‘When you can’t breathe, nothing else matters’

OBERLIN — Synapse Biomedical Inc. has received Food and Drug Administration premarket approval for its NeuRx diaphragm pacing system device, which allows quadriplegic patients to breathe without a ventilator.

“When you can’t breathe, nothing else matters,” Synapse co-founder Dr. Raymond Onders said, borrowing a slogan from the American Lung Association. “We look to that in helping people utilize their diaphragm muscles to breathe more naturally.”

The NeuRx device electrically stimulates the diaphragm to contract and relax, pulling air in and out of the lungs. It operates similarly to how a cardiac pacemaker stimulates the heart to keep it pumping.

In 2008, NeuRx received a Humanitarian Device Exemption from the FDA, allowing it to be implanted in patients, but only in hospitals that undertook lengthy review and approval processes.

“The catch is that you have to have each and every hospital that you work with, on an annual basis, give their approval of what you’ve done,” Synapse CEO Anthony Ignagni said. “So every hospital has to go through the paperwork review that the FDA normally does.”

Hospitals had to renew that approval every year, and Ignagni said that NeuRx was available in between 20 and 25 hospitals every year across the country.

After gaining premarket approval this month, the NeuRx device can be used in any hospital in the U.S. that is capable of safely implementing it.

This approval opens up the life-altering technology to more than 400 trauma centers in the U.S. and thousands of new patients.

“It makes it infinitely easier,” Ignagni said. “A hospital in Oklahoma, or in the middle of Texas, that has a spinal cord patient can call us up and we can send a device and go down there and help them through the surgery, and get that patient off the ventilator within 10 days.”

Onders is a surgeon at University Hospitals who co-founded Synapse Biomedical alongside Ignagni and with assistance from University Hospitals and Case Western Reserve University.

He has worked in the field of spinal cord injuries for more than 25 years, and he said he was glad to finally see their work available to more hospitals and patients.

“We really hope that this will allow these patients that are injured in more rural areas to get access to this technology earlier,” Onders said. “That’s really kind of our hope after all these years because it really is life-changing for these patients.”

Approving the device for use on a new patient was time-intensive for trauma centers, and many do not have the research and approval framework in place at all, meaning it was impossible for them to ever treat a patient with a NeuRx device before approval.

Traumatic spinal cord injuries are very rare, the National Spinal Cord Injury Statistical Center estimates there are about 17,730 new cases in the U.S. each year.

This rarity means that traumatic spinal cord injuries and their treatment are sometimes overlooked in the medical research field.

“Spinal cord injured patients are really a small group of orphaned patients,” Onders said. “It’s an injury that changes everything. And ventilators are tough, they’re terrible. It’s really life-changing to get someone off a ventilator.”

Onders and Ignagni both spoke about their experience seeing what NeuRx returning independent breathing to patients does for their physical and mental well-being.

The second patient ever to successfully be implanted with the NeuRx device was actor Christopher Reeve, who is best known for his role as Superman in the 1978 and 1980 films.

Reeve suffered a spinal cord injury during a horse riding competition in 1995, and in 2003 he was implanted with a precursor to the NeuRx by Onders.

After his surgery, Reeve told CBS News about being able to breathe and speak and about regaining his sense of smell.

“I actually woke up and smelled the coffee,” Reeve told CBS in 2003. Patients on NeuRx are still breathing with assistance, but without the noise or impact to sense of smell and speaking ability a ventilator brings.

“When somebody is on a ventilator, it changes everything,” Onders said. “There is always noise from that ventilator, everybody knows you’re on a ventilator. They may still be quadriplegic, but you have a little bit more normalcy.”

Undergoing a traumatic spinal cord injury and becoming quadriplegic immediately alters the life of a patient, but Synapse seeks to ease the burden of that trauma.

“(Our devices) are not cures for the injury, but they provide a sense of independence,” Ignagni said. “You can go to church without a ventilator whooshing behind you, you know, you can go to the movies, you can go back to school. We’re not curing spinal cord injury, but we are providing a reduction in the level of injury.”

FDA premarket approval not only allows for NeuRx devices to be used in more hospitals but speeds up the process dramatically.

This is crucial, as Synapse’s data has shown that the earlier a newly paralyzed patient is fitted with a NeuRx device, the faster the device can help them breathe without a ventilator.

Ignagni said that a spinal cord patient who is implanted with NeuRx within two weeks of their injury can be taken off of their ventilator, on average, 19 days earlier than a patient without the device.

