Cryoport Inc. (Nasdaq: CYRX), the Irvine-based cold-chain shipping logistics provider, is riding the gene and cell therapy development boom. It recently expanded its footprint internationally, opening a 6,800-square-foot global logistics center in Amsterdam, according to a company spokesperson. It’s the company’s third logistics center, following New Jersey and Singapore.
The facility is near the Amsterdam Airport Schiphol, which serves as the country’s main aviation hub for international air traffic, the company said.
Cryoport, which has a $340 million market cap, has proprietary shipping containers that keep materials in constant cold temperature for up to 10 days; the company provides continuous tracking and monitoring. Clients include Novartis AG (NYSE: NVS) and Gilead Sciences Inc. (Nasdaq: GILD). Novartis and Gilead own the first two FDA-approved CAR-T cell therapies targeting patients with B-cell lymphoma, a blood cancer in the lymph nodes.
The center will allow Cryoport “to more effectively support our global biopharmaceutical client base throughout the research, clinical and commercialization phases of their revolutionary regenerative therapies,” Chief Executive Jerrell Shelton said in a statement.
There are about 900 developers of cell therapy, gene therapy, tissue engineering and other regenerative medicine therapeutics worldwide, according to an annual report from the Alliance for Regenerative Medicine.
The company said the center, in addition to serving the aforementioned companies, will support Bellicum Pharmaceuticals Inc. (Nasdaq: BLCM), Immatics Biotechnologies GmbH and Janssen Pharmaceuticals Inc.
Cryoport said it chose Amsterdam because of its reputation as a hub for the life sciences industry, as well as its favorable import and export environment and significant transit infrastructure.
Last month, the European Medicines Agency moved its headquarters to Amsterdam, the company pointed out.
Cryoport currently supports 295 clinical trials, of which 38 are in a third phase, according to its third-quarter earnings announced in November. Its other business units are animal health and reproductive medicine.
Recall Update
Irvine-based aortic disorder device maker Endologix Inc. (Nasdaq: ELGX) is still working on quality. Chief Executive John Onopchenko made that a priority when he took over in May last year, but the company suffered another blow on Jan. 22 when it said its Nellix EndoVascualr Aneurysm Sealing System got its European CE Mark suspended. The news followed a voluntary recall by Endologix on Jan. 4.
Chief Medical Officer Dr. Matt Thompson said the recent notification is a regulatory action and is not in response to any new information beyond what was previously announced.
“This action is consistent with our previously articulated plans for the Nellix System and does not affect other Endologix products,” he said. Suspension of the CE Mark means that Endologix may not sell the product in the European Union during the term of the suspension.
It said the Jan. 4 recall was aimed at patient safety and optimal clinical outcome. Endologix said in a statement it would cease selling the system; the product will only be available for use under clinical protocol with pre-screened patients that adhere to the current indications.
Onopchenko has over 30 years of executive leadership in medical devices and was most recently executive vice president for Acutus Medical Inc. in Carlsbad before joining Endologix in 2016 as chief operating officer.
The company’s shares have fallen more than 90% since June to about 56 cents a share. It currently has a $58 million market cap.
US Launch
Irvine-based Masimo Corp. (Nasdaq: MASI) launched its Iris Device Management System, a software to streamline management of all Masimo devices used throughout a hospital system.
“More and more clinicians are recognizing the benefits of providing continuous Masimo patient monitoring, not just during surgery or in the ICU, but in all medical-surgical wards, especially for patients on opioids … but as a result their software is increasingly complex,” Chief Executive Joe Kiani said.
He said Iris aims to not only provide detailed diagnostic information about connected Masimo devices via an easy-to-use dashboard, but also to simplify the process of maintaining, updating, and standardizing these devices.
It has a $6.7 billion market cap.
Ex-Edwards
PQ Bypass Inc. added a new board member, appointing Stanton Rowe, previously chief scientific officer and corporate vice president of advanced technology of Orange County’s largest publicly traded device maker Edwards Lifesciences Corp. (NYSE: EW).
The Sunnyvale-based company develops devices used to treat blocked artery in the leg.
Rowe is currently chief executive of NXT Biomedical, a medical device incubator he created with Deerfield Management in September. Locally-based NXT plans to invest up to $25 million over the next five years and New York-based Deerfield has allotted up to an additional $250 million for the development of five to eight startup companies that emerge from the incubator.
