CE Mark Digital Health Sensors

WaveForm Technologies Inc. Awarded CE Mark Approval for Their Continuous Glucose Monitoring System

Novel CGM System Offers 14 Day Wear, Simple, Virtually Pain-Free Insertion and Minute-to-Minute Glucose Readings Transmitted Directly to Smartphone

WILSONVILLE, Ore.Nov. 5, 2019 /PRNewswire/ — WaveForm Technologies Inc. a wholly owned subsidiary of AgaMatrix Holdings LLC and developer of novel continuous glucose monitoring products, today announced it has received CE Mark (Conformité Européenne) approval for its Cascade Continuous Glucose Monitoring (CGM) system. Commercialization of the product for the European market is anticipated to begin in select countries.

The WaveForm Technologies Cascade CGM system is based on several pioneering, patented innovations in glucose sensor technology offering users a convenient way to view up-to-the-minute glucose readings on a smartphone. This innovative system continuously monitors glucose levels in interstitial fluid through a small, disposable sensor that can be worn on the body for up to 14 days. Together, the sensor and Bluetooth® transmitter accurately measure and transmit glucose data to the mobile app every minute, without the need for an additional receiver device.

“This is a substantial milestone for our company and marks our commercial entrance into the transformative and rapidly growing CGM marketplace,” said John Alberico, CEO of AgaMatrix Holdings LLC. “The CE approval of the WaveForm CGM system allows us to reach a broader patient base and provide a powerful new tool in diabetes management. This achievement is shared with all our employees, and I want to take this opportunity to thank them for their tireless efforts and dedication.”

Real-time glucose data provided by the WaveForm CGM facilitates blood glucose control through informative glucose trends, predictive and customizable alerts, and personalized glucose reports. Persons ages 2 years and older, including pregnant women and those requiring dialysis treatment, can use the WaveForm CGM in making diabetes treatment decisions. Unlike similar systems on the market which use a needle to apply the glucose sensor, the novel sensor and applicator design for the WaveForm CGM enables a needle-free, virtually pain-free experience.

“We have demonstrated the performance of our system in extensive clinical testing, and the introduction of the WaveForm CGM system to the market represents another step forward in helping persons with diabetes maintain control of their lives,” stated Mihailo Rebec, CTO for WaveForm Technologies. “The user experience has always been foremost in our minds during the development of this system and by delivering glucose results every minute, the WaveForm CGM will allow users to make real-time diabetes management decisions.”

The WaveForm CGM system consists of a thin filament (sensor) that collects glucose data from just below the skin which is processed and wirelessly transferred to a mobile app through a small transmitter. The rechargeable transmitter lasts an entire 14 day session on one complete charge, and uses Bluetooth® wireless technology to transfer data to an Android and iOS compatible mobile app.

The WaveForm CGM system also provides the following user benefits:

  • Needle-free sensor insertion, which is virtually painless and reduces insertion complications observed with other systems, such as bleeding at the insertion site.
  • Non-adjunctive use, which empowers users to make diabetes treatment decisions using data from the WaveForm CGM without the need to confirm their glucose level through a fingerstick test.
  • Predictive glucose alerts, which notify users 15 minutes before a predicted high or low glucose level, providing time to act and potentially avoid severe hypoglycemia or hyperglycemia.
  • Customizable glucose alerts, which notify users when something happens that requires their attention, such as a low glucose level, quickly rising or falling glucose levels, and more.
  • Industry-leading “catch-up mode” to sync valuable glucose data from the past 24 hours from the on-body transmitter to the app, anytime a user was inadvertently separated from their app.
  • Trend arrows and color-coded app visuals to help users distinguish the trended direction of their glucose levels, high and low glucose levels, and glucose history over the past 1, 3, 6, 12, or 24 hours.
  • Reusable sensor applicator and transmitters over a multi-year lifespan, which reduce plastic biological waste concerns associated with single-use systems on the market.
  • Limited interference concerns, for example for those taking acetaminophen.
  • Limited calibrations, 1 per day after initialization, to reduce the amount of fingerstick testing needed while optimizing CGM performance.
  • Rapid warm up time, so that users can start to view glucose data in less than 1 hour.
  • Personalized glucose reports to help users and their healthcare team better visualize time-in-range trends.

WaveForm Technologies is also conducting clinical trials for extended sensor wear time and preparing for clinical studies in the U.S. WaveForm anticipates filing an application with the FDA for the clearance of their CGM system in 2020, with U.S. commercialization anticipated in 2021.

About AgaMatrix Holdings LLC, and WaveForm Technologies, Inc.

AgaMatrix Holdings LLC is a holding company for two businesses that develop novel and proprietary technologies for diabetes care, AgaMatrix Inc. and WaveForm Technologies Inc.

WaveForm Technologies Inc. discovers and develops novel and proprietary new technologies for diabetes care. WaveForm’s products under development include innovative continuous glucose monitoring sensor technology, related firmware, software and data storage platforms. WaveForm is also developing a proprietary “closed loop” insulin delivery platform designed to provide a complete solution for patients living with diabetes.

AgaMatrix Inc. provides diagnostic technologies for diabetes care, including blood glucose monitoring devices and related firmware, software and data storage solutions. AgaMatrix has developed, manufactured and commercially launched 17 blood glucose monitoring products since the Company’s 2001 inception, and produced over 8 million blood glucose monitors and over 3 billion test strips. AgaMatrix Inc. owns and operates manufacturing and engineering facilities in Salem, NH USA and in Guangdong ProvinceChina.

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

SOURCE WaveForm Technologies Inc.

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