Humacyte Partners with Fresenius, Nets $150M Equity Investment
Morrisville-based Humacyte, developer of a bioengineered blood vessel, has formed a global partnership with Fresenius Medical Care, the world's largest provider of dialysis products and services and will receive a $150
million equity investment as part of the deal.
Fresenius will obtain the exclusive global rights to commercialize Humacyte’s investigational vessel, Humacyl, potentially making it available to more patients worldwide following approval of the product, the two companies said in a news release.
Humacyl is being developed as a vascular access for hemodialysis patients with end stage renal disease. It may prove more effective than current synthetic grafts and fistula, the companies said.
"This is a transformational milestone for Humacyte, giving us the world's strongest partner to help bring our product to more patients globally," said Carrie Cox, chief executive officer and chairman of Humacyte. "Our partnership will allow Humacyte to focus on advancing the potential for Humacyl as a substantial breakthrough in the science of regenerative medicine, and to continue our development of an exciting future pipeline."
Fresenius will be responsible for the marketing, sales and distribution of Humacyl following approval by the relevant regulatory authorities.
The company’s equity investment in Humacyte will give it a 19 percent fully diluted ownership stake in the company. The transaction is expected to close in July.
"By partnering with Humacyte, Fresenius Medical Care has an opportunity to offer a dialysis vascular access option with the potential for significant clinical efficacy and safety improvements, including the potential to minimize catheter contact time to the benefit of our patients," said Franklin Maddux, M.D., chief medical officer for Fresenius Medical Care North America. "Our exclusive rights to distribute this innovative technology to dialysis patients worldwide may have significant benefits not only to patients, but health systems as well. With the potential for fewer anticipated complications and interventions compared to synthetic grafts, we may see increased safety for patients and reduced medical and economic burdens to the healthcare system.
Most patients with end stage renal disease require fistulas, grafts and central venous catheters so doctors can access their blood system for dialysis. All three options have limitations.
Half of fistulas fail and do not mature in patients, delaying vascular access for dialysis treatment. In the meantime, many patients need a central venous catheter, which increases the risk of infection.
Compared to a fistula, Humacyl can be available for use in hemodialysis within weeks and may have an overall higher rate of maturation, the companies said. It also may offer a more durable, biologic alternative to synthetic grafts.
Humacyl is currently in Phase 3 pivotal trials in the United States and Europe, and Humacyte plans to seek regulatory approval in both regions after the trials are completed.
Unlike most regenerative medicine companies, Humacyte does not use a patient’s own cells for therapies or products. Instead, it uses a proprietary cell-culture technology to engineer tissues that can be shaped into tubes, sheets, or particulate conformations, with properties similar to native tissues.
It is focused on creating off-the-shelf, ready-to-use bioengineered blood vessels that can be easily stored until doctors and patients need them. The blood vessels are known as human acellular vessels.
They are derived from human vascular cells that are seeded onto a degradable scaffold and then cultured so they secrete a matrix that forms a tissue in the shape of the scaffold. To avoid triggering an immune response in patients receiving the tissue, the vascular cells are removed – hence the term acellular.
Humacyte’s product pipeline includes other potential applications that may improve treatment outcomes for patients suffering from both vascular and non-vascular diseases.
Early NCBiotech funding, new facilities
Humacyte received a $150,000 Small Business Research Loan from the North Carolina Biotechnology Center in 2006. In October 2015 it raised $150 million in a Series B preferred stock financing ̶ among the largest ever by a life science company in North Carolina.
In March of this year Humacyte raised $75 million in a Series C preferred stock financing, led by a consortium of private investors and new investors, including PointState Capital of New York.
With the new Fresenius partnership and funding, Humacyte has raised $480 million to date ̶ $440 million in private investments and $40 million in state and federal grants and contracts.
Earlier this year Humacyte completed construction of a new, state-of-the-art research and development and bioprocessing facility in Durham. The company plans to move all operations into the facility by the end of the year.
Humacyte has already grown to 110 employees, and recently had 18 job openings listed on its website.
The privately held company was started in 2004 by Laura Niklason, M.D., Ph.D., currently a professor of biomedical engineering and anesthesia at Yale University. She co-founded Humacyte with Juliana Blum, Ph.D., and Shannon Dahl, Ph.D.
Humacyte’s research platform and core technologies are based on the work of Niklason and Dahl at Duke University, and by Niklason at the Massachusetts Institute of Technology in the laboratory of Robert Langer, Sc.D.
Fresenius Medical Care is the world's largest provider of products and services for people with renal diseases. Through its network of 3,790 dialysis clinics, Fresenius provides dialysis treatments for 322,253 patients around the globe. It is also the leading provider of dialysis products such as dialysis machines or dialyzers.
The company, headquartered in Bad Homburg, Germany, is listed on the Frankfurt Stock Exchange and New York Stock Exchange