Articles from Femasys Inc.

Regulatory approval follows FemaSeed U.S. FDA-clearance announced September 2023 and EU CE mark approval announced June 2024

European patents expand coverage for both essential components of FemBloc for fallopian tube occlusion, resulting in non-surgical permanent contraception

FemaSeed® patent application provides additional coverage for Femasys’ therapeutic option for women seeking infertility solution

HRC Fertility to begin providing FemaSeed infertility treatment to patients at centers across California

Trial results demonstrated safety and effectiveness of FemaSeed intratubal insemination with high satisfaction ratings from both practitioners and patients

Company accelerated commercialization with significant new partnerships both in the U.S. and Europe

Premier conference focused on gynecological surgery

FemBloc issued patent provides additional coverage for Femasys’ therapeutic option for women seeking permanent birth control

Boston IVF to begin providing FemaSeed as an infertility treatment option to expand access for patients across nearly 30 centers nationwide

Company’s VP of Education and Global Training Named Chairman of ASRM Corporate Member Council

ATLANTA, Oct. 08, 2024 (GLOBE NEWSWIRE) -- Femasys, Inc., (Nasdaq: FEMY), a leading biomedical company focused on addressing significant unmet needs of women worldwide with a broad portfolio of in-office, accessible, and innovative therapeutic and diagnostic products, announces that Kathy Lee-Sepsick, Founder, President, and CEO, will participate in a fireside chat at the 2024 Maxim Healthcare Virtual Summit with Jason McCarthy, Ph.D., Senior Managing Director, Head of Biotechnology Research at Maxim Group. The summit is being held virtually on October 15 – 17, 2024.

ATLANTA, Oct. 02, 2024 (GLOBE NEWSWIRE) -- Femasys, Inc., (Nasdaq: FEMY), a leading biomedical company focused on addressing significant unmet needs of women worldwide with a broad portfolio of in-office, accessible, and innovative therapeutic and diagnostic products, announces that the Company has received its second order from its strategic distribution partners after successfully completing its first commercial FemaSeed® procedures in Europe. Members of the Femasys team traveled to Madrid to in-service healthcare practitioners on the innovative FemaSeed infertility treatment, designed to enhance natural fertilization by precisely delivering sperm into the fallopian tube where conception occurs.

Leading medical clinics become key regional resources to offer FemaSeed infertility treatment

Company taps Comercial Medico Quirurigca, SA and Durgalab as first EU distributors for its CE-marked women’s reproductive healthcare products

In addition to 510(k) clearance, FemChec, a contrast generating product, is an integral part of the confirmation test following administration of FemBloc non-surgical permanent birth control, currently in late-stage pivotal trial

ATLANTA, Sept. 05, 2024 (GLOBE NEWSWIRE) -- Femasys, Inc., (Nasdaq: FEMY), a leading biomedical company focused on addressing significant unmet needs of women worldwide with a broad portfolio of in-office, accessible, and innovative therapeutic and diagnostic products, announces that the Company will be exhibiting at the Canadian Fertility and Andrology Society’s (CFAS) 70th Annual Meeting, to be held September 12-14, 2024 at The Westin Bayshore, Vancouver, British Columbia. The Company will be exhibiting at Booth #S26.

ATLANTA, Sept. 03, 2024 (GLOBE NEWSWIRE) -- Femasys, Inc., (Nasdaq: FEMY), a leading biomedical company focused on addressing significant unmet needs of women worldwide with a broad portfolio of in-office, accessible, and innovative therapeutic and diagnostic products, announces that Kathy Lee-Sepsick, Founder, President, and CEO, will participate in a fireside chat at the H.C. Wainwright 26th Annual Global Investment Conference. The fireside chat will be hosted by Emily Bodnar, Life Sciences Analyst. The conference is being held on September 9 – 11, 2024 at the Lotte New York Palace Hotel.

ATLANTA, Aug. 29, 2024 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQFEMY), a leading biomedical company focused on addressing significant unmet needs of women worldwide with a broad portfolio of in-office, accessible and innovative therapeutic and diagnostic products, announces that it has received CE mark certification and product approval from Health Canada, the Public Health Agency of Canada, for its compact, eco-friendly FemVue® MINI for fallopian tube assessment.

