A new study published in The American Journal of Surgery demonstrates improved long-term patient outcomes, with no reinterventions, and a 10% two-year radiographic recurrent rate when MIROMESH® Biologic Matrix was utilized for crural reinforcement during laparoscopic paraesophageal hernia repair (PEHR).
The durability of MIROMESH Biologic Matrix was prospectively evaluated in an 85-patient study. Patients underwent laparoscopic Nissen hiatal hernia repair with MIROMESH to reinforce the hiatal junction. Post surgery (up to 1.8 years), patients reported no endoscopic or surgical reinterventions. This data should be encouraging to surgeons seeking to reinforce hiatal hernias.
Miromatrix has been chosen as one of only five innovators to present at the first ever KidneyX prize competition. During the presentation, Miromatrix will highlight not only its ground-breaking technology, but also its progress towards creating bioengineered transplantable organs -- including kidneys -- in order to eliminate the organ transplant waiting list.
Miromatrix received a $99,950 grant from Regenerative Medicine Minnesota (RMM), a publicly funded initiative established in 2014 with a $43.6 million allocation over a 10-year span. With its patented perfusion decellularization and recellularization technology, Miromatrix is able to engineer new kidney grafts that combine pig-derived scaffolds with human kidney cells. This grant money will assist Miromatrix in designing and developing a prototype perfusion system to test function in its bioengineered kidney grafts.
Miromatrix has raised $15.7 million in Series B-2 funding, surpassing its goal of $10 million. The additional funding supports the company’s mission to bioengineer transplantable organs and save lives by eliminating the organ transplant waiting list, as well as the continued commercialization of Miromatrix’ novel acellular products based on perfusion decellularization.
Miromatrix Medical is among the emerging biotech companies “Making BIO History” at the 2018 BIO International Convention, June 4-7 in Boston, Mass. CEO Jeff Ross, Ph.D. will present on The Future of Bioengineered Organs and Miromatrix’ vision to eliminate the organ transplant waiting list on Wednesday, June 6 at 11 a.m. in Theater 1. “It is an honor to have Miromatrix selected to present at BIO and share our ground-breaking technology with investors and companies in the biotech, pharma, and medical device space," said Ross.
Sponsored by the Biotechnology Innovation Organization (BIO), the convention is one of the largest gatherings representing over 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. It provides biotech organizations the opportunity to gather together, learn from one another and advocate for the global biotech industry.
Check out Dr. Ross' overview presentation in the link below.
Miromatrix is pleased to announce that it will presenting at the annual Cell & Gene Therapy Investor Day hosted by The Alliance for Regenerative Medicine (ARM) on April 17, 2018 in New York City. This gathering will provide institutional, strategic and venture investors a chance to learn more about Miromatrix and our vision to eliminate the transplant waiting list.
Healthline has published an article about our bioengineered liver project and our hopes to eliminate the liver transplant waiting list.
“We remove all the cellular material from the liver, but the architecture is still there. We have a perfect architecture of the organ,” Ross, the chief executive officer of Minnesota-based Miromatrix Medical, told Healthline.
Having that scaffolding, or functional vasculature, overcomes what he says has been one of the major roadblocks in being able to engineer livers in the lab.
Click here to read the full article.
LeapMag has published an article focusing on the medical field's efforts to solve the world's organ shortage problem. This is a great overview of different approaches to creating life-saving solutions and our role as the leader in these efforts.
"Much further along, and less ethically fraught, is a technique in which decellularized pig organs act as a scaffold for human cells. A Minnesota-based company called Miromatrix Medical is working with Mayo Clinic researchers to develop this method. First, a mild detergent is pumped through the organ, washing away all cellular material. The remaining structure, composed mainly of collagen, is placed in a bioreactor, where it’s seeded with human cells."
LeapsMag was created by Leaps by Bayer, a new innovation initiative whose mission is to “aim for fundamental breakthroughs in the life sciences – ‘leaps’ that have the potential to change our world for the better.” Leaps by Bayer holds the conviction that ‘fundamental breakthroughs’ are absolutely necessary to conquer the most demanding challenges facing humanity. And that these breakthroughs will only be made possible by those willing to take risks and do what many think can’t be done.
