AGA Tech Summit

Endoscopic ultrasound survives the sharks at AGA Tech Summit


 

FROM 2022 AGA TECH SUMMIT

After a 3-year, pandemic-induced hiatus, the American Gastroenterological Association’s Tech Summit returned to a live meeting in San Francisco. As usual, the highlight of the 2-day event, which is sponsored by the AGA Center for GI Innovation and Technology, was the Shark Tank, where selected companies presented lightning-round overviews of their technology and business plans. A panel of sharks and the audience voted for their favorite.

The contestants presented technologies such as a cell phone app to improve gut health (Agora Health), a polypectomy suite (IzoMed), an implantable weight-loss device (Lean Medical), a device to alleviate gastric obstruction in pancreatic cancer (Myka Labs), a pill designed to map out the gastrointestinal system to aid in diagnosis (Rock West Medical Devices), and an endoscopic ultrasound device (EndoSound).

Six finalists were selected from 20 submissions, and EndoSound was the winner. According to Raman Muthusamy, MD, medical director of endoscopy at UCLA Health and professor of clinical medicine at the University of California, Los Angeles, and past chair of the AGA Center for GI Innovation and Technology, the quality of presentations and the sophistication of the companies have increased year after year. “This was really the very best,” said Dr. Muthusamy.

Both the judges and the audience chose EndoSound. Endoscopic ultrasound (EUS) focuses on diagnosis and treatment of chest and abdomen disorders, particularly the pancreas. The EndoSound device attaches to an upper endoscope and converts it to a fully therapeutic endoscope that can perform all standard EUS procedures. Moreover, it does not use an elevator, which has been linked to infection risk.

Most clinical facilities lack EUS capability: 97% of ambulatory surgical centers and 80% of hospitals. EUS systems have hardly changed since the late 20th century, and they cost about $450,000. The projected cost of the EndoSound device is closer to $50,000.

“Just like colonoscopies and upper endoscopies, most endoscopic ultrasounds ought to be done in surgical centers. The idea that they can do them efficiently, and at lower cost and greater convenience to their patients and themselves, seems to me the way everything is going, and the way this procedure ought to go as well. The only obstacle to that has been the cost of the equipment. If we can take away that obstacle, then people who are already doing procedures in hospitals where it’s not convenient and not efficient, will be able to do the procedures in surgical centers,” said Stephen Steinberg, MD, founder and President of EndoSound.

“It’s a radical redesign. You’ve cut cost and you’ve cut space. And it’s something that could be put on at a moment’s notice. Rather than referring the patient for [ultrasound], it could allow you to do it on the spot, and perhaps save a second trip for a patient. It allows flexibility in terms of site of service,” said Dr. Muthusamy.

Dr. Muthusamy called it a “godsend” for low-resource institutions in the United States or abroad who have the expertise, but not the equipment, to perform EUS. “There’s no question that more EUS procedures could be done than are currently being done because of issues of availability, and this device takes a significant step to alleviate that.”

The Food and Drug Administration has granted a breakthrough device designation to EndoSound, which allows the company to forgo human clinical trials to support the application. “We’re hoping and expecting to have our application in the beginning of the fourth quarter, and with a little bit of luck to be approved by the end of the year. That’s our goal,” said Dr. Steinberg.

The technology started out as a challenge that Dr. Steinberg set for himself. His career overlapped with some of the earliest innovators of therapeutic endoscopy. “They were the stars. I wasn’t, but I was there,” said Dr. Steinberg. In his practice, Dr. Steinberg was doing procedures that included endoscopic ultrasound.

By the new millennium, EUS had gained a lot of interest, but there was a problem. “It was expensive, and it could only be done in hospitals. I started wondering if we couldn’t get it into a different environment by having a simpler solution,” said Dr. Steinberg.

But success didn’t come quickly. “I started drawing on the back of napkins to see if there wasn’t some solution,” said Dr. Steinberg. It wasn’t until a serendipitous meeting occurred that the concept took shape. Dr. Steinberg’s wife was the CEO and provost of Oregon Health Sciences University, Portland, as well as head of the technology transfer program. Dr. Steinberg’s practice, however, was in Florida so he commuted to Oregon every weekend.

One day, she told him about a presentation by Scott Corbett, MD. “My wife said: ‘Hey, they’re doing ultrasound. Why don’t you come and sit in [on the meeting] because I don’t know anything about it.’ [Dr.] Corbett was working with Sonivate, a point-of-care ultrasound company that was developing an ultrasound that could be placed over the end of the finger, to be used in battlefield triage. I thought, well, if you could put it on a finger, why couldn’t you put it on a scope? So, Scott and I got to talking, and went through a couple of iterations that didn’t work, and then finally came up with one that seemed like it was suitable.”

The device has been tested in five animal models with 20 EUS physicians who concluded that the images were equivalent to legacy devices and that they could be adopted quickly. The company also presented results from a human study that demonstrated noninferiority to the latest EUS system from Pentax.

Dr. Steinberg is an employee and stockholder of Sonivate. Dr. Muthusamy has no relevant financial disclosures. The 2022 AGA Tech Summit was supported by independent grants from Castle Biosciences, Medtronic, Boston Scientific, Exact Sciences, Olympus, 3-D Matrix, Apollo Endosurgery, Motus GI Holdings, STERIS Endoscopy, Cook Medical, FUJIFILM Healthcare Americas, and Virgo.

This article was updated 5/10/22.

*Correction, 5/17/22: An earlier version of this article stated that Geneoscopy was a finalist in the competition. It was not. Also, EndoSound should have been listed as a finalist in this paragraph.

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