Here’s A Look At Two Promising CLI Companies And Their Near Term Milestones – Pluristem Therapeutics Inc. (PSTI) Cesca Therapeutics Inc (KOOL)

Moving on, let’s look at Cesca Therapeutics Inc (NASDAQ:KOOL).

This one is different to Pluristem. While Pluristem has developed a direct treatment for CLI, Cesca has created a kit that includes all of the components required for stem cell therapy to treat the condition. It’s kit, called SurgWerks kit, contains harvesting and anticoagulant systems, a cell processing system, a cell delivery balloon catheter and analytic reagents (designed for rapid cell testing). The idea is that the company will sell them directly to hospitals, and physicians undertaking bone marrow transplants will use the kit in the operating room to perform the surgery.

Because this isn’t a drug, the company doesn’t have to put together an NDA for its approval. Instead, Cesca Therapeutics Inc (NASDAQ:KOOL) needs to apply for what’s called an Investigational Device Exemption (IDE). It still has to perform rounds of clinical tests to form the basis of the application, and the company is about to carry the kit into a pivotal trial. The endpoint of the pivotal just changed from amputation free survival (AFS) to what’s called Change in Transcutaneous Oxygen Pressure (TcPO2), which markets think will be easier to demonstrate (and in turn, are scooping up stock in the company at time of writing). There’s still a couple of hurdles, however, most notably, the proving that TcPO2 is surrogate to AFS in this indication. That might take a couple of months, or it might take much longer and Cesca is in discussions with the FDA to try and figure out the best way of getting this proof.

Near term milestones on this one are the just mentioned surrogate proof, and the follow on initiation of the pivotal trial. Beyond that, we’re looking for positive outcome data to support an IDE in the US and, eventually, marketing approval.

Note: This article is written by Adam Russell and originally published at Market Exclusive.