Femasys

Femasys, Inc. operates as a medical device company that focuses on women's healthcare. Its products include FemVue Saline-Air Device, which creates and delivers an alternating pattern of saline and air as a continuous stream, and enables physicians to assess their patients fallopian tubes, and FemChec Pressure Management Device, which limits the maximum applied pressure while performing hysterosalpingogram. The firm offers FemCerv, an endocervical curettage device to collect a non-contaminated tissue sample for cervical cancer screening. The company was founded by Kathy Lee-Sepsick in 2004 and is headquartered in Suwanee, GA.

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Femasys, Inc. is a biomedical company, which engages in the development of novel solutions for reproductive healthcare. The company was founded by Kathy Lee-Sepsick in 2004 and is headquartered in Suwanee, GA.

-- Paving the way forward for the broader commercial availability of FemaSeed, an accessible, safe, and cost effective alternative to IVF -- -- Ongoing uncertainty following recent Alabama Supreme Court Ruling creates continued anticipation with top-line pivotal data expected to be announced during Q1 2024 --

Femasys Completes the First In-Office Commercial Procedure with the FDA-Cleared FemaSeed Infertility Solution

-- Femasys readies for the commercial launch of FemaSeed ® in the U.S. amidst the uncertainty following the Alabama Supreme Court Ruling on how to handle embryos used for in vitro fertilization (IVF) -- -- Femasys to announce top-line data from recently completed pivotal clinical trial for FemaSeed in first quarter 2024 --

Femasys' FemaSeed FDA Clearance Brings Timely Access to a First-Line Infertility Treatment Option as an Alternative to IVF

-- Seasoned sales and marketing executive with 25 years of experience leading public and private healthcare companies throughout various stages of commercialization will lead commercial launch of FemaSeed -- ATLANTA, Feb. 06, 2024 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a biomedical company focused on meeting significant unmet needs for women worldwide with a broad portfolio of in-office, accessible solutions, including a lead, late-clinical stage product candidate and innovative therapeutic and diagnostic products, today announced the appointment of Richard Spector to chief commercial officer (CCO), effective February 2024. Mr. Spector has 25 years of experience spanning a continuum of commercial stages at both public and private medical device and biopharmaceutical companies.

Femasys Inc. Advances Commercial Readiness with Appointment of Richard Spector to New Position of Chief Commercial Officer

ATLANTA, Jan. 26, 2024 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a biomedical company focused on meeting significant unmet needs for women worldwide with a broad portfolio of in-office, accessible solutions, including a lead, late-clinical stage product candidate and innovative therapeutic and diagnostic products, today announced that it has activated enrollment for its pivotal FemBloc® trial at University of California, Davis (“UC Davis”) Medical Center in Sacramento, California. The FemBloc Intratubal Occlusion for TranscervicAL Permanent Birth Control (the “FINALE” trial) is being conducted to investigate the safety and efficacy of its investigational permanent birth control candidate, FemBloc®. The FDA-approved, multi-center trial is designed to address the high unmet need that exists for women seeking permanent birth control, for whom elective surgery currently remains the only option.

Femasys Inc. Begins FemBloc Pivotal Trial Enrollment at UC Davis Medical Center, a Hub for Innovation and Groundbreaking Research in Health Care for Women

- University of Utah Hospital, Lori Gawron, M.D. of the Obstetrics and Gynecology (OB/GYN) Department, was an instrumental investigator in Femasys' earlier FemBloc study -

Femasys Inc. Begins FemBloc Pivotal Trial Enrollment at University of Utah, an Internationally Recognized Center in Obstetrics and Gynecology

- Stanford Medicine, a center with a long tradition of leadership in pioneering gynecological research and innovation, is the second academic center to participate in the FemBloc pivotal trial since enrollment began last quarter -

Femasys Inc. Begins FemBloc Pivotal Trial Enrollment at Stanford Medicine

-- Thought leader from top-ranked academic gynecology program to lead clinical and medical affairs at Femasys -- -- Thought leader from top-ranked academic gynecology program to lead clinical and medical affairs at Femasys --

Femasys Inc. Announces the Appointment of James Liu, M.D., as Chief Medical Officer

Femasys is a medical device company that offers a suite of minimally invasive reproductive health products for women. The company recently received clearance for its FemaSeed product and plans to launch it in early 2024. Femasys is also developing a device called FemBloc for permanent birth control and a device called FemCerv for cervical tissue biopsy.

