A Rice University team of engineers designed a low-cost ventilator, and now the device, which has been picked up for manufacturing, has received approval from the FDA. Photo courtesy of Jeff Fitlow/Rice University

A ventilator that was designed by a team at Rice University has received Emergency Use Authorization from the U.S. Food and Drug Administration amid the COVID-19 pandemic.

The ApolloBVM was worked on March by students at Rice's Brown School of Engineering's Oshman Engineering Design Kitchen, or OEDK. The open-source plans were shared online so that those in need could have access to the life-saving technology. Since its upload, the ApolloBVM design has been downloaded by almost 3,000 registered participants in 115 countries.

"The COVID-19 pandemic pushed staff, students and clinical partners to complete a novel design for the ApolloBVM in the weeks following the initial local cases," says Maria Oden, a teaching professor of bioengineering at Rice and director of the OEDK, in the press release. "We are thrilled that the device has received FDA Emergency Use Authorization."

While development began in 2018 with a Houston emergency physician, Rohith Malya, Houston manufacturer Stewart & Stevenson Healthcare Technologies LLC, a subsidiary of Kirby Corporation that licensed ApolloBVM in April, has worked with the team to further manufacture the device into what it is today.

An enhanced version of the bag valve mask-based ventilator designed by Rice University engineers has won federal approval as an emergency resuscitator for use during the COVID-19 pandemic. Photo courtesy of Stewart & Stevenson

The Rice team worked out of OEDK throughout the spring and Stewart & Stevenson joined to support the effort along with manufacturing plants in Oklahoma City and Houston.

"The FDA authorization represents an important milestone achievement for the Apollo ABVM program," says Joe Reniers, president of Kirby Distribution and Services, in the release. "We can now commence manufacturing and distribution of this low-cost device to the front lines, providing health care professionals with a sturdy and portable ventilation device for patients during the COVID-19 pandemic."

Reniers continues, "It is a testimony to the flexibility of our people and our manufacturing facilities that we are able to readily utilize operations to support COVID-19 related need."

The device's name was selected as a tribute to Rice's history with NASA and President John F. Kennedy's now-famous speech kicking off the nation's efforts to go to the moon. It's meaningful to Matthew Wettergreen, one of the members of the design team.

"When a crisis hits, we use our skills to contribute solutions," Wettergreen previously told CultureMap. "If you can help, you should, and I'm proud that we're responding to the call."

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Axiom Space-tested cancer drug advances to clinical trials

mission critical

A cancer-fighting drug tested aboard several Axiom Space missions is moving forward to clinical trials.

Rebecsinib, which targets a cancer cloning and immune evasion gene, ADAR1, has received FDA approval to enter clinical trials under active Investigational New Drug (IND) status, according to a news release. The drug was tested aboard Axiom Mission 2 (Ax-2) and Axiom Mission 3 (Ax-3). It was developed by Aspera Biomedicine, led by Dr. Catriona Jamieson, director of the UC San Diego Sanford Stem Cell Institute (SSCI).

The San Diego-based Aspera team and Houston-based Axiom partnered to allow Rebecsinib to be tested in microgravity. Tumors have been shown to grow more rapidly in microgravity and even mimic how aggressive cancers can develop in patients.

“In terms of tumor growth, we see a doubling in growth of these little mini-tumors in just 10 days,” Jamieson explained in the release.

Rebecsinib took part in the patient-derived tumor organoid testing aboard the International Space Station. Similar testing is planned to continue on Axiom Station, the company's commercial space station that's currently under development.

Additionally, the drug will be tested aboard Ax-4 under its active IND status, which was targeted to launch June 25.

“We anticipate that this monumental mission will inform the expanded development of the first ADAR1 inhibitory cancer stem cell targeting drug for a broad array of cancers," Jamieson added.

According to Axiom, the milestone represents the potential for commercial space collaborations.

“We’re proud to work with Aspera Biomedicines and the UC San Diego Sanford Stem Cell Institute, as together we have achieved a historic milestone, and we’re even more excited for what’s to come,” Tejpaul Bhatia, the new CEO of Axiom Space, said in the release. “This is how we crack the code of the space economy – uniting public and private partners to turn microgravity into a launchpad for breakthroughs.”