|Nemaura's SugarBeat continuous glucose monitoring system--Courtesy of Nemaura|
Nemaura Medical ($NMRD) stealthily listed on the Nasdaq OTC market late last year. That followed a corporate restructuring in late 2013. All this is in the name of developing a novel continuous glucose monitoring system that includes a disposable patch, a watch and a smartphone app--that the company has dubbed SugarBeat.
Now Nemaura has started a joint venture in anticipation of an EU launch for the device next year after it receives an anticipated CE mark, for which it expects to apply this month. The JV is with DBJ Jersey, whose founder, Dr. Dallas Burston, recently sold U.K. branded pharma company DB Ashbourne to French sustained release drug player Ethypharm.
Alongside the JV, Burston also is investing personally $10 million into Nemaura. He bought 5 million shares for $2 apiece and gained warrants for an additional 10 million shares at a $0.50 exercise price. Shares in the highly illiquid small-cap are trading publicly at about $1.75 shortly after the announcement.
"The methods of measuring blood glucose levels, and managing the longer-term complications of diabetes are expanding very quickly. The landscape is rapidly changing towards less invasive wearable devices," Burston said in a statement. "Together with intelligent use of data, I believe that there is potential to reduce the overall healthcare burden."
The company's aim is to market the SugarBeat system to Type 1 and Type 2 diabetics, as well as for use as for pre-diabetic screening. The expectation is that this system would eliminate the daily finger-prick calibrations that are required typically with CGMs. In addition, unlike many existing CGMs that integrate an insulin pump aiming for a Type 1 diabetic population, SugarBeat does not. However, the system is expected to be, at least initially, still be used as an adjunct to other methods.
Last year, with much fanfare, the blood glucose monitor mainstay Abbott ($ABT) launched its Freestyle Libre CGM in the EU that also doesn't require daily finger calibration--but it does need a dedicated handheld monitor. DexCom ($DXCM) also got an FDA nod for a patch-based, smartphone-connected CGM in August that also requires a worn transmitter.
The SugarBeat patch sensor works by applying a small electrical current to the skin to extract glucose into a chamber within the patch for measurement. Some other CGMs rely upon tiny needles that are inserted into the skin. The continuous data can be transmitted wirelessly to display on the watch and/or the smartphone app.
The company expects to conduct U.S. trials aiming for FDA approval of SugarBeat during the first half of 2016. Interim data from October in a trial in Type 1 and Type 2 diabetics found patients were able to reduce the difference between CGM values and finger-stick measures from 18% to less than 12%.
"Nemaura's SugarBeat system has been developed to provide a very cost effective and minimally invasive alternative for diabetics," concluded Nemaura CEO Dr. Faz Chowdhury.
- here is the announcement