| Catalyst | Drug/Treatment | Stage | Probability of Approval | Description | Drug Type | Therapeutic Area | Source |
|---|---|---|---|---|---|---|---|
PDUFA 2026 | Phase 3 | -% | FDA review of the new drug application for the treatment of example condition. Read More | Small Molecule | Oncology | ||
PDUFA 2026 | Phase 3 | -% | FDA review of the new drug application for the treatment of example condition. Read More | Small Molecule | Oncology | ||
PDUFA 2026 | Phase 3 | -% | FDA review of the new drug application for the treatment of example condition. Read More | Small Molecule | Oncology |
Recent Updates
Recently added Catalysts
Femasys Inc. Common Stock$2.86
-0.05 (-1.72%)
F 2Pipeline Score MedTech · Clinical
Market Cap
23.98 M
EPS
-0.56
P/E Ratio
-0.71 $
Value Trade
259.33 K
SEC Financials
Q1 2026Dilution Risk
Revenue
424.89 K
R&D Expenses
1.31 M
Operating CF
-4.14 M
Total Assets
16.50 M
Total Liabilities
9.21 M
Equity
7.29 M
D/E Ratio
12,345
%
Week
%
1 Month
%
3 Month
%
6 Month
%
5 Year
%
All Time
Cash Data
Cash Position
5.39 M
Monthly Burn
1.38 M
Runway
1.2 mo
Burn Trend
StableSEC Filing
May 8, 2026
Overview
Volume
10.82 K
52 Week Range
0.31 - 1.29
% held by Insiders
8.96 %
% held by Institutions
15.26 %
Enterprise Value
19.41 M
Total Shares
58.50 M
Short %
0.55 %
Float Shares
35.10 M
Company Description
locked
Upcoming Catalyst
Past FDA Catalysts & PDUFA Decisions
| Date | Drug | Catalyst | Stage | Outcome | Reaction | Event Move % | Best Trade % |
|---|---|---|---|---|---|---|---|
— | Example Drug | Phase 3 data readout | Phase 3 | — | – | 0% | 0% |
— | Example Drug | Phase 3 data readout | Phase 3 | — | – | 0% | 0% |
— | Example Drug | Phase 3 data readout | Phase 3 | — | – | 0% | 0% |
Drug Pipeline Intelligence
F2
Pipeline Score -
Pipeline ValueValuation Signal
0
Drugs Scored—
rNPV / MCap Top 4%
Micro Cap (rank 888 of 924)
Percentile RankFemasys Inc. Common Stock has significant pipeline risk (2/100), but cash runway is a concern.
Clinical Trial Results
| Drug Name | Indications | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
FemaSeed | infertility | — | 2024-03-20 | 24% of women became pregnant after FemaSeed; 6.7% pregnancy rate noted for traditional IUI methods Read More | Femasys Announces Positive Topline Data from Pivotal Trial for its FDA-Cleared FemaSeed for the Treatment of Infertility -- In the severe male factor cohort, findings show 24% of women became pregnant after FemaSeed -- - Read More | |
FemaSeed | infertility | — | 2024-03-20 | 24% of women became pregnant after FemaSeed; 6.7% pregnancy rate noted for traditional IUI methods Read More | Femasys Announces Positive Topline Data from Pivotal Trial for its FDA-Cleared FemaSeed for the Treatment of Infertility -- In the severe male factor cohort, findings show 24% of women became pregnant after FemaSeed -- - Read More | |
FemaSeed | infertility | — | 2024-03-20 | 24% of women became pregnant after FemaSeed; 6.7% pregnancy rate noted for traditional IUI methods Read More | Femasys Announces Positive Topline Data from Pivotal Trial for its FDA-Cleared FemaSeed for the Treatment of Infertility -- In the severe male factor cohort, findings show 24% of women became pregnant after FemaSeed -- - Read More |
Inside Trades
YEARLY INSIDER TRANSACTIONS
Sector Avg.
INSIDERS
SOLDINSIDERS
BOUGHT
SOLDINSIDERS
BOUGHT
POSITIVE SENTIMENT Based on 22 Insiders Transactions
Hedge Funds
Shares Held
HEDGE FUNDS
SOLDHEDGE FUNDS
BOUGHT
SOLDHEDGE FUNDS
BOUGHT
POSITIVE SENTIMENT Based on 27 hedge funds in the last quarter
18 buying (3 new)·9 selling (1 exited)·2 unchanged
Hedge Funds invested in FEMY
| HedgeFund Name ( 3 ) | % of Portfolio | Current MV - | Shares Owned - | Activity Avg Price $0 |
|---|---|---|---|---|
Example Capital Management | 2.5 % | 15.00 M | 250.00 K | |
Example Capital Management | 2.5 % | 15.00 M | 250.00 K | |
Example Capital Management | 2.5 % | 15.00 M | 250.00 K |
FEMY Institutional Ownership Trends
Current Insider %
5.20%
—+0.00%
Current Institutional %
62.40%
—+0.00%
Total Ownership
67.60%
Insider + Institutional
Data Points
1
1 Ticker(s)
Option Chain Statistics
| Expiration | Volume | Open Interest | Implied Volatility Calls | Implied Volatility Puts | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Calls | Puts | Put-Call Ratio | Calls | Puts | Put-Call Ratio | IV | OiWaIv | VWaIv | IV | OiWaIv | VWaIv | |
Option Chain
| Calls | Strike | Puts | ||||
|---|---|---|---|---|---|---|
| Last Price | Volume | Open Interest | Last Price | Volume | Open Interest | |
| No data available | ||||||
Open interest
Today's Open Interest
1.00 M
Put-Call Ratio
1.1
Put Open Interest
480.00 K
Call Open Interest
520.00 K
Open Interest Avg (30-day)
900,000
Today vs Open Interest Avg (30-day)
11.11%
Option Volume
Today's Volume
750.00 K
Put-Call Ratio
0.95
Put Volume
360.00 K
Call Volume
390.00 K
Volume Avg (30-day)
800,000
Today vs Volume Avg (30-day)
-6.25%
Company News
-FEMY
Jun 24, 2026▼ -8.5%on this news
Femasys Regains Compliance with Nasdaq Listing Requirements
Femasys Inc. has announced that it has regained compliance with Nasdaq's minimum bid price requirement, closing the matter. CEO Kathy Lee-Sepsick highlighted the importance of this development for shareholders and emphasized the company's commitment to advancing its reproductive health solutions. Femasys continues to focus on commercializing its innovative products in the U.S. and international markets.
