Frequently

Asked

Questions
OBESITY: 16.9% of adult population is overweight
more than 30% of the population is affected by weight problems*
OBESITY: 16.9% of adult population is overweight
more than 30% of the population is affected by weight problems*
6.5% of the population is affected by DIABETES*
7% of adult population is affected by GERD*
HEART DISEASES: 117 deaths per 100,000 people caused by ischemic heart disease,54 deaths per 100,000 people due to stroke*
10% of adult population is affected by CONSTIPATION*
*OCSE

How did the BNM develop from the gastric pacemaker?

Dr. Cigaina, a general surgeon, invented the gastric pacemaker.  In the 1990s he was performing bariatric surgery and presenting scientific papers on his research.

As often happens in scientific experimentation, the results can be different from expectations.  Although Dr Cigaina was searching for an inverted gastric peristalsis (i.e. an effect on the muscle type), he in fact obtained an effect on the nervous system (a neurological effect) that changed eating behavior. Unfortunately, he found these conclusions after the first presentation was done to the scientific world, and in a bariatric surgery environment.

The scientific assumptions that inspired Dr. Cigaina to introduce the gastric pacemaker were shown to be incorrect during animal and clinical studies. The motility of the stomach was not inverted, but the nervous apparatus of stomach was used as an intermediary for a communication with the brain (the brain-stomach axis).  Therefore, the new satiety, early and longer lasting, was not the consequence of an impaired gastric motility but was instead the result of a neurological change of the subject.

 

On the other hand, the surgical approach to obesity is to induce a disease in order to correct the excess weight.

We will see below that obesity and excess weight should be viewed as two distinct things, although they are usually associated.

Weight-loss is the goal of surgery and achieves it at a high cost, even though it may be for a short time and on a temporary basis.  This process creates a disease considered to be "minor", which is a digestive malabsorption or obstruction, or both.

In medicine, an electrostimulation system, like the BNM, is not employed with the purpose of inducing a disease in order to correct a dysfunction.

The surgical and the functional approach to obesity have completely different targets, so they are not comparable to each other on the same grounds:

  • Bariatric surgery looks at the weight only, as a variable to reduce quickly.
  • Neuromodulation looks at obesity as an eating behavior that needs to be corrected, and weight loss is a consequence of a change in behavior.

Why is the BNM different from gastric pacing and why will it succeed?

  1. It tackles obesity in terms of etiology. Obesity is a neurological defect due to the prevalence, at rest, of the sympathetic system. Normalization of the ratio of sympathetic/parasympathetic activity is the goal; the weight loss is a consequence, as are the lowering of the heart rate, the slowing of the aging processes, the control of the reflux (GERD), lower blood pressure etc.
  2. It tackles obesity from a medical and not a surgical point of view. So, the target is less daring and, above all, different (focus is normalization of eating, then weight loss).
  3. There is no surgery under general anesthesia.
  4. There is no hospitalization.
  5. There is no catheter that it can break and then needs to be replaced.
  6. There are no batteries to replace.
  7. There are only minor limitations related to patient age.
  8. The sale price will be much lower than that of a gastric pacemaker.
  9. There is less need of SSN or Health Care support (in any case, they will be interested because of the low price of the BNM and the significant reduction in health care costs per obese patient).
  10. The follow-up does not require a specialized engineer (no hidden costs).
  11. A simple objective method is available to monitor the effectiveness of the procedure.
  12. The BNM does not change the neurological digestive system; the BNM enters inside the digestive neurological system.
  13. 13.   There is no vagal stimulation, neither a vagal block nor a celiac block. The BNM sends a message for a new set up of the system.

In what areas is the BNM superior?

1. The "obesity market" wants weight loss.
The several solutions presently available provide different responses:
a) The pharmaceutical industry offers non-decisive drugs, ensuring a steady market and continuing revenue.
b) The obesity surgery proposals provide an immediate weight loss through digestive mutilations (restrictive or malabsorptive), with an important turnover for bariatric surgeons (about $3 billion a year, 2010 estimate).
c) The Brain Neuro Modulator (BNM) can guarantee the normalization of eating in an obese individual, therefore stopping weight gain without dietary restrictions, and later stabilizing the target weight. The amount and speed of weight loss depend on environmental conditions (personal habits, family history, food availability, etc.).

2. Obesity is a genetic malfunction that cannot be changed and has to be treated from youth to old age (see exhibit 1).
If untreated, obesity becomes a disease.
a) Medical therapy with drugs does not repair the genetic defect, leaving unchanged the autonomic neurological imbalance (exaggerated sympathetic nerve activity).
b) The surgical therapy does not repair the genetic defect.
c) The gastric pacemaker does not repair the genetic defect, but interacts with the neurological consequence by decreasing the ratio of sympathetic and parasympathetic activity (etiological therapy). Unfortunately, there are two drawbacks of gastric pacing:

  • A new surgical procedure is needed to replace a broken lead (laparoscopic surgery under general anesthesia).
  • Batteries had to be replaced in the existing pacemaker (surgery under local anesthesia)

d) Alternatively, the BNM can achieve the normalization of eating in an obese individual in order to stabilize the target weight, without negative side effects.

3. Follow-up of the patient has to be considered.
a) In drug therapy, the physician should follow the patient with medical therapy for problems related to diet (moderate and short-term efficacy) and the drugs (possible side effects).
b) In surgical therapy, the surgeon must strictly follow the patient because of the many possible side effects of bariatric surgery, and weight gain may show up again in the long term.
c) In gastric pacing, the patient should be followed for any breakages, battery depletion and changes in efficacy of the device.
d) With the BNM, other than monitoring the patient, there is no follow-up related to broken leads, batteries and dislodgement of the device.


Exhibit 1 - different weight trends in 1) normal weight subjects (blue line), 2) obese patients (red line), 3) obese patient after BNM implant (orange area)
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