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FDA Grants De Novo Clearance for Z-Medica’s QuikClot Control+

July 12, 2017

Z-Medica, LLC announces that QuikClot® Control+™ has been cleared for use by the US Food and Drug Administration (FDA) under the de novo classification process and is designated as a Class II medical device.

Z-Medica, LLC, a leading developer and marketer of hemostatic devices, announces that QuikClot® Control+™ has been cleared for use by the US Food and Drug Administration (FDA) under the de novo classification process and is designated as a Class II medical device.

QuikClot Control+ is the first and only non-absorbable hemostatic dressing cleared for internal organ space use in severely bleeding patients. QuikClot Control+ is indicated for temporary control of internal organ space bleeding for patients displaying class III or class IV bleeding. It may also be used for control of severely bleeding wounds such as surgical wounds and traumatic injuries.

“This clearance marks another major milestone in the growth of our company and expansion of the QuikClot brand,” says Z-Medica President and CEO Stephen J. Fanning. “Z-Medica has worked tirelessly with the FDA during the de novo process. The availability of QuikClot Control+ will fill a critical unmet need for hospitals across the country.”

Uncontrolled bleeding is a major cause of preventable deaths1 and various studies have shown that bleeding-related complications or transfusions due to significant blood loss lead to increased risk of infection,2,3 longer ICU stay,3,4 longer hospital stay,3,4 higher total hospital costs3,4 and increased postoperative morbidity & mortality.3 Safe and intuitive devices like QuikClot Control+ that improve hemorrhage control5 can potentially save lives and reduce healthcare costs.

“In a preclinical study, we saw significantly less blood loss after packing with QuikClot Control+ compared to packing with laparotomy sponges,” 5 said Dr. Joshua P. Hazelton, Director of Trauma Research at Cooper University Hospital, who was the principal investigator in the study. “The development of a non-absorbable hemostatic dressing that can be used internally during surgery only enhances our ability to stabilize a severely injured patient. Control+ will become a necessary piece of equipment in our trauma bays and operating rooms.”

Domestically, Z-Medica has already obtained several patents for QuikClot Control+ and has numerous patents granted and pending internationally. QuikClot Control+ will be manufactured in the United States.

About Z-Medica, LLC 
Z-Medica, LLC is a privately-held medical device manufacturer based in Wallingford, CT that is focused on the development, sale, and marketing of innovative hemorrhage control products for healthcare providers, military personnel, the law enforcement community, first responders, and consumers around the globe. For over a decade, Z-Medica has helped save lives and improve medical outcomes with a growing portfolio of QuikClot® hemostatic products that include 4x4 Hemostatic Dressing, Radial®, Interventional®, Combat Gauze®, Belt Trauma Kit®, Bleeding Control Bag® and now Control+. QuikClot products are manufactured in the United States. For more information, visit QuikClot.com and Z-Medica.com. Follow us on Twitter @QuikClot and Facebook @QuikClotFans.

1. Curry N, Hopewell S, DorĂ©e C, Hyde C, Brohi K, Stanworth S. The acute management of trauma hemorrhage: a systematic review of randomized controlled trials. Crit Care. 2011;15(2):R92. 
2. Carson JL, Altman DG, Duff A, et al. Risk of bacterial infection associated with allogenic blood transfusion among patients undergoing hip fracture repair. Transfusion. 1999 Jul; 39(7):694-700. 
3. Morton J, Anastassopoulos KP, Patel ST, et al. Frequency and outcomes of blood products transfusion across procedures and clinical conditions warranting inpatient care: an analysis of the 2004 healthcare cost and utilization project nationwide inpatient sample database. Am J Med Qual. 2010 Jul/Aug; 25(4):289-296. 
4. Stokes ME, Ye X, Shah M, et al. Impact of bleeding-related complications and/or blood product transfusions on hospital costs in inpatient surgical patients. BMC Health Serv Res. 2011; 11:135. 
5. Koko KR, McCauley B, Hagaman A, et al. Kaolin-based hemostatic dressing improves hemorrhage control from a penetrating IVC injury in coagulopathic swine [published online April 27, 2017]. J Trauma Acute Care Surg. doi:10.1097/TA.0000000000001492



Z-Medica Products Approved For Use In Brazil

April 11, 2017

Z-Medica announces today that a portfolio of QuikClot® products has been approved by the National Health Surveillance Agency (ANVISA), the Brazilian regulatory agency responsible for medical devices.

Z-Medica, LLC, a leading developer and marketer of hemostatic devices, announces today that a portfolio of QuikClot® products has been approved by the National Health Surveillance Agency (ANVISA), the Brazilian regulatory agency responsible for medical devices.