Read more →-FEMY
May 13, 2026Femasys Expands Fertility Care Portfolio in Europe with CE Mark Approval for FemHSG™ Catheter
Femasys Inc. has received CE Mark approval for its FemHSG Catheter, enhancing its fertility care portfolio in Europe. This catheter, designed for in-office fertility evaluations, works in conjunction with the FemVue device. The approval aims to improve access to timely and affordable fertility diagnosis and treatment for women. CEO Kathy Lee-Sepsick emphasized the importance of expanding in-office fertility services.
Read more →-FEMY
May 13, 2026CONFIDENTAIL | NASDAQ: FEMY 1 CORPORATE PRESENTATION May 2026 2026 Femasys Inc. Redefining Women's Reproductive Health at Global Scale NASDAQ: FEMY Forward Looking Statements NASDAQ: FEMY 2 This Presentation contains "fo
Femasys Inc. is positioning itself as a leader in women's reproductive health with innovative products aimed at enhancing patient access and care. The company highlights its strong infrastructure, experienced leadership, and a promising pipeline of products, including permanent birth control options and fertility treatments. With regulatory approvals in various regions and plans for significant market expansion, Femasys aims to capture a large, underserved patient population. The presentation emphasizes the opportunities in the current healthcare landscape, particularly in light of evolving trends in women's health.
Read more →-FEMY
May 8, 2026Femasys Announces Financial Results for Quarter Ended
Femasys Inc. (NASDAQ: FEMY) announced its financial results for the first quarter of 2026, highlighting significant progress in its clinical and regulatory initiatives. The company is moving forward with the commercialization of its FemaSeed product family and has initiated enrollment in the FINALE pivotal clinical trial for FemBloc, a non-surgical permanent birth control solution. Despite a reported net income of $846,100 for the quarter, Femasys experienced a decrease in total assets compared to the previous quarter, coupled with rising liabilities.
Read more →-FEMY
May 5, 2026▲ +7.4%on this news· ran to +22% by day 1shared move
Femasys Enables OB/GYNs to Deliver First-Line Fertility Treatment with Initial Commercial Use of FemaSeed® Complete
Femasys Inc. has launched FemaSeed as a first-line fertility treatment in OB/GYN practices, enabling in-office sperm preparation with FemSperm. This innovation addresses the significant gap in infertility care access, allowing earlier intervention at a lower cost. The approach aims to streamline fertility treatment, improving patient outcomes and satisfaction.
Read more →-FEMY
Apr 16, 2026Femasys Drives International Growth with Israeli Market Entry for Fertility Portfolio
Femasys Inc. has entered a strategic partnership with AMI Technologies to introduce its fertility portfolio in Israel. This collaboration aims to enhance market access for innovative treatments like FemaSeed and FemVue, leveraging AMI's established infrastructure and expertise. The partnership is part of Femasys's broader strategy to expand its global footprint in women's health.
Read more →-FEMY
Apr 1, 2026Femasys Announces Financial Results for Year Ended December 31, 2025 and Provides Corporate Update
Femasys Inc. reported its financial results for the year ending December 31, 2025, highlighting significant clinical and regulatory advancements. The company is actively enrolling patients in the FINALE pivotal trial for its FemBloc product, aiming for FDA approval. Additionally, Femasys is expanding its FemaSeed commercialization efforts in the U.S. market.
Read more →-FEMY
Apr 1, 2026Femasys Appoints John Canning as Chief Operating Officer to Drive Operational Execution and Advance Commercial Growth ATLANTA
Femasys Inc. has appointed John Canning as Chief Operating Officer to enhance operational execution and drive commercial growth. Canning, a veteran in the medical device sector with over 25 years of experience, will leverage his skills to expand Femasys' portfolio in fertility and permanent birth control solutions. With a track record of successful leadership in prior roles, his hire is seen as pivotal for the company's strategic ambitions. The appointment is coupled with a stock option grant, signaling the company's commitment to Canning's role in its growth strategy.
Read more →-FEMY
Mar 2, 2026▼ -5.6%on this news
Femasys Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) - February 27, 2026
Femasys Inc. has announced the granting of stock options to two new non-executive employees as part of their inducement grants under Nasdaq Listing Rule 5635(c)(4). The options, totaling 185,000 shares, were granted at prices reflecting the stock's closing value. This move aims to attract talent while ensuring compliance with regulatory standards.
Read more →-FEMY
Feb 26, 2026Femasys Announces FemBloc® Permanent Birth Control Has Achieved MDSAP Certification, Advancing Global Market Access
Femasys Inc. announced that its FemBloc permanent birth control system has received MDSAP certification, facilitating regulatory and commercial execution in key global markets. This certification enhances the company's manufacturing credibility and operational scalability, supporting ongoing commercialization efforts. FemBloc is positioned as a non-surgical alternative to traditional sterilization, aiming to expand access to permanent contraception.
Read more →-FEMY
Feb 23, 2026Femasys Receives AMA CPT Editorial Panel Approval for New Category III CPT Code for FemaSeed Intratubal Insemination
Femasys Inc. has received approval from the AMA for a new Category III CPT code for its FemaSeed intratubal insemination procedure. This approval is expected to enhance reimbursement strategies and support broader adoption of the treatment, which has shown to significantly improve pregnancy rates compared to traditional methods. The new code will be effective from January 1, 2027.
Read more →-FEMY
Feb 4, 2026Femasys Expands European Commercial Footprint with Swiss Partner for FemBloc, FemaSeed, and Portfolio Products
Femasys Inc. has entered a strategic distribution partnership with OR Consulting to launch its product portfolio in Switzerland, including FemBloc and FemaSeed. This agreement is part of Femasys's broader European expansion strategy, which also includes recent market entries in Spain and France. The collaboration aims to enhance access to innovative women's health solutions across Europe.
