APNEA TEK MEDICAL DEVICES
A Medical Device Research Company
A Division of Real 3D Polymers LLC
SLEEP APNEA TREATMENT DEVICES
Apnea Tek Oral Devices
Bridging the GAP between MAD and CPAP
No Air Pressure, No Mask, No Hoses
With Little to No Repositioning of Jaw
FACTS & FIGURES
Sleep Apnea Sufferers Worldwide
Economic Impact of Sleep Apnea in the US
Apnea Tek Medical Devices (A Division of Real 3D Polymers LLC) is a Michigan-based medical device research company, developing several innovative sleep apnea treatment devices. The company is co-founded by two industry veterans with experience in the field of medicine, health and across product, material, process development, and commercialization.
We have already developed a First-of-its Kind Sleep Apnea Treatment device for which NSR Clinical Study underway and 510(k) is pending.
We are also working on innovative concepts which do not require implant or surgery to treat moderate to severe sleep apnea
FOUR GRANTED US patents, Two continuation-in-part (CIP) patents have been filed with expedited review.
The international Patent Cooperation Treaty (PCT) application has been also filed.
Risks: High Blood Pressure, Diabetes, Concentration & Memory Problems, Depression, Heart Failure
CPAP Machines, Oral Appliances & Surgery/Implants
Apnea Tek Oral Devices
Bridging the GAP between
MAD & CPAP
No Air Pressure, No Mask, No Hoses
With Little to No Jaw Repositioning
Other Patented Devices with Innovative concepts
The American Academy of Sleep Medicine (AADSM) defines Obstructive sleep apnea (OSA) as: “A sleep-related breathing disorder that involves a decrease or complete halt in airflow despite an ongoing effort to breathe. It occurs when the muscles relax during sleep, causing soft tissue in the back of the throat to collapse and block the upper airway.
There are 100 million Sleep Apnea Sufferers Worldwide and 80% are Undiagnosed. Frost & Sullivan calculated that the annual economic burden of undiagnosed sleep apnea among U.S. adults is approximately $149.6 billion. The estimated costs include $86.9 billion in lost productivity, $26.2 billion in motor vehicle accidents and $6.5 billion in workplace accidents.
Untreated sleep apnea also increases the risk of costly health complications such as hypertension, heart disease, diabetes, and depression. The report estimates that undiagnosed sleep apnea also costs $30 billion annually in increased health care utilization and medication costs related to these comorbid health risks. Reference
Large CPAP Machines: Continuous Positive Airway Pressure (CPAP) therapy accounts for 85% of diagnosed sleep apnea patients, yet nearly half don't comply with the therapy. CPAP devices are cumbersome, loud, uncomfortable and overall intrusive. Some patients have difficulty tolerating the forced air, can feel claustrophobic, and have a leaky mask or skin irritation.
Oral Appliances: Oral Appliances moves the lower jaw forward to open the airway. Excessive movement can cause bite changes, TMJ pain, or pain in the jaws and teeth.
Surgery/Implants: Surgery is invasive, non-reversible, cost-prohibitive, and can have serious complications.
Patients need a better option
With over 6 years of research, we have developed a first-of-its-kind, oral airflow sleep apnea treatment device called "Apnea Tek”. The Apnea Tek comfortably provides therapeutically-controlled atmospheric air flow, without the need for air pressure or significant repositioning of the lower jaw. This device operates without a hose, mask, or nasal pillows, which results in unobstructed, comfortable sleep. The Apnea Tek's compact, detachable control unit houses a micro-fan, sensors, and battery. It is attached to an adjustable oral mouthpiece for minimal repositioning, if combination therapy is desired, and capable of Bluetooth, Wi-Fi, or cellular connectivity. We are in preparation of filing with the FDA for approval in the USA. Our 510(k) status is pending. The NSR Clinical study is underway.
The Apnea Tek brings in room-air at atmospheric levels and has an adjustable flow rate – the air moves from the front of the mouth to rear of the throat, completely bypassing the teeth, palate and tongue. The consistent airflow increases oxygen levels during sleep and stimulates and stabilizes the tongue and oral airway. Stimulation at the base of the tongue and pharyngeal walls helps to prevent throat tissues from collapsing during sleep.
The Apnea Tek is a patient-specific 3D-printed device made from FDA-accepted medical grade material. It has high tensile strength and is resistant to cracking and abrasion. It is also resistant to bruxism. The material is biocompatible and ensures the rarest levels of allergy and intolerances.
Current and Future developments in our Intellectual Property Portfolio include following concepts:
Air-stimulation Apnea-Tek Device (No implant) - Device is already developed and clinical study underway
Minimal electric current Stimulation of Tongue Device- (No implant, No Surgery) - "Proof of Concept" underway
Hybrid Air/Electric stimulation Device (No Implant, No Surgery)
Nasal Apnea Tek Device - "Proof of Concept" underway
Patient's Sleep Position Control Apnea Tek Device -"Proof of Concept" underway
“Dual Purpose Electric Stimulation Apnea Tek Device” - No Implant, No Surgery (Sleep Apnea Treatment with Nightguard to avoid Bruxism or teeth Grinding). No External housing. It is just a mouthguard with sensors and electronics
DR. SURESH SHAH
CEO & Co-founder
Plastics Hall of Fame inductee
SPE Lifetime Achievement Award recipient
Michigan ESD Scientist of the Year
International SPE Research and Technology Award recipient
Dr. Shah has extensive knowledge of sleep apnea devices and background in Plastics/Polymers Materials, Product, Process and 3D Printing technology expert.
Dr. Suresh Shah – CEO and Co-founder
Dr. Dinesh Shah – Co-founder, Cardiologist and Medical Advisor
Dr. Avi Desai – Sleep Doctor, Pulmonary and critical care, Advisor
Dr. Earl Bogrow – Sleep Dentist. Diplomat of AADSM (American Academy of Dental Sleep Medicine)
Dr. Anjoo Ely - Sleep Dentist, Diplomat of AADSM
Dr. Regina Dailey – Sleep Dentist, Diplomat of AADSM
(Several other Dentists for NSR Clinical Study)
Dr. Prasanna-Kumar Shivapuja, Orthodontist and Key Advisor (BDS, MDS, DDS, MS)
Laura Sheppard – Certified Dental Technician - SVP Clinical & Regulatory
Priscilla Kao - Clinical Study Manager
Shail Chokhavatia – Vice President of Engineering, Sleep Apnea Expert
Udayan Patel – Vice President of Quality and Regulatory Affairs
Jitesh Desai – Vice President of Business Development and Marketing
Ajit Shah – Vice President of Finance and M&A
Bruce Bennett II – Mechanical Design and Senior Plastics Engineer
Nidhi Shah - Free-hand Artist and Mechanical Engineer
Development Partnership Agreements with companies specialized in electronics, sensors, software etc.