Aspira Women's Health Inc. (AWH): History, Ownership, Mission, How It Works & Makes Money

Aspira Women's Health Inc. (AWH): History, Ownership, Mission, How It Works & Makes Money

US | Healthcare | Medical - Diagnostics & Research | NASDAQ

Aspira Women's Health Inc. (AWH) Bundle

Get Full Bundle:
$12 $7
$12 $7
$12 $7
$12 $7
$25 $15
$12 $7
$12 $7
$12 $7
$12 $7

TOTAL:

How does a specialty diagnostics company like Aspira Women's Health Inc. pivot its business model to deliver financial efficiency in a challenging market?

Through the first nine months of 2025, the company has demonstrated a sharp focus on operational discipline, slashing its operating cash burn by a substantial 54.5% to $5.0 million and boosting its gross margin to 64.1%, a significant jump from 58.4% in the prior year period. This strategic shift, emphasizing AI-enhanced bio-analytics for non-invasive gynecologic disease diagnostics like Ova1Plus and OvaWatch, has translated into a remarkable 156% increase in sales per full-time equivalent (FTE) in Q2 2025, even as nine-month revenue held at approximately $7.0 million. If you're looking at a company that's trading volume for value, you defintely need to understand how Aspira's history, core mission, and revenue streams are setting the stage for its next phase of growth, especially with the $2.0 million in non-dilutive ARPA-H funding expected by year-end 2025 to advance its ENDOInform™ endometriosis test.

Aspira Women's Health Inc. (AWH) History

The story of Aspira Women's Health Inc. is one of scientific persistence and strategic pivots, starting not with its current name, but with a foundational diagnostics company. You need to understand this origin, because the core technology for ovarian cancer risk assessment, Ova1Plus®, is the anchor that has allowed for the aggressive strategic reset seen in 2025.

Given Company's Founding Timeline

Year established

The company was established in 1997 as Vermillion, Inc., which later rebranded to Aspira Women's Health Inc. in 2020.

Original location

While incorporated in Delaware, the operational headquarters were later established in Austin, Texas, where the company continues to operate today.

Founding team members

Specific individual founders are not the focus of the public record; the company's trajectory is defined more by its evolution through various scientific and executive leadership teams focused on diagnostic innovation.

Initial capital/funding

The company secured initial capital through an early Initial Public Offering (IPO) on the Nasdaq stock exchange in 2005, trading under the symbol VRML. More recently, a critical capital infusion occurred on September 16, 2025, with a Post IPO funding round raising $2.95 million.

Given Company's Evolution Milestones

Year Key Event Significance
2005 Initial Public Offering (IPO) on Nasdaq as Vermillion, Inc. Secured significant funding to finance research and development efforts in diagnostics.
2009 FDA clearance for Ova1® First multivariate index assay (MIA) cleared for ovarian cancer risk assessment, validating the core technology platform.
2016 FDA clearance for Overa® Launched the second-generation MIA, offering improved specificity for ovarian cancer risk assessment.
2020 Rebranded to Aspira Women's Health Inc. Signaled a strategic shift to focus exclusively on women's health diagnostics and a broader product pipeline.
2025 Achieved third ARPA-H milestone for ENDOinform™ Qualified for a $1.5 million payment, providing crucial non-dilutive funding for the endometriosis diagnostic test development.

Given Company's Transformative Moments

The most transformative period for Aspira Women's Health Inc. has defintely been the strategic and financial overhaul implemented throughout the 2025 fiscal year. This wasn't a slow adjustment; it was a hard pivot under new leadership to achieve financial stability and focus on scale.

The new management team initiated a significant business model reset in the first quarter of 2025, shifting the commercial focus away from a broad sales force to deep relationships with large-scale health care systems and Integrated Delivery Networks (IDNs). This is a classic move to drive higher volume and better reimbursement rates.