Miromatrix will present its most recent bioengineered kidney milestone at Kidney Week 2017 hosted by the American Society of Nephrology (ASN) on October 31st through November 5th in New Orleans. As we progress towards a bioengineered kidney we must demonstrate functional vasculature to be able to continuously perfuse blood. We have been able to show that functional vasculature can be achieved by repopulating decellularized kidneys with human primary endothelial cells.
A poster, presented by Senthuran Atputhanathan B.S., describing this achievement entitled “Development of Functional Vasculature in Decellularized Whole Porcine Kidneys with Human Endothelial Cells” will be presented at the conference on November 3rd (Poster #FR-PO977). Whole porcine kidneys were perfusion decellularized and human umbilical vein endothelial cells (HUVEC) and primary human epithelial cells (HRE) were perfused into the kidney graft’s vascular and tubular compartments respectively. Key metabolic parameters were monitored to assess cell proliferation and viability while whole organ culture was performed under continuous media perfusion. Additionally, recellularized kidneys were introduced into blood loops using whole porcine blood to model in-vivo performance as functional vasculature assessments were performed. Cellular engraftment and viability were measured by metabolic parameters including glucose consumption over 3 to 4 weeks (n=12) to achieve the desired level. These data were further corroborated by histological analysis of formalin fixed kidney sections demonstrating the presence of a single layer of engrafted cells on vascular and tubular compartments. Furthermore, cells positive for the endothelial cell marker CD31 were confined to the vascular compartment and cells positive for the epithelial cell marker e-cadherin were confined to the tubular compartment. Vascular functionality was characterized by blood loops and demonstrated long-term continuous perfusion of whole blood compared at physiological pressures compared to non-recellularized kidneys that demonstrated the lack of flow after a few minutes. These results demonstrate the ability to generate a functional vasculature in our recellularized kidney grafts, a critical first step in the engineering of a fully bioengineered kidney.
“The progress represented in our revascularized kidneys is a tremendous milestone in our goal to bioengineer transplantable kidneys,” says Senthuran Atputhanathan, Miromatrix Kidney Scientist. “Our ability to demonstrate functional vasculature in these large animal kidney grafts is exciting as it enables us to continue to build upon our success by introducing additional functional kidney cells into our kidney grafts.”
Kidney Week is the world's premier nephrology meeting. The conference showcases the latest scientific and medical advances and hosts engaging and provocative discussions with leading experts in the field of nephrology.
Our close collaboration with the Mayo Clinic continues to be a key ingredient in our advancing efforts towards a bio-engineered liver. Miromatrix’ mastery of liver decellularization and recellularization combined with the world renowned Mayo Clinic’s liver transplant and hepatocyte expertise enables us to progress towards addressing the world’s transplantable liver shortage.
Our partnership is highlighted in a recent issue of Mayo Clinic Alumni Magazine. Click here to read article.
Medgadget, an online publication covering the latest medical devices, technology breakthroughs and discoveries, published an interview with Miromatrix CEO Jeff Ross, Ph.D. As Miromatrix gears up to demonstrate large animal survival with our bioengineered liver, Conn Hastings of Medgadget interviewed Dr. Jeff Ross about the whole organ program.
Click here to read the whole interview.
New Scientist published an article focusing on our bio-engineered organ efforts. The publication describes the decellularization and recellularization process along with our ongoing progress to bring bio-engineered organs to people who need it.
Click here to read the article.
Miromatrix will present its latest transplantable liver milestone at The Liver Meeting® hosted by the American Association for the Study of Liver Diseases (AASLD) on October 20-24 in Washington, D.C. Building on the company’s successful liver re-endothelialization efforts, Miromatrix has advanced its ability to demonstrate functional liver vasculature by maintaining long-term vascular patency of its engineered liver grafts in a porcine model.
