Memorandum

WaveForm partners with A. Menarini Diagnostics to commercialize CGM internationally – April 25, 2019

CE Mark still anticipated in 2019; A. Menarini to provide sales, marketing, training, and customer support for WaveForm’s CGM in EMEA and LATAM

WaveForm Technologies, a subsidiary of AgaMatrix, recently announced a distribution partnership with A. Menarini Diagnostics to commercialize the “WaveForm Technologies CGM” – previously branded the Cascade 1 CGM. Italy-based A. Menarini will perform sales, marketing, training, and customer support for WaveForm’s CGM in territories throughout Europe, the Middle East, Africa, and Latin America. No specific terms of the agreement were provided, though the partnership was characterized as “long term.”

A. Menarini is an unconventional partner choice – while it has an established diabetes device portfolio with personal and hospital BGMs, lancing devices, and insulin pen needles, it does not have major market share (that we are aware of – admittedly, this field has become harder to follow again with various divestitures following pricing cuts in the US).

The press release confirms the WaveForm CGM’s anticipated CE Mark in “2019” – at DTM, we heard more specifically that it would launch in the EU in “3Q19.” This agreement with A. Menarini Diagnostics is an early sign that the CGM is progressing towards commercialization.

The product’s commercial feature set remains unclear. At DTM, the implication was WaveForm’s CGM would require calibration, and accuracy did not look as good as the no-cal Dexcom G6 or Abbott FreeStyle Libre. The press release reiterates “extended wear time and virtually pain-free insertion”; it’s unclear if the former means 14-day or longer wear. We assume the plan is still a reusable, needle-free inserter (the sensor filament pierces the skin and stays in place); no receiver (Bluetooth-to-phone); one-hour warmup or less; a reading every minute, and a rechargeable transmitter.

Can WaveForm successfully launch a competitive CGM in Europe? Can it compete with FreeStyle Libre on price? Can it match G6 and FreeStyle Libre 2 on features? WaveForm has pushed back its CGM launch timelines meaningfully over the past few years, though perhaps there is clearer line of sight to a launch now. As of DTM, a US pivotal study of the CGM was expected from September to November 2019 ahead of an FDA filing in December 2019.

AgaMatrix and A. Menarini are also discussing terms to commercialize an AgaMatrix Bluetooth-enabled BGM (presumably Jazz Wireless 2), as well as future enhancements to the WaveForm CGM. Plans remain to develop a “vertically integrated” automated insulin delivery system, though specifics have not been shared for some time. As of last June, WaveForm had licensed two hybrid closed loop control algorithms from OHSU. The company expected to begin testing the hybrid closed loop system this year with its CGM, the OHSU algorithms, and a “specifically-selected” pump (which WaveForm previously said it intends to own or build in-house).

 

--by Maeve Serino, Adam Brown, and Kelly Close