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Recently, Equipment Home learned that , the United States-based medical device company Xenocor announced that the FDA has approved the enhanced version of its Saberscope, which is the world's first truly high-definition, fog-free, and high degree of freedom, disposable laparoscopy. is designed to improve patient safety and cost and reduce hassles such as fog, smoke and steam, workflow complexity and waste.
As a private medical equipment company focusing on the development and commercialization of innovative laparoscopic equipment, Xenocor's first generation of disposable laparoscopy, XENOSCOPE, was approved by the FDA as early as April 2020. is expected to change the disadvantages of the existing endoscopy (laparoscopy/thoracoscopy), and also has the advantages of low-priced and disposable use.
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Xenocor is a private medical equipment company focusing on the development and commercialization of innovative laparoscopic equipment, headquartered in Salt Lake City, Utah. At the beginning of its establishment, the company formed a strong management team and board of directors, with rich experience in clinical and commercial development, and cooperated with top medical centers. Dr. Dinesh Patel, co-founder and executive board chairman of the company, co-founded and led several biotech companies, many of which were sold or successfully listed before joining Xenocor. includes TheraTech, founded in 1985, a biotech company focused on the development and commercialization of innovative therapies (co-founder, chairman of the board and CEO), sold to Watson Pharmaceuticals for $350 million in 1999. and Ashni, a company specializing in the research, development and marketing of natural products (founder, chairman and CEO) and so on.
Dinesh Patel
At its beginning, Xenocor aimed at providing clinically relevant high-definition imaging to doctors performing minimally invasive laparoscopy. Its goal is to completely change minimally invasive laparoscopy by introducing the company's disposable laparoscopy, a market scope for innovative, single-purpose, high-definition imaging, multi-purpose market. This sector is expected to disrupt the market for high-capital cost laparoscopic systems and greatly expand high-quality surgical services to hundreds of millions of patients around the world.
In April 2020, Xenocor's first generation disposable laparoscopy, XENOSCOPE, was approved by the FDA. is expected to change the disadvantages of existing endoscopy (laparoscopy/thoracoscopy); it has the advantages of low-priced and disposable use. Less than half a year after the company was approved, the company reached a group purchase agreement with Premier, a leading health care company, on the disposable laparoscopy Xenoscope™. It is reported that Premier has joined forces with a coalition of about 4,100 hospitals and 200,000 suppliers in the United States to simplify and change health care. Through integrated data and analytics, collaboration, supply chain solutions, consulting and other services, Premier enables better care and outcomes at a lower cost. The three-year agreement, effective November 1, 2020, allows members of the alliance to take advantage of the pre-negotiated special pricing terms at their sole discretion.
has completed three rounds of financing in less than a year
As a result, the company has also attracted much attention from capital. It has completed several rounds of financing since its establishment. includes a strategic investment made by Barvest Ventures Inc., a member company under Trudell Medical Group, on June 22, 2021, was a strategic investment made by Barvest Ventures Inc., a member company under Trudell Medical Group, which is an innovator and global leader in the field of respiratory care and medical device development. and on April 27, 2021 are invested by Growing Impact Ventures, which will enable Xenocor to increase production and respond to growing demand for Xenoscope™.
and received investments from the Mountain Pacific Investment Fund in October 2020. In other words, after Xenocor was approved for the company's first-generation product, it completed three rounds of financing in less than a year, but the specific amount has not been disclosed.
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The first disposable 5mm laparoscopy with autofocus
It is reported that This time, the Saberscope enhanced version approved by the FDA is the world's first truly high-definition, fog-free, and high degree of freedom. is designed to improve patient safety and cost and reduce hassles such as fog, smoke and steam, workflow complexity and waste. In addition, compared with traditional laparoscopy, which mostly requires refocusing images in multiple quadrants of the abdomen, the autofocus feature of Saberscope enhanced version will truly increase the possibility of rapid adoption in the surgical market.
Before Saberscope, traditional laparoscopic surgery mostly required bulky and expensive equipment, which would bring unnecessary patient risks, troubles, costs, workflow complexity and waste. This includes cleaning problems after multiple uses, which not only complex workflows can also bring the risk of cross infection to patients.
For the approval of Saberscope enhanced version, Xenocor Chief Operating Officer Tony Watson said: "This approval highlights Saberscope's key leadership in all other disposable endoscopes, which is already the most feature-rich laparoscopy approved by the FDA, so this increase makes us further ahead in the value it provides for surgeons and hospitals."
According to reports, the new Saberscope consists of an endoscope and a main mechanism. The endoscope is a 5mm electronic endoscope, has anti-fog function, and can be bent at the front end 90°. The host combines an endoscope camera and a traditional cold light source, which is different from a traditional endoscope camera and a conventional camera light source all-in-one machine with its compact size, simple operation and extremely low power.
