APNEA TEK MEDICAL DEVICES
A Medical Device Research Company
A Division of Real 3D Polymers LLC
SLEEP APNEA TREATMENT DEVICES
Miniature, No-Mask, No Hose, No Air Pressure CPAF® (Controlled Positive Air Flow) Device
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 and directly 3D-printed teeth-straightening aligners. The company is co-founded by two industry veterans with experience in the field of medicine and across product, material, process development, commercialization.
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
Miniature, No-Mask, No Hose, No Air Pressure, No MAD CPAF® Oral Device
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. The excessive movement can cause bite changes, TMJ pain, or pain in the jaws and teeth.
Surgery/Implants: Surgery can have complications and is cost-prohibitive.
Patients need a better option
Over 6 years of research, we have developed first-of-its-kind miniature sleep apnea treatment device called CPAF® (Controlled Positive Air Flow) having No air pressure. This device operates without a hose, mask, or nasal pillow, which results in comfortable sleep. CPAF®’s detachable miniature unit houses sensors, a micro-fan, and electronics, and is attached to the mouthpiece and capable of Bluetooth, Wi-Fi, or cellular connectivity. We are in preparation of filing with the FDA for approval in USA. The Clinical trial is underway.
The device brings air in at atmospheric pressure with the desired controlled flow rate – the air moves from the front of the mouth to rear of the throat, completely bypassing the tongue. It stabilizes the lower jaw and tongue, keeping airways open and free from obstruction during sleep. The device has capability of air stimulation of tongue and soft tissues which may not allow soft tissues to relax, keeping air passageway in throat area open during the sleep.
The customized 3D-printed device is made from FDA-approved medical grade material. It has high tensile strength and resistance 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 CPAF® (No implant)
Minimal electric current Stimulation of Tongue - CPAF® (No implant)
Hybrid Air/Electric simulation Device (No Implant)
Patient's Sleep Position Control CPAF® Device
Nasal CPAF® Device
“Dual Purpose” (Sleep Apnea Treatment with directly 3D printed Aligner to straighten the teeth)
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 a 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
Dr. Prasanna-Kumar Shivapuja, Orthodontist and Key Advisor (BDS, MDS, DDS, MS)
Laura Sheppard – Certified Dental Technician - SVP Clinical & Regulatory
Dr. Suresh Shah - COO and CEO
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
Ankur Shah – Finance
Bruce Bennett II – Mechanical Design and Plastics Engineer
Nidhi Shah - Mechanical Engineer
Development Partnership Agreements with companies specialized in electronics, sensors, software etc.