Read more →-FEMY
Jan 15, 2026▼ -6.9%on this news
Femasys Granted 180-Day Extension by Nasdaq to Regain Compliance with Minimum Bid Price Requirement
Femasys Inc. has been granted a 180-day extension by Nasdaq to meet the minimum bid price requirement of $1.00 per share. The company must achieve this price for ten consecutive business days to maintain its listing. Femasys is committed to compliance and is monitoring its share price closely, with plans to take necessary actions if needed.
Read more →-FEMY
Jan 14, 2026▲ +17.8%on this newsshared move
Femasys Announces Partnership with Refuah Health Center to Expand First-Line Access to FemaSeed® in Community-Based Care
Femasys Inc. has partnered with Refuah Health Center to enhance access to its FemaSeed product, a first-line infertility treatment. This collaboration aims to improve the availability of FemaSeed in community-based fertility care, making it more accessible and cost-effective for patients. The partnership is expected to accelerate the adoption of FemaSeed, which has demonstrated superior pregnancy rates compared to traditional methods.
Read more →-FEMY
Dec 18, 2025Femasys Secures U.S. FDA Clearance for Next-Generation FemVue Diagnostic Device -- Innovative single-device solution integrates proven FemVue and FemChec technologies to support fallopian tube evalu
Femasys Inc. has received 510(k) clearance from the U.S. FDA for its next-generation FemVue Controlled device. This innovative diagnostic solution aids in evaluating fallopian tube status by using a controlled contrast delivery method. The device combines features of the previous FemVue and FemChec technologies, thus improving efficiency and capability in clinical settings. This approval is an important step for Femasys as it continues to advance its product offerings in fertility and birth control.
Read more →-FEMY
Nov 14, 2025▲ +8.6%on this news
Femasys Announces Third Quarter Financial Results for 2025 - FDA Approval to Advance Final FemBloc Trial with Clear Pathway to Potentially Achieve U.S. FDA Approval - - $12 Million Financing Strengthens Balance Sheet and
Femasys Inc. reported its third-quarter financial results for 2025, highlighting significant progress in advancing its FemBloc non-surgical birth control system. The FDA has granted approval to move forward with the final pivotal trial phase, essential for U.S. market approval. Additionally, Femasys secured $12 million in new financing, strengthening its financial position. However, the company faced operating losses amounting to $4.19 million for Q3, emphasizing ongoing financial challenges as it seeks to penetrate international markets.
Read more →-FEMY
Nov 6, 2025▼ -6.4%on this news· ran to +25% by day 1
Femasys Advances Global Growth with Second Partner Order for FemBloc in Europe -- Continued rollout of FemBloc, the breakthrough non-surgical permanent contraceptive solution, expands the Company's
Femasys Inc. announced a significant commercial launch of its non-surgical permanent birth control solution, FemBloc, in France and the Benelux region through a $500,000 order from distributor Kebomed. The order signifies Femasys' strategic efforts to expand its reach in European markets after recent initiatives in Spain. FemBloc aims to fill a gap in permanent contraception options, providing a safer alternative without the risks associated with surgical procedures. The company is leveraging partnerships to accelerate its growth and enhance access to women's healthcare solutions.
Read more →-FEMY
Nov 3, 2025Femasys Secures FDA Approval to Advance Final FemBloc Trial Phase and $12 Million Financing, with Potential to Reach $58 Million -- Successful completion of first trial phase enables continued pivot
Femasys Inc. has secured FDA approval to advance the final phase of its FemBloc pivotal trial and announced a $12 million financing initiative. This approval follows a successful first phase of the trial, paving the way towards U.S. market entry for FemBloc, a non-surgical permanent birth control solution. The financing furthers Femasys' mission to make reproductive health more accessible and strengthens its capital position, potentially impacting a significant segment of women's health. The company aims to redefine options for birth control with innovative, non-invasive solutions.
Read more →-FEMY
Aug 20, 2025▼ -7.4%on this news· ran to -23% by day 3
Femasys Secures UK Regulatory Approval of FemBloc Permanent Birth Control --Advances European commercialization strategy following CE mark approval-- ATLANTA
Femasys Inc. has received regulatory approval from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for its FemBloc Permanent Birth Control. This approval represents a significant step in the company's strategy to expand its presence in Europe, following a recent CE mark approval. Acquiring this certification establishes confidence in FemBloc's safety and effectiveness, allowing Femasys to target partnerships for commercialization in the UK. The product aims to provide a non-surgical and cost-effective solution to women seeking permanent birth control options.
Read more →-FEMY
Aug 8, 2025Femasys Announces Second Quarter Financial Results for 2025 -- Continued Progress on Regulatory Approvals and Global Commercialization of Fertility Portfolio -- ATLANTA
Femasys Inc. reported its financial results for the second quarter of 2025, highlighting progress in regulatory approvals and commercialization of its fertility products. Notably, the FemBloc System received European approval, marking a significant milestone for the company's non-surgical birth control approach. Additionally, the company secured approvals for FemaSeed in Australia and New Zealand, which could enhance its revenue opportunities. However, financial results showed ongoing net losses and rising operational expenses, further emphasizing the challenges Femasys faces as it pursues growth.
Read more →-FEMY
Aug 6, 2025Femasys Secures First European Order for FemBloc , Marking Strategic Milestone in Global Expansion --Initiation of access to FemBloc, a revolutionary non-surgical permanent contraceptive, as global availability accelerat
Femasys Inc. announced its first European order for FemBloc, a non-surgical permanent contraceptive, with an order valued at approximately $400,000 from Spain. This development marks an important milestone in the company's global expansion strategy. Femasys plans to partner with local firms to effectively commercialize FemBloc, which has received regulatory approval in Europe. The company aims to address unmet needs in women's reproductive health by providing a safer and more accessible alternative to surgical sterilization.
