SnooZeal Award Write Up

2017 European Sleep Apnea TherapiesNew Product Innovation Award

BEST PRACTICES RESEARCH

© Frost & Sullivan 2017 2 “We Accelerate Growth”

Contents

Background and Company Performance ........................................................................ 3

Industry Challenges .............................................................................................. 3

New Product Attributes and Customer Impact .......................................................... 4

Conclusion........................................................................................................... 7

Significance of New Product Innovation ......................................................................... 7

Understanding New Product Innovation ......................................................................... 7

Key Benchmarking Criteria .................................................................................... 8

New Product Attributes ......................................................................................... 8

Customer Impact ................................................................................................. 8

The Intersection between 360-Degree Research and Best Practices Awards ....................... 9

Research Methodology .......................................................................................... 9

Best Practices Recognition: 10 Steps to Researching, Identifying, and Recognizing Best Practices ................................................................................................................. 10

About Frost & Sullivan .............................................................................................. 11



Background and Company Performance

Industry Challenges

Sleep Disordered breathing is a category of medical conditions associated with breathing

difficulties during sleep. Sleep apnea is a condition in which breathing is briefly and

repeatedly interrupted during sleep (these interruptions last longer than 10 seconds). This

condition is due to collapse of the airway, most commonly attributed to loss of muscle

tone in the throat during sleep where breathing becomes restricted. Over 100 million

people worldwide are affected by this sleeping disorder, 80% of which are undiagnosed or

untreated during the course of their lifetime (Source: World Health Organization). While

the condition’s prevalence is vaguely defined by leading global health organizations,

sleeping disorders is estimated to affect almost 30% of men and 20% of women

worldwide. The good news is that these disorders can be managed.

Four major treatment options are widely prescribed for this sleeping disorder. Non-

invasive treatment options include the current gold standard of the continuous positive

airway pressure (CPAP), automatic positive airway pressure (APAP), and the use of a

custom-fitted mandibular repositioning device (MRD) prescribed to patients with severe

sleep apnea. Other treatment options prescribed for patients with severe sleep apnea

include invasive surgical procedures that could increase the risk of negative side effects

difficulties in swallowing, bleeding, and respiratory compromise just to name a few.

Lifestyle modifications, exercises, and therapies to lose excess weight have been clinically

demonstrated to alleviate the symptoms of sleep apnea.

Over the past decade, demand for collaborative care and connectivity have driven the

commercial adoption of a range of non-invasive therapeutic options. All non-invasive

treatment options for snoring and sleep apnea, rely on stenting one or more parts of the

breathing passage. Further, all therapies require patients to use them during sleep, adding

to the discomfort of an unnatural device affecting natural breathing patterns. While

physicians widely prescribe commercially available non-invasive therapeutic devices (i.e.

CPAP, MRD), compliance and continued use remain a difficult challenge as up to 50% non-

compliance due to a poor night's sleep or discomfort.

The magnitude of challenges associated with most commercially available therapies for

sleep apnea significantly impact patient compliance, negatively impacting the patient’s

quality of life and sleep in some way or another. Over the last 20 years, this industry has

seen no new therapy options other than improvements in the hardware and software of

the pre-existing treatment options mentioned above. Market demand is huge for

innovative medical therapies for sleep apnea that are clinically proven to be safe and

effective and that exponentially improve patient compliance to these therapies.



New Product Attributes and Customer Impact

Match to Needs of Sleep Apnea Patients

Most anti-snoring products prescribed to sleep apnea patients require regular use during

sleep, throughout the duration of therapy. Recently, newer implanted technologies have

been introduced involving electrical stimulation of the tongue nerves, thus stimulating the

collapsing muscles during periods of obstruction. Despite large-scale commercial

availability, adoption of these therapies by most physicians and patients has been limited

due the need for surgical implantation and associated complications and side effects in the

form of repeat procedures to replace batteries, periodic modulation of treatment

parameters, and bodily resistance to externally implanted devices.