This allows patients to avoid complications of long-term ventilator use like pneumonia and can save hospitals roughly $140,000 per patient.

“So better outcomes for patients, you save the hospitals money, and obviously the resource burden on caregivers in the hospital is much reduced,” Ignagni said. “So at this time where they are already experiencing a lot of burnout in hospitals from COVID and everything, this is right where we need to be.”

The team at Synapse continues to look for further ways their technology can change lives.

Ignagni said the company is actively developing a temporary version of the NeuRx device, and Onders has explored its potential for use in other cases.

“Our mission is to be a sustainable company that really helps people with our neurostimulation technology,” Ignagni said. “It’s about getting out there and helping patients.”

Oberlin College students shine in theater design competition

STAFF REPORT

Oberlin theater students excelled in the biennial Venue Renovation Challenge, an event co-sponsored by the American Society for Theatre Consultants and the United States Institute for Theatre Technology, the college recently announced.

The competition took place at the United States Institute for Theatre Technology’s conference in St. Louis in March, according to a March 29 news release.

Students work in teams with an American Society for Theatre Consultants professional to propose and document a theoretical renovation to a venue or space on or near their campus, according to the college.

The Oberlin team’s presentation focused on proposed renovations to Oberlin’s Hall Auditorium, the longtime home of main stage opera and theater productions on campus.

The students’ proposed renovations to Hall Auditorium topped submissions from graduate school programs, according to Oberlin College.

The Oberlin team earned a second-place finish, topping teams from Yale and Ohio State, and also won the Director’s Award, a prize established by the United States Institute for Theatre Technology to acknowledge the best undergraduate team in the competition. The team consisted of Nelson Gutsch, Ansel Mills, Leanne O’Donnell, Nova Gomez, all from the class of 2025; Andrew McCraken and Charley Davis, both class of 2026.

The students were mentored over the past year by Howard Glickman, Oberlin College class of 1992 and an associate principal at Auerbach Pollock Friedlander.

Wellington railroad crossing to get LED lighting upgrades

WELLINGTON — The Public Utilities Commission of Ohio announced the Wheeling & Lake Erie Railway crossing on Erie Street in Wellington will receive upgraded LED lights as part of a $1.17 million package across 15 counties, according to a news release.

Wheeling & Lake Railway will install LED lights at grade crossings at a cost of $7,500 for each crossing.

PUCO is responsible for evaluating Ohio’s public grade crossings to determine the need for installing active warning devices. Since the PUCO began implementing these evaluations, the annual number of train-motor vehicle crashes in Ohio has decreased significantly, from 356 in 1990 to 61 in 2022. The Ohio Rail Hotline, at (866) 814-RAIL (7245), provides Ohioans with a toll-free resource for all railroad crossing questions. For more information regarding these crossings, access the Ohio railroad information system website at gradecrossings.puco. ohio.gov.

Black River bests Keystone

ABOVE: Black River’s shortstop Tyler Mrakuzic (2) look over to first to try to make an out against Keystone on Monday, April 10.

Comets collide with Middies

Pirates slide for a steal

RUSS GIFFORD | The Community Guide

Black River’s Noah Hopek slides into second base safely for the steal against Crestview. The Pirates lost against the Cougers 8-7 on April 7 at Black River High School.

Wellington shut out at Wendy’s Spring Classic

RUSS

THOMAS FETCENKO | The Community Guide

Amherst’s Nevaeh Sadler (4) slides safely into third base, colliding with Midview’s third baseman Addison Reisinger (1) on Monday, April 3. The Middies rallied for a close 2-1 win against the Comets.

Wildcats beat Dukes

RUSS GIFFORD | The Community Guide activities and more.

Wellington’s Riley Reyna sends the ball to the plate against Keystone. The Dukes lost to the Keystone Wildcats 5-4 on April 4 at Wellington High School.

Duke Pride Carnival

Wellington Schools Duke

Pride Carnival is 9 a.m. to 12 p.m. Saturday at Wellington High School. A free breakfast will be from 8 a.m. to 11 a.m.

The carnival benefits free/reduced lunch students.

Amherst Historical Society

● Afternoon Tea is 1-3 p.m. May 21 at The Grange Hall in Sandstone Village. Please join us for tea and refreshments, enjoy beautiful wedding dresses on display, and tour the Village gardens maintained by the Amherst Garden Club. Tickets are $20 per person, $15 for members. Please RSVP by May 15 to (440) 988-7255 or office@ amhersthistoricalsociety. org. Payments can be made by cash, check or card.