  • Aggressive Cost Control: Total operating expenses for the first six months of 2025 were reduced to $8.1 million, a 31% decrease compared to the same period in 2024.
  • Improved Efficiency: The specialist field sales team was drastically cut from 19 to 7, yet the company realized a 156% increase in revenue generated per full-time equivalent salesperson in Q2 2025 versus Q2 2024.
  • Financial Stabilization: Cash used in operations (cash burn) for the first half of 2025 dropped to $4.8 million, representing a 41% reduction compared to the prior year period. This improvement is critical for a growth-stage medtech company.
  • Pipeline Validation: The company secured a total of $3.5 million from the Advanced Research Projects Agency for Health (ARPA-H) award by Q2 2025 for its ENDOinform™ project, with an additional $2.0 million expected by the end of 2025. This non-dilutive funding validates the potential of their endometriosis diagnostic pipeline.

Here's the quick math: The company generated approximately $7.0 million in revenue for the nine months ended September 30, 2025, which, combined with the sharp reduction in cash burn, shows a clear path toward operational efficiency. To be fair, this revenue was relatively flat year-over-year, but the underlying profitability improved significantly, with gross profit rising to $4.5 million (a 64.1% gross margin) for the nine-month period. This focus on margin over volume is the new playbook.

For a deeper dive into the capital structure and institutional interest, you should read Exploring Aspira Women's Health Inc. (AWH) Investor Profile: Who's Buying and Why?

Aspira Women's Health Inc. (AWH) Ownership Structure

Aspira Women's Health Inc. is a publicly traded company, though its ownership is highly concentrated among insiders and retail investors following its delisting from a major exchange in 2025.

The company's governance is currently steered by a new executive team and a Board of Directors that has seen significant changes throughout 2025, reflecting a pivot in commercial and financial strategy.

Given Company's Current Status

Aspira Women's Health transitioned from the Nasdaq Capital Market (NASDAQ: AWH) to the over-the-counter (OTC) market in April 2025, trading under the symbol OTCQX: AWHL due to non-compliance with Nasdaq's minimum stockholders' equity requirement.

This shift to the OTC market means the stock is less liquid and subject to different reporting standards, a critical factor for investors to consider. As of November 14, 2025, the company's market capitalization stood at approximately $16.05 million. The company is focused on commercial activities and R&D for its ENDOinform product, securing a $3.06 million equity capital infusion in September 2025 from existing and new investors, including board members.

If you want to understand the full financial picture, you should check out Breaking Down Aspira Women's Health Inc. (AWH) Financial Health: Key Insights for Investors.

Given Company's Ownership Breakdown

The ownership structure for Aspira Women's Health is heavily weighted toward individual shareholders, with a relatively small percentage held by institutional funds, which is typical for a micro-cap stock on the OTC market.

Shareholder Type Ownership, % Notes
Public/Retail Shareholders (Float) 80.73% Calculated as the remainder of shares not held by Insiders or Institutions. The total float is 36.40 million shares.
Insiders (Management & Directors) 18.05% This significant stake aligns management's interests with shareholder returns, but also means a few individuals have substantial influence.
Institutional Investors 1.22% Includes mutual funds and other institutions; this is a very low percentage, reflecting the company's micro-cap status and recent market challenges.

Given Company's Leadership

The executive team has seen significant turnover and new appointments throughout 2025, bringing in fresh expertise focused on commercial strategy and financial discipline. Management's average tenure is relatively short, suggesting a new team is executing a turnaround strategy.

  • Mike Buhle, Chief Executive Officer (CEO): Joined in January 2025, bringing over 25 years of leadership in clinical and life sciences. He is driving the commercial refocus on large health systems.
  • Brian Hungerford, Chief Financial Officer (CFO): Appointed in September 2025, he has over 20 years of executive finance experience across public and private companies, focusing on SEC reporting and process improvement.
  • Todd Pappas, Ph.D., Chief Science Officer: Brings 25 years of experience in research and product development, essential for advancing the company's diagnostic pipeline, like the ENDOinform test.
  • Jack Fraser, Chairman of the Board: Appointed to the board and as Chairman in April 2025, he provides critical financial and operational expertise to the board's oversight.

The board's recent appointments, including Dr. Jeffrey Cohen and Cindy Hundorfean in April 2025, were designed to add commercial healthcare and medical expertise, defintely a necessary move to accelerate growth.

