The average excess body weight loss has increased to 22.1% – up from 16% at week one.  The weight loss ranged from a low of 10% to a high of nearly 43%.  The first followup endoscopy has been performed on all patients with good results.

There was a migration of the device in one patient – with the device successfully removed from the stomach using an endoscope.  This was likely due to insufficient knot tying in the esophagus during implant (the older knot pusher used in the first cases did not function as well as the newer version used in the last half of the cases).  The device migrated at day 16 – the weight loss was 34% at the time of the migration.  The patient has since regained 4 1/2 lb and his hunger has returned.  We will continue to monitor this patient  over the next several weeks.  Dr. Trevino reports that he is very sad that he no longer has a Full Sense Device and is ready for another one ASAP!

The patient who had gall bladder surgery is doing well and losing weight.

There are two diabetic patients in the study – one is completely off their diabetic medications and the other has reduced their dosage by 50%.

We are only a few weeks away from exceeding the longest implant times (the first study lasted 6 1/2 weeks).

This week all patients return for their first endoscopy (examination of the device with a camera positioned on the end of a flexible tube).  This will permit an evaluation of the positioning of the device, the esophageal and stomach tissue in contact with the device and the security of the fixation sutures.

The patient with the greatest weight loss has been reported to be “excercising like crazy”.  Another patient is “playing a lot of basketball” again which he has not done in a while.  His diabetes is also improving requiring less medications.

To put this in perspective, most medical programs hope to have patients lose 5-6% of excess body weight by the conclusion of the program.  The weight loss we are seeing is better than most bariatric surgical patients experience at this point.

Note:  Excess body weight was calculated as the patient’s weight at a BMI of 25 subtracted from their actual weight.

The view inside the abdomen from the laparoscope showing the distension of the stomach caused by the Full Sense Device.  This distension puts pressure on the upper portion of the stomach causing satiety.

Dr. Foote and Dr. Trevino are assisting laparoscopically, while Dr. Kemmeter and Dr. Baker are operating the endoscope.

J Foote MD, R Baker MD, J Treviño MD,P Kemmeter MD, F Walburn PhD, P Freswick BS, Grand Health Partners, Grand Rapids MI, Sentinel Group, Grand Rapids MI, Hospital Galenia, Cancun Mexico, Michigan State Medical School, East Lansing, MI

Background: In the US alone there are nearly 100 million overweight, obese and morbidly obese individuals. Existing bariatric surgical therapies address a very small percentage of these individuals. Of the 23 million morbidly obese patients in the United States, approximately 1% undergoes conventional weight loss surgery. Diet, exercise, and medications produce minimal weight loss at best and most regain or exceed baseline weight within 5 years. The typical result is decreased metabolism, constant hunger, depression which results in a high failure rate. Additionally many bariatric patients experience weight regain over time due to difficulty in achieving continued satiety. As a result there is a critical need for a non-invasive, reversible, safe device that can deliver effective satiety and result in weight loss.

Description: The Full Sense™ is a reversible bariatric device, deployed and removed endoscopically. It incorporates an esophageal component and a gastric disk connected by a strut. It is designed to induce satiety and fullness in the absence of food by placing pressure on the distal esophagus and cardia of the stomach.

Clinical Animal Results: In four separate studies, animals lost approximately 23% of their body weight whereas controls gained 3% in 28 days.

Clinical Human Results: The device was endoscopically placed in 3 female patients (mean BMI of 44.0, mean age of 38 years), and secured via laparoscopic assistance. Patients lost an average of 28% of their excess body weight in 46 days. The devices were removed endoscopically. There was no device migration, no ulcers and no compromise of the GE junction. Inflammation, which was present at the time of explantation was confirmed resolved at three week post operative follow up endoscopy. The patients were required to record their satiety levels daily using a standardized satiety scale. All patients recorded increased satiety with The Full Sense™ Device in place than after removal.

Conclusions: The Full Sense™ Device has been shown to be an effective endoscopically placed and removable bariatric treatment in pre-clinical and clinical studies.

