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On October 18th The official website of the National Medical Products Administration issued an announcement:
In accordance with the provisions of the " Medical Device Supervision and Administration Regulations ", according to the enterprise application, is now canceling the medical device registration certificate for Heyer Medical AG ventilator (Ventilator), and the registration certificate number: National Machinery Injection 20203083010.
Heyer Medical AG is a century-old ventilator company from Germany. was acquired by the domestic ventilator leader Yian Medical in 2020. In May this year, the German government suddenly proposed to prevent this acquisition on the grounds of public safety issues.
The intervention of the German government caused heated discussions in public opinion for a while.
Although it has a century-old history, by 2018, Heyer had filed for bankruptcy due to financial difficulties. His business conditions were good. Yian Medical, which actively sought overseas market expansion, became Heyer's last life-saving straw.
In 2020, the ventilator market rose sharply. After being acquired by Yian, the Heyer factory started a lot of work and the performance soared 42 million euros, equivalent to RMB 294 million.
bizarrely, was completed in March of that year. It was only two years after Heyer was "rescued" by Yian that the German government turned around and traced the acquisition, saying that wanted to protect important German assets. After the incident, the foreign network commented: Germany did not hesitate to take the most severe measures to protect its economic independence from foreign influences, even companies like Heyer Medical with obvious financial problems may eventually disappear from the market due to bankruptcy.
The cancellation of Heyer products in the country may be the impact of the termination of the acquisition.
01
A century-old German companies will eventually "can't save"?
According to the official website of the Medical Administration Bureau, the ventilator models that were cancelled this time are: iTERNIS ADV, iTERNIS BASE
The scope of application is: it can be used in adults, children, and newborns in the short term or long term (iTERNIS BASE can be optionally equipped with NEO-INF module) patients who need invasive or non-invasive ventilation support, and the main ventilation parameters can be monitored.
is a ventilator that supports both invasive/non-invasive ventilation. obtained a domestic three-category registration certificate after the company's acquisition was completed on August 25, 2020. product agent is Hebei Yian Aomei Medical Equipment Co., Ltd. According to the Qichacha equity penetration diagram, this is a 3100% holding subsidiary of Aomei Medical html.
can be found on the official website of the State Food and Drug Administration. Heyer previously had three registration certificates in China, namely two portable anesthesia machines and one anesthesia system. They were all obtained before the acquisition was completed. At present, these three registration certificates have expired.
That is to say, after this cancellation, all registration certificates for Heyer products in China have been invalidated and have completely withdrawn from the Chinese market.
Looking back at 2020, the joint efforts of Chinese and German companies have created a brilliant win-win situation.
At that time, the epidemic began to sweep across Europe and the United States, and overseas demand for ventilators surged. Originally, the global ventilator market had been dominated by European and American companies, but due to the serious shortage of production capacity, foreign countries relaxed the threshold for ventilator access, and coupled with the support of domestic export policies, domestic ventilators seized the opportunity.
Because Yi'an Medical has early layout in overseas markets and has established branches in the United States, Germany and other countries. At that time, 56 products had obtained EU CE certification. In the ventilator purchase wave, Yi'an's ventilator products VG70 and 510S were hotly hyped. The price of
Yian VG70 ventilator
VG70 has soared. In the past, the ex-factory price was basically over 100,000, but the quotation was no less than 350,000 yuan.In order to rush production, Yi'an Company transformed the production lines of anesthesia machines and operating beds into ventilators. The workers work in three shifts and the machine continues to produce 24 hours a day.
However, there are still obstacles to large-scale production expansion and export of products. Since the core components of the ventilator involve turbine fans, flow pressure sensor , chips, etc., most of them are imported from Swiss company micronel, US Honeywell , Japanese SMC and other companies.
In addition, the after-sales and installation services of export ventilators are also a problem. Suitable for invasive breathing in critically ill patients with respiratory failure, it must be equipped with English manuals, installation videos, FAQs and other auxiliary materials to allow doctors to get started quickly.
So he filed for bankruptcy in 2018. Heyer, who was looking for buyers, hit it off and Yi'an Medical hit it off. In March 2020, all acquisition procedures were completed, and the expansion of ventilator production and the opening of overseas channels were greatly improved, which not only enhanced the technology, but also further opened up the international market.
Hot Springs century-old German company
Heyer's history can be traced back to 1883. Bad Ems, the company's location, is a world-famous hot spring health resort. rumored that the hot springs here are rich in minerals, and inhaling the steam here can play a role in treating respiratory diseases. At that time, the tsars, emperors, ministers and writers all came here to see them.
In order to facilitate steam treatment, mechanic Carl Heyer invented an inhalation device in 883, which does not have to use hot spring steam to achieve therapeutic effects. This device has promoted the popularization of atomization drugs and has also become an opportunity for the company to enter the field of inhalation anesthesia equipment and ventilator manufacturing.
Company focuses on the manufacturing of anesthesia machines and medical ventilators. has offices in China, Malaysia , India, Saudi Arabia and the United States, and its products are sold to 80 countries around the world.
