An oral form of insulin doesn’t exist yet, but Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) has announced it’s taking a major step toward attaining the Holy Grail of diabetes care.
The Israeli company, whose U.S. headquarters is in New York, recently launched a nationwide study, “the company’s largest and most advanced clinical trial under the U.S. Food and Drug Administration to date,” it said in a press release. Selected sites include Tustin-based Integrium Clinical Research, its largest clinical trial in the country, a company spokesperson said.
Chief Executive Nadav Kidron said insulin injection is “a complex process that relies on patient compliance.” He explained that there’s a danger of injecting too much insulin and that injection is often viewed as a last resort, though early insulin therapy can help ease the burden on a diabetic’s pancreas. Injection introduces insulin directly into the bloodstream. Only a fraction reaches the liver, causing excess sugar to be stored in fat and muscle, which can result in weight gain.
The company’s drug is designed to travel orally through the stomach and into the intestine, where absorption is increased along the intestinal wall. The delivery “[mimics] the body’s natural process of insulin going directly to the liver rather than the bloodstream,” Kidron said.
Executives hope to use data from the trial, available early next year, to seek Food and Drug Administration approval.
Heart Study
Medtronic PLC (NYSE: MDT) has started enrolling patients in a new clinical trial evaluating the ECG (electrocardiography) Belt Research System as a diagnostic tool for optimizing cardiac-resynchronizing therapy for patients with heart failure. The study will initially enroll patients at 10 centers across the U.S. and expand to additional sites overseas, enrolling a total of 400.
Cardiac-resynchronizing therapy is an established treatment option that uses an implantable device to send low energy levels to stimulate the heart in order to improve pumping efficiency. Medtronic’s device will be wrapped around the chest and back at the time of the implant to provide real-time measurement of the heart’s electrical activity.
“The aim of this technology is to give physicians immediate feedback that may impact clinical decision making at the time of implant and also during follow-up visits,” said Troy Hounshell, electrophysiologist at Iowa Heart Center. He said pairing of the implant and ECG Belt provides a more personalized and noninvasive approach to help heart-failure patients.
Patient Data
Irvine-based Masimo Corp. (Nasdaq: MASI) continues to expand its noninvasive patient monitoring device platform, announcing it added a vital signs check application to its Root device. The new feature helps automate hospital vital signs testing workflow by bringing together additional measuring capabilities, including SET Pulse CO-Oximetry, which measures oxygen level in the blood; brain function monitoring; and concentration of carbon dioxide. It’s available through a software upgrade.
The device collects up to 14 data points and can calculate early warning scores based on the metrics.
“From the operating room to the emergency room, from the ICU to the med-surg unit, Root is streamlining care, simplifying access to critical data and improving hospital workflows,” said founder and Chief Executive Joe Kiani.
This month, the company also announced new studies investigating the use of its technology in patients undergoing one-lung ventilation and colorectal surgery. It also announced researchers at Dartmouth Hitchcock Medical Center published findings that evaluate hospital workflow impact through use of Root, an enhanced monitoring system.
Addiction Center
Costa Mesa-based New Vista Behavioral Health announced it opened a new facility, Avalon Integrative Wellness in Malibu, following its March acquisition of rehabilitation and mental health treatment center Avalon Malibu. The new center is a sister program of Avalon Malibu.
The integrative wellness center offers detox, residential and after-care for both mental health disorders sans substance use, and disorders that come with substance abuse in people 18 and older.
Christine Baker, corporate director of marketing and clinical outreach at New Vista, said Avalon is unique to New Vista and to the industry and community.
“The industry norm for mental health treatment is either residential or hospital-based, and has very few options as it relates to ongoing or step-down treatment after residential stay,” she said. The center is designed to provide continued support for mental health issues, including holistic approaches, such as yoga, sound baths and breathing techniques.
