SALEM, N.H. and WILSONVILLE, Ore., March 8, 2018 /PRNewswire/ -- WaveForm
Technologies Inc. a developer of novel products for continuous
glucose monitoring and a wholly owned subsidiary of AgaMatrix
Holdings LLC, announced that the Patent Trial and Appeal Board
(PTAB) has ruled two early patents held by WaveForm are not
invalid, based on challenges brought by Dexcom,
Inc. (NASDAQ:DXCM).
In its final written decisions last week, the PTAB found that
three claims from WaveForm's U.S. Patent No. 7,146,202 and all
challenged claims from its U.S. Patent No. 8,187,433, are not
invalid. Dexcom's validity challenge before the PTAB on a third
WaveForm patent remains pending.
The patented technology in WaveForm's sensor design and
methodology used in their Continuous Glucose Monitoring System
(CGMS) allows the use of small, flexible, sensor wires. This unique
sensor design enables a reduced diameter, which may aid day-one
performance, reduced warm up time, and reduced wound diameter for
significantly less pain and faster healing. WaveForm Technologies
anticipates the features of its CGMS, clinical performance, and
cost profile to be competitive compared to currently available CGMS
options.
The two patents addressed in the recent PTAB rulings are part of
ongoing litigation respecting three of WaveForm's patents. In the
lawsuit filed in the US District Court for the District of
Oregon in 2016, WaveForm
Technologies has asserted that all of Dexcom's G4 and G5 CGM
products sold in the US since 2012 willfully infringe on three
WaveForm patents. According to SEC filings, Dexcom's sales of
products accused of infringement in that case are approximately
$2 billion. The case has been on
hold pending the PTAB decisions since March
2017.
On February 27, in an action
brought by Dexcom against AgaMatrix, Inc., a separate wholly owned
subsidiary of AgaMatrix Holdings LLC, in the Central District of
California, the court ruled in
AgaMatrix's favor by granting Final Judgment of non-infringement of
a patent that Dexcom had asserted against AgaMatrix in that
case.
WaveForm and AgaMatrix believe that these recent legal victories
support the value of its intellectual property and confirm the
merits of its Oregon patent suit
against Dexcom.
WaveForm Technologies is conducting human clinical studies for
their CGMS, and expects to file for CE mark approval for the
product in 2018. The WaveForm CGMS will offer several potential
advantages as compared to currently marketed systems, including
easy and virtually painless on-body sensor insertion, limited
interferences (for example, for patients taking acetaminophen),
rapid, one hour sensor warm up time, and potentially longer sensor
wear life (14 days). The WaveForm system is designed to work with
leading smartphone platforms and utilizes Bluetooth®
wireless technology to transfer glucose data more frequently, with
up to the minute glucose readings viewable directly on a patient's
smartphone without the need for an additional receiver.
About WaveForm Technologies, Inc.
WaveForm Technologies Inc. discovers and develops novel and
proprietary technologies for diabetes care. WaveForm's products
under development include an innovative continuous glucose
monitoring technology, which is currently undergoing human clinical
trials, and related firmware, software and data storage platforms.
WaveForm is also developing a proprietary "artificial pancreas" or
"closed loop" insulin delivery platform designed to provide a
complete solution for patients living with diabetes.
Forward-Looking Statements and Historical Financial
References
This press release contains forward-looking statements, which
provide our current expectations or forecasts of future
events. Forward-looking statements include, without
limitation:
- information concerning possible or assumed future operations,
business plans, product development plans or financial results for
AgaMatrix Holdings LLC and WaveForm Technologies Inc.;
- statements about our potential or prospects for future product
sales;
- statements about our future levels of operating expenses, or
operating profit or loss;
- statements about our research and product development
activities and schedules;
- statements about our future capital requirements and the
sufficiency of our cash, cash equivalents, investments and other
sources of funds to meet these requirements;
- other statements about our plans, objectives, expectations and
intentions; and
- other statements that are not historical fact.
In some cases, you can identify forward-looking statements by
words such as "anticipate," "believe" or "intend," but the absence
of those words does not necessarily mean that a statement is not
forward-looking. Forward-looking statements are subject to known
and unknown risks and uncertainties and are based on potentially
inaccurate assumptions that could cause actual results to differ
materially from those expected or implied by the forward-looking
statements. Our actual results could differ materially from those
anticipated in the forward-looking statements for many
reasons.
You should not unduly rely on these forward-looking statements,
which speak only as of the date of this press release. We undertake
no obligation to publicly update any forward-looking statements to
reflect circumstances or events after the date of this press
release, or to reflect the occurrence of unanticipated
events.
For Additional Information Contact
Cara Mottolo, AgaMatrix Holdings LLC and
WaveForm Technologies Inc.
(603) 328–6000
investors@agamatrix.com
View original content with
multimedia:http://www.prnewswire.com/news-releases/waveform-technologies-receives-favorable-decision-on-critical-glucose-monitoring-patents-300610961.html
SOURCE WaveForm Technologies, Inc.