for the children

Houston startup with life-saving innovation receives $2M grant

Houston-based PolyVascular has invented a polymer-based heart valve for children with congenital heart disease. Photo courtesy of TMC Innovation

A $2 million federal grant will enable Houston-based PolyVascular to launch human trials of what it hails as the first polymer-based heart valve for children.

In conjunction with the grant, Dr. Will Clifton has joined the medical device company as chief operating officer. He will oversee the grant as principal investigator, and will manage the company's operations and R&D. Clifton is president and co-founder of Houston-based Enventure, a medical innovation incubator and education hub. He previously was senior director of medical affairs at Houston-based Procyrion, a clinical-stage medical device company.

PolyVascular's Phase II grant came from the Small Business Innovation Research (SBIR) program, which promotes technological projects.

The PolyVascular heart valve will help treat congenital heart disease affecting more than 1 million around the world. PolyVascular plans to launch clinical trials of the valve in children 5 and over within two years.

"Congenital heart disease remains the most common category of birth defect and a leading cause of childhood death in the developed world," reads a March 30 news release from PolyVascular, founded in 2014.

PolyVascular says the valve can be implanted without surgery, and can avoid the use of valve replacements from humans or animals. Those valve replacements are difficult to find and often don't last too long, leading to frequent follow-up surgeries.

"Our aim at PolyVascular is to transform the care of children with congenital heart disease by developing an entirely new generation of valves made of medical-grade polymer devoid of any biological tissue," Dr. Henri Justino, chief medical officer at PolyVascular, says in a release. "The valves in use so far for children have been made of biological tissue. Unfortunately, our immune systems target and destroy this biological tissue, sometimes rapidly, rendering the valve ineffective."

The SBIR grant isn't the only win for PolyVascular in recent years.

In 2019, the startup came away with several honors in the 2019 Texas A&M New Ventures Competition. It won the pitch competition (complete with a $5,000 cash award), and received the Biotex Investment Prize, Amerra Visualization Services Prize, and GOOSE Society Investment Prize.

Also in 2019, PolyVascular, a member of TMCx's 2017 medical device cohort, won in the medical device and health disparities and equity categories at the fifth annual Impact Pediatric Health pitch competition. Additionally, the Southwest National Pediatric Device Consortium granted the company up to $25,000.

Last year, MedTech Innovator, a nonprofit accelerator in the medical technology sector, announced PolyVascular was one of 50 companies chosen to participate in the organization's flagship four-month accelerator program.

"During these uncertain and challenging times, the need for health innovations — specifically those that promise to deliver long-term value to the health care system and patients — is more critical than ever," said Paul Grand, CEO of MedTech Innovator.

Another Houston startup, Vivante Health, also was picked for the MedTech Innovator program. Vivante is a digital health company that helps people address digestive health and wellness.

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A research team housed out of the newly launched Rice Biotech Launch Pad received funding to scale tech that could slash cancer deaths in half. Photo via Rice University

A research funding agency has deployed capital into a team at Rice University that's working to develop a technology that could cut cancer-related deaths in half.

Rice researchers received $45 million from the National Institutes of Health's Advanced Research Projects Agency for Health, or ARPA-H, to scale up development of a sense-and-respond implant technology. Rice bioengineer Omid Veiseh leads the team developing the technology as principal investigator.

“Instead of tethering patients to hospital beds, IV bags and external monitors, we’ll use a minimally invasive procedure to implant a small device that continuously monitors their cancer and adjusts their immunotherapy dose in real time,” he says in a news release. “This kind of ‘closed-loop therapy’ has been used for managing diabetes, where you have a glucose monitor that continuously talks to an insulin pump. But for cancer immunotherapy, it’s revolutionary.”

Joining Veiseh on the 19-person research project named THOR, which stands for “targeted hybrid oncotherapeutic regulation,” is Amir Jazaeri, co-PI and professor of gynecologic oncology at the University of Texas MD Anderson Cancer Center. The device they are developing is called HAMMR, or hybrid advanced molecular manufacturing regulator.

“Cancer cells are continually evolving and adapting to therapy. However, currently available diagnostic tools, including radiologic tests, blood assays and biopsies, provide very infrequent and limited snapshots of this dynamic process," Jazaeri adds. "As a result, today’s therapies treat cancer as if it were a static disease. We believe THOR could transform the status quo by providing real-time data from the tumor environment that can in turn guide more effective and tumor-informed novel therapies.”

With a national team of engineers, physicians, and experts across synthetic biology, materials science, immunology, oncology, and more, the team will receive its funding through the Rice Biotech Launch Pad, a newly launched initiative led by Veiseh that exists to help life-saving medical innovation scale quickly.

"Rice is proud to be the recipient of the second major funding award from the ARPA-H, a new funding agency established last year to support research that catalyzes health breakthroughs," Rice President Reginald DesRoches says. "The research Rice bioengineer Omid Veiseh is doing in leading this team is truly groundbreaking and could potentially save hundreds of thousands of lives each year. This is the type of research that makes a significant impact on the world.”

The initial focus of the technology will be on ovarian cancer, and this funding agreement includes a first-phase clinical trial of HAMMR for the treatment of recurrent ovarian cancer that's expected to take place in the fourth year of THOR’s multi-year project.

“The technology is broadly applicable for peritoneal cancers that affect the pancreas, liver, lungs and other organs,” Veiseh says. “The first clinical trial will focus on refractory recurrent ovarian cancer, and the benefit of that is that we have an ongoing trial for ovarian cancer with our encapsulated cytokine ‘drug factory’ technology. We'll be able to build on that experience. We have already demonstrated a unique model to go from concept to clinical trial within five years, and HAMMR is the next iteration of that approach.”

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