In war, and in wound care, sometimes success is as simple as sending in reinforcements to the site of conflict. Israeli biopharma Macrocure has developed a serum filled with hyperactivated immune cells – a simple-yet-brilliant approach to treating diabetic foot ulcers and other such hard-to-heal wounds that sends in backup at the site of the infection.
The company says its product, called CureXcell, has shown a 90 percent wound reduction rate.
It’s been approved, and has shown success, in Israel since 1997 – but now, it’s headed stateside. Macrocure in the midst of a couple of large, Phase 3 clinical trials – over 500 patients – for diabetic foot ulcers and venous leg ulcers. The studies’ results are slated for the latter half of 2015; it projects to apply for a biologics license from the Food and Drug Administration in 2016. Macrocure held a $75 million IPO in June.
CureXcell is made up of a concentrated amount of white blood cells, developed out of a serum byproduct taken from blood banks. Macrocure’s proprietary tech uses hyperosmolytic shock, exposing cells to water, to incite neutrophiles and other immune cells to excrete a number of different growth factors and cytokines, CEO Nissim Mashiach says, stimulating the body’s natural healing process. This is because once they’re in this state, the cells are in a hyper-curative mode – kind of like sending in a SEAL to do the job.
It takes three injections, on a monthly basis, directly to the wound site to do the job. It’s very different from skin grafts, Mashiach says, because the process requires far fewer treatments.
New solutions are in demand in the wound care space – after all, amputation is a very real outcome still for conditions like diabetic foot ulcers. The company said in September it reached an agreement with the FDA to remove a blood matching requirement – the product will work regardless of blood type, the company asserts.
“I think the fact that we’re not using any stabilizer or chemicals – it’s a pure, human-based product – that gives us a unique safety profile,” Mashiach said. “There have been no adverse events.”
