technology breakthroughs in sleep apnea

Technology Breakthroughs in Sleep ApneaTechnology Breakthroughs in Sleep Apnea

Medical advances to minimize sleep Medical advances to minimize sleep apneaicapneaic risksrisks

Saju John Mathew, Team Leader

Technical Insights

Healthcare – Medical DevicesHealthcare – Medical Devices

21st Nov 2013

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Functional Expertise

• Over 11 years of industry expertise, which includes working in R&D, IT projects and consulting. Particular

expertise in:

- Qualitative technology/product analysis and benchmarking

- Tech tracking across nanotechnology, healthcare, automation and electronics

- Managing and mentoring team members and in charge of quality for deliverables

Industry Expertise

� Experience base covering broad range of sectors under Healthcare and a few sectors under Automation &

Electronics. Maintaining and leveraging long-standing working relationships with leading industry participants’ and

Senior Executives in

- Medical Devices

- Medical Imaging

- Printed Electronics

- Energy Harvesting

Saju John Mathew

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- Energy Harvesting

What I bring to the Team

• Sharp analysis and technical insights

• Ability to handle assignments apart from my core competence

• Strong research background

• Effective communication skills

Career Highlights

• Experience working as a software programmer freelance and under contract.

• Experience working as a researcher with the University of Texas at Arlington, TX, USA

• Providing consult for major players such as ITRI, MFLEX

Education

• M.S. in Bioengineering from University of Texas at Arlington/University of Texas Southwestern Medical Center at

Dallas (Joint Program), Arlington, TX, USA

• B.E. in Instrumentation and Applied Electronics from M.S. Ramaiah Institute of Technology, Bangalore, Karnataka,

India

Saju John MathewTeam Leader

Frost & SullivanTechnical InsightsChennai, India

Focus Points

• Introduction

• Overview

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• Drivers and Challenges

• Technology Roadmap

• Conclusion

Overview of Sleep Apnea

Definition and Technology Background

Sleep apnea can be defined as a group of disorders characterized by

abnormalities of breathing while sleeping. Breathing is interrupted

from a few seconds to minutes, occurring several times over the

course of a routine sleep. When breathing is obstructed, oxygen

levels drop resulting in low supply to the heart and brain.

Most common etiology is adenotonsillar

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Source: Frost & Sullivan

Daytime sleepiness

Slow reflexes

Poor Concentration

Increased risk of accidents

Diabetes

Heart Disease

Stroke

High blood pressure

Weight Gain

Premature Death

Most common etiology is adenotonsillar

hypertrophy. The gold standard evaluation

is overnight polysomnography.

Overview of Sleep Apnea (contd…)

General procedures in a Sleep Lab

PSGs are conducted in sleep labs which are designed to evaluate,

diagnose, treat and help patients to manage OSA. The patient has to

spend the night in the sleep lab, with no sedatives. A sleep

technician measures the nasal air flow of the patient through a nasal

thermistor, in addition to a microphone for recording snoring and,

sensors to the head, face, chest, abdomen and legs.

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Surgeries

Surgical Approach

• Surgery to straighten the nasal septum, remove obstructions and enable better airflow.

Septoplasty

• Enlarged inferior turbinate is reduced either through radio frequency ablation or by sectioning.

Turbinate Surgery

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• Removal of enlarged tonsils and adenoids that block the airway during sleep.

Tonsillectomy and Adenoidectomy

• Tonsils, and parts of the uvula and soft palate are removed allowing more room for airflow.

Uvulopalatopharyngoplasty (UPPP or UP3)

• Providing pillars into the soft palate for support making the palate rigid.

Pillar Procedure

Non-surgical approach

PA

PP

AP

Po

sitiv

e a

irw

ay p

ressu

re

APAPAPAPAdjustable positive airway pressure

The most common sleep apneaalternative, however they suffer

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PA

PP

AP

Po

sitiv

e a

irw

ay p

ressu

re

BIPAPBIPAPBi-level positive airway pressure

CPAPCPAPContinuous positive airway pressure

alternative, however they sufferfrom poor compliance.

TimeC

om

plia

nce

Drivers and Challenges

High Low

2014-2016 2017-2019 2020-2022

Impact:

Change in Lifestyle

Advances in technology

Increasing number of service providers

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Poor compliance

Reimbursement policies

Shortage of qualified personnel

Key Challenges: Low Compliance Over Time

OSA is a chronic disease that requires long term treatment, however, in the US, a staggering 78% ofdiagnosed patients who are recommended to use CPAP do not comply with treatment after 24 months.Although the compliance in Germany and France are much better, with 35% and 62% respectively theyare still very low.

Proportion of Patients Compliant with CPAP Treatment over time

Recommended

CPAP

Trying

CPAP

On CPAP

After 1m

On CPAP

After 3m

On CPAP

After 6m

On CPAP

After 12m

On CPAP

After 24m

US 100% 78% 58% 53% 34% 26% 22%

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Source: Frost & Sullivan analysis.

Base: All physicians: n=46

Q9. Based on your experience, what proportion of your patients refuse using CPAP without even trying? Q15. Based on your experience, what

proportion of your patients is compliant with CPAP therapy as prescribed at the following checkpoints? Q16. Do you usually recommend any

alternative treatment to those patients who refuse continuing with a CPAP device?

