Pacing System

Emma Benardete Editor-in-Chief

Synapse Biomedical, an Oberlinbased biotechnology company, received FDA premarket approval on April 5 for the NeuRX Diaphragm Pacing System.

“Approval for the NeuRx DPS® is intended for use in patients with stable, high spinal cord injuries with stimulatable diaphragms, but who lack control of their diaphragms,” the FDA’s Approval Order Statement reads. “The device is indicated to allow the patients to breathe without the assistance of a mechanical ventilator for at least four continuous hours a day. Its use is only in patients 18 years of age or older.”

Onders, one of the main project leaders, noted that in certain cases, the electrodes can eventually be removed when the nerves regain function.

“We have very good evidence now of what we call the trophic effect of electrostimulation, and we stimulate the diaphragm and there’s an afferent effect to the nerve that changes the spinal cord milieu,” Onders said.

The system was designed by Professor Emeritus J. Thomas Mortimer of Case Western Reserve University in Cleveland. Mortimer said that he developed an interest in electrical stimulation after a childhood friend was paralyzed in an automotive accident. Mortimer later recruited Onders when he was a resident to help recruit patients for human trials at the suggestion of Dr. Tom Stellato, another doctor with whom he was working on the project.

Raymond

The system works by using electrodes to stimulate the paralyzed diaphragm, causing it to contract and allowing the patient to breathe. Dr.

See FDA, Page 2

Friday, April 21

5:30–7:30 p.m.: Oberlin Green

Group Vegetarian Potluck

Gathering at First Church

Oberlin, Fellowship Hall

Attendees are invited to bring a vegetarian dish to serve six to eight. “Green group” representatives will briefly present on their organizations at 7 p.m., and College Campus Energy and Resource Manager

Joel Baetens will speak on updates to the geothermal energy project. Organizers hope this potluck serves as both a celebration and a networking opportunity.

Saturday, April 22

10 a.m.–12 p.m.: 2023 Earth Day 5K Run, beginning in Tappan Square

This year’s iteration of the annual Earth Day 5K Run is open to runners of all ages. Participants may register for $25 on the day of the race.

1–4 p.m.: Reproductive Justice Spring Flea Market in StudiOC

The Reproductive Justice Alliance is set to host a spring flea market, which will serve as a gathering space for student musicians and speakers with an emphasis on centering BIPOC voices. Student-made art will also be available for purchase, and proceeds will go toward Midwest organizations dedicated to reproductive justice for BIPOC people.

8:30 p.m.: #OCDragBall23

America Has a Problem Drag Ball in Hales Gymnasium

This year’s iteration of the annual Drag Ball is themed “#OCDragBall23 America Has a Problem.”

Sunday, April 23

12:30–1:30 p.m.: Concert in Memory of Maura Olivero in Warner Concert Hall

Colleagues of Maura Olivero will gather in Warner Concert Hall to perform in celebration of Olivero’s life and impact. Light refreshments will be served.

4–5:30 p.m.: OberlinWellington Rescue Documentary World Premiere at the Apollo Theater

A Higher Law: The OberlinWellington Rescue of 1858 will make its debut in the Apollo Theater. The film details a key event in Ohio’s history of abolitionism during which 37 men were charged with violations of the Fugitive Slave Act. Filmmakers Scott Spears and Christina Paolucci will be present for a question-andanswer session after the showing.

Monday, April 24

7:30–9 p.m.: OJS + Crimson Collective Present: Brandee Younger Trio at the Cat in the

Cream Harpist, composer, and educator Brandee Younger, accompanied by Rashaan Carter and Allan Mednard, will perform. Younger will also host a master class earlier on Monday in Bibbins Hall, room 237, at 1 p.m. Both the performance and master class are hosted by the Oberlin Jazz Society and the Crimson Collective.

Thursday, April 27

4:30–6 p.m.: Stitched & Sewn: A Testimony from a Holocaust Survivor in Dye Lecture Hall

Sponsored by the Chabad at Oberlin Student Group, attendees are invited to view the story of Holocaust survivor and artist Trudie Strobel through the lens of tapestry and other works of art. Admission is free and open to all.

City Council Works to Acquire Funds for Affordable Housing

Continued from page 1 member household is $42,700. Income can be adjusted based on the number of individuals in the household.

The City of Oberlin would provide the smallest portion of funds in the total finances of the project — $20,000 of American Rescue Plan Act funding per house as a loan.

Despite the $2.3 million price tag of the project, the City is only contributing $160,000. Michael Bowen and his team assume the majority of the financial risk in the project.

“He would take out a loan of over a million dollars to make this whole thing happen, and that is part of his risk in this,” English said. “He has to perform. And to get a loan like that, he would pledge certain assets of his own, where if for any reason he defaulted on the loan or couldn’t come through with payments, he would potentially be in a position where he could lose assets. If this somehow failed like that, which I think is unlikely if he’s able to put together the initial funding of about $2.3 million, then we would have expended ARPA funds when we could have used those funds for something else that might have also improved housing in the community.”

Once RSG has secured funding for the project, the City would transfer the land for the project to RSG. Bowen had requested tax abatement from the City, which would allow RSG to be exempt from property taxes while his company owned the property as well as allowing families who assume ownership to be exempt. English said that he thinks it is unlikely that the City would provide tax abatement.

According to the proposal draft, RSG could begin building in the first quarter of 2024.