“Brazil is the largest market for Z-Medica products in South America,” says Z-Medica President and CEO Stephen J. Fanning. “This approval marks a major milestone achievement for Z-Medica, further expanding our global footprint. It is also very important to the people of Brazil, who will now have proven life-saving products available to help them stop severe bleeding.”

The ANVISA approval covers all of Z-Medica’s QuikClot products, which will be marketed to Brazilian military, hospitals and emergency medical services.

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Z-Medica Provides Bleeding Control Kits to UPMC to be Distributed to Schools in Pennsylvania

March 28, 2017

Z-Medica, LLC, announces today that the University of Pittsburgh Medical Center will acquire QuikClot® Bleeding Control Kits® to equip up to 1,000 schools in Central and Western Pennsylvania.

Wallingford, CT (PRWEB) March 28, 2017

Z-Medica, LLC, a leading developer and marketer of hemostatic devices, announces today that the University of Pittsburgh Medical Center (UPMC) will acquire QuikClot® Bleeding Control Kits® (BCK) to equip up to 1,000 schools in Central and Western Pennsylvania.

The program, developed in association with efforts by the American College of Surgeons, U.S. Department of Defense, Department of Homeland Security and the White House national “Stop the Bleed” campaign, ensures the schools in that region align with guidelines established by the Hartford Consensus.

“We are seeing more and more communities coming together and training key personnel to respond to traumatic situations,” says Z-Medica President and CEO Stephen J. Fanning. “Being prepared means first responders on the scene of traumatic events have the tools they need to control bleeding quickly and effectively. Stopping uncontrolled bleeding in those precious minutes can mean the difference between life and death.”

UPMC recently participated in training nearly 200 law enforcement officers in the management of traumatic bleeding injuries and will be working to further the training and provide BCKs to school nurses and resource officers.

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Z-Medica to Provide New York City Police Department with QuikClot Belt Trauma Kits

December 27, 2016

Initiative represents the largest standardization of advanced bleeding control kits ever deployed by a single city.

Z-Medica, LLC, a leading developer and marketer of hemostatic devices, announces today that they have signed a three-year agreement to equip the New York City Police Department with life-saving QuikClot® Belt Trauma Kits™ (BTK).

The BTK is designed to fit on an officer’s duty belt and contains Z-Medica’s QuikClot Combat Gauze®, a tourniquet, compression bandage and gloves which can be used by a police officer to administer emergency first aid to control bleeding until medical attention can be sought.

According to the Hartford Consensus III, a set of guidelines established by the American College of Surgeons in collaboration with the medical community and federal government to create a protocol for national policy to enhance survivability from active shooter and intentional mass casualty events, uncontrolled hemorrhage is the single most preventable cause of death in these situations.

Following a program initiated by the New York State Division of Homeland Security and Emergency Services (DHSES) several months ago, this initiative represents the largest standardization of advanced bleeding control kits ever deployed by a single city. The NYPD is the largest police force in the United States.

“Our products have been battlefield tested and deployed with active military personnel in war zones for years,” stated Z-Medica’s President and CEO Stephen J. Fanning. “In the United States, QuikClot has become a standard product now used by law enforcement, emergency services and hospitals.”

The three-year, $2.7 million agreement provides for BTKs and help with training personnel on how to use the kits. Training and deployment of the kits is expected to begin early 2017.

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Z-Medica Teams Up with the ACS to Provide Basic Bleeding Control Instructor Training

December 05, 2016

Z-Medica, LLC, a leading developer and marketer of hemostatic devices, announces today that they have teamed up with The American College of Surgeons (ACS) to provide basic bleeding control instructor training to surgeons.

Working with the ACS’s Committee on Trauma, the “Bleeding Control Basic” course is a pilot program that fulfills the intent of the White House’s “Stop the Bleed” national initiative which is designed to increase the public’s awareness of how they can play a role in saving lives by applying basic bleeding control techniques until appropriate medical care is available.

So far, more than 350 surgeons have participated in the training program, which instructs surgeons how to train laypersons on the basics of bleeding control. Those surgeons who participate in the program can then return to their communities and teach the basic bleeding control techniques.

“Teaming up with the American College of Surgeons to provide this training was a natural fit for us,” said Z-Medica President and CEO Stephen J. Fanning. “By providing the necessary tools, products and personnel to support this effort, Z-Medica continues its commitment to helping save lives.”

More information on the White House initiative and basic bleeding control can be found at http://www.bleedingcontrol.org.

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