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Miromatrix Medical Inc. (Nasdaq: MIRO) has priced an underwritten public offering of 6,250,000 shares at $1.60 per share, aiming for gross proceeds of $10 million before expenses. The closing is expected on March 10, 2023, pending customary conditions. An additional option for underwriters to purchase 937,500 shares is included. This offering is part of a shelf registration filed with the SEC. Miromatrix focuses on developing bioengineered organs and seeks to address the shortage of transplantable organs, primarily targeting human livers and kidneys.
Miromatrix Medical Inc. (Nasdaq: MIRO) announced an underwritten public offering of its common stock, including a 30-day option for underwriters to buy an additional 15% of shares. The offering, subject to market conditions, aims to raise funds for research, development, and production of product candidates, as well as general operations. Miromatrix has no current plans for investments or acquisitions. Piper Sandler & Co. is the book-running manager. The offering is registered under Form S-3, effective since July 2022. Forward-looking statements indicate uncertainties regarding the offering's completion and potential regulatory challenges.
Miromatrix Medical and Baxter International have launched a collaboration to develop a new liver therapy called miroliverELAP, aiming to assist patients with acute liver failure (ALF). This innovative approach combines Miromatrix's bioengineered liver technology with Baxter's PrisMax system, enhancing organ support therapies. Miromatrix has submitted an IND application for miroliverELAP and plans to initiate a Phase I clinical trial following FDA approval. This therapy could provide crucial support for ALF patients, potentially improving their chances of recovery. Baxter supports Miromatrix through collaboration and investment.
Miromatrix Medical Inc. (NASDAQ: MIRO) has provided an update regarding its miroliverELAP™ Investigational New Drug (IND) application. Initially submitted in November 2022, the IND application was placed on clinical hold by the FDA, with a formal letter detailing required additional information received in January 2023. The CEO, Dr. Jeff Ross, stated that the clinical hold letter offers a clear path forward for the company, allowing them to respond to the FDA by the second half of 2023 and hope to begin human trials soon after. Miromatrix remains confident in its cash position to support operations through 2023 and its commitment to addressing organ failure.
Miromatrix Medical Inc. (NASDAQ: MIRO) announced that the FDA has placed its miroliverELAP Investigational New Drug (IND) application for treating acute liver failure on clinical hold. The application was submitted in mid-November, and the FDA will provide an official letter within 30 days. Miromatrix plans to update stakeholders following further communication with the FDA. This development marks a significant regulatory hurdle for Miromatrix as it seeks to advance its innovative bioengineered organ technology.
Miromatrix Medical Inc. (NASDAQ: MIRO) reported its Q3 2022 financial results, highlighting key advancements in their bioengineering projects.
The company submitted an IND application for miroliverELAP™, positioning it as the first bioengineered organ IND submitted to the FDA. They aim to start a Phase 1 clinical trial upon clearance.
Financially, Miromatrix ended Q3 with $31.5 million in cash, down from $38.6 million in Q2. Total operating loss increased to $7.8 million, reflecting rising R&D and administrative costs. Net loss was reported at $7.6 million, or $0.37 per share.
Miromatrix Medical Inc. (NASDAQ: MIRO) will announce its third quarter 2022 financial results after the market close on November 14, 2022. The company is dedicated to bioengineering transplantable organs to address organ shortages. A conference call will follow at 3:30 PM Central Time, where management will discuss the results. Interested parties can join by phone or via a live webcast on the Miromatrix investor relations website. The firm focuses on developing organs, primarily human livers and kidneys, using its proprietary perfusion technology.
Miromatrix Medical Inc. (NASDAQ: MIRO) announced CEO Jeff Ross will deliver a keynote address at BioFabUSA’s 2022 Fall Summit on October 26, 2022. This event, hosted by the Advanced Regenerative Manufacturing Institute (ARMI), aims to unite leaders in biofabrication to discuss advancements in cell, tissue, and organ therapies. Miromatrix focuses on bioengineering fully transplantable organs, primarily developing human livers and kidneys through its proprietary perfusion technology platform.
Miromatrix Medical (NASDAQ: MIRO) announces CEO Jeff Ross will present at the 2022 Cell & Gene Meeting on the Mesa from October 11-13. This event showcases advancements in cell therapy, gene therapy, gene editing, and regenerative medicine. Ross's presentation is scheduled for October 12 at 6:30 pm ET. Miromatrix focuses on bioengineering fully transplantable human organs, primarily targeting liver and kidney development, utilizing a proprietary perfusion technology platform to combat organ shortages.
Miromatrix Medical Inc. (NASDAQ: MIRO) announced that CEO Jeff Ross will present at the Innovations in Solid Organ and Hematopoietic Stem Cell Transplant Virtual Event on September 28-29, 2022. The event focuses on advancements in kidney transplants on the first day and innovations in hematopoietic stem cell transplants on the second. Ross's presentation is scheduled for September 28 at 10:00 am CT. Miromatrix specializes in bioengineering fully transplantable organs, particularly focusing on human livers and kidneys to address organ shortages.