Conversely, compared to commercially available anti-snoring therapies that are widely

prescribed as viable treatment options for sleep apnea patients, SnooZeal’s anti-snoring

product reverses the over relaxation of the tongue muscles, thereby relieving snoring

within a time span of less than six weeks. SnooZeal redefines most commercially

prescribed therapies for sleep apnea by offering the only product in the European market

available for use as a therapy during waking hours. Further, with recent CE-marking

approval, SnooZeal is available over-the-counter (OTC) as a clinically safe and effective

alternative for treating sleep apnea. The product is going through the FDA process and will

soon be available in the US as well.

Reliable Therapy for Snoring and Sleep Apnea

As an OTC medical device, SnooZeal is one of the most accessible anti-snoring products

available in the market. Ease of access for this anti-snoring therapy is significantly

enhanced by its simple yet clinically accepted principle of electrically stimulating the

tongue muscles, offering adequate training to over-relaxed muscles. Sleep apnea therapy

using SnooZeal involves wearing a mouthpiece twice a day, with each session spanning a

minimum duration of 20 minutes. The entire therapy duration spans over a period of 6

weeks, which has been clinically demonstrated to be an effective window for treating

various stages of sleep apnea.

In addition, the device is designed to accommodate the treatment needs of patients

suffering from various degrees of sleep disordered breathingby optimizing treatment

parameters. Most therapeutic devices prescribed for snoring necessitate use during sleep,

whereas SnooZeal is designed to be used when the patient is awake. Thus, SnooZeal

offers more convenience to patients as well as a high level of adherence to the therapy.

SnooZeal anti-snoring therapy helps patients consciously correct their symptoms, which is

clinically demonstrated to be more effective that therapies that are delivered when

unconscious. SnooZeal is the only therapeutic option to date aimed at reversing the cause

of this condition, rather than simply "splinting" the condition.



Features an Innovative Design

One of SnooZeal’s most innovative features is its simple design, which is clinically

demonstrated to be safe and effective in treating various stages of sleep apnea. SnooZeal

has 3 components: a wearable mouthpiece designed in the form of a glove that fits onto

the tongue, a rechargeable control unit attached to the mouthpiece through a mini-USB

connection, and a remote control unit and a smartphone app to manage various treatment

parameters that are ideal for patients.

During product development, SnooZeal's team worked with various dentists and

maxillofacial surgeons in designing the mouthpiece that is flexible enough to cover and fit

various tongue sizes adequately. The company evaluated 132 sleep apnea patients,

spanning various ages and diverse ethnographies, to design an ideal mouthpiece that best

fits sleep apnea patients.

Compared to anti-snoring products in the market, SnooZeal's simple design, ease of

therapeutic use, enhanced mobile connectivity, and better collaboration with care

providers during the therapy contribute to the product’s innovative design.

Enhances Value of Care Offered to Patients

A major challenge facing the European market for OSA therapies include lack of

adequately qualified and experienced care providers (e.g., pulmonologists and

otolaryngologists) who can diagnose the disease in a timely manner. Other factors include

poor compliance to CPAP therapies and side effects of surgical therapies that often that

can often slip in their efficacy with the pass of time..

Designed to address both sleep apnea and snoring, SnooZeal is positioned to demonstrate

superior value of care to patients. Moreover, the OTC price at which SnooZeal is offered to

patients makes the product the only one in the European market that provides more

clinical safety and effectiveness at a reasonable cost.

Positive Experience throughout the Product’s Lifecycle

Unlike most commercial medical devices available in the European market for treating

sleep apnea and snoring disorders, SnooZeal is designed to prevent the root causes of

these disorders. Most anti-snoring therapies are designed for continuous use during sleep,

which adds discomfort and effect on normal sleep architecture. On the other hand,

SnooZeal can be used at the patient's convenience during waking hours, improving quality

of life. Compared to current prescription-based sleep apnea products, SnooZeal is

available as an OTC product across various medical supply channels, adding more ease of

access to the therapy.

