infuse Life Science

infuse Life Science Announces AMED Grant Selection and Funding from BD Fund and Incubate Fund

2026-07-14T14:00:00+09:00

infuse Life Science Announces Selection for AMED's Medical-Engineering Collaboration Global Expansion Program and Funding from BD Fund and Incubate Fund

Advancing R&D of a single-use endoscope for direct observation inside the fallopian tubes, aiming to improve access to fallopian tube diagnostics.

Tokyo, Japan — July 14, 2026

infuse Life Science, Inc. (Headquarters: Tokyo; Representative Director and CEO: Daisuke Saito; "the Company"), a life science startup dedicated to advancing women's health and the beginnings of life through innovative solutions, today announced its selection for the Japan Agency for Medical Research and Development's (AMED) FY2026 "Medical-Engineering Collaboration Global Expansion Program (R&D Program)," alongside a funding round led by BD Fund, Inc. and Incubate Fund, Inc.

The Challenge We Are Addressing

Tubal factor is one of the leading causes of infertility, yet its diagnosis remains challenging. Hysterosalpingography (HSG), the standard diagnostic test, is available only at a limited number of medical institutions, forcing patients to navigate geographic and scheduling constraints to receive care. Moreover, HSG evaluates tubal patency rather than the internal condition of the fallopian tube itself, limiting its diagnostic value.

Our R&D Focus

The Company is developing an endoscope designed for direct observation inside the fallopian tube. By enabling direct visual assessment of structural abnormalities that HSG struggles to detect, and by adopting a single-use design that eliminates the need for complex high-level disinfection and sterilization processes, the device is intended to be practical for adoption even in outpatient clinic settings. The goal is to enable more precise tubal evaluation at accessible healthcare facilities, supporting faster, better-informed decision-making on the path to pregnancy.

This product is under development and has not received regulatory approval or certification under Japan's Pharmaceuticals and Medical Devices Act (PMD Act). It is not currently available for sale or distribution.

About the AMED "Medical-Engineering Collaboration Global Expansion Program" Selection

Project title: Research and development of an outpatient-compatible single-use fallopian tube endoscopy system aiming to replace hysterosalpingography

The single-use fallopian tube endoscopy system the Company is developing aims to serve as an alternative to HSG, the standard test for infertility screening. Designed for use in an outpatient setting, it aims to reduce the physical and psychological burden on patients while improving access to care. This selection will allow the Company to accelerate non-clinical research aimed at U.S. market entry, moving the device closer to clinical implementation.

About the Funding Round

The Company has completed a funding round with BD Fund, Inc. — which brings deep expertise in supporting global healthcare startups — and Incubate Fund, Inc., Japan's largest seed-stage-focused venture capital firm, as investors. Proceeds will be used to accelerate R&D of the Company's flagship product line and to prepare for U.S. market expansion.

Comment from Representative Director and CEO, Daisuke Saito

"We are grateful to have reached two milestones at once: the strong backing of BD Fund and Incubate Fund, and our selection for AMED's Medical-Engineering Collaboration Global Expansion Program. This would not have been possible without the support of everyone involved, and we are deeply thankful.

The fallopian tube is an organ directly connected to the beginning of life, yet it has received insufficient attention throughout medical history. Building on this selection, we will accelerate R&D that goes beyond diagnostic innovation through endoscopy — pursuing new treatment methods, applying AI to unlock the mysteries of fertility, and extending into oncology research — to approach this small but vital organ from every possible angle. To watch over the beginning of life and breathe new vitality into it through the power of life science, we will carry ourselves with the pride of an AMED-selected company and continue to move forward with even greater strength."

Comments from Investors

Yujiro Maeda, Representative Director, BD Fund, Inc.

"infuse Life Science is a startup taking on an uncharted frontier of medicine tied to the beginning of life. The fallopian tube is a vital organ essential to human birth, yet one that has long been left behind by technological innovation. Facing that reality, CEO Saito's drive to move the business forward, combined with co-founder Dr. Suzuki's deep clinical insight, gives this challenge real substance. The team built around these two isn't simply building a medical device — they carry a strong resolve to advance women's health, reproductive medicine, and the future of life itself. We were deeply moved by their passion and execution, and that conviction led us to this investment."

Masataka Izumi, Business Development Analyst, Incubate Fund, Inc.

"Through more than a year of conversations with CEO Saito and CMO Dr. Suzuki, I've learned just how deep the world of medicine and life science runs, and that led us to this partnership. Selection for AMED's Medical-Engineering Collaboration Global Expansion Program is, I believe, further proof of infuse Life Science's technical strength and the soundness of its vision. Despite being essential to human birth, much about the fallopian tube remains unexplained — and I'm genuinely confident that the Company's work will help unlock that, opening the way for more people to live the lives they choose. We will do everything we can to support the Company's continued growth."

About infuse Life Science, Inc.

Founded in December 2024, infuse Life Science is a life science startup dedicated to women's health and the beginning of life, taking on bold challenges spanning diagnostics, treatment, and biotechnology. Starting from obstetrics/gynecology, reproductive medicine, and perinatal care, the Company's mission is to bring new value to clinical practice.

