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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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
Saju John Mathew
Team Leader
Technical Insights
+91(0)44.66814116 sajum @frost.com
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Sandhya Kamath
Industry Manager
Technical Insights
(91) 80-67028001
Nicolas Votano
Sales Director
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(212) [email protected]