Shanghai Stand Medical Technologies Submits IPO Prospectus for Non-Invasive 'Cancer Optoelectrical Graph' Technology Enabling Cervical Cancer Screening at the Mucosal Layer Stage

Cervical cancer is one of the most common cancers in women.

According to data from the International Agency for Research on Cancer (IARC) of the World Health Organization, in 2020, more than 600,000 women worldwide were newly diagnosed with cervical cancer, and over 340,000 women lost their lives to the disease. Early screening is a critical component in the fight against cancer.Studies show that the earlier cancer is detected and intervened upon, the higher the cure rate.

In cancer treatment, a key metric isFive-Year Survival Rate. Since most cancer recurrences and metastases occur within five years after curative surgery, with approximately 80% occurring within the first three years postoperatively and about 10% between years three and five, the probability of recurrence drops significantly after five years.

The five-year survival rate is also used to evaluate the efficacy of cancer treatments. However, for any type of cancer, earlier detection and intervention lead to a higher five-year survival rate, underscoring the importance of early screening.

Professor Song BogenHe has been engaged in pathological research and teaching at the School of Medicine, Tongji University for over 30 years, during whichTumor pathology and novel methods for the early diagnosis of mucosal carcinoma have been his primary research focus for many years.To enable cervical cancer patients to receive effective treatment at an earlier stage, he collaborated with multiple clinical and engineering technology experts over several years to develop a targeted“Cancer Photoelectric Spectroscopy” Detector for Early Cervical Cancer Screening(hereinafter referred to as the Cervical Early Cancer Detector).

According to statistics from the World Health Organization (WHO),In China, there were approximately 150,000 new cases of cervical cancer in 2022.However, 90% of these patients were already at the invasive stage at initial diagnosis, missing the optimal treatment window.resulting in 56,000 annual deaths.These alarming figures have sounded an alarm for the entire society.

To reduce the incidence and mortality rates of cervical cancer, the National Health Commission issued the Action Plan for Accelerating the Elimination of Cervical Cancer in January 2023 and introduced a series of policies to strengthen prevention, control, and early screening for cervical cancer.

In the prevention of cervical cancer, the widespread adoption of the 9-valent HPV vaccine has played a crucial role. However, there have been no breakthrough advancements in treatment. Under current medical technologies, reducing mortality among cervical cancer patients still requires a focus on early screening and early intervention.

Currently, cervical cancer screening is mostly conducted through gynecological colposcopy during physical examinations. However, this method can only detect tissues with obvious pathological changes, which are already at the middle to late stages of disease progression. The existing intrinsic fluorescence imaging technique in clinical practice, similar to traditional colposcopy, also requires acetic acid testing and cannot definitively diagnose malignancy. A definitive diagnosis of cancerous changes can only be confirmed through pathological biopsy.Abnormalities are difficult to detect promptly during routine physical examinations, thereby delaying cancer treatment.

In addition, for other tumors, although endoscopic techniques and imaging modalities can clearly detect the tumor's location, size, morphology, and relationship with surrounding tissues,However, it is not possible to determine the nature of the tumor.Pathological examination of lesion tissue or cells obtained from the patient via surgical resection or fine-needle aspiration is required to determine the benign or malignant nature and grade of the cancer. During this period, patients must endure approximately one week of anxious waiting for the results, during which time physicians are unable to provide precise treatment.

Professor Song Bogen and his team have been researching new technologies for early tumor diagnosis for many years. They deeply recognize that the earlier cervical cancer is detected, the higher the patient’s five-year survival rate.Moreover, treatment yields the best outcomes when administered before a tumor mass forms, at the stage confined to the mucosal layer (intraepithelial neoplasia).

However, tumors at the mucosal stage appear indistinguishable from healthy mucosa. This implies that traditional endoscopy cannot detect tumors at this stage, whereas tissue photoelectric technology can address this limitation.

