Somnics GmbH

At MEDICA 2021 held at Messe Düsseldorf from November 15 to 18, Somnics Inc., a medical devices maker specializing in sleep breathing disorders, presents to international medical professionals its “iNAP Remote Sleep Management System” and “iNAP Oral Interface I08”, as well as “Omni9 Home Sleep Testing Device” for the tracking of sleep biological data of sleep apnea patients. These are all Somnics’ updated achievements to meet the medical trends in the post-COVID era.

Obstructive sleep apnea (OSA) is a common sleep disorder. Currently, the medical examination of sleep apnea primarily depends on polysomnography (PSG) conducted at a sleep center. Whilst the data collected is comprehensive, there are limitations and insufficiencies. The waiting time for beds in medical institutions is always too long. The test may not be accurate due to interferences such as wires or changes in the sleep environment at the medical center. In addition, sleep tests at medical institutions during the pandemic come with COVID-19 infection risks. Therefore, easy-to-operate at-home sleep testing has become one of the products in high demand in sleep medicine.

Somnics’ “Omni9 Home Sleep Testing Device” is specially designed for sleep apnea patients. It is a signal recorder that detects electrocardiography (ECG), oxygen saturation, nasal inspiratory pressure, and positions. Omni9 is a compact wearable for the chest front or the upper arm. The interface is simple and intuitive so that users can obtain accurate signals at home and establish the true picture of day-to-day sleep. The biological data integrated by Omni9 meets the standards set by the American Academy of Sleep Medicine (AASM). When combined with the iNAP Remote Sleep Management System, the physician will be able to monitor the cloud data and track the progress of the apnea therapy during the patient’s sleep, to provide long-distance instructions and optimize OSA treatment results.

Since the Omni9 prototype was introduced in early 2020, after one year of effort, this product now comes with comprehensive features in diagnosis, treatment, and monitoring for sleep apnea and the next step is to bring this product to the market. Somnics, Inc. hopes to establish cooperative ties with international medical professionals to promote this forward-looking and convenient solution in home sleep testing at the major annual exhibition of MEDICA in Germany.

The 30th Taiwan Excellence Award recently announced the winners from a long list of candidates. Somnics, Inc. won its third Taiwan Excellence Award for the new generation iNAP Oral Interface I08, an accessory for the OSA (obstructive sleep apnea) treatment device iNAP Sleep Therapy System. This is the acknowledgment of the company’s R&D and manufacturing capability and the encouragement for continued innovation to meet the market’s unmet needs.

The Taiwan Excellence Award, organized by the Bureau of Foreign Trade and operated by Taiwan External Trade Development Council (TAITRA), is an important event that celebrates Taiwanese companies’ achievement in product development and production. This award has established international credibility with over 100 judges from Taiwan and overseas screening and selecting winners based on R&D, design, quality, marketing and local manufactured in Taiwan. In its 30th year in 2021, Taiwan Excellence issued its third award to Somnics, Inc. On this occasion, the Oral Interface I08, an accessory of iNAP, stood out from the crowd.

The iNAP One Sleep Therapy utilizes intraoral negative air pressure to treat OSA patients. The iNAP creates a gentle oral vacuum to stabilize the tongue and soft tissues and free the airway. Unlike the traditional CPAP, the iNAP lets a patient breathe normally through the nose during sleep without a mask and blowing air. iNAP has a soft, flexible oral interface that users wear during sleep, which gives excellent wearing comfort compared to a CPAP facial mask. The oral interface has to be used throughout the sleep and is the key to whether the patient can adopt the negative pressure treatment for the long term. This seemingly simple design is the achievement after years of development.

The new generation iNAP Oral Interface, I08, improves the fitting and fixation by advanced pressure distribution and adjustable parts. The I08 comprises with three modularized parts: a Lip Shield, a Tongue Shield, and a Flexible Plate with different sizes. Users can select the proper size from 80 combinations according to the physician's evaluation and personalize their own oral interface that is most comfortable, best secured and has better therapeutic effects.

