OSI Announces Partnership with U.S. Army

Open Standard Industries, Inc. and the U.S. Army Medical Materiel Development Activity (USAMMDA) Announce Partnership to Submit OSR-M1 Face Mask for NIOSH Certification 


Boston, Mass., April 7 2021: Open Standard Industries, Inc. (OSI), manufacturer of the OSR-M1 face mask, is pleased to formally announce they have entered into a Cooperative Research & Development Agreement (CRADA) with the U.S. Army Combat Capabilities Development Command, Chemical Biological Center (CBC) and the U.S. Army Medical Materiel Development Activity (USAMMDA). OSI intends to submit the OSR-M1 face mask to the National Institute for Occupational Safety and Health for certification as an N95 elastomeric half mask respirator. 

In response to shortages in personal protective equipment as a result of the global coronavirus pandemic, the U.S. Government has played a leading role in ramping up production of certified respirators for healthcare and essential workers. In the fall of 2020, OSI entered into this joint CRADA with USAMMDA and CBC.

As part of the U.S. Army Medical Research and Development Command’s N95 Respirator Working Group, multiple prototypes have undergone testing at the CCDC-CBC. The OSR M1 is the first elastomeric half mask respirator to successfully pass this pre-NIOSH testing through a CRADA collaboration using this streamlined processes established by the Working Group. 

As demonstrated in testing by the CCDC-CBC as well as other independent laboratories, the OSR-M1 mask filters provide  >99% particulate filtration efficiency when tested against NIOSH standardized test procedures. The elastomeric materials used in the mask design produce an airtight seal, allowing the mask to fit securely on the wearer’s face and ensuring that any inhaled or exhaled air passes through the filter. The mask is also highly breathable, passing preliminary NIOSH tests of inhalation and exhalation resistance. 

Dr. Matt Carney, CEO of Open Standard Industries, notes, “With these results from the CBC validating our earlier test data, I am confident in the performance of our mask and in our ability to take the next steps toward certification in collaboration with the Army.”

In addition to introducing new N95 respirators to the civilian and military markets, the CRADA may enable the USAMMDA to bolster the Department of Defense’s capability to manufacture protective respiratory devices. The Army has previously published efforts to 3D-print masks for prototyping respirators; the OSR-M1 is different, as it is produced through high-volume manufacturing processes, ensuring it can be rapidly and sustainably manufactured at scale in the USA while maintaining the quality control needed for medical-grade materials. 

Maj Daniel Williams, Air Force Acquisition Fellow at the USAMMDA, states, “Collaborations with small business partners such as OSI, allows us to develop respirators for quality respiratory protection, both for future public health emergencies and military operations. This helps us to address the needs of the military and the general public.”

OSI and the USAMMDA intend to submit their joint application to NIOSH in March 2021. 

About Open Standard Industries      

Open Standard Industries, Inc., is committed to rapidly deploying and broadening access to safe, effective health technology. The OSR-M1 Mask is the company’s first product aimed at addressing the specific needs of frontline healthcare and essential workers. OSI is working in collaboration with various organizations and hospitals in the United States to test, validate, and scale mask production. OSI is a collaborative spinoff of the MIT Media Lab, Wake Forest Baptist Health, and multiple product development organizations.

About USAMMDA

USAMMDA is a subordinate command of the U.S. Army Medical Research and Development Command, under the Army Futures Command. As the premier developer of world-class military medical capabilities, USAMMDA is responsible for developing and delivering critical products designed to protect and preserve the lives of Warfighters across the globe. USAMRDC is leading research to prevent, detect and treat COVID-19. USAMMDA is applying existing field-leading research capabilities, a global research network and established partnerships to support the Whole-of-Government response to COVID-19.

About USACCDC CBC

The U.S. Army Combat Capabilities Development Command Chemical Biological Center (DEVCOM Chemical Biological Center) is the primary Department of Defense technical organization for non-medical chemical and biological defense.  DEVCOM Chemical Biological Center possesses an unrivaled chemical biological research and development infrastructure with scientists, engineers, technicians and specialists located at four different sites in the United States: Edgewood Area of Aberdeen Proving Ground, Md., Pine Bluff, Ark., Rock Island, Ill., and Dugway Proving Ground, Utah.  DEVCOM Chemical Biological Center has a unique role in technology development that cannot be duplicated by private industry or research universities. It fosters research, development, testing, and application of technologies for protecting warfighters, first responders and the nation from chemical and biological warfare agents.

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