After a summer in prominent Silicon Valley accelerator Y Combinator, Astek Diagnostics cofounder and CEO Mustafa Al-Adhami is ready to take on the medtech world.
A spinout of the University of Maryland, Baltimore County (UMBC), Baltimore-based Astek is developing a diagnostic device that quickly identifies patients with blood-borne bacterial infections, particularly sepsis. The device is a single-use cartridge designed to be used by doctors as they are prescribing treatment to them determine the needed amount of antibiotics.
The company, previously backed by TEDCO, recently closed a funding round at $850,000. The money will go toward applying for breakthrough designation with the Food & Drug Administration (FDA) in March and setting up three clinical studies in different labs to further validate its technology.
The time in Y Combinator helped Al-Adhami hone his expertise in the business side of technical product development.
“To be a good founder, you have to be an expert on your users,” Al-Adhami told Technical.ly. “Coming from a science background, I did not really realize that fact until Y combinator.”
The company was founded in 2020 by Al-Adhami, who holds a Ph.D. in mechanical engineering from UMBC, and CTO Kevin Tran. If their device earns breakthrough designation — which is meant for products that treat or diagnose life-threatening diseases — the FDA will give feedback and help Astek map out its clinical studies, the CEO said. Another key benefit is that it will allow the device to come with a Medicare code for reimbursement, similar to what’s been the game changer in the telehealth field.
It’s all part of the company’s five-year roadmap of getting to market. If the March FDA application succeeds, next up is clinical studies in late 2023, then FDA approval, which can take 10 months. Then, following pilot studies for the device, Astek can finally take its device to market sometime in 2025.
The early-stage startup is seven people strong and looking to hire a biotech engineer. They’re a team led by a mission, Al-Adhami said.
“Every single person in the company has a piece of it,” he said. “And I think that helps encourage people to see it through. [Working at Astek is] not just, ‘Get some experience and go work for AstraZeneca.'”
Donte Kirby is a 2020-2022 corps member for Report for America, an initiative of The Groundtruth Project that pairs young journalists with local newsrooms. This position is supported by the Robert W. Deutsch Foundation.-30-