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Cold-Ship Specialist Grows Biotech Firm Account

Irvine-based Cryoport Inc. will step up its shipping business with ProMab Biotechnologies Inc. in Richmond, Calif., a biotechnology company.

Cryoport specializes in the transport of materials that need to be kept frozen.

ProMab develops and commercializes recombinant proteins and custom monoclonal antibodies—antibodies made by identical immune cells that are clones of a parent cell. It focuses on generating CAR-T cells for use in research and preclinical studies, and has only started selling the cells over the past two years.

“We are sending shipments to their manufacturing site in China, and product is being delivered from China to ProMab here in the U.S. for resale,” said Cryoport Chief Commercial Officer Mark Sawicki.

ProMab is working with Forever Biotechnology Ltd. in Hunan, China, according to Sawicki.

Cryoport started working with ProMab in 2012 by supporting its antibody reagent business. The transport of CAR-T-cell materials to and within China, a new area for Cryoport, stemmed from growing industry interest in developing immunotherapy. The therapy harnesses the power of a patient’s immune system, or CAR-T cells, to recognize and fight cancer.

“Cryoport is well-versed in international best practices for transporting cryogenically preserved material,” said ProMab Chief Executive John Wu, adding that the liquid nitrogen refrigerant in Cryoport transport containers preserves materials at minus-150 degrees Celsius. Containers also include monitoring and tracking technologies.

Wu said that transporting living cells using Cryoport containers results in a much higher cell survival rate than another method—approximately 80% to 90%.

“I spent almost two to three years trying to ship cells from China to the U.S. using regular flasks with a little bit of cell culture medium. But cell survival rate was so low, [around] 5% to 10%. You can use dry ice, but [cells can only be preserved] a max five days, [whereas] with Cryoport it’s up to 11 days,” he said.

Wu estimated ProMab previously used Cryoport’s service twice a month to ship internationally, and wants to grow that by 30% to 40%.

Cryoport has an approximately $53 million market cap.

Valve Market Grows

Medtronic PLC, a competitor of Irvine-based Edwards Lifesciences Corp., recently announced the CE mark and European launch of its 34-millimeter CoreValve Evolut R transcatheter aortic valve, which adds to the Dublin, Ireland-based device maker’s existing valve offerings.

The company, whose U.S. headquarters is in Minneapolis, Minn., maintains manufacturing facilities in Irvine.

The Evolut R valve was already available in 23-, 26- and 29-millimeter sizes.

The 34 millimeter valve, which received approval from the Food and Drug Administration in October, expanded on the platform’s ability to target patients who need larger valve implants. That group accounts for approximately 25% to 30% of the global transcatheter aortic valve implantation patient population, according to Medtronic.

Edwards’ newest valve, the Sapien 3, trends toward the other end of the spectrum: Instead of going larger, it downsized. Valve sizes are 20 millimeters, 23 millimeters, 26 millimeters and 29 millimeters.

Patient body size and severity of valve condition can contribute to different valve implant size needs.

Spokespersons from both companies declined to speak about their competitor.

Medtronic and Edwards have respective market caps of approximately $103.5 billion and $20.3 billion. Medtronic, unlike Edwards, which is focused solely on heart valve replacement and repair products, has four businesses: cardiac and vascular; restorative therapies; minimally invasive therapies; and diabetes. The cardiac and vascular group makes up approximately 35% of revenue.

Bits & Pieces

Irvine-based Modulated Imaging Inc. received FDA clearance for its Ox-Imager CS technology, a noninvasive device that measures tissue oxygenation. The product uses infrared light to provide surface and subsurface imaging.

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