A poster describing these advancements entitled “Towards Long-Term Vascular Patency of Tissue Engineered Liver Grafts: a Large Animal Study” will be presented at the conference on October 20th (Poster #712). Twenty-seven porcine liver grafts were seeded with endothelial cells cultured in bioreactors, 20 of which were evaluated in vitro to determine important factors that predict in vivo vascular patency. Grafts with higher glucose consumption rate (GCR) had evidence of better endothelial coverage (p=0.012) and correlated significantly with graft flow (r=0.83, p<0.01). Three grafts had radiological evidence of vascular patency via advanced CT imaging until complete graft thrombosis 7 to 10 days after transplantation. Grafts with longer vascular patency had higher flow rates immediately after transplantation (p=0.028). Immune studies using pig serum suggested that graft thrombosis at day 7-10 was likely attributable to development of cytotoxic antibodies and acute humoral rejection. It was concluded that GCR is an excellent marker of endothelial coverage and subsequent portal blood flow in engineered liver grafts. The 7 to 10 days of vascular patency achieved in humanized revascularized liver grafts transplanted in pigs (without heparinization) provides the required foundation for engineering functional liver grafts. This is the first such study to demonstrate long-term patency of a clinically relevant liver graft in vivo, setting the stage for longer term implants with completely recellularized liver grafts.
Additionally, Dr. Mohammed Shaheen from the world-renowned Mayo Clinic in Rochester, MN will make an oral presentation entitled “Impact of Xeno-Compatibility on Outcomes of Bioengineered Humanized Liver Grafts” at the meeting on October 22nd (Parallel 20: Organ Preservation and Cell Transplantation, 4:45-6:15pm EDT). The presentation will focus on the xeno-compatibility of Miromatrix’ bioengineered liver grafts revascularized with HUVECs in a porcine model of auxiliary liver transplantation and successful in vivo reperfusion as measured by CT imaging. Highlights include the characterization of porcine sera and related cytotoxicity to HUVECs with mean cell death of 83.2±14.4%. There are high levels of anti-HUVEC IgM in naïve pig serum as deactivation of IgM by heat and dithiothreitol significantly reduced cell death to 22.2±11.8% and 6.15± 4.4%, respectively (p<0.01). The cytotoxicity profile of pig sera to HUVEC cells rose further after transplantation (95.7 ± 3.4%) at day 7, and remained high even after IgM deactivation (85 ± 8.9%, p< 0.01) suggesting the appearance of new anti-HUVEC IgG. The relative contribution of IgG and IgM to cytotoxicity in day 7 samples increased by ~35% and ~460% (p=0.047), respectively, compared to baseline and corresponded with the loss of perfusion to the implanted liver grafts. Blood group incompatibility between pigs and HUVECs had no measurable contribution to the level of cytotoxicity. It was concluded that pigs harbor naturally occurring anti-human antibodies targeted against HUVECs. In addition, an adaptive immune response ensues within 7 days after exposure to our HUVEC-derived bioengineered liver grafts. Immunosuppression studies to delay the buildup of antibodies to the human endothelial cells are ongoing with promising results, providing the appropriate preclinical model to evaluate a fully recellularized liver graft.
“The work being presented at The Liver Meeting® represents a significant achievement in our mission to bioengineer transplantable organs,” says Jeff Ross, Ph.D., CEO of Miromatrix. “We’re excited to demonstrate our ability to revascularize decellularized, whole grafts with human endothelial cells and to achieve long-term continuous perfusion within the host. This demonstration of functional vasculature sets the stage for our upcoming preclinical trial later this year and gets us one step closer to our goal of creating lifesaving organs.”
The Liver Meeting® is the premier Annual Meeting in the science and practice of hepatology, including the latest findings on new drugs, novel treatments, and the results from pilot and multicenter studies. For conference details, visit aasld.org/events-professional-development/liver-meeting.
Miromatrix Medical Inc. is a Minnesota-based biotechnology company on a mission to save and drastically improve countless lives by eliminating the organ transplant waiting list. Through their proprietary perfusion decellularization and recellularization technology, the company is creating fully implantable human organs including livers, kidneys and heart products, as well as liver-derived biological products such as MIROMESH® (soft tissue reinforcement) and MIRODERM® (advanced wound care). Miromatrix’ perfusion decellularization and recellularization technology is protected by a series of issued patents and pending patent applications in all major markets worldwide. Miromatrix’ collaborators include The Mayo Clinic, Texas Heart Institute and Mount Sinai Hospital.
