How far is the dream of human beings living to 120 years old?
Stem cells, with a “magic power”, are known as the most promising areas of 21st century regenerative medicine. Stem cells can differentiate into a variety of functional cells, such as a “universal cell”, with the ability to self-renew, multi-directional differentiation, tissue repair.
The medical value of stem cells attracts a large number of institutions. The 2012 Nobel Prize was awarded to Prof. Yamanaka, Professor of Stem Cell, and a number of related clinical studies have since emerged.
What is the stem cell industry like?
At the same time, some people have seen the huge business opportunities of stem cells. They want to share a piece of cake. The so-called “stem cells” are actually making false propaganda. Therefore, the stem cell market was once quite confusing and mixed.
In order to curb chaos, in 2015, China introduced a strict policy, “Cell Cell Clinical Research Management Measures (Trial)”. This is considered to be the most stringent policy so far – only after becoming a “stem cell clinical research filing agency”, the top three hospitals can engage in stem cell clinical research in the name of “clinical research” and “no charge.” The introduction of this policy has cleared the market to a certain extent.
The recent biotech company “Lifecare” is doing serious medical treatment for stem cells and wants to use autologous fat stem cells to help fight aging.
In particular, Lifecare is doing two things, one is to develop automated equipment for autologous fat stem cell extraction, and the other is to provide preventive medical services for stem cell anti-aging.
Lifecare’s stem cell therapy is expected to be primarily for the treatment of degenerative arthritis, followed by a variety of geriatric conditions: orthopedics, gout, diabetes, and may also be suitable for medical beauty. The treatment that Lifecare is developing is to transfer autologous adipose-derived stem cells into the body through veins. The stem cells are transmitted to various tissues and organs of the human body, so it is possible to treat a variety of geriatric diseases at the same time.
International Stem Cell Market Competition Pattern
Overview of the global stem cell research and development situation, the United States, South Korea, Belgium, Australia, Canada, India and other countries, there have been more than 10 stem cell drugs listed, mostly for bone repair and arthritis diseases. For these international stem cell drugs, here is a detailed combing.
Looking at the domestic market, there is still a long way to go from the commercialization of stem cells in China. There are no listed drugs, but 7 new stem cell drugs have been accepted by the Food and Drug Administration, and 3 of them have been approved.Admitted to the clinic. 
Image from stem cell headline
Lifecare’s Business Strategy: Seeking the Fastest Cell Stem Cell Therapy
In this context, what is Lifecare’s positioning? What are the advantages?
Lifecare founder Zhang Zhejia said, “Lifecare wants to do is to quickly commercialize stem cell therapy, and the threshold for research and development is lower than drugs.”
The equipment and medical technology developed by Lifecare is an autologous fat-extracted mesenchymal stem cell that belongs to the FDA-361 test standard.
One of its advantages is that it does not require in vitro amplification, genetic modification, cell culture and other processes. Other stem cell technologies, such as the use of allogeneic placenta and cord blood to separate stem cells, are too small to be cultured and expanded to a certain amount before they can be returned. Autologous fat-extracted mesenchymal stem cells are about 1000–2500 times more than bone marrow in the same volume and 100,000 times more cord blood. According to Lifecare, adult 150ml of fat can extract about 500 million mesenchymal stem cells, a quantity sufficient to treat sub-health problems associated with aging, such as degenerative arthritis.
In addition, because it is an autologous stem cell, the return of the day will not cause problems related to immune rejection and cell canceration during culture. The only concern is the bacterial contamination problem in the extraction process, so Lifecare is developing an automatic separation instrument for stem cells, and plans to use automated equipment instead of manual work to avoid bacterial contamination.
In the development of technology and equipment, Lifecare also plans to establish a domestic and international marketing network to establish a stem cell anti-aging preventive medicine center in several cities as a scenario to provide stem cell services. Founder Zhang Zhejia said, “From the perspective of commercialization, we believe that the most important thing is to expand coverage and quickly cover the market. Therefore, we will lower the price in the initial stage. The initial customer price is about 100,000 RMB. This price is compared with the US. About $60,000-70,000 of competing products will be much lower.”
Key to company development: medical approval
For companies in the stem cell industry, the biggest difficulty is getting a medical certificate.
In this regard, Lifecare’s current situation is that Dr. Chang Lanyang, the founder, has done more than 30 clinical trials. Next, Lifecare needs two approvals: approval for stem cell therapy, and a second-class medical device certificate for automated equipment.
In the medical field, this technology has been opened and legal in Europe, the United States, Japan, Taiwan and other countries. According to the FDA-361 regulations, as long as it is an autologous cell that is not modified or proliferated, it is legally applicable to medical treatment.
At present, China is only allowed to open in Hainan Boao Special Zone before the regulations have passed. Therefore, Lifecare will establish the first stem cell anti-aging prevention medical center in Boao, and will expand to other cities after approval by the CFDA in the future. Founder Zhang Zhejia said, “Every clinic needs about 10 million yuan, which is much smaller than the hospital.”
As for the application for medical device certificate, Lifecare expects to complete the prototype in 6-9 months and send it to CFDA. It is expected to obtain the certificate 10-14 months after the test.
So, how does Lifecare plan to earn revenue when it is not approved?
In this regard, Lifecare said that the company plans to sell the device at a low price to the research unit, and also sell consumables. The purpose of low price is to cooperate with scientific research units to obtain research results and experimental data to help apply for medical device certificates. The company said that there are about 115 institutions in China applying for stem cell clinical research, so there is a certain market space in this area. The establishment of Boao Medical Center will also earn income and is expected to open within one year. In addition, this technology can also be applied to veterinary, horse racing and other industries.
The core technology of the team, founder Dr. Chang Lanyang is a biomedical doctor at Vanderbilt University, a professor at Taiwan University, and a researcher at the American Biotechnology Corporation. Pan Hai is a master’s degree in biomedical engineering at Shenzhen University and has 17 years of experience in design and development of medical machinery.
At present, Lifecare is in the process of financing for the first time, with a planned financing of 50 million yuan. The funds will be used for the development and production of consumables for the separation and extraction of fat stem cell automated equipment, cell-related product development, and the Hainan Boao Special Zone Stem Cell Anti-Aging Prevention Medical Center.