, to an even younger people with medical issues that need
to be tracked on a regular basis.
Wearable Health Solutions
offers a wide range of solutions for the user from a simple at home medical alarm to a mobile device that enables the user to
get help anywhere they go. With the introduction of the telehealth product by the end of 2017, users will be able to get help,
before they even know they need it.
Market Opportunity
The healthcare industry
is the largest industry in the world, with the home healthcare market in developed countries in particular growing rapidly, driven
in part by aging baby boomers and a growing shift toward moving some types of healthcare away from the hospital and into the home.
These trends help make
the home healthcare sector an increasingly attractive market for successful companies that offer effective solutions in the PERS
industry space. The most obvious and common use for personal medical alarms is as a safeguard for the aged and persons with certain
medical conditions, not only in case of an age or health related incident that requires immediate attention, but in which the
victim is unable to reach out for assistance via traditional means, including the placement of a telephone call. While very few
things can prevent falls by aged persons or other unforeseen medical emergencies, medical alarms mitigate the potential harm and
expensive hospital stays done by initiating a timely response to such an incident. And tracking devices, like the iHelp+3G™
for wearable biosensors will be able to monitor people with pre-existing conditions.
In fact, there has
been a boom in the PERS market in recent years because of the growing aging population worldwide and in the United States in particular.
According to the U.S. Census Bureau, the number of people over 65 in the United States is set to jump from approximately 34 million
today to approximately 65 million in 2025. By 2050, this number is projected to reach 86.7 million, with many of them living at
home or in an alternative home-type environment. Worldwide, this figure number is expected to double from some 550 million people
currently at age 65 years old to over 1.2 billion seniors by the time period around the year 2025.
Not surprisingly, experts
in the health care industry expect many of these seniors will want to continue living independently at home for as long as possible.
Likewise, more than any aging generation of the past, this population is expected to be more technology-savvy as consumers of
healthcare are very interested in playing an active role in personally managing their health and well-being. Importantly, they
will likely look to technologies that help them gain access to medical care while being able to remain independent and outside
a hospital environment.
Effective personal
emergency response systems (PERS), with their emergency alert capabilities, are a key technology solution that can greatly help
the vulnerable segment of the population live a more free and active life while maintaining the security of being able to access
immediate assistance as needed. According to Forrester Research, Inc., the PERS market in the United States has grown at double
digit rates, from approximately $350 million in 2004 to $2 billion in 2012 and increasing every year thereafter.
According to statistics
from some of the industry's largest providers of traditional PERS solutions, customers of these emergency alert systems are typically
individuals over the age of 75 years old whom are predominantly female and live alone, with the actual buyers of PERS systems
often being the end user's children who purchase the medical alarms for their parents.
Regarding purchases
of PERS solutions worldwide, the large majority of customers currently pay for their PERS products out-of-pocket, with government
reimbursement for PERS items varying from country to country. In the United States, for example, 25% of PERS sales were government
reimbursed in 2004, compared to 35% in Germany, just over 50% in France and nearly 100% in the United Kingdom. Furthermore, it
is estimated government reimbursement for PERS will ramp up in a number of countries, further fueling demand for these products.
Interestingly, as an
approximation of the potential PERS market size in the United States, Lifeline Systems, Inc., the founder of the PERS industry
in the U.S. approximately 35 years ago, served 250,000 users in the United States and Canada around the time frame of 1992. Today,
Philips Medical Systems' acquisition of Lifeline Medical Alarm has positioned it as the largest provider of traditional PERS systems
with over 700,000 monitored accounts, implying that the total market size of users is likely much larger.
Sales and
Marketing
The
company's marketing efforts are focused in four main areas
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i.
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Internet sales & marketing,
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iii.
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wholesale distribution and
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iv.
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International markets.
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1) Internet Sales & Marketing
The Company markets the MediPendant®
through its website at www.MediPendant.com and its iHelp™ mobile medical alarm to dealers at www.ihelpalarm.com. Due to the
complex sales process for medical alarms, which often require several phone calls among the end user customer's family members
before a decision is reached, the MediPendant® and iHelp™ websites are used mainly for informational purposes with the
actual sale typically taking place over the phone with one of our customer service representatives or one of our many dealers.
The company uses a variety of techniques, such as Internet paid ad campaigns and social media, in order to drive web traffic to
the websites, and initiate potential customer sales calls.
2) Retail Distribution
During 2012, the company announced
its plans to promote the MediPendant® product utilizing an e-commerce marketing strategy program designed specifically for
Costco Wholesale Corporation and its members. Costco began offering the MediPendant® to its customers via its website during
the spring of 2012.
3) Wholesale Distribution
The Company currently has
several relationships with wholesalers who resell the MediPendant® and the iHelp™ in conjunction with their own monitoring
services. The company believes its relationships with its strategic partners is good. The company is currently in discussions with
several other wholesale groups looking to distribute our products through their own independent channels. With the introduction
of the iHelp+ 3G™, Wearable Health Solutions will be selling only through Wholesale Distribution and in International Markets.
4) International Markets
The Company also distributes
its products in a wholesale manner to selected international markets. To date, the company has made sales in Denmark, Ireland,
Bermuda, and the People's Republic of China. There has recently been a lot of International interest in the company's new iHelp+
3G™, and the company plans to distribute its product initially in Canada and Europe, and expand from there.
Competition
The market for Personal
Emergency Response Systems (PERS) is highly fragmented. Because the vast majority of the market participants are private corporations,
only limited information about competitors is available.
