Rivulet Media Inc (fka RIVU)

[Krisandtilly]

According to FDA's new standards to review

This supports why safety issue will pass

"Given the HemaXellerate I(TM) product is derived from the patient's own fat tissue, and numerous key opinion leaders support clinical entry of our product, as demonstrated by our peer reviewed publication http://www.translational-medicine.com/content/pdf/1479-5876-10-231.pdf., we are confident the safety studies the FDA requested clarification on can be addressed in a timely fashion," stated Thomas Ichim, Regen's Chief Scientific Officer and Board Member.

These key leaders stated "Given the established safety and ease of
autologous SVF administration, it is anticipated that
the proposed procedure will be rapidly adopted by
the market.

Just as a side note current treatment cost ranges into...Current hematopoietic growth factors have several
limitations: their inability to stimulate all hematopoietic
lineages, their inability to heal damaged bone marrow
microenvironment, and their adverse effects associated
with prolonged usage. From a health economics perspective,
these agents are associated with high costs. For example,
according to one report, the cost of treating
neutropenic fever with Neupogen is approximately
$40,000 [46]. This included the cost of drug, hospital
stay, and care of the patient.

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