Aspira Women's Health Inc. ("Aspira" or the "Company") (Nasdaq:AWH), a bio-analytical based women's health company focused on the development of gynecologic disease diagnostic tools, today announced the appointment of Mike Buhle as SVP of Commercial Operations.
Mr. Buhle has over 25 years of experience driving commercial growth and new product launches in the diagnostics and life science tools domains, working for start-up, scale-up, and established businesses. He brings hands-on leadership experience in clinical diagnostics specializing in precision medicine and patient outcomes in oncology, rare diseases, infectious diseases, and drug development and preventative interventions. Prior to joining Aspira, Mr. Buhle served as Chief Commercial Officer at Biovision Diagnostics and Vice President of Sales, Americas for Congenica.
"I am excited and honored to join Aspira Women's Health and look forward to leading such a dedicated and passionate commercial team," said Mike Buhle, Aspira's SVP of Commercial Operations. "Together, we will continue to build on the momentum established, driving growth, and creating new opportunities. I believe that Aspira is poised for an outstanding year, not only in expanding market share for our current portfolio but also in achieving the key milestones required for the successful launch of our upcoming product pipeline."
"We are pleased to welcome Mike to the Aspira management team," said Dr. Sandra Milligan, Interim Chief Executive Officer of Aspira Women's Health. "Mike's commercial experience and deep understanding of the micro-cap, life sciences industry will be immediately beneficial to Aspira, and we look forward to his commercial expertise and guidance to help take us through our next phase of growth."
Separately, Interim Chief Financial Officer John Kallassy will be leaving the Company on January 10, 2025, to pursue other business opportunities. In his place, the Company has retained Mr. James O'Brien as CFO advisor. Mr. O'Brien brings over 30 years of experience in the biotechnology, pharmaceutical, and medical device industries. Over the short term, he will assist the Company in strategic initiatives, business development, and financial matters.
Mr. O'Brien is the founder of Great Island Advisors LLC, a firm dedicated to leading and growing public and privately held businesses. Previously, he served as Chief Financial Officer of Faron Pharmaceuticals Ltd. (FARON), a clinical stage biotechnology company focused on oncology and immunotherapies. Mr. O'Brien also served as the inaugural Chief Financial Officer of Cognition Therapeutics, Inc. (CGTX), a clinical stage biopharmaceutical company which successfully completed an initial public offering in October 2021, raising $52 million. Earlier in his career, he held positions at pharmaceutical companies including Actavis PLC (now AbbVie, Inc. (ABBV)), the US subsidiary of Swiss company Nycomed Pharma S.A., which has since been acquired by Takeda Pharmaceutical Company Limited, and The Bristol Myers Squibb Company. He spent close to a decade at PricewaterhouseCoopers and is a certified public accountant (CPA) with a Bachelor of Accountancy degree from George Washington University and a Master of Business Administration degree from Fordham University.
Mike Buhle and Jim O'Brien will be joining interim CEO, Dr. Sandra Milligan for meetings during the JP Morgan Healthcare Conference week beginning on January 13th in San Francisco, CA.
About Aspira Women's Health Inc.
Aspira Women's Health Inc. is dedicated to the discovery, development, and commercialization of noninvasive, AI-enabled tests to aid in the diagnosis of gynecologic diseases.
OvaWatch® and Ova1Plus® are offered to clinicians as OvaSuiteSM. Together, they provide the only comprehensive portfolio of blood tests to aid in the detection of ovarian cancer risk for the more than 1.2 million American women diagnosed with an adnexal mass each year. OvaWatch provides a negative predictive value of 99% and is used to assess ovarian cancer risk for women where initial clinical assessment indicates the mass is indeterminate or benign, and thus surgery may be premature or unnecessary. Ova1Plus is a reflex process of two FDA-cleared tests, Ova1® and Overa®, to assess the risk of ovarian malignancy in women with an adnexal mass planned for surgery.
Our in-development test pipeline will expand our ovarian cancer portfolio and address the need for non-invasive diagnostics for endometriosis, a debilitating disease that impacts millions of women worldwide. In ovarian cancer, we intend to combine microRNA and protein biomarkers with patient data to further enhance the sensitivity and specificity of our current tests and expand the indicated population to screen women with a family history of ovarian cancer or a germline mutation. Through our ongoing endometriosis development program, we are combining microRNA and protein biomarkers with patient data, with the intent of identifying endometriosis independent of disease location or severity.
Forward-Looking Statements
This press release contains forward-looking statements, as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements involve a number of risks and uncertainties. Such forward-looking statements include statements regarding, among other things, the timing and completion of any products in the development pipeline and other statements that are predictive in nature, and whether the marketing of the OvaSuite portfolio will prove successful. Actual results could differ materially from those discussed due to known and unknown risks, uncertainties, and other factors. These forward-looking statements generally can be identified by the use of words such as "designed to," "expect," "plan," "anticipate," "could," "may," "intend," "will," "continue," "future," and other words of similar meaning and the use of future dates. These and additional risks and uncertainties are described more fully in the Company's filings with the Securities and Exchange Commission (SEC), including those factors identified as "Risk Factors" in our most recent Annual Report on Form 10-K, for the fiscal year ended December 31, 2023, and subsequent Quarterly Reports on Form 10-Q. If any of these risks materialize or our assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that Aspira presently does not know, or that Aspira currently believes are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect Aspira's expectations, plans, or forecasts of future events and views as of the date of this press release. Subsequent events and developments may cause the Company's assessments to change. However, while Aspira may elect to update these forward-looking statements at some point in the future, Aspira expressly disclaims any obligation to do so, except as required by law. These forward-looking statements should not be relied upon as representing Aspira's assessments of any date after the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements.