Most of the Taiwan Excellence Award winners this year are the optimal solutions developed to address users’ needs and experience, accompanied by new and smart business models and services for consumers. Somnics Inc.’s iNAP new generation Oral Interface I08, since its debuts with European Product Design Award in 2019, has been certified in Europe (CE Marking) in 2020 and Taiwan (TFDA) in 2021. For the first launched set, a total of 9 combinations are available to meet the needs of 80% of the OSA patients, who can personalize their treatment.

COVID-19 has changed many aspects of life and business and particularly the case in sleep medicine. With many sleep doctors providing virtual consultations to reduce risks, remote care for sleep disorders has become mainstream. At MEDICA 2021, from November 15 to 18 in Messe Düsseldorf, Somnics will present the newest developments of its iNAP Remote OSA Therapy Services. The innovative functions include the iNAP Lab+ mobile app, sleep management platform on the cloud, and remote pressure adjustments by physicians demonstrate their long-term vision for creating the industry value chains for sleep disorders management.

Over recent years, Somnics, Inc. has successfully obtained regulatory approval in the U.S. and Europe for its signature product, the iNAP One Sleep Therapy System. With entry into the German market and the establishment of the U.S. subsidiary, Somnics Health, the company has accumulated extensive market experience and clinical feedback. This has helped its team enhance the iNAP user experience by centering on patients. For example, the new generation Oral Interface, I08, improves the fitting and fixation by providing 80 size combinations according to the physician’s evaluation. The Omni9 Home Sleep Testing Device helps track patients' sleep and biological data remotely, while the iNAP remote sleep management system which meets the post-COVID-19 medical megatrend is also the highlight of Somnics’ achievements be presented at MEDICA 2021.

Somnics iNAP remote sleep management system is based on iNAP Lab+ APP installed on the mobile phone and connected with the oximeter, health bracelet, and sleep ring or with Omni9 so that users can record and stay on top of the biological data during sleep for obstructive sleep apnea (OSA) therapy. Then, physicians can analyze and instruct from the cloud, adjust the negative pressure parameters remotely, and optimize OSA treatment effectiveness via the iNAP remote sleep management system.

Somnics’s iNAP Lab+ remote OSA therapy services include a well-developed diagnosis, treatment, and monitoring features. The service is scheduled for launch in the U.S. and Taiwan by the end of this year so that patients can enjoy better OSA negative pressure therapy. The company hopes to establish cooperative ties with international medical professionals to promote this forward-looking and convenient solution at the major annual exhibition, MEDICA 2021 in Germany.

Somnics, Inc. will present the iNAP® One Sleep Therapy System at Taiwan Expo 2021 in Thailand VR Exhibition on September 29th to October 1st. Though the moment is still hard due to the pandemic, the company expecting that to join the online event could gain more attentions from local visitors who have been frustrated with first-line sleep therapies and are looking for some new solution for Obstructive Sleep Apnea (OSA).

Citing on a 2011 study by HRH Princess Maha Chakri Srinthorn Medical Center, the prevalence of Obstructive Sleep Apnea in men was 15.4% and in women was 6.3% respectively, affects about one in ten Thai people, which means OSA is a common problem in Thai adult population. Therefore, understanding the mask-free and non-surgical innovative OSA treatment like iNAP® may be essential to reduce the risk of related medical problems. iNAP® One Sleep Therapy System obtained the medical device certification in April 2020 and already signed distribution agreements with Thailand distributors since then.

Like many patients who are diagnosed with obstructive sleep apnea, it took Somnics founder Chen, Chung-Chu more than 20 years to finding a therapy that worked for him. After years of failed attempts at first-line OSA therapy like CPAP, he decided to take matters into his own hands and developed a prototype for the iNAP® in 2006 when he worked at Taiwan’s Industrial Technology Research Institute. Unlike CPAP, the iNAP® therapy uses “intraoral negative air pressure” that treats the problem differently and without a mask. To make iNAP® from a therapy concept to a real medical product, in 2011, he established Somnics, Inc. in Hsinchu Biomedical Science Park, Taiwan.

Since then, the company has been improving the comfort and efficacy of the therapy. iNAP® One Sleep Therapy System has earned awards from iF Design in Germany, A’ Design in Italy, holding marketing authorizations in USA(FDA), EU(CE) and many countries. It also twice achieved the Hsinchu Science Park Innovation Product Award, a symbol of innovation and manufacturing golden standard in ICT field of Taiwan.

