Irvine-based AiVita Biomedical Inc., the latest creation of local stem cell entrepreneur Hans Keirstead, is working to set itself apart from other companies in the field that have struggled.
Keirstead recently shared his thoughts on how AiVita, which is developing what it calls “curative and regenerative therapies” for various elements using stem cells, will be differentiated. The company, in concert with Irvine-based lifestyle medicine company Alphaeon Corp., launched the Provoque facial serum last month and is preparing to start a series of clinical trials in ovarian cancer.
“I’m pretty excited as a new company hitting the scene here,” Keirstead said of AiVita, which he established in January.
“This whole sector has not done tremendously well.”
Some stem cell-focused companies have faced setbacks as they attempt to commercialize. The most recent example took place in late May when Bay-area company Stem Cells Inc. said it was winding down its operations after it terminated a midstage clinical trial for a spinal cord injury therapy.
“Having seen the birth of the sector and its various successes and failures, and working on even shaping policy along the way, we’ve learned a few things,” Keirstead said, “and I’ve tried to bring them into AiVita.”
One of those things involves how AiVita is choosing to use its stem cells to create products, he noted.
“Transplantation of stem cells and their differentiated progeny, of course, poses near-insurmountable obstacles to manufacturing and [Food and Drug Administration] approval. So we don’t do that,” Keirstead said.
AiVita instead uses stem cell secretions for its products.
“We’re not transplanting the cells. That is a fundamental distinction from every other stem cell company that has ever existed or currently exists,” Keirstead said.
“It sounds like a subtlety, but from my point of view, it is [an] absolutely critical differentiator of this stem cell company from what’s occurred in the past.”
Moody’s Upgrades CareTrust
San Clemente-based CareTrust REIT Inc. said Moody’s Investor Service upgraded its credit ratings.
CareTrust owns, acquires and leases senior housing and healthcare properties.
The company said in a news release that the New York-based ratings agency raised its corporate credit rating from B2 to B1 with a stable outlook. Moody’s also raised its rating on CareTrust’s senior unsecured debt from B2 to B1.
B1 is an investment-grade rating, according to Moody’s system.
CareTrust said the update came because of improved cash flow, reduction in tenant concentration, and “the complete unencumbering of its portfolio.”
Moody’s upgrades “highlight the substantial progress we have made toward optimizing our balance sheet while significantly growing our portfolio in a responsible way,” said CareTrust Chief Financial Officer Bill Wagner in a news release.
CareTrust now has 144 leased and three operated properties in 20 states.
Axonics Device OK’d
Irvine-based Axonics Modulation Technologies Inc. received European regulatory approval for its implantable Sacral Neuromodulation System device.
The company makes implantable medical devices for several indications, including overactive bladder, fecal incontinence and urinary retention. The company’s investors include Paris-based Edmond de Rothschild Investment Partners. It’s run by OC medical device veteran Raymond Cohen.
Axonics said in a news release that results from a study comparing its rechargeable device to nonrechargeable devices were published in medical journal Neurology and Urodynamics.
The study’s findings showed that using a rechargeable overactive bladder treatment device could save the United States healthcare system more than $12 billion over the next 15 years. Axonics estimates that overactive bladder affects 85 million adults in the U.S. and Europe.
Bits & Pieces
San Clemente-based Avenu Medical Inc. said it was granted European approval of its Ellipsys Vascular Access device for hemodialysis. Ellipsys also is being studied domestically under an investigational device exemption by the Food and Drug Administration. … Lake Forest-based Cryoport Inc. said it signed a deal with Glasgow, Scotland-based Tissue Solutions Ltd. The company, which specializes in cryogenic shipping of biological materials, will transport human cells and cryopreserved cell lines from Tissue Solutions’ global network of more than 100 locations.