Read more →-FEMY
Jul 1, 2025Femasys Achieves Australian and New Zealand Regulatory Approvals for FemaSeed for First-Line Infertility Treatment and FemVue Diagnostic -- Milestone expands global reach and reinforces commitment to accessible, first-li
Femasys, Inc. has announced regulatory approvals for its infertility treatment FemaSeed and diagnostic FemVue in Australia and New Zealand. These approvals are part of Femasys's strategy to expand global access to its innovative infertility solutions. FemaSeed enhances fertilization by delivering sperm directly to the fallopian tube and has demonstrated significantly higher pregnancy rates than traditional intrauterine insemination. FemVue serves as a companion diagnostic tool to assess fallopian tube patency, supporting patient management in infertility treatments.
Read more →-FEMY
Jun 25, 2025▲ +10.7%on this news
Femasys Announces Historic Milestone with European Approval of FemBloc , the First Non-Surgical Permanent Birth Control --European CE mark approval of the entire FemBloc system marks pivotal achievement in expanding safe
Femasys Inc. has announced the receipt of the European CE mark approval for FemBloc, marking the first non-surgical permanent birth control option. This achievement represents a critical milestone in expanding women's health solutions and will enable the commercialization of FemBloc in the European Economic Area. The patented delivery system is designed to ensure safety by avoiding typical surgical risks. Femasys plans to launch the product in Spain initially, with ambitions to expand into more European countries as they seek additional approvals.
Read more →-FEMY
Jun 17, 2025Femasys Names New Chief Commercial Officer to Drive Execution and Global Growth --New CCO to Lead U.S. Commercialization of Fertility Products, Including FemaSeed , and Expand Strategic Global Partnerships Across Full Po
Femasys has appointed Kelley Nicholas as Chief Commercial Officer to oversee the company's commercial strategy and drive growth in the U.S. fertility market. With over 25 years of industry experience, Ms. Nicholas is expected to enhance Femasys' market presence and establish strategic partnerships globally. Her previous roles in leading commercial teams at notable healthcare organizations position her well to contribute to the company's goals. This move comes as Femasys aims to increase accessibility to its fertility solutions.
Read more →-FEMY
Mar 27, 2025▼ -12.2%on this news
Femasys Announces Financial Results for Year Ended
Femasys Inc. announced its financial results for the year ending December 31, 2024, highlighting notable achievements in commercialization and regulatory approvals for its FemBloc and FemaSeed products. The CEO reported expectations of a 50% increase in U.S. revenue for the first quarter of 2025 compared to the previous quarter. However, the company also disclosed a significant net loss and increased current liabilities, indicating ongoing financial challenges. Despite these concerns, Femasys remains committed to addressing unmet needs in women's health.
Read more →-FEMY
Mar 18, 2025Femasys Secures Distribution Partnerships for Commercialization of FemBloc in Spain -- Company taps first EU distributors, Comercial Medico Quirurigca, SA and Durgalab, as the first globally to be granted rights to comme
Femasys Inc. has announced distribution partnerships in Spain for its innovative product FemBloc, aiming to enhance access to non-surgical permanent birth control. The company has teamed up with Comercial Medico Quirurigca, SA for northern Spain and Durgalab for the south, leveraging their expertise in women's healthcare. FemBloc's approach uses a non-invasive method, distinguishing itself from traditional surgical options. The partnerships signify a crucial step in Femasys's global expansion and commitment to women's health.
Read more →-FEMY
Mar 13, 2025Femasys Announces FemBloc Delivery System Approval in Europe; A Significant Step Towards FemBloc Permanent Birth Control Availability as the First-Ever Non-Surgical Approach --First-in-world approval of FemBloc delivery
Femasys Inc. announced the CE mark certification for the FemBloc delivery system, the first regulatory approval worldwide for a non-surgical permanent birth control method. This certification represents a significant advancement in women's health, offering an alternative to traditional surgical sterilization. The company is preparing for a potential market introduction in European countries while continuing to enroll participants in a clinical trial to secure FDA approval in the U.S. The breakthrough could address longstanding unmet needs in women's reproductive health.
Read more →-FEMY
Oct 29, 2024Investor presentation October 2024 NASDAQ: FEMY Disrupting Convention in Women's Reproductive Health Through Continuous Innovation This Presentation contains "forward-looking statements" within the meaning of the Private
Femasys Inc. (NASDAQ: FEMY) has presented its investor update focusing on innovations in women's reproductive health. The company emphasizes its mission to provide advanced, accessible solutions for infertility, contraception, and cancer diagnostics. Femasys is positioned in a multi-billion dollar market with a strong intellectual property portfolio and multiple commercial-stage products. Global regulatory approvals have been achieved for their offerings, highlighting their commitment to driving change in women's health.
Read more →-FEMY
Sep 11, 2024▲ +7.5%on this news
Femasys Secures Strategic Distribution Partnerships for Commercialization of FemaSeed for over $1.3M in Spanish Market Company taps Comercial Medico Quirurigca, SA and Durgalab as first EU distributors for its CE-marked
Femasys, Inc. has announced strategic distribution partnerships with Comercial Medico Quirurigca, SA and Durgalab to market its CE-marked women's reproductive healthcare products, including FemaSeed, in Spain. The partnerships, marking the company's entry into the European market, come with a commitment for an initial purchase of over $1.3 million. This move is seen as a significant step in Femasys's global expansion efforts, aiming to address unmet needs in women's healthcare and infertility treatments. FemaSeed is presented as a cost-effective alternative to IVF and traditional IUI methods.
Read more →-FEMY
Sep 9, 2024Femasys Inc. Receives U.S. FDA Clearance to Market FemChec , an Innovative Diagnostic Solution for Fallopian Tube Check In addition to 510(k) clearance, FemChec, a contrast generating product, is an integral part of the
Femasys Inc. has announced that it received 510(k) clearance from the FDA for FemChec, an innovative diagnostic tool for evaluating fallopian tubes. This clearance is an important milestone for Femasys, as FemChec plays a crucial role in confirming the success of their FemBloc non-surgical permanent birth control method. The product aims to provide a safer alternative to traditional x-ray dye methods, avoiding unnecessary radiation exposure. Additionally, FemChec is designed to deliver controlled contrast during ultrasound evaluations, enhancing women’s health solutions.