The Full Sense™ Device is a stent like device placed through the mouth into the top of the stomach to cause satiety thus decreased hunger and increased fullness.  It causes satiety by placing pressure on the bottom of the esophagus and the top of the stomach.

Patients not only lost significant weight in the study but also noted significant satiety with the device in place.  Without the device they noted extreme hunger before meals whereas with the pressure from the Full Sense™ Device they experienced at most slight to no hunger before meals.  The devices were removed safely and patients have stopped losing weight and are beginning to regain the weight that they had lost.

“The patients were extremely happy with the lack of hunger and resulting weight loss.  They did not want the devices removed but reluctantly underwent removal per the protocol to demonstrate that the device could be easily removed,” said Fred Walburn.  “This technology represents potentially a new era of safe non-surgical weight loss treatment and offers hope for the millions of Americans who need treatment for obesity but can’t afford the cost or possible complications of traditional weight loss surgery.”

“Obesity is increasingly causing devastating effects on individuals and our society as a whole.  This technology, I believe, offers the best opportunity yet to deliver consistent satiety and weight loss.  Even many people with traditional weight loss surgery are experiencing significant hunger and subsequent weight regain.  The potential to deliver satiety without classic incisions and surgery will give hope to many more people struggling with weight and weight related medical conditions,” stated Randal Baker MD.

“The patients were very pleased with the results of the Full Sense™ Device,”said Dr. Trevino, Head of Bariatric Surgery.  “They are asking for the device to be implanted again!”

ABOUT GALENIA

Successful weight loss achieved with new device

January 5, 2009

Grand Rapids, Michigan. Sentinel Group announced the first implants of the Full Sense™ Device on November 3-4, 2008 at Galenia Hospital in Cancun, Mexico by American doctors Randal Baker MD, James Foote MD and Mexican doctor Jorge Trevino MD.

The Full Sense Device is a stent like device placed through the mouth into the top of the stomach to cause a feeling of fullness.  It causes fullness by placing pressure on the bottom of the esophagus and the top of the stomach.  The device can be placed and removed via endoscopy.  “The Full Sense Device essentially tricks the brain into thinking that the stomach is full when it is not,” said Fred Walburn, PhD., President of Sentinel Group.  “This technology represents potentially the greatest step forward in the battle against obesity since the inception of bariatric surgery.”

“Most of today’s bariatric surgeries require some type of pouch filled with food to create a full feeling.”  stated Randal Baker MD.  “This device, so far, is showing better weight loss than most surgeries because it does not depend on food intake.”  Dr. Foote adds, “We believe this technology will be another great tool in the fight against obesity.”

“Galenia Hospital is pleased to be the first center to treat patients with the Full Sense Device, said Dr. Trevino, Head of Bariatric Surgery.  “The patients are losing weight better than most of my surgery patients and are extremely happy.”

ABOUT GALENIA

The Galenia Hospital located in Cancun, Quintana Roo, Mexico is a modern facility with state of the art equipment which go beyond the everyday services, with highly trained doctors and a wide range of medical specialties along with experienced people working for health care of national and international patients.

ABOUT SENTINEL GROUP
Sentinel Group is a medical device development company founded to commercialize patents owned by its principals and to assist physician inventors in commercializing their ideas.  The company’s intellectual property portfolio includes technologies in the areas of: bariatrics, colorectal anastomoses, diverticulitis, hiatal hernia, depression, Natural Orifice Translumenal Endoscopic Surgery (NOTES), Endoscopy and GERD.  The Company’s first product is the Full Sense™ Bariatric Device.

The Full Sense™ Device is not available in all markets pending regulatory clearance. Sentinel Group^® and Full Sense™ Device are trademarks of Sentinel Group LLC.

Fred Walburn, PhD

President

SENTINEL GROUP

866-278-0206 (office)

443-593-0091 (FAX)

fwalburn@SentinelGroupLLC.com

http://www.SentinelGroupLLC.com