An Irvine-based team for Medtronic PLC (NYSE: MDT) helped the company gain Food and Drug Administration clearance for an expanded use of its Pipeline Flex device to treat patients with small or medium wide-necked brain aneurysms.
The device, which was previously for patients with large neck aneurysms, is designed to divert blood flow away from an aneurysm. The approval was based on a follow-up study of 141 subjects.
The “study not only demonstrated excellent safety and efficacy outcomes, but also delivered on our commitment to broadening access to innovative therapies for new groups of patients requiring aneurysm treatment,” said Stacey Pugh, vice president and general manager of the neurovascular business, which is part of the restorative therapies group at Medtronic.
An estimated 500,000 people worldwide die each year due to ruptured brain aneurysms, with half the victims younger than 50, Medtronics said.
The study “moves the bar” on the safety treatment of brain aneurysms, according to Dr. Ricardo Hanel, the principal investigator for the trial and director of Stroke and Cerebrovascular Center at Jacksonville, Fla.-based Baptist Health.
The neurovascular unit in January also received FDA clearance for its Riptide Aspiration System, designed to retrieve blood clot and restore blood flow in patients experiencing ischemic stroke, or blockage of an artery in the brain. Stroke is the fifth leading cause of death in the U.S. and a leading cause of disability, according to the American Heart Association/American Stroke Association.
Dublin-based Medtronic, which has a $123 billion market cap, employs 900 at its Irvine neurovascular unit while another 700 work at its heart valve unit in Santa Ana.
Gut Health
Biomerica Inc. (Nasdaq: BMRA) said that the FDA has provided the regulatory pathway for clearance for its H. pylori diagnostics product for stomach ailments.
The Irvine-based company has thus far collected 210 clinical trial patient samples and will need 40 more for final FDA clearance.
H. pylori is one of the most common bacterial infections, including stomach cancer and ulcers. Diagnosis of the condition is important given that specific antibiotic treatment is highly effective, according to a company press release.
The company said final clinical patient samples are scheduled to be collected over the next few months. Chief Executive Zack Irani told the Business Journal that it plans to file for FDA clearance this year and that the test represents a significant revenue opportunity for Biomerica.
It’s also actively seeking FDA approval for its InFoods IBS diagnostic-guided therapy.
IBS, or irritable bowel syndrome, is a common disorder that affects the large intestine. Symptoms include constipation, diarrhea, bloating, pain and indigestion.
Irani said the test is designed to allow physicians to identify specific foods that when removed from the diet may alleviate the IBS symptoms.
The company generates about $5 million annually with diagnostics tests used in homes, hospitals and clinical laboratories. Shares in Biomerica have risen about 40% this year to $2.75 and a $26 million market cap.
Stem Cell Significance
Irvine-based biotech company Aivita Biomedical Inc. recently announced findings that indicate the significance of its stem cell vaccine.
Chief Science Officer Gabriel Nistor said results point to a category of T lymphocyte, a subtype of white blood cell, called Th17 cells. These cells, commonly found in tissue surrounding tumors, undergo a transformation—from passive cells into tumor-fighting cells—in response to the company’s therapy.
“It’s clear that Aivita’s cancer stem cell vaccine elevates an appropriate antigenic signal in all immune responding cells, and particularly induces a cytotoxic transformation of the Th17 subpopulation,” he said.
The company is in three active clinical studies. It is conducting a Phase 2 study of its therapy in patients with ovarian cancer or glioblastoma—a malignant tumor affecting the brain or spine—as well as a Phase 1B study on melanoma, the most serious type of skin cancer.
Bits & Pieces
Irvine-based Biolase Inc. (Nasdaq: BIOL) named Sinclair Dental Co. as its exclusive distributor for all its dental products and services. Sinclair, the fastest-growing dental supply company in Canada has over 600 employees and sales of more than $250 million, according to a Biolase press release. … Stanbridge University in Irvine has been ranked No.1 nursing school program by RegisteredNurse.org in its third annual state RN program ranking survey of 126 accredited nursing schools in California. … Healthgrades named Hoag Memorial Hospital Presbyterian one of America’s 50 Best Hospitals for 2019, marking the eighth consecutive year it’s received this designation. The provider is the only Orange County hospital in the Top 100.