Company website: https://infuselifescience.com/

Contact: infuse Life Science, Inc. Tel: +81-50-5810-2508 info@infusels.com

インフューズライフサイエンス株式会社、AMED「医⼯連携グローバル展開事業」採択およびBD Fund・インキュベイトファンドからの資⾦調達のお知らせ

卵管内を直接観察する単回使用内視鏡の研究開発に取り組み、卵管診断へのアクセス改善を⽬指します。

インフューズライフサイエンス株式会社

2026年7月14日 14時00分

⼥性の健康と⽣命のはじまりに向き合い、⾰新的ソリューションの創出を⽬指すライフサイエンス・スタートアップであるインフューズライフサイエンス株式会社（本社：東京都、代表取締役CEO：齋藤⼤介、以下「当社」）は、国⽴研究開発法⼈⽇本医療研究開発機構（AMED）令和8年度「医⼯連携グローバル展開事業（研究開発事業）」への採択、およびBD Fund株式会社・インキュベイトファンド株式会社を引受先とする資⾦調達の実施を発表します。

■ 当社が取り組む社会課題

不妊症の主要な原因の⼀つに卵管因⼦があり、その診断には課題があります。標準的検査である⼦宮卵管造影検査（HSG）は実施できる医療機関が限られ、患者さんは地理的・時間的な制約のなかでの受診を強いられています。さらにHSGは卵管の通過性を調べる検査であり、卵管内の状態そのものを評価する点では限界があります。

■ 当社が取り組む研究開発

当社は、卵管内を直接観察することを⽬指した内視鏡の研究開発に取り組んでいます。HSGでは捉えにくい器質的異常を直視下で観察・評価できる⼿法の確⽴を⽬指し、単回使⽤（使い捨て）設計を採⽤することで、従来必要だった複雑な⾼度消毒・滅菌⼯程を不要にし、クリニックでも導⼊しやすい仕組みを狙います。これにより、アクセスしやすい医療機関でより精密な卵管の評価を受けられ、妊娠に向けた意思決定を迅速かつ適切に⽀える——そうした医療の実現を⽬標に開発を進めています。

※本製品は研究開発段階であり、⽇本国内において薬機法上の承認・認証を取得していません。現時点で販売・授与はできません。

■ AMED「医⼯連携グローバル展開事業」採択について

課題名：⼦宮卵管造影検査の代替を⽬指した外来で施⾏可能な単回使⽤卵管鏡システムに関する研究開発

当社が開発を推進する単回使⽤卵管鏡システムは、不妊検査の標準的⼿法である⼦宮卵管造影検査（HSG）の代替を⽬指した内視鏡システムです。外来環境での施⾏を可能とする設計により、患者さんの⾝体的・⼼理的負担の軽減と診療アクセスの改善への貢献を⽬指します。本採択を通じ、⽶国市場展開を視野に⼊れた⾮臨床研究を本格的に推進し、⼀⽇も早い臨床実装に向けた開発を加速させます。

■ 資金調達について

当社はこのたび、グローバルヘルスケアスタートアップ⽀援に深い知⾒を持つBD Fund株式会社、および国内最⼤規模でシードステージに特化した投資を⾏うインキュベイトファンド株式会社を引受先として、資⾦調達を実施いたしました。調達資⾦は、旗艦製品群の研究開発促進および⽶国事業展開に向けた準備に充当します。

■ 代表取締役CEO 齋藤大介コメント

■ 代表取締役CEO 齋藤大介コメント

「このたびはBD Fund様、インキュベイトファンド様からの⼒強いご⽀援、そしてAMED医⼯連携グローバル展開事業への採択という⼆つの節⽬を同時に迎えることができました。これもひとえに関係者の皆様のご⽀援の賜物と、深く感謝申し上げます。

卵管は、⽣命の誕⽣に直接関わる臓器でありながら、その⻑い医療の歴史の中で⼗分な光が当たってこなかった領域です。当社はこの採択を起点に、内視鏡による診断の⾰新にとどまらず、新たな治療法の開発、AIを活⽤した妊孕性解明への挑戦、さらには腫瘍領域の研究開発まで、⼩さくも重要な臓器である卵管に対しあらゆる⼿段でアプローチする研究開発を加速してまいります。⽣命のはじまりを⾒守り、ライフサイエンスの⼒で新たな息吹を注ぎ込むため、AMED事業採択者としての矜持を貫き、その歩みをさらに⼒強く進めてまいります。」

■ 投資家からのコメント

■ BD Fund株式会社代表取締役前田祐二郎コメント

「インフューズライフサイエンス社は、生命のはじまりに関わる医療の未踏領域に、真正面から挑むスタートアップです。卵管は、人の誕生に欠かせない重要な臓器でありながら、長い間、十分な技術革新が届いてこなかった領域です。その現実に対し、齋藤代表の事業推進力で道を切り拓き、共同創業者である鈴木先生は医療現場に根差した深い知見で、その挑戦に確かな重みを与えています。この二人を中心とするチームには、単に医療機器をつくるのではなく、女性の健康、生殖医療、そして生命の未来そのものを前に進めようとする強い覚悟があります。私たちはその熱量と実行力に強く心を動かされ、今回の投資を決断しました。」

◾️インキュベイトファンド株式会社事業開発アナリスト泉雅貴コメント

「齋藤代表及び鈴木CMOと⼀年以上会話をさせていただく中で、医療・ライフサイエンスの奥深さを学びながら今回のご縁をいただきました。AMED医⼯連携グローバル展開事業への採択は、インフューズライフサイエンスの技術⼒と構想の確かさを改めて⽰すものだと感じております。卵管は⼈間の出⽣に⽋かせないにも関わらず未解明な部分が多いですが、当社の取り組みによってそれが解明され多くの⼈が⾃由な⼈⽣を歩める事を⼼から確信しております。同社の成⻑に少しでも貢献できるよう、全⼒で伴⾛して参ります。」

