Could neuromodulation be an effective means of stopping overeating and lead to the treatment of obesity? A clinical study from Stanford University researchers will be conducted to find out the answer.
The researchers said that Mountain View, CA-based NeuroPace’s RNS System can be used to manage loss-of-control eating for patients with body mass index (BMI) of 45-60 kg/m2 for whom medication and gastric bypass surgery have not been effective treatments, and for whom loss-of-control eating is a contributing factor.
“Loss-of-control eating” refers to a feeling that one cannot control what or how much one is eating. This typically takes one of two forms, either eating objectively large amounts of food or eating continuously and can compromise even the most aggressive of obesity treatments, such as bariatric surgery.
There is evidence to suggest that long-term alterations in brain function, particularly in the reward and impulse control circuitry, occur with eating disorders, including loss-of-control eating. In addition, there is growing evidence to suggest that there are discrete changes in brain activity, or biomarkers, which immediately precede loss-of-control eating events.
As part of the study, the RNS System will provide the first long-term ambulatory recordings of human brain activity from this key area of the reward circuit, the nucleus accumbens. Data captured by the system will be analyzed using artificial intelligence and machine learning to provide initial insights into the function of the human reward circuit as well as to initiate the development of algorithms that can individualize treatment in the future.
“Obesity is a disease with many contributing factors. Unfortunately, obesity is often associated with multiple comorbidities that can lead to reduced quality of life and even premature death. For some patients, loss-of-control while eating can be a significant contributor to their condition,” Tara Skarpaas, PhD, Principal Scientist at NeuroPace and one of the study’s researchers, said in a release. “This study will evaluate whether neurostimulation can automatically respond to the signals that occur immediately before a loss-of-control eating episode to help patients regain control, a potentially groundbreaking intervention for the most severely affected patients. The RNS System’s ability to continuously monitor brain activity and respond with therapy when these biomarkers are detected makes the system an ideal fit for this research.”
Changes in the Market
With this study, NeuroPace is venturing out into new territory. Typically, the firm’s closed-loop neuromodulation technology is used to treat adults with medically refractory focal onset epilepsy.MD+DIreported in 2013 that NeuroPace landed a PMA from FDA for the RNS System.
If the investigators are successful, then NeuroPace’s technology could be transformative for the ever-shifting obesity treatment market. Companies in the space have gone through significant changes in the last few months. Competition has ramped up; there has been a change in sales models; and product swaps.
Obalon has made some changes recently that might have left some in the industry puzzled. In April, the San Diego, CA-based company cut staff by 50% in a move that included the elimination of its direct sales force and a reduction in headquarters staff. Obalon said it was jettisoning off its sales force to transition to a new selling model intended to efficiently use the existing resources to develop the market and drive revenue.
Nearly a week after the staff reduction, Obalon then revealed it retained Cowen as an independent financial advisor to assist in exploring financial and strategic alternatives. Then about a week ago, the obesity-treatment specialist said it would reduce debt under a facility with Pacific Western Bank from $20 million to $5 million.
BAROnova, reported significant progress by receiving approval from FDA for the TransPyloric Shuttle (TPS) device, a non-surgical treatment option for obese patients.
The San Carlos, CA-based company’s TPS device is an intragastric implant that is trans-orally placed into the stomach during a standard endoscopic procedure. The device was designed to reside in the stomach for 12 months before being removed with another endoscopic procedure.
GI Dynamics has slowly been making a comeback with its EndoBarrier technology and getting a second shot at redemption. The Boston-based company has struggled to get to the obesity treatment market in the U.S. and approval of the EndoBarrier was suspended in Europe.
The EndoBarrier is designed to treat obese patients with type 2 diabetes by creating a barrier between food and the wall of the small intestine. GI Dynamics said this changes the metabolic pathways by controlling how food moves through the digestive system.
In February, GI Dynamics won a nod from FDA and the Institutional Review Board to launch another pivotal trial of the EndoBarrier. GI Dynamics’ first pivotal trial was halted in 2015 after four cases of hepatic abscess were found among the 325 patients enrolled in the study.
The approval of the 2019 pivotal trial came about a month before GI Dynamics touted promising data from the UK’s National Health Service EndoBarrier study that showed a significant reduction in HbA1c, weight, liver fat, and cardiovascular disease risks as well as a reduction in the need for insulin in some patients.
And late last year, ReShape Medical and Apollo EndoSurgery announced a deal that would allow for a product swap of sorts. In the transaction, Apollo said it would sell its surgical product line, which includes the Lap-Band adjustable gastric banding system to its rival ReShape Medical. In addition, ReShape decided to sell its intra-gastric balloon line to Austin, TX-based Apollo. The transactions were worth about $17 million.