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The Future of Sleep-Disordered Breathing Solutions
LinguaFlex

Sleep-Disordered Breathing


What is Sleep-Disordered Breathing?
The term Sleep-Disordered Breathing is used to describe a group of disorders that are characterized by abnormal respiratory patterns where a person stops breathing (apnea) or has shallow breathing (hypopnea) or has insufficient ventilation (breathing is ineffective to maintain oxygen levels) during sleep. Sleep Disordered Breathing is often characterized by excessive snoring and a person feeling tired or sleepy during the day. The most prevalent form of Sleep Disordered breathing is known as Obstructive Sleep Apnea (OSA).

Obstructive Sleep Apnea (OSA)

It is estimated that 4 – 6 % of the general population and up to 26% of adults age 30 – 70 years have obstructive sleep apnea. In real numbers that is approximately 45 million adults in the US alone and up to 80% have not been diagnosed.

OSA occurs when the airway is blocked and air can no longer flow through the nose or mouth. It is often characterized by loud snoring followed by periods where the person gasps or chokes during sleep. During sleep the muscles of the throat and upper airway relax causing the airway to narrow. During inspiration the vibration of this narrow airway creates a sound known as snoring. When the narrowing becomes worse by relaxation of the soft palate inward and the tongue moving backward, this causes airway obstruction known as OSA. A person may experience this airway collapse from a few times to hundreds of times a night causing disruption in oxygen flow to the lungs and ineffective sleep. Left untreated obstructive sleep apnea can contribute to other health issues such as hypertension, heart attack, stroke and a higher risk for early death. Untreated OSA has also been identified as a cause of many traffic and work place accidents.

Source: US Census 2010; Encyclopeida of Neurological Scienses (Elsvier 2014); Peppard PE, Young T, Bamet JH, et al. Increased prevalence of sleep-disoreded breathing in adults, Am J Epidemiology 2013 May 1;177(9):1006-14. Epub2013 Apr 14


The Effects of Untreated OSA

Health Risks

Our Mission:

At LinguaFlex™, we are dedicated to improving the lives of people who suffer from sleep-disordered breathing through innovative, clinically proven, and practical treatment solutions.


The Values that drive us:

• Patient Firstthe heart of everything we do
• Meaningful Innovationcreating solutions that matter
• Learning Agilityconstantly growing and anticipating the needs of the market we serve
• Integrityalways operating with the highest ethical standards
• Teamworkworking together with passion, respect, trust and collaboration
• Successhappy customers / changed lives

LinguaFlex Technology


The LinguaFlex™ Tongue Retractor (LTR™) is a revolutionary patented technology for the treatment
of obstructive sleep apnea and snoring.

The LinguaFlex Tongue Retractor is a small, flexible, implantable device designed to treat obstructive sleep apnea (OSA) and snoring. The LTR acts like a flexible tongue stud that supports the tongue base to prevent the backward collapse of the tongue during sleep.

The LTR's flexible design does not interfere with normal tongue functions like speaking or swallowing. Unlike other implantable devices, it does not require the use of general anesthesia and the entire procedure takes only a few minutes.

Photo of an LTR
LTR
510(k) Pending

Leadership


John Miclot

John L. Miclot
President and CEO

Mr. Miclot joined LinguaFlex, Inc. in 2016 bringing his vast experience in the healthcare industry. He most recently served as CEO of Tengion Inc., a pioneer in organ regeneration technology (2011-2016). He served as an Executive in Residence at Warbug Pincus and President/CEO of CCS Medical, Inc., a provider of products and services for patients with chronic diseases from 2008-2010. Prior to that Mr. Miclot served as President/CEO of Respironics, Inc. from 2003-2008, after previously holding positions as Chief Strategic Officer, and President of the Homecare Division. At Healthdyne Technologies, Mr. Miclot held the position of Sr. VP, Sales and Marketing from 1995-1998. Currently, Mr. Miclot is a Director at Wright Medical and Dentsply, and serves as Chairman of Breathe Technologies, a Kleiner Perkins company. He is also a member of altruistic boards, including the Pittsburgh Zoo & PPG Aquarium, Burger King Cancer Caring Center, and Central Catholic High School in Pittsburgh, PA.

Ira Sanders

Ira Sanders, MD
Founder and Chief Medical Officer

Dr. Sanders founded LinguaFlex, Inc. in 2006 in order to bring the LTR's life-changing technology to the forefront of sleep apnea treatment. Dr. Sanders is a leading authority on the anatomy of the human upper airway as well as a board certified Otolaryngologist with 20 years of experience treating sleep apnea patients. He was a faculty member in the Department of Otolaryngology at Mount Sinai Medical Center in New York City for 17 years. During this time, Dr. Sanders was the Principal Investigator on five NIH grants researching unique aspects of the human upper airway. Dr. Sanders has published over 60 articles in medical journals and has received 15 major research awards. In addition, he is a prolific inventor with 21 awarded patents and more than 50 patents pending.

Information for Investors


The economic costs of untreated Obstructive Sleep Apnea (OSA) have skyrocketed.

The High Cost of Untreated Sleep Apnea

The market for Disordered Breathing Treatment/Obstructive Sleep Apnea (OSA) products is currently approaching USD $4 billion worldwide. Market growth is predicted to be 16-19% per year globally due to demographic factors and growing awareness of the condition. According to Global Market Insights, Inc., the sleep apnea devices market is poised to exceed USD $8.7 billion by 2023.


"Sleep apnea is a major public health problem and a replacement for CPAP is needed."
—The U.S. National Institutes of Health


The standard treatment for patients with sleep apnea is Continuous Positive Airway Pressure (CPAP). CPAP requires the patient to wear a mask over their mouth and/or nose while sleeping and provides continues air flow that generates pressure to keep the airways open.

Compliance to CPAP is Poor

  • Compliance rate < 50%
  • 15% of patients abandon therapy within 1-2 years
  • 31% of patients never start therapy after diagnosis
  • Mask discomfort and nasal or oropharyngeal dryness is prevalent

The LinguaFlex™ LTR™ Difference

  • Implanted
  • 5-minute out-patient procedure
  • Comfortable and barely noticed by the patient
  • Requires no patient intervention to meet compliance

Learn more about the experienced LinguaFlex team, our breakthrough technology, clinical trial results and premarket FDA clearance status by completing the Contact Us Form below.

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