Aspira Women's Health Inc. (AWH) Mission and Values

Aspira Women's Health Inc. stands on a core belief: that better, non-invasive diagnostics can radically improve gynecologic health outcomes for millions of women. Their mission is grounded in using artificial intelligence (AI) to deliver precise, actionable information to clinicians, moving beyond the status quo of traditional testing.

This commitment to patient health and technological disruption is defintely visible in their recent financial moves, like the strategic shift in 2025 to focus on profitable revenue growth over sheer volume, which helped cut operating cash burn by 54.5% to $5.0 million for the nine months ended September 30, 2025.

Aspira Women's Health Inc. Core Purpose

Official mission statement

The company's formal mission centers on a tangible, technology-driven goal: to discover, develop, and commercialize AI-powered, noninvasive tests that aid in the diagnosis of gynecologic diseases. This is about giving doctors and patients better tools, plain and simple.

  • Develop and commercialize noninvasive, AI-powered diagnostic tests.
  • Aid in the diagnosis of gynecologic diseases, starting with ovarian cancer.
  • Provide the only comprehensive portfolio of blood tests for ovarian cancer risk.

This focus is what drives their flagship OvaSuite™ products, Ova1Plus™ and OvaWatch℠, which are designed to assess ovarian cancer risk for the over 1.2 million American women diagnosed with an adnexal mass each year.

Vision statement

The vision extends beyond current products to a fundamental change in women's healthcare, positioning Aspira Women's Health as a catalyst for better, more personalized care. They aim to empower both patients and providers with data-driven solutions.

  • Radically improve health outcomes for all individuals with a female reproductive system.
  • Empower providers to deliver optimal care through data-driven solutions.
  • Expand the pipeline to address debilitating diseases like endometriosis with non-invasive diagnostics.

Their dedication to efficiency supports this vision; for instance, the sales team restructuring in 2025 led to an impressive 156% increase in revenue per full-time equivalent salesperson in the second quarter compared to the prior year. That's a clear action mapping to their goal of improving operational performance and long-term profitability.

Aspira Women's Health Inc. Core Values

These values define the cultural DNA and guide strategic decisions, especially as the company navigates a major commercial refocus on large healthcare systems and Integrated Delivery Networks (IDNs) in 2025. The core values are: Diligent, Caring, Proactive, Disruptive, and Inspiring.

  • Diligent: Operating with integrity and precision in all health solutions.
  • Caring: Acting with kindness to heal and provide hope in the community.
  • Proactive: Moving with intentional urgency to change life trajectories.
  • Disruptive: Striving to upend cancer through bold innovation.
  • Inspiring: Serving as a catalyst for a different outlook on health and life.

The financial results show the impact of being Diligent and Proactive: gross margins for the first nine months of 2025 jumped to 64.1%, up from 58.4% in the same period in 2024. Here's the quick math: that margin improvement, driven by favorable adjustments and stronger profitability from the OvaWatch® product line, shows their values translate to better business. Exploring Aspira Women's Health Inc. (AWH) Investor Profile: Who's Buying and Why?

Aspira Women's Health Inc. slogan/tagline

Aspira Women's Health Inc. uses a concise statement that captures their market position and technological advantage.

  • Transforming Gynecologic Care. Through AI-powered Diagnostics.

Aspira Women's Health Inc. (AWH) How It Works

Aspira Women's Health Inc. operates as an AI-enhanced bio-analytics company, providing noninvasive blood tests that help physicians quickly and accurately assess the risk of gynecologic diseases, primarily ovarian cancer, to guide patient management and treatment decisions.

Aspira Women's Health Inc.'s Product/Service Portfolio

The company's commercial value is delivered through its OvaSuite, a portfolio of tests that use proprietary algorithms and biomarkers to differentiate between malignant and benign ovarian masses, serving over 1.2 million American women diagnosed with an adnexal mass each year.

