Heart failure (HF) – a condition in which the heart can’t pump effectively enough to meet the needs of the body – affects more than 6 million people in the US. Patients with HF struggle with shortness of breath, chest pain, and other symptoms caused by the build-up of fluids, and medications like diuretics often become less effective over time. To help the nearly 30% of HF patients who become refractory to medications, Selera, the newest member of the Fogarty Innovation Company Accelerator Program (CAP), is taking a whole new approach.
“Our system targets fluid retention directly as a chronic treatment for HF in order to improve quality of life, reduce hospitalizations and associated mortality,” said Selera co-founder, Stacie Arechavala.
Arechavala and co-founder Kevin Bui first met during the 2021-22 Stanford Biodesign Innovation Fellowship. Both biomedical engineers, Arechavala and Bui were part of a four-person team that included two physicians, Ankit Garg, MD, and Paola Calvachi, MD. The team identified a unique approach while exploring unmet needs in cardiovascular care. “With a problem as big as HF, we knew we needed to come up with a radically different methodology,” recalled Arechavala. “We couldn’t just go with something that had been tried before or an incremental improvement to existing technology.”
At the end of the Fellowship year, Arechavala and Bui decided to take the idea forward. “Both Ankit and Paola had previously committed to other programs,” said Bui. “Ankit still supports our clinical efforts – as an interventional cardiology fellow, his input is invaluable as he is essentially the end user for our device.”
Arechavala and Bui won Biodesign summer extension funding which allowed them to continue advancing their concept over the summer with help from both Biodesign and Fogarty mentors. During that time, they focused on understanding the key risks of the project and determining whether there were “killer risks” that could effectively terminate the project.
“We identified three main areas that we needed to focus on and better understand,” said Arechavala.
“First, the mechanism of action – would the approach have the clinical effect we anticipated based on existing literature and data? The next question was whether our solution was technically feasible. And third – the biggest risk of all – was the intellectual property landscape. We had to determine whether we had freedom to operate and patentability in a very crowded space.”
By the end of the summer, the team had gone deep enough to feel confident that they could mitigate all three major risks. They applied to participate in FI’s Invention Accelerator Program (IAP), an early-stage incubation program that helps innovators pressure-test their ideas. During the following six months, they worked closely with IAP director John Morriss to create and execute a development plan that helped them achieve many firsts and further advance their concept.
Progress in IAP
“During the IAP, we went through the process of converting our first provisional patent into a non-provisional patent application,” said Bui. “We were also able to develop our first prototypes and run our first preclinical studies.”
“On the clinical side, we were able to really solidify our relationship with our main KOL (key opinion leader,) recalled Arechavala. “That was a game-changer for us. We also started laying the groundwork for our first clinical study, which will be a pilot study at his center.” She continued, “The fact that we were able to make significant progress across these key areas is due to the incredible support that we’ve had from so many team members at FI.”
Despite a shared background in engineering, Arechavala and Bui found it easy to divide the many tasks involved in bringing a startup to life. Bui, who came to Stanford immediately after completing his PhD in robotics and stroke rehabilitation, had innovation experience from working at the Center for Healthcare Innovation at the University of Pennsylvania. Arechavala, who holds master’s in biomedical engineering, was an R&D engineer at Medtronic for several years before transitioning to leading strategy and operations at an early-stage healthtech startup. “Given our experiences, Kevin leads R&D while I focus on strategy and operations” said Arechavala. “As with most startups, we both wear multiple hats and work closely together to get things done.”
Arechavala and Bui attribute their strong working relationship to a focus on shared team values that they first instilled in their team at Biodesign. “We prioritized team dynamics from the beginning. During the Fellowship year, we planned weekly team bonding activities and would also spend time together on evenings and weekends,” said Bui. “That gave us a really good foundation for the relationship we have now.”
During the six-month CAP program, the team hopes to achieve two more big milestones. “First, we hope to transfer our first device to a contract manufacturer and prepare to submit to the FDA for regulatory approval,” said Bui. “We’ve prototyped and gone through several design iterations, so getting this accomplished would be huge.”
For technical development, the team is especially excited to continue their work with the preclinical serices team at Veranex, which has been a very collaborative partner. “We needed a lab that was willing to dive in and learn alongside us because we’re working on things that have never been done,” said Arechavala. “They have been proactive in conducting their own research, anticipating challenges, and practicing procedures to ensure our studies run as smoothly as possible.”
“Because they have more than 20 years of experience working on interventional devices, they also provide comparative feedback that helps us think about making design changes to our prototypes or addressing other issues they observe,” said Bui. “They’re very much in it with us.”
The team also hopes to continue making progress on the clinical side. “Starting enrollment of our study – which includes all of the necessary approvals and setup – would be another significant milestone,” said Arechavala. “Early clinical data demonstrating proof-of-concept would truly unlock the next phase of our project and company.”