

A variety of stem cells (embryonic, fetal, adult, cord, induced pluripotent, parthenogenic), as well
as genetic trans-differentiation, have been promoted over the last decade as methods to
improve the regenerative capacity of humans.
However, despite the unprecedented excitement that stem cells have received in recent years,
there exists an endless array of hurdles related to sourcing, plasticity, genomic instability,
standardization, stress induced apoptosis, senescence, engraftment, tissue homeostasis,
paracrine inhibition, heteroplasmy, tumorigenicity, immunogenicity, infection, and control of the
fate of such cells, especially as they possess the genetically determined potential to form
approximately 220 distinct human cell types.
Additionally, the current paradigm of removing cells from the optimal bio-reactor (the human
body), placing them in synthetic environments where they are exposed to a range of
contaminants, xenobiotics, mutagens, and dimensional constraints, and then re-introducing them
to a living being, is inefficient and reductionist.
Lastly, the regulatory, economic, and ethical challenges surrounding various facets of stem cell
transplantation represent significant barriers for the meaningful development of the industry.
Cellular / Genetic Repair - Situation Analysis
Despite the majority of all chronic diseases having an underlying cellular / genetic
damage component, nothing within the pharmaceutical industry’s current offerings are
capable of doing anything to repair and reverse this damage once it has occurred.
Modern day pharmaceuticals are limited to a handful of very discreet treatment modalities, and
are at best only capable of slowing progression along the damage-disease-degeneration
continuum to delay organ failure and eventual death.
Market Potential of Reprogramming-Based Medicine
As a result of the insufficient state-of-the-art for both therapeutic regeneration and repair, a new
option is required that can mimic the natural reprogramming abilities seen in regenerative
species, by selectively targeting and inducing controllable, de-differentiation and re-modeling of
diseased, damaged, or aged cells, and coordinate their subsequent re-differentiation and
morphogenesis into healthy tissues and organs.
With the annual combined costs of organ transplantation, organ replacement, and medical care /
pharmaceuticals for diseases that lead to organ failure, at over $1 trillion annually in the U.S.
alone, a therapeutic product such as BQ-A, represents a lucrative and transformational
opportunity.
Organ / Tissue Regeneration - Situation Analysis
Because it is difficult for humans to regenerate damaged tissues, organ transplantation has
been developed as a therapeutic option. However, the limited number of donors, as well as the
host-versus-graft reaction, are major hurdles that prevent widespread use.