Read more →-FEMY
Aug 30, 2024Investor presentation August 2024 NASDAQ: FEMY Disrupting Convention in Women's Reproductive Health Through Continuous Innovation This Presentation contains "forward-looking statements" within the meaning of the Private
Femasys, listed on NASDAQ under the ticker FEMY, is presenting its innovative approach to women's reproductive health through a variety of technological advancements. The company focuses on addressing unmet needs in infertility, contraception, and cancer diagnostics, emphasizing its commitment to empowering women. There are four commercial-stage products and one in late-stage clinical trial, reflecting Femasys's strategic goals in capturing significant market opportunities. The presentation includes important forward-looking statements and details on their leadership team and market landscape.
Read more →-FEMY
Aug 29, 2024▲ +10.5%on this newsshared move
Femasys Announces CE Mark and Canadian Approval for FemVue MINI, a Fallopian Tube Assessment Solution ATLANTA
Femasys Inc. announced the CE mark certification and Health Canada approval for its FemVue MINI, a compact solution for fallopian tube assessment. This new product emphasizes environmental consciousness while maintaining efficacy. The FemVue MINI not only enhances diagnostic capabilities in women's health but also aligns with Femasys' commitment to responsible resource management and innovation. These approvals open new avenues for expanding access to advanced diagnostic technologies for women in Europe and Canada.
Read more →-FEMY
Jun 20, 2024▲ +33%on this news
Femasys Receives CE Mark Approval for Four of its Women's Health Products, Clearing the Path for the Company to Begin Commercialization Efforts in Europe ATLANTA
Femasys, Inc. recently received CE Mark approval for four of its women's health products, allowing the company to begin commercialization efforts within the European Union. The certifications follow the successful completion of the European Union Medical Device Regulation (EU MDR) process, which ensures compliance with stringent safety and quality standards. Femasys plans to identify strategic distribution partners and is poised to provide further updates on its commercial endeavors. This regulatory milestone enhances the company's capability to address unmet needs in women's reproductive health with innovative therapeutic and diagnostic solutions.
Read more →-FEMY
Apr 24, 2024Investor presentation April 2024 NASDAQ: FEMY Disrupting Convention in Women's Reproductive Health Through Continuous Innovation This Presentation contains "forward-looking statements" within the meaning of the Private S
Femasys has presented its investor outlook for April 2024, emphasizing its commitment to advancing women's reproductive health through innovative products. The company's portfolio addresses significant market opportunities in infertility treatments, permanent birth control, and cancer diagnostics. As of April 2024, Femasys has four commercial-stage products and is actively pursuing market entry, following successful regulatory approvals in major regions. The management emphasizes an uncertain business landscape but remains optimistic about future developments and the potential impact of their products on women's health.
Read more →-FEMY
Mar 20, 2024▼ -10%on this news
Femasys Announces Positive Topline Data from Pivotal Trial for its FDA-Cleared FemaSeed for the Treatment of Infertility -- In the severe male factor cohort, findings show 24% of women became pregnant after FemaSeed -- -
Femasys Inc. announced positive topline data from its pivotal trial for FemaSeed, a device cleared by the FDA for infertility treatment. The trial focused on severe male factor infertility, revealing a 24% pregnancy rate among women using FemaSeed, significantly higher than the 6.7% rate noted for traditional IUI methods. Notably, a majority of pregnancies occurred after a single FemaSeed procedure. The company aims to commercialize FemaSeed in the U.S. following its successful trial and FDA clearance, signifying a potential first-line treatment for couples facing infertility challenges.
Read more →-FEMY
Mar 6, 2024▼ -11.3%on this news
Femasys Completes the First In-Office Commercial Procedure with the FDA-Cleared FemaSeed Infertility Solution -- Paving the way forward for the broader commercial availability of FemaSeed, an accessible, safe, and cost e
Femasys Inc. has announced the successful completion of the first in-office commercial procedure using its FDA-cleared FemaSeed infertility solution, which aims to provide a safer and cost-effective alternative to traditional infertility treatments like IVF. This development signifies a potential revolution in women's health and infertility management. However, ongoing uncertainties from recent legal rulings in Alabama may affect future acceptance and market potential of the product. The pivotal data from a clinical trial is expected to be released in the first quarter of 2024, further supporting the commercialization of FemaSeed.
Read more →-FEMY
Feb 28, 2024▲ +9.3%on this news· ran to +37% by day 3
Disrupting Convention in Women's Health Through Continuous Innovation February 2024 Corporate Presentation 1 Forward-Looking Statements This Presentation contains "forward-looking statements" within the meaning of the Pr
Femasys presented its corporate outlook in February 2024, highlighting its commitment to women's health through innovative and accessible solutions. The company, which has developed a range of in-office medical products, aims to address significant unmet needs in the multibillion-dollar global women's health market. With a cash runway projected into Q2 2025 and a leadership team with extensive experience, Femasys showcases a promising future in the healthcare sector. Furthermore, the company's strong intellectual property portfolio and limited competition bolster its market position.
Read more →-FEMY
Feb 6, 2024▲ +13.3%on this news· ran to +57% by day 3
Femasys Inc. Advances Commercial Readiness with Appointment of Richard Spector to New Position of Chief Commercial Officer -- Seasoned sales and marketing executive with 25 years of experience leading public and private
Femasys Inc. has appointed Richard Spector as the new Chief Commercial Officer, effective February 2024. With 25 years of experience in sales and marketing within the healthcare sector, Spector will lead the commercial launch of FemaSeed and other products. His previous roles and success in product launches are expected to bolster Femasys' position in the women's health market, particularly with its innovative infertility and birth control solutions.
