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 ...
That’s it. A needle. But not like any other needle.
Winner: Toufic Kachaamy, MD, FASGE, AGAF – An EUS-guided access needle
This EUS-guided access needle, invented by Dr. 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.
Many “ERCPs are considered difficult, and sometimes fail, depending on the center and the endoscopist,” Dr. 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, Dr. 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,” Dr. 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.”
Dr. 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, Dr. 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,” Dr. Kachaamy said. “So [this is] very, very, very exciting. Very rewarding. Pride would probably be the best way I’d describe it.”
Dr. 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. 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],” Dr. 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: Dr. Kachaamy. Their decision aligned with a “Fan Favorite” audience poll.
“A lot of [Dr. Kachaamy’s win] had to do with the potential applications and commonality of the problem,” Dr. Muthusamy said in an interview. He highlighted how the EUS-guided access needle allows for an immediate response to ERCP failure without the need for a second procedure.
Dr. Muthusamy also noted that several product designs previously failed to achieve what the 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],” Dr. Muthusamy said.
For innovators who didn’t make the cut this year, or those with products still in development, Dr. Muthusamy suggested applying next year.
“We encourage our colleagues and members of the AGA to continue to apply to this program,” Dr. 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, MPH – Fecobionics
“Fecobionics is a simulated electronic stool with the consistency and shape of normal stool,” Dr. 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,” Dr. 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 Dr. 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.
Dr. 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.”
Ms. Pattison is a nurse clinician and endoscopy assistant at WestGlen GI Consultants, Weston, Mo.