The Congresswoman representing Georgia’s 7th district in the U.S. House of Representatives toured Femasys’ facilities to gain a better understanding of our advancements for women’s reproductive health

Company gained CE Mark approval for four of its women’s health products and completed buildout of commercial team for its infertility portfolio

Leading women’s reproductive health conference directly follows the company’s EU CE Mark approval for four of its products

ATLANTA, June 20, 2024 (GLOBE NEWSWIRE) -- Femasys, Inc., (Nasdaq: FEMY), a leading biomedical company focused on addressing significant unmet needs of women worldwide with a broad portfolio of in-office, accessible, and innovative therapeutic and diagnostic products, announces it has received its European Union Medical Device Regulation (EU MDR) certificate and CE Mark certification for four of its products. The four products – FemaSeed®, FemVue®, FemCerv®, and FemCath® – are compliant with the new European Union legislation for medical devices. The MDR certification and the four CE Mark product approvals allow Femasys to deliver its innovative solutions for women’s reproductive health within the EU market.

Lee-Sepsick Discussed Company’s FemCerv® Endocervical Tissue Sampler and its Role in Cervical Cancer Diagnosis

Lee-Sepsick Discussed Atlanta-Based Biomedical Company’s Women’s Reproductive Health Products

-- Recruitment of the commercial team for our infertility portfolio and the pivotal trial of FemBloc® for permanent non-surgical birth control continues --

Team to Drive Strategic Initiatives, Launching Efforts at 2024 ACOG Meeting

ATLANTA, April 18, 2024 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQFEMY), a leading biomedical company focused on addressing significant unmet needs of women worldwide with a broad portfolio of in-office, accessible, and innovative therapeutic and diagnostic products, today announces its CEO and Founder Kathy Lee-Sepsick has met with several members of Congress to discuss the current women’s healthcare landscape. Further, Lee-Sepsick is raising awareness of Femasys and the status of its reproductive products in light of the recently announced women’s health initiative from the White House. In mid-March President Biden released an executive order, which calls for a $200M investment in research for women’s health and a coordinated approach from more than 20 federal government agencies in addition to the $100M investment announced in November 2023.

Following FDA Clearance of FemaSeed®, Company Secures Capital to Support Commercial Initiatives; Cash Expected to Fund Operations Into 2H 2025

-- CEO Kathy Lee-Sepsick and Chief Medical Officer James Liu to Join Jones Trading Analyst Catherine Novack in a Conversation on Current Treatment Options in Infertility Including FemaSeed® at 1PM ET --

-- In the severe male factor cohort, findings show 24% of women became pregnant after FemaSeed --

-- CEO Kathy Lee-Sepsick and Chief Medical Officer James Liu to Join Jones Trading Analyst Catherine Novack in a Conversation on Current Treatment Options in Infertility Including FemaSeed® at 1PM ET --

-- Paving the way forward for the broader commercial availability of FemaSeed, an accessible, safe, and cost effective alternative to IVF --

-- 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) --

-- 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, Jan. 26, 2024 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQFEMY), 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.

- 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 -

- 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 -

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

- Topline results from FemaSeed® pivotal trial expected in 1H 2024 -

- $6.85 million upfront investment provides $23 million total cash runway into second half 2025 -

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

– 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 –

ATLANTA, Oct. 25, 2023 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQFEMY), 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 highlight its product candidate in late stage clinical development, FemBloc®, as well as showcase three of its marketed products advancing women’s health, FemVue®, FemCath® and FemCerv®, at the annual meeting of the American Association of Gynecologic Laparoscopic Surgeons (AAGL) being held in Nashville, Tennessee from November 5-8, 2023. The annual AAGL meeting gathers laparoscopic surgeons worldwide dedicated to the research and advancement of minimally invasive gynecologic procedures.

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.

ATLANTA, Oct. 04, 2023 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQFEMY), 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 demonstrates compliance with harmonized regulatory requirements for Australia, Brazil, Japan, Canada and the USA –

ATLANTA, Sept. 27, 2023 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQFEMY), 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.

- 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 -

ATLANTA, Sept. 20, 2023 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQFEMY), 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.

