Therapeutic Solutions International Files to Initiate Phase III Clinical Trial for Acute Respiratory Distress Syndrome (ARDS) Leveraging Positive COVID-19 Data with JadiCell Stem Cell Therapy

Regenerative Medicine Company Leverages Recent Patent Victory and Positive Results to Accelerate Late-Stage Clinical Pulmonary Candidate

Therapeutic Solutions International (TSOI) announced today filing of a new Phase III clinical trial application with the FDA for use of its JadiCell adult stem cells in treatment of acute respiratory distress syndrome (ARDS). This investigational drug application (IND) is based on the Company’s existing data and experiences associated with its Phase III clinical trial in the area of COVID-19 associated ARDS.

ARDS is a condition in which lung injury causes fluid to leak into the spaces between the capillaries and the alveoli. Pressure on the alveoli increases, and eventually fluid accumulates. Fluid in the lungs causes the alveoli to collapse, leading to a series of cascading problems, each further decreasing the lungs’ capacity to move oxygen into the blood, and directly impacting the body’s tissues and organs. ARDS afflicts approximately 190,000 Americans a year¹ and is expected to reach a 19.5 billion dollar a year market by 2029².

The decision of the Company to accelerate development of the ARDS programs came in part from a published decision from the U.S. Patent Trial and Appeal Board to uphold validity of Patent 9,803,176 B2 after an Inter Partes Review initiated by Restem, LLC³. This patent, which is exclusively licensed to Therapeutic Solutions International for lung and brain indications, covers composition of matter of the JadiCells, which have previously been published to be 100% effective in COVID-19 induced ARDS patients under 85 years of age⁴.

“The Company has stayed a steady course in accomplishing its milestones of in-licensing an advanced cell therapeutic product, filing additional patents surrounding it, demonstrating in animal models and various clinical situations benefits of the product, and now taking the next step in product development by filing for entry into the ARDS patient population, which presents a significantly greater market than COVID-19 induced ARDS,” said Dr. James Veltmeyer, Principle Investigator of the Study.

“We are happy to report the decision of our medical advisors to support entry of our adult stem cell based product into the greater patient population of ARDS,” said Timothy Dixon, President, and CEO of the Company. “We have numerous physicians eager to join the new trial, including ones who have previously witnessed significant patient improvement in previous clinical uses of our cells.”

About Therapeutic Solutions International, Inc.

Therapeutic Solutions International is focused on immune modulation for the treatment of several specific diseases. The Company's corporate website is www.therapeuticsolutionsint.com.

¹ Acute Respiratory Distress Syndrome (ARDS) > Fact Sheets > Yale Medicine

² Global Acute Respiratory Distress Syndrome Market $19.5 Billion by 2029 (ihealthcareanalyst.com)

³ ptab-filings/IPR2021-01535/42

⁴ https://pubmed.ncbi.nlm.nih.gov/33400390/

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