AGA Shark Tank 2021: A Simple Design Survives

Will Pass, MDedge News

May 13, 2021

William of Ockham would have been proud because, at this year's American Gastroenterological Association's Shark Tank pitch competition, one product clearly demonstrated Ockham's razor – that sometimes the simplest solution is best – and came away as the winner at the 2021 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology.

Out of five innovative products, ranging from an educational app to a high-tech anorectal sensor, all aimed at improving outcomes in patients with gastrointestinal disorders, the winner was ... drumroll please ...

A needle.

That's it. A needle. But not like any other needle.

Winner: Toufic Kachaamy, MD, FASGE, AGAF – EUS-guided access needle

This EUS-guided access needle, invented by Kachaamy, enterprise clinical leader at Cancer Treatment Centers of America, Phoenix, is a simple device that overcomes a longstanding challenge presented by endoscopic retrograde cholangiopancreatography (ERCP): biliary access.

Dr Toufic Kachaamy

Many "ERCPs are considered difficult, and sometimes fail, depending on the center and the endoscopist," Kachaamy said during a virtual presentation. "Most failures are due to failed initial access to the bile duct."

Indeed, one study cited a failure rate in ductal cannulation of 5%-15% even among experienced hands.

Failure can have several consequences, Kachaamy noted, including increased complications, higher cost, delayed care, longer hospitalization, and greater likelihood of patient transfer.

He went on to explain why biliary access can be so challenging and how this EUS-guided access needle helps address these issues.

"[The] two main limitations [during endoscopic ultrasound–guided biliary access] are directing the wire into the narrowed areas and the wire shearing as we are manipulating the wire to get it to where we want it," Kachaamy said. "[This EUS-guided access needle] is a 19-22 gauge, rotatable needle with a smooth, side exit for the wire to allow wire manipulation and direction without shearing."

Kachaamy highlighted the simple design, which will keep the production cost below $300 per unit, and suggested that failed ERCPs are just the first potential indication of many. Future uses may include gallbladder access, peri-GI collection, gastrojejunostomy, and others.

In an interview, Kachaamy reacted to the win, which follows 2 years of collaborative development with Cancer Treatment Centers of America.

"For people who are innovators, there's nothing that feels more rewarding than their ideas being recognized as adding something to the field and potentially helping people and patients," Kachaamy said. "So [this is] very, very, very exciting. Very rewarding. Pride would probably be the best way I'd describe it."

Kachaamy anticipates that this EUS-guided access needle will be commercially available within 1-2 years, pending regulatory approval. In the meantime, he and his colleagues are seeking a strategic partner.

A Shark Speaks

V. Raman Muthusamy, MD, AGAF, immediate past chair of the AGA Center for GI Innovation and Technology and director of endoscopy at UCLA Health System, moderated the Shark Tank session, calling it "the highlight" of the AGA Tech Summit.

Dr V. Raman Muthusamy

Muthusamy and four other "sharks," including a gastroenterologist, venture capitalist, regulatory device reviewer, and entrepreneur, scored the pitches using three equally weighted categories: the quality of the pitch, the level of innovation and impact on the field, and the quality of the business plan and overall feasibility.

"We saw a full spectrum [of innovations]," Muthusamy said. "I think it was an enjoyable session."

Behind closed doors, the sharks narrowed the field to two top contenders. Ultimately, however, there could be only one winner: Kachaamy. Their decision aligned with a "Fan Favorite" audience poll.

"A lot of [Kachaamy's win] had to do with the potential applications and commonality of the problem," Muthusamy said in an interview. He highlighted how this EUS-guided access needle allows for an immediate response to ERCP failure without the need for a second procedure.

Muthusamy also noted that several product designs previously failed to achieve what this EUS-guided access needle has the potential to do.

"I think the feeling was that this seemed to be a way that may address some of the limitations and challenges that we've had with earlier [attempts at solving this problem]," Muthusamy said.

For innovators who didn't make the cut this year, or those with products still in development, Muthusamy suggested applying next year.

"We encourage our colleagues and members of the AGA to continue to apply to this program," Muthusamy said.

Other Fish in the Sea

Four other innovators entered the AGA Shark Tank this year. Here are snippets of their pitches:

Hans Gregersen, MD, PhD, MPHFecobionics

"Fecobionics is a simulated electronic stool with the consistency and shape of normal stool," Gregersen said.

The balloon device, which contains multiple sensors, provides "real-time, quantitative, and mechanistic insights by simulating defecation."

"It ... is inserted into the rectum," Gregersen said. "It measures multiple pressures; it has gyroscopes that measure orientation; we can compute the bending of the device; and we can calculate the shape of the device."

According to Gregersen, Fecobionics has "diagnostic potential for patients with fecal incontinence and for subtyping patients with constipation." He highlighted fewer false-positives than current technology, alongside greater efficiency and lower cost.

Gregersen is a research professor at California Medical Innovations Institute, San Diego.

Mary J. Pattison, RN – Trans-Abdominal Gastric Surgical System ( TAGSS )

TAGSS is a trans-abdominal gastric access device that "represents a novel and exciting means to address multiple gastrointestinal conditions that are without a standardized approach," Ms. Pattison said. "Placed as simply as a [percutaneous endoscopic gastrostomy tube], TAGSS offers disruptive technology to address [gastroesophageal reflux disease], fundoplication, achalasia, gastroparesis, gastric tumors, and even obesity in a safe, efficient, and cost effective manner. TAGSS offers the first true hybrid approach for endoscopic/laparoscopic collaboration."

Pattison is a nurse clinician and endoscopy assistant at WestGlen GI Consultants, Weston, Mo.

Pankaj Rajvanshi, MD, FAASLD – Healthswim App

"At this time, most patient education is provided by Google," Rajvanshi said, "and we want to change that. We have built a platform which allows you, the physician, to create custom, curated, credible content that can be delivered seamlessly to your patients on an ongoing basis."

Through the Healthswim app, patients subscribe to their providers, allowing access physician-approved content. Subscribers also receive provider updates through their social media feeds.

Rajvanshi is a gastroenterologist at Swedish Medical Center, Seattle.

Ali S. Karakurum, MD, FACP, FACG – A Device for Removal of Esophageal Food Impactions

"I would like to propose a device which consists of a clear overtube, a collapsible plastic cylindrical basket secured to the distal end of the overtube ... and a snare wire attached to the distal end of the basket which is controlled by the snare handle externally," Karakurum said. "The device is ... gradually advanced over the scope for the basket to encompass the food bolus under direct visualization. Once the food bolus is within the basket, the wire loop at the end of the basket is closed via the external handle, securing the food bolus in the basket for safe removal."

Karakurum is a gastroenterologist at Advanced Gastroenterology & Endoscopy, Port Jefferson, N.Y.

This article originally appeared on GI & Hepatology News, the official newspaper of the AGA Institute.


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