Product/Service Target Market Key Features
Ova1Plus® (Ova1® and Overa®) Women with an ovarian adnexal mass who are scheduled for surgery. FDA-cleared serum test; assesses the likelihood of ovarian malignancy pre-surgery; high sensitivity for all ovarian cancer types.
OvaWatch℠ Women with an indeterminate or benign adnexal mass who are being monitored. Laboratory-developed test (LDT); aids in initial clinical assessment of malignancy risk; helps avoid unnecessary follow-up imaging or specialist referral.
ENDOinform™ (Pipeline) Women with symptoms suggestive of endometriosis. Noninvasive, AI-powered diagnostic test currently in research and development; aims to provide a definitive diagnosis for endometriosis.

Aspira Women's Health Inc.'s Operational Framework

Aspira Women's Health's operational model has undergone a significant transformation in 2025, moving away from a volume-at-all-costs strategy to a focus on profitable revenue and efficiency. This shift is defintely working to reduce their cash burn.

  • AI-Driven Diagnostics: The core process involves collecting a patient's blood sample, analyzing multiple protein biomarkers, and feeding the data into proprietary algorithms (like the OvaCalc® algorithm) to generate a risk score for malignancy.
  • Strategic Commercial Focus: The sales strategy now heavily emphasizes securing contracts with leading large-scale health care systems and Integrated Delivery Networks (IDNs) in the U.S. This is a big change from the prior focus on individual physician offices.
  • Refined Clinical Integration: The company is working directly with IDNs to implement OvaSuite into patient care protocols, like refining the risk assessment for O-RADS 4 patients (a relatively high-risk group) to better identify low-risk women who do not need immediate referral to a gynecologic oncologist.
  • Cost and Productivity Overhaul: The company dramatically streamlined its operations in 2025, leading to a 34% reduction in operating expenses and a 54.5% reduction in operating cash burn for the nine months ended September 30, 2025. They achieved this while increasing sales per full-time equivalent salesperson by 167% in the third quarter of 2025.

You can learn more about the company's long-term goals here: Mission Statement, Vision, & Core Values of Aspira Women's Health Inc. (AWH).

Aspira Women's Health Inc.'s Strategic Advantages

The company's ability to compete rests on its proprietary technology and its disciplined new commercial execution, which is driving financial efficiency.

  • Proprietary AI-Enhanced Technology: Aspira Women's Health offers the only comprehensive portfolio of noninvasive blood tests cleared or developed to aid in the detection of ovarian cancer risk for women with an adnexal mass. This bio-analytical expertise creates a high barrier to entry.
  • Clinical Utility and Cost Savings: By providing a clear, objective risk assessment, the tests help health systems save resources and costs by reducing unnecessary procedures, imaging, and specialist referrals for low-risk patients.
  • Pricing Power: The strategic shift to large-scale health systems has allowed the company to realize pricing improvements, with the average unit price (AUP) growing by 9.3% for the first nine months of the 2025 fiscal year.
  • Strong Margin Profile: Operational discipline has pushed the gross margin up to 64.1% for the nine months ended September 30, 2025, compared to 58.4% in the prior year period. This improved efficiency is crucial for long-term sustainability.

Here's the quick math: The company generated approximately $7.0 million in revenue through the first nine months of 2025, but the significant margin expansion shows they are getting more profitable from each dollar of sales.

Aspira Women's Health Inc. (AWH) How It Makes Money

Aspira Women's Health Inc. generates revenue primarily by selling its proprietary, non-invasive diagnostic blood tests, the OvaSuite™ portfolio, to clinicians and health systems for ovarian cancer risk assessment. A secondary, but critical, near-term revenue source has been milestone payments from government research grants for its in-development endometriosis test, ENDOinform™.

Aspira Women's Health Inc.'s Revenue Breakdown

For the nine months ended September 30, 2025, the company's total revenue was approximately $8.5 million, a figure that combines commercial product sales and non-dilutive grant funding. The product revenue itself was flat year-over-year at $7.0 million.

