An incisionless, implantable antiobesity medical device from EndoSphere has received the CE Mark, which signifies European regulatory approval.
EndoSphere’s device, called the Satisphere, works by slowing the passage of food through the duodenum, the upper part of the smaller intestine that breaks down food. Because food is in contact with the duodenum for a longer time, the device essentially fools the body into thinking that it’s consumed more food than it actually has.
The company says the device helps patients lose weight without requiring surgery or medication.
Behavioral Health, Interoperability and eConsent: Meeting the Demands of CMS Final Rule Compliance
In a webinar on April 16 at 1pm ET, Aneesh Chopra will moderate a discussion with executives from DocuSign, Velatura, and behavioral health providers on eConsent, health information exchange and compliance with the CMS Final Rule on interoperability.
The device, which is inserted using an endoscope, can be placed in the small intestine in about 15 minutes, taken out in five minutes, if necessary, and doesn’t require any suturing or hooks to hold it in place. The ability to quickly and easily remove the device if a patient no longer needs it figures to be one of its chief advantages.
Now that the device has been approved for European sales, the company’s next big step is to start selling it. EndoSphere is already in discussions with potential customers, said Chris Thorne of Broadline Capital, who serves as EndoSphere’s executive chairman.
Broadline is one of EndoSphere’s investors, a list that also includes Glengary, North Coast Angel Fund, Ohio TechAngel Fund and Queen City Angels — all based in Ohio.
EndoSphere recently received a boost when it was awarded a $1 million loan from the state of Ohio. The funding will go toward a post-market-approval study of the Satisphere and commercialization of the device, Thorne said.
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.
There’s no time line on an application for U.S. Food and Drug Administration approval of the device, Thorne said.
Other medical device companies with implantable antiobesity devices include EnteroMedics, Obalon Therapeutics and Aspire Bariatrics.
