Miromatrix Presents Progress on Engineering a Transplantable Liver at The Liver Meeting® in Washington, D.C.

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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. They achieved 7 to 10 days of vascular patency in humanized revascularized liver grafts transplanted in pigs - without hepranization provide 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 EST).   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 cytotoxcity 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. 

About Miromatrix
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. 

Contact:
Jeff Ross, Ph.D.
(952) 942-6000
jross@miromatrix.com

 

Study Evaluating MIRODERM Performance on Hard to Heal DFUs Published in WOUNDS®

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. 

Click to read full article. 

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Published Milestone: Sustained In Vivo Perfusion of a Re-Endothelialized Tissue Engineered Porcine Liver

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.

Click to read full article. 

Click to read full article. 

FIRST MIRODERM® TREATMENT IN THE MIROMATRIX HARD-TO-HEAL DIABETIC FOOT ULCER STUDY

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.


About Miromatrix

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
(952) 942-6000
jross@miromatrix.com

 

Doris Taylor Rejoins Miromatrix As Scientific Advisor

Miromatrix is excited to announce the appointment of Doris A. Taylor, Ph.D., FACC, FAHA as a key scientific advisor. Dr. Taylor's groundbreaking research on perfusion decellularization and recellularization, which was published in Nature Medicine in 2008, is the basis of Miromatrix' patented technology.

"I am extremely pleased to rejoin Miromatrix in a consulting role,” says Dr. Taylor. “I founded Miromatrix in 2008 to apply the technology I helped pioneer. Since leaving the company, I followed its progress and watched it develop a new industry standard for hernia and advanced wound care. I believe the company’s new leadership combined with my intimate knowledge of this leading-edge technology will help Miromatrix realize its goal of bringing whole organs to patients worldwide. It's an exciting time for the company and for me.”

“We are extremely delighted to have Dr. Taylor rejoin Miromatrix and be a part of our talented team as we continue on our mission to end the organ transplant waiting list,” says Jeff Ross, Ph.D., CEO of Miromatrix. “Dr. Taylor brings a wealth of scientific and regulatory knowledge that will continue to help us accelerate our goals to create lifesaving organs,” Dr. Ross adds.

Dr. Taylor is the Director, Regenerative Medicine Research and Director of the Center for Cell and Organ Biotechnology at the Texas Heart Institute in Houston. She holds faculty appointments at both Texas A&M and Rice University and is a Fellow of the American College of Cardiology; American Heart Association Basic

Science Council and Council on Functional Genomics and Translational Biology, among others.  She has published extensively, authoring or co-authoring more than 130 scientific publications. She has been recognized for breakthrough research related to cell therapy, stem cell biology, and tissue engineering based therapies.  In addition to her research director responsibilities at THI, she co-directs the Cardiovascular Cell Therapy Research Network (CCTRN) Biorepository and leads a cell and cytokine profiling core lab that serves multiple NIH, National Heart Lung and Blood Institute (NHLBI) networks, medical centers, and research foundations in the U.S. and Canada.

About Miromatrix
Miromatrix Medical Inc., is a Minnesota-based 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, respectively.  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.  For more information visit www.miromatrix.com

Contact:
Jeff Ross, Ph.D.
(952) 942-6000
jross@miromatrix.com

August 7, 2017

Star Tribune: Miromatrix has high hopes for its bioengineered liver

The Star Tribune has published a piece about about Miromatrix.  The article highlights our progress towards creating the world's first bioengineered human liver.  

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"It may sound like science fiction, but the first attempt at this will take place before the year is out: A pig at the Mayo Clinic will have its liver removed, and a new liver “recellularized” with human and pig cells implanted in its place, to test whether a Miromatrix bioengineered liver can keep the pig alive for at least two days. Results of the experiment should be in by this time next year, and that may clear the way for the first human implant around 2020."

Click to read the whole article.

The Atlantic Includes Miromatrix in an Article

The Atlantic has featured Miromatrix in an article about how large pork businesses are creating new company units that will work with medical organizations interested in using pig tissues for medical devices and whole organ therapies.

The article highlights Miromatrix’ technology, our wound matrix and the development of transplantable organs based on our patented technology.  As the promise of fully biologic organs grows nearer we are excited to see porcine industry leaders, such as Smithfield Foods and Johnsonville, create entire biologic divisions to address the growing need for high-quality organ procurement for the medical market.  

Keeping the structure of the protein scaffold is important, which is why the company has special partnerships with local farms and slaughterhouses. “We make sure it doesn’t have any nicks and cuts it (sic), which takes a little bit of training,” says CEO Jeff Ross. He says the company is aiming to achieve the first human implant sometime in 2020 or 2021.

Click to read the article.

