Fogarty Company Pursues A Therapy That Eclipses All Others to Treat a Devastating Pediatric Syndrome

by | Mar 5, 2021 | Companies

Imagine if your child’s body wasn’t able to absorb the nutrients it needs from food. That can be the result of short bowel syndrome (SBS), a malabsorption disorder caused by the lack of a functional small intestine.

In pediatrics, common causes of SBS are necrotizing enterocolitisvolvulus and atresia. These conditions lead to death or malfunction of the small intestine, which then needs to be surgically removed, leaving the patient without enough intestine to absorb the appropriate amount of nutrients naturally. Patients become dependent on intravenous nutrition, which comes with high rates of central line infections, metabolic imbalance and liver failure.

This is an issue that Eclipse Regenesis seeks to alleviate with the first restorative therapy to address pediatric and adult SBS patients. The disorder has no cure, and current treatment options are only supportive and include expensive medication or intestinal surgery, which come at a staggering five-year cost of care average of $1.6 million per patient. And even when using these existing interventions, pediatric patients still face up to 30% mortality rates by age five.

Eclipse is part of Fogarty’s new Company Accelerator Program (CAP) program, which supports early-stage companies in developing a comprehensive, cross-functional approach to address their desired opportunity by “starting with the end in mind.” The six-month program is designed to help companies clearly focus on their opportunity and identify barriers to success.  

An innovative solution 

The company’s Eclipse XL1 Distraction Enterogenesis System aims to significantly enhance patients’ quality of life by harnessing the body’s own tissue regenerative capabilities to produce new, fully functional intestine. The device features a mechanical nitinol coil that works to internally grow new, healthy tissue to lengthen existing segments, thus increasing the nutritional absorption surface area.

Given that intestinal tissue is very thin and flexible, the device is placed inside in its compressed state, and as it naturally starts to extend, it stimulates the growth of healthy intestinal tissue, lengthening the targeted region two or three-fold. The sutures holding the device in place are biodegradable so they dissolve, then release the device, which passes out of the intestine via the stool. The new tissue will absorb nutrients and function just like healthy intestinal tissue, with the intent to eliminate or minimize the need for intravenous feeding.

The Eclipse XL1 not only aims to revolutionize a patient’s quality of life, but it does so at a great cost savings for our healthcare system, says company co-founder and CEO Andre Bessette. The average first year cost of care for a pediatric SBS patient is more than $500,000. Market research with public and private payors has shown a favorable reception for this new technology as the clinical and economic burdens are so severe.  

Discovering the potential 

Eclipse’s beginning comes with a Fogarty Innovation connection, given that Andre has long worked with Fogarty chairman of the board Tom Krummel, MD. While they were looking at potential medical device deals in which to invest, Andre first came across what he recognized as “this amazing concept out of UCLA for stimulating the growth of small intestine tissue.” 

Coincidentally, Andre realized that James Dunn, the physician who had been conducting this research at UCLA for the past 12 years, happened to be coming up to assume Tom’s previous position as surgeon-in-chief at Lucile Packard Children’s Hospital at Stanford.

James and Tom both know all too well the repercussions of leaving a baby without enough intestine. As surgeons, they had to perform the surgeries that left the child with SBS and all its complications. James, being a surgeon and Ph.D. in biomedical engineering, wanted to find a solution to address the condition and give these kids a chance to lead a normal life.  

His inspiration for the device design came from watching his colleagues in orthopedics. He saw that when you put a bone into distraction, it stimulates growth, and he set out to do the same for the intestine. 

“Tom and I were blown away, seeing 12 years of peer-reviewed, published science on this new concept to address a terrible syndrome for which there was no solution, and here was a possible cure,” Andre said. In no time, the group decided to work together here in Silicon Valley, which is ripe with entrepreneurs and investors. They started fundraising at the end of 2018; in January 2019, they raised their first funding, and “it’s been, go, go, go, ever since,” said Andre.  

Eclipse has pulled together a world class team of top physicians — Mark Puder, MD, Ph.D., from Boston Children’s Hospital; and Michael Helmrath, MD, MS, from Cincinnati Children’s Hospital. They work at the top two U.S. centers for managing pediatric SBS patients. Mark and Mike have already signed up to be the primary investigators for the upcoming first in human clinical trial. 

Looking forward to the opportunities at CAP—and beyond 

Andre is excited about the doors that will open as part of the CAP program. “Obviously being part of the Fogarty Innovation network and family is extremely powerful and helpful,” he says. “I am looking forward to immersing myself in this project and benefitting from the knowledge and skills we will have access to here.”

The larger community has taken notice of Eclipse’ potential, leading to multiple awards, including receiving a Stanford-Coulter Translational Research Grant, winning the prestigious UCSF-Stanford Pediatric Device Accelerator Shark Tank Pitch Competition, and the company recently received a Phase I Small Business Innovation Research (SBIR) grant from the National Science Foundation. 

“The science behind this is really what’s incredible, and it’s well known in the pediatric surgeon community, having been published in over 20 peer-reviewed journal articles and presented at all the major meetings.”

In May, Eclipse plans to submit its investigational device exemption (IDE) to the FDA for its first human trial and prepare to fundraise for Series A at the end of 2021. The team is also exploring the potential for a less-invasive endoscopic version of the treatment.

“We’re going to be saving babies’ lives, which is incredibly significant. This is an impact project and we are looking for those investors who want to change medicine and change the lives of these kids,” Andre says.

Photo caption: Eclipse Regenesis aims to solve a life-threatening condition, Short Bowel Syndrome, together with some of the top pediatric surgeons in the country. From left to right, James Dunn, MD, Ph.D. (Stanford Children’s Health); Mark Puder, MD, Ph.D. (Boston Children’s Hospital); Michael Helmrath, MD, MS (Cincinnati Children’s Hospital); Tom Krummel, MD (Stanford Medicine and Fogarty Innovation); and Andre Besette, CEO.

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