AcuVu Medical and Hologic Enter Exclusive Distribution Partnership to Advance Integrated Office-Based Hysteroscopy in the U.S.

Recently,AcuVu Medical and Hologic Inc. Reach Exclusive Distribution and Co-Development Agreement in the United StatesHologic will become the exclusive distributor in the United States of AccuBio’s single-use hysteroscope system, the “Hummingbird Scope,” integrating it with Hologic’s existing minimally invasive surgical instruments to promote its adoption. This integration enables “diagnosis-and-treatment-in-one” hysteroscopic procedures, transforming the traditional model where diagnosis and treatment are separate. Meanwhile, both parties will continue to collaborate on developing additional innovative single-use endoscopic products needed for clinical practice.

Akuyu is an international medical device innovator built on the platform of single-use endoscopes, with profound technical expertise in single-use endoscopy and related surgical instruments. The company’s Hummingbird Endoscope has received approval from both the FDA and the NMPA, and is widely used for outpatient and day-case hysteroscopic diagnosis and treatment in renowned hospitals and gynecological clinics worldwide. Hologic is a publicly listed medical device company focused on women’s health, offering a comprehensive product portfolio spanning medical diagnostics, breast health, minimally invasive gynecological surgery, ultrasound imaging, and skeletal health. As a global leader in women’s health, Hologic enjoys strong brand recognition and has established a robust marketing network worldwide.

This strategic partnership will accelerate the adoption and promotion of AccuBio’s Hummingbird Hysteroscope in the United States, enhancing brand influence. Furthermore, the combined product portfolio of AccuBio and Hologic offers a more comprehensive hysteroscopic diagnosis and treatment solution for clinical practice, facilitating the integration of outpatient diagnostic and therapeutic services.Streamlining the diagnosis and treatment process through an "immediate diagnosis and treatment" model saves patients time and costs, reduces physicians' workload, alleviates hospital bed shortages, and curbs national health insurance expenditures.

Hysteroscopy is the clinically recognized gold standard for diagnosing intrauterine pathology. Through hysteroscopy, physicians can directly and clearly visualize intrauterine lesions, such as abnormal uterine bleeding, recurrent miscarriage, infertility, and endometrial polyps. Furthermore, minimally invasive treatments can be performed under direct visualization, preserving the uterus while removing pathological tissue, thereby restoring the morphology and function of the uterine cavity.Offers advantages such as minimal trauma, rapid recovery, and short hospital stays.。

According to the Chinese Expert Consensus on the Diagnosis and Treatment of Endometrial Polyps (2022 Edition), hysteroscopic examination with hysteroscopic resection of endometrial polyps for pathological evaluation is the gold standard for diagnosing endometrial polyps. Compared with hysteroscopically guided biopsy, hysteroscopic diagnosis of endometrial polyps has a sensitivity of 58%–99% and a specificity of 87%–100%. The Clinical Practice Guidelines for Hysteroscopic Diagnosis and Surgery in China (2023 Edition) recommend direct hysteroscopic visualization to assess uterine cavity morphology, the extent of endometrial injury, and the distribution of residual endometrium as the preferred method for preoperative evaluation before adhesiolysis for intrauterine adhesions, assigning it a Grade A recommendation.

In recent years, hysteroscopic technology has advanced rapidly, and hysteroscopic surgery is now recognized alongside open abdominal surgery, transvaginal surgery, and laparoscopic surgery as one of the four fundamental skills in gynecological surgery. The "Standards for Medical Equipment Configuration in Maternal and Child Health Institutions," issued by the National Health Commission, stipulates that secondary-level maternal and child health institutions must be equipped with at least one hysteroscope, while tertiary-level institutions must have at least two.Professor Xia Enlan from the Hysteroscopic Diagnosis and Treatment Center of Fuxing Hospital, Capital Medical University, once stated that 50 million infertility patients and 70 million patients with abnormal uterine bleeding in China require hysteroscopic diagnosis and treatment.

According to a World Health Organization report, approximately 17.5% of adults worldwide are affected by infertility. In the United States, intrauterine lesions are also common gynecological conditions; however, hysteroscopy was adopted earlier there, resulting in high penetration rates for hysteroscopic diagnosis and treatment, as well as high disease treatment rates.

Traditional hysteroscopic diagnosis and treatment often involve complex procedures and prolonged patient waiting times. Meanwhile, traditional reusable hysteroscopes entail high procurement costs and may pose infection risks.Disposable hysteroscopes are single-use and discarded after each procedure, eliminating the need for sterilization management and reducing infection risks. They feature simple, plug-and-play operation, generally requiring no cervical dilation or anesthesia, with minimal trauma. This enables outpatient diagnosis and treatment, promoting the shift of hysteroscopic procedures to outpatient settings.

A number of disposable hysteroscope products have been approved both domestically and internationally. The Hummingbird Hysteroscope has distinguished itself and gained favor among major gynecological device manufacturers, achieving widespread global adoption, owing to its innovative technology and differentiated design.

The primary challenge facing disposable endoscopes is maintaining high performance and ensuring image quality while enabling single-use application. Hummingbird EndoscopeUtilizing the “Diamond Window” patented image processing technology, it can provide clear clinical images, while leveraging self-developed software integrated with a high-performance image signal processing engine,Capable of automatic white balance, automatic signal gain adjustment, and auto-focusing, facilitating clinical procedures.

of AkuYuThe Hummingbird Scope has a minimum outer diameter of just 4.5 mm, eliminating the need for cervical dilation and anesthesia., simplifying the surgical workflow;Compatible with all 5Fr/7Fr/9Fr rigid instruments and the 3mm resectoscope, enabling over 80% of hysteroscopic procedures.; Features triple waterproofing with leak-proof mechanical ingress and egress; supports independent water inflow and outflow for smoother irrigation; the scope body rotates 350° while maintaining a consistently horizontal image, facilitating surgeon observation. Additionally, the product adopts an integrated intelligent design that requires no assembly, ensuring ease of operation. Leveraging these advantages, the Hummingbird Scope is better suited for outpatient or day-surgery settings, enabling immediate diagnosis and treatment.