US 100% 78% 58% 53% 34% 26% 22%

France 100% 91% 74% 72% 69% 66% 62%

Germany 100% 73% 67% 45% 42% 38% 35%

Key Challenges: Treatment Features to Improve

By large, physicians consider the long term compliance to achieve long term medical impact as the main feature to improvein future sleep apnea treatments. Treatments with a higher efficacy its as highly desired aspect to improve (in the US),increased patient comfort (France and Germany), reduced side effects (Germany) and on-line monitoring (France) are alsounmet needs and as a consequence market opportunities.

Sleep Apnea Treatment Features to Improve

Long Term compliance to achieve long term

medical impact

Increased efficacy of the treatments

Increased comfort of the treatment for the

patients

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Source: Frost & Sullivan analysis.

Base: All physicians: n=46

Q24. Please rank the following treatment features according to their improvement importance in the sleep

apnea market?

USA (n=15)

France (n=15)

Germany (n=16)

Reduced side effects of the treatments

Increased safety of the treatments

Transversal solutions for all patient types (AHI

ranges)

On line / real time compliance monitoring

Real time monitoring of vital signs (oxygen

saturation, etc.)

Less evasive surgical procedures

Alternatives

NeurostimulatorsPatients who refuse CPAP

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AlternativesAlternativesTransOral Robotic Surgery (TORS).Bariatric Surgery Other surgical technologies are to remove the tissues with least amount of blood loss and peripheral damage.

Pharmacological approaches:Increase in tone of the upper airwaysIncrease in ventilatory driveHowever, many side-effects are associated with it.

Recent Developments

Company/University/Organization

Technology/Product and Developments

Nyxoah S. A.(Brussels, Belgium)

A neurostimulator is implanted (15 mins) close to the nerves of the tongue muscle. It measures 20mm high and 2.5mm wide. The implant is 16 times smaller than its competition and has a device life expectancy of 12 years. A disposable patch (placed over the implant) with its own battery powers the implant from its position on the patient’s chin. Recently obtained over 11 patents for their Sleep Apnea Innovative Implant Technology.

Flinders Medical Center

Surgeon repositions tissue in the throat with a treatment that creates channels in the tongue. The new technique takes about 45 mins.

The center did a study of 48 sleep apneic patients where there was significant benefits and the

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(Bedford Park, SA, Australia)

The center did a study of 48 sleep apneic patients where there was significant benefits and the symptoms improving for every patient. The number of pauses in between the breathing of people involved in the study was reduced by 76% and daytime sleepiness was reduced by half.

University of Texas at Arlington (Arlington, TX, USA)

New collar like device wrapped around the patient’s neck to detect if a person suffers from sleep apnea. The device employs ultrasonic sensors; non-audible sound waves are sent across the neck to detect whether the patient’s airway is open to allow airflow to the lungs.

Indian Association of Surgeons for Sleep Apnea (Chennai, TN, India)

Group formed among ENT surgeons for proper diagnosis and to choose proper surgical approach for affected patients. Conducting training workshops, live surgeries, hands on training. Public awareness programs all over India.

Recent Developments

Company/University/Organization

Technology/Product and Developments

The Pure Sleep Company

(Larkspur, CA, USA)

PureSleep Anti-snoring device utilizes mandibular repositioning device (MRD) technique to reduce sleep obstruction. The device is FDA cleared, it holds the lower jaw slightly forward from its normal position eliminating vibrations and hence snoring.The PureSleep includes two different kinds of high-quality plastic; a hard plastic on the outside and a soft plastic on the inside which gives it more structural rigidity making it less bulky and more comfortable.

ApniCure Inc.

Winx Sleep Therapy System, for home use in the treatment of OSA in adults. It uses a proprietary platform technology called Oral Pressure Therapy (OPT) which generates a gentle, negative pressure and holds the tongue and soft palate out of the airway.

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ApniCure Inc. (Redwood City, CA, USA)

negative pressure and holds the tongue and soft palate out of the airway.The system consists of three main components – a small, quiet vacuum console; a soft, flexible mouthpiece; and a slim tubing set. The mouthpiece is worn inside the mouth during sleep and is attached to the console with the tubing set.

Imthera Medical Inc. (San Diego, CA, USA)

The aura6000 Targeted Hypoglossal Neurostimulation (THN) Sleep Therapy System, activates the hypoglossal nerves (HGN) to prevent or reduce OSA episodes. The system is an open loop system comprising of an implanted and external components. The multi-contact electrode, specific to the HGN is connected to the implantable pulse generator via a lead wire. The external component comprises of the patient’s controller, charger and programmer device. It interfaces to the IPG for patient functions and to the physician’s computer for set-up and programming.

Technology Roadmap

Interdisciplinary research and wireless connectivity. Portable devices (wireless, small footprint) which can reduce sleep apnea with minimal inconvenience to the patients.Remote monitoring of sleep to enable data capture and analysis and help health care personnel to develop effective treatment strategies for apneic patients.

Shift to home based diagnostics resulting in early diagnostics and treatment.

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diagnostics and treatment. Cost effective MRDs are extremely beneficial as a near term device for people globally.

2015 20172013 2019

Recommendations

Recommendations

ENT surgeons should participate in the evaluation and management of sleep apneaand must offer home sleep testing and also PAP administration as part of their sleepservices.

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Recommendations and

InsightsAny new device should ideally not have mask like design features to it.

Bring awareness to payors and employers to the long-term economic benefits of screening and treatment.

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For Additional Information

Jennifer Carson

Corporate Communications

Healthcare

(210) 247-2450

[email protected]

Saju John Mathew

Team Leader

Technical Insights

+91(0)44.66814116 sajum @frost.com

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Sandhya Kamath

Industry Manager

Technical Insights

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[email protected]

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technology breakthroughs in sleep apnea

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