As Covid-19 spread across the world, Taiwan gained worldwide attention for its quick control of the virus and its cutting-edge med-tech companies and products, as well as Somnics and its iNAP®, which will be introduced to Southeast Asia market through virtual events in up-coming month, including: PHARMEDI VIETNAM 2021 Virtual Exhibition (9/15-10/15, 2021), Taiwan Expo 2021 in India (10/27-10/29, 2021), Taiwan Expo 2021 in Indonesia (11/24-11/26, 2021) and International Greentech & Eco Products Exhibition & Conference Malaysia, IGEM (10/18-12/31, 2021)；Besides the promotion of iNAP®, achievements such as a new in-vitro diagnostic device regarding PCR quality COVID-19 at-home test will also be presented in these virtual exhibition.

2021 Taiwan EXPO in Thailand VR Exhibition – Somnics, Inc Information for Visitors
--- Exhibition Date : September 29th – October 1st, 2021
--- Opening Hour : 10:00AM - 18:00PM ( GMT+7 )
--- Exhibition Hall : Hsinchu Science Park Medical Device Pavilion
--- Exhibition Entrance URL : https://thai.taiwanexpoasean.com/en/index.html

Somnics, Inc. will honorably present its Taiwan Excellence awarded Obstructive Sleep Apnea (OSA) treatment solution - iNAP® One Sleep Therapy System to join Pharmedi Vietnam 2021 virtual exhibition from 9/15 – 10/15. Pharmedi Vietnam, considered to be the largest and most influential professional regular exhibition in the field of medical and health care in Vietnam, as well as one of the well-known professional medical exhibitions in Southeast Asia.

Citing on a 2019 worldwide study from The Lancet Respiratory Medicine, suggested that 936 million individuals in the age 30-69 group may have mild-to-severe OSA (AHI≥5), including 425 million with moderate-to-severe OSA(AHI≥15). Countries with the highest numbers of OSA individuals were China, followed by the U.S., India, and Brazil; rounding out the top 10 were Pakistan, Russia, Nigeria, Germany, France and Japan, with positive correlation to country population.

But how about in Vietnam? On a sleep medicine conference held around year-end 2018 at Pham Ngoc Thach University of Medicine, Dr. Duong Quy Sy, Chairman of the ASEAN Sleep Federation, said “OSA is a serious pathology and major risk factor for cardiovascular diseases.” The serious sleep disorder impairs quality of life, as well as intellectual and professional performances, and can also lead to accidents in the workplace and in traffic, and he added “an estimated 800,000 people in Vietnam suffer from obstructive sleep apnea syndrome” but most of them are undiagnosed. Which means, Vietnam is a big and undeveloped market for OSA treatments such as CPAP, dental devices and surgeries, or innovative therapy alternatives like iNAP® One from Somnics.

Unlike current first-line OSA therapy such as CPAP, the iNAP® One therapy device using “intraoral negative air pressure” that treats OSA differently and without a mask: it delivers a light, oral vacuum to comfortably open the airway while breathing normally through the nose during sleep. The system has a soft, flexible oral interface that enables excellent wearing comfort; its quiet battery-powered console with the size of a smartphone makes it ultra-portable for any situation. Somnics developed a tele-health OSA Remote Management System, with iNAP® Lab+ APP been installed on smart mobile devices, allowing users to see their own OSA treatment records. Since data been uploaded to the cloud platform, physicians can track and analysis, accomplishing maximum effects for sleep therapy.

Since its launch in 2017, iNAP® One Sleep Therapy System has earned awards from iF Design in Germany, A’ Design in Italy, holding marketing authorizations in Taiwan(TFDA), USA(FDA), EU(CE) and Southeast Asian countries. It also achieved the 2021 Taiwan Excellence award, the symbol of innovation and manufacturing golden standard for Taiwanese products.

Recently, Somnics leverages its knowledge, experience and quality management system in developing and manufacturing iNAP®, as the V&V domain of medical device, been capable of developing innovative medical device solutions in accordance with its CDMO clients’ orders. Achievements such as a new in-vitro diagnostic device regarding PCR quality COVID-19 at-home test, will also be presented in 2021 Taiwan Excellence Pavilion at Pharmedi Vietnam virtual exhibition virtual exhibition.