Revenue Stream % of Total (9M 2025) Growth Trend
Ovarian Cancer Risk Assessment Diagnostics (OvaSuite™) 82.4% Stable (in dollar value)
Government Grant/Milestone Payments (ARPA-H) 17.6% Decreasing/Terminated

Business Economics

The core economic engine is the OvaSuite™ portfolio, which includes Ova1Plus™ and OvaWatch℠. The company's strategy in 2025 has been a sharp pivot: moving away from chasing volume at any price toward prioritizing higher-reimbursement accounts, specifically large-scale health systems and Integrated Delivery Networks (IDNs).

  • Pricing Power: The average unit price (AUP) for the commercial portfolio grew by a strong 9.3% for the nine months ended September 30, 2025, validating the shift to higher-value contracts.
  • Volume vs. Value Trade-off: This AUP gain, however, only offset a 6.4% decline in the number of tests sold over the same period, which is a clear sign of transitional volume shifts as the company resets its commercial model.
  • Cost Structure: The gross margin improved substantially to 64.1% for the nine months, up from 58.4% in the prior year, driven by better collection accruals and improved profitability from the OvaWatch® product line. That's a strong margin for a diagnostic test.
  • Sales Efficiency: The sales team was significantly restructured, but sales productivity per full-time equivalent salesperson (FTE) increased by a massive 167% in the third quarter of 2025, showing the new focus on large accounts is defintely paying off in efficiency.

The short-term risk here is that the non-dilutive ARPA-H grant funding, which contributed $1.5 million in 2025, was terminated in June 2025 after a failure to meet the third milestone's specifications, removing a vital source of R&D capital for the ENDOinform™ endometriosis test development.

Aspira Women's Health Inc.'s Financial Performance

From an operational standpoint, the first nine months of 2025 show a company aggressively cutting costs to extend its runway, despite flat top-line product revenue. The focus is on survival and efficiency, not yet explosive growth, which is a key distinction for investors to grasp. You can learn more about the shareholder base by Exploring Aspira Women's Health Inc. (AWH) Investor Profile: Who's Buying and Why?

  • Operating Expense Reduction: Total operating expenses were slashed by 34.0%, or $5.7 million, to $11.1 million for the nine months ended September 30, 2025, primarily through headcount reductions and other cost containment measures.
  • Cash Burn Improvement: This cost control translated to a remarkable 54.5% reduction in operating cash used, which fell to $5.0 million for the nine-month period.
  • Liquidity Concern: Despite the improved burn rate, the company's cash and cash equivalents stood at a precarious $3.8 million as of September 30, 2025, which is a critically low balance.
  • Shareholder Dilution: The need for capital has led to significant shareholder dilution, with common shares outstanding increasing by 145% over the nine-month period, a necessary but costly measure to fund operations and the reduced burn.

Aspira Women's Health Inc. (AWH) Market Position & Future Outlook

Aspira Women's Health Inc. is a niche player in the multi-billion-dollar ovarian cancer diagnostics market, currently focused on a strategic pivot toward profitability and high-value partnerships rather than pure volume growth.

The company's near-term outlook is defined by a successful, albeit transitional, business model reset in 2025, evidenced by a dramatic 54.5% reduction in operating cash burn to $5.0 million for the nine months ended September 30, 2025, and a gross margin improvement to 64.1% for the same period.

Competitive Landscape

Aspira Women's Health operates in the blood-based ovarian cancer risk assessment segment, a small but critical part of the larger diagnostics market dominated by major lab and pharma companies. Its primary competition comes from established diagnostic platforms and large-scale reference laboratories that offer older, but widely adopted, biomarker tests.

Company Market Share, % (Ovarian Diagnostics Niche) Key Advantage
Aspira Women's Health Inc. ~0.37% (of estimated $1.901B total market) AI-powered, multi-biomarker non-invasive tests (OvaSuite) for high negative predictive value.
Quest Diagnostics >10% (Estimated Diagnostics Market Share) Vast national lab network, high-volume testing capacity, and comprehensive menu including CA-125 and HE4.
Roche Holding AG >15% (Estimated Diagnostics Market Share) Global scale, proprietary platforms (Elecsys), and widely adopted ROMA (Risk of Ovarian Malignancy Algorithm) test.