You can also register and pay by card using https://form.jotform. com/230463915767161

● The Sandstone Village Car and Bike Show will be June 4 with registration from 10 a.m.-12 p.m. and the Car Show from 12-4 p.m. There will be a photo area, Village building tours, garage sales, a blessing of the cars and bikes, raffles, DJ, food court, and more! Spectator parking will be at Amherst Junior High School with shuttle service to Sandstone Village.

● The Taste of History Military Living History event is 9 a.m. to 6 p.m. June 17 at The Sandstone Village, 763 Milan Ave. The event will have samples of military food and rations, displays, kids’

Pittsfield Community Church

● The Pittsfield Community Church’s “Springspiration Day” is April 18.

Registration is at 10 a.m., concert at 10:30 a.m., salad lunch at noon.

For reservations, call Margaret at (440) 9655773 or Phyllis at (440) 647-347.

The special guest is Cheryl Wellert, CEO of DAT Travel and Christian Treasure Seekers, which plans family-friendly and faith-based vacations.

● The church’s Fish Fry Dinner is 5-7 p.m. Friday. Dine-in or carry-out available. Meals are $15 and all are welcome. The church is located at the corner of state Routes 58 and 303.

Avon Democratic Club

Join the Avon Democratic Club for our meeting on 6:30 p.m. today at the Avon Senior Center at 36784 Detroit Rd. All are welcome.

Candidates Geoffrey Smith and Wayne R. Nicol will discuss their campaigns for Municipal Judge of the Avon Lake Courts. The Avon Lake Municipal Court serves Avon Lake, Avon and Sheffield Village.

To learn more about the ADC, visit our website at www.avonohdems.com

Avon-Avon Lake Republican Club

The Avon-Avon Lake Republican Club will

Cartoon Characters

Bulletin Board

The Lorain County Community Guide Bulletin Board is for local nonprofit and not-for-profit events. Items are published on a space-available basis and will be edited for style, length, and clarity. Send your items to news@lcnewspapers.com meet 6 p.m. April 20 at the Knights of Columbus Ragan Hall, 1783 Moore Rd., Avon. The evening’s speakers will be County Commissioners David Moore and Jeff Riddell and County Administrator Jeff Armbruster. Sarah McGervey, executive director of Right to Life of Northeast Ohio will also speak. Members are free and guests are $5.

League of Women Voters of the Oberlin Area

The League of Women Voters of the Oberlin Area will hold a public informational meeting about Ranked Choice Voting and what it could mean for Lorain County voters. The meeting is in the Dye Auditorium of the Oberlin College Science Center at 6:30 p.m. April 26. Speakers will include Justin Wells, the Co-Executive of Ranked Choice Ohio, and Duncan Buell, Chair Emeritus in Computer Science and Engineering at the University of South Carolina, a noted researcher in electronic voting, and currently visiting professor at Denison University. The meeting will consider what ranked choice voting has to offer the voters of Lorain County and what difficulties lie in wait before any implementation can hap- pen. Parking will be available in the Woodland Street lot across from the science building.

Knights of Columbus

The Knights of Columbus will present “Behind the Scenes: TV News” at 7 p.m. April 20 at the Knights’ Ragan Hall, 1783 Moore Rd. in Avon. Paul Orlousky, a recently retired TV news reporter and author will speak. RSVP by April 17 to rudybreglia@ gmail.com

Amherst Library

● Canine reading buddies is 6:30 p.m. April 18.

● Create special occasion makeup looks with makeup artists Sarah Swanzer and Elsie Salgado, for ages 15-and-up at 6:30 p.m. April 17. Attendees must bring their own makeup brushes. Registration is required.

● Celebrate spring with a short story contest. Youth of all ages are invited to enter the Amherst Public Library’s short story contest now through April 29. Winners will be chosen by May 5.

● Learn how to make your own cleaning products at the Amherst Library’s program 6:30 p.m. April 20 with baking soda, vinegar, peroxide, castile soap and essential oils.

● Adapted storytime is 10:15 a.m. April 22.

A creative storytime for children is 11:30 a.m. April 22. The program is designed for ages 2-5 and their caregivers. Dress for a mess.