For more information of iNAP® One, please visit: https://www.inapsleep.com/en

PHARMEDI Vietnam 2021 virtual exhibition – Somnics, Inc Information for Visitors
--- Exhibition Date: September 15th – October 15th, 2021
--- Opening Hour: 10:00AM - 18:00PM ( GMT+7 )
--- Exhibition Hall: XIII) TAIWAN EXCELLENT PAVILION
--- Visitor Registration URL: https://www.pharmed.vn/registration-form

Somnics, Inc. today announced that its consolidated revenue for June 2021 reached NT$11.736 million, benefiting from record sales of the imported Lucira Check It COVID-19 Test Kit. It led to an annual increase of 2,156.9% in revenue in June, a record high over the same period last year as well as setting a new revenue high for a single month.

In early June, Taiwan Food and Drug Administration (TFDA) approved the project of importing at-home rapid test products, and Somnics was one of the earliest manufacturers to receive approval. Somnics subsequently introduced the Lucira™ Check It COVID-19 Test Kit, which is the first PCR-quality single-use molecular test kit for COVID-19 available in the Taiwanese market. In order to accelerate the capacity of epidemic prevention and screening for communities and enterprises, Somnics has not only provided a compelling solution through the introduction of Lucira™ to more than ten enterprises but also put the product on the shelves of selected pharmacy chains and retail channels since July 1.

According to Somnics, although the domestic epidemic situation is gradually improving and restrictions are being "partially lifted", in the next chapter against corona virus epidemic, the need for using rapid test with higher accuracy to ensure business activities can operate safely just increased rather than decreased. The company is confident that Lucira™ will continue to drive sales growth as it continues to ship orders from enterprise clients as well as respond to frequent inquiries from channel partners.

During the process of introducing COVID-19 molecular test products to Taiwan, Lucira Health, Inc. (Nasdaq: LHDX), the provider of Lucira™, recognized Somnics’ professional medical material service capabilities and the company became the first entity to obtain the overseas distributorship of Lucira™. Somnics, Inc. has officially signed a distribution agreement with Lucira Health as an exclusive distribution agent in Taiwan. In addition, new progress of iNAP® Sleep Therapy System in the U.S., South Korea and German markets in the third quarter is expected to further boost the revenue performance of Somnics in the second half of 2021.

Somnics Health announces the launch of iNAP Sleep, its innovative Obstructive Sleep Apnea (OSA) treatment and service coinciding with the annual SLEEP 2021 Conference on June 10-13 sponsored by the American Academy of Sleep Medicine. Access to iNAP Sleep is now available in most states through a direct-to-consumer digital approach and through its partnerships with board-certified sleep physicians.

iNAP Sleep provides its members with iNAP®- a new therapy, onboarding, ongoing support, and an e-commerce platform, www.inapsleep.online for its nightly OSA treatment alternative.

Olivier Lauzeral, General Manager of Somnics Health, states, "We believe that there is an unmet need for a large number of individuals who haven't yet been officially diagnosed with OSA. These individuals are aware that they have a sleep-breathing disorder, they may have heard of CPAP therapy or oral appliances and outright reject these most common sleep apnea treatments. We believe that when they discover the comfort, convenience, and form factor of iNAP, many will decide to pursue a diagnosis and treatment to address their sleep issues. Allowing more patients to be diagnosed and treated and live better lives is our main aspiration.”

The company's goal is to provide a “high-touch coaching program that maintains an adherence rate above 80% for its users,” said Lori Schulman, Director of Marketng and Patient Experience. iNAP is not for everyone; however, for most customers who are candidates and adhere, the treatment can be life-changing given the comfort, convenience, and simplicity. “As with any new therapy, some patients may take longer to acclimate. Through our dedicated coaching program, we will be able to bring more patients into full nightly compliance”, Schulman explained.

The company received FDA clearance in May 2020 and is the only FDA-cleared oral negative pressure technology for OSA on the market and is approved to treat all severities of OSA. With over 155 patents issued worldwide and 35 publications in peer-reviewed journals, this treatment option is backed up by solid clinical evidence and is significant to anyone interested in Sleep Apnea treatment.

