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Kuldeep Singh Rajput, the founder of Boston-based Biofourmis, is imagining a future where heart failure patients go home with a prescription, a wearable sensor and an app. Today, a new FDA designation gets the company one step closer to that goal.
Founded in 2015, Biofourmis is a digital therapeutics company that develops software to “augment” patient care. So far, the company has raised about $145 million in funding, and has around 350 employees, Rajput estimates.
On Thursday, Biofourmis BiovitalsHF, a platform designed for heart failure medication monitoring received an FDA breakthrough device designation. Breakthrough device designation doesn’t signal FDA clearance, but it does allow for an expedited review process, and gives the company access to expertise from the federal agency during development.
Biofourmis has two major focus areas, says Rajput. The first is on developing digital therapies in conjunction with drug companies (apps for dosage delivery, for instance, or sensors that can monitor health). The second is on providing followup care for patients with acute conditions at home.
BiovialsHF is an example of the company’s forays into that first area of focus. So far, the company has developed digital therapies for a “pipeline” of conditions, like coronary artery disease or atrial fibrillation, and has digital therapies in the works for patients managing chemotherapy, or people dealing with chronic pain. The BiovitalsHF system, though, is the first to receive FDA breakthrough designation, and Rajput calls it the company’s “lead digital therapy.”
The BiovitalsHF product is a software platform designed manage medication for patients with heart failure. The idea is patients may initially get a certain prescription, but once they go home, they might need to adjust the levels of certain medication they’re taking.
Doctors do often treat heart failure with multiple medications, and doses may need to be changed over time. Particularly in the case of two types of medication, ACE inhibitors or beta-blockers, medication may need to be titrated – a process where a patient begins treatment on a low dose, and slowly up the dosage over time to achieve the optimal “target” dose.
However, titration is hard to achieve in real life – one 2020 study suggests that less than 25 percent of heart failure patients are on their optimal dosages (other studies suggest it’s less than one percent). Another 2017 commentary in Cardiac Failure Review estimates that just 29 percent of patients were on target doses of ACEs and 18 percent on their target beta blocker dose.
By contrast, in clinical trials, many to 50-60 percent of patients manage to obtain their optimal dosages, suggesting that there is a gap between how people take medicine in studies and how they do so in the real world.
BiovitalsHF is supposed to streamline the titration process once patients leave hospitals by collecting and analyzing data from a wearable device. That data, in theory, could be used to titrate the medication depending on a patient’s health status.
The software tweaks medication dosage using information from the patient, a wearable, and outside lab results. The wearable device would collect data like heart rate, respiration rate, stroke volume or cardiac output. Meanwhile, a patient might report their own symptoms into an app, and a physician might input lab results.
“Based on the data collected from the patients using sensors, and the mobile platform, we are able to automatically up titrate or down titrate and switch medication, so that patients are on the right, optimal dose,” says Rajput.
Patients would then receive a notification to let them know medications were going to be tweaked.
The BiovitalsHF program has only been tested in one proof-of-concept study (more on that later), but the Biovitals patient monitoring platform has been tested on other diseases as well.
For example, the Biovitals system was adapted to monitor 34 mild COVID-19 patients from the Queen Mary Hospital in Hong Kong who wore a biosensor 23 hours per day. A paper published in Scientific Reports suggested that the platform was able to predict whether a patient would deteriorate with 93 percent accuracy, and predict length of hospital stay with 78 percent accuracy.
The BiovitalsHF system is slightly different. While the system does aim to monitor patients, Rajput aspires to have the technology itself be administered as a treatment program.
In essence, a doctor might “prescribe” you three months of BiovitalsHF program in which the software itself might monitor patient outcomes and help determine dosage on its own.
The aim is to be able to market Biovials HF not just as a decision support software, but as a treatment regimen. The distinction is subtle, but it means that the company is trying to be more than a delivery device, and more like a drug in itself.
“The label of the product for digital therapy will have actual treatment claims as compared to just a monitoring tool for clinical decision support,” says Rajput.
Naturally, you need robust results to make these claims. The company has already done some early testing of the concept in a proof-of-concept clinical trial that concluded in March 2021, but will need to perform more rounds of testing in the future to prove efficacy.
The study monitored 282 patients for 90 days, and compared people using BiovitalsHF to those using regular standard of care. The goal of the trial was to determine whether the platform could optimize medication dosage – which, in this case, means getting them within 50 percent of optimal dose.
Results have yet to be posted publicly from that study. However, Rajput notes that the study did meet that endpoint, and seemed to be linked with other improvements in patients’ life quality and heart health.
“Patients had, within three months, significant increases in quality of life, cardiac function, as well as reduction in a blood biomarker NT-proBNP [a marker of heart failure]. Based on this, we submitted the data to the FDA and received the breakthrough designation,” he says.
The company has submitted the data for publication in a peer-reviewed journal.
With the breakthrough designation in hand, we might expect progress on BiovitalsHF to proceed quickly – though it’s still a long way from true FDA approval, or even a premarket approval at the moment.
“We will be kicking off our pivotal trial, you know, anytime now. And we expect to make a formal submission to the FDA sometime in June [or] July next year,” Rajput says.
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Virtual reality did not turn into the ultimate office replacement telepresence machine during the pandemic — and it wasn’t for lack of trying — but some startups focused on employee training in VR have found added validation in the past year as professionals across industries were forced to access institutional knowledge in remote settings.
Osso VR, a San Francisco-based virtual reality startup focused on medical training, has piqued investor attention as they’ve bulked up on partnerships with medical devices powerhouses like Johnson & Johnson, Stryker and Smith & Nephew during the pandemic. The startup tells TechCrunch they’ve recently closed $27 million in Series B funding led by GSR Ventures with additional participation from SignalFire, Kaiser Permanente Ventures and Anorak Ventures, among others.