The difference between traditional laparoscope devices is that the new Saberscope is very lightweight, both endoscope and host, and is compatible with all high-definition displays , TV, and tablet computers, and has a cost advantage. can also provide high-definition 1080P images and Clearview technology (TM), integrated light source and digital HD camera using plug-and-play technology. Also the first product to have true HD and manual or autofocus options. In addition, the Saberscope outer insulated shell also eliminates the risk of leakage. The low-temperature LED technology used can eliminate the risk of lens heating, avoid the risk of cross-infection when used once, and avoid expensive cleaning and disinfection time and costs.
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Disposable endoscope market blue ocean
The risk of cross-infection of traditional reusable endoscopes still exists and cannot be ignored, that is, it has become the source of cross-infection. In addition, reusable endoscopes also have low penetration rate due to high cost and difficult operation. The emergence of disposable endoscope not only solves the problem of cross infection, but also increases the popularity of endoscopy in terms of cost. If you have enough respiratory endoscopes during the COVID-19 pandemic, you can quickly diagnose the lung tissue condition of new crown patients, improve the utilization efficiency of ventilators, and save more patients.
Currently, the application of disposable endoscopes has covered Galectical internal medicine , urology, gynecology and respiratory dysfunction and other clinical departments with high risk of cross-infection. , and with the continuous improvement of awareness of the benefits of using disposable endoscopes, technological progress and the launch of new products, it is expected to be applied to more clinical departments. In recent years, the disposable endoscope market has also ushered in rapid development.
According to statistics, the global disposable medical endoscope market size has increased from US$108.4 million in 2016 to US$528.3 million in 2020, with an annual compound growth rate of 48.6%. is expected to increase to US$3.3928 billion by 2025, with an annual compound growth rate of 45.1%.
From a domestic perspective, China's disposable endoscope market is an emerging market, with a growth rate higher than the average growth rate of the global disposable endoscope market. has reached RMB 36.8 million in 2020, and is expected to increase to RMB 1.42 billion by 2025, with an annual compound growth rate of 107.6%.
The market for disposable medical endoscopes is emerging in recent years and is highly concentrated. According to Frost & Sullivan data permanently, based on product sales revenue in 2020, the three major manufacturers (i.e. Ambu, Xingfu Factory and General Medical) account for 91.2% of the total domestic market share. With the gradual manifestation of the "consumables" of endoscopes, many domestic and foreign companies have also successively deployed in the field of disposable endoscopes.
Ambu
Ambu launched the world's first disposable flexible bronchoscope Ambua Scope in 2009, and became the absolute king in the field of disposable bronchoscope . Starting from bronchoscopy, Ambu gradually completed the entire industry layout of disposable endoscopy, and has successively launched a variety of disposable endoscopy, duodenoscope, cystoscopy, and disposable endoscopy, covering four major fields: breathing, facial features, urinary and digestion. It is the world's largest disposable endoscopy supplier. Its sales of disposable endoscopes in 2021 reached an astonishing 1.5 million units.
Boston Science
Boston Science is a global high-value medical device giant, and its disposable endoscopy layout begins with urinary and digestive endoscopy, which is most relevant to its business. In December 2019, Boston Science’s world’s first disposable duodenoscopy, EXALT MODEL D, was approved by the US FDA and awarded “Breakthrough Medical Device Certification”.
In May 2021, Boston Science EXALT Type B bronchoscopy obtained CE certification . In August 2021, it was approved by the FDA. It is the latest product in Boston's disposable imaging product portfolio and is suitable for various bronchoscopic surgeries. In addition, its LithoVue™ is the first disposable electronic soft mirror in the true sense. The current product layout has extended to EXALT duodenoscope, bronchoscope, gastroscopy , and SpyGlass cholangoscope.
Karl Stooth
Karl Srorz was founded in 1945 and is committed to providing high-quality endoscopic systems for the fields of human medicine, veterinary and industrial endoscopy. In 2018, it launched its first disposable soft endoscope, marking the beginning of mainstream players in the endoscope industry entering this field. Currently disposable products include nasopharyngeal and esophageal syringoscopy, and disposable ureteral pyeloscopy is expected to be launched within this year.
Xenocor
Xenocor is a private medical equipment company focusing on the development and commercialization of innovative laparoscopic equipment. In April 2020, Xenocor's disposable laparoscopy, XENOSCOPE, was approved by the FDA. XENOSCOPE is expected to change the disadvantages of existing endoscopy (laparoscopy/thoracoscopy).
Pentax Medical
Pentax Medical is a branch of the HOYA Group that provides endoscopic imaging solutions. It is a diversified multinational company with R&D innovation and manufacturing centers in Japan, Europe and the United States. In November 2019, Pentax's DEC HD disposable sterile duodenoscopy was approved for FDA.