Clinical safety and efficiency are critical to the wide-scale adoption of therapies for chronic

lifestyle disorders. SnooZeal is one of the companies in the European healthcare market

that has garnered a high level of commitment in demonstrating clinical success of its new



product. The company has conducted rigorous trials in identifying absolute stimulation

parameters, achieving clinical effectiveness. Designed by well-qualified and reputed

physicians, SnooZeal is an innovative product that offers better clinical outcomes within a

reasonable time span and elevates patients’ positive experience every time they use the

product.

Positive View of the Brand

SnooZeal has demonstrated phenomenal success in extending the benefits of an

innovative and clinically effective therapy in Europe for patients suffering from snoring and

sleep apnea. Within a year of its inception, SnooZeal managed to receive commercial

approval from the European healthcare authorities to offer its product OTC across more

reliable care facilities. Because of the product’s OTC status, the company continues to

pioneer market innovation by offering its products through other retail and online

channels, building a clear competitive advantage in terms of early market access.

In addition to garnering significant commitment from globally reputed investors, SnooZeal

continues to build strong ties with strategic partners in the European healthcare market.

Another critical factor for SnooZeal as an early market success is its team of clinical

professionals that include senior researchers and globally reputed practitioners in the field

of otolaryngology, head/neck surgery, sleep medicine, reconstructive prosthetics, and

medical engineering. As an ISO 13485-certified organization, SnooZeal retains its status

to commit to the medical community's quality requirements from medical device

manufacturers. SnooZeal's commitment to the clinical success of its therapy is evident as

the company continues with the pre-market launch across influential teaching hospitals

worldwide, such as the University College Hospital in London and Harvard Medical School.

With the recent CE-approval to distribute its innovative therapy within the EU and the high

level of commitment from its strategic partners, SnooZeal aims to offer its products

(across both retail and online channels) in the United Kingdom, Germany, Switzerland,

France, and other major EU economies in the near future. Considering its current growth

plans, SnooZeal is best positioned to net revenues upwards of £50 million by 2018

(Source: Frost & Sullivan), mostly within the EU alone, offering an exponential increase in

annualized yield in investment returns. At a total addressable market opportunity of £18

billion, the market potential for a clinically proven product such as SnooZeal is

significantly higher than most other products in the market today.

Considering its product value and market potential, SnooZeal is positioned to be a

valuable competitor in the European market for sleep apnea therapies. With plans to

expand its market across emerging economies such as Russia, Mexico, India, China,

Canada, and Brazil, SnooZeal's net value could cross most innovative medical device

companies in the European market, building exponentially on its local brand equity in the

near future.



Conclusion

Frost & Sullivan sees SnooZeal as an extremely innovative product that intelligently

addresses the root causes of sleep apnea by training the muscles of the tongue through a

clinically proven concept of continuous transmucosal electrical stimulation therapy.

Designed to be used during waking hours and with its demonstrated clinical value,

SnooZeal is positioned as a unique and innovative therapy for sleep apnea patients in the

European market. Because of its strong overall performance, SnooZeal is recognized with

Frost & Sullivan’s 2017 New Product Innovation Award.

Significance of New Product Innovation

Ultimately, growth in any organization depends upon continually introducing new products

to the market, and successfully commercializing those products. For these dual goals to

occur, a company must be best-in-class in three key areas: understanding demand,

nurturing the brand, and differentiating from the competition.

Understanding New Product Innovation

Innovation is about finding a productive outlet for creativity—for consistently translating

ideas into high quality products that have a profound impact on the customer.



Key Benchmarking Criteria

For the New Product Innovation Award, Frost & Sullivan analysts independently evaluated

two key factors— New Product Attributes and Customer Impact—according to the criteria

identified below.