ATLANTA, Sept. 06, 2023 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQFEMY), 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 Kathy Lee-Sepsick, founder, president & chief executive officer, will virtually present and also participate in one-on-one investor meetings at the H.C. Wainwright 25th Annual Global Investment Conference, being held September 11-13, 2023.

ATLANTA, Aug. 31, 2023 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQFEMY), 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.

                  - Patient enrollment has commenced in landmark pivotal trial for lead product candidate, FemBloc®

- First of its kind, non-surgical, permanent birth control option begins enrollment in landmark trial -

- Pivotal clinical trial to begin in the third quarter of 2023 -

-- Keith Kendall former President, COO and CFO of drug delivery company, Aquestive Therapeutics and Alistair Milnes COO of biotechnology company, Bicycle Therapeutics both join Femasys’ Board of Directors --

ATLANTA, June 14, 2023 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQFEMY), a biomedical company aiming to meet women's needs by developing a suite of products and product candidates that include minimally invasive, in-office technologies for reproductive health, today announced that Kathy Lee-Sepsick, founder, president & chief executive officer, has been invited to present at the Healthcare Virtual Conference Part II, presented by Maxim Group LLC and hosted by M-Vest. The conference is being held virtually on June 20-22, 2023.

-- FemCath® is the first intrauterine catheter that allows for selective evaluation of a fallopian tube with natural saline and air contrast --

-Received regulatory approval for both FemaSeed® and FemCerv® products from Health Canada-

ATLANTA, May 11, 2023 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQFEMY), a biomedical company aiming to meet women's needs by developing a suite of products and product candidates that include minimally invasive, in-office technologies for reproductive health, today announced that the Company’s management team will be attending the annual American College of Obstetricians and Gynecologists (ACOG) Annual Clinical & Scientific Meeting (ACSM) being held May 19-21, 2023 in Baltimore, Maryland. ACSM is a scienfific meeting for the leading experts in obstetrics and gynecology.

- FemCerv® is the first endocervical tissue sampler designed to collect and contain a comprehensive sample to maximize quality and quantity -

ATLANTA, May 01, 2023 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQFEMY), a biomedical company aiming to meet women's needs by developing a suite of products and product candidates that include minimally invasive, in-office technologies for reproductive health, today announced that the Company’s management team will be attending the annual Conference for the American Society for Colposcopy and Cervical Pathology (ASCCP) held May 4 -7, 2023 at the Marriott Marquis in Houston. The conference is a scientific meeting on anogenital and human papillomavirus (HPV)-related diseases, such as cervical cancer.

ATLANTA, April 19, 2023 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQFEMY), a biomedical company aiming to meet women’s needs by developing a suite of products and product candidates that include minimally invasive, in-office technologies for reproductive health, today announced that it has entered into a definitive agreement for the issuance and sale of an aggregate of 3,196,722 of its shares of common stock (or common stock equivalents) at a purchase price of $1.22 per share (or common stock equivalent) in a registered direct offering priced at-the-market under Nasdaq rules. In a concurrent private placement, Femasys has also agreed to issue and sell unregistered warrants to purchase up to an aggregate of 3,196,722 shares of common stock. The offering is expected to close on or about April 20, 2023, subject to the satisfaction of customary closing conditions.

- FemaSeed® is the first-ever, first-line approach designed to deliver sperm directly where contraception occurs -

- 2022 was a landmark year for women in the U.S. due to the overturn of Roe v. Wade which underscored the importance of potential reproductive health options like Femasys’ FemBloc® for permanent birth control and FemaSeed® for infertility

ATLANTA, March 09, 2023 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQFEMY), a biomedical company aiming to meet women's needs worldwide by developing a suite of product candidates that include minimally invasive, in-office technologies for reproductive health, announced today that Kathy Lee-Sepsick, founder, president & chief executive officer, will participate in the South By Southwest (SXSW) 2023 Conference being held in Austin, Texas from March 10-19, 2023.

--FemaSeed® de novo trial enrollment accelerates with strategic trial design update to focus on male factor infertility--

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

- FemCerv® is the first endocervical tissue sampler designed to improve tissue quality and quantity that is expected to be an improvement over the existing standard of care -