Jeff Ross, Ph.D.
Miromatrix is excited to announce that a pilot study to evaluate the effectiveness of MIRODERM to close difficult to heal diabetic foot ulcers (DFU) that had previously failed other advanced biologic therapies was just published in WOUNDS. The data demonstrated a >40% closure rate in 12 weeks with the average treated wound having been open for >2 years. It is a great article and the basis of our current multicenter prospective clinical study to further demonstrated the ability of MIRODERM to treat these difficult to heal wounds and provide innovative solutions to physicians and patients.
WOUNDS is the most widely read, peer-reviewed journal focusing on wound care and wound research. Wound care leaders and professionals look towards WOUNDS to provide them with the most current in research and practice in this complex field of medicine.
Click to read the article.
The path to developing fully biological human organs has a number of major milestones. This includes demonstrating that our decellularized liver matrix can be re-endothelialized and then sustain in vivo perfusion in a large animal model.
We are proud to share the recently published article in the International Journal of Transplantation Research and Medicine. Our ability to sustain in vivo perfusion of our re-endothelialized livers paves the way for our next milestone of rescuing a large animal with a fully recellularized liver.
Miromatrix, has announced that on August 4th the first subject enrolled into their multi-center Hard-to-Heal Diabetic Foot Ulcer study was treated with MIRODERM Biologic Wound Matrix by Dr. Payam Rafat of A Step Ahead Foot Care in New York. Dr. M. Mason Macenski, Head of Clinical Affairs at Miromatrix, said, “I am pleased to initiate this trial and have the opportunity to further demonstrate the healing potential of this unique wound care matrix.”
A pilot series by Study Principal Investigator Dr. Robert Fridman of Foot Associates of New York, demonstrated that MIRODERM had substantially improved the healing of recalcitrant diabetic foot ulcers that previously failed other advanced wound therapies. In the pilot study MIRODERM closed 50% of the subjects’ hard-to-heal wounds within 12 weeks. This is notable in that the subjects’ wounds had been open for an average of more than 2 years and had received a median of 4 treatments with other advanced biologic products. This motivated Miromatrix to initiate a larger multi-center trial. “It is important to treat and rapidly close diabetic foot ulcers. persistent wounds are predictive of poor clinical outcomes, including infection and possible amputation,” says Dr. Fridman. “The pilot study results showed that MIRODERM was able to heal challenging, long-standing wounds that have failed other advanced therapies and biologics. I am excited to have the opportunity to further evaluate MIRODERM in a larger, multi-centered clinical trial.”
MIRODERM Biologic Wound Matrix is the first-and-only wound matrix derived from porcine liver. MIRODERM is manufactured using Miromatrix’s patented Perfusion Decellularization technology allowing the wound matrix to retain the intact extracellular matrix of the original biologic material including all vascular channels. MIRODERM is available in a variety of sizes both solid and fenestrated and is cleared for the management of wounds including but not limited to pressure ulcers, venous ulcers, chronic vascular ulcers and diabetic ulcers. MIRODERM received an innovative technology contract from Vizient and was awarded a federal supply schedule contract for government sales.
Miromatrix, is a biotechnology company engaged in the development of fully biological human organs to solve the chronic shortage of transplantable organs, utilizing its patented perfusion decellularization/recellularization technology, as well as organ-derived biological products such as MIROMESH® and MIRODERM® for soft tissue reinforcement and advanced wound care. Miromatrix’ perfusion decellularization/recellularization technology is protected by a series of issued patents and pending patent applications in all major markets around the world. In addition to MIROMESH and MIRODERM, internal development programs at Miromatrix focus primarily on creating fully implantable human organs including livers, kidneys and heart products, with collaborators including The Mayo Clinic, Texas Heart Institute and Mount Sinai Hospital, and aim at eliminating the organ transplant waiting list.
Jeff Ross, Ph.D. CEO