Read more →-FEMY
Nov 28, 2023Femasys Inc. Completes Enrollment of FemaSeed Pivotal Trial in Support of Commercial Launch - Topline results from FemaSeed pivotal trial expected in 1H 2024 - - Commercial launch planned for early 2024 - ATLANTA
Femasys Inc. has announced the completion of enrollment in its FemaSeed pivotal clinical trial, aimed at providing a new treatment option for male factor infertility. This marks a significant step forward for the company, which has received both FDA and Health Canada approvals for the FemaSeed product. The trial's results are anticipated in the first half of 2024, with a commercial launch expected shortly thereafter. The FemaSeed procedure offers a less invasive and more affordable alternative to traditional assisted reproductive techniques.
Read more →-FEMY
Nov 15, 2023▲ +8.6%on this news
Femasys Inc. Secures Additional Financing with Strategic Investment from Investors led by PharmaCyte Biotech - $6.85 million upfront investment provides $23 million total cash runway into second half 2025 - - Financing a
Femasys Inc. has announced a strategic investment of $6.85 million led by PharmaCyte Biotech and other investors, providing a total cash runway of $23 million through the second half of 2025. This financing will facilitate the commercialization of Femasys' infertility-related products and support the ongoing development of its lead candidate, FemBloc, geared towards permanent birth control. The investment also includes the addition of Joshua Silverman, interim CEO of PharmaCyte, to Femasys' board of directors, strengthening the company's leadership. Overall, this funding positions Femasys for significant growth in women's health solutions.
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Nov 14, 2023▼ -10.6%on this newsshared move
Femasys Inc. Announces Financial Results for the Third Quarter Ended
Femasys Inc. announced its financial results for the third quarter ending September 30, 2023, highlighting a significant milestone with FDA clearance for its product FemaSeed. The company has initiated the pivotal FINALE trial for its product candidate, FemBloc, which aims to provide a non-surgical option for permanent birth control. Additionally, Femasys raised $11.3 million to support its operations. Despite these advancements, the company reported an increased net loss and a decrease in total assets year-over-year.
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Oct 11, 2023▼ -6.3%on this news· ran to -20% by day 3
Femasys Inc. Regains Compliance with Nasdaq Listing Requirements ATLANTA
Femasys Inc. has successfully regained compliance with the Nasdaq minimum bid price requirement, thereby ensuring its continued listing on the Nasdaq Capital Market. This achievement follows a notification issued on June 1, 2023, regarding non-compliance due to a drop below the necessary bid price. The compliance was regained as the company's stock maintained a price of over $1.00 for ten consecutive trading days as of October 9, 2023. Femasys is focused on women's healthcare, particularly with innovative solutions that include non-surgical birth control and diagnostic products.
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Sep 27, 2023▼ -25%on this news· ran to +163% by day 3
Disrupting Convention in Women's Health Through Continuous Innovation September 2023 Corporate Presentation 1 Forward-Looking Statements This Presentation contains "forward-looking statements" within the meaning of the P
Femasys, a biotech company, aims to meet unmet needs in women's health with a range of innovative solutions, including FDA-cleared products like FemaSeed for infertility. The company emphasizes its commitment to developing disruptive technologies in areas such as permanent birth control and infertility. With a strong intellectual property portfolio and clear reimbursement paths, Femasys is positioned for growth within a competitive landscape. They have financial plans assuring operational continuity into mid-2024, despite the inherent uncertainties in their market and development endeavors.
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Aug 10, 2023▼ -6.5%on this news
Femasys Inc. Announces Financial Results for the Second Quarter Ended
Femasys Inc. has announced its financial results for the second quarter of 2023, reporting significant advancements in women's health products, particularly with their lead candidate FemBloc and multiple product approvals in Canada. The company raised $3.9 million in a recent offering and began patient enrollment for a pivotal trial of FemBloc. Despite positive developments, Femasys continues to face financial challenges, including notable losses and a decrease in total current assets compared to the end of the previous year.
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Aug 3, 2023Femasys Initiates Enrollment in Pivotal Trial of its Permanent Birth Control Candidate FemBloc - First of its kind, non-surgical, permanent birth control option begins enrollment in landmark trial - ATLANTA
Femasys Inc. has begun enrollment in a pivotal multi-center clinical trial for FemBloc, a prospective non-surgical permanent birth control option. This trial, known as the FINALE trial, seeks to establish FemBloc's safety and efficacy as a solution to the existing unmet needs for female permanent contraception. Femasys aims to provide an innovative alternative to traditional surgical sterilization methods that involve greater risks. The management has expressed optimism about the trial's potential to support future FDA approval for FemBloc.
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Jul 27, 2023▲ +130.8%on this news
Femasys Announces Notice of Allowance for New U.S. Patent Application Covering Use of FemBloc for Female Permanent Birth Control - FemBloc patent application provides additional coverage for Femasys' therapeutic option f
Femasys Inc. has announced a Notice of Allowance for a U.S. patent application covering its FemBloc product, a non-surgical solution for permanent birth control. This patent strengthens the company's intellectual property position and is expected to support the product's market potential. FemBloc is in late-stage clinical development and aims to provide a safer, cost-effective alternative to traditional surgical options. The anticipated patent expiration in 2039 underscores Femasys's commitment to innovation in women's reproductive health.
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Jun 26, 2023▲ +6.2%on this news
Disrupting Convention in Women's Health Through Continuous Innovation June 2023 Corporate Presentation 1 Forward-Looking Statements This Presentation contains "forward-looking statements" within the meaning of the Privat
Femasys, a biomedical company focused on women's health, presented its corporate outlook for June 2023. The company is developing innovative, minimally invasive technologies designed to improve reproductive health. Notably, Femasys aims to address significant market needs in infertility and permanent birth control. The company highlights its strong patent portfolio and experienced leadership, alongside a cash runway into Q2 2024 to support its development efforts.
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Jun 15, 2023▲ +10.9%on this news
Femasys Inc. Replaces Two Board Members with Seasoned Industry Leaders in the Life Sciences -- Keith Kendall former President, COO and CFO of drug delivery company, Aquestive Therapeutics and Alistair Milnes COO of biote
Femasys Inc. has appointed Keith Kendall and Alistair Milnes to its board of directors, replacing John Dyett and John Adams. Kendall, with a strong background in drug delivery and financial leadership, will also chair the Audit Committee. Milnes brings significant experience in biotechnology and human resources. The appointments aim to enhance Femasys' growth and development in the women's health sector, with a focus on expanding its product portfolio and commercial stage operations.
