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To Amputate Or Not….That Is The Question!

|Includes: Pluristem Therapeutics, Inc. (PSTI)

Lower-extremity peripheral arterial disease (PAD) is estimated to affect between 8 million and 10 million Americans

A study analyzing Medicare data for 2001 found that $4.37 billion was spent on PAD-related treatment

PAD-related treatment accounted for approximately 13% of all Medicare Part A and B expenditures for the PAD-treated cohort, and 2.3% of all Medicare Part A and B annual spending.

I tried to write a nice article on Vascular Insufficiency and one companies plan to address the Huge Market and the editors of SA said I was too scientific and that I did not speak to Balance Sheet issues,Market potential,etc enough!

I said Great,here we go again and decided to BLOG on it!

Critical Limb Ischemia

Critical Limb Ischemia

“Critical limb ischemia (CLI), defined as chronic ischemic rest pain, ulcers, or gangrene attributable to objectively proven arterial occlusive disease, is the most advanced form of peripheral arterial disease. Traditionally, open surgical bypass was the only effective treatment strategy for limb revascularization in this patient population. However, during the past decade, the introduction and evolution of endovascular procedures have significantly increased treatment options. In a certain subset of patients for whom either surgical or endovascular revascularization may not be appropriate, primary amputation remains a third treatment option.

In a certain subset of patients for whom either surgical or endovascular revascularization may not be appropriate, primary amputation remains a third treatment option. Definitive high-level evidence on which to base treatment decisions, with an emphasis on clinical and cost effectiveness, is still lacking. Treatment decisions in CLI are individualized, based on life expectancy, functional status, anatomy of the arterial occlusive disease, and surgical risk. For patients with aortoiliac disease, endovascular therapy has become first-line therapy for all but the most severe patterns of occlusion, and aortofemoral bypass surgery is a highly effective and durable treatment for the latter group. For infrainguinal disease, the available data suggest that surgical bypass with vein is the preferred therapy for CLI patients likely to survive 2 years or more, and for those with long segment occlusions or severe infrapopliteal disease who have an acceptable surgical risk. Endovascular therapy may be preferred in patients with reduced life expectancy, those who lack usable vein for bypass or who are at elevated risk for operation, and those with less severe arterial occlusions. Patients with unreconstructable disease, extensive necrosis involving weight-bearing areas, nonambulatory status, or other severe comorbidities may be considered for primary amputation or palliative measures.” See Ncbi/nih

With the rapidly increasing number of people w/ Diabetes, High Blood Pressure, Lipid Abnormality and Smoking as risk factors we are seeing a huge increase in the number of cases of PAD in America.

Surgical Interventions to bypass clogged/occluded arteries is commonplace today.

Is it possible that people could be fixed w/o the need for Surgery or maybe less complex surgery..after all its better to walk on two legs than one or none, right?

A small BT company in Israel thinks they may have the answer called Pluristem. Before I go further in FULL DISCLOSURE I own this stock but have NO relationship w/ the Company.I am simply conveying to my readers the facts about PSTI as I see them! I have been in this Company for years and Ive watched its shares continually pull bck as they raised NEEDED money through Shares Dilutions.I still hold my original position and I added along the way....I don’t like catching KNIVES but in this case I think eventually we will be SPARING the KNIFE!

Ok I will give you  a short History in PSTI but first the exciting new news is this:

Pluristem's Ischemia Candidate Gets Fast Track Designation

Pluristem's Ischemia Candidate Gets Fast Track Designation

Zachs did a nice review and so no need to re invent the wheel here.

Pluristem Therapeutics, Inc.PSTI announced that the FDA has granted Fast Track designation to a phase III study evaluating its critical limb ischemia ("CLI") candidate, PLacental eXpanded (PLX)-PAD cells. The candidate is being evaluated in patients who are not eligible for revascularization.The FDA grants fast track designation to help the development and a faster review of drugs, which treat serious and unmet medical conditions. With this designation, the drug is expected to be granted priority review once it files a New Drug Application (NDA).Pluristem's shares were up almost 8.2% including after-market movement on Monday as investors cheered the FDA's decision. However, shares of the company are down 0.7% so far this year, underperforming the industry 's gain of 15.6%.The phase III study is currently enrolling patients in the United States and Europe. The candidate has also been included in Adaptive Pathways program by the European Medicines Agency. Any positive results from interim analysis of the phase III study will help Pluristem to receive an early conditional marketing authorization for the candidate.Meanwhile, Japan's Pharmaceuticals and Medical Devices Agency has also included PLX-PAD cells into its accelerated regulatory pathway for regenerative therapies.

I will do this posting in multiple postings REPLYING to myself so you can read my entire paper on PSTI!I am LONG PSTI and I believe PSTI is on the cutting edge of redefining the Management of VI(Vascular Insufficiency)!


Disclosure: I am/we are long PSTI.