August 17, 2022
It's hump day, Health Tech readers.
🦻Situational awareness: The FDA announced yesterday it will allow hearing aids to be sold over the counter, representing a boon for Apple and other digital health players tapping into the hearing space.
1 big thing: Ryan Breslow bolts into pharma
Ryan Breslow, the millennial billionaire and founder of buzzy fintech company Bolt, is returning to his entrepreneurial journey with Love, Erin writes.
Why it matters: The startup — named because it aims to crowdsource pharmaceutical R&D — has raised $7.5 million in seed funding at a $180 million valuation.
- Breslow has also named Kevin Horgan, who once served as GE Healthcare's head of internal medicine diagnostics, Love's chief medical officer.
- "Instead of focusing on developing a new drug, we’re open-minded about what the solutions might be," Horgan tells Erin exclusively. "Could be a natural supplement, a dietary solution, an old drug, a new drug, or combinations of the above."
Deal details: Human Capital and MaC Venture Capital participated in the fundraise.
The backstory: Love is Breslow's first foray into digital health.
- Asked if he had health care experience, Breslow says: "No. Did I have a background in fintech before Bolt? No. I just try to be the dumbest person in the room and surround myself with smart people. I think that’s my superpower."
How it (should) work: Love is launching a decentralized autonomous organization (DAO) to gather real-world evidence — also known as data — from people's lived experiences.
- The company plans to include information on people's experiences with what it calls "natural" and homeopathic solutions, generic chemicals, and non-substance-based treatments such as meditation. (To be clear, the scientific evidence supporting homeopathy is scant.)
- Its initial focus areas include long COVID, chronic fatigue syndrome, fibromyalgia and substance use disorders, says Horgan.
- Stacy McIntosh, the former SVP of regulatory affairs for Ridgeback Biotherapeutics, is the chief regulatory officer.
Yes, and: Randomized clinical trials are considered the gold standard source of information for drug development, but recent FDA guidance encourages pharma companies to use real-world evidence in addition to RCT data.
- "Mining real-world evidence will be a focal point of our activities," Horgan says.
The intrigue: Crowdsourcing feedback based on individual experiences with alternative treatments is a tricky endeavor that could result in more anecdotes than data because, unlike drugs, alternative approaches are unregulated.
- "It seems they’re building out a lane for alternatives, but that’s a tough lane to build in," says Antonio Ciaccia, a pharmacy sector analyst and the CEO of research firm 46brooklyn. "There’s a lot of room for bullsh-- there. It’s kind of the Wild West, and from a consumer perspective, you’re very much left guessing."
What they're saying: Breslow and Horgan aim to assemble a dataset for alternative approaches — including homeopathy — whether that means finding evidence to back it or discount it altogether.
- "It’s not patentable for Big Pharma, so it’s an area we’d like to provide the data for and put an end to the speculation," says Breslow.