The vast majority
of competitors market first generation PERS systems that rely on a centralized base station for communication between the
user and the monitoring center. The second largest of these market participants is believed to be Life Alert, which was
founded in 1987. The largest participant is thought to be Philips Medical Systems, which several years ago purchased Lifeline
Medical Alarms. Additionally, there are dozens of smaller organizations marketing PERS devices and monitoring services.
Mobile Medical Alerts have recently been introduced to the market. They are designed for the younger and more active person
with medical issues and also the active elderly adult.
Termination of Patent
Purchase Agreement and New Patent Licensing Agreement
On July 10, 2008, the
Company entered into a Purchase Agreement and Patent Assignment Agreement (the "Agreement") effective July 31, 2008.
The Company was obligated to pay the seller $2,500,000 on June 30, 2012. The Agreement specifies interest of 6% payable monthly,
commencing on July 31, 2008. The seller had the right to reacquire all patents and applications if payment was not made on June
30, 2012; however, this agreement has been extended quarterly since June 30, 2012. The patent purchase agreement refers to patent
#RE41845 and RE41392. The scope of the patents are as follows: A personal emergency communication system includes a user-carried
portable communication unit having a single button, which when depressed by the user, wirelessly sends a call request signal to
a base unit. The base unit initiates a telephone call through a dial-up network to an emergency response center and places an
operator at the emergency center responder in wireless voice communication with the portable unit when the call is connected.
The telephone number to be called can be stored in at least one of the portable unit and the base unit. A speech synthesizer operating
in combination with automated voice messages stored in at least one of the base unit and portable unit system memory are used
to advise the user of the status of the call, and to provide the user with verbal confirmation that functional systems of the
base unit are operating properly.
In June 2015, the
Company made a decision to terminate its patent agreement with Nevin Jenkins, the patent holder. Mr. Jenkins and the Company
agreed to a new revised licensing agreement whereby the company still has the ability to order and sell product utilizing the
patent. The company feels that the old agreement was too costly, and money would be better served based on its decision of
investing in more cellular type mPERS devices. Its new agreement with Mr. Jenkins will enable the Company to continue selling
the MediPendant® based on a cost plus structure.
Products
The Company's primary focus
is the sale of its medical alarm and safety alert devices, which are some of the most advanced systems on the market today.
a) MediPendant®
MediPendant® is
the Company's traditional medical alarm product and the world's first monitored two-way voice speakerphone pendant for the PERS
(personal emergency response) industry. It allows the user to speak and listen to the operator directly through the pendant. Wearable
Health Solutions' alarm pendant also offers superior range radio frequency capabilities and an enhanced communication range that
enable the user to move freely in and about the home, including up to an extended range that is revolutionary in the PERS industry.
Specifically, the MediPendant® system enables the device wearer to move up to 600+ feet (line of sight) away from the main
base station, a distance that far exceeds competitive offerings on the market today that instead require the user to be within
speaking distance of the base station box, a situation that may not be conducive to an emergency if the end user is not at the
base station.
As part of the MediPendant®
product offering, users receive Wearable Health Solutions' two- way communication pendant, base station unit and a subscription
to the Company's around- the-clock personal response service monitoring center.
Emergency calls
made through the Company's MediPendant® device are always handled by certified operators who are available around the
clock 24-hours a day and guaranteed to remain on the line with MediPendant® subscribers until the problem is resolved
and/or help arrives. Operators are trained to immediately assess the situation and can either connect the caller to a
loved-one or dispatch medical personnel to the user's location. All emergency operators are prepared to bring calm,
professional, knowledgeable insight to any situation. Additionally, the call center can also maintain an important list of
personal information for all MediPendant® users that includes an updated list of medications, health information and the
subscriber's contact information including home address for location and dispatch purposes. This personal information and
medical history are securely stored by the monitoring center and can be provided to the dispatched authority and emergency
responders as necessary.
b) iHelp™
The company recently announced
the launch of a new, advanced medical alarm device called the iHelp™. The iHelp™ is an advanced mobile medical alert
system, designed to be easy to use, lightweight yet durable, but with significantly advanced features. The company has invested
time, manpower, and money into the development and launch of this product. The iHelp™ has enhanced features and functions
including an advanced GPS system, the ability to remotely locate a loved one, voice prompts, and a dealer portal that enables dealers
to manage their own iHelp™ customer base. A significant amount of time was spent on the back end systems, including the dealer
portal. iHelp™ dealers have significant benefits, most importantly the ease of use in ordering product, activating and deactivating
customers, tracking their customer usage, and creating and printing a variety of reports. The iHelp™ dealer program is a
turn-key program that offers the dealer the opportunity to provide his/her customers with the latest products without having to
change his/her own "back end" systems. With the introduction of the new and greatly improved iHelp+ 3G™ unit, the
iHelp™ will no longer be produced.
c) iHelp + ™ 3G
The iHelp+ 3G™ is currently
in the final approval stage and is expected to be available to the marketplace by December 2016. The iHelp+ 3G™ is similar
to the iHelp™ in that it is an mPERS product. However, the iHelp+ 3G™ will have more advanced features and functions,
including the ability to detect if the wearer of the unit falls such as in the shower, have Geo-Fencing and Tracking ability, will
operate on the "3G" networks, and be telehealth enabled via blue tooth low energy 4.0. The unit will have superior audio
quality, an extended battery life, and will operate on GSM networks allowing for use with AT&T providers both domestically
and internationally (with AT&T partners), therefore enabling extended coverage almost anywhere the user may go.