Winnipeg, Manitoba

Cerebra Health Inc., a digital health-tech company focused on the diagnosis of sleep disorders, is pleased to announce the completion of a $2.5 Million private round of financing and the acquisition of Younes Medical Technologies Ltd. (YMT), a medical device company devoted to the development of systems for the assessment of sleep and the diagnosis of sleep disorders. As a part of the transaction, Cerebra has also acquired YMT’s portable PRODIGY sleep monitor, as well as a worldwide exclusive license to the MICHELE SLEEP SCORING system. Both technologies are being integrated to support Cerebra’s scaled, high-volume delivery platform for in-home diagnostic sleep studies.                                

Cerebra’s business model is built around the use of digital sleep analysis technologies to improve the diagnosis and treatment of sleep disorders. Digital sleep analysis involves the application of computer based algorithms to assess data gathered from a sleep study (polysomnography), and particularly in relation to brain activity as measured by EEG. Digital analysis offers the potential to detect and measure EEG characteristics that cannot be quantified by the human eye, and therefore not accessible using current, manual polysomnography scoring techniques. Cerebra’s diagnostic service platform provides the latest in digital sleep analysis through an easy to use, in-home device. The Company’s objective is to make high quality clinical sleep analysis accessible to patients in the comfort of their home environment, and without the wait time and costs associated with conventional in-lab polysomnography.  

“This financing, together with the acquisition of YMT and the securing of the PRODIGY and MICHELE technologies, establishes a base upon which we can advance the delivery of sleep diagnosis to the patient’s home,” stated Dawson Reimer, President of Cerebra Health. “Sleep is increasingly recognized as one of the major health issues facing society, and we are excited by the opportunity this provides to impact the lives of individuals in Canada, and around the world.” 

Cerebra is continuing to work closely with world-renowned respirologist and sleep physician Dr. Magdy Younes, the founder of YMT and inventor of the Company’s digital sleep technologies. Dr. Younes will support Cerebra in the capacity of Chief Scientific Officer, as well as pursuing independent research initiatives. “I am confident that the focus and experience of the Cerebra team will ensure that these new technologies will be successfully incorporated in clinical sleep medicine and will, over time, result in improvements to the way we address difficult to treat sleep disorders”, stated Dr. Younes.

                                                                                                                               

About PRODIGY

The PRODIGY device, which was approved by Health Canada in July 2016, is one of only two approved devices that evaluates sleep based on gold-standard, brain wave activity as opposed to body movement, and can be applied by the patient at home without the help of technologists1,2. The wireless, easy-to-use device generates clinical quality EEG signals that are indistinguishable from signals collected concurrently using conventional, in-lab polysomnography acquisition systems1, and has been validated in peer–reviewed studies to provide good agreement with manual scoring of sleep stages1,2. When used with the MICHELE SLEEP SCORING (MSS or MICHELE) system, PRODIGY provides a one-of-a-kind sleep recording system that affords increased operational efficiency, computer-assisted scoring, as well as the latest in contemporary digital sleep analytics – including the Sleep Depth Scale.  

 

About MICHELE and the SLEEP DEPTH SCALE

The MICHELE system is medical device software that has received US-FDA clearance and approval by Health Canada, European Union (CE Mark) and other national regulatory bodies for use in assisting the diagnosis of sleep disorders. Through fully-automated or digitally-assisted sleep scoring, MICHELE greatly reduces the time and effort required to consistently score sleep studies with a high level of accuracy. Agreement between the sleep scoring results of MICHELE and that of highly-experienced academic sleep technologists was shown to be similar to, if not better than, agreement between individual scorers in an arms-length, multicenter study3. 

In addition to providing automatic and computer-assisted conventional sleep scoring, MICHELE also provides advanced, digital sleep analysis of EEG and other data gathered during a sleep study, extracting significantly more information than could be obtained through conventional review by a technician. An example of the power of MSS for data extraction is a continuous measure of sleep depth, known as the Odds Ratio Product (ORP or SLEEP DEPTH SCALE).  This validated4-6, proprietary, bio-marker identifies and quantifies differences in sleep depth/quality between patients who have the same sleep patterns scored according to the current manual guidelines. By providing a greater insight into sleep depth, this validated algorithm is becoming a valuable new tool for sleep science and clinical sleep medicine.                          