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Jun 8, 2023▼ -10%on this news
Femasys' FemCath Intrauterine Catheter Receives Product Approval in Canada -- FemCath is the first intrauterine catheter that allows for selective evaluation of a fallopian tube with natural saline and air contrast -- --
Femasys Inc. announced the approval of its FemCath intrauterine catheter by Health Canada, marking it as the first device that allows for selective evaluation of fallopian tubes using natural saline and air contrast. FemCath is designed to be used alongside the FemVue product as part of an ultrasound-based diagnostic test for infertility. The approval is seen as a significant step for Femasys to enhance its presence in the North American market, providing vital diagnostic capabilities for women facing infertility challenges. However, some of its related products remain unapproved in the U.S., posing potential market limitations.
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May 11, 2023Femasys Inc. Announces Financial Results for the First Quarter Ended
Femasys Inc. reported its financial results for Q1 2023, revealing a net loss of nearly $2.95 million. The company received regulatory approval from Health Canada for its FemaSeed and FemCerv products, which aim to enhance women's reproductive health options. Despite the positive developments, the company noted a decline in total assets and an increase in operating expenses from the previous year's quarter, highlighting ongoing financial challenges.
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May 3, 2023Femasys' FemCerv Endocervical Tissue Sampler for Cervical Cancer Diagnosis Receives Product Approval in Canada - FemCerv is the first endocervical tissue sampler designed to collect and contain a comprehensive sample to
Femasys has received product approval from Health Canada for its FemCerv Endocervical Tissue Sampler, the first of its kind designed to collect comprehensive cervical tissue samples in a relatively pain-free manner. This device is expected to enhance the quality and quantity of samples taken for cervical cancer diagnosis, addressing significant limitations of current methods. The approval allows Femasys to offer FemCerv across North America, complementing existing practices such as colposcopy. With this innovation, Femasys aims to improve women's health outcomes in cervical cancer detection.
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Apr 19, 2023▼ -22.6%on this news
Femasys Announces $3.9 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules ATLANTA
Femasys Inc. has announced a $3.9 million registered direct offering of common stock priced at $1.22 per share, set to close around April 20, 2023. The offering includes a concurrent private placement of unregistered warrants allowing the purchase of additional shares at $1.095 each. The funds raised will primarily be used for working capital and corporate purposes. Despite the positive aspect of securing funding, the offering is contingent on market conditions and subject to investor restrictions on resale of shares.
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Apr 18, 2023▲ +16.7%on this newsshared move
Femasys' FemaSeed Localized Directional Insemination for Infertility Receives Product Approval in Canada - FemaSeed is the first-ever, first-line approach designed to deliver sperm directly where contraception occurs ATL
Femasys Inc. has received product approval from Health Canada for FemaSeed, an innovative localized insemination treatment designed to deliver sperm directly to the fallopian tube. This marks the first time such a method is available as a first-line infertility treatment, aiming to provide a safer and more cost-effective alternative to traditional IVF. Additionally, FemaSeed's companion diagnostic, FemVue, facilitates efficient fallopian tube assessments in a clinical setting. The company also plans to launch the product in the U.S. in 2024 after completing clinical trials.
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Mar 31, 2023▼ -5.7%on this news
Disrupting Convention in Women's Health Through Continuous Innovation March 2023 Corporate Presentation 1 Forward-Looking Statements This Presentation contains "forward-looking statements" within the meaning of the Priva
Femasys is advancing women's health through innovative, minimally invasive technologies aimed at addressing fertility and reproductive health. The company is positioned within a multi-billion dollar market by offering proprietary diagnostic and device solutions. Despite its promising portfolio and experienced leadership, Femasys faces challenges from a competitive landscape and the inherent risks in clinical development. The company maintains a significant intellectual property portfolio to support its market position.
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Mar 30, 2023Femasys Inc. Announces Financial Results for the Year Ended
Femasys Inc. reported its financial results for the year ending December 31, 2022, highlighting significant developments in women's reproductive health. Amidst a challenging landscape post-Roe v. Wade, Femasys is advancing its clinical programs, namely FemBloc for permanent birth control and FemaSeed for infertility solutions. The company experienced a net loss of $11.39 million, though it maintains a sufficient cash position to fund operations into the first quarter of 2024. The year also saw the launch of FemCath and FemCerv, expanding treatment options available to women.