"The sleep industry is ripe for disruption", continues Lauzeral. " I've personally been on the OSA patient’s journey, and coming from the tech world, I was frustrated by the way I was moved through the healthcare system. iNAP Sleep will provide sleep physicians and OSA patients with a new, patient-preferred alternative therapy that is simple, comfortable, effective, and easy to use. We are assembling a team of professionals who understand patients' mindsets through the diagnostics and treatment odyssey. Together, we are building a company that will provide superior care and outcomes."

Currently, most physicians prescribe Continuous Positive Air Pressure (CPAP/APAP) as first-line therapy for patients diagnosed with OSA of all severity levels. But approximately 50% of patients quit CPAP due to intolerance, inconvenience, or lifestyle issues. CPAP involves a nasal or full-face mask strapped to the patient's face, a 6' long tube, and a pump that blows air all night into the mask. Most CPAPs require an electrical connection to operate and doctors rely on Durable Medical Equipment (DME) providers for inventory and distribution. Unfortunately, most DMEs are not specialized in sleep care and do not focus on personalized patient coaching to improve adherence to therapy. Physicians need more tools in their medical toolbox to offer patients, as there is no one therapy appropriate to all patients.

About Somnics

Somnics, Inc. was established in 2011 in Taiwan and in 2020 in the US and is in commercialization phase in a number of countries: Germany, Israel, Singapore, Taiwan, Vietnam, Malaysia, and Australia. To find out more, including how to start with the iNAP Club, reselling opportunities, learn how it works, and read the broad clinical evidence, please visit www.inapsleep.online

Somnics, Inc. announced that the company has passed the GMP approval of the Korean Ministry of Food and Drug Safety (MFDS, formerly known as the Korea Food & Drug Administration or KFDA) overseas inspection in May 2021 and is expected to obtain the product certification of the iNAP® Sleep Therapy System in the third quarter of this year. The company is joining forces with LMT Korea Co. Ltd. to enter the Korean market to benefit Obstructive Sleep Apnea patients in Korea.
 
According to Somnics, in 2020, the company signed a contract with LMT Korea Co., Ltd, based in Gyeonggi-do to promote the iNAP® Sleep Therapy System and services in Korea after obtaining certification. LMT Korea is one of the leading sleep respiratory diagnostic and treatment equipment providers in South Korea and the exclusive Korea distributor of Lowenstein respirators from Germany. With its comprehensive service coverage and close collaboration with more than 200 medical institutions, LMT holds the largest market share of CPAP devices in Korea. LMT Korea also operates LÖWENSTEIN Academy, the only sleep professional training center in South Korea. Based on similar company missions, that "patients deserve a better OSA treatment experience", LMT Korea and Somnics have joined together in a strategic partnership.
 
The iNAP® Sleep Therapy System developed by Somnics, Inc. has been marketed and promoted in many countries, including Taiwan, the United States, Germany, Hong Kong, Singapore, Thailand, etc. Korea is also one of the main target markets in Asia. According to the research report of Ansan Hospital of Korea University and Korea Center for Disease Control and Prevention, one out of every five Koreans may suffer from sleep apnea. There isstrong growth potential in sleep apnea treatment services for OSA patients in Korea, and the innovative, safe and effective iNAP® sleep therapy treatment solution offers a promising market potential in Korea.

Somnics, Inc. (6633) develops the patented negative air pressure Obstructive Sleep Apnea (OSA) therapy device and solution. It will exhibit its iNAP products at the 2021 Smart Healthcare Expo. As IoT becomes a part of daily life, smart healthcare is a goal actively promoted by the government. At the exhibition, Somnics will share how it can help patients overcome OSA with smart interconnection technology.

In 2021 Smart Healthcare Expo (SHE Taipei), the popular “Smart Healthcare Interactive Pavilion” will exhibit three major themes: Smart Hospital, Smart Healthcare, and Smart Sleep, with the carefully planned visions and experts in different professional medical domains gathered by the sponsor. Somnics takes pleasure in exhibiting its latest negative pressure OSA treatment solution – iNAP One Sleep Therapy System. To improve the deficiencies of positive air treatment solution, the iNAP One therapy device using intraoral negative air pressure that treated the problem differently and without a mask. The system uses a soft, flexible mouthpiece, thin tubing, and a quiet battery-powered console the size of a smartphone to deliver a light, oral vacuum to comfortably open the airway while breathing normally through the nose during sleep.

