SafeStitch to introduce AMID Stapler in March 2012
SafeStitch Medical (OTCBB:SFES) plans to introduce its AMID Stapler, a repair system for inguinal and ventral hernias, at a joint meeting of the American and European Hernia Societies on March 28, 2012 in New York City.
“We see the AMID Stapler as a new and innovative device in the treatment of hernias that can promote faster patient turnaround in the operating room,” co-founder and CEO Jeffrey Spragens said in an interview with BioTuesdays.com. “Fast procedure time and less tissue manipulation are expected to provide patients with a more comfortable recovery and the potential to return to work in less time.”
The AMID Stapler, which was developed with direct involvement from Dr. Parvis Amid, who pioneered and teaches the widely used Lichtenstein hernia procedure, is pre-loaded with titanium staples. The staples secure a mesh screen in the hernia sac, as part of a Lichtenstein repair, which helps prevent the recurrence of a hernia.
There are over 600,000 Lichtenstein inguinal, or groin, hernia procedures performed in U.S. annually, with an annual growth rate of 5%, and virtually all of them are sutured. “The stapler is designed for ventral (abdominal) hernias as well but our initial focus will be on hernias in the groin,” Mr. Spragens says. “With a Lichtenstein repair, patients leave the hospital on the same day as the procedure because treatment is minimally invasive.”
SafeStitch’s premarket evaluations have identified approximately 250 hernia surgeons who collectively perform some 40,000 procedures a year. “They have tried the stapler in various non-human models and the feedback we have is that they like the device and they’re ready for the sales introduction,” he adds. SafeStitch’s initial marketing plans will focus on these early adopters.
“Our competition is hand suturing,” he says, noting that the “stapler will cost more than suturing but has many offsetting advantages. These 250-plus doctors seem to agree.”
SafeStitch anticipates deploying a sales team of eight employees, 14 independent contracted sales reps, and one distributor, with 10 sales people, to market the AMID Stapler.
Mr. Spragens says that the second phase of the company’s sales and marketing strategy, running from 2014 through 2016, will target formulary acceptance by Group Purchasing Organizations (GPOs), which currently cover approximately 480,000 hernia procedures a year.
SafeStitch was founded by Dr. Charles Filipi, Dr. Phillip Frost, Dr. Jane Hsiao and Jeffrey Spragens in 2006 largely to develop medical devices that manipulate tissues for the treatment of obesity, gastroesophageal reflux disease (GERD), esophageal obstructions, Barrett’s Esophagus, upper gastrointestinal bleeding, and other intraperitoneal abnormalities through endoscopic and minimally invasive surgery. SafeStitch’s offices and manufacturing facilities are located in Miami, Florida and its animal laboratories in Omaha, Nebraska.
The company’s gastroplasty (GST) system is under development to treat GERD and obesity, using a device that passes through the mouth, with moderate sedation in an outpatient setting.
GERD is a condition where stomach contents, food or liquid, leak from the stomach into the esophagus, which is the tube from the mouth to the stomach. GERD results not only in heartburn but can led to ulcers as well as development of Barrett’s Esophagus, a precancerous condition where cells lining the esophagus turn into stomach-lining cells because of the continued presence of stomach juices in the esophagus.
Mr. Spragens explains that there are surgical procedures to narrow the opening around the esophageal sphincter valve and stop reflux, but they are invasive operations with corresponding recovery time. “Our GST system has a full surgical array of transoral tools,” he says.
Dr. Filipi, SafeStitch’s chief medical officer, said that after 17 months, “GERD and obesity patients from our first human trial are doing well. We demonstrated that our GST devices can perform the intended procedure safely at the gastroesophageal junction. The patients are continuing to do well with the procedures displaying the necessary durability.”
To treat obesity, Mr. Spragens explains that the GST device can make a mini-pouch below the esophageal sphincter, using the body’s own tissue rather than a prosthetic device such as a lap band. Food goes down through the opening into the stomach and hits the mini-pouch that has been made internally with the GST system.
“We have the only transoral procedure that uses endogenous tissue formation for optimal efficacy and durability,” he contends. “This is what differentiates us.”
Many people suffering from obesity resort to adjustable lap bands, which are placed around the top portion of the stomach. In 2010, the number of gastric bypass and banding procedures totalled 370,000 in the U.S. and 79,000 in the EU, with expected growth rates of 10% to 15% a year, respectively.
But complications from gastric banding have led to a reported 20% to 30% removal rate in the first year. “This trend is expected to continue,” Mr. Spragens says, adding that this could be an “additional marketing opportunity for our GST product. Our procedure also may expand the market because it is transoral and is expected to require moderate sedation in an outpatient setting.”
Even though the same SafeStitch GST device can perform both procedures, the company will need to conduct two separate trials for GERD and obesity, and seek FDA clearance and approval for two indications. “The plan now is to move into feasibility trials in the U.S. for both indications sometime next year,” he says.
Mr. Spragens says the company also is evaluating commercialization options for its Smart Dilator and Bite Blocks products.
Esophageal dilations are performed to expand the esophagus, which has narrowed often because of GERD-induced ulcers. There are over one million dilations performed in the U.S. each year, with studies pointing to a nearly 1% perforation rate. Untreated perforation of the esophagus is fatal, usually within two days. Research also indicates that during dilation, a physician should place no greater than two pounds of pressure on the dilator.
“Our Smart Dilatorhas an indication on the handle that provides a physician with a cost effective, visual indicator before reaching the recommended two-pound limit,” Mr. Spragens says.
“While there are numerous dilators on the market, we believe none include a feedback mechanism similar to that contained in the Smart Dilator,” he adds, noting that the device was cleared by the FDA in February, 2009.
Mr. Spragens says a bite block is used to keep patients from biting down on an endoscope and damaging it during GI procedures. “In fact, more money is spent each year repairing endoscopes than on buying new endoscopes,” he says.
SafeStitch’s Airway Bite Block, contains a built-in airway that assists breathing in patients with larger tongues or smaller throats, usually because of obesity, during an endoscopic procedure.
“This is probably a commodity product but the fact is no one has ever tried to incorporate an airway and a bite block in the same device, and with more and more obese patients undergoing endoscopic procedures, there is a need for such a device,” he adds.