● The Library’s Japanese Tokusatsu club will meet at 6 p.m. April 25. The group is recommended for ages 15-and-up. The group meets the fourth Tuesday of the month. To register for events, or for more information, call the library at (440) 9884230 or visit amherstpubliclibrary.org.

Ohio Genealogical Society

The Lorain County chapter of the Ohio Genealogical Society will have a virtual program on finding ancestors in Census records at 7 p.m. Monday. The program is free and open to the public. Contact meetings@loraincoogs. org to receive a link to the meeting.

Brownhelm Historical Society

Brownhelm Historical Association is hosting their first Grandma’s Attic Sale of 2023 at the end of April. We’ve finally cleared out all the backlog of donations received during COVID, so this sale will feature anything and everything! From kitchenware and household goods, to antiques, tools, and furniture, you’re sure to walk out with an armful (or car load!) of treasures. We are also putting on our spring plant sale, so definitely stop by to stock up on beautiful spring foliage for your yard! Please note that everything will be half price on Saturday and we will also be holding a $2/ bag or $5/box sale the following Monday, May 1st, at 10am. All proceeds from this sale will go toward the restoration and maintenance of the Historic Brownhelm School.

Amherst Workshop Players

The Amherst Workshop Players will present “Free To Be … You And Me” at 7:30 p.m. April 27, 28, 29; May 5, 6 and 3 p.m. April 30 and May 7 at 44820 Middle Ridge Rd. Amherst. Call the Box Office for tickets at (440) 634-0472. Tickets are $18.50 each and group rates are available.

Doors open 45 minutes before show time

NAMI of Lorain County

NAMI (National Alliance on Mental Illness) of Lorain County will be holding their 8-session weekly Family to Family educational class beginning Tuesday April 25th and ending Tuesday, June 13th from 2pm to 4pm at the NAMI of Lorain County office, located at 6125 South Broadway, Lorain. NAMI Family-to-Family is a free educational program for family, significant others and friends of people with mental health conditions. It is a designated evidenced-based program. This means that research shows that the program significantly improves the coping and problem-solving abilities of the people closest to a person with a mental health condition.

NAMI Family-to-Family is taught by NAMI-trained family members who have been there, and includes presentations, discussions and interactive exercises.

To register or inquire call NAMI at (440) 2408477 or email office@ nami-lc.org.

Firelands

Genealogical Society

The Firelands Genealogical Society (OGS) is holding its Annual Meeting and Awards Dinner on Monday, April 24th, at the Elks Club, 2949 State Route 250 in Norwalk (just south of Fisher-Titus Hospital).

Social time will start at 6 p.m. and dinner will be served at 6:30 p.m.

The meal is $20 per person and includes honeyroasted chicken, green beans, roasted red potatoes, salad, and brownie parfait for dessert (includes gratuity). Reservations should be mailed by April 17 to the Firelands Genealogical Society, PO Box 923, Norwalk OH 44857.

Our dinner, annual meeting, and awards presentation will be followed by some Genealogy Fun and Games. Help support the programs of this great nonprofit by joining us in an evening with great friends and comradery.

Mozart’s “L’____ del Cairo”

66. Like a whistle?

68. Optical illusion creation (2 words) 69. “Time,” e.g., colloquially 70. Hint of color 71. “The Way We ___” 72. Farm pen 73. Skedaddle

DOWN

1. What hedonism and idealism have in common

2. Rejections 3. Flatfoot’s lack 4. Pie option 5. Calamitous

6. One of the Eagles

7. *Pluto or Snoopy

8. Acrobat maker

9. Rural building

10. Homesteader’s purchase, sing.

11. Nabisco’s “Chips ____!”

12. To use a Singer

15. Dairy industry missing person-seeking prop

20. Nordic glühwein

22. Ooh and ____

24. Troublemaker

25. *Fudd’s first name

26. Line to the audience

27. “It is silent,” in sheet music

29. Living space

31. Don Johnson’s Bridges

33. Bake an egg

34. *One of the Pickles

36. Like a broken horse

38. *Phineas’ stepbrother

42. Be a parasite

45. Just about (2 words)

49. Hula necklace

51. Builds a tower, e.g.

54. Very small particles

56. Opposite of ecbatic

57. Ready for picking

58. A bit cracked

59. Not the life of the party

60. Same as cagey

61. Lotto variant

62. Palm starch

63. Gift topper

65. *Garfield or Tom

67. Butterfly catcher SOLUTION

32. Plaudit and pomp