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Conavi Expands Leadership Team to Support Next Phase of U.S. Commercialization

  //business-finance.news-articles.net/content/202 .. support-next-phase-of-u-s-commercialization.html
  Published in Business and Finance on Monday, November 3rd 2025 at 7:39 GMT by Toronto Star

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A Strategic Talent Boost

In a move that signals Conavi’s intent to accelerate growth, the company has hired four new executives:

Conavi’s CEO, Dr. Anil Gupta, highlighted that the new appointments will "enable us to deepen our relationships with pathology labs, secure additional regulatory approvals, and bring our AI‑powered workflow to more clinicians and patients across the country." He also noted that the company’s focus remains on improving diagnostic accuracy, reducing turnaround times, and lowering costs in cytology testing.

Building on Existing Momentum

Conavi’s core product, the Conavi® 3000, is a handheld, AI‑enabled imaging system designed to capture and analyze cervical cytology specimens in real time. The system integrates with Conavi’s cloud‑based analytics platform, which applies machine learning models trained on millions of labeled images to detect precancerous lesions. Early trials have demonstrated sensitivity and specificity comparable to, or surpassing, manual cytopathology review.

The company recently received CE marking for the Conavi® 3000 in Europe and has begun a Phase 3 U.S. study under an Investigational Device Exemption (IDE). According to the press release, the study will enroll 3,000 patients across 30 pathology labs nationwide. “The results from this study will be critical to establishing the platform’s clinical utility in the U.S. market,” said Dr. Gupta.

A Vision for U.S. Commercialization

Conavi’s expansion strategy focuses on three key pillars:

1. Regulatory Advancement – With Dr. Patel’s appointment, Conavi intends to streamline the FDA clearance process. “We plan to pursue a 510(k) clearance for the Conavi® 3000, leveraging predicate devices in the same category,” Dr. Patel said. Conavi has already filed a pre‑submission with the FDA and anticipates a decision within the next 12 months.

2. Clinical Partnerships – The new CMO will lead the clinical validation and training efforts. Conavi is currently collaborating with the New York State Department of Health to pilot the system in over 50 laboratories. These partnerships aim to demonstrate the platform’s effectiveness in reducing missed diagnoses and to gather real‑world evidence for reimbursement discussions.

3. Commercial Scale – Marcus Lopez will build a U.S. sales force that includes a mix of direct‑to‑lab and distributor channels. Conavi plans to launch a digital marketing campaign targeting pathologists and lab managers, emphasizing the system’s ease of use and integration with existing laboratory information systems (LIS). Lopez mentioned that the company is exploring strategic alliances with major medical device distributors such as Stryker and Medtronic.

Funding and Financial Outlook

Conavi’s latest Series C funding round, closed in early March 2024, raised $42 million, bringing the total capital raised to $115 million. The new leadership will also help drive commercial revenue growth, which the company projects to reach $30 million in annual recurring revenue (ARR) by 2026, based on current pipeline traction and projected uptake in the U.S. market.

The press release also highlighted a partnership with Pathology Partners Inc., a leading laboratory services provider, which will supply Conavi’s system to a network of 120 laboratories in the southeastern United States. “This partnership gives us immediate access to a large customer base and will accelerate our go‑to‑market efforts,” said Lopez.

Industry Context and Competitive Landscape

The U.S. cytology market is valued at approximately $2.5 billion and is projected to grow at a CAGR of 4.2% over the next five years. AI‑assisted cytology solutions are gaining traction, driven by the need to address pathologist shortages, reduce human error, and improve patient outcomes. Conavi’s competitors include companies like PathAI and Lunit, which also offer AI‑based pathology solutions. Conavi’s differentiators—handheld imaging, real‑time analysis, and a lightweight data management platform—position it uniquely in this space.

Looking Ahead

Conavi’s leadership expansion underscores its ambition to transform cervical cancer screening and diagnostics in the United States. By aligning regulatory expertise, clinical validation, and commercial strategy, the company aims to secure FDA clearance, broaden its clinical footprint, and achieve meaningful market penetration. If successful, the Conavi® 3000 could become a standard tool in pathology laboratories, providing faster, more accurate diagnoses and ultimately improving patient care.

For more details on Conavi’s products and corporate updates, visit the company’s website at [ conavi.com ]. The full press release can be accessed via GlobeNewswire’s portal, ensuring transparency about the company’s milestones and future plans.