Digital therapeutics company Biofourmis took software into the realm of pharmaceuticals and then brought remote monitoring technology into patients’ homes. Now it has $300 million to ramp up its efforts on both fronts.

The Series D round of financing announced Tuesday was led by General Atlantic.

Boston-based Biofourmis employs artificial intelligence and machine-learning techniques to analyze patient physiological data. When used alongside a drug, the software recommends dose changes. Novartis was Biofourmis’s first pharma industry partner, striking up an alliance in 2019 that pairs the blockbuster heart failure drug Entresto with Biovitals, the FDA-cleared Biofourmis platform. Patients discharged from the hospital and prescribed the Novartis heart drug also receive a prescription for the Biofourmis digital therapeutic. Using sensors on wearable devices, the digital technology captures information that is then used to optimize dosing of the Novartis drug. The goal is to reduce hospital readmissions that are frequent with heart failure patients.

The Biovitals platform is also the basis of Biofourmis’s remote-monitoring technology, which is intended to bring hospital-level care to patients in their homes. Similar to its use with Novartis’s Entresto, the Biofourmis technology monitors physiological signals to provide insights about a patient’s disease progression across dozens of indications. Insight from this virtual care technology, called Care@Home, enables clinicians to intervene before problems escalate. Earlier this year, the company launched Biofourmis Care, a care management service designed that combines medication management and remote care in an offering designed specifically for chronic conditions.

Biofourmis plans to use the new financing to scale up its virtual care offerings, including the expansion of Biofourmis Care to patients with complex chronic conditions. The company sees its technology filling a need to gather data used in value-based care, in which reimbursement of a drug or device is tied to measurable patient outcomes. Biofourmis cites research from McKinsey calculating that $265 billion worth of care services for beneficiaries of Medicare fee for service and Medicare Advantage could shift from traditional clinical sites to the home within the next three years.

The fresh capital will also be used to finance new clinical trials. In an email, Biofourmis CEO Kuldeep Singh Rajput said that the evidence generation strategy spans both Care@Home and digital therapeutics.

“For Care@Home we will focus on more clinical, operational, and economic/ROI evidence generation across the continuum of care—acute, post-acute and virtual specialty care,” he wrote. “For therapeutics, we will advance our own digital therapeutics and combination therapeutics pipeline.”

Biofourmis currently has five combination therapeutics partnerships with drug candidates in cardiology, oncology, and pain. Cardio indications that the company is researching include heart failure, atrial fibrillation, hyperlipidemia, and coronary artery disease. Biofourmis entered the oncology space with the 2020 acquisition of Gaido Health, a remote monitoring technology that Takeda Pharmaceutical had developed for cancer patients. In cancer, Rajput said Biofourmis is focused on the monitoring patients undergoing chemotherapy and radiation treatment, as well as those who have received CAR T treatment, a type of cell therapy that can lead to dangerous side effects. In pain, Biofourmis is developing technologies for managing acute and chronic pain.

Biofourmis is also developing a heart failure digital therapeutic. Similar to the use of the Biofourmis technology under the Novartis partnership, this new digital therapeutic captures patient physiological data for analysis. But instead of sending dose recommendations to a clinician, this new digital therapeutic will send those recommendations directly to the patient. When Biofourmis closed its $100 million Series C round of financing in 2020, Rajput said that this heart failure digital therapeutic would be ready for an FDA submission in 2021. However, Covid-19 led to clinical trial delays. Rajput now says he expects pivotal clinical trials will finish in the current quarter. After that, Biofourmis plans to seek FDA clearance for the technology.

With the new round of funding, Biofourmis says its valuation is now $1.3 billion, pushing the company well into unicorn territory. Since its start in 2015, the company says it has raised $445 million total. Other participants in the latest round include CVS Health, along with earlier investors in the firm. Biofourmis is also bolstering its board of directors with a medical industry veteran. Omar Ishrak, the former CEO of Medtronic, is joining the board as its chairman.

Photo by Biofourmis