AngioSoma Prepares for Final FDA Approval Process on Company's Flagship Biologic
HOUSTON, TX, June 25, 2018 (GLOBE NEWSWIRE) -- AngioSoma, Inc. (OTC: SOAN) is in discussions to engage a respected pharmaceutical regulatory advisory firm to help it navigate the Food and Drug Administration’s (FDA) third and last step in the approval process. If the biologic – named LiprostinTM – gets the FDA’s nod, it would then become the flagship product of AngioSoma, Inc.
“This is a critical step forward,†said Alex Blankenship, CEO of AngioSoma. “The regulatory firm has the extensive needed experience to get us through this final FDA procedure. Our team has worked with this firm before on other projects and are quite comfortable with them. Together, we’re confident the FDA will see the many benefits of LiprostinTM and that it will pass. Upon successful completion of this final approval phase, we can provide relief for patients suffering Peripheral Arterial Disease (PAD).â€
LiprostinTM has already passed its Phase II Clinical Study. All that now remains before the biologic can be manufactured and marketed is a positive outcome on Phase III.
AngioSoma and the regulatory firm will now meet with the FDA in a Phase III presubmission meeting to establish protocols and request permission for the third and final clinical trial of LiprostinTM.
Currently, one in 20 Americans over the age of 50 is afflicted with PAD. PAD narrows and constricts the peripheral (or outer) arteries in the human body's lower limbs. However, it may also affect a person’s arms, stomach or head. People who have smoked, have high blood pressure and/or diabetes, and are over the age of 50 are most at risk.
AngioSoma’s patented biologic LiprostinTM is believed to reduce walking pain, treat diabetic ulcerations and reduce inflammations associated with PDA. (A biologic differs from a drug in that a biologic – as its name suggests – is manufactured by a biotechnological process rather than a chemical one.)
For more information, visit the company website www.angiosoma.com.
About AngioSoma, Inc.
AngioSoma, Inc. (OTC:SOAN) is a Nevada corporation based in Houston, TX. As a clinical stage biotechnology company, AngioSoma focuses on improving the effectiveness of current standard-of-care treatments related to pharmaceutical or endovascular interventions. The company’s end-to-end solution will provide interventional radiologists, cardiologists, and internal medicine physicians with both pharmaceutical and or endovascular interventional options prior to infarction or critical limb ischemic events, stabilizing or reversing the atherosclerotic disease. For more information, visit the company website www.angiosoma.com.
Notice Regarding Forward-Looking Statements
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This news release contains forward-looking information within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements that include the words “believes,†“expects,†“anticipate†or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of the company to differ materially from those expressed or implied by such forward-looking statements. In addition, description of anyone’s past success, either financial or strategic, is no guarantee of future success. This news release speaks as of the date first set forth above and the company assumes no responsibility to update the information included herein for events occurring after the date hereof.
CONTACT: Contact Alex Blankenship CEO AngioSoma, Inc. 832-781-8521 Alex@AngioSoma.com
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