Biomimetic Platform To Rapidly and Accurately Uncover Blood Clotting Abnormalities

Our Innovation

FloBio’s innovative approach brings the power of microfluidics to the bedside and creates a biomimetic platform that simulates and visualizes clot formation. The current platform is designed to directly measure blood clotting function components and the entire clotting process.

Our platform technology will include a fully automated table-top analyzer and a proprietary disposable microfluidic device that evaluates the patient’s blood biology in real-time, under physiological and dynamic flow conditions.

We are designing a system that:

  • Is simple and easy to use and interpret
  • Uses a small volume of blood (<250 uL)
  • Uses multiplex detection of clotting abnormalities
  • Provides rapid beside, point-of-care analysis and results

This near patient diagnostic platform can help to personalize patient care by rapidly evaluating bleeding and thrombotic risk within 10 minutes. The results inform therapy choice and provide insight into drug activity and reversal, as well as the ability to monitor effectiveness.

Proven Science and Versatile Platform

Our technology is based on more than 10 years of research with more than 30 related publications, demonstrating the scientific proof of concept across a broad range of clinical and pharmacologic applications where understanding bleeding and clotting risk is essential.  Our versatile R&D pipeline includes tests for anticoagulation drug activity, trauma-induced coagulopathy and neonate applications.

Our 1st Test In Development

Blood thinner medications and related adverse drug events have been a leading reason for emergency department visits costing hospitals $2.5B annually.  With the advent of newer blood thinners or direct oral anticoagulants (DOACs) over the last ten years, there has been increasing focus on their safe use in certain clinical situations and the need for a DOAC specific test to assess anticoagulation levels.

Our first test addresses the growing need for Direct Oral Anticoagulant (DOAC) testing. Today, DOACs can not be easily monitored, presenting diagnostic challenges for clinicians when faced with bleeding concerns and managing emergent critical patients.  Our initial test will be the first of its kind to provide information on blood clotting function and DOAC status to improve clinical decision-making and drive cost-effective treatment.

GRANTS & AWARDS

FloBio has received funding from several sources, including the National Science Foundation and the National Insitute of Health.

  • November 2020: NSF Phase 1 SBIR
  • August 2020: NIH Phase 1 SBIR
  • September 2019: NIH Phase 1 SBIR
  • March 2020: Pennsylvania Pediatric Device Consortium Grant

 

FEATURED PUBLICATIONS

Rossi, J. M., S. L. Diamond, 2020, ‘Point-of-care and storage-stable, single-use 8-channel microfluidic chip for rapid testing of DOACs and DOAC Reversal agents under whole blood flow’ (abstract), Res Pract Thromb Haemost.; 4

Rossi, J. M., S. L. Diamond, 2019, ‘Feasibility of a single-use, storage-stale, point-of-care microfluidic chip for evaluation of platelet function and coagulation in whole blood under flow’ (abstract), Biomedical Engineering Society Conference

 

ADDITIONAL SELECT PUBLICATIONS

  • Zhu, S., B. A. Herbig, X. Yu, J. Chen, and S. L. Diamond. 2018. ‘Contact Pathway Function During Human Whole Blood Clotting on Procoagulant Surfaces’, Front Med (Lausanne), 5: 209.
  • Li, R., K. A. Panckeri, P. F. Fogarty, A. Cuker, and S. L. Diamond. 2017. ‘Recombinant factor VIIa addition to haemophilic blood perfused over collagen/tissue factor can sufficiently bypass the factor IXa/VIIIa defect to rescue fibrin generation’, Haemophilia, 23: 759-68.
  • Kaza, E. A., M. C. Egalka, H. Zhou, J. Chen, D. Evans, J. Prats, R. Li, S. L. Diamond, J. A. Vincent, E. A. Bacha, and T. G. Diacovo. 2017. ‘P2Y12 Receptor Function and Response to Cangrelor in Neonates With Cyanotic Congenital Heart Disease’, JACC Basic Transl Sci, 2: 465-76.
  • Li, R., T. Grosser, and S. L. Diamond. 2017. ‘Microfluidic whole blood testing of platelet response to pharmacological agents’, Platelets, 28: 457-62.
  • Li, R., H. Elmongy, C. Sims, and S. L. Diamond. 2016. ‘Ex vivo recapitulation of trauma-induced coagulopathy and preliminary assessment of trauma patient platelet function under flow using microfluidic technology’, J Trauma Acute Care Surg, 80: 440-9.
  • Li, R., K. A. Panckeri, P. F. Fogarty, and S. L. Diamond. 2015. ‘Recombinant factor VIIa enhances platelet deposition from flowing haemophilic blood but requires the contact pathway to promote fibrin deposition’, Haemophilia, 21: 266-74.
  • Zhu, S., B. A. Herbig, R. Li, T. V. Colace, R. W. Muthard, K. B. Neeves, and S. L. Diamond. 2015. ‘In microfluidico: Recreating in vivo hemodynamics using miniaturized devices’, Biorheology, 52: 303-18.
  • Colace, T. V., R. W. Muthard, and S. L. Diamond. 2012. ‘Thrombus growth and embolism on tissue factor-bearing collagen surfaces under flow: role of thrombin with and without fibrin’, Arterioscler Thromb Vasc Biol, 32: 1466-76.
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