Memorandum
GWave uses RF-based sensing to measure capillary blood glucose; no details on any potential study or regulatory submission timing
We put in our competitive landscape for BGM/CGM a new company last week, Hagar.
It is developing GWave, which measures glucose using radio frequency (RF) - though it is not continuous technology, it is very similar to the “flash” glucose monitoring that Abbott FreeStyle uses that requires a “wand” action to check - but no finger sticks and no inserted sensors! Dr. Irl Hirsch is a medical advisor, and we learned about it through him and his brother Jim, who also just wrote a story about it in DiaTribe.
Our take on the advantages are (i) no lag (none!); (ii) it could be in a wristwatch one day with no sensor under the skin needed; (iii) there is no calibration needed; (iv) there is no disposable needed; (v) it will be very inexpensive to manufacture if development goes well. It is being developed by retired leaders in the Israeli military who also have extensive experience in engineering and technology as well as business. Funding so far includes a seed round as well as money from a Serie A. Potential downsides are all the other non-invasive companies that haven’t worked (xxxx, Fovi Optics, etc.), first-gen product that will be perceived as very easy to use by some and inconvenient for others (it’s a ceramic object to wear on wrist - even if that is inconvenient to some, this should be only a temporary issue since the second gen is planned to be in a wristwatch), and regulatory (the company wants the first approval to be in the US, where the FDA is very busy outside new projects, with delays at Abbott, Dexcom, Tandem, Senseonics, and Medtronic, to name a few - on a brighter note, Bigfoot did recently get approval, so they like innovation …). Questions include how the technology works, how the IP will play out (filed in Israel), what the data management plan would be, how the accuracy is (said to be high, based on 15,000+ tests to date and one small clinical trial), perceived and real hassle factor, regulatory, and whether or not it could be used for people with pre-diabetes and people on the closed loop. We see this as a great potential substitute for BGM for virtually all that use it and as a cool leapfrog for many in low- and middle-income countries who have no access to BGM. It will also be far more accessible if things go well for many to replace CGM who do not use closed loop (it would not be approved for closed loop until, at minimum, it is actually continuous).
--by Kelly Close