■ インフューズライフサイエンス株式会社について

女性の健康と生命のはじまりに向き合い、診断から治療・バイオ領域まで果敢に挑むライフサイエンス・スタートアップとして2024年12月に設立。産婦人科・生殖医療・周産期領域を起点に、医療現場に新たな価値を届けることを使命としています。

会社ウェブサイト：https://infuselifescience.com/

お問い合わせ先
インフューズライフサイエンス株式会社

Tel：050-5810-2508

info@infusels.com

PR Timesリンク先

infuse Life Science Enters Strategic Partnership with Alira Health

2026-06-18T15:00:00+09:00

Combining Japan-rooted medical device and diagnostics expertise with bio-centric global life sciences strategy to advance healthcare to its next stage

infuse Life Science, Inc. (Headquarters: Hino, Tokyo, Japan; CEO: Dai Saito; hereinafter “iLS”) today announced that it has entered into a regional partnership with Alira Health, a global healthcare advisory firm headquartered in Framingham, Massachusetts, USA.

This partnership unites iLS’s technology, market-insight, and commercialization expertise in the medical device and in-vitro diagnostics (IVD) fields—built from a base in Japan—with the comprehensive life sciences strategy that Alira Health has delivered worldwide, centered on pharmaceuticals and biotech. Together, the two companies will address the complex challenges their clients face in the global market by providing consulting that goes beyond strategy into execution—rolling up our sleeves alongside our clients.

Background

Healthcare has entered an era in which devices, diagnostics, therapeutics, and data converge, and where success depends on designing the full journey—from development through market access to reaching the patient—as a single, seamless line. Yet whether the goal is expanding Japanese companies abroad or bringing overseas companies into Japan and the wider Asian market, there remain very few partners able to accompany clients across the regulatory, clinical, and market environments of each region.

iLS possesses Japan-rooted global life sciences knowledge and experience built on medical devices and diagnostics, with its core in the gynecology, reproductive medicine, and women’s health fields. Its strengths include fluency in both the FDA and PMDA regulatory frameworks and a network spanning the United States, Singapore, and Asia.

Since its founding in 1999, Alira Health has provided integrated services—spanning regulatory, clinical, market access, management consulting, and transaction advisory—to pharmaceutical, biotech, and medical technology companies, delivered globally from its offices across North America, Europe, and Asia. A defining feature is its consistent, patient-centric philosophy.

Synergies

The value created by this partnership can be summarized in three points.

First, the complementarity of devices/diagnostics and bio/pharma. Combining iLS’s deep practical expertise in medical devices and IVD with Alira Health’s strategic foundation centered on bio and pharma enables solution design that spans modalities.

Second, geographic complementarity—Japan and Asia meeting the global stage. Connecting iLS, with its command of the clinical, regulatory, and market landscape across Japan and Asia, with Alira Health’s worldwide footprint including North America and Europe, allows the two companies to support market entry seamlessly in both directions.

Third, end-to-end coverage from strategy through execution. Both companies share the conviction that advice must not end at the recommendation stage, and they will jointly provide consulting that accompanies clients all the way into the execution phase, working from the same vantage point as the client.

Comments

Dai Saito, CEO, infuse Life Science

“Lifting healthcare to its next stage requires the ability to connect devices, diagnostics, bio, and the voice of the patient into a single line. By bringing together our Japan-rooted expertise and the global strategic foundation that Alira Health has built on the world stage, I am convinced we can deliver cross-cutting, executable answers to challenges that until now have been addressed only in isolation. We are committed to rolling up our sleeves alongside our clients and moving global healthcare forward.”

Benjamin Chambon, Co-Chief Executive Officer, Alira Health SAS

“Our long-standing relationships with Japanese clients have shown us the depth of innovation emerging from Japan’s life sciences sector. By investing further in this partnership with iLS, we are reinforcing our commitment to help Japanese companies bring those innovations to global markets.”

About infuse Life Science

infuse Life Science (iLS) is a medtech startup established in December 2024, focused on the gynecology, reproductive medicine, and women’s health fields. Guided by its mission to “observe the beginning of life,” the company develops innovative medical devices and provides consulting in the life sciences field.

About Alira Health, SAS

Alira Health is a global healthcare advisory firm and CRO founded in 1999 and headquartered in Framingham, Massachusetts, USA. Guided by its mission to humanize healthcare and life sciences in partnership with patients, the firm delivers services integrating strategy, execution, and clinical capabilities to pharmaceutical, biotech, and medical technology companies from offices across North America, Europe, and Asia.

Learn more: https://alirahealth.com/

インフューズライフサイエンス、Alira Healthと戦略的パートナーシップを締結

日本発のメディカルデバイス／診断知見と、バイオを軸とするグローバル・ライフサイエンス戦略を融合。世界のヘルスケアを次のステージへ

インフューズライフサイエンス株式会社（本社：東京都日野市、代表取締役CEO：齋藤大介、以下「iLS」）は、グローバル・ヘルスケアアドバイザリーファームであるAlira Health（本社：米国マサチューセッツ州フラミンガム）と、ライフサイエンス分野における地域パートナーシップを締結したことをお知らせします。

本提携は、日本を起点としたメディカルデバイス・体外診断（IVD）領域でのiLSの技術・市場インサイト・事業化の知見と、製薬・バイオを中心にAlira Healthが世界規模で展開してきた包括的なライフサイエンス戦略を掛け合わせるものです。両社は、クライアントが直面するグローバル市場の複雑な課題に対し、戦略立案にとどまらず実行まで踏み込んで「共に汗をかく」コンサルティングを提供してまいります。