Since iNAP launched into the market in 2017, it has kept making progress. The latest iNAP One model provides precise personal therapy, coming in multiple interfaces and sizes for consumers’ to choose from. It makes using it more comfortable. Embracing the smart healthcare trend, it is interconnected with the remote management system allowing users to see their own OSA treatment conditions - the data could be uploaded to the cloud platform for further tracking and analysis, accomplishing maximum effects for sleep therapy.

Somnics developed a smart interconnected OSA remote management system, including curative effect tracking iNAP Lab+ APP and treatment management cloud platform. iNAP Lab+ APP can be installed on smart mobile devices, such as smartphones, tablet computers, etc. It can also be connected to home monitoring equipment, such as an oximeter, health bracelet, etc. It records treatment data of patients every day to make it transparent. The cloud management platform can compile and track users’ treatment conditions and feedback analysis and suggestions, encouraging them to undergo continual treatment. Doctors and sleep physicians can adjust treatment plans appropriately in accordance with the data.

iNAP One Sleep Therapy System earned awards from iF Design in Germany, A’ Design in Italy, holding marketing authorizations in Taiwan (TFDA), USA (FDA), EU (CE), and Southeast Asian countries. The safety of the products is certified by many countries across the world.

2021 Smart Healthcare Expo Taipei - Opening Information
--- Date : March 23 - 26, 2021
--- Opening Time : 10 AM to 6 PM (Last day 5 PM)
--- Show Venue : TaiNEX2 (No.2, Jingmao 2nd Rd., Nangang District, Taipei, Taiwan)
--- Pavillion : Smart Healthcare Interactive Pavilion / Booth No. Q1024

Since its launch in 2017, iNAP® One Sleep Therapy System has earned awards from iF Design in Germany, A’ Design in Italy, holding marketing authorizations in Taiwan(TFDA), USA(FDA), EU(CE) and Southeast Asian countries. It also achieved the 2021 Taiwan Excellence award, a symbol of innovation and manufacturing golden standard for Taiwanese products.

Unlike current first-line OSA therapy such as CPAP, the iNAP® One therapy device using “intraoral negative air pressure” that treats OSA differently and without a mask: it delivers a light, oral vacuum to comfortably open the airway while breathing normally through the nose during sleep. The system has a soft, flexible oral interface that enables excellent wearing comfort; its quiet battery-powered console with the size of a smartphone makes it ultra-portable for any situation. Somnics developed a tele-health OSA Remote Management System, with iNAP® Lab+ APP been installed on smart mobile devices, allowing users to see their own OSA treatment records. Since data been uploaded to the cloud platform, physicians can track and analysis, accomplishing maximum effects for sleep therapy.

For more information of iNAP® One, please visit: https://www.inapsleep.com/en

Somnics, Inc. (Taiwan Stock Exchange: 6633.TW) announced that it has received 510(k) Clearance from the U.S. Food and Drug Administration (FDA) for its iNAP® One Sleep Therapy System.

Welcome to visit us at MEDICA 2016, booth at Hall 11 Stand C61.

Somnics, Inc. is a research-based and needs-driven medical device company engaging in the development of innovative treatment for sleep-disordered breathing. Our device, iNAP® Sleep Therapy System works without a mask or a bulky machine and instead uses a soft oral interface, pocket-sized and battery-powered console, which allow more patients with OSA (Obstructive Sleep Apnea) to breath naturally wherever they are.

The iNAP® Sleep Therapy System by Somnics, Inc. received the prestigious iF DESIGN AWARD 2016 for the Discipline Product.

This award is recognized as a symbol of design excellence around the world and has been attributed for over 60 years to the extraordinary projects that stand out for design excellence. A total of almost 5,300 entries from about 2,500 participants from more than 50 countries were submitted to the iF DESIGN AWARD 2016, an increase of more than 500 entries compared to the preceding year. As the iF DESIGN AWARD 2016 winner, Somnics, Inc. will join the glamorous awarding ceremony, the iF design award night, at the BMW Welt in Munich on February 26 2016.