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Sapphire PSG™ is a wireless, Type I, 22-channel, full PSG sleep platform from CleveMed, and here’s why you should care.

1. Wireless: This complete sleep study system is small and wireless, and fits in a portable brief-case of sorts. This saves a lot of time and lab set-up costs, because it operates wirelessly, and the facility won’t have to be expensively hard-wired with cables. (It’s also more convenient for the patient who need not be tethered to the acquisition system)
2. Expanding the reach of sleep services: If you are unsure how the sleep market changes will affect your sleep business, Sapphire PSG™ can be used for traditional in-sleep-lab full PSG studies, as well as, remotely attended, or unattended (full PSG) sleep studies in the home, nursing homes, hotel-based-labs, hospital sleep labs, etc.
3. Accommodating multi-purpose facilities: Sapphire PSG has successfully aided facilities in becoming multi-purpose spaces, since it small and can be easily stored away when not in use. For example, a night-time sleep lab space can be used as a daytime clinic in the same facility.
4. Sapphire PSG uses state-of-the-art, wireless hardware with two frequency options (902-928 MHZ or 2.4-2.485 GHz.) built into the system; you can choose the model that best suits your environment.
5. Reliable Data Storage: Sleep study data is wirelessly transmitted from the patient unit at very high speeds, and stored on the computer unit and as well as removable SD memory card in the patient unit.
6. Meets AASM guidelines: Six of the 22 channels are EEG channels.
7. DreamPort is a recently launched accessory to the Sapphire PSG system. Now sleep technicians can take full PSG to the patient wherever they are located (especially if they can’t make it to the sleep lab), and remotely attend/monitor patients over the internet.

CleveMed specializes in the manufacture of wireless, subject-worn physiological monitoring equipment. Within the Division of Research and Education systems, a number of wireless data acquisition devices are offered for a variety of applications.

BioCapture is a research system that uses the BioRadio, a wireless data acquisition device for physiological monitoring. The BioRadio can measure any combination of signals such as ECG, EMG, EEG, EOG, respiration, SpO2 and more. Data is telemetered to a receiver connected to a nearby PC. The information is displayed through the software and data can be exported for analysis in third party applications, such as LabView, Matlab or Excel. The BioCapture system is suitable for a number biomedical research applications.

CleveLabs is a laboratory course system that uses the same data acquisition device as BioCapture, the BioRadio. The software is different, in that it is tailored toward students as a laboratory teaching system focusing on engineering, physiology and clinical applications. Biomedical engineering, physiology, electrical & computer engineering and other departments can benefit from this technology. The system is very flexible and can be used in biomedical engineering labs and classrooms, biomedical research applications, physiology labs and research, and more.

KinetiSense is a wireless data acquisition system that measures three dimensional motion using accelerometers and gyroscopes. Linear acceleration and angular velocity are measured from different portions of the body and data is transmitted to a received connected to a nearby PC. The software displays and stores the data and some analysis features are included. An export utility is also included for easy export for custom analysis applications using programs such as LabView, Matlab or Excel.

CleveMed has announced the promotion of Joseph P. Giuffrida, PhD to Vice President, General Manager of the Division of Movement Disorders. CleveMed is continually expanding as a medical device company and Dr. Giuffrida will continue to fill a crucial role to assist with the company’s success.

Dr. Giuffrida, 33, completed his BS, MS and PhD in Biomedical Engineering at Case Western Reserve University with a concentration in rehabilitation engineering. He began his career at CleveMed in 2000 as an Applications Engineer and upon receipt of his PhD in 2004, became a Principal Investigator and eventually Director of the Division of Movement Disorders. Within these roles, Dr. Giuffrida has secured over $10 million in funding from both the National Institutes of Health and the State of Ohio to fuel the research, development, and commercialization of innovative medical devices focused on aiding in the diagnosis and therapy of movement disorders. He has secured FDA clearance to market for a number of CleveMed systems, managed reimbursement strategies for new and emerging technology, established multiple world renowned key opinion leaders and clinical consultants, and lead the marketing and sales teams for CleveMed’s clinical movement disorder products as well as the research and education product lines.

Most notably, CleveMed’s Division of Movement Disorders commercialized and launched Kinesia under Dr. Giuffrida’s direction. This technology is intended to provide a standardized platform for objectively quantifying motor symptoms associated with Parkinson’s disease. Additional research and development in this Division is focused on extending the market applications for Kinesia from clinical office visits to home monitoring and deep brain stimulation programming, assistive technologies to aid in communication for persons with limited mobility and speech impairment and the development of rehabilitation systems to aid in motor recovery after brain injuries such as stroke or cerebral palsy.

In addition to the Division of Movement Disorders, Dr. Giuffrida also manages CleveMed’s line of products focused on the research and education market. Dr. Giuffrida was able to commercialize CleveMed’s wireless physiological monitoring technology into specific academic and university based target applications to increase CleveMed’s sales both domestically and internationally.

About Sleep Apnea:

According to the National Institutes of Health, 50 to 70 million Americans are affected by chronic sleep disorders which can significantly diminish health, alertness and safety. An estimated 18 million Americans have sleep apnea, one of the most common sleep disorders. Yet, many sufferers are undiagnosed. Untreated sleep disorders can lead to hypertension, heart disease, stroke, depression, diabetes and other chronic disorders. In order for sleep apnea to be diagnosed, a patient normally undergoes a polysomnography (PSG), which is a noninvasive, pain-free procedure that usually requires spending a night in a sleep lab. During a PSG study, a sleep technologist records multiple biological functions during sleep, such as brain wave activity, eye movement, muscle tone, heart rhythm and breathing using electrodes and monitors placed on the head, chest and legs.

About DreamPort:

CleveMed recently introduced DreamPort™, an accessory to CleveMed’s Sapphire PSG™ (full PSG wireless system). Using broadband technology and built-in camera, DreamPort is a gateway to transmit full PSG data from the patient’s location to a sleep lab, thus, allowing remote attendance for patients who may be anxious or incapable of attending a sleep lab. With this new emerging medical device technology, diagnosing and treating sleep disorders has become timelier.

Why DreamPort is Suitable for Clinical Trials:

DreamPort is suitable for clinical trials as it allows for cost effective research studies to be conducted nearly anywhere. According to Cutting Edge Information, the average drug company spends about 37% of their overall R&D budgets on clinical trials. The average per-patient cost of clinical trials ranges roughly from $5,500 $7,600¹. Typical clinical trials follow a set of rules called a protocol and are managed by doctors. The studies are commonly run by nurses or other health care professionals². Now, DreamPort gives clinicians and researchers greater flexibility to conduct clinical trials where the patient is. Researchers and clinicians are able to obtain new types of research, like location specific research -home, hotel, hospital or lab; which can lead to support and establish a wider patient base.

The cost of home testing is a fraction of the cost of in-lab testing and can be less than the cost of using personnel for a full night sleep study. The average in-lab sleep studies cost range between $1,000-$5,000 a night. The cost of home studies range 35% to 88% lower than in-lab studies. The lower cost of home sleep studies makes DreamPort a practicable screening tool to collect meaningful research for patients with suspected sleep disorders, like Obstructive Sleep Apnea (OSA).³

This post draws on the experience of CleveMed professionals and professionals in the Sleep Disorder industry.