Coagulation Sciences

The Opportunity Coagulation Sciences has developed disruptive technology to improve Transfusion Medicine. Approximately 50% of blood transfusions are unnecessary, administered simply because existing tests are too slow, and provide insufficient information to guide management of bleeding patients. Our expert team developed the MCTS, which rapidly compares ability of treatments to normalize blood clotting, in a fully automated, single‑use disposable Cartridge, from a small tube of blood. Existing tests detect abnormalities, but our device compares response to treatment(s). Our device is expected to be the first and only device to provide personalized information with actionable results, at the POC, within 10 minutes. Complications of transfusions increase morbidity, mortality and cost, and shorten lifespan. In addition to improving patients' outcomes, by preventing unnecessary transfusions, the MCTS will save hospitals and insurance companies billions of dollars annually.

Unmet Need Large amounts of bleeding occur in patients undergoing heart, liver, trauma, transplant and major orthopedic surgery. Combined, these procedures use more than half the nation's blood supply. There is an unmet need for advanced blood testing for these patients. Most tests currently used were developed, or based on tests developed in the 1940s and 1950s. There is an unmet need for technology that measures the response to treatments to stop bleeding.

The Technology Coagulation Sciences' Multiple Coagulation Test System (MCTS) compares the ability of eight treatments, each in two doses, to restore blood clotting towards normal. Results are shown in real‑time, at the point‑of‑care (POC) within 10 minutes. Research validating the technology, in five in‑vitro coagulopathies (bleeding disorders), won first prize at a Mount Sinai conference. An animation of Multiple Coagulation Test System may be seen at this URL: https://www.dropbox.com/s/m9a4l88nehyb2f1/MCTS_480p.mp4?dl=0

The Team The team includes key opinion leaders in management of bleeding and transfusion from world‑renowned medical centers. Management has extensive experience in early stage companies, medical devices, and entrepreneurship.

The Market The US and the EU represent an addressable market of $3B annually. The worldwide market (25+ countries) in addition to the US and EU represents additional opportunities for licensing revenue.

Business Model The company’s single‑use disposable Cartridge and small device support a razor and razor‑blade business model. The Cartridge is expected to generate a 73% profit margin.

Intellectual Property The Company’s patent portfolio includes 31 issued patents in the US, EU, Israel, Japan, Australia and China. A patent is pending in India.

Exit Strategies Acquisition is the most likely exit in this space, and the Company has had conversations with several global corporations that represent potential acquirers.

Current Stage The Company has completed a pilot study in 100 patients undergoing heart surgery at the Mayo Clinic. These results will help guide improvement of the technology during development of the GMP (commercial) quality system.

Regulatory The Company has had three pre‑submission meetings with the FDA. The FDA and the Company are in agreement that a de novo 510(k) pathway is appropriate.

Summary Approximately 50% of blood transfusions are unnecessary. They harm patients and hospitals lose money, as they are not reimbursed what it costs them to administer transfusions. Coagulation Sciences' MCTS will provide advanced information, not currently available, to help doctors arrest bleeding in patients. The Company has letters from key opinion leaders confirming the need for this advanced technology. An independent market research survey of blood bank directors, cardiac surgeons and cardiac anesthesiologists indicates substantial interest in the system.