提携の背景

ヘルスケアは、デバイス・診断・治療・データが融合し、開発から市場アクセス、患者への到達までを一気通貫で設計することが求められる時代に入っています。一方で、日本企業の海外展開、海外企業の日本・アジア参入のいずれにおいても、地域ごとの規制・臨床・市場環境を横断して伴走できるパートナーは限られているのが実情です。

iLSは、産婦人科・リプロダクション・女性ヘルスケア領域の医療機器開発を中核に、メディカルデバイスと診断薬を軸とした日本発のグローバルなライフサイエンス知識と経験を有しています。FDA／PMDA双方の規制フレームワークに精通し、米国・シンガポール・アジアにわたるネットワークを持つことが強みです。

Alira Healthは、1999年の設立以来、製薬・バイオテック・メディカルテック企業を対象に、レギュラトリー、クリニカル、マーケットアクセス、マネジメントコンサルティング、トランザクションアドバイザリーにわたる統合的なサービスを、北米・欧州・アジアの拠点からグローバルに提供してきました。「患者中心（patient-centric）」を一貫した思想に据えている点が大きな特徴です。

両社のシナジー

本提携が生み出す価値は、次の3点に集約されます。

第一に、デバイス／診断 × バイオ／製薬の補完性です。iLSのメディカルデバイス・IVDにおける深い実務知見と、Alira Healthのバイオ・製薬を中心とした戦略基盤を組み合わせることで、モダリティを横断したソリューション設計が可能になります。

第二に、日本・アジア × グローバルの地理的補完性です。日本を起点にアジアの臨床・規制・市場に通じたiLSと、北米・欧州を含む世界規模のAlira Healthの基盤が結びつくことで、双方向の市場参入をシームレスに支援します。

第三に、戦略から実行までの一気通貫です。両社はいずれも「提言で終わらせない」ことを信条としており、クライアントと同じ目線で実行フェーズまで伴走するコンサルティングを共同で提供します。

インフューズライフサイエンス株式会社代表取締役CEO 齋藤大介

「ヘルスケアを次のステージへ引き上げるには、デバイス、診断、バイオ、そして患者の声を一つの線でつなぐ視点が欠かせません。日本発の私たちの知見と、世界を舞台にしてきたAlira Healthの戦略基盤が重なることで、これまで個別最適に留まっていた課題に、横断的かつ実行可能な答えを出せると確信しています。私たちはクライアントの皆様と共に汗をかき、世界のヘルスケアを前に進めることにコミットします。」

Alira Health SAS 共同代表ベンジャミ・シャンボン

「日本のクライアントとの長年にわたる関係を通じて、私たちは日本のライフサイエンス分野から生まれるイノベーションの奥深さを実感してきました。iLSとの本提携にさらに投資することで、日本企業がそうしたイノベーションをグローバル市場へ届けることを支援するという私たちのコミットメントを、いっそう確かなものにします。」

インフューズライフサイエンス株式会社について

インフューズライフサイエンス株式会社（iLS）は、2024年12月に設立された、産婦人科・リプロダクティブメディシン・女性ヘルスケア領域を中心とするメドテックスタートアップです。「Observe the beginning of life.（生命の始まりを見守る）」をミッションに、革新的な医療機器の研究開発と、ライフサイエンス分野のコンサルティングを手がけています。

Alira Healthについて

Alira Healthは、1999年設立、米国マサチューセッツ州フラミンガムを本拠とするグローバル・ヘルスケアアドバイザリーファーム兼CROです。「ヘルスケアとライフサイエンスを患者と共に人間味あるものにする」をミッションに掲げ、北米・欧州・アジアの拠点から、製薬・バイオテック・メディカルテック企業に対し、戦略から実行・臨床までを統合したサービスを提供しています。

詳細：https://alirahealth.com/

infuse Life Science Completes Prototype of Simplified Infertility Treatment Catheter

2026-03-12T00:00:00+09:00

Tokyo, Japan – March 12th, 2026 – infuse Life Science Co., Ltd. announced that it has completed the prototype development of a catheter for infertility treatment under the “Medical Device Industry Entry Promotion Subsidy Program” administered by the Tokyo Metropolitan Small and Medium Enterprise Support Center.

The project focused on exploring a new design approach aimed at simplifying mechanisms that are often complex in existing therapeutic medical devices. By reducing structural complexity, the prototype is designed to improve usability for clinicians and may enable certain procedures to be performed in outpatient clinical settings.

While specific technical details are not disclosed at this stage due to ongoing intellectual property considerations, the successful completion of the prototype represents an important milestone toward further development, validation, and potential commercialization.

infuse Life Science believes that simplifying device architecture while maintaining clinical functionality may contribute to improving accessibility and efficiency in reproductive healthcare.

The company will continue advancing research and development in collaboration with clinical partners and industry stakeholders, aiming to bring innovative life science technologies to the field of reproductive medicine.

This development project was supported by the Tokyo Metropolitan Small and Medium Enterprise Support Center through its Medical Device Industry Entry Promotion Subsidy Program.

Related Grant Program
Tokyo Metropolitan Small and Medium Enterprise Support Center
Medical Device Industry Entry Promotion Subsidy Program
https://www.tokyo-kosha.or.jp/support/josei/medical/r7medical20.html

Company
Infuse Life Science Co., Ltd.
Tokyo, Japan
https://infuselifescience.com/

Forward-Looking Statements: This press release contains forward-looking statements regarding future plans and expectations. Actual results may differ due to various factors. The device has not been approved for sales by the authorities yet.

