About Miromatrix
Miromatrix Medical Inc. is a life sciences company pioneering a novel technology for bioengineering fully transplantable human organs to help save and improve patients' lives. The Company has developed a proprietary perfusion technology platform for bioengineering organs that it believes will efficiently scale to address the shortage of available human organs. The Company's initial development focus is on human livers and kidneys. For more information, visit miromatrix.com.
About Baxter
Every day, millions of patients, caregivers and healthcare providers rely on Baxter’s leading portfolio of diagnostic, critical care, kidney care, nutrition, hospital and surgical products used across patient homes, hospitals, physician offices and other sites of care. For more than 90 years, we’ve been operating at the critical intersection where innovations that save and sustain lives meet the healthcare providers who make it happen. With products, digital health solutions and therapies available in more than 100 countries, Baxter’s employees worldwide are now building upon the company’s rich heritage of medical breakthroughs to advance the next generation of transformative healthcare innovations. To learn more, visit www.baxter.com and follow us on Twitter, LinkedIn and Facebook.
Intended Use for PrisMax in the U.S.
The PrisMax control unit is intended for:
Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kg or more with acute renal failure and/or fluid overload.
Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kg or more with diseases where removal of plasma components is indicated.
All treatments administered via the PrisMax control unit must be prescribed by a physician.
Rx Only. For safe and proper use of the PrisMax device, refer to the full Instructions for Use.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts are forward looking statements of Miromatrix Medical Inc., including statements regarding the potential initiation of miroliverELAP clinical trials. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "outlook," "guidance," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. The forward-looking statements in this press release are only predictions and are based largely on Miromatrix’s current business plans, expectations, and projections about future events and financial trends that Miromatrix believes may affect its business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of known and unknown risks, uncertainties and assumptions, including, but not limited to, Miromatrix’s history of significant losses, which it expects to continue; Miromatrix’s limited history operating as a commercial company; Miromatrix’s expectations with respect to the regulatory pathway of its product candidates, Miromatrix’s ability to obtain regulatory approvals for such product candidates, and the anticipated effect of delays in obtaining any such regulatory approvals; Miromatrix’s expectations with respect to preclinical and clinical trial plans for our product candidates, the results of such activities and the safety and efficacy of Miromatrix’s product candidates; Miromatrix’s ability to commercialize its product candidates; Miromatrix’s ability to compete successfully with larger competitors in its highly competitive industry; Miromatrix’s ability to achieve and maintain adequate levels of