Femasys: A Women's Health Medical Devices Company Ready To Turn The Corner

- Topline results from FemaSeed ® pivotal trial expected in 1H 2024 - - Commercial launch planned for early 2024 - ATLANTA, Nov. 28, 2023 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a biomedical company focused on meeting significant unmet needs for women worldwide with a broad portfolio of in-office, accessible solutions, including a lead, late-clinical stage product candidate and innovative therapeutic and diagnostic products, today announced completion of enrollment in the LOCAL FemaSeed® pivotal clinical trial, designed to evaluate women undergoing FemaSeed cycles due to male factor infertility. FemaSeed, an intratubal insemination approach that delivers sperm to the fallopian tube where conception occurs is now readying for commercialization.

Femasys Inc. Completes Enrollment of FemaSeed Pivotal Trial in Support of Commercial Launch

PharmaCyte Biotech

LAS VEGAS--(BUSINESS WIRE)--PharmaCyte Biotech, Inc. (Nasdaq: PMCB) (“PharmaCyte” or the “Company”) announces it has made a $5 million investment in Femasys, Inc. (Nasdaq:FEMY) (“Femasys”), a biomedical company focused on meeting significant unmet needs for women worldwide. Femasys offers a broad portfolio of in-office, accessible solutions, including a lead late-stage product candidate and innovative therapeutic and diagnostic products. This is the Company's first investment in externally deve.

PharmaCyte Biotech Acquires $5 Million Stake in Emerging Women's Health Innovator Femasys, Inc.

- $6.85 million upfront investment provides $23 million total cash runway into second half 2025 - - Financing allows for focused commercial team to bring Femasys' infertility-related products to women in the U.S. - - Additional financing supports the advancement of Femasys' lead product candidate, FemBloc ® for permanent birth control, to initial clinical data readout - ATLANTA, Nov. 15, 2023 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a biomedical company focused on meeting significant unmet needs for women worldwide with a broad portfolio of in-office, accessible solutions, including a lead, late-clinical stage product candidate and innovative therapeutic and diagnostic products, today announced a strategic upfront investment of $6.85 million by public biotech company, PharmaCyte Biotech, Inc. (Nasdaq: PMCB) and other healthcare investors. Femasys is creating accessible innovative options for women, as exemplified by its lead product candidate, FemBloc, in late-stage clinical development for permanent birth control and FDA-cleared product, FemaSeed ® for infertility treatment (also approved in Canada).

Femasys Inc. Secures Additional Financing with Strategic Investment from Investors led by PharmaCyte Biotech

- 510(k) product clearance gained for lead product, FemaSeed potentially allowing sooner-than-expected product commercialization -

Femasys Inc. Announces Financial Results for the Third Quarter Ended September 30, 2023 and Provides Corporate Update

– Completion of the European Union Medical Device Regulation (MDR) final audit is the last step in obtaining an MDR certificate and CE marking, confirming Femasys' compliance with the highest required regulatory standards –

Femasys Inc. EU MDR Final Audit Successfully Completed

ATLANTA, Oct. 11, 2023 (GLOBE NEWSWIRE) -- Femasys Inc. (Nasdaq: FEMY), a biomedical company focused on meeting significant unmet needs for women worldwide with a broad portfolio of in-office, accessible solutions, including a lead late-clinical stage product candidate and innovative diagnostic products, today announced that it has it has received notice from The Nasdaq Stock Market LLC (Nasdaq) informing Femasys that it has regained compliance with the minimum bid price requirement under NASDAQ Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market. Consequently, Femasys is now in compliance with all applicable listing standards, and its common stock will continue to be listed on The Nasdaq Capital Market.