In 2021, the Hummingbird Hysteroscope was the first to obtain rigorous FDA approval, enabling its overseas application and earning widespread recognition from clinical experts. Dr. Jim Greenberg, Chief of Gynecology at Boston Children’s Hospital (Harvard-affiliated), commented: “Akoyu’s products offer superior image quality and ease of operation, eliminating my concerns about sterilization.” Dr. Michael Scheiber, Director of the Cincinnati Center for Reproductive Medicine, stated: “Akoyu’s products deliver high-quality images and are very convenient to insert and use. I utilize the HTx40 model for pre-embryo transfer evaluation, and combine the HTx60 model with a morcellator for efficient and convenient removal of polyps and fibroids.”

Following the strategic partnership between Accuview and Hologic, the overseas application of the Hummingbird Scope will be further accelerated. Meanwhile, the Hummingbird Scope has also received approval from China’s National Medical Products Administration (NMPA) this year, and efforts are being vigorously undertaken to promote its clinical adoption within China.

For enterprises, globalization is not merely a challenge of cross-regional operations, but also a test of their international resource integration and collaborative capabilities. By joining forces with strong “allies,” AkuYu has further expanded its overseas business footprint, marking a significant step in the company’s internationalization strategy. Meanwhile, both parties will establish a long-term partnership to jointly develop single-use endoscope products required for clinical practice, prioritizing the U.S. market to create a “lighthouse effect.”

Since its establishment in 2019, AkuYu has adhered to innovation as its foundation.Founder Yu Zengping spent decades in Silicon Valley, USA, engaged in medical device product development and corporate management. He launched multiple globally leading device products, such as the world’s first single-use hysteroscope and the fully automated ultrasound breast cancer detection system, earning him recognition as a “pioneer” in the global single-use hysteroscope field., with extensive experience in management and industrialization.

Meanwhile, Akuyu’s in-house team brings together multidisciplinary talents from medicine, engineering, law, and other fields, possessing keen market insights and efficient execution capabilities. By maintaining close collaborations with renowned clinical experts both domestically and internationally, Akuyu can promptly capture clinical needs and feedback. Consequently, the company is well-positioned to continuously iterate its existing line of single-use hysteroscopes and expand its portfolio of single-use endoscopes and accompanying instruments.

Akuyu is headquartered in Suzhou, with an 800-square-meter R&D center. Its Changzhou branch features a 2,000-square-meter cleanroom workshop, capable of meeting mass production requirements.. Meanwhile,The company has established a research and development center as well as a sales and service center in Silicon Valley, USA.. In both the Chinese and U.S. markets, Akuyu boasts sustainable development advantages, enabling it to deliver rapid and comprehensive services.

According to Boston Scientific, the global market for single-use endoscopes is projected to reach $2 billion in 2024. Meanwhile, Frost & Sullivan predicts that China’s single-use endoscope market will experience explosive growth starting in 2022. In the face of China’s vast market and uncertain medical insurance policies, having high-quality products alone is insufficient; an appropriate marketing model is also essential. Through in-depth research, AkuYu has launched a “precision marketing” model to expand its presence in the Chinese market.

In recent years, the growing demand for assisted reproductive technology has driven an increase in the application of hysteroscopic diagnosis and treatment. To address the rapidly increasing patient volume and limited medical resources, the concept of integrating outpatient hysteroscopic diagnosis and treatment is gradually being implemented.

Europe and the United States pioneered outpatient hysteroscopic surgery, leveraging a wide range of disposable hysteroscope products and robust medical resources to achieve “diagnosis-and-treatment-in-one-visit” hysteroscopy, while continuously refining relevant clinical guidelines to standardize outpatient surgical procedures. Akuyu has also participated in promoting outpatient hysteroscopic diagnosis and treatment, facilitating the transition of certain hospitals and clinics from the traditional model of “separate diagnosis and treatment using reusable hysteroscopes” to an integrated “disposable hysteroscope-based diagnosis-and-treatment” model.

In China, the penetration rate of outpatient hysteroscopic surgeries has remained low due to constraints such as product shortages and strained medical resources. However,In the context of uneven distribution of medical resources, scarce inpatient beds at tertiary hospitals, and low diagnosis and treatment rates at primary care institutions, it is even more necessary for China to develop outpatient hysteroscopic surgery.In recent years, with the successive launch of disposable hysteroscopic products and the issuance of guidelines such as the "Chinese Expert Consensus on the Setup and Management Processes for Day-Case Hysteroscopy Surgery Centers," both the government and clinical sectors are vigorously promoting outpatient hysteroscopic diagnosis and treatment.

Through this collaboration with Hologic, AccuUterus will combine its Hummingbird Hysteroscope with globally leading gynecological devices to provide a comprehensive instrument solution for clinical hysteroscopic procedures. This integration facilitates physician operation and promotes the adoption of outpatient hysteroscopic diagnosis and treatment. Furthermore, this long-term partnership with a global giant in gynecological devices will further accelerate AccuUterus’s international expansion and innovation-driven R&D efforts.

Reference: “Experts’ Views | China’s 50 Million Infertility Patients Require Hysteroscopic Diagnosis and Treatment” — Physicians’ Daily