Public Medical
Public Medical has been expanding rapidly since its establishment in 2014. It took only two years of marketing promotion time, and its product sales have increased significantly, ranking among the top in the same industry in China.In June 2020, we obtained the registration certificate for disposable ureteral soft lens. We have passed CE and FDA certification for and started overseas sales. The company's future product line also includes disposable nasopharyngeal and laryngeal syringoscopy, disposable bronchoscope, disposable cystoscopy, etc.
Innowei Medical
Innowei Medical was founded in 2009, focusing on the research and development of minimally invasive interventional medical devices. It is China's leading provider of non-vascular interventional surgery integration solutions. To date, it has 31 approved products and 17 under development products in China, the United States, Europe and Japan. In 2014, the company established a subsidiary, Anqing Medical, focusing on medical endoscopes. It is expected that the endoscopic equipment can form a closed loop with consumables to provide an overall solution for minimally invasive surgery . In 2020, Anqing Medical was approved for disposable ureteral soft lens and has launched overseas sales in the early stage.
Xinguangwei Medical
Xinguangwei Medical Xinguangwei Medical was founded in 2016 and has the R&D and production capabilities of disposable endoscopy technology, 3D endoscopy technology, 4k ultra-high-definition endoscopy and fluorescent intelligent navigation technology. On December 23, 2020, it signed a strategic cooperation agreement for with Medtronic on the research and development and commercial promotion of endoscopic innovative products. Many of its disposable electronic endoscope products have entered the clinical, registration, or sales stages in China, the United States, Europe and other countries and regions, and have certain international competitiveness.
Hanmei Medical
Hanmei Medical was founded in 2017. The company independently developed a new generation of CMOS image sensors and an innovative endoscopic system platform that includes endoscopic image processing, early cancer screening, lesion measurement, dynamic light source, precision lumen tube and other technologies. Based on this, it has laid out multiple product pipelines including disposable electronic bladder soft lens, disposable bronchoscope, disposable gastroscopy, etc., realizing consumables and low cost of the endoscopic insertion part.
Xingfu Factory
Anhui Xingfu Factory Medical Equipment Co., Ltd. was established in 2017. It has an internationally leading disposable electronic endoscopy R&D technology platform. It is mainly engaged in the research and development and production of disposable electronic ureteral soft mirrors, cystic soft mirrors, etc. It completed two rounds of equity financing in December 2020 and March this year. It is mainly engaged in the research and development and production of disposable electronic ureteral soft mirrors, cystic soft mirrors, etc. After 3 years of registration and approval, the first Zebra brand disposable electronic ureteral soft mirror in China was approved for listing in NMPA in January 2020.
Huaxin Medical
Huaxin Medical was established in 2018 and has a branch in Shanghai. The main business of the branch is the research and development and sales of medical endoscopes and related devices or consumables. The company's exclusive design, research and development and production of H-SterisSope includes 5 product specifications and is introduced into the US market through Olympus . Olympus is the general agent of Huaxin Medical in the United States.
Northern Tengda
Northern Tengda was established in 2008. On March 17, 2020, NMPA issued an announcement to approve the registration application for the innovative product "disposable use of electronic ureteral pelvic endoscopic catheter" produced by Beijing North Tengda. The product consists of a head end, a bent part, an insertion part, an operating part, a working channel and a connecting part. It is used in medical institutions and cooperates with an image processing device to be used for observation and imaging of the human urethra, bladder, and ureteral renal pelvis.
Ruipai Medical
Ruipai Medical was founded in 2015 on Guangzhou International Bio Island . It is a global supplier of all-use minimally invasive surgery overall solutions. Its product development plan covers urology, gynecology, otolaryngology, gastroenterology, respiratory medicine, general surgery, etc. Ruipai Medical was approved for the registration certificate for disposable ureteral soft lens and disposable electronic vesicle endoscopy in 2020. It is also the company that currently holds the most Class III registration certificates in the field of disposable endoscopy.
Liansert
Liansert was founded in 2017 and is one of the companies focusing on the field of disposable endoscopes. Rooted in gastroenterology, has created products such as disposable ERCP (retrograde cholangiopancreatography) electronic endoscopes, and two products have been approved by the FDA.
Zhiguang Technology
Zhiguang Technology was founded in 2013. Now the company has research and development, operation and production bases in Ningbo, China and Silicon Valley, the United States. The team independently developed the earliest electronic endoscopy gastroenteroscope in China in early 2000. The products under development of include disposable gynecological endoscopes, minimally invasive urology endoscopes, surgical robot vision systems, 3D printers, animal breeding endoscope systems, etc.
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The enhanced version of the disposable laparoscope approved by Xenocor is the world's first disposable 5mm laparoscopy with autofocus. It has an incomparable advantage in improving patient safety and cost. In addition, the addition of its autofocus function will further increase the possibility of rapid adoption of the company's products in the surgical market, which is worth looking forward to in the future.