CEO Justin Barad tells TechCrunch that the pandemic “created an intense level of urgency” for the startup as customers found new demand for their platform.
Osso VR is looking to upend modern surgical instruction with a virtual reality-based solution that allows surgeons to interact with new medical devices in 3D space, “performing” a surgery over and over on a digital cadaver from the comfort of anywhere they have enough room to stretch out their arms. Osso’s efforts are particularly useful to its medical device customers who can use the platform to boost familiarity with their solutions while helping surgeons gain proficiency in implanting them.
One of the startup’s broader aims is to bring video games’ multiplayer mechanics into the virtual operating room, allowing surgeons and medical assistants to collaborate in real-time so they not only know their responsibility but how they fit into the whole of each operation.
“It’s a lot like a symphony, everyone has a different role to play and you need to communicate with each other.” Barad says.
It’s a process that needs virtual reality’s spatial breadth, Barad notes, though instruction is always supplemented by text and videos as well.
Barad calls the startup’s aim “something unambiguously good,” a quality which has helped the team poach talent as it has scaled to some 100 employees, which includes what he claims is the world’s largest team of medical illustrators. That team has helped scale the platform’s content to more than 100 modules spanning 10 specialties.
Virtual reality founders have struggled in recent years to coax investor attention as consumer and enterprise uptake has proven slower than the early wild ambitions for the technology. In its stead, investors have looked more towards bets on adjacent technologies like gaming and computer vision that don’t require the specialized head-worn hardware. Osso VR’s platform runs on Facebook’s Oculus Quest 2 headset through the company’s Oculus for Business program.
Coming on the heels of the Neuralink announcement earlier this month—complete with video showing a monkey playing Pong with its mind, thanks to a wireless brain implant—researchers with the BrainGate Consortium has successfully demonstrated a high-bandwidth wireless brain-computer interface (BCI) in two tetraplegic human subjects. The researchers described their work in a recent paper published in the journal IEEE Transactions in Biomedical Engineering.
BCIs interact with brain cells, recording the electrical activity of neurons and translating those signals into action. Such systems generally involve electrode sensors to record neuronal activity, a chipset to transmit the signals, and computer algorithms to translate the signals. BCIs can be external, similar to medical EEGs in that the electrodes are placed onto the scalp or forehead with a wearable cap; or they can be implanted directly into the brain. The former are less invasive but can be less accurate because there is more noise interfering with the signals; the latter require brain surgery, which can be risky.
BrainGate is an implanted device, used in research efforts focused on treating patients with spinal cord injuries or Lou Gehrig’s disease. Back in 2012, two paralyzed subjects with BrainGate implants successfully controlled a robotic arm; since then, subjects have been able to type on computers and use tablet apps. That BrainGate system employs a large, gray box cable, tethering the implanted sensor array to the external computers that decode the signals. This has restricted the system’s usefulness because technicians need to be on site during operation and take the cable with them when they finish a session.
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The idea for this so-called robotic pill came out of a research project around eight years ago from InCube Labs—a life sciences lab operated by Rani Therapeutics Chairman and CEO Mir Imran, who has degrees in electrical and biomedical engineering from Rutgers University. A prominent figure in life sciences innovation, Imran has founded over 20 medical device companies and helped develop the world’s first implantable cardiac defibrillator.
In working on the technology behind San Jose-based Rani Therapeutics, Imran and his team wanted to find a way to relieve some of the painful side effects of subcutaneous (or under-the-skin) injections, while also improving the treatment’s efficacy. “The technology itself started with a very simple thesis,” said Imran in an interview. “We thought, why can’t we create a pill that contains a biologic drug that you swallow, and once it gets to the intestine, it transforms itself and delivers a pain-free injection?”
Rani Therapeutics’ approach is based on inherent properties of the gastrointestinal tract. An injecting mechanism in their pill is surrounded by a pH-sensitive coating that dissolves as the capsule moves from a patient’s stomach to the small intestine. This helps ensure that the pill starts injecting the medicine in the right place at the right time. Once there, the reactants mix and produce carbon dioxide, which in turn inflates a small balloon that helps create a pressure difference to help inject the drug-loaded needles into the intestinal wall. “So it’s a really well-timed cascade of events that results in the delivery of this needle,” said Imran.
Despite its somewhat mechanical procedure, the pill itself contains no metal or springs, reducing the chance of an inflammatory response in the body. The needles and other components are instead made of injectable-grade polymers, that Imran said has been used in other medical devices as well. Delivering the injections to the upper part of the small intestine also carries little risk of infection, as the prevalence of stomach acid and bile from the liver prevent bacteria from readily growing there.
One of Imran’s priorities for the pill was to eliminate the painful side effects of subcutaneous injections. “It wouldn’t make sense to replace them with another painful injection,” he said. “But biology was on our side, because your intestines don’t have the kind of pain sensors your skin does.” What’s more, administering the injection into the highly vascularized wall of the small intestine actually allows the treatment to work more efficiently than when applied through subcutaneous injection, which typically deposits the treatment into fatty tissue.
Imran and his team have plans to use the pill for a variety of indications, including the growth hormone disorder acromegaly, diabetes, and osteoporosis. In January 2020, their acromegaly treatment, Octreotide, demonstrated both safety and sustained bioavailability in primary clinical trials. They hope to pursue future clinical trials for other indications, but chose to prioritize acromegaly initially because of its well-established treatment drug but “very painful injection,” Imran said.
At the end of last year, Rani Therapeutics raised $69 million in new funding to help further develop and test their platform. “This will finance us for the next several years,” said Imran. “Our approach to the business is to make the technology very robust and manufacturable.”
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