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Dec 2013 | Download as pdf

Soluble Therapeutics Inc. has a second cash infusion that will help the company continue its work in protein-based pharmaceuticals as well as more

Dec 2013 | Download as pdf

StemBioSys, a San Antonio-based bioscience startup, is looking to raise $8 million in new Series A investor funding. The company has already secured more

29 Nov 2013 | Download as pdf

Medical-device firm Xenex attracts big Investment. When Rackspace Hosting co-founder Morris Miller more

25 Nov 2013 | Download as pdf

Xenex CEO expects 2013 revenues to be north of $20 Million. Xenex Disinfection Services’ Morris Miller expects more

21 Nov 2013 | Download as pdf

Xenex Secures $11.3 Million in Funding; Superbug Zapping Robot Enhances Patient Safety by Eliminating Pathogens that Cause Hospital Infections more

14 Nov 2013 | Download as pdf

DNAtrix Announces Treatment of First Patient in Study with Recurrent Glioblastoma Using DNX-2401 and Temozolomide more

Sept 2013 | Download as pdf

Medical Innovation iTClamp Hemorrhage Control System Used for First Time in United States more

Aug 2013 | Download as pdf

BiO2 Medical Executes Full Commercialization in the United Kingdom Partnering with United Drug Medical (UDM) as an Exclusive Distributor for the Angel® Catheter more

July 2013 | Download as pdf

DNAtrix, Inc. to Present Clinical Study Results for DNX-2401 (Delta 24-RGD), A Conditionally Replication-Competent Adenovirus more

July 2013 | Download as pdf

ArthroCare Announces Acquisition of ENTrigue Surgical, Inc more

May 2013 | Download as pdf

Vidacare projects big revenue spike for 2013 more

May 2013 | Download as pdf

BiO2 Medical's IDE Application for the Angel(TM) Catheter Receives FDA Approval more

May 2013 | Download as pdf

Medical Device Firm iTraumaCareTM Receives FDA 510(k) Clearance for iTClampTM Hemorrhage Control System more

May 2013 | Download as pdf

BiO2 Medical's IDE Application for the Angel(TM) Catheter Receives FDA Approval.

SAN ANTONIO, May 1, 2013 /PRNewswire/ -- BiO2 Medical, Inc., a Texas based medical device manufacturer with corporate offices in San Antonio, Texas, and R&D and manufacturing operations in Golden, Colorado, is among the first to receive U.S. Food and Drug Administration (FDA) approval of their Investigational Device Exemption (IDE) application to begin an Early Feasibility Pilot Study (EFPS) using the Angel(TM) Catheter.

The Angel(TM) Catheter is the first to combine the functions of an Inferior Vena Cava (IVC) Filter and a multi-lumen Central Venous Catheter (CVC) for the prevention of Pulmonary Embolism (PE), and for access to the central venous system. The device is designed to be placed in the inferior vena cava, at the patient's bedside, without the need for fluoroscopy. The Angel(TM) Catheter was the first IVC Filter to receive CE Mark approval for a prophylactic indication, in addition to traditional IVC Filter & CVC indications.

According to Christopher E. Banas, BiO2 Medical's Chairman and Chief Executive Officer, "With this program, the FDA's forward thinking approach will allow innovative technologies, like the Angel(TM) Catheter, to become available for patients in the U.S. in a more expeditious manner."

The clinical investigation is being conducted as part of a new FDA program, the Early Feasibility Pilot Study Program. BiO2 Medical, Inc. is one of only nine U.S. based, medical device companies selected to participate.

The EFPS Program provides study sponsors (manufacturers), as well as FDA device reviewers', a foundation to establish criteria for device modifications and/or protocol development for subsequent clinical studies. The FDA's new approach to clinical studies will facilitate the development of safer, more effective products, while expediting their availability to the patients that need them.

According to John A. Kaufman MD, Director of the Dotter Interventional Institute, Portland Oregon, "The Early Feasibility studies are a welcome innovation that will allow physicians, industry, and the FDA to accomplish the shared goal of bringing new devices to Americans in an expeditious and safe manner. This is a great example of how close collaboration between industry and the FDA can lead to a vastly improved process and benefit our patients."

The primary objective of BiO2 Medical's EFPS clinical trial is to obtain continued insight into the safety of the Angel(TM) Catheter in critically ill patients with high risk of Venous Thromboembolism disease. For more information on BiO2 Medical's clinical studies, please visit

SOURCE BiO2 Medical, Inc. back

March 2013 | Download as pdf

Woman, 80, gets new blood clot prevention device more

Feb 2013 | Download as pdf

BioDtech, Inc. Issued New United States Patent more

Jan 2013 | Download as pdf

Successful Completion of Santalis Pharmaceuticals Initial Clinical Trials more