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As the CEO of Sarepta Therapeutics from 2011 to 2015, Chris Garabedian led a biotech firm striving to find cures for rare diseases. But because such diseases usually affect only a small population, it became difficult to collect a robust dataset on patients during clinical trials—the lengthy and rigorous process by which drugs are able to receive Food and Drug Administration approval for safety and efficacy.
At the time, Garabedian wanted to see if Sarepta could collect more data on its trial patients through the use of wearable sensors—but in 2011, as he recalled to dot.LA, it was hard to find technology that could collect and organize that kind of information.
More than a decade later, as the portfolio manager of an early-stage biotech investment fund, Garabedian is backing a company that’s looking to do just that.
VivoSense, a Newport Beach-based biometric data company, announced on Wednesday that it has raised $25 million in Series A funding co-led by Garabedian’s Perceptive Xontogeny Venture Fund and the Debiopharm Innovation Fund, the corporate venture arm of Swiss biopharma company Debiopharm. The new funding takes VivoSense to a total of $27 million raised to date..
VivoSense CEO Dudley Tabakin.
Photo courtesy of VivoSense
The startup collects and organizes data from biometric sensors that are used during clinical trials. The sensors track data like heart rate, breathing and bone density as participants use a drug, and provide valuable information to help understand how a drug affects a patient’s day-to-day life.
“There was a need to analyze that data and start using it to develop outcome measures that could be used in clinical trials by pharmaceutical companies,” VivoSense co-founder and CEO Dudley Tabakin told dot.LA.
The Series A funding will go towards building out VivoSense’s data technology for clinical trials, as well as for physicians who rely on remote monitoring technology to track patients who cannot visit the doctor as frequently.
“Pharmaceutical companies and biotechs should be proactively thinking about incorporating these types of methods into their clinical trials,” Garabedian told dot.LA. “It could make the difference between an approved drug or not.”
In 2020, the FDA revised its clinical trial standards after the pandemic kept people from leaving their homes, opening the door to a slew of companies tackling every aspect of a remote and distributed clinical trial system that still needs to be painstakingly accurate. El Segundo-based Lightship raised $40 million in September to create a fully-integrated virtual clinical trial setting, while Culver City-based Science 37 has received backing from large pharma companies like Thousand Oaks-based Amgen to make it easier for clinical trial conductors to find patients in a socially distant world.
- Science 37 Aims to Take Clinical Trials to Homes - dot.LA ›
- MedVector's Hybrid Virtual Clinical Trials Aim for Accuracy - dot.LA ›
- Lightship Raises $40M to Speed Virtual Clinical Trials - dot.LA ›
- Topography Health Launches to Diversify Clinical Trials - dot.LA ›
Wearable technology has come a long way.
The Apple Watch — often touted as a way to help people monitor their steps and sleep — may soon be able to check your blood sugar levels, making it more akin to a medical device.
Rockley Photonics, a photonic sensor company based in Pasadena, has been quietly working on small blood sensors that can be affixed to wearables and parse alcohol intake, blood sugar and glucose levels. Its biggest customer according to a story from the Telegraph is none other than Apple.
The technology reportedly uses sensors on the back of a smartwatch to shine light through the skin in order to assess blood. Apple and another unnamed company account for as much as 100% of Rockley Photonics' revenue, according to SEC filings.
Neither company replied to requests for comment.
Glucose monitors, once used primarily by diabetics, are reaching the masses. Increasingly companies are offering glucose monitoring services as the obsession with micromanaging one's health grows.
January.ai is a California-based metabolism tracker startup that provides continuous glucose monitors (CGMs) to subscribers, and uses AI to predict what kind of exercise users need to maintain their health. The sticker price for a package is $488. Another —Levels — pairs with an existing CGM to track one's glucose levels at $395. With the added cost of sensors that need to be ordered frequently, these services are out of reach for many, especially for those with type 2 diabetes which has a high correlation with poverty.
What makes glucose monitors more attractive than traditional blood tests is that they continuously track, allowing users to see which foods spike their blood sugar, since different foods have varying results on individuals.
It is unclear if Apple will use this blood sugar monitor the same way January.ai has, but the company (and Rockley) are toeing the line between a consumer health wearable and an actual medical device, which would need to get approval from the Food and Drug Administration. It's a process that could take years to complete, which is incompatible with Apple's typical innovation cycles.
The advent of 24/7 blood sugar monitors that have smartphone capabilities for people to store, track and send data, have been a game changer for diabetics and physicians — doctors can more accurately treat patient health.
"There's also patients who are eating right and are taking all their medicines as prescribed and sometimes putting a CGM on them shows us that, 'oh wow, we've been just treating this patient incorrectly'," said Khan.
But dedicated glucose monitors aren't always reliable — Dexcom came under fire in 2019 when its system stopped notifying patients when their blood sugar was too high or too low, and a parent monitoring their children's diabetes said he was afraid to drop her off at school in case the system failed again.
"These wearable technologies are only as useful to the patients as they are accurate and precise," Khan said. "But because they're so fine-tuned to our diabetes patients, they're a lot less prone to error."
"I certainly wouldn't tell my patients to dose their insulin based on what their Apple Watch is telling them," Khan said. "I would tell them to trust their sensor or trust their fingerstick."