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An endless cycle of discomfort, limited quality of life, and high costs as chronic heart patients with excess fluid in their lungs and tissue are hospitalized, stabilized, and then sent home, where the fluid starts building up again.
A combination device and digital therapeutic for at-home monitoring of bodily fluid levels, providing doctors with reliable data to prescribe diuretic (fluid-reducing) medication that will keep the patient self-sufficient and out of the hospital.
The device has the potential to lower healthcare costs and improve efficiency of clinical studies for new drugs. Other possible medical uses include dialysis optimization, surgical anesthesiology volume management, and pediatrics.

In its LifeHub in Boston, Bayer’s innovation team interacts with the local Life Science community to identify and accelerate promising startups. One of them is Bitome who were granted a Fellowship to advance their “HydroCor” device which promises more quality of life for heart patients.

It was a friend’s mother who got the ball rolling, recalls Bitome CEO Herb Ryan: “She had been hospitalized a dozen times for fluid management. In one instance the hospital removed too much fluid, so she had to reenter hospital to get her fluid levels up again.” That’s when he knew they had found a single indication to highlight the potential of their tool in healthcare: the technology would provide heart patients with an easy-to-use self-monitoring tool – all they have to do is put a finger inside and the device calculates the fluid content of the whole body. It’s as easy as checking the blood pressure. 

When Bayer learned about the device, they appreciated its value immediately: The Bayer portfolio includes drugs that address heart failure, so a therapeutic device such as “HydroCor” would be a perfect complement. In addition it has the potential to help simplify clinical studies for new drugs. In June 2018, the Pharma Open Innovationteam invited Bitome to move into the LifeHub for a six-month Fellowship, facilitated by the local Open Innovation lead, to accelerate the development of their “HydroCor” invention. 

Cohabitating in the LifeHub opened up a wealth of expertise to Bitome: “We got tons of feedback not only from Bayer’s pharmaceutical and healthcare experts, but also from their agricultural specialists,” says Bitome CEO Herb Ryan. “We had eight core mentors from Pharma Early Research, Clinical Development, Digital Health and even from Early Marketing. And each mentor connected us to other people in Bayer. All in all, we got to know over 100 Bayer experts in the US and Germany who gave us insights and advice. That was fantastic.”

3 questions to Herb Ryan 

Bitome CEO talks about his Fellowship experience
Herb Ryan
Bitome CEO

1 Herb, what was the impact of your Fellowship on the development of your device?

For an early stage startup, access to Bayer and its pharmaceutical expertise is a huge boost! You would have to pay a fortune to consultants for equivalent expertise. They opened our eyes to new applications that were not on our radar: from expanded medical uses, to consumer uses, and even industrial applications you talk to one Bayer person, an idea comes up, and it snowballs. That was powerful! 

2 And how did your business advance? 

It was a game changer for our company trajectory; a massive boost to our credibility; the stamp of approval in the market. In addition, the Bayer experts shared their experience as to the processes involved of bringing such a device to the market. They know the medical landscape – the competitors, the devices on the market – and they gave us lots of insights and advice on how to proceed. 

3 What is the next step? 

We have a prototype now, and it works. It was tested with healthy volunteers, but so far it hasn’t been validated on patients. In order to get an FDA clearance, you need to prove that it works in clinical studies on many patients. It would be hard for us to fund our own studies for the device. Our hope now is that we will have the opportunity to test the prototype by helping Bayer reach its own clinical trial objectives and in that way also get the FDA clearance for our device when it turns out to be success in Bayer’s clinical trials.  

The Pharma Open Innovation team is continually working with Bitome to leverage the achieved outcome for the benefit of both parties.