東京都中小企業振興公社「医療機器産業参入促進助成事業」における
不妊治療用カテーテル試作開発完了のお知らせ

インフューズライフサイエンス株式会社は、公益財団法人東京都中小企業振興公社が実施する「医療機器産業参入促進助成事業」の支援を受けて進めてきた不妊治療用カテーテルの試作開発を、このたび完了いたしました。

本プロジェクトでは、不妊治療に用いられる医療機器において既存技術では複雑になりがちな機構を簡略化する新しい設計アプローチの検討を行いました。これにより、医療従事者の操作性向上や、将来的には外来ベースでの治療への応用可能性が高まることが期待されます。

なお、本技術の詳細については知的財産保護の観点から現時点では公表を控えておりますが、本試作の完了は今後の開発・検証および実用化に向けた重要なマイルストーンとなります。

当社は今後も、臨床現場および産業パートナーとの連携を通じて、生殖医療分野における革新的医療技術の研究開発を進めてまいります。

将来見通しに関する注意事項

本プレスリリースには、将来の計画や期待に関する将来見通しを含む記述が含まれています。実際の結果は、さまざまな要因により異なる可能性があります。また、本製品は薬機法等未承認です。

infuse Life Science Completes Tokyo Met Small & Medium Enterprise Support Center Femtech Project

2026-01-14T00:00:00+09:00

Tokyo, Japan – January 14th, 2026 – infuse Life Science, Inc. is proud to announce the successful completion of the FY2024 Femtech Development Support and Promotion Project, a flagship initiative by the Tokyo Metropolitan Small and Medium Enterprise Support Center. Following a rigorous audit and final verification process, the company has officially received the grant funding, validating the technical maturity and operational integrity of the project.

This initiative centered on the development of a next-generation diagnostic medical device designed for the early detection of infertility causes. By providing a radiation-free, non-invasive alternative to traditional radiology-based diagnostics, infuse Life Science aims to significantly lower the barriers to early screening in reproductive health.

Dai Saito, CEO of infuse Life Science, Inc., stated:

“The successful close of this grant project is a testament to our team's efficiency and dedication to excellence. This milestone does more than just secure funding; it validates our mission to revolutionize women’s healthcare with safer, more accessible technology. As we pivot to our next growth phase—accelerating clinical trials and navigating the regulatory path toward a 2027 market launch—we are well-positioned to lead the transformation of the global femtech landscape.”

About infuse Life Science, Inc.

infuse Life Science, Inc. is a Tokyo-based startup specializing in AI-integrated medical devices for gynecology and reproductive health. Our solutions address unmet needs in infertility, oncology, and perinatal care, empowering women with safer, more accessible diagnostic tools. For more information, visit https://infuselifescience.com/ or contact us at 050-5810-2508.

インフューズライフサイエンス、東京都中小企業振興公社フェムテック事業を完了　革新的な不妊原因診断デバイス試作に対し助成金が正式交付

東京、日本 – 2026年1月14日 – インフューズライフサイエンス株式会社は、東京都中小企業振興公社が推進する令和6年度（2024年度）フェムテック開発支援・普及促進事業を無事完了したことを発表いたします。厳格な監査および最終検証プロセスを経て、当社は助成金の正式交付を受け、本プロジェクトの技術的成熟度と運用上の健全性を証明しました。

本事業は、不妊原因の早期発見を目的とした次世代診断医療機器の開発に焦点を当てたものです。従来の放射線を用いた診断法に代わる、放射線被ばくゼロの非侵襲型代替手段を提供することで、当社は生殖医療分野における早期スクリーニングの障壁を大幅に低減することを目指しています。

インフューズライフサイエンス株式会社　代表取締役CEO　齋藤大介のコメントです。

「この助成事業の成功裏の完了は、当社チームの効率性と卓越性への献身を物語っています。このマイルストーンは単なる資金確保にとどまらず、より安全でアクセスしやすい技術によって女性のヘルスケアに革命を起こすという私たちの使命を裏付けています。今後、臨床試験の加速と規制当局への申請を進め、2027年の市場投入を目指す次の成長フェーズに移行します。私たちは、グローバルなフェムテック分野の変革をリードする準備が整っています。」

インフューズライフサイエンス株式会社について

インフューズライフサイエンス株式会社は、東京を拠点とするスタートアップ企業で、産婦人科および生殖医療分野におけるAI統合型医療機器を専門としています。不妊、腫瘍学、周産期ケアにおける満たされていないニーズに対応し、女性に、より安全でアクセスしやすい診断ツールを提供しています。詳細は https://infuselifescience.com/ をご覧いただくか、050-5810-2508 までお問い合わせください。

将来見通しに関する注意事項

New Year Greetings 2026

2026-01-01T00:00:00+09:00

Happy New Year 2026🎠

As we welcome the new year, we at infuse Life Science, Inc. extend our heartfelt greetings and deepest gratitude to all our stakeholders, partners, clients, and supporters for your continued trust and collaboration throughout 2025.

This past year has been one of remarkable progress and achievement across our core initiatives. In our medical device development efforts, the prototype phase for our innovative diagnostic device aimed at early detection of infertility has been successfully completed, and we look forward to announcing these exciting results through an upcoming press release. Similarly, development of our therapeutic medical device is progressing smoothly, with key achievements expected to be reported as early as January.