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Dec 19, 2022Femasys Inc. Announces Commercial Availability of its FemCath Intrauterine Device --FemCath is the first FDA-cleared intrauterine catheter that allows for selective evaluation of a fallopian tube with contrast -- -- FemC
Femasys Inc. Announces Commercial Availability of its FemCath Intrauterine Device --FemCath is the first FDA-cleared intrauterine catheter that allows for selective evaluation of a fallopian tube with -- FemCath is used in conjunction with FemVue as a baseline diagnostic test
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Oct 20, 2022Disrupting Convention in Women's Health Through Continuous Innovation October 2022 Corporate Presentation 1 Forward-Looking Statements This Presentation contains "forward-looking statements" within the meaning of the Pri
Disrupting Convention in Women's Health Through Continuous Innovation October 2022 Corporate Presentation 1 Forward-Looking Statements This Presentation contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 relating to
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Oct 12, 2022▼ -16.2%on this news
FEMASYS INC. ANNOUNCES THE APPOINTMENT OF CHRISTINE THOMAS AS SENIOR VICE PRESIDENT OF REGULATORY AND CLINICAL AFFAIRS - Accomplished industry leader with over twenty years of experience building lasting relationships wi
FEMASYS INC. ANNOUNCES THE APPOINTMENT OF CHRISTINE THOMAS AS SENIOR VICE PRESIDENT OF REGULATORY AND CLINICAL AFFAIRS -Accomplished industry leader with over twenty years of experience building lasting relationships with global regulatory agencies and guidance in the total pro
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Oct 6, 2022Femasys Inc. Announces Enrollment Completion for Stage 2 Study of FemBloc for Permanent Birth Control - Company remains on track to file an investigational device exemption (IDE) for a pivotal trial to support a pre-mark
Femasys Inc. Announces Enrollment Completion for Stage 2 Study of FemBloc for Permanent Birth Control - Company remains on track to file an investigational device exemption (IDE) for a pivotal trial to support a pre-market authorization (PMA) in the first quarter of 2023- ATLA
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Sep 29, 2022Femasys Inc. Announces the Commercial Availability of FemCerv for Cervical Cancer Screening and Expands Management Team - FemCerv is the first endocervical tissue sampler designed to improve tissue quality and quantity t
Femasys Inc. Announces the Commercial Availability of FemCerv for Cervical Cancer Screening and Expands Management Team - FemCerv is the first endocervical tissue sampler designed to improve tissue quality and quantity that is expected to be an improvement over the existing sta
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Aug 2, 2022▲ +6.6%on this news· ran to +22% by day 3
Disrupting Convention in Women's Health Through Continuous Innovation August 2022 Corporate Presentation 1 Forward-Looking Statements This Presentation contains "forward-looking statements" within the meaning of the Priv
Disrupting Convention in Women's Health Through Continuous Innovation August 2022 Corporate Forward-Looking Statements This Presentation contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 relating to our business, op
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Feb 28, 2022Disrupting Convention in Women's Health Through Continuous Innovation February 2022 Corporate Presentation 1 Forward-Looking Statements This Presentation contains "forward-looking statements" within the meaning of the Pr
Disrupting Convention in Women's Health Through Continuous Innovation February 2022 Corporate Forward-Looking Statements This Presentation contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 relating to our business,
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Feb 24, 2022Femasys Inc. Announces the Appointment of Dov Elefant to New Position of Chief Financial Officer -- Seasoned financial executive with 25 years of experience leading public and private biotech companies throughout various
Femasys Inc. Announces the Appointment of Dov Elefant to New Position of Chief Financial Officer -- Seasoned financial executive with 25 years of experience leading public and private biotech companies throughout various ATLANTA, February 24, 2022 -- Femasys Inc. (NASDAQ: FEMY)
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Jan 20, 2022Femasys Inc. Announces the Appointment of Wendy Perrow, Transformational Biotech Entrepreneur, as New Board Member -- Industry leader Wendy Perrow brings decades of expertise in fundraising, global product launches and c
Femasys Inc. Announces the Appointment of Wendy Perrow, Transformational Biotech Entrepreneur, as New Board Member -- Industry leader Wendy Perrow brings decades of expertise in fundraising, global product launches and corporate strategy to the Femasys team - ATLANTA, January
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Jan 5, 2022▼ -10.1%on this news
Disrupting Convention in Women's Health Through Continuous Innovation January 2022 Corporate Presentation Forward-Looking Statements This Presentation contains "forward-looking statements" within the meaning of the Priva
Disrupting Convention in Women's Health Through Continuous Innovation January 2022 Corporate Forward-Looking Statements This Presentation contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 relating to our business, o
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Nov 10, 2021Femasys Inc. Announces Financial Results for the Third Quarter of 2021 -- Up to 792-patient, pivotal LOCAL trial progressing for FemaSeed after receipt of investigational device exemption (IDE) submission approval - -- F
Femasys Inc. Announces Financial Results for the Third Quarter of 2021 -- Up to 792-patient, pivotal LOCAL trial progressing for FemaSeed after receipt of investigational device exemption (IDE) submission approval - -- Femasys added to the Russell Microcap Index in Q3 -- ATLA
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Sep 20, 2021▼ -5%on this news
Femasys Inc. To Join the Russell Microcap Index ATLANTA
Femasys Inc. To Join the Russell Microcap Index ATLANTA, September 20, 2021 -- Femasys Inc. (NASDAQ: FEMY) ("Femasys" or the "Company"), a biomedical company developing a suite of product candidates to transform women's healthcare with minimally invasive, non-surgical, in-offic
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Sep 1, 2021Femasys Inc. Announces the Appointment of Edward Evantash, M.D. as Chief Medical Officer -- Industry veteran with over than two decades of experience in medical affairs to lead clinical and medical affairs at Femasys --
Femasys Inc. Announces the Appointment of Edward Evantash, M.D. as Chief Medical Officer -- Industry veteran with over than two decades of experience in medical affairs to lead clinical and medical affairs at Femasys -- ATLANTA September 1, 2021 -- Femasys Inc. (NASDAQ: FEMY),
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Aug 11, 2021Femasys Inc. Announces Financial Results for the Second Quarter of 2021 Completed initial public offering ("IPO") raising net proceeds of $31.6 million Appointed Anne Morrissey to the Board of Directors, an industry expe
Femasys Inc. Announces Financial Results for the Second Quarter of 2021 Completed initial public offering ("IPO") raising net proceeds of $31.6 million Appointed Anne Morrissey to the Board of Directors, an industry expert with decades of medical device experience Initiated 79
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Jul 20, 2021▲ +14.7%on this news
Femasys Inc. Announces First Patient Treated in Pivotal Trial for FemaSeed First in Class Insemination Treatment for Infertility LOCAL Pivotal Trial to Enroll Up to 792 Patients Across 20 U.S. Centers Atlanta, GA.
Femasys Inc. Announces First Patient Treated in Pivotal Trial for FemaSeed First in Class Insemination Treatment for Infertility LOCAL Pivotal Trial to Enroll Up to 792 Patients Across 20 U.S. Centers Atlanta, GA. --- July 20, 2021 --- Femasys Inc. (NASDAQ: FEMY), a biomedical
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Jul 13, 2021▲ +14.7%on this news
Transforming Women's Healthcare 2021 Femasys Inc. Corporate PresentationJuly 2021 Forward Looking Statements 2 This Presentation contains "forward-looking statements" within the meaning of the Private Securities Litigati
Transforming Women's Healthcare 2021 Femasys Inc. Corporate PresentationJuly 2021 Forward Looking Statements 2 This Presentation contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 relating to our business, operations
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