NEW YORK, NY / ACCESSWIRE / May 20, 2015 / Potent game-changing medicine is what makes Pluristem Therapeutics (NASDAQ:PSTI) a home run stock in the biotech sector, and they are now recognized by a European regulatory powerhouse that will propel them closer to marketing approval.

Just this week, Pluristem was selected by the European Medicines Agency (EMA) in its new Adaptive Pathways pilot project for fast-tracking placental-derived PLX cells in critical limb ischemia (CLI), or leg artery blockage often leading to amputation and death. Adaptive Pathways, much like the FDA's Breakthrough Designation, would allow drugs to get to market sooner than lengthy, expensive and big Phase III trials. Pluristem finished a Phase I trial in CLI with good results. With the EMA program, approval to sell PLX cells could come as early as the end of a Phase II study.

CLI is a huge market - $12 billion globally. According to experts at SAGE Group, three million Europeans have CLI. Driven by an aging population, this number is projected to grow to four million by 2030. That's almost 35% in just 15 years! No wonder the EMA wants an answer to this pervasive problem.

Based on research conducted by my team, getting into Adaptive Pathways makes Pluristem ahead of other cell therapy companies and first in line to get Europe's regulatory green light. A gigantic win for Pluristem, putting them in the lead of regenerative medicine while altering the landscape of biotechnology itself.

Looking back, an April 1st Reuters article by European pharmaceuticals, biotechnology and healthcare correspondent Ben Hirschler stated that 58 drugs had been submitted to the EMA for the Adaptive Pathways project and only eight were selected for a second stage of screening. Reuters' Hirschler writes that, "The EMA declined to identify specific drugs or companies involved but an official said the first stage II meeting on April 7 would concern an advanced therapy product, meaning it is a medicine based on genes, cells or tissue engineering." We think the April 7 meeting was favoring Pluristem and the EMA clearly liked what they saw. Now this is confirmed!

As an 'off-the-shelf' product, PLX cells offer huge advantages over other cell therapies in the works developed by large and small drug companies alike. They come from the human placenta, usually discarded after a healthy, full born birth. Pluristem's patented, fully automated cell expansion methods at its state-of-the art manufacturing facility are capable of very cost-effectively producing 150,000 doses of PLX cells annually. Better yet, Pluristem's cells do not cause an autoimmune reaction and can be given to anyone. The cells treat different diseases by sensing where the body needs repair, and then healing through a systemic effect. After all of our years of research, we believe Pluristem has the perfect cell therapy.

Japan, one of the largest consumers of pharmaceuticals and world-renowned for interest in cell therapy, has a fast-track approval process in place - the Accelerated Pathway for Regenerative Medicine - and Pluristem's PLX cells are a part of it. That makes two important medical territories the company can sell into quickly.

Acceptance of PLX cells into the Adaptive Pathways for CLI makes Pluristem a hugely desirable partner. Pluristem already has partnerships in place, including United Therapeutics (NASDAQ:UTHR) with an $8 billion market cap, but Pluristem's dance card is far from full. On the other hand, with $42 million in cash and equivalents on its balance sheet, Pluristem is very well positioned to go this alone and pay for a Phase II trial with its own funds.

Investors should remember, Pluristem's success in early trials has led it to conduct a Phase II in intermittent claudication, a disease that often leads to CLI, with clinical sites all over the world. PLX cells have also shown strong efficacy in a Phase I/II muscle injury trial that concluded in Germany in 2013, with more studies planned.

The impact of this latest news is big for Pluristem, its investors and its pharma partners. Beyond the potential benefit to patients, trends toward accelerated approvals will shift the valuation of innovative biotechs like Pluristem who have a pipeline of drugs that Big Pharma needs and constantly hunts for. Being just one successful trial away from commercialization should completely change Pluristem's ridiculously low valuation of under $200 million (the current market cap) now, and propel the company to newer heights of not only value, but recognition as the worldwide premier cell therapy company that it is.

RAY DIRKS Research suggests that Readers/Investors place no more than 1% of the funds they devote to common stocks in any one issue. It's best to diversify.

Media Contact:

Jackie Rodriguez
jackie@jvprny.com

SOURCE: RAY DIRKS Research