Researchers and medical device companies are using electrical stimulation in new products to address pain, sleep apnea, paralysis and ALS. But a young St. Louis company is applying electrical stimulation to gastroesophageal reflux disease to reduce the need for treatment with proton pump inhibitors.
EndoStim has already secured European approval to market its implantable electrical stimulation device and is working its way through the regulatory approval process in the U.S. Now it’s raising a $12 million round of financing, two-thirds of which it’s already secured from 41 investors.
The device is designed to strengthen a weak or dysfunctional lower esophageal sphincter muscle, which acts like a valve to allow food into the stomach but keeps stomach contents from leaking up into the esophagus. When it doesn’t work properly and acid leaks up into the esophagus, GERD occurs, which includes symptoms such as heartburn, nausea, cough and difficulty swallowing.
While antacids, H2 blockers and proton pump inhibitors can be used to treat occasional heartburn, there is concern about side effects from long-term use of H2 blockers and PPIs, which suppress the production of stomach acid.
EndoStim’s device, intended for those with severe GERD, includes a pulse generator that’s implanted under the skin of the abdomen during a laparoscopic procedure. A bipolar lead connects two electrodes on the pulse generator to the esophagus. The generator sends low-energy electrical pulses to stimulate the LES muscle.
In clinical trials, the treatment significantly reduced esophageal acid and improved LES function in patients who didn’t respond to PPI therapy, according to the company.
EndoStim got the green light to market its device regulators in the EU in August. According to a company statement, a U.S. study should begin in late 2013. A clinicaltrial.gov listing indicates that a phase 3 study has already begun recruiting in the U.S.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
This device presents an interest scenario for the GERD treatment market: How many people would be willing to undergo a procedure and have a device implanted for the sake of potentially improved quality of life? Most GERD is not life threatening; only about 10 percent to 20 percent of chronic GERD sufferers develop Barrett’s esophagus, a condition associated with increased risk of esophageal cancer.
The U.S. Food and Drug Administration approved another implantable device for chronic GERD treatment early last year called the LINX Reflux Management System. Torax Medical’s system is a series of titanium beads with magnets in their cores that’s placed around the LES during a laparoscopic procedure that increases strength to keep a weak LES closed. Another device used for minimally invasive treatment of GERD, by Medigus Ltd., was also approved in May.
Founded in 2009 based on technology licensed from Arizona State University, EndoStim appears to have raised about $13 million since its inception, based on figures disclosed in U.S. Securities and Exchange Commission documents. (A more detailed description of the company’s founding is presented in The New York Times). Venture capital investors include Sante Ventures, Prolog Ventures and Vectis Healthcare & Life Sciences Fund.
EndoStim says it will use the platform technology to develop micro-electronic devices for GERD, urinary incontinence and sexual dysfunction through local neurostimulation.
[Photo from EndoStim]
