Trauma Surgeon Forms Small Business on Quest for Innovative Patient Care, Seeks Pharmaceutical Licensing

Tammy Allen, Director | Marketing & Programs, The NIIC

Frustrated—The Problem

Dr. Cuthbert Simpkins, MD, FACS, is an experienced trauma surgeon who has been in practice for 40 years.  He has successfully operated on patients with gunshot wounds to the heart and other vital organs. However, too many died later of septic shock due to infection. These patients died despite his use of state-of-the-art medications and devices.  During his service in the U.S. Navy, where he was a Research Fellow and later became a Scientific Principal Investigator at the Naval Medical Research Institute, he began his formal study of sepsis and septic shock.

He grew increasingly frustrated with treatment options for these types of patients. There had to be more to do to help them. In 2013 he brought a team together to work on this problem.

New Approach to A Solution. Now, as President and Chief Innovation Officer, Vivacelle Bio, Inc., he developed a new class of fluids to sustain life after massive blood loss or bloodstream infection. These fluids are capable of redistributing nitric oxide, which is overproduced in shock due to sepsis, blood loss, or other causes. This is a new mechanistic approach. These fluids also block damage to organs that occurs when blood or other fluids are given, called reperfusion injury.

Accelerated Pathway. The U.S. Food and Drug Administration (FDA) granted permission for this product, that is based upon phospholipid nanoparticles to bypass Phase I Clinical Trials and proceed directly to Phase II Clinical Trials, funded by a U.S. Navy $5.3 million grant.

During a recent fireside chat hosted by The NIIC Connected Health Lab, Dr. Simpkins spoke with Michael Fritsch, NIIC Senior Entrepreneur in Residence, about the process of biomedical discovery, development, and commercialization. Dr. Simpkins has been a part of the entrepreneurial community at The NIIC since 2016.

Innovate to Save Lives. As they say, if you’ve met one entrepreneur, you’ve met one entrepreneur. There are individuals with the insight and inspiration to meet human needs through innovation in every walk of life. In this case, a trauma surgeon thought differently about a significant challenge in the operating room and intensive care unit. He went back to the basics, tearing down the problem to the molecular level. Rethinking conventional wisdom and conventional treatments led to innovative ideas with the potential to save 10 million lives around the globe each year.

From Bootstrapping to Funders. Major innovations in any industry —and perhaps especially in health care — require significant investment. As entrepreneurs build teams of advisors and managers, they need to develop sources of investment that can fund every step along the way toward achieving a big vision. Funding comes from many sources — some large and some small. With Vivacelle, it started with Dr. Simpkin’s own money. Then friends and family chipped in, along with medical colleagues.

Angel investors and Venture capitalists became interested. Ultimately, Vivacelle’s potential drew the attention of the Department of Defense, which awarded Vivacelle Bio $5.3 million to fund clinical trials from phase II through III. Some investors become fixated on one form of funding; however, it often requires a melting pot of funding sources to make things happen.

Intellectual Property Builds Capacity. Vivacelle Bio has multiple U.S. patents and has more than 10 products in development. While the underlying nanotechnology links all these, no one product will make or break the company. Vivacelle Bio is a maker of medical fluids AND is in the business of discovery and development. Entrepreneurs like Dr. Simpkins intentionally develop the capacity to build multiple products over time. As each product comes to market, the discovery company is ready to take another “bite of the apple” by developing additional products.

Conversations and Collaboration. Conversations like this often happen at The NIIC. Through the Connected Health Lab, we’re working on expanding Indiana’s global network of healthcare experts, pioneers, and innovators. We’re building collaboration among scientists, healthcare companies, IoT supplier companies, universities, and other partners in innovation. Join us at https://theniic.org/iot/.


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