Coagulo Medical Technologies Inc. raised $6.5 million in financing to accelerate delivery of its precision-medicine coagulation diagnostics platform. 20/20 Healthcare Partners led the investment with participation from Sands Capital, Good Growth Capital, IAG Capital Partners, and private investors. The company also received funding through a Small Business Innovation Research (SBIR) grant from the National Science Foundation to develop a COVID-19-related coagulation test.

“Coagulo has developed a platform that directly responds to current medical needs and, further, will support traditional tests like prothrombin time and activated partial thromboplastin time,” said Hillel Bachrach, managing partner of 20/20 Healthcare Partners. “We are excited to invest in Coagulo and to help accelerate their path to market as they up-end an industry that has seen very little innovation for decades.”

The company is completing the final phase of development of the platform and actively engaged in discussions with the U.S. FDA in anticipation of clinical trials. The new funds will support further expansion of the platform’s capabilities. “This funding will also continue to support multiple, ongoing collaborations with leading institutions across the country. These collaborations have generated a significant amount of clinical data ahead of our pivotal study for submission to FDA,” Coagulo’s Chairman and CEO Jarrod Niebloom told BioWorld.

The last substantial advance in coagulation testing methods occurred more than 50 years ago and provides general information on blood clotting function without specifying the cause. In contrast, Coagulo’s technology can identify coagulation factor-specific deficiencies, inhibition and abnormalities and quantify the effect on coagulation.

Coagulo’s point-of-care device delivers actionable information in 10 minutes from a few drops of blood. Powered by artificial intelligence, the platform combines more than 20 tests to analyze the entire coagulation cascade in one pass. That allows it to be used for personalized and rapid diagnosis and management of any coagulation disorder and enables it to identify the use, type, and current effect of any anticoagulant, even on patients unable to communicate their medical history.

“This is a huge advancement over traditional coagulation tests – like prothrombin time (PT/INR) and activated partial thromboplastin time (aPTT) – which are only capable of indicating whether a clotting problem is a result of a problem in the intrinsic or extrinsic pathway. We can actually home in on which particular factor is aberrant,” Niebloom explained.

The Cambridge, Mass.-based startup operates out of Alexandria Launchlabs and licensed technology from the Massachusetts Institute of Technology (MIT) and Massachusetts General Hospital. Coagulo’s platform combines patent-pending assays, innovative microfluidic technology, proprietary data analytics and digital connectivity.

COVID connection

Excess clotting emerged as an unexpectedly common symptom of COVID-19, contributing significantly to organ failure and death early in the pandemic. Inflammation and coagulation each further activate the other, complicating treatment in patients with serious disease.

Coagulo is working with hospitals to better understand the mechanisms of thrombosis in patients infected with SARS-CoV-2 and to develop optimal treatments for those needing complex coagulation management. Clarification of the cause and effects of thrombosis in these patients is urgently needed as current anticoagulation recommendations vary in what to administer, when to start therapy, how much to administer, and the monitoring required.

Coagulo could play a significant role in identifying the factors driving increased clotting, which may differ from person to person. “We are assessing our technology’s ability to evaluate the effect of various anticoagulants on patients with COVID-19, quantify anticoagulation levels and detect the presence of prothrombotic phenotypes,” Niebloom said.

Anticoagulant identification

More than 10 million people in the U.S. use anticoagulants to manage a range of conditions such as atrial fibrillation, autoimmune disorders, COVID-19, cancer, and joint replacement surgery, among others. Anticoagulants are also the leading cause of drug-related adverse events and associated hospitalizations. Hospitalizations related to the drugs themselves or to trauma are often complicated by difficulty determining how much anticoagulant effect remains in the patient’s system.

For patients who are unconscious or otherwise unable to communicate whether they take an anticoagulant and, if so, which one, knowing how and when to proceed safely can be tricky. No FDA-approved test can identify the five commonly used direct-acting oral anticoagulants (DOACs) – apixaban, dabigatran, rivaroxaban, edoxaban, and betrixaban – from a blood sample. Dabigatran, a direct thrombin or factor IIa inhibitor, requires a different reversal agent than the other four, which are all factor Xa inhibitors.

In a 100-patient clinical study conducted at MGH Emergency Department, Coagulo identified patients on DAOCs with 100% specificity and more than 95% sensitivity. It can also detect the reversal of anticoagulation.