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, butter 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

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 companies 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. Revenue is expected to exceed $70M inter four of sales.

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.  (A standard 510(k) does not apply, because no existing device performs the tests that  the MCTS does).

Financing:
The Company has raised $5.8M to date from private investors.

Investment Terms:
The Company plans to accept up to $3M in this round. ($2.2M is available, as $840,000 has been raised).
The minimum investment for new investors is $500,000. The pre-money valuation = $20.1M.  
Investments up to $499,999 receive 25% warrant coverage, at the same price per unit as this round, exercisable for up to five years.

Investments of $500,000 and above receive 50% warrant coverage, at the same price per unit as this round, exercisable for up to five years.
The Company will only accept funds from accredited investors.

NOTE: The Company is currently an LLC, but will convert to a C Corp if required by an institutional investor.

Use-of-Funds
$2.2M will fund further validation work and will fund the company through an Investment Bank led Series A round. Several Investment Banks have offered to work with the company. Series A funds will be used to build the GMP quality system and fund the company through FDA clearance. 

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. 

Website:
www.coagulationsciences.com

For Information, contact:
Sheldon Goldstein, MD, Chief Executive Officer
email: [email protected]
cell:    917-363-6542

Allen Goldman, BBA, MBA, CPA, Chief Financial Officer;
email: [email protected]
cell:   609-851-9464