Femasys Inc. Regains Compliance with Nasdaq Listing Requirements

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ATLANTA, Oct. 04, 2023 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a biomedical company focused on meeting significant unmet needs for women worldwide with a broad portfolio of in-office, accessible solutions, including a lead late-clinical stage product candidate and innovative diagnostic products, today announced that it will be exhibiting at the annual meeting of the American Society of Reproductive Medicine (ASRM): “The Past, The Present, and The Pipeline”, being held in New Orleans, Louisiana from October 14-18, 2023.

Femasys Inc. to Showcase FemaSeed at the Annual Meeting of the American Society of Reproductive Medicine

– Femasys demonstrates compliance with harmonized regulatory requirements for Australia, Brazil, Japan, Canada and the USA –

Femasys Inc. MDSAP Surveillance Audit Successfully Completed

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The remarkable Femasys (NASDAQ: FEMY) stock price comeback continued on Monday as demand for the shares continued. The shares surged by more than 45% on Friday and gained by another 15% in the pre-market session.

Femasys (FEMY) stock price is up 1,250% but there are 2 key risks

ATLANTA, Sept. 27, 2023 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a biomedical company focused on meeting significant unmet needs for women worldwide with a broad portfolio of in-office, accessible solutions, including a lead late-clinical stage product candidate and innovative diagnostic products, today announced that it has activated enrollment for its pivotal FemBloc trial at its first academic site located in Brooklyn, New York. The FemBloc INtratubal Occlusion for TranscervicAL PErmanent Birth Control (the “FINALE” trial) is being conducted to investigate the safety and efficacy of its investigational permanent birth control candidate, FemBloc®. The FDA approved multi-center pivotal trial is designed to address the high unmet need that exists for women seeking permanent birth control for whom elective surgery remains the only option.

Femasys Inc. Expands FemBloc Pivotal Trial Enrollment Securing First Academic Site to Participate

Femasys (NASDAQ: FEMY) stock price has made a strong comeback in the past few days as investors cheer the company's FDA news. The shares surged to a high of $1.71, the highest level since October last year.

FEMY stock price has surged: Is Femaysis still a good buy?

Femasys (NASDAQ: FEMY ) stock is rocketing higher on Tuesday following approval from the Food and Drug Administration (FDA) for FemaSeed. FemaSeed is an infertility treatment that delivers sperm directly into a woman's fallopian tube.

Why Is Femasys (FEMY) Stock Up 181% Today?

- The 510(k) Clearance from the United States Food and Drug Administration (FDA) allows for the U.S. commercialization of FemaSeed ® , an intratubal artificial insemination option designed to augment the natural fertilization process -

Femasys Inc. Receives U.S. FDA Clearance to Market FemaSeed, an Innovative Infertility Treatment Solution

ATLANTA, Sept. 20, 2023 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a biomedical company focused on meeting significant unmet needs for women worldwide with a broad portfolio of in-office, accessible solutions, including two lead revolutionary late-clinical stage product candidates and FDA-cleared, innovative diagnostic products, today announced the achievement of First-Patient-In for its pivotal clinical trial evaluating FemBloc®, a first-of-its-kind, non-surgical, non-implant, in-office solution for permanent birth control for women. The landmark pivotal clinical trial (the “FINALE” trial) is currently enrolling patients and additional clinical sites are planned to support the further expansion of the trial.

Femasys Announces First-Patient-In for Pivotal Clinical Trial Evaluating its FemBloc Permanent Birth Control

ATLANTA, Aug. 31, 2023 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a biomedical company focused on meeting significant unmet needs for women worldwide with two lead revolutionary product candidates in late-stage clinical development for reproductive health in addition to innovative diagnostic products constituting a broad portfolio of in-office accessible solutions, today announced that it has obtained a Medical Device Establishment License (“MDEL”) from Health Canada (License Number 24825). The MDEL license is issued by Health Canada's Regulatory Operations and Enforcement Branch (ROEB) to companies for the activities of manufacturing, importing and distributing and selling of medical devices for human use in Canada. This license allows Femasys to directly sell its four products, FemaSeed®, FemVue®, FemCath® and FemCerv®, approved in Canada.

News for Femasys Stock (FEMY)