Our consulting business has also thrived, thanks to your invaluable support. We are proudly advancing four clients across six projects, each delivering significant outcomes and impactful results.

In the cardiovascular field, we marked a milestone by participating as a sponsor in the GREAT network meeting 2025 for the first time, which has notably increased awareness and recognition of our work among key opinion leaders in emergency and intensive care medicine in Europe and the United States.

https://www.greatnetwork.org/site/our-supporting-partners/

Reflecting on Key Advances in Reproductive Medicine in 2025

The field of reproductive medicine saw remarkable progress in 2025, with several groundbreaking developments that promise to transform diagnosis, treatment, and outcomes for patients facing infertility.

One of the most exciting advancements was the evolution of AI-driven embryo selection systems. A foundational model known as FEMI, trained on millions of time-lapse embryo images, demonstrated superior performance in predicting euploidy (chromosomal normality), blastocyst quality, and other key metrics compared to traditional manual grading and earlier AI models. This non-invasive technology achieved high accuracy in implantation potential assessment, potentially leading to improved implantation rates, higher live birth success, and reduced risks such as miscarriage—offering a more standardized and efficient approach to embryo selection in IVF cycles.

https://www.nature.com/articles/s41467-025-61116-2

Another significant breakthrough came in our understanding of polycystic ovary syndrome (PCOS), a leading cause of infertility. Research identified four distinct subtypes of PCOS—hyperandrogenic, obesity-related, high-SHBG, and high-LH/AMH—through data-driven clustering of clinical variables across large international cohorts. These subtypes differ in metabolic risks, reproductive outcomes, and complications, enabling more personalized diagnosis and treatment strategies. For instance, certain subtypes showed higher live birth rates or specific risks like ovarian hyperstimulation, paving the way for tailored interventions that could enhance fertility preservation and overall patient care.

https://www.nature.com/articles/s41591-025-03984-1

Finally, on the policy front, the Trump administration advanced initiatives to expand access to infertility treatments, including efforts to reduce costs for fertility medications and encourage employer-based coverage options. Notably, there was increased attention to Restorative Reproductive Medicine (RRM), an approach supported by conservative and Catholic-aligned groups that emphasizes identifying and treating root causes of infertility through holistic methods, lifestyle interventions, and natural fertility restoration—rather than relying primarily on artificial techniques like IVF. This alignment with promoting natural conception resonates deeply with emerging paradigms that prioritize underlying health restoration, offering a complementary pathway for patients seeking ethical and root-cause-focused solutions.

https://www.wsj.com/opinion/want-babies-treat-infertilitys-root-causes-ivf-rrm-boom-trump-fe49bb4b

These developments underscore a dynamic year of innovation and policy evolution in reproductive health, bringing hope to countless individuals and families.

Looking Ahead to 2026 with Renewed Commitment

As we step into 2026, infuse Life Science, Inc. is poised for an exciting phase of growth and impact. We are committed to transitioning our innovative medical device into full-scale production development, ensuring they reach patients and healthcare providers worldwide.

To uphold the standards of quality and safety, we will advance our development processes in compliance with QMSR (Quality Management System Regulation) and QMS (Quality Management System) requirements, with the goal of achieving ISO 13485 certification—a milestone that will strengthen our global credibility and facilitate broader market access.

Furthermore, we aim to deepen collaborations with key opinion leaders across reproductive and cardiovascular medicine on an international scale, fostering knowledge exchange and innovation. Building on this momentum, we will further expand and strengthen our consulting business, delivering even greater value to our clients through cutting-edge expertise and successful project outcomes.

With gratitude for your continued partnership and inspired by the remarkable advancements in reproductive medicine throughout 2025, we look forward to a year of meaningful progress, ethical innovation, and lasting contributions to patient care.

Wishing you a prosperous and joyful 2026.

Dai Saito, CEO.

infuse Life Science, Inc.

謹賀新年 2026

新年を迎え、インフューズライフサイエンス株式会社一同より、ステークホルダーの皆様、パートナーの皆様、クライアントの皆様、そしてこれまで支えてくださった全ての支援者の皆様に、心より新年のご挨拶と感謝を申し上げます。2025年も変わらぬご信頼とご協力をいただき、誠にありがとうございました。

昨年は、当社の中核事業において目覚ましい進展と成果を上げた一年となりました。不妊の早期発見を目指す革新的な診断機器については、試作開発フェーズを無事完了し、近日中にプレスリリースにてその成果を発表できる運びとなりました。また、治療用医療機器の開発も順調に進んでおり、1月には主要な成果を助成金事業ご採択元へご報告できる見込みです。

コンサルティング事業におきましても、皆様のご支援のおかげで大きな成長を遂げました。現在、4社のクライアントに対し6つのプロジェクトを推進しており、それぞれにおいて顕著な成果を上げております。

循環器領域では、初めてGREATシンポジウムに賛助参加するというマイルストーンを達成し、欧米の救急・集中治療分野のキーオピニオンリーダー（KOL）への認知が大幅に向上しました。

2025年生殖医療分野のホットトピック

2025年の生殖医療分野は、不妊に悩む患者さんの診断・治療・予後を大きく変革する可能性を秘めた、数々の画期的な進展が見られました。

最も注目すべき進歩の一つは、AIによる胚選択システムの進化です。数百万枚のタイムラプス胚画像で学習された基礎モデル「FEMI」は、従来の手動グレーディングや従来のAIモデルを上回る性能を示し、染色体正常性（euploidy）、胚盤胞の質、その他の重要指標を高精度に予測しました。この非侵襲的な技術は、着床可能性の評価精度を飛躍的に向上させ、着床率の改善、生児獲得率の上昇、流産リスクの低減を実現する可能性があり、IVFサイクルにおける胚選択のより標準化された効率的な手法を提供します。