New Product Attributes

Criterion 1: Match to Needs

Requirement: Customer needs directly influence and inspire the product’s design and

positioning

Criterion 2: Reliability

Requirement: The product consistently meets or exceeds customer expectations for

consistent performance during its entire life cycle

Criterion 3: Quality

Requirement: Product offers best-in-class quality, with a full complement of features and

functionality

Criterion 4: Positioning

Requirement: The product serves a unique, unmet need that competitors cannot easily

replicate

Criterion 5: Design

Requirement: The product features an innovative design, enhancing both visual appeal

and ease of use

Customer Impact

Criterion 1: Price/Performance Value

Requirement: Products or services offer the best value for the price, compared to similar

offerings in the market

Criterion 2: Customer Purchase Experience

Requirement: Customers feel like they are buying the most optimal solution that

addresses both their unique needs and their unique constraints

Criterion 3: Customer Ownership Experience

Requirement: Customers are proud to own the company’s product or service, and have a

positive experience throughout the life of the product or service

Criterion 4: Customer Service Experience

Requirement: Customer service is accessible, fast, stress-free, and of high quality

Criterion 5: Brand Equity

Requirement: Customers have a positive view of the brand and exhibit high brand loyalty



The Intersection between 360-Degree Research and Best

Practices Awards

Research Methodology

Frost & Sullivan’s 360-degree research

methodology represents the analytical

rigor of our research process. It offers a

360-degree-view of industry challenges,

trends, and issues by integrating all 7 of

Frost & Sullivan's research methodologies.

Too often, companies make important

growth decisions based on a narrow

understanding of their environment,

leading to errors of both omission and

commission. Successful growth strategies

are founded on a thorough understanding

of market, technical, economic, financial,

customer, best practices, and demographic

analyses. The integration of these research

disciplines into the 360-degree research

methodology provides an evaluation

platform for benchmarking industry

players and for identifying those performing at best-in-class levels.

360-DEGREE RESEARCH: SEEING ORDER IN

THE CHAOS



Best Practices Recognition: 10 Steps to Researching,

Identifying, and Recognizing Best Practices

Frost & Sullivan Awards follow a 10-step process to evaluate Award candidates and assess

their fit with select best practice criteria. The reputation and integrity of the Awards are

based on close adherence to this process.

STEP OBJECTIVE KEY ACTIVITIES OUTPUT

1 Monitor, target, and screen

Identify award recipient candidates from around the globe

• Conduct in-depth industry research

• Identify emerging sectors • Scan multiple geographies

Pipeline of candidates who potentially meet all best-practice criteria

2 Perform 360-degree research

Perform comprehensive, 360-degree research on all candidates in the pipeline

• Interview thought leaders and industry practitioners

• Assess candidates’ fit with best-practice criteria

• Rank all candidates

Matrix positioning all candidates’ performance relative to one another

3

Invite thought leadership in best practices

Perform in-depth examination of all candidates

• Confirm best-practice criteria • Examine eligibility of all candidates

• Identify any information gaps

Detailed profiles of all ranked candidates

4

Initiate research director review

Conduct an unbiased evaluation of all candidate profiles

• Brainstorm ranking options • Invite multiple perspectives on candidates’ performance

• Update candidate profiles

Final prioritization of all eligible candidates and companion best-practice positioning paper

5

Assemble panel of industry experts

Present findings to an expert panel of industry thought leaders

• Share findings • Strengthen cases for candidate eligibility

• Prioritize candidates

Refined list of prioritized award candidates

6

Conduct global industry review

Build consensus on award candidates’ eligibility

• Hold global team meeting to review all candidates

• Pressure-test fit with criteria • Confirm inclusion of all eligible candidates

Final list of eligible award candidates, representing success stories worldwide

7 Perform quality check

Develop official award consideration materials

• Perform final performance benchmarking activities

• Write nominations • Perform quality review

High-quality, accurate, and creative presentation of nominees’ successes

8

Reconnect with panel of industry experts

Finalize the selection of the best-practice award recipient

• Review analysis with panel • Build consensus • Select winner

Decision on which company performs best against all best-practice criteria

9 Communicate recognition

Inform award recipient of award recognition

• Present award to the CEO • Inspire the organization for continued success

• Celebrate the recipient’s performance

Announcement of award and plan for how recipient can use the award to enhance the brand

10 Take strategic action

Upon licensing, company may share award news with stakeholders and customers

• Coordinate media outreach • Design a marketing plan • Assess award’s role in future strategic planning

Widespread awareness of recipient’s award status among investors, media personnel, and employees



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SnooZeal Award Write Up

Health & Medicine

Transcript of SnooZeal Award Write Up