Tissue Optoelectronic Spectroscopy is a non-invasive, multispectral tissue analysis method.It excites tissues with light of specific wavelengths, generating a tissue-specific multispectral profile from the light reflected after absorption by tissue proteins, known as the tissue photogram. Tumor tissues exhibit their characteristic tissue photogram, referred to as the cancerous tissue photogram, or simply the cancer photogram.Through optical coherence tomography, physicians can identify tumor tissue located 3 mm beneath the mucosa for immediate diagnosis.

Guided by this pathological logic, Song Bogen’s team developed a “Cancer Photovoltaic Map” detector for early-stage cervical cancer, using cervical cancer as the entry point.

The essence of a tumor lies in abnormal cell proliferation. Abnormal cellular differentiation manifests in two aspects: morphological abnormalities and functional and metabolic disturbances.

Abnormal differentiation of cell morphology can be directly observed with the naked eye using microscopy techniques.Currently, the gold standard for clinical cancer screening is based on the assessment of morphological and differentiation abnormalities in tissues and cells.Aberrant differentiation in cellular function and metabolism in tumors leads to the production of abnormal gene products, such as oncoproteins and embryonic enzyme profiles.These products cause tissues to reflect abnormal spectra, which forms the fundamental principle behind cervical precancer screening using early detection devices.

Therefore, in principle, the cervical early cancer detector and pathological diagnosis share a mirror-image relationship.Song Bogen told VCBeat, “Research data show that the accuracy of the cervical early cancer detection device has reached 90%.”However, the team’s development of the cervical early-cancer detection device is not intended to disrupt traditional cancer diagnostic methods, but rather to provide functional diagnosis based on pathophysiology and to assist morphological pathological diagnosis.Improve the accuracy of early screening and provide a new method for immediate pathological diagnosis.

Principle of Cancer Photoelectric Graph (Image source: Provided by the interviewee)

In addition to high accuracy, the cervical early cancer detection device offers a gentler and faster screening method. Traditional monitoring requires obtaining a portion of the lesion tissue for microscopic examination. In contrast, the cervical early cancer detection device utilizes tissue optoelectronic spectrum comparison; by simply inserting the probe into the lesion site, real-time screening can be completed without any waiting period.

This completely non-invasive screening method not only spares patients from pain but also saves testing time, enabling them to receive subsequent treatment more quickly.

The real-time monitoring capability also enables the early cervical cancer detector to play a role in radical surgery. During the procedure, physicians can use the device to check for any residual mucosal-stage cancer that has not been cleared, while minimizing excessive damage to the patient’s organ function.Performing a curative surgery with minimal trauma.Song Bogen introduced, “Much like a detector, the cervical early-cancer screening device can easily and accurately identify potential submucosal malignancies, thereby safeguarding patients’ health.”

Currently, the team has built a technological moat through its independently developed patents, including fiber-optic transmission technology and spectral analysis systems.This cervical early cancer detection device is the team’s third-generation product. The first and second generations have passed clinical trials, while the third generation is exempt from clinical trials.

Optical electrocardiography technology for early cancer detection can also be applied to other mucosal tumors. Building on the cervical early-cancer detection device, the team aims to expand its coverage to include early screening for various luminal organ cancers—such as nasopharyngeal, esophageal, gastric, rectal, and colon cancers—as well as the detection of lymph node metastasis and residual cancerous tissue at surgical margins.

Professor Song Bogen had just celebrated his 61st birthday when he granted the interview. To many, this marks a stage of life where one should be enjoying the comforts of retirement. Yet his passion for medical innovation and strong sense of mission prevent him from “lying flat.”

Faced with unmet needs and challenges in the healthcare sector, he resolutely chose to embark on a new journey. In 2019, he and his team establishedShanghai Sitande Medical Technology Co., Ltd.(hereinafter referred to as: Sitande Medical). In the face of the market, he has maintained the focus and perseverance of a researcher, driving the iterative advancement of the cervical early cancer detection device.

To expedite the clinical adoption of the cervical early-cancer detection device, the team is about to launch a new round of financing.For product provincial packaging approval and new pipeline development. Song Bogen hopes that his more than thirty years of research will not remain confined to textbooks, but will be truly applied in clinical practice, driving progress in healthcare through technological innovation and benefiting more patients.