Miromatrix Awarded $1.9 Million NIH Grant to Advance the Development of a Bioengineered Liver

2012-logo.png

Miromatrix Inc., a Minnesota-based biotechnology company, was awarded a $1,970,000 Direct to Phase II Small Business Innovation Research (SBIR) grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) to advance the development of a bioengineered transplantable liver to address the chronic shortage of transplantable livers.

Currently, liver transplantation is the only treatment for End-stage Liver Disease (ESLD), the 8th most frequent cause of death in the United States with over 40,000 deaths annually. Demand for transplantable donor livers continues to exceed the available supply; as a result, only half of the 13,000 wait-listed patients will receive transplants. Miromatrix’s approach to solving the shortage is to bioengineer a transplantable liver utilizing their proprietary perfusion decellularization and recellularization technology.

"We’re thrilled to receive support from the NIDDK and NIH along with additional affirmation of the groundbreaking work we're doing to develop fully functional transplantable livers and provide more options for the thousands of patients with liver failure who face an uncertain future,” says Dr. Jeff Ross, Miromatrix CEO. “Our mission is to eliminate the liver transplant waiting list and save thousands of lives. The support of this grant brings us one step closer to our goal.”

About Miromatrix

Miromatrix Medical Inc. is a Minnesota-based biotechnology company on a mission to save and drastically improve patients’ lives by eliminating the organ transplant waiting list. Through their proprietary perfusion decellularization and recellularization technology, the company is developing fully implantable human organs including livers, kidneys, lungs and hearts. The company previously developed and commercialized the only liver-derived biological products including MIROMESH® (soft tissue reinforcement) and MIRODERM® (advanced wound care). Miromatrix’s perfusion decellularization and recellularization technology is protected by a series of issued patents and pending patent applications in all major markets worldwide. For more information, visit miromatrix.com.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. For more information about NIH and its programs, visit nih.gov.

Disclaimer: Research reported in this press release is supported by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health under the award number R44DK122894. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

KARE 11: Kidney transplant alternative research gives transplant patients on the waiting list new hope

Researchers at Eden Prairie-based Miromatrix are leading the race to develop the first transplant alternatives.

Right now a Minnesota company is working to develop a kidney transplant alternative. It’s a one-of-a-kind solution to end the transplant waiting list as we know it. Using a breakthrough process developed at the University of Minnesota, Eden Prairie-based Miromatrix Medical Incorporated is creating transplantable human organs out of pig organs.

Dr. Jeff Ross, Miromatrix CEO, said Minnesota researchers are leading the regenerative medicine race. “We’re creating human organs out of discarded pig organs. We take what nature designed, a fully functioning liver, kidney or heart and with our patented technology, which was developed at the University of Minnesota, we remove all of the cells from the organ. What’s left is a ‘scaffold.’ All of the organ’s natural design and architecture remain. Then from the inside out, we seed or implant new, human cells back into it, ultimately creating a completely functional, transplantable organ that could save a life,” explained Dr. Ross.
— KARE 11

Click here to watch a recent KARE 11 segment on Miromatrix.

REPRISE BIOMEDICAL RAISES $12.5 MILLION AND COMPLETES SPIN-OFF FROM MIROMATRIX MEDICAL

Reprise Biomedical.png

New Minnesota-based medical device company focuses on biological medical devices manufactured using perfusion decellularization technology

Minneapolis, Minn. (July 1, 2019) – Reprise Biomedical, Inc., a Minnesota-based startup focused on commercializing biological medical devices manufactured using a proprietary perfusion decellularization technology, has successfully completed a $12.5 million private placement and commenced operations as a spin-off from Miromatrix Medical Inc.

Through the spin-off, Miromatrix transferred to Reprise two existing FDA 510(k) cleared, commercially available medical devices – MIROMESH® and MIRODERM® -- as well as all acellular medical devices in development. After the spin-off, Miromatrix will continue its primary focus on the development of transplantable organs to address the chronic organ shortage.

MIROMESH is a biological mesh derived from perfusion decelluarized porcine liver, compressed and cut into a variety of sizes suited for hernia repair applications. MIRODERM is also derived from decellularized porcine liver and further processed for use in the management of wounds including diabetic foot ulcers, venous ulcers, pressure ulcers, and surgical and trauma wounds. Combined, these two medical devices generated net sales of $1.75 million in 2018 and address U.S. market opportunities that Reprise estimates exceeds $1 billion.

Reprise is led by Carrie Powers, who previously served as Senior Vice President of Marketing at Vascular Solutions, Inc., a Maple Grove-based medical device company that developed and launched over 100 new medical devices before it was sold to Teleflex in 2017 for $1 billion. The Board of Directors of Reprise includes Ron Eibensteiner, President of Wyncrest Capital; Erwin Kelen, venture capitalist and founder of Kelen Ventures; Jeff Ross, CEO of Miromatrix; and Howard Root, co-founder and former CEO of Vascular Solutions, as Chairman.

The $12.5 million private placement was sold to accredited investors without the use of a placement agent. Faegre Baker Daniels provided legal counsel for the spin-off.

About Reprise Biomedical

Reprise Biomedical’s mission is to deliver solutions to the unmet clinical needs of physicians in biological medical device markets through a highly-innovative, clinically focused company. To learn more about Reprise Biomedical and its medical devices, visit reprisebio.com.

About Miromatrix Medical

Miromatrix is on a mission to save and drastically improve patients’ lives by eliminating the organ transplant waiting list. Through its proprietary perfusion decellularization and recellularization technology, the company is developing fully implantable human organs including livers, kidneys, lungs and hearts. For more information, visit miromatrix.com.

New Study Utilizing MIROMESH® Biologic Matrix Reports Excellent Patient Outcomes with No Reinterventions

New Study Utilizing MIROMESH® Biologic Matrix Reports Excellent Patient Outcomes with No Reinterventions

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).

MIROMESH Hiatal Hernia Data Released at the American Hernia Society Meeting Today

MIROMESH Hiatal Hernia Data Released at the American Hernia Society Meeting Today

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 Invited to Highlight Advances in Kidney Disease Treatment at KidneyX

Miromatrix Invited to Highlight Advances in Kidney Disease Treatment at KidneyX

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 Receives State-Funded Grant for Kidney Program

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 Raises $15.7 Million in Series B-2 Funding, Welcomes Large Strategic Investor

Miromatrix Raises $15.7 Million in Series B-2 Funding, Welcomes Large Strategic Investor

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 Presents at BIO International Convention, June 6, Boston

BIO Logo 2018.png

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.

Announcement: Miromatrix at Cell & Gene Therapy Investor Day

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: Scientists Hope to Grow Bioengineered Livers for Transplants

hl-logo.v1.20171218143242.png

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.  

LeapsMag by Bayer: "Can Spare Parts from Pigs Solve Our Organ Shortage?"

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.  

Click here to read the article. 

organ2-1600x1067.jpg
"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 Presents Milestone on Engineering a Transplantable Kidney at Kidney Week 2017 in New Orleans

Kidney Week.png

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.