Dormio Tech Division of CHAD Therapeutics Receives FDA Clearance to Market Its FloCHANNEL Sleep Diagnostic Device
July 29 2008 - 11:50AM
Business Wire
Dormio Tech, a division of CHAD Therapeutics, Inc. (AMEX:CTU),
announced today that it received 510(K) clearance from the FDA to
market the Company's proprietary FloCHANNEL� Diagnostic System,
Dormio's first product for the large and rapidly growing sleep
disorder market. CHAD currently expects to begin shipping this new
device and associated disposables by September. "With its patented
features and unique capabilities, we believe FloCHANNEL is a
significant advance in the diagnosis of obstructive sleep apnea and
other sleep disorders, and may become an invaluable tool in
attended sleep laboratories," said President and CEO Earl Yager.
There are approximately 2,800 attended sleep labs in the United
States. Dormio Tech's innovative FloCHANNEL is the only diagnostic
device that independently monitors left and right nasal airflow.
This allows the system to detect and measure nasal cycling (the
periodic alternation in nasal airflow resistance between the two
nasal cavities), as well as oral airflow and snoring, and provides
constant baseline airflow volumetric sleep scoring. The patented
device connects easily to standard sleep lab systems. About CHAD
Therapeutics CHAD Therapeutics, Inc. develops and markets
innovative products for the sleep disorder market. For more
information, visit www.dormiotech.com. Safe Harbor Statements under
the Private Securities Litigation Reform Act of 1995. The foregoing
statements regarding prospects for future earnings and revenues,
future sales trends and the introduction of products under
development are forward-looking statements that involve certain
risks and uncertainties. A number of important factors could cause
actual results to differ materially from those contemplated by such
forward-looking statements. These include the introduction of new
products with perceived competitive advantages over the Company's
products, changes or proposed changes in health care reimbursement
which affect home care providers, and DORMIO's ability to
anticipate and respond to technological and economic changes in the
sleep market. Moreover, the success of the Company's products and
products under development will depend on their efficacy,
reliability and the health care community's perception of the
products' capabilities and benefits, the degree of acceptance the
products achieve among sleep labs and patients, and, with respect
to products under development, obtaining timely regulatory
approval. Additional factors that could cause actual results to
differ materially from those contemplated in this press release can
be found in the Company's annual and quarterly reports filed with
the Securities and Exchange Commission under the caption "Outlook:
Issues and Risks."
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