Bariatric Treatment: A Buffet of Options in Development

Individuals who approach and exceed 40% over their ideal weight seem to no longer have the physiological feedback of satiety. This makes it nearly impossible to stay on a diet because their lifestyle revolves around eating. Medication can provide some help but for these extreme patients, there needs to be extreme results. Based on the research we’ve seen, surgical intervention currently provides the best options for aggressive and rapid %EWL.

Patients could soon have multiple options for treatment

Looking over the vast number of companies with extremely differentiated products in development, it is obvious to us that this industry is about to explode with a number of options for physicians in treating their obese patients. With every product having its own strengths and weaknesses, we believe that the variety of different mechanisms used to combat the disease will allow for a customized treatment of each individual patient.

For these companies embarking on the commercialization journey from development to product launch, a decision must be made as to what point in the continuum of care the product will fall into. Currently, there seem to be three distinct markets within the bariatric treatment industry, with a fourth likely to develop:

1. Permanent modification – This represents the largest and most common target market in obesity. For products competing in this space, the goal is to show superiority over the current treatment options (gastric bypass, banding, etc) for lifelong resolution of obesity. This includes any surgical modifications or permanent implants designed to reduce large amounts of body weight for the morbidly obese patient.

2. Revision surgery – This market includes products designed to treat patients who have already had a bariatric procedure but have since regained the weight that was lost. This is fairly common following surgeries that create a small pouch, or stoma, to take the place of the older stomach. Over time, some non-compliant patients will eat more than their diet specifies and the stoma will stretch. The products targeting this patient population are mostly endoscopic suturing devices that cinch the stoma. Furthermore, endoscopic suture devices that are approved to treat GERD (gastroesophageal reflux disease) are being used off-label in bariatric revision.

3. Bridge to surgery – Products used for this market are temporarily implanted for three to six months in order to bring the patient’s weight down to a level where it is safe to operate. Patients with a higher BMI, such as the super obese (BMI > 50,g/m2), often carry a higher risk of complication from surgery. The bridges to surgery products that are currently in development are implants that will be placed endoscopically, and are intended to enable these difficult-to-treat patients to stabilize their health condition before they undergo a more invasive surgical procedure.

Lower BMI/cosmetic – Currently, bariatric surgery is indicated for patients having a BMI greater than 40 kg/m2, or a BMI greater than 35 kg/m2 plus at least one co-morbid condition. For patients who do not fit into this indication, the treatment is considered to be cosmetic. As the safety profile for products and procedures improve, we believe this market will continue to expand. We anticipate the products in this segment will derive from the “bridge to surgery” offerings. We believe that temporary products will fit into a cash-pay environment similar to what is seen in aesthetics (dermal fillers, body contouring, etc) for patients looking for quick, aggressive, short-term weight loss.

Mechanism of action

Bariatric surgery is the general classification of procedures that modify the anatomy of the gastrointestinal tract to reduce the amount of food and nutrient intake. Current and in-development technology can best be categorized into five distinct mechanisms of action:

• Restriction: products which limit the quantity of food that can be consumed by the individual through the physical restriction of a segment of the gastrointestinal system
• Space occupation/filler: device which is deployed in the stomach to occupy space and in turn limit the volume of food that the stomach can hold
• Flow control: devices which manipulate the rate of gastric emptying
• Malabsorptive: products that limit the amount of digested material that is absorbed into the body. This can be achieved by bypassing segments of the gastrointestinal tract or utilizing products to block contact between digested food and intestinal walls.
• Appetite suppression: products and techniques designed to stimulate satiety and therefore the consumption of smaller amounts of food.

The developmental and currently approved procedures and devices in bariatric surgery vary in clinical results and risk of complication. It is up to the patient and doctor to perform the risk-versus-reward analysis. However, it is the different approaches, risk profiles, lifestyle impacts, ancillary benefits and costs for each product that we believe will create a new market with multiple players and varying degrees of success.

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