MILWAUKEE, WI, TAI Diagnostics, focused on developing innovative diagnostic tests for monitoring the health of transplanted organs, today announced the final closing of a $10 million Series A preferred equity financing.
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The company has now raised over $21 million since its inception. The proceeds of this financing will support on-going research and development of TAI's innovative cell-free DNA (cfDNA) transplant monitoring technology, clinical studies, and the upcoming commercial launch of its post-transplant monitoring assays performed by its CLIA and CAP accredited reference laboratory.
TAI Diagnostics was founded in 2015 to further develop and commercialize cfDNA technology licensed from the Medical College of Wisconsin for monitoring the health of transplanted organs. Dr. Michael Mitchell, a Pediatric Cardiothoracic Surgeon at the Herma Heart Institute of Children's Hospital of Wisconsin, and Dr. Aoy Tomita-Mitchell, a Professor and researcher at the Medical College of Wisconsin, are inventors of the technology and founders of TAI Diagnostics.
Transplant rejection is the major determinant of patient outcome and routine monitoring is necessary to detect rejection. The current gold standard for monitoring for the status of organ rejection is tissue biopsy. However, tissue biopsies are very invasive with risks for the patient, subject to sampling error, can be a lagging indicator of organ damage, and expensive for the patient and healthcare system. The TAI test is performed with a small blood sample and is a direct measurement of organ injury through identification and quantification of donor specific cfDNA which is released from injured cells in the patient's blood.
In addition, TAI Diagnostics announced that it has entered into a Collaboration Agreement with United Therapeutics Corporation. "We are very excited about working with United Therapeutics and utilizing our proprietary cfDNA technology as a companion diagnostic in their mission to increase the supply of transplantable organs and tissues and improve transplant patient outcomes through a variety of technologies under development, including xenotransplantation, organ manufacturing, regenerative medicine and ex-vivo lung preservation. United Therapeutics has demonstrated the ability to be a leader in therapeutics for pulmonary arterial hypertension and we believe they will also be transformational in organ transplantation," said Frank Langley, CEO of TAI Diagnostics. United Therapeutics was also an investor in TAI Diagnostics in this recent financing.
"We're delighted to be a development partner with TAI and also invest in the company. We are impressed with the sophistication and innovation of TAI's technology and the passion of its mission to improve transplant outcomes, which we share," said Paul Mahon, Executive Vice President of United Therapeutics. "As we continue development toward our goal of creating an unlimited supply of transplantable organs, the importance of transplant monitoring is an area of interest, and TAI's cfDNA technology nicely complements our efforts."
Statements included in this press release that are not historical in nature are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, among others, statements regarding the efforts by TAI Diagnostics to develop and commercialize its cfDNA technology, and efforts by United Therapeutics to develop organ transplantation-related technologies. These forward-looking statements are subject to certain risks and uncertainties, such as those described in United Therapeutics' periodic and other reports filed with the Securities and Exchange Commission that could cause actual results to differ materially from anticipated results. Such forward-looking statements are qualified by the cautionary statements, cautionary language and risk factors set forth in United Therapeutics' periodic reports and documents filed with the Securities and Exchange Commission, including United Therapeutics' most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. United Therapeutics and TAI Diagnostics claim the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. United Therapeutics and TAI Diagnostics are providing this information as of January 8, 2018, and assume no obligation to update or revise the information contained in this press release whether as a result of new information, future events or any other reason.