Here's the quick math: Aspira's $7.0 million in product revenue for the first nine months of 2025 positions it as a micro-cap innovator against giants like Quest Diagnostics, which reported $9.61 billion in revenue in 2024, and Roche, whose Diagnostics Division sales were CHF 10.3 billion for the first nine months of 2025.

Opportunities & Challenges

The company's future trajectory hinges on its ability to convert recent efficiency gains into sustainable revenue growth and successfully commercialize its pipeline products within the massive U.S. women's health market.

Opportunities Risks
IDN/Health System Adoption: Focused strategy on large Integrated Delivery Networks (IDNs) and health systems to drive high-volume, profitable test adoption. Capital Constraints & Delisting: Small market capitalization of approximately $20.86 million (Nov 2025) and delisting from Nasdaq to OTCQX, limiting access to institutional capital.
Pipeline Commercialization: Advancing ENDOinform, a non-invasive test for endometriosis, which addresses a market need for a disease affecting over 6.5 million women in the U.S. Volume Decline: Test volume declined by 6.4% for the nine months ended September 30, 2025, a direct result of the strategic shift to profitable revenue over raw volume.
Government Funding & Validation: Receipt of a $1.5 million milestone payment from the ARPA-H Sprint for Women's Health Award, validating the company's AI-enhanced bio-analytics platform. Reimbursement & Payer Coverage: Continued risk in securing and maintaining favorable reimbursement rates and broad payer coverage for new diagnostic tests like OvaWatch.

Industry Position

Aspira Women's Health Inc. holds a position as a technology-focused disruptor in a segment where clinical utility is defintely paramount.

The company is strategically positioned at the intersection of women's health and Artificial Intelligence (AI) diagnostics, a rapidly growing area. Its core value proposition is OvaSuite's ability to refine ovarian cancer risk assessment for the 1.2 million American women diagnosed with an adnexal mass each year, particularly in identifying low-risk patients who may avoid unnecessary surgery.

  • Focus on AI-enhanced diagnostics: The company is leveraging machine learning to develop next-generation diagnostic tools, a key trend in the $1.901 billion ovarian cancer diagnostics market.
  • Sales Productivity Leap: The commercial reset has been effective, with sales per Full-Time Equivalent (FTE) increasing by a remarkable 167% in Q3 2025 year-over-year, indicating a much more efficient sales model focused on key accounts.
  • Strategic Partnerships: A new laboratory service contract with the University of Texas Medical Branch at Galveston, announced in October 2025, provides a scalable lab services agreement in one of the largest U.S. markets.

The shift to prioritizing Average Unit Price (AUP), which grew 9.3% through September 30, 2025, over volume, shows a clear path toward financial sustainability, even if it means a smaller market footprint initially. You can read more about the company's long-term vision here: Mission Statement, Vision, & Core Values of Aspira Women's Health Inc. (AWH).

DCF model

Aspira Women's Health Inc. (AWH) DCF Excel Template

    5-Year Financial Model

    40+ Charts & Metrics

    DCF & Multiple Valuation

    Free Email Support


Disclaimer

All information, articles, and product details provided on this website are for general informational and educational purposes only. We do not claim any ownership over, nor do we intend to infringe upon, any trademarks, copyrights, logos, brand names, or other intellectual property mentioned or depicted on this site. Such intellectual property remains the property of its respective owners, and any references here are made solely for identification or informational purposes, without implying any affiliation, endorsement, or partnership.

We make no representations or warranties, express or implied, regarding the accuracy, completeness, or suitability of any content or products presented. Nothing on this website should be construed as legal, tax, investment, financial, medical, or other professional advice. In addition, no part of this site—including articles or product references—constitutes a solicitation, recommendation, endorsement, advertisement, or offer to buy or sell any securities, franchises, or other financial instruments, particularly in jurisdictions where such activity would be unlawful.

All content is of a general nature and may not address the specific circumstances of any individual or entity. It is not a substitute for professional advice or services. Any actions you take based on the information provided here are strictly at your own risk. You accept full responsibility for any decisions or outcomes arising from your use of this website and agree to release us from any liability in connection with your use of, or reliance upon, the content or products found herein.