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- Due to the rapid spread of Zika virus in the US and recent terrorist attacks that resulted in a lack of blood for the wounded, we are pursuing a US approval of VIDAPHOR in parallel with our plans for Mexico and South America.   In July, 4 cases of Zika were reported in Southern Florida.  Four weeks later, there were 34 cases of Zika virus.  Just 4 weeks later, there are now well over 2000 cases of Zika in the US and a strong possibility that Zika will eventually get into the US blood supply.  FDA has now mandated that all blood supplies be tested for Zika.  President Obama has also declared a public health emergency in Puerto Rico, where tens of thousands of cases of Zika have been reported.  There is no risk of viral transmission with VIDAPHOR.   

Because we have data from over 30,000 exposures to VIDAPHOR post-approval, our path to FDA approval is expected to be a very brief one.


 

- We are pleased to announce a strategic manufacturing collaboration with Bioserv Corporation, whereby Bioserv will manufacture all commercial, GMP-compliant supplies of VIDAPHOR and VENOFLUX. Bioserv, located in San Diego, California, was founded in 1988 as a small boutique contract manufacturing organization serving the pharmaceutical, medical diagnostics, medical device, and biotechnology sectors. Today, Bioserv is a leading regional contract manufacturing services provider with over 37,000 square feet of manufacturing and warehouse facilities. Bioserv’s core competencies include aseptic bulk formulation, filtration, filling, stoppering, lyophilization services, labeling, finished goods assembly, kitting and packaging, as well as controlled temperature storage and distribution services to support manufacture and distribution of drug products and Class III medical devices, including medical diagnostics. Bioserv Corporation


 

- BOCA RATON, Fla., Dec. 2, 2014 (GLOBE NEWSWIRE) -- FluorO2 Therapeutics, a newly formed US company, wants to change the world.

FluorO2 Therapeutics owns the licensing rights and intellectual property to Perftoran®, a perfluorocarbon nanoemulsion approved as a blood substitute in four countries. Perftoran has been given to approximately 30,000 people, with good results. 

There is an annual shortage of almost 200 million units of blood worldwide. In many countries, friends and family are called on to give blood but it often doesn't arrive in time. This product could change that. In addition, the use of artificial blood virtually eliminates the possibility of viral transmission, which still occurs in parts of the world where screening of blood donors is inadequate, and artificial blood does not need to be matched to blood type, saving precious time and resources.   

FluorO2 Therapeutics is a spin-off of the British company Perftoran West Limited. It was established in the US in order to globalize, expand use of the product within countries where it is already approved, and conduct research in other indications to expand the product labeling beyond blood substitute. In order to accomplish these goals, the company will now be manufacturing their raw materials and final product in the United States, at GMP-compliant facilities.  

The company is rebranding their product as VIDAPHOR, which means life-bearing. "We believe this new name better conveys what our product is all about," said Anthony Flores, DVM, PhD, the company's head of preclinical research. 

The company is seeking to raise a $5MM investment. With this funding, the company will begin manufacturing product in the US that can be sold in Mexico once it is newly registered as VIDAPHOR. The company estimates having product sales 12 to 14 months after receipt of funding. Mexico is short an estimated 2.4 million units of blood every year and desperately needs a blood substitute. The company then plans to expand into Latin America, focusing on countries that have mutual recognition agreements with Mexico. Future plans also include initiating studies needed to obtain marketing approval in the US.

"Perftoran is safe, efficacious, and reduces the need for allogeneic blood and blood derivatives in patients undergoing cardiac surgery," says Adolfo Chávez-Negrete, MD, PhD in the article titled Perftoran emulsion to decrease allogeneic blood transfusion in cardiac surgery: clinical trial [Artificial Cells, Blood Substitutes and Biotechnology 2006;34(4):433-54]

The financial value of the global market for whole blood exceeds $7 billion USD. Interested investors are asked to contact the company.


 

- SAN DIEGO, Apr. 7, 2015 /PRNewswire-iReach/ -- FluorO2 Therapeutics, Inc., based inBoca Raton, Florida and Bioserv Corporation, based in San Diego, CA are pleased to announce a strategic manufacturing collaboration. Bioserv will manufacture Vidaphor for FluorO2 Therapeutics, Inc.  Vidaphor, a blood substitute product, approved in Russia,Ukraine, Kazakhstan and Mexico. Vidaphor is also known as Perftoran®.

Vidaphor is a potentially life-saving product that has been given to over 30,000 people to date with good results and very few adverse reactions.  It is a completely synthetic product; i.e., it is not hemoglobin-based. Vidaphor is a perfluorocarbon nanoemulsion; it does not need to be matched to any blood type, saving precious time and resources.  Its use virtually eliminates the risk of viral transmission, such as HIV.  Screening of donors is inadequate in many countries, therefore, "tainted" blood is still very common.  Unlike blood, which expires in 4-6 weeks, the shelf life of Vidaphor is 3-5 years when stored at -4 to -20 degrees C.  Adverse reactions, some of which are very serious and can result in lengthy hospital stays and even death, can occur following a blood transfusion, while serious reactions reported with Vidaphor use have been rare.

Deborah Thompson, President of FluorO2 Therapeutics states, "We are pleased to have Bioserv as our manufacturing partner.  Vidaphor is a potentially life-saving product needed by many worldwide who do not have access to safe whole blood supplies.  This is particularly important for countries like Mexico, where some women die during childbirth due to the lack of blood.  We also intend to seek approval in the U.S. so it could be used in life-threatening situations where the right whole blood may not be immediately available, such as serious auto and industrial accidents."

Al Hansen, CEO of Bioserv comments, "This is an exciting opportunity for Bioserv. We are excited to manufacture this product for export first to Mexico and to other countries in the future."  

Media Contact: Albert Hansen, Bioserv Corporation, +1 917-817-1326, This email address is being protected from spambots. You need JavaScript enabled to view it.