Biofourmis, a health technology developer specializing in digital medicine and virtual care solutions, has landed $300m USD in a Series D investment round, with contributors including CVS Health. The company intends to use the investment funds (which brings its total raised to $445m USD) to grow its digital medicine, fund clinical trials to advance digital therapeutics (DTx), and expand its Care@Home virtual care platform.
To learn more about the investment and the company’s plans for the road ahead, Outsourcing-Pharma reached out to Jaydev Thakkar, chief operating officer.
OSP: Please talk about how the field of digital medicine has evolved in the years leading up to the pandemic.
JT: The evolution of digital therapeutics started with mental health and using digital interventions to change behaviors, modify lifestyles, and engage patients in their care. Since then, and partially due to the COVID-19 pandemic, US Food and Drug Administration (FDA) approvals of digital therapeutics have broadened in scope, such as our Breakthrough Device designation we earned last year for our BiovitalsHF digital therapy for heart failure.
A digital therapeutic can be approved as monotherapy or it can be combined with a pharmaceutical or specialty drug to improve the drug’s efficacy and safety profile. We are engaged in developing our own digital therapies but also work with pharma companies to optimize and support their drugs.
From many pharma companies that we work with, we have seen a significant shift in their digital medicine strategy with long-term investments made in digital companion products from very early stages of clinical development programs for novel drugs. Also, use cases for the digital companion to a novel drug vary based on the therapeutic area; often we partner with pharma companies in pre-clinical and early development phases to develop a drug-specific, unique digital companion solution.
For example, a digital therapy could have applications in oncology, where it is often critical to carefully manage potential negative side effects of drugs, such as detecting sepsis or cytokine release syndrome associated with CAR-T cell therapy. Pain is another area where digital components can more precisely measure a patient’s condition, objectively translate that into a pain score, and allow the appropriate titration or intervention to pain medications. The most essential element now to drive the evolution forward is to build clinical validation around these therapies; we have multiple clinical trials in various stages of completion.
OSP: How did the challenges created by the global pandemic impact interest in and demand for digital health solutions, especially regarding drug development and clinical research?
JT: The widespread hospital overcrowding issues we experienced through various surges in the pandemic demanded providers, researchers, and life sciences companies rapidly reconsider which patients truly needed to be in a medical facility and who could be safely cared for at home supported by tech-enabled monitoring and management. That led to a major expansion of remote patient monitoring and demand for related technology across a wide range of acute, post-acute, and chronic conditions.
It also prompted the Centers for Medicare and Medicaid Services’ Acute Hospital Care at Home program where patients with certain acute conditions can be admitted to their homes instead of a hospital facility. Under the program, hospitals are incentivized to admit to the home because they receive the same reimbursement rate as if the patient were in a facility. As studies have shown, home-based acute care can deliver equal if not better outcomes and a better patient experience while lowering costs.
These factors also urged clinical researchers and life sciences companies to explore new ways to study and develop drugs with decentralized or completely virtual clinical trials. Many pharmaceutical companies started to collect data remotely through wearables and devices to support clinical research and commercial projects to enhance a drug’s efficacy and improve engagement.
To ensure that the data collected remotely is relevant, artificial intelligence (AI)-/machine learning (ML)-based tools are needed to process multiple physiologic parameters and detect the context. For example, sensors and analytics can determine if a patient is sleeping, running, or climbing stairs, which can help avoid false-positive notifications that can contribute to clinician alert fatigue.
Biofourmis’s FDA-cleared Biovitals Analytics Engine can combine activity data with heart rate, respiration rate, oxygen level, and multiple other parameters to more meaningfully describe a drug’s effects on a patient. Our analytics engine—which is now calibrated with more than 8m real-world data points—offers a level of precision that life sciences companies need when deciding whether to move forward with a new product.
This level of personalization improves safety, too. Continuous data collection combined with algorithms that process the data in near real-time can notify researchers and clinicians to engage with the patient by phone or a video telehealth visit if there’s a potential issue. All these pieces coming together is where we see the safety and efficacy of drugs being improved while patients’ lives are being improved or even saved through early interventions on a timely basis.