The domestic agent was originally named Heer Medical, but later changed to Heyue Medical.
000, Heyer was held by American investors and operated under the name of HEYER Medical AG, gradually entering a business dilemma. On October 24, 2018, Heyer filed for bankruptcy. As part of the bankruptcy plan, a Hong Kong subsidiary from Beijing Yian participated in the acquisition of shares of previous shareholders and continued to operate the company under the same name after completion.
Heyer flag flying on Yi'an official website
In March 2020, the acquisition was completed in the first month of the official outbreak of the new crown epidemic in Europe. Ventilators in the market became hard currency. Heyer's performance soared that year, with a turnover of 42 million euros, equivalent to RMB 294 million.
Heyer has also become a bridge for Yi'an Medical to expand overseas.
November 15, 2021, the 53rd MEDICA Exhibition was held at the Exhibition Center of Düsseldorf, Germany. Yian Group uses German subsidiary HEYER Medical AG as the platform to show the world "Yan's solutions under the epidemic", focusing on five major areas: respiratory, anesthesia, home sleep, operating rooms, ICU solutions and IVD epidemic solutions.
belated review
Unfortunately, with the intervention of the German government, this mutually beneficial and win-win situation may be over.
According to foreign media, The German Ministry of Economic Affairs and Climate Protection BMWK is the German institution responsible for the review of foreign direct investment. It was not until the acquisition was completed that it realized that it would review and began to intervene in April this year.
Yi'an Medical (Aenomed) submitted a non-objection certificate under Article 58 of the German Foreign Trade Regulations, requiring liquidation through the non-objection certificate (Außenwirtschaftsverordnung – AWV).
From the public information, it is not clear whether Yian Medical is trying to negotiate potential commitments and remedies to enable BMWK to pass the transaction. Since the previous review process took nearly two years, this means that the review period must be extended, while the standard statutory review period is up to about six months.
From the results of the extended review, it is likely that the parties are negotiating remedies. Nearly 6 months have passed, and no more information has been released.
Once the acquisition is determined to be terminated, Heyer, who has experienced bankruptcy, may become the sacrifice sheep for the German government to "protect" its economy.
03
How is the respirator market in the third year of the epidemic?
ventilator production threshold, technical requirements, difficult, and complicated process. market concentration is relatively high. According to MEDCAPTAIN data, in the ICU application market, the market share of invasive ventilator of Jieding Getinge, Hamilton, and Dräger has reached 60% , followed by GE Medical, Medtronic, Weiyaan, Mindray and other companies.
Before 2020, the export products of the life support system department of the leading domestic enterprises were mainly anesthesia machines and electrocardiogram monitoring, and the sales of ventilators in the international market were bleak. In the sales ranking of medical ventilators in China in 2019, medical device giants such as Delger, Philips , and Maikewei are in an advantageous position. The leading domestic companies are Mindray Medical , Shenzhen Koman and Beijing Yi'an.
However, benefiting from the stable initial supply performance of the new crown , the situation has reversed in recent years.
Minery Medical Ventilator
Domestic leader Mindray Medical takes the lead and has obtained dual certifications for the US FDA and EU CE with its products, so it quickly breaks through the European and American markets. not only occupies more than half of the export share of domestic ventilators, but also achieves the goal of first-class domestic market share in 2021.
Data source: JOINCHAIN® Zhongcheng Digital
According to the latest ventilator brand rankings released by Zhongcheng Digital 2022, Mindray still ranks first, among the domestic brands, Koman ranked fourth after Philips, and 5th in the friendship arrangement.
According to Tianyancha February 1 to March 30, 2020, a total of 10 new ventilator companies were added in my country, an increase of 100% compared with the same period in 2019. According to incomplete statistics, as of the beginning of 2021, the industry has achieved exports of more than 30 billion yuan and domestic sales of more than 15 billion yuan. Domestic ventilator suppliers have made significant contributions to the global fight against the epidemic.
Although the market triggered by sudden factors will always be calm, from the demand side, the number of per capita ventilator and ICU beds in China is already quite different from that in developed countries in Europe and the United States. There are only about 6 units/100,000 and 3.6 units/100,000 people respectively. Moreover, the epidemic has sounded the alarm for the construction of public health infrastructure.
In May 2020, the National Development and Reform Commission jointly issued the "Notice on Issuing the Plan for the Construction of Public Health Prevention, Control and Treatment Capacity", which put forward new requirements for the configuration of necessary medical equipment such as cardiopulmonary resuscitation, ventilators, and extracorporeal membrane pulmonary oxygenation (ECMO).
According to the institution, the domestic ventilator market will achieve rapid growth of 20-30% in the future according to the normal market size of about 12 billion yuan in 2019.
Moreover, the ventilator has long working time and easy to lose use characteristics. The normal product life cycle is only about 5 years, and there will be about 20% of the updates every year. As a key device in the life support system, the ventilator market is definitely a blue ocean market with stable growth in the future.
So in the future, will Yian and Heyer be forced to "break up" eventually? How will domestic ventilator companies go to sea? Equipment Home will continue to pay attention.
