“We wanted to make sure that our models are trained at a granular level, at a raw sensor-data level,” said Kuldeep Singh Rajput, founder and CEO of the Biofourmis, a four-year-old startup, said in a phone interview.
The company’s chief product, BiovitalsHF, uses predictive analytics and artificial intelligence to anticipate problems in patients with heart failure. It works in conjunction with an app that captures continuous physiological data, which is processed on the company’s FDA-cleared analytics engine. Doctors can use the data and get recommendations for adjusting treatment.
Biofourmis had been taking an agnostic approach to hardware, with its software running on about 20 devices, including armbands, patches and wrist-worn devices, Rajput said. But most device makers do not share all the raw sensor data that Biofourmis felt it needs as it adds more conditions to be treated with its predictive analytics. In addition to heart failure, the company is focused on COPD, oncology and pain.
“As we scale the company, it becomes critical that we have our own biomarker capturing data in the ecosystem,” Rajput said.
That’s where Biovotion, based in Zurich, Switzerland, came in. The company’s device, an armband called Everion, was the best of those that have been running with the Biofourmis platform, Rajput said.
The Everion armband measures 22 parameters in real time, including heart rate, respiratory rate, blood oxygenation and skin temperature. The next iteration of Everion is expected to pick up even more, including continuous blood pressure. It also will have longer battery life and communicate via Bluetooth and GSM, instead of just Bluetooth.
Biofourmis also announced Monday that it is undertaking a commercial project with Novartis to manage potentially millions of heart-failure patients. Patients who are taking Novartis’ Entresto drug will wear Everion devices powered by BiovitalsHF. The partners aim to reduce hospital readmissions and emergency-room visits.
“It is far better than any other device existing in the market today,” Rajput claimed of the Everion device.
Who else is in that crowded market?
There are consumer-friendly devices like the Kardia and the newest Apple Watches, which measure EKG, and of course Google’s Fitbit, many of whose products measure heart rate. There also are implantable sensors from companies such as Boston Scientific, Medtronic and St. Jude Medical.
Under Biofourmis’ program, patients wear a biosensor for 12 weeks after a hospital discharge. The greatest risk of hospital readmission due to heart failure is in the first 30 days but the 12-week program affords enough time to ensure patients are on the optimal dose of medication. The wearable is just as effective in anticipating problems in patients, but less expensive and less invasive, than an implantable device, Rajput added.
Biofourmis plans to use Everion for most of its applications and products, but it will continue to make its analytics platforms available for use on other devices, Rajput said. Health systems or remote-monitoring companies, for example, can send data to be processed on the Biofourmis platforms and then used to intervene as needed in patient care.
Rajput is not shy about making grand declarations about the future of the company. For instance, while the current valuation of the company is nearly $500 million, he predicted it would hit so-called “unicorn” status, a $1 billion valuation, within 24 months based on its revenue so far, its portfolio of intellectual property and expectations that some of its products will earn FDA breakthrough designation.
However, while being more forthcoming than most startup CEOs about valuation, Rajput declined to disclose annual sales, ony noting that Biofourmis has been generating revenue since 2017. Revenue for the first three quarters of 2019, he declared, was about four times the company’s revenue in all of 2018.
Perhaps Rajput’s confidence stems in part from the abovementioned partnership it has struck with Novartis, the Swiss drugmaker who appears to be fairly invested in connected health and digital therapeutics. The project with Novartis where patients using a Novartis drug wear the Everion armband began in November in Singapore, Malaysia, Thailand, the Philippines, Taiwan and South Korea. These are the regions where Novartis wants to persuade payers to cover Entresto, Rajput said.
Additional areas, possibly including the U.S., could be announced in the first quarter or early in the second quarter of 2020, he said.
Biofourmis has partnerships with other pharmaceutical companies but Rajput declined to name them. In the meantime, the company is continuing to develop its BiovitalsHF platform and preparing to roll out others.
The next version of BiovitalsHF will allow doctors to automate therapeutic interventions so they are sent to patients directly, Rajput said. Doctors will be able to turn off the automation mode if they want, he added.
In addition to its platform for heart failure, Biofourmis is working to develop analytics for use in pain management and oncology.
BiovitalsPain would track pain levels and help patients stick to their treatment plans. It has been validated for post-orthopedic surgery and cancer pain, Rajput said. BiovitalsOnco would allow for remote monitoring of cancer patients with a focus on assessing pain and preventing sepsis or other infections, Rajput said.