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Femasys, a biomedical company specializing in women's reproductive health solutions, reported a decrease in sales for the three months ended June 30, 2024, with a 30.9% drop to $221,484 compared to the same period in 2023. The company's net loss widened by 61.9% year-on-year to $4,684,574. Research and development expenses rose by 29.4%, primarily due to increased material and development costs, while sales and marketing expenses surged by 656.6% as the company prepared for the commercialization of FemaSeed. Despite the increased losses, Femasys secured $6.85 million in financing and completed enrollment for the FemaSeed pivotal trial, indicating progress towards commercial launch. The company also received European Union Medical Device Regulation (EU MDR) and CE Mark certification for several products, including FemaSeed. Looking forward, Femasys expects to commence FemaSeed sales in the second half of 2024 and is exploring strategic partnerships for distribution in Europe. However, the company acknowledges the need for additional financing to continue operations beyond July 2025 and has expressed substantial doubt about its ability to continue as a going concern without securing further funds.
Femasys, a biomedical company specializing in women's reproductive health solutions, reported a decrease in sales for the three months ended June 30, 2024, with a 30.9% drop to $221,484 compared to the same period in 2023. The company's net loss widened by 61.9% year-on-year to $4,684,574. Research and development expenses rose by 29.4%, primarily due to increased material and development costs, while sales and marketing expenses surged by 656.6% as the company prepared for the commercialization of FemaSeed. Despite the increased losses, Femasys secured $6.85 million in financing and completed enrollment for the FemaSeed pivotal trial, indicating progress towards commercial launch. The company also received European Union Medical Device Regulation (EU MDR) and CE Mark certification for several products, including FemaSeed. Looking forward, Femasys expects to commence FemaSeed sales in the second half of 2024 and is exploring strategic partnerships for distribution in Europe. However, the company acknowledges the need for additional financing to continue operations beyond July 2025 and has expressed substantial doubt about its ability to continue as a going concern without securing further funds.
生物医学に特化した女性の生殖健康のソリューションを提供するFemasysは、2024年6月30日までの3か月間の売上高が2023年同期比で30.9％減少し、221,484ドルになったことを報告しました。同社の純損失は、年間比で61.9％拡大して468万4,574ドルになりました。研究開発費が29.4％増加し、主に材料費および開発費用の増加が原因であり、販売およびマーケティング費用は、FemaSeedの商業化に備えて656.6％急増しました。増加した損失にもかかわらず、Femasysは685万ドルの資金調達を確保し、FemaSeedの主要試験の参加者募集は完了し、商業化への進展を示しています。同...すべて展開
生物医学に特化した女性の生殖健康のソリューションを提供するFemasysは、2024年6月30日までの3か月間の売上高が2023年同期比で30.9％減少し、221,484ドルになったことを報告しました。同社の純損失は、年間比で61.9％拡大して468万4,574ドルになりました。研究開発費が29.4％増加し、主に材料費および開発費用の増加が原因であり、販売およびマーケティング費用は、FemaSeedの商業化に備えて656.6％急増しました。増加した損失にもかかわらず、Femasysは685万ドルの資金調達を確保し、FemaSeedの主要試験の参加者募集は完了し、商業化への進展を示しています。同社はまた、FemaSeedを含むいくつかの製品に対して、欧州連合医療機器規制（EU MDR）およびCEマーク認証を受けました。今後、Femasysは2024年後半にFemaSeedの販売を開始することを予定し、欧州での流通のための戦略的パートナーシップを模索しています。ただし、同社は2025年7月以降の事業継続に必要な追加資金の必要性を認識し、さらなる資金調達を行わなければ、事業を継続することができなくなる可能性があると述べています。
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