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 [email protected]