When the houses are completed, families will be selected to occupy the homes. According to English, it has been projected that construction could finish in as little as one year after financial closing. While the selection parameters have not been negotiated with RSG yet, English said that Oberlin residents and former Oberlin residents would receive preference for housing.

“A preference will be given to either current Oberlin residents who are rent-burdened, who are paying a much too high percentage of their income for housing, or to former Oberlin residents who want to return here and want to assume home ownership,” English said at the work session.

Additional parameters will likely come from income, as many federal and state funding sources set income limits on who projects that are funded can serve.

“The financing that this company puts together would determine what level of income people would be eligible for,”

English said. “And it could be, say, 80 percent of the area median income, it could be 100 percent, or the like. So people would qualify for this, they could apply and be selected and it would be based on their income.”

The selected families would participate in programs to help them prepare for assuming ownership of the home. Within five years, the families would assume a long-term mortgage and transition from renting to owning their home.

“They would pay an affordable rent, which is, again, based on their income, ensuring that they are not rent-burdened by having to pay more than they can really afford for rent,” English said. “Their mortgage payment would be tied and similar to their payment for their rent.”

English clarified that the mortgage would not be for the full cost that it took to build the home, but instead would be in the range of $125–150,000.

Attendees expressed both gratitude and concerns to the Council during the work session.

“I would like to thank the social equity committee for their work on this,” William Jindra, a resident of Oberlin, said at the work session. “I would like to see the city take a holistic approach at looking at housing issues. There’s a great need across the spectrum, both for [low-cost,] affordable homes and older people that want to downsize.”

April 21, 2023

Volume 152, Number 21 (ISSN 297–256)

Editors-in-Chief

Kushagra Kar

Emma Benardete

Managing Editor

Nikki Keating

News Editors

Alexa Stevens

Cal Ransom

Opinions Editors

Emily Vaughan

Hanna Alwine

Arts & Culture Editors

Dlisah Lapidus

Yasu Shinozaki

Sports Editors

John Elrod

Kayla Kim

Conservatory Editor

Delaney Fox

Photo Editors

Abe Frato

Erin Koo

This Week Editor

Eloise Rich

Senior Staff Writers

Ava Miller

Chris Stoneman

Celia Perks

Lyric Anderson

Maeve Woltring

Web Manager

Nada Aggadi

Production Manager

Isaac Imas

Production Editors

Addie Breen

E.J. LaFave

Gideon Reed

Jasper Swartz

Serena Atkinson

Trevor Smith

Lia Fawley

Layout Editors

Erin Koo

Grace Gao

Katie Rasmussen

Molly Chapin

Illustrator

Molly Chapin

Distributors

Leah Potoff

Nondini Nagarwalla

Neva Tayler

FDA Approves Distribution of Respiratory Aid

Continued from page 1

According to Synapse CEO Anthony Ignagni, the device has helped 2,500 people in over 30 countries including Japan, Canada, Australia, the U.S., and others in Europe and the Middle East.

“We’ve completed mapping 11 patients,” Mortimer said. “Tom Stellato says to me ‘I don’t know [what] Ray’s telling these people. He recruited 10 and I was only able to recruit one.’ … Dr. Onders was a critical force in getting this into the place where it is now where it’s a commercial product,” Mortimer said.

According to Onders, the DPS was previously approved under Humanitarian Device Exemption Approval, which it received in 2007. He explained that the HDE approval severely limited the number of hospitals at which the device could be used. In order for a device with a HDE approval to be used at a given hospital, it must be greenlit by the hospital’s institutional review board.

“Under this program, there’s a 1988 FDA rule that requires somebody to have an IRB approval to do it, even though it’s not research,” Onders said. Additionally, Ignani wrote that the IRB would have to review the data each year, not just as a one-off occurrence, a timeconsuming process.

“If you’re injured in Iowa or someplace and you don’t have a hospital that’s already doing it, it’s very difficult to transfer,” Onders said.

Onders noted that the COVID-19 pandemic introduced a broader need for the device given a shortage of ventilators.

“So year 2020, roughly, that’s when we started realizing we needed to have improved access,” Onders said. “The COVID pandemic started highlighting that also. … We can help get anybody off the ventilator earlier, and that’s very important when you reach a shortage of ventilators.”

The premarket approval removes the IRB requirement, meaning that any hospital in the country can now use the device. While currently only approved for patients over the age of 18, the device has shown preliminary success with much younger patients.

“I’ve actually implanted NICU babies,” Onders said. “We [also] just implanted a very unfortunate one year old at our hospital within four weeks of her injury.”

Synapse Biomedical was officially founded in Oberlin in 2002 to commercialize the

NeuRx DPS. Mortimer and Ignagni chose Oberlin because they were able to find an old seed factory to operate out of without having to pay rent. Onders noted that because agricultural operations are subject to FDA requirements, the seed factory was up to the standard they would need for biotech. Synapse currently employs 29 people out of its office in Oberlin and may expand its operations.

“As we grow our business we will continue to add to our staff in that facility,” Ignagni wrote. “We currently have sufficient people to build our forecasted needs, but certainly know that we will need to add in the future.”

Onders noted that in addition to the NeuRX DPS, Synapse is working on securing approval for a device for stroke patients.

Will Young

Published by the students of Oberlin College every Friday during the fall and spring semesters, except holidays and examination periods. For advertising rates, please contact edsinchief@ oberlinreview.org.

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