The MICHELE SLEEP SCORING system is provided by Cerebra under a worldwide, exclusive license from Younes Respiratory Technologies Ltd. (YRT). For more information on MICHELE visit www.michelesleepscoring.com .

 

About the Financing 

The $2.5 million financing was provided by a group of private Manitoba investors, and will be used as working capital for the advancement of Cerebra’s business plan. Cerebra utilized the Province of Manitoba’s Small Business Venture Capital Tax Credit (SBVCTC) Program to support the private equity raise.  The SBVCTC program provides a 45% provincial tax credit to eligible Manitoba investors who purchase eligible shares in an eligible Manitoba business.

 

About Cerebra Health Inc.

Cerebra Health is a Manitoba based, digital health-tech company focused on improving access to advanced, diagnostic technology for the assessment of sleep and the diagnosis of sleep disorders. Cerebra was founded and initially funded by Rana Respiratory Care Group, a sleep and respiratory care provider that has been operating in Western Canada for 25 years. Cerebra provides in-home sleep study services for dental and home-care companies that offer treatments for sleep apnea and other sleep disorders in the Canadian market. The Company’s digital service platform provides unmatched capabilities for in-home sleep analysis, with a focus on improved user experience, state-of-the-art diagnosis, and increased operational efficiency.  Cerebra is also working in partnership with leading sleep scientists and researchers to revolutionize clinical sleep medicine by leveraging its core capabilities in digital sleep analysis.  

For more information on Cerebra Health please visit www.cerebrahealth.com

 

CONTACT INFORMATION

Cerebra Health Inc.

 Dawson Reimer

President

5-55 Henlow Bay, Winnipeg, MB, Canada

 204-272-2835

 204-928-8040 (FAX)

 Dawson.Reimer@cerebrahealth.com

www.cerebrahealth.com

 

Disclaimer

MICHELE and PRODIGY are Class II medical devices and are restricted to sale by or on the order of a physician.  Refer to product labeling for specific information and directions regarding product purpose, use, warnings and cautions.

 

Regulatory Statement

YMT operates a Quality Management System that complies with the requirements of ISO 13485:2003 and holds Certificate Number FM 551942 issued by the British Standards Institute (BSI). This certification includes the Standards Council of Canada (SCC) endorsement under the Canadian Medical Device Conformity Assessment System (CMDCAS) scheme.

YMT is also in conformance with the provisions of Annex V/Annex VII and of the Essential Requirements of Annex I of the European Medical Devices Directive 93/42/EEC as amended by Directive 2007/47/EC. As well, YMT’s Quality Management System incorporates all requirements of the US FDA Quality System Regulations, as per Part 820 of Title 21 of the Code of Federal Regulations (CFR).

Younes Medical Technologies is committed to continual improvement of its product and Quality Management System.

 

References

  1. Younes M, Soiferman M, Thompson W, Giannouli E. Performance of a New Portable Wireless Sleep Monitor  J Clin Sleep Med. 2017:13:245–258
  2. Levendowski DJ, Ferini-Strambi L, Gamaldo C, Cetel M, Rosenberg R, Westbrook PR. The Accuracy, Night-to-Night Variability, and Stability of Frontopolar Sleep Electroencephalography Biomarkers. J Clin Sleep Med. 2017;13:791-803.
  3. Malhotra A, Younes M, Kuna ST, Benca R, Kushida CA, Walsh J, Hanlon A, Staley B, Pack AI, Pien GW. Performance of an automated polysomnography scoring system versus computer-assisted manual scoring (2013) Sleep 36:573-82.  
  4. ounes M, Ostrowski M, Soiferman M, Younes H, Younes M, Raneri J, Hanly P. Odds ratio product of sleep EEG as a continuous measure of sleep state (2015) Sleep 38:641-654. 
  5. Younes M, Hanly PJ. Immediate postarousal sleep dynamics: an important determinant of sleep stability in obstructive sleep apnea (2016) J Appl Physiol 120:801-8. 
  6. Meza-Vargas S, Giannouli E, Younes M. Enhancements to the multiple sleep latency test (2016) Nat Sci Sleep 8:145-58.
  7. Younes M. The case for using digital EEG analysis in clinical sleep medicine. Sleep Sci Practice. Sleep Science and Practice. 2017-1:2.