IRVINE, CA – OCTOBER 19, 2023 – VESICA HEALTH, INC., a multi-omics, liquid biopsy company transforming the management of hematuria patients and improving the early detection of bladder cancer, today announced the appointment of three accomplished industry veterans with proven executive leadership, strategic and commercial experience to its Board of Directors.
“It is with great pleasure that we announce the appointment of Dr. Jan Groen, Mark McDonough, and Joe Sollee to our Board of Directors. Their extensive experience in genomics and molecular pathology spans across research and development, operations, finance, human resources, reimbursement, and corporate governance,” commented Christopher Thibodeau, Chief Executive Officer of Vesica Health. “We are confident that the Board's collective strategic, operational, and commercial expertise will provide valuable insights and contributions to the organization, supporting management's efforts to maximize value for both patients and shareholders alike.”
“With a well-differentiated, scalable solution addressing a multi-billion-dollar market opportunity, I am thrilled to support Vesica's management team on its commercialization strategy,” stated Mark McDonough. “Based on my experience, Vesica has a singular opportunity to not only take market share but drive widespread clinical adoption of its AssureMDx test.”
“Vesica is uniquely positioned with an impressive portfolio of intellectual property issued both domestically and internationally,” commented Joe Sollee. “The AssureMDx test is equally well-suited to Vesica's laboratory services model, as well as IVD kits, thereby enabling the company to address its total available market directly and in combination with key strategic partners.”
“Vesica is poised to immediately reap the benefits of its extensive clinical validation studies and take market share with its AssureMDx test, which promises to significantly enhance the quality of life for patients with hematuria and bladder cancer,” stated Dr. Jan Groen. “Speaking on behalf of my fellow Board members, we are excited to be joining Vesica's Board at this important time for the company. We are eager to work alongside the management team to ensure that Vesica is well-positioned for successful commercialization.”
The Board of Directors will advise the company’s management team on strategic, operational, and commercial objectives. Provided below are brief summaries of the Board's credentials:
Dr. Jan Groen, Chair of the Board
Dr. Groen is the Chairman & CEO of Intravacc (The Netherlands) a contract development & manufacturing organization for the development of innovative human vaccines. His career spans many years in biotechnology, formerly as CEO at MDxHealth (MDXH), where he established the company as a market-leading molecular diagnostic uro-oncology company in the U.S. and EU. Earlier, as the President and COO of Agendia, responsible for the diagnostic operations in the U.S. and EU, he led the introduction of the first FDA-cleared breast cancer recurrence assay in the U.S. He served as VP of Research & Development at Focus Diagnostics, a subsidiary of Quest Diagnostics in California, and co-founded ViroClinics B.V. and DxOrange B.V. He has held numerous scientific leadership positions at the Erasmus Medical Center, RIVM (National Institute of Public Health, NL) and Akzo-Nobel. Previously, Dr, Groen served on the Board of IBL-International (DE) and MyCartis (BE), presently serves as Chairman of the Board at Cergentis (NL), and currently as Independent Director at Novigenix (CH), and Chairman of the Board member Angle Plc.(UK).
Mark McDonough, Independent Director
Mr. McDonough is the CEO and Board member of ChromaCode, Inc, a genomics multiplexing company that leverages their High-Definition PCR (HDPCR™) platform to enable comprehensive, fast, less expensive testing solutions. Previously, he served as CEO of PierianDx where he raised ~$48M to fund the company’s growth initiatives and successfully completed an exit to Summa Equity which resulted in the formation of Velsera. Mr. McDonough served as President, CEO, and Board member for Immunis.AI, a privately held pre-commercial liquid biopsy platform company, and at CombiMatrix, a publicly traded company and leader in high-complexity reproductive health testing. At CombiMatrix, he successfully led the company’s turnaround growth and ultimately orchestrated its sale in November 2017. Earlier, he served in various leadership roles at high-growth diagnostic companies including US LABS (acquired by LabCorp) and Ventana Medical Systems (acquired by Roche). Mr. McDonough is a proud former Naval Officer having served as a Navigator and Communications Officer on the USS FLETCHER (DD 992).
Joe Sollee, Independent Director
Mr. Sollee is the Executive Vice President of Corporate Development and General Counsel at MDxHealth and has more than 20 years of experience in the healthcare industry, including senior management roles in both private and publicly listed pharmaceuticals, health information technology, and molecular diagnostics companies. He has served as chief legal counsel to MDxHealth since its inception in 2003. Prior to MDxHealth, he led the Life Sciences Practice Group at the law firm of Kennedy Covington (now K&L Gates) and held senior legal and management positions at TherapyEdge and Triangle Pharmaceuticals. In addition, he has practiced as a corporate attorney in the Washington D.C. legal firm Swidler & Berlin and as an investment banker at Smith Barney in New York. Mr. Sollee received a Juris Doctorate in Law and a master’s degree in international law from Duke University, a BA degree from Harvard University, and has been awarded New York, Washington D.C. and North Carolina legal bar certifications.
Vesica Health’s patented, noninvasive, urine-based AssureMDx test helps physicians accurately triage hematuria patients, distinguishing those at increased risk for bladder cancer, who may benefit from immediate referral to urology and clinical evaluation, from those at very low risk for bladder cancer, who may safely avoid invasive procedures and secondary cancer risk from harmful CT scans. AssureMDx biomarkers and technology have been extensively reported in 20 peer-reviewed and published studies on over 5,878 patients, including three sequential, prospective clinical validation studies, delivering robust clinical performance with a 0.96 AUC (area under the receiver operating characteristic curve), 99% Negative Predictive Value (NPV), 96% Sensitivity and 83% Specificity for the detection of bladder cancer in hematuria patients. AssureMDx also provides urologists with a noninvasive method to monitor bladder cancer patients at increased risk of recurrence after initial treatment, thereby improving patient management and outcomes.
Vesica Health's mission is to transform the management of hematuria patients and improve the early detection of bladder cancer. Each year it is estimated that upwards of 17M (1-in-5) adults will present with hematuria, the primary symptom of bladder cancer, yet despite guideline recommendations only ~12% of patients are referred to urology for clinical evaluation. As a consequence, ~20% of bladder cancers are missed each year, leading to later-stage disease at diagnosis and higher mortality. Vesica has translated 20 years of advanced multi-omics research in bladder cancer into a well-validated, commercial-ready precision diagnostic test to improve the evaluation of hematuria, early detection of disease, and recurrence monitoring. For more information, please visit www.vesicahealth.com.
For more information:
Vesica Health Corporate Communications
publicrelations@vesicahealth.com
This company announcement contains forward-looking statements and estimates with respect to the anticipated future performance of Vesica Health and the market in which it operates. Such statements and estimates are based on assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable but may not prove to be correct. Actual events are difficult to predict, may depend upon factors that are beyond the company’s control, and may turn out to be materially different. Vesica Health expressly disclaims any obligation to update any such forward-looking statements in this announcement to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based unless required by law or regulation. This company announcement does not constitute an offer or invitation for the sale or purchase of securities or assets of Vesica Health in any jurisdiction. No securities of Vesica Health may be offered or sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. securities laws.
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