 

MIRODERM® Awarded Federal Supply Schedule Contract for Government Sales

Miromatrix Medical Inc., 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 for soft tissue reinforcement and advanced wound care, announced today that they have been awarded a Federal Supply Schedule (FSS) contract to sell their product, MIRODERM® in all government facilities (e.g. VA Hospitals, DOD, etc.).  The MIRODERM family of products are acellular wound matrices derived from porcine liver and are intended for the management of wounds including: partial and full thickness wounds; venous and diabetic ulcers; surgical and trauma wounds, among others.  The earning of this contract adds MIRODERM to the existing contract that Miromatrix was awarded on December 1, 2016 for MIROMESH® (Contract Number V797D-70029). 

“With an FSS contract in place, we are excited to bring MIRODERM, our next-generation biologic wound matrix into the VA network of hospitals,” explained Jeff Ross, Ph.D., Chief Executive Officer of Miromatrix Medical.  “We are proud to be able to help the many veterans who serve our country.”

About Miromatrix:
Miromatrix Medical Inc. 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.

 

Paul Buckman, John Erb, and Mark Wagner join Miromatrix' Board of Directors

We are delighted to announce that Paul Buckman, John Erb, and Mark Wagner have joined the Miromatrix Board of Directors! 

Collectively they bring over a 100 years of leadership experience in successfully developing and commercializing medical devices and medical technologies.  The willingness of these professionals to serve on the Board demonstrates their excitement about the remarkable potential of Miromatrix devices and technology to save lives and transform medicine.  It also highlights the Company’s compelling combination of a robust patent portfolio matched with exceptionally talented and dedicated people.  We are very excited about Mr. Buckman, Mr. Erb and Mr. Wagner joining the Board. 

Click the link to read the full press release.

Miromatrix Medical Receives Innovative Technology Contract from Vizient, Inc. for MIROMESH® and MIRODERM® Products

Miromatrix Medical is honored to announce that it has been awarded a Vizient Innovative Technology contract.  Vizient is "the largest member-owned health care company in the country and is dedicated to leading health care innovation, creating knowledge and fostering collaboration to help our members thrive." 

Click to read the full press release and watch the video below.

"Digital Trends" Published an Article About Miromatrix

Digital Trends, a publication focused on understanding how new technology effects our lives, published an article about Miromatrix.

"Our goal is nothing short of eliminating the organ transplant waiting list and saving the lives of the thousands of people who die each year waiting for an organ replacement."  

Click to read the article published by Digital Trends.

"Futurism" Published a Video about Miromatrix' Tech

Futurism is a publication that covers the breakthrough technologies and scientific discoveries that will shape humanity’s future.

Futurism posted a short video about Miromatrix’ patented organ technology and how they hope to save lives with it.  

View the video here or click here.   

Vice's "Motherboard" Covers Miromatrix

Motherboard is a publication that seeks to uncover the tech and science stories that define what's coming next.

"Reprogramming Organs Could Be the Future of Transplants"

Motherboard wrote a small article about Miromatrix' goal of eliminating the organ transplant waiting list.

Click on the link to read the article.  

CMS Grants MIRODERM® Biologic Wound Matrix with HCPCS Code Q-4175

The U.S. Centers for Medicare and Medicaid Services (CMS) has granted a HCPCS code (healthcare common procedure coding system) for MIRODERM® Biologic Wound Matrix, a non-crosslinked acellular wound matrices derived from porcine liver and indicated for the management of wounds including: partial and full thickness wounds; venous and diabetic ulcers; surgical and trauma wounds among others.  A HCPCS code is a required for reimbursement in the CMS and other health insurance program systems.

Miromatrix Medical Inc 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 for soft tissue reinforcement and advanced wound care.

NSF Highlights Miromatrix at the 2016 BIO International Convention

The National Science Foundation caught up with us at the 2016 BIO International Convention and highlighted our tech.
 
"Dominique Seetapun, Ph.D., Miromatrix’ senior project development scientist, says the new technique improves upon existing technologies, which largely immerse organs in detergents that also degrade organ scaffolds, and complicate the growth of new cells into functional tissues and organs. Instead of submerging organs entirely in detergent, Miromatrix instead pumps the decellularization solution through the blood vessels, removing cells in less time and avoiding degradation of the scaffold, she says. The organs then can be recellularized and transplanted using current organ transplantation techniques."

Click on the link to read the article or watch the video.  

Miromatrix Awarded Federal Supply Schedule Contract for Government Sales

Miromatrix Medical Inc., 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 for soft tissue reinforcement and advanced wound care, announced today that they have been awarded a Federal Supply Schedule (FSS) contract to sell their product, MIROMESH® in all government facilities (e.g. VA Hospitals, DOD, etc.).  The earning of this contract further accentuates the innovative nature of MIROMESH, as it is the only highly vascularized porcine liver-derived biologic soft tissue reinforcement mesh in the world.  Pending review, MIRODERM®, Miromatrix’ porcine liver-derived biologic wound matrix is expected to be added to the contract in Q2 ’17.