March 22, 2016
by Aimee Balfe, Biomedical Engineering
PreDxion: Reimagining the treatment of organ failure in the ICU
BME medical product development graduate student Walker McHugh (MSE ’17) hopes the device he’s helping bring to market will transform treatment in the intensive care unit.
Called MicroKine, the microfluidic sensor enables doctors to determine quickly and from only a drop of a patient’s blood which cytokines are causing a hyperinflammatory state that can lead to organ failure.
After working on the product and the science behind it for more than a year in the lab of his advisor, Pediatric Critical Care Professor Timothy Cornell, MD, McHugh proposed using the MBC to explore the path to commercialization.
Cornell agreed, and McHugh teamed up with business student Caroline Landau (MBA '16) to form a company, PreDxion, based on an initial application for the device: monitoring cancer patients receiving chimeric antigen receptor T-cell (CAR-T) therapy. CAR-T uses a patient’s own immune cells which have been genetically engineered to recognize a specific protein on tumor cells. Once reintroduced into the body, these cells seek out and destroy the patient’s cancer.
Though this treatment has had promising results, a potential downside is that a patient’s immune system can overreact, producing a flood of inflammatory cytokines which can quickly lead to organ failure. MicroKine can determine in just 30 minutes which cytokines are out of the normal range, allowing doctors to prescribe the specific anti-cytokine medication that matches those elevated in the patient.
The technology has already achieved proof of concept. In late 2014, Cornell’s lab received an emergency use exemption from the FDA to use the device in a patient experiencing cytokine release syndrome in late 2014. The case was a success, and the team began envisioning a larger impact.
That’s what impelled McHugh to throw his hat into the MBC. He hoped to use its structure – the deadlines, the coaching from Zell Lurie, and partnership with a business student – to explore potential markets, walk through financial models, and flesh out a business plan.
Their work has paid off; the team won $30,000 in the MBC, which they will add to awards from The Coulter Foundation and U-M’s Michigan Translational Research and Commercialization for Life Sciences Program, to continue down the path to commercialization. One of the challenges, says McHugh, is that the product is in a new, niche area of the companion diagnostic space, so the FDA and potential drug-company partners need to assess how to approach it. Ultimately, PreDxion hopes it can structure a pharmaceutical-company partnership that could open the door to cooperative clinical trials and marketing efforts.
McHugh is hopeful that the technology will one day be a game-changer. “Things haven’t changed much over the last 25 years in terms of how we treat organ failure in the ICU,” he says. “We’re are still largely limited to supporting the failing organs. By targeting the inflammatory processes that are actually driving that dysfunction, we hope MicroKine will bring personalized medicine to the ICU.”
Other contributors to MicroKine include Professor Katsuo Kurabayashi and postdoc Pengyu Chen.
Project MESA: Bringing safety and dignity to mobile gynecological exams
Taking fourth place in the MBC social impact category is a team from M-HEAL (Michigan Health Engineered for All Lives), the U-M student-run organization that brings biomedical engineering to global health work.
The team, which includes several BME undergraduates, used the competition to evaluate its plans to scale up work on a portable gynecological exam table for use by mobile health workers traveling to remote villages.
Called Project MESA, the team has been working with partner clinics and NGOs in Nicaragua since 2010 on iterative designs for the table. They hoped to use the MBC to test their assumptions about producing and distributing the table on a larger scale to make a bigger impact on healthcare delivery.
Project MESA’s business lead, Katherine Chen, says the coaching was invaluable in helping these mostly engineering students think more critically about issues such as customer preferences, pricing strategies, and business models. “Originally, we designed the product to be produced in the U.S. with the idea that it should be repairable with locally available materials,” she says. “But through customer discovery, we learned that most clinics don’t have the resources to do repairs, so we’ve decided to design the table to be more durable in the first place. In addition, we assumed that a distribution channel in Nicaragua would be hard to manage, but the MBC judges encouraged us to explore that option.”
With $1,200 in prize money from the MBC, the team returns to Nicaragua in May to, among other things, talk with local machinists and distributors; delve into how clinics make their purchasing decisions; assess potential market size; develop new partnerships; and solicit feedback on the newest iterations of the table, which better address durability, portability, aesthetics, and patient positioning.
Chen says the MBC is a great resource for BME design students. “Developing the business plan really helps you define your end goal and determine if it’s financially and logistically feasible,” she says. “It helps you gain an even stronger sense of direction for your design.”
Project MESA’s co-lead is BME student Erik Thomas; other members include: Maya Ben-Efraim, Val Coldren, Bansili Desai, Sabrina Deutsch, Samantha Fox, Hannah Heberle-Rose, Steven Houtschilt, Christina Khouri, Jaime Landsman, Lillian Lantis, Jennifer Lee, Siri Manam, Andrea Mathew, Keely Meyers, Kyle Morrison, Molly Munsell, Madhu Parigi, Monica Patel, Maddie Price, Bharathi Ramachandran, Jen Spiegel, Alejandra Vaquiro Valencia, Shreya Wadwhani, Eldy Zuniga.