Creighton University

by Nicole Resnick, Ph.D.

While minimally invasive surgery has revolutionized medical procedures and spared surgical patients pain and lengthy hospitalizations, the next wave of surgical innovation – noninvasive surgery – promises even more benefits. One company, which has received key assistance from Intellectual Resources Management, is focused on developing the key surgical devices that would make noninvasive procedures a reality.

SafeStitch Medical Inc. based in Miami, Fla., recently announced the development of a new gastroplasty device designed to treat two different disorders – morbid obesity and gastroesophageal-reflux disease (GERD). Charles Filipi, M.D., co-founder and medical director of the company, invented the device with the aid of Intellectual Resources Management at Creighton University. As a professor of surgery at Creighton, Filipi is optimistic that the innovative device will be approved for human trials by early next year.

Bariatric surgery performed to treat obesity, as well as operations for GERD, usually involve incisions and require hospitalization. Moreover, any kind of incision, even if performed laparoscopically, can be painful and carries the risk of complications. SafeStitch’s Obesity Device would allow surgeons to do surgery endoscopically through the patient’s mouth, or transorally, avoiding the need for an incision. This would allow patients to undergo the procedure on an outpatient basis and go home that very same day. Pain would essentially be eliminated and recuperation time would be significantly reduced.

Filipi says that more patients would be willing to undergo surgery for their health problems if they were less afraid of the potential for complications. The SafeStitch device offers a solution that could allay patient fears and provide the treatment they need.

“If we establish a track record of outpatient procedures that are effective, more will be willing to come for treatment. There are a lot of GERD patients with very severe disease who do not want to go to a surgeon because they are afraid of surgical intervention,” says Filipi. “But if they were offered a way to do it safely and effectively, they would.”

“We’re looking not for just a novel and interesting technology, but rather for something that can return patients to a normal state of health,” adds Filipi. “For many they can’t even remember what that feels like; this device creates some hope for them.”

The SafeStitch Obesity Device, a three-foot-long flexible tube less than an inch in diameter, is introduced into the patient’s gastrointestinal tract through the mouth and esophagus. After insertion it treats obesity by first suctioning two sides of the stomach lining into position for excision of the stomach wall inner lining. A row of stitches through the two sides of the stomach is then placed as commonly done during gastric surgery. A small stomach “pouch” that accommodates only a few bites of food is formed. Bringing the remaining areas together for healing and scarring increases the strength of the stomach-pouch wall so it will last longer. This distinguishes the procedure from other noninvasive methods that have been tried.

This same device can be used in the treatment of GERD, a condition in which a patient’s gastroesophageal junction does not close completely, allowing stomach acid, or bile, to enter and damage the esophagus. Treatment involves suturing the esophageal junction to make it smaller.

SafeStitch Medical’s product portfolio also includes an endoscopic device for excision and diagnosis of Barrett’s esophagus, a condition affecting 11 million patients worldwide, in which the lining of the esophagus imitates the stomach mucosa. Such tissue is pre-cancerous and can cause difficulty in swallowing, spreading malignancy and even death.

The company will soon market a novel bite block, a device used during transoral endoscopy, and is pioneering other related products for gastroesophogeal disorders. Through its partnership with Creighton University, SafeStitch has obtained exclusive licenses for over 22 patents and patent applications.

Last spring SafeStitch announced that it had raised 6.2 million dollars for product development and clinical trials through the sale of almost two million shares of the company’s common stock to a number of private investors. The company intends to use the funds for general working capital purposes and the continued development and testing of its products. It hopes to achieve its mission of the “development and production of medical devices to promote patient health and quality of life.”

Filipi’s passion for inventing, together with his surgical training, was the key combination behind the founding of SafeStitch. Early in his surgical career he had the opportunity to experience the new field of laparoscopic surgery and performed the first ever animal laparoscopic cholecystectomies (removal of the gallbladder) in dogs. Wishing to pursue this area of research after settling back in his home state of Iowa as a practicing surgeon, he initiated key collaborations with medical researchers around the country.

The mentorship of Dr. Tom DeMeester and Dr. Ronald Hinder, Creighton University surgeons, were turning points in Filipi’s career. Hinder and Filipi performed the first laparoscopic reflux surgery in the U.S., and Filipi’s appetite for invention only increased as he sought more opportunities.

Intellectual Resources Management (IRM) was a valuable source of information for Filipi, and introduced him to Ideation, an inventor’s think tank. Filipi eventually figured out a better way of performing an antireflux procedure and then applied it to the challenge of treating obesity.

“Creighton University provided a culture of inquiry,” says Filipi. “As a practicing surgeon the culture is typically about production, but in a medical school environment like Creighton, everyone is thinking about the research possibilities, and I appreciate that most.” 

Filipi further benefited from IRM when the time came to move forward with his inventions and start a company.

“They helped me work through the inventive and patenting processes, and to learn how to raise funds for a new company,” he says. “IRM created a good opportunity for me to understand the business side of this venture and helped educate me. At Creighton there is a good environment that is conducive to exploring possibilities.”

SafeStitch was founded in 2005 by Filipi and an old friend of his, entrepreneur Jeffrey Spragens, along with Creighton University. The following year they joined forces with Phillip Frost, M.D., founder, CEO and Chairman of IVAX Corp. and Jane Hsiao Ph.D., vice-chairman of IVAX Corp., and expanded their operations.

The company is now publicly traded, and although it is headquartered in Miami, it maintains a research and development office in Omaha. Of its 14 employees, half are engineers that are dedicated to the creation of medical devices in the areas of bariatric surgery, reflux interventions, endoscopy, and hernia repair.

As a physician first and foremost, Filipi finds the growing problem of obesity in the U.S. particularly troublesome.

“The obesity epidemic is like a tsunami out there that will soon hit our medical system. The earthquake is quaking but the wave hasn’t yet hit,” he says. “The issue is not only those who are obese now, but what will happen to those patients in 15 years.”

Although a number of established companies are developing a variety of approaches for treating this problem, the morbidity for obesity remains high. There is much room for improvement and access to treatment, and SafeStitch Medical is poised to make a difference.