Singapore-founded health technology startup Mesh Bio has announced the regulatory approval of its HealthVector® Diabetes as a Software Medical Device (SaMD) by the Health Sciences Authority (HSA).
Mesh Bio said in a statement on Thursday that HealthVector® Diabetes will be involved in an implementation pilot at Singapore General Hospital (SGH), Tan Tock Seng Hospital (TTSH), and selected polyclinics for potential clinical adoption.
According to the statement, the implementation pilot is supported by the National Health Innovation Centre Singapore (NHIC), through the Innovation to Adopt (I2Adopt) Grant.
HealthVector® Diabetes, a metabolic digital twin-based SaMD developed using computational systems biology and artificial intelligence, is intended to predict a three-year onset risk of chronic kidney disease (CKD) in patients with type 2 diabetes.
Its algorithm uses anonymized clinical data from the hospitals’ electronic medical records to derive a risk score for prediction of worsened kidney function.
HSA’s approval of HealthVector® Diabetes came on the back of a validation study led by SGH, using SingHealth Diabetes Registry dataset, and the National Healthcare Group (NHG)’s Chronic Disease Management Datamart.
According to the statement, diabetes continues to affect many individuals worldwide, and one of its complications is CKD.
Cited the National Population Health Survey 2022, it said about one in 12 of Singapore residents have diabetes.
It said a local study has also found that about 40 percent of diabetes patients will go on to develop CKD1.
It noted that if not managed, CKD could lead to kidney failure.
Cited a recent report, it estimated that dialysis costs Singapore SGD 300 million ($219 million) each year.
“Our mission at Mesh Bio is to deliver actionable solutions utilizing state-of-the-art predictive analytics to mitigate complications from chronic diseases like diabetes,” said Arsen Batagov, Co-Founder and Chief Technology Officer of Mesh Bio.
According to him, the regulatory approval of HealthVector® Diabetes by HSA, is a monumental achievement, marking a new era of innovation in patient care.
“We are dedicated to improving the lives of patients and are excited about the potential of HealthVector® Diabetes to predict chronic kidney disease risk in type 2 diabetes patients,
“HealthVector® Diabetes is our commitment to a future of proactive and tailored healthcare,” he added.
Associate Professor Bee Yong Mong, Head and Senior Consultant, Department of Endocrinology, SGH, who led the validation study, said that about two in three cases of kidney failure in Singapore are due to diabetes.
“As one would expect, the socio-economic burden associated with kidney diseases will grow exponentially given the rising number of diabetes patients,
Associate Professor Rinkoo Dalan, Senior Consultant of Endocrinology from TTSH, who co-led the research study, said that the mechanistic digital twin paradigm within HealthVector® Diabetes provides new insights into patient health trajectories.
“It can enable clinicians to design and implement a personalized care plan for patients with diabetes to prevent specific complications,” he said.
He also said collaborating in synergy with industry partners like Mesh Bio strengthens their focus on harnessing innovation and precision medicine to improve preventive and population health.
Mesh Bio is a health technology startup dedicated to the digital transformation of care delivery.
With a focus on clinical workflow automation and predictive analytics, Mesh Bio aims to revolutionize the healthcare landscape.
The company’s flagship product, HealthVector Diabetes (HVD), is the world’s first digital twin approved for clinical use, predicting CKD risk in Type 2 diabetes patients.