Comparison of SEER Technology to TEG in Cardiac Surgery Published in Anesthesia and Analgesia

Charlottesville, VA – May 10, 2016– HemoSonics today announced that a paper comparing its novel SEER technology to Thromboelastography (TEG) was published online in Anesthesia and Analgesia. The paper, A Comparison of a New Ultrasound-based Whole Blood Viscoelastic Test (SEER Sonorheometry) versus Thromboelastography (TEG) in Cardiac Surgery, describes the results of a study conducted at Virginia Commonwealth University in 50 cardiac surgery patients. The study compared the results of a research version of the Quantra™, a point-of-care in vitro diagnostic platform that measures blood clot formation and breakdown and provides actionable information to aid in the management of critical bleeding and clotting, with the TEG 5000 and standard laboratory tests. The study found that the Quantra results were significantly correlated with TEG measures of clot time (r=0.6-0.7) and clot stiffness (r=0.8-0.9) as well as standard laboratory tests for fibrinogen and platelet count (r=0.6-0.8). Complete Quantra results were available substantially faster than the TEG results (11 minutes vs 42 minutes, averages of Quantra vs TEG respectively), an important distinction in critical care settings where rapid treatment of bleeding is of the essence. The study substantiated the use of the Quantra’s Fibrinogen Contribution parameter, suggesting it may determine a more functional fibrinogen activity as compared to the TEG and conventional laboratory methods. In addition, the study showed a significant correlation between platelet count and the Quantra’s Platelet Contribution measure of platelet function (r=0.6-0.8), a parameter existing viscoelastic technologies do not measure. “Current viscoelastic testing is limited by long result times and incomplete parameter measures,” said Dr. Bruce Spiess, Professor and Associate Chief Anesthesiology (Research) at University of Florida and lead author of...

HemoSonics Opens New Facility in Durham, NC

Charlottesville, VA – December 7, 2015 – HemoSonics, a medical device company developing a point-of-care diagnostic platform to guide the management of critical bleeding, today announced that it has opened a new facility in Durham, NC. “The expertise in hemostasis in the Research Triangle is unparalleled, and we are excited to have a new facility that will leverage the wealth of talent in the region. This new facility will support the final stage of development and clinical testing of our Quantra™ platform,” said Tim Fischer, CEO of HemoSonics. “The university ecosystem provides ample sites for clinical testing and we have built out a strong team to fuel our future growth.” The Durham Facility currently has 11 employees. The facility will focus on software development, system engineering, reagent development, and clinical...

SEER Technology Published in Annals of Biomedical Engineering and to be Presented at IEEE International Ultrasonics Symposium

Charlottesville, VA – October 19, 2015 – HemoSonics, a medical device company developing and commercializing a point-of-care diagnostic platform to guide the management of critical bleeding, today announced that a paper detailing its novel SEER technology was published in the Annals of Biomedical Engineering. The paper, Sonic Estimation of Elasticity via Resonance: A New Method of Assessing Hemostasis, details the core technology behind the Quantra™, a point-of-care in vitro diagnostic platform that measures blood clot formation and breakdown and provides actionable information to guide the management of critical bleeding and clotting. SEER uses ultrasound to initiate and measure mechanical resonance in a clotting blood sample. The characteristics of this resonance are analyzed to precisely measure the evolving clot stiffness. SEER requires no moving parts and uses commodity electronics. An abstract detailing HemoSonics’ SEER technology was also accepted for the IEEE International Ultrasonics Symposium. The conference will be held in Taipei, Taiwan, on October 21-24th, 2015. Paper Citation Corey, FS, and WF Walker. “Sonic Estimation of Elasticity Via Resonance: A New Method of Assessing Hemostasis.” Annals of biomedical engineering (2015)doi:10.1007/s10439-015-1460-y. Abstract Details Title: Sonic Estimation of Elasticity via Resonance (SEER): Initial Results from a New Method of Assessing Hemostasis Authors: FS Corey, WF Walker Session: 3I – MEL: Towards clinical application of elasticity imaging Date: October 24, 2015, 10:30am –...

