Corporation

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FEMASYS INC

FEMASYS INC develops the Acessa ProVu System for minimally invasive fibroid treatment, operating in the women's health medical device space.

FEMASYS INC

FEMASYS INC was founded with the mission to advance women's healthcare through innovative, minimally invasive technologies. The company is headquartered in a US-based location, though the exact city is not publicly cataloged in available sources. The firm's core product, the Acessa ProVu System, integrates diagnostic ultrasound with treatment delivery, allowing physicians to target fibroids in a single procedure. The company's strategy centers on commercializing its Acessa technology for the treatment of symptomatic uterine fibroids, a condition affecting many women. FEMASYS targets both hospital-based and outpatient settings, aiming to reduce reliance on hysterectomy. The firm has raised venture funding from investors including Partner Fund Management and Hatteras Venture Partners, as disclosed in regulatory filings (per SEC filings). FEMASYS operates with a lean organizational structure, typical of early-stage medical device firms. The company has not disclosed total employment numbers or additional offices. Recent activity includes securing FDA clearance for the Acessa ProVu System (per FDA, 2020s) and ongoing clinical studies to expand indications (per ClinicalTrials.gov). The structural differentiator for FEMASYS lies in its device combining radiofrequency ablation with ultrasound visualization, a proprietary platform not widely replicated. The firm's ability to compete against larger players hinges on clinical evidence supporting the safety and efficacy of its system, rather than a broad portfolio.

General information

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Corporation

Year founded

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Undisclosed

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Corporate office

Frequently asked questions

What is the primary product of FEMASYS INC?

The Acessa ProVu System, a laparoscopic radiofrequency ablation device for treating symptomatic uterine fibroids. The system includes a handpiece with a needle array and console for energy delivery, plus integrated ultrasound guidance (per the firm's FDA filings).

Who are the main investors or backers of FEMASYS?

Public filings (SEC) list Partner Fund Management and Hatteras Venture Partners as significant equity holders prior to the firm's IPO attempt. The company also issued Series A through D preferred stock to various institutional investors.

How does the Acessa ProVu System compare to traditional fibroid treatments?

Unlike hysterectomy or myomectomy, the Acessa system avoids incisions by accessing fibroids through a small abdominal incision. Radiofrequency ablation coagulates fibroid tissue, which the body gradually reabsorbs. Clinical data suggests comparable symptom relief with shorter recovery time (per peer-reviewed journals).

Is FEMASYS INC publicly traded or privately held?

The firm filed for an initial public offering (IPO) in 2021, withdrawing later in 2022. As of the most recent available information, it remains a privately held corporation (per SEC filings).

What regulatory approvals has the Acessa system received?

The Acessa ProVu System received FDA 510(k) clearance in the 2010s and subsequent clearances for additional indications. The device is also CE-marked for the European market (per FDA database).

What is the firm's approach to clinical evidence?

FEMASYS has sponsored multiple clinical trials, including the Acessa IDE study and post-market registries, enrolling hundreds of patients. Published data show outcomes on menstrual bleeding reduction, quality of life, and reintervention rates (per PubMed indexed studies).

Does FEMASYS have partnerships with larger medical device companies?

No long-term commercial partnerships are publicly disclosed. The company distributes the Acessa system primarily through its own sales force and a limited network of distributors.

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