WoundSeal (QR Powder)

WoundSeal (Formerly QR Powder) Stops Bleeding Fast! WoundSeal Powder is composed of a hydrophilic, or water-loving, polymer and potassium ferrate. When the powder is poured onto a bleeding wound, the hydrophilic polymer instantly dehydrates the blood by absorbing only the plasma or liquid portion of the blood stacking the blood solids beneath the powder. Simultaneously, the potassium ferrate dissolves, releasing iron that agglomerates (binds together) the blood solids to create an occlusive seal.

Biolife, L.L.C. is a privately owned company, founded in 1999 by Jim Reding, Charlie Entenmann, John “Alf” Thompson and
James Patterson, Ph.D and is headquartered in Sarasota, Florida.

The Biolife Mission statement reads: “To develop and market products that improve our consumers’ quality of life.”  Of the numerous contacts we receive each day, the vast majority share the delight and excitement our consumers feel after using our products.  We are grateful that our products can truly change lives for the better.  We relentlessly pursue our corporate Vision “To contribute to the universal greater good by providing products that save lives and reduce pain and suffering” and will continue to broaden the availability and affordability of our products.

Biolife’s Vision, Mission and Values

• Our Mission is to develop and market products that improve our consumer’s quality of life.
• Our Vision is to contribute to the universal greater good by providing products that save lives and reduce pain and suffering.
• Our Values – These core values guide us in our journey to fulfill the Mission and Vision.

Biolife:

• Maintains a Customer focus – both internal and external
• Are Process oriented – using the analysis of data to continuously improve
• Maintain integrity in everything they do
• Respect one another
• Communicate openly
• Enjoy themselves

Regulatory Status

Biolife was initially granted FDA (510k) clearance (Premarket Notification: K070520) to market the powder technology in October 23, 2007 for the treatment of minor external bleeding from wounds and medical procedures. Biolife was further granted FDA (510k) clearance (Premarket Notification: K080210) on February 10, 2009 for expanded application to include treatment for
moderate to severe external bleeding wounds. The powder has passed all required safety, toxicity and biocompatibility testing.
As new healthcare indications emerge, Biolife is preparing and submitting additional 510k filings as required.

Regulations and Licensure

Biolife’s powder products are distributed in accordance with current US FDA Regulations. The powder is a Health Canada Class
II Medical Device (wound dressing, hydrophilic, for wound exudates absorption) and, therefore, requires licenses for distribution.
Biolife powder products can be distributed in Europe as a Class IIa under Annex V and VII Rule 4.

Quality Management System

Biolife has established its Quality Management System (QMS) according to the standards and regulations of:

US Department of Health and Human Services, Food and Drug Quality System Regulation, Title 21 of the Code of Federal
Registrations, Part 820.

International Organization for Standardization (ISO) ISO 13485:2003 The Canadian Medical Device Regulations (SOR/98-282).

The Medical Device Directive, MDD 93/42/EEC, Annex I, Annex V and VII.

The scope of the QMS is for the manufacture and distribution of topical hydrophilic dressings for temporary bleeding control
associated with minor cuts, lacerations, skin tears, vascular access and surgical wounds. Biolife will comply with the most
recent edition of the aforementioned documents and standards as well as new standards that the Company’s Quality /
Regulatory Affairs departments deem appropriate. Biolife makes necessary revisions to its Quality Management System to
ensure compliance with all applicable standards.
Biolife management conducts regular audits of the Quality Management System, with both inside and outside company support
as required to assure it is performing in accordance with all regulations. These audits are both scheduled and/or
ad-hoc as required to meet operational requirements and regulatory commitments.