One of the biggest challenges to treating pain and developing drugs for it is that unlike the size of a tumor of the presence of a pathogen, it’s a highly subjective measure dependent on a variety of external factors. In an effort to overcome these hurdles, a U.S.-based digital therapeutics company is partnering with a Japanese company owned by Swiss drugmaker Roche.
Boston-based Biofourmis and Tokyo-based Chugai said Wednesday that they would collaborate to develop a digital therapeutic for the objective assessment of pain associated with endometriosis. The companies will sponsor a clinical trial that will enroll more than 120 ambulatory patients with endometriosis who will use a wearable biosensor to capture physiology biomarkers and deliver them to a mobile app for monitoring symptoms, analyzing the data using artificial intelligence. Endometriosis affects 1-in-10 women in their 20s to 40s and is a cause of infertility.
Biofourmis CEO Kuldeep Singh Rajput explained that Biofourmis’ sensor works by using three components – an optical signal, a galvanic skin response sensor and an accelerometer – to pick up digital biomarkers like oxygen saturation, energy expenditure and skin temperature. The AI then learns them over time and is able to quantify pain level of a 0-10 scale. The goal is to improve the care of patients with pain problems, as doctors – especially those prescribing opioids – frequently do not know how much of a drug to prescribe, when to prescribe it or when patients should stop taking it.
“So it’s really providing a value-added service on top of pharmaceutical therapy,” Rajput said in a phone interview, referring to Biofourmis’ product.
The Food and Drug Administration gave 510(k) clearance in October 2019 to Biofourmis’ Biovitals analytics engine as a medical device for ambulatory physiology monitoring, a move that the company called part of the agency’s growing recognition of machine learning and AI in the software as a medical device category. It had previously received an approval, in May of last year, for Biovitals RhythmAnalytics, which is for automated interpretation of more than a dozen cardiac arrhythmias. In November, the company partnered with another Swiss drugmaker, Novartis, to remotely manage patients with heart failure.
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