もう一つの大きなブレークスルーは、多嚢胞性卵巣症候群（PCOS）に関する理解の深化です。不妊の主要原因であるPCOSについて、大規模国際コホートにおける臨床変数のデータ駆動型クラスタリングにより、4つの明確なサブタイプ（高アンドロゲン型、肥満関連型、高SHBG型、高LH/AMH型）が同定されました。これらのサブタイプは、代謝リスク、生殖予後、合併症において異なり、より個別化された診断・治療戦略を可能にします。例えば、あるサブタイプでは生児獲得率が高く、別のサブタイプでは卵巣過剰刺激症候群のリスクが高いことが示され、個別化された介入により妊孕性温存と患者ケア全体の向上が期待されます。

最後に、政策面では、トランプ政権が不妊治療へのアクセス拡大に向けた取り組みを推進し、治療薬のコスト低減や企業による保険適用促進を図りました。特に注目されたのは、Restorative Reproductive Medicine（RRM：修復生殖医療）への関心の高まりです。保守派やカトリック系団体が支持するこのアプローチは、ホリスティックな手法、生活習慣介入、自然な妊孕性回復を通じて不妊の根本原因を特定・治療することに重点を置き、IVFなどの人工的な手法に過度に依存しないことを特徴とします。自然妊娠を促進するこの方向性は、根本的な健康回復を優先する新たなパラダイムと深く共鳴し、倫理的かつ根因治療を求める患者さんに補完的な選択肢を提供します。

これらの進展は、生殖医療分野におけるイノベーションと政策のダイナミックな進化を示すものであり、多くの個人と家族に希望をもたらしました。

2026年への抱負

2026年を迎え、インフューズライフサイエンス株式会社はさらなる成長とインパクトのステージに立っています。診断用医療機器を量産開発フェーズへと移行させることに全力で取り組んでまいります。これにより、世界中の患者さんや医療従事者の皆様のお手元に製品をお届けできるようにいたします。

品質と安全性の水準を維持するため、QMSR（Quality Management System Regulation）およびQMS（Quality Management System）省令に準拠した開発プロセスを推進し、ISO 13485認証の取得を目指します。このマイルストーンは、当社のグローバルな信頼性を強化し、より広い市場アクセスを実現するものです。

さらに、生殖医療および循環器医療の国際的なキーオピニオンリーダーとの連携を深め、知識交換とイノベーションを促進します。この勢いを活かし、コンサルティング事業もさらに拡大・強化し、最先端の専門性とプロジェクト成功により、クライアントの皆様にさらなる価値を提供してまいります。

2025年の生殖医療の目覚ましい進展に触発され、皆様とのパートナーシップに感謝しつつ、2026年は意義深い進歩、倫理的なイノベーション、そして患者ケアへの持続的な貢献を実現する一年となることを楽しみにしております。

皆様のご多幸とご発展を心よりお祈り申し上げます。

齋藤大介, 代表取締役CEO

インフューズライフサイエンス株式会社

Declares "SECURITY ACTION" One Star, Committing to Robust Information Security

2025-12-01T12:00:00+09:00

infuse Life Science, Inc. today announced that it has successfully declared the “SECURITY ACTION” One Star level, an information security self-declaration program promoted by the Information-technology Promotion Agency (IPA) of Japan.

This declaration signifies iLS's commitment to implementing the fundamental "Information Security 5 To-dos" (情報セキュリティ5か条) recommended by the IPA. By making this public commitment, we aim to ensure the safe and reliable handling of information for our customers and business partners.

2025 3Q Progress Report

2025-10-22T20:00:00+09:00

Time truly flies! We are thrilled to announce the celebration of infuse Life Science's 1st anniversary on October 1st. We are steadily approaching the realization of the vision we promised that day: to use the power of life science to solve Japan and the world's demographic challenges, particularly the declining birthrate.

This report details our progress over the nine months leading up to this milestone.

1. Research & Development in Ob-Gyn

The planned functional prototype has been successfully completed and is now in excellent operational condition. We are developing a specialized, multi-product lineup focused on the vital yet often underfunded field of Ob-Gyn—a market deemed small but highly significant, often overlooked by larger corporations.

This prototype represents a crucial step in our strategy to expand our offerings across the entire clinical pathway: observation, examination, diagnosis, and ultimately, treatment.

Based on this successful result, we have initiated collaboration discussions with several key investors and medical device manufacturers, receiving overwhelmingly positive feedback and strong indications of interest from nearly all parties. The next phase involves transitioning to final product development, operating under a robust QSR/QMS/ISO13485 level.

2. Consulting Business

As detailed on the Services page of our website, our business model education and consulting services continue to be highly regarded. We encourage you to read the testimonials and contact us today. We promise to provide proposals—in terms of content and pricing—that are precisely aligned with your company's specific needs and demands.

3. Staff Recruitment

As we enter this critical new phase of growth and development, we are actively seeking passionate staff members. Join us in the fight against global and domestic demographic challenges, leveraging cutting-edge medical devices to address the declining birthrate. We need your skills and dedication to stand with us.

While we enjoy the arrival of autumn, we are also mindful of the intense spread of infectious diseases. We wish everyone good health and continued well-being.

