Technology Breakthroughs in Sleep Apnea


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• Insight into the sleep apneic industry
• Drivers and restraints of the industry
• Current trends and technology roadmap

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Technology Breakthroughs in Sleep Apnea

  1. 1. Technology Breakthroughs in Sleep Apnea Medical advances to minimize sleep apneaic risks Saju John Mathew, Team Leader Technical Insights Healthcare – Medical Devices 21st Nov 2013 © 2013 Frost & Sullivan. All rights reserved. This document contains highly confidential information and is the sole property of Frost & Sullivan. No part of it may be circulated, quoted, copied or otherwise reproduced without the written approval of Frost & Sullivan.
  2. 2. Saju John Mathew 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 Team Leader Frost & Sullivan Technical Insights Chennai, India 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 2
  3. 3. Focus Points • Introduction • Overview • Drivers and Challenges • Technology Roadmap • Conclusion 3
  4. 4. 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 hypertrophy. The gold standard evaluation is overnight polysomnography. Daytime sleepiness Slow reflexes Poor Concentration Increased risk of accidents Diabetes Heart Disease Stroke High blood pressure Weight Gain Premature Death Source: Frost & Sullivan 4
  5. 5. 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. Source: Frost & Sullivan 5
  6. 6. Surgical Approach Surgeries Septoplasty • Surgery to straighten the nasal septum, remove obstructions and enable better airflow. Turbinate Surgery • Enlarged inferior turbinate is reduced either through radio frequency ablation or by sectioning. Tonsillectomy and Adenoidectomy • Removal of enlarged tonsils and adenoids that block the airway during sleep. Uvulopalatopharyngoplasty (UPPP or UP3) • Tonsils, and parts of the uvula and soft palate are removed allowing more room for airflow. Pillar Procedure • Providing pillars into the soft palate for support making the palate rigid. Source: Frost & Sullivan 6
  7. 7. Non-surgical approach Adjustable positive airway pressure BIPAP The most common sleep apnea alternative, however they suffer from poor compliance. Bi-level positive airway pressure CPAP Continuous positive airway pressure Compliance Positive airway pressure PAP APAP Time Source: Frost & Sullivan 7
  8. 8. Drivers and Challenges Impact: High 2014-2016 Low 2017-2019 2020-2022 Change in Lifestyle Advances in technology Increasing number of service providers Poor compliance Reimbursement policies Shortage of qualified personnel Source: Frost & Sullivan 8
  9. 9. Key Challenges: Low Compliance Over Time OSA is a chronic disease that requires long term treatment, however, in the US, a staggering 78% of diagnosed 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 they are 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% France 100% 91% 74% 72% 69% 66% 62% Germany 100% 73% 67% 45% 42% 38% 35% 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? Source: Frost & Sullivan analysis. 9
  10. 10. 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 improve in 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 also unmet 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 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 USA (n=15) France (n=15) Germany (n=16) Base: All physicians: n=46 Q24. Please rank the following treatment features according to their improvement importance in the sleep apnea market? Source: Frost & Sullivan analysis. 10
  11. 11. Alternatives Neurostimulators Patients who refuse CPAP TransOral Robotic Surgery (TORS). Bariatric Surgery Other surgical technologies are to remove the tissues with least amount of blood loss and peripheral damage. Alternatives Pharmacological approaches: Increase in tone of the upper airways Increase in ventilatory drive However, many side-effects are associated with it. Source: Frost & Sullivan 11
  12. 12. 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 (Bedford Park, SA, Australia) 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 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. Source: Frost & Sullivan 12
  13. 13. 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. (Redwood City, CA, USA) 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. 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. Source: Frost & Sullivan 13
  14. 14. 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. Cost effective MRDs are extremely beneficial as a near term device for people globally. 2013 2015 2017 2019 Source: Frost & Sullivan 14
  15. 15. Recommendations ENT surgeons should participate in the evaluation and management of sleep apnea and must offer home sleep testing and also PAP administration as part of their sleep services. Recommendations and Insights Any 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. Source: Frost & Sullivan 15
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  19. 19. For Additional Information Jennifer Carson Corporate Communications Healthcare (210) 247-2450 Saju John Mathew Team Leader Technical Insights +91(0)44.66814116 sajum Sandhya Kamath Industry Manager Technical Insights (91) 80-67028001 Nicolas Votano Sales Director Technical Insights (212) 402-1813 19