Miromatrix, a bio-engineering company based in Eden Prairie, focuses on addressing one of the most significant challenges in the healthcare system: the shortage of available organs for life-saving transplants.
Miromatrix CEO Jeff Ross states that tens of thousands of potential transplant patients in the U.S. alone do not receive organs annually, which is a matter of life and death for them.
The Miromatrix solution to the problem involves using organs from a nonhuman source and implementing two patented processes. The first process, perfusion decellularization, was originally developed at the University of Minnesota. The second process, called recellularization, is conducted at the Miromatrix laboratory using a bioreactor manufactured by the company.
Despite sounding like science fiction, this process is a reality and is taking place in Eden Prairie. Miromatrix is currently focusing on liver and kidney transplants, the most common forms of human organ transplants.
Xenotransplantation is the process of transplanting an organ from a nonhuman animal source into a human recipient. Ross disputes the use of the term “xenotransplantation” to describe the Miromatrix process. However, Miromatrix begins with porcine organs, meaning organs from pigs, to develop their patented process, making it a form of xenotransplantation.
Why a pig? Miromatrix uses pig organs in its process, and Ross says there’s a ready supply of them for obvious reasons. Pigs are biologically similar to humans, and there’s a long history of using pig organs and tissue in medical devices and products. Ironically, pigs also provide a more pristine starting point, as they don’t drink alcohol or smoke tobacco.
Miromatrix’s patented process called perfusion decellularization is used to remove all the cellular material from a pig organ. The resulting product, according to Ross, is essentially a “protein scaffold or matrix” of the pig organ. Ross explained that a good analogy for this process is to imagine “tearing your house down to the studs.” Even though the cellular material is removed, the organ still maintains its micro and cellular structure, similar to how a house torn down to the studs retains the architecture of the original structure. As a result, the decellularized organs have a ghostly white appearance.
The decellularized organ undergoes another process known as recellularization, which involves using a bioreactor. This process mimics the natural vascular mechanics as cells from human organs grow and mature inside the recellularized organs. The use of decellularized organ scaffolds provides an ideal template for supporting the growth and differentiation of stem cells into functional tissues.
Miromatrix uses a recellularization approach that involves taking human donor transplant organs that are unsuitable for transplants, according to Ross. These donor organs may have cuts, nicks, tears, a long ischemia time, or may not meet the required functional matrix. Miromatrix takes human cells from the donor organ, places them on the decellularized matrix, and uses a bioreactor to produce a functional human organ. One human kidney can produce up to eight transplantable kidneys, while one human liver can produce up to four transplantable livers, Ross said.
The end result of this amazing science will hopefully be Miromatrix having the ability to produce kidneys and livers suitable for transplantation into people in the very near future.
Ross said the company aims to obtain FDA approval to begin human clinical trials in the second half of this year. Miromatrix has gained many reputable scientific partners, such as the Mayo Clinic, Mount Sinai, and the Texas Heart Institute.
The organ availability problem
Human organ transplantation, particularly of kidneys and livers, is a well-developed healthcare procedure. Skilled surgeons are proficient in performing the surgery, and there is a substantial body of knowledge on how to manage the complexities of immuno-suppression issues. However, the biggest challenge is the scarcity of organs.
Ross stated that there are currently 110,000 patients on the organ transplant waiting list in the United States, with 70,000 of them unable to receive an organ. Additionally, the transplant list could potentially see a significant increase if there were a better supply of organs. In the U.S., there are approximately 550,000 patients who are on kidney dialysis alone, as well as many thousands more who require other organ transplants.
Miromatrix’s ability to produce transplantable organs on-demand, once necessary approvals have been obtained, has the potential to significantly improve the healthcare delivery model.
According to Ross, the current model is difficult for patients and healthcare providers. He said potential transplant patients are very sick due to organ failure and must wait by the phone for a donor organ to become available. Once an organ is available, they must rush to the hospital, and the transplant team must be prepared to operate regardless of time or other circumstances.
Producing organs on demand could improve efficiency and scheduling, he said. The surgical suite and medical professionals can be scheduled, and patients would have time to prepare for this life-altering surgery.
Strides toward proving the efficacy
Miromatrix faced several issues in its strategy, including the need to prove the viability of its use of porcine organs and the assurance that its products would be free of the porcine virus.
To address these concerns, Miromatrix developed and commercialized two medical device products: Miromesh, mainly used for soft tissue reinforcement, such as hernia treatment, and Miroderm, used for various wound care applications.
After demonstrating the effectiveness of these products in thousands of patients and the absence of porcine virus risk, Miromatrix out-licensed both to Reprise Biomedical, a new company, in 2019, to concentrate on the transplant space.
To help the 50,000 people in the United States who die each year from liver failure, Miromatrix has developed miroliverELAP.
This technology is intended to offer external therapeutic support to acute liver failure patients, allowing their livers to regenerate and recover. It functions as a form of liver dialysis, a treatment not previously available. The company is currently working towards obtaining FDA approval to commence human clinical studies.
Miromatrix was established in 2009 and was based at the Enterprise Labs at the University of Minnesota until 2011.
In 2010, Ross joined Miromatrix as its vice president of product development. The company relocated to Glencoe, Minnesota, in 2012 and then to Eden Prairie in 2015. Ross was appointed as CEO of Miromatrix in 2017. In June 2021, the company went public and is traded on NASDAQ under the ticker symbol MIRO.
The company relocated to its current Eden Prairie headquarters in March 2022. It has 70 employees, ranging from warehouse and administrative personnel to medical technicians and Ph.D. scientists.
Ross is a native Minnesotan. He grew up in Prior Lake, got his undergraduate degree from the University of Minnesota Duluth, and a master’s degree in bio-engineering and a doctorate in cellular, molecular and developmental biology from the University of Minnesota Twin Cities.
In addition to Ross, Miromatrix has a top-notch management team, including CFO Jim Douglas, Medical Director Dr. John Lake, R&D VP John Barry, and VP of Clinical and Regulatory Affairs M. Mason Macenski.
The ‘holy grail’
One of the biggest issues in transplant surgery is rejection. Transplant patients are required to take a range of potent anti-rejection drugs. Ross believes that at some point, science will achieve what he calls the “holy grail” of transplant surgery: the ability to bio-engineer an organ for transplant that is genetically identical to the patient receiving the transplant. This would eliminate the issue of rejection.
Ross quickly acknowledges that has yet to be achieved, but he believes that science will lead there in the next few years and that the Miromatrix approach will play an important role.
Editor’s note: Contributor Frank Farrell is on the EPLN Board of Directors.
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