The devices are not approved as medical device. These are aiming at introducing our business to the investors, but not intend to show to the medical professionals or patients.

2025 2Q/First Half Progress Report

2025-08-01T00:00:00+09:00

Seven months have passed since our incorporation last December, and we are pleased to report significant progress. In these complex times, our company and every one of our employees are working diligently toward a new dimension of medicine that no one has yet explored.

Here are the two key updates on our business activities for the second quarter.

1. R&D in the Obstetrics and Gynecology Field

We were aiming to complete our prototype by the end of June. However, due to a delay in procuring some components and the development of new features and patentable inventions, the prototype was finalized at the end of July. We expect to complete all non-clinical evaluations by mid-August. While there has been a slight delay, we consider it a positive one that will benefit our future endeavors.

2. Consulting Business

Thanks to the strong reception, we now have six projects running simultaneously, starting with our very first client. We've also begun negotiations with potential clients in the drug discovery field, aiming to diversify our services. Furthermore, we've received an order from a client in India, which is helping us to further our international expansion.

Japan is currently experiencing a severe heatwave.

Please take care of yourselves.

The devices are not approved as medical device. These are aiming at introducing our business to the investors, but not intend to show to the medical professionals or patients.

infuse Life Science, Inc. Selected for Tokyo Metropolitan Femtech Grant

2025-02-20T14:00:00+09:00

Tokyo, Japan – [February 20th, 2025] – infuse Life Science, Inc. has been selected for a grant for the Reiwa 6th (Fiscal Year 2024) Femtech Development Support and Promotion Project by The Tokyo Metropolitan Small and Medium Enterprise Support Center.

This grant will be used to further develop our innovative ob-gyn diagnostic medical device, which aims to improve the current standard of care by replacing radiology-based methods and enhancing women's lives.

Dai Saito, CEO of infuse Life Science, Inc., expressed his enthusiasm for being selected for this prestigious project. "We are committed to diligently working to bring our product to market as soon as possible, thereby contributing to improved women's healthcare," said Saito.

Receive second pass notification of the Tokyo SME grants for the therapeutic method

2024-12-02T00:00:00+09:00

infuse Life Science, Inc., a pioneering research-driven startup focused on revolutionizing the life sciences for the Ob-GYN healthcare industry, today announced that it has been selected as a finalist of the Tokyo SME grant. This grant will support the development of the company's second product, which follows its previously Tokyo SME grant-selected diagnostic method.

The selection is an important step to the company's commitment to innovation and its strong track record in research and development. This latest product, combined with our existing diagnostic solution, will enable us to offer a comprehensive suite of products to address unmet needs in the life sciences field.

“This notification of grant approval is a testament to the broader understanding of our vision beyond a single product, but as a comprehensive solution,” said Dai Saito, CEO of infuse Life Science, Inc. “We are committed to working diligently to bring these products to clinical implementation as soon as possible.”

infuse Life Science is incorporated, and welcomes Dr. Yukio Suzuki as CMO & Co-Founder

2024-12-02T00:00:00+09:00

We are pleased to announce that we have officially become a corporation and are embarking on a new chapter of growth. Concurrently, we are thrilled to welcome Dr. Yukio Suzuki as our new Chief Medical Officer and Co-Founder.

As a corporation, we will be able to accelerate our business initiatives and pursue our vision to provide innovative breakthrough methods in Ob-Gyn medical solutions. By focusing on developping technology in women's health, we aim to achieve continuous growth of the business and drive sustainable world population issues.

Under Dr. Suzuki's leadership in our medical affiars, we will expedite the Ob-Gyn medical products R&D and clinical evaluation to strengthen and expand our business pipeline.

We are committed to providing innovative solutions to address the critical issue of women's health. We appreciate your continued support.

Tokyo SME development grant, 1st round passes

2024-11-21T15:00:00+09:00

Tokyo metropolitan SME support center advised on October 20, 2024 that one of our applications for a groundbreaking medical device development grants for women's health has advanced to the final round. This grant will enable us to maximize design possibilities and improve the lives of women worldwide.

blog updates

2024-11-15T10:50:00+09:00

We periodically update our blogs to keep connecting the world to infuse LS.

Under the circumstance of limitation which allows us to disclose R&D status in this beginning of the business phase, we love to have your attention and interests to our challenge for innovation.

Please drop by and check our blogs.

we are thrilled to announce the launch of Infuse Life Science on October 1st.

2024-10-01T17:00:00+09:00

Our headquarters is located in Akishima City, Tokyo, at the Incubation Office TAMA, supported by the Tokyo Metropolitan SME Support Center. We are currently operating as a private LLC and plan to incorporate in December.

This is just the beginning of our life. We'll be sharing more details about our business and R&D initiatives soon.

Thank you for your continued interest and support.

CEO Dai Saito

令和6年10月1日、東京都中小企業振興公社様のご支援のもと、インフューズライフサイエンスを無事に創業いたしました。

インフューズは、産婦人科領域、Women's Healthにおいて、従来の日本固有のクラシカルな技術にAIを融合させた世界初の革新的な製品開発を進めています。スタートアップならではの機動性を活かし、一日も早く臨床現場へ製品を届けることを目標に、事業を推進してまいります。

これまで解明が難しかった領域に新たな選択肢を提供するため、東京都多摩を起点として、アメリカをはじめとする世界へ積極的に展開してまいります。日々革新に挑戦し、さらなる発展を目指してまいりますので、今後とも温かいご支援を賜りますようお願い申し上げます。

代表齋藤大介