The 7% jump in Nemaura Medical’s shares is likely a result of investors’ confidence that the performance of its needle-free glucose monitoring technology in the clinic will attract an acquirer – the UK company is surely too small to compete with the likes of Abbott, Medtronic and Dexcom on its own.
But are the trial results good enough? The top-line results come from a subset of 25 patients in an open-label, single-arm trial, and the only data point released suggests the monitor is no better than marketed devices. It seems unlikely that one of the big players would feel the need to take out Nemaura, at least on this showing.
Nemaura’s glucose monitor is called SugarBeat and consists of a disposable patch sensor connected to a rechargeable transmitter, with a mobile app displaying glucose readings at regular five minute intervals. The patch is worn on the upper arm and passes an imperceptible electric current across the skin, drawing a small amount of glucose out of the interstitial fluid for analysis.
Nemaura says that “unlike competing systems from Dexcom or [the] Abbott Libre device”, SugarBeat does not require the insertion of a needle-like sensor into the skin.
In a right Mard
The European trial from which the subset was taken enrolled 75 patients, 80% of whom had type 1 and 20% type 2 diabetes. The patients wore SugarBeat for 14 hours on seven consecutive days. On three of those days venous blood samples were also taken at 15 minute intervals over a continuous 12 hour period.
Comparison of the SugarBeat readings with the blood samples showed an overall mean absolute relative difference (Mard) – a measure of how far away the glucose sensor reading is from a reference blood glucose reading – of 13.76%.
This compares to published Mard values of between 13.6 and 9.0 for marketed continuous glucose monitors (CGMs). The device boasting the lowest variance from blood samples is Dexcom’s G5, which was approved in the US in 2015 but a year later gained the FDA’s further approval as a way for patients to make diabetes treatment decisions without confirmation with a traditional fingerstick test.
|CGM accuracy comparison|
|Abbott Laboratories||FreeStyle Libre||11.4|
|Abbott Laboratories||FreeStyle Navigator II||12.3|
|Sources: company websites, published data|
But Mard is only one measure of a CGM’s accuracy, and a fairly crude one – for a start it does not take account of whether the readings of a particular CGM are higher or lower than the reference values. And the table above naturally involves data from separate trials and is therefore far from an ideal comparison.
Neither is Mard the main criterion when patients, doctors or payers evaluate a device. At the moment, for instance, Abbott’s Freestyle Libre is the subject of most excitement by far, thanks to its ability to free patients from frequent calibration with fingerstick blood tests (Dexcom crashes as Abbott FreeStyles its way to the US, September 28, 2017).
When Abbott released its fourth quarter results last week it reported that revenues from its Diabetes Care unit increased 27.6% quarter-on-quarter on an operational basis, and with the new CGM having recently gained Medicare coverage further sales growth is near-inevitable.
Nemaura has not yet begun US trials of SugarBeat, but it expects the device to get European CE mark “in the coming months”, after which it will launch the device in the UK and then in other countries.
It will then enter a market dominated by the two largest medtech companies in the world – plus Dexcom, which though much smaller than Abbott or Medtronic is still vastly larger than Nemaura. Perhaps one of them will see something in Nemaura’s technology that it feels makes the tiny company worth buying. Nemaura and its shareholders must hope so, because it will have a hard time competing on its own.
|Nemaura: a minnow among sharks|
|Company||Market cap ($bn)||WW 2017 medtech sales ($m)||Number of employees|
|Nemaura Medical||0.38||Nil||3, plus 12 contractors|
|Sources: EvaluateMedTech, Yahoo Finance|