Hibernicor – A Innovative New Startup Medical Device Company

Company description

Hibernicor develops solutions to improve the lives of organ transplant recipients and patients with its three products. Its mission is to be the standard of care for increasing the quality and quantity of donor hearts available for transplantation.

Problems we solve

The current method of procuring and transporting donor hearts for transplants allows for a 3- to 4-hour window. With its Asporto heart preservation device, Hibernicor has working prototypes that will safely increase the window of viability of hearts to 6 hours and with further refinement, possibly 24 hours.  Hibernicor is also working with leading US academic institutions to optimize donor procurement and transportation logistics.

Revenue model

Hibernicor will earn revenue by selling its Asporto heart preservation device for a flat fee. The sterile disposable kit used to house the heart during transport will be sold on a per-use rate. Hibernicor has proprietary sales forecasting software of the US heart transplant center market from 1998 onwards.  A robust set of assumptions for new center setup, projected growth, and fiscal forecasts were developed into the software model.

Target markets

Asporto and disposable kits will be purchased by organ procurement organizations (58 nationwide) and medical centers that perform heart transplants (>2oo nationwide).

Hibernicor is also pursuing CE Marking, which will allow Asporto and disposable kits to be purchased by organ procurement organizations and medical centers that perform heart transplants in 28 countries in the European Union. In 2013, Hibernicor started a European company called Hibernicor Ltd to expand into the European market.

Competitive landscape

Transmedics, Inc., of Boston, MA (Organ Care System)
Organ Transport Systems of Amarillo, TX (LifeCradle)
Paragonix Technologies of Braintree, MA (Sherpa Pak)

Funding sought

$2,000,000 for completion of clinical trials and FDA approval.

EB-5 Visa Investment Opportunity

U.S. Congress created the employment-based fifth preference visa program in 1990 to stimulate the U.S. economy through job creation and capital investment by foreign investors.  The United States Customs and Immigration Service  administers the EB-5 program, created by Congress in 1990 to stimulate the U.S. economy through job creation and capital investment by foreign investors.

The EB-5 investors must invest a minimum of $1 million in Hibernicor which was formed on August 1st, 2002  and is a commercial enterprise with the purpose to conduct ongoing lawful business. The investor must invest enough capital to create 10 new qualified full-time employee positions.​

More information about applying for the EB-5 program can be found on the USCIS website.  Hibernicor will provide legal assistance for the visa application process to the investor, as needed.

Introduction to market timeline

Timeline after receiving startup funding:

  • 6 months: Hibernicor will apply for FDA approval through an Investigation Device Exemption and submit CE Mark application.
  • 9 months: Fourth-generation prototyping begins.
  • 12 months: FDA approval of 510(k) application.
  • 14 months: Initiation of a multicenter clinical trial.
  • 16 months: Launch of U.S. distribution.
  • 18 months: CE approval completed, begin pursuit of distribution in Europe.

More information?

Hibernicor Emerging Medical Competition Presentation

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Key Questions to Consider:

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