HemoSonics appoints Josep Manent to Board of Managers

Former CEO of Instrumentation Laboratory Adds Depth to Board Charlottesville, VA – September 17, 2015 – HemoSonics, a medical device company developing and commercializing a point-of-care diagnostic platform to guide the management of critical bleeding in surgery and acute care settings, announced that Josep Manent has been elected to its Board of Managers. Mr. Manent has over 35 years of business, financial, product development and marketing experience in the in vitro diagnostics (IVD) industry.  He previously held senior management positions in the Werfen Life Group, a family of leading companies in the IVD sector. Most recently, he served as the CEO of Instrumentation Laboratory (IL), a leader in critical care, hemostasis and point-of-care diagnostics, from 1999 until his retirement in 2011.  Under his leadership at IL, the company returned to profitability and became a world leader in hemostasis and point-of-care through a combination of creative customer targeting, efficient manufacturing and a focus on innovative product development. “Josep brings an unparalleled depth of experience and industry knowledge in the in vitro diagnostics space,” said William P. Moffitt, Chairman of the Board of HemoSonics. “His perspective, global reputation and insight will be invaluable as we initiate commercialization of the Quantra™ platform and seek to accelerate shareholder value.” Prior to his employment with Werfen, Mr. Manent was a co-founder of Biokit, a developer of systems and immunoassay tests for clinical laboratories, and served as its President and General Manager for 20 years.  Biokit was acquired by Werfen. Mr. Manent received his MBA at ESADE Business School and participated in Executive and Marketing programs at Stanford University. “I believe HemoSonics has a unique...

HemoSonics Awarded $1M Phase II Grant from the US Air Force

Phase II to Validate Use of the QuantraTM for Measuring Platelet Impairment Charlottesville, VA – August 7, 2015 – HemoSonics, a medical device company developing a point-of-care diagnostic platform to guide the management of critical bleeding, today announced that it received a $1 million Phase II grant from the United States Department of the Air Force. The Phase II grant will help fund the development of the Quantra™  and the evaluation of its clinical utility in assessing coagulopathies in trauma. “This grant validates the need for a fast, comprehensive and accurate point of care test to measure platelet impairment and guide treatment of critical bleeding in trauma settings,” said Francesco Viola, Chief Science Officer of HemoSonics. “These funds will support the continued development of our Quantra™  platform, designed to deliver actionable information to guide the management of critical bleeding and clotting in critical care settings.”  ...

HemoSonics Expands Management Team

Seasoned Diagnostic Executives Bolster Leadership in Preparation for Regulatory Process and Commercialization Charlottesville, VA – May 2, 2015 – HemoSonics, a medical device company developing a point-of-care diagnostic platform to guide the management of critical bleeding, today announced that it has named two seasoned diagnostic executives to lead its development team, David Bryant will serve as HemoSonics’ Vice President of Quality Systems, and Thomas Givens will serve as Vice President of Engineering. “As we continue to progress towards commercialization of our Quantra Dx™ diagnostic platform, Dave and Thomas bring extensive experience in developing diagnostic instruments for manufacturing and successfully taking them through the regulatory and commercialization process,” said Timothy Fischer, President and Chief Executive Officer of HemoSonics. “We are confident that their leadership will strengthen our abilities to effectively achieve regulatory clearance of our products.” Bryant is an experienced engineer who has led several teams through the development and registration of novel, high value diagnostic products. Prior to joining HemoSonics, he was Senior Director of Program Management at LipoScience, Inc. and Director of Platform Imaging at Beckton Dickinson Diagnostics, formerly TriPath Imaging. Bryant holds a BS in Industrial Engineering from North Carolina State University. Givens has extensive experience leading engineering research and development teams of diagnostic products. Prior to joining HemoSonics, he was Senior Director of Engineering R&D At LipoScience, Inc. and Principal Engineer at Beckton Dickinson. Givens hold a BS in Engineering Science from the University of Tennessee and an MS in Mechanical Engineering from Duke...