OSP: Then, could you please share a little bit about all the happenings at Biofourmis—achievements, milestones, tech releases, etc.—in the past couple of years?
JT: The pandemic and the CMS home-hospital program have accelerated the demand for the virtual care and digital medicine solutions that Biofourmis offers. Since the pandemic began, Biofourmis has grown to more than 500 employees, gained numerous clients across the ecosystem, published peer-reviewed research, and secured $300m in additional funding.
Among the most notable agreements in the pharmaceutical arena is a clinical trial we are participating in, which is being led by Vanderbilt University Medical Center, concerning chimeric antigen receptor (CAR) T-cell therapies. These treatments, which utilize the patient’s white blood cells, have demonstrated the ability to eradicate very advanced leukemias and lymphomas and to cause remission for several years.
Although they are effective against certain blood cancers and have the potential to be successful against other strains, the therapy is not without its risks. It possesses a unique set of acute toxicities that include cytokine release syndrome (CRS) and neurologic toxicity, which can be fatal and requires close management following treatment. As a result, patients often need to stay in the hospital for a week or longer while they are monitored. While CRS is a common reaction, serious CRS (grades 3 or higher) occur in as few as 2% of patients and as many as 22%, according to a review of trials.
Vanderbilt is examining whether lymphoma patients can be safely and effectively monitored in a home-like setting using Biofourmis to monitor participants and notify clinicians if a patient is likely to decompensate, requiring an intervention. The researchers hope that this pilot study leads to a larger trial verifying the safety and efficacy of home-based recovery and monitoring after CAR-T therapy, which has the potential to be a significant cost saving for healthcare providers and payers, while also vastly improving the patient experience.
We also completed a poster presentation at the Heart Failure Society of America conference of a proof-of-concept study. We demonstrated that patients with heart failure with reduced ejection fraction within three months can be optimized to their target drug dose and therapy using our BiovitalsHF® digital therapy. This study is important because only 1% of patients are on the optimal dosage of heart failure medication and less than 20% even receive guideline-directed medication therapy. Another study shows that improper medication selection and dosage are associated with 57% of hospital readmissions among these patients, which presents a major economic burden, as well as a clinical issue.
We demonstrated two hard endpoints in our pilot. One was that the remote, tech-enabled medication optimization improved patients’ quality of life and functional capacity. The second was we showed, also within three months, a significant reduction in N-terminal pro-b-type natriuretic peptide (NT-proBNP), which is an important blood biomarker indicating heart health. We also wanted to ensure clinicians were reviewing and accepting the recommendations from BiovitalsHF, which occurred around 95% of the time.
We anticipate completion of a pivotal trial with this solution by the third quarter of this year and approval either by end of the year or the first quarter of 2023. At the same time, other than the Breakthrough Device designation we earned last year, we have three additional Breakthrough Device applications currently with the FDA.
Biofourmis’ Care@Home solution was also featured in a peer-reviewed clinical trial published in the journal Nature. Researchers at the Queen Mary Hospital in Hong Kong concluded that Biofourmis’ AI/ML platform for remotely monitoring patients with COVID-19 delivered more accurate and timely predictions about increased viral load than traditional methods.
Lastly, Biofourmis completed its Series D financing round, securing an additional $300m led by growth equity firm General Atlantic, bringing our total investment to more than $445m and a valuation of $1.3b, surpassing unicorn status. Our Board of Directors is also now chaired by former Medtronic CEO and current Chairperson at Intel Dr. Omar Ishrak. Dr. Ishrak’s guidance combined with the major influx of funding will help us further optimize our solutions, expand our health system customer base, and forge new partnerships with pharma and life sciences companies.
OSP: Please share some detail about new developments and expanded efforts that this latest growth investment might be used to fuel.
JT: Our goal with the funding round before this, our $100m Series C, was to expand our digital therapeutics pipeline, as well as pharma partnerships. We initiated several clinical trials and moved from proof of concept to pivotal trials and are now working with 15 of the 20 top pharma companies (based on revenue). With this $300m Series D round, we will continue to expand our pharma agreements and our digital therapeutics pipeline.