Active market for weight-loss procedures
That being so, the passive approach has been abandoned by many, who are more attracted by weight-loss procedures/surgery and the potential for greater control over the pace and effect of their weight-loss attempt. Surgery is a lucrative procedure, and often available only privately. Furthermore, a constant stream of innovations is in development and being made available to surgeons.
A recent example is GI Dynamics’ receipt of conditional US FDA approval to conduct a pivotal clinical trial of its EndoBarrier treatment of patients who have uncontrolled type 2 diabetes and are obese. The product is placed in the intestine through a small tube that is inserted through the mouth, mimicking the effects of a gastric bypass.
EndoBarrier, already approved and commercially available in the UK, Germany, Austria, Australia, the Netherlands and Chile, is described by the US company as a non-pharmaceutical, non-surgical device that lines a portion of the intestinal wall to affect the way in which the body responds to food. Clinical studies outside the US have shown rapid reductions in blood sugar levels, improvement of select cardiovascular risk factors, and weight loss of approximately 20% in 1 year.
Surgical options are plentiful, as commercial activity in this year alone shows. In August 2012, US surgical devices specialist ConMed agreed to acquire Viking Systems, giving it a 3D imaging system for use during minimally-invasive surgery, the Viking 3DHD Vision System, used by surgeons in bariatric and other laparoscopic procedures.
And Teleflex agreed to acquire the assets of Axiom Technology Partners, which developed the EFx family of laparoscopic fascial closure systems, a technology that will open up new markets, including bariatric surgery.
And as to investment activity, EndoSphere raised $3.1 million this year to help commercialise its CE-marked SatiSphere implant, inserted endoscopically into the duodenum, where it causes food to slow down, tricking the body into thinking it has consumed more food than it actually has.
[pull_quote align=”right” ]The passive approach has been abandoned by many, who are more attracted by weight-loss procedures/surgery.[/pull_quote]
Obalon Therapeutics and Vibrynt are two more companies targeting the bariatric market. Obalon recently raised $1.5 million to develop a similar device to EndoSphere’s, in that it occupies the gastrointestinal space to promote an artificial sense of fullness. Meanwhile, the Vibrynt Prevail Implant uses a minimally-invasive laparoscopic procedure to place the implant on top of, but outside, the stomach. This restricts the stomach’s ability to expand, and thus the limits the amount of food consumed. The Californian firm is planning an initial public offering (IPO) on the Australian Stock Exchange to raise $120 million.
Some studies claim that bariatric surgery is almost 10-times more effective for losing weight and keeping it off than other approaches, but there are mixed views on what types of gastric surgery are best.
Gastric band surgery is less invasive than bypass surgery, and the device can be removed, but patients require more maintenance and follow-up for adjustments. Allergan’s Lap-Band APL system competes with Johnson & Johnson’s Realize Band/Band-C, with both companies currently lobbying for better reimbursement for their devices in the US.
Another camp claims that gastric bypass is superior to banding, with bypass patients losing more weight and keeping it off better than patients who receive the band. The American Society for Metabolic and Bariatric Surgery and the National Institutes of Health (NIH) both say that the Roux-en-Y gastric bypass is the most frequently performed weight-loss surgery in the US, and is in fact, the gold standard procedure for weight-loss surgery.
Laparoscopic sleeve gastrectomy is another bariatric procedure in which the surgeon removes approximately 85% of the stomach, shaping the remaining stomach into a tube, or ‘sleeve’.
