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.
With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
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.
Photo: boygovideo, Getty Images