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Why do Goldman Sachs and Sequoia Capital favor domestic transcatheter aortic valve replacement (TAVR)?

Date:2016-11-18 14:24
At the end of March,2016, leading investment bank Goldman Sachs Group Inc. has injected $37 million into Chinese medical device company Venus Medtech (Hangzhou) Inc. Venus Medtech also received investment from Sequoia Capital China. Why can this company attract global giants like Goldman Sachs and Sequoia Capital?
 
Venus Medtech’s website describes itself as follows: The company aims at developing and manufacturing an internationally advanced interventional artificial cardiac valve system, to fill the gap of this field in China. Its aortic valve product first completes domestic clinical trial. The company has so far declared 34 China invention/utility model patents, with 7 invention patents having been authorized. It has submitted 8 PCT applications for international protection with independent intellectual property rights. What on earth is interventional prosthetic heart valve? Let's start the introduction.
 
The heart is composed of four cavities, namely left and right ventricles, and left and right atria. The valves lie between the atria and ventricles, ventricles and arteries. The valves are the doors that prevent blood from flowing into the ventricles when they close, and they coordinate with the heart’s systole and diastole when they open, and the blood is injected from the heart into the artery. If the valves are affected by disease and are forced to retire, it will cause blood regurgitation, inadequate blood supply and other problems, patients in mild cases will feel weak, dyspnea and dizziness, while severely ill patients will suffer from angina pectoris, thromboembolism and heart failure.
 
Initial valve lesions can only be treated with medication. Surgical Aortic Valve Replacement (SAVR) appeared in the late 20th century, when artificial valves were implanted through surgical thoracotomy. In 2010, 65,000 cases of SAVR were performed in the United States, but there were many surgical problems: the mechanical valve required long-term anticoagulant, and the biological valve was short-lived. And the surgical risk was very high especially for the high-risk elderly group. The incidence rate of aortic valve diseases soars with the increase of age, and the mortality rate exceeds 50% after two years [1], but most of the elderly patients can only be treated conservatively.
 
Entering the 21st century, the patients finally embrace the blessing of Transcatheter Aortic Valve Replacement (TAVR), interventional prosthetic heart valve, which was first reported by Dr. Criber of France in 2002. After years of development, currently interventional products from two companies, Edwards and Medtronic, have passed the U.S. FDA review to be launched in the market. Since 2015, there’s a growing concern of TAVR in China, so Venus Medtech has gained the attention from more investors.

TAVR Schematic Drawing
TAVR is commonly performed as the artificial heart valve is delivered through the femoral artery into the catheter, enters the aortic valve area and expands itself, completing valve replacement without thoracotomy, featuring minimal invasive characteristics. Compared with conservative treatment or SAVR surgery, it brings more benefit for the aged. According to Edwards' official data release, patients with severe aortic stenosis using THV valves are compared with conservative treatment, and the results show that the survival rate and life quality of high-risk elderly patients 1-2 years later after receiving TAVR are higher than those receiving conservative treatment [2].

Comparisons with Standard Treatment for All-cause Mortality Reduction Rate

Comparisons with Standard Treatment for Hemodynamics

Comparisons with Standard Treatment for NYHA Level
In the official data released by Medtronic, results of the use of CoreValve valves and SAVR surgery are compared to show the same conclusion that the survival rate and life quality of TAVR patients are higher than SAVR patients [3].

Comparisons with SAVR for Two-Year All-cause Mortality Rate

Comparisons with SAVR for Hemodynamics and Effective Valve Area overtime

Comparisons with SAVR for NYHA Level overtime
To avoid the suspicion of boasting for the two companies, we have also searched and summarized some relevant information, which show that although there are fewer mortality rate of TAVR, especially for 5-year mortality rate, it is still necessary to improve TAVR products due to the problems of perivalvular leakage and complication caused by device issues.

Comparisons with SAVR [4] [5]

Comparisons with Standard Treatment for 5-year All-cause Mortality Rate [6]

Edwards Product(Left 1、Left 2)Medtronic Product(Right 1、Right 2)

Comparison of Medtronic CoreValve Conveying System and EvolutR Conveying System 
In this case, there is a common defect of interventional prosthetic valves: perivalvular leakage, a complication caused by a device problem, and the need to implant an expensive pacemaker. Currently the products launched in the market have promoted upgraded models and in 2015 have passed FDA review. For example, there is an "apron" of polyethylene terephthalate on the outside of Sapien3 valve to reduce the valve regurgitation. For another example, EvolutR valve allows the valve to retract and has an "apron" structure to extend the attached area to reduce the regurgitation, and the new technology can load larger valves, allowing it to be closely aligned with the inner wall of the heart with more precise positioning ; and the size of the interventional catheter can be narrowed and the minimal size can conduct in the 5mm diameter artery, causing smaller damage to the blood vessels and reducing the risk of blood vessel rupture and stroke during surgery. 
The hot concern for TAVR has led to the active research efforts of other companies, for example, Porticovalve valve system of St. Jude, Lotusvalve valve system of Boston Scientific Corporation, Direct Flow valve system of Direct Flow Medical, all of which belong to self-expanding Valve System. Even Edwards abandoned the balloon-expanding valve system to develop a self-expanding centera valve system [7].
The application prospect of minimally invasive catheter technology is promising, as TAVR technique is not only used in the treatment of high-risk elderly patients with aortic stenosis but also suitable for intermediate-risk and low-risk patients: The study selected 1076 patients in total, with 30-day all-cause mortality rate 1.1%and cardiovascular mortality rate 0.9%. There’s no significant difference between 2-year all-cause mortality rate(TAVR vs SAVR:8.0%vs9.8%;P=0.8. 
 
In addition, in 2012, the implementation of Melody Transcatheter Pulmonary Valve surgery started. In 2014, the world's first Transcatheter Mitral Valve Implantation (TMVI) was conducted successfully. In 2015, the world's first in-human transcatheter tricuspid valve repair operation was successfully performed.  All those developments demonstrate that the research on interventional treatment on valve lesions has become more comprehensive.
 
In 2010, the first case of TAVR was carried out in Zhongshan Hospital of Fudan University in China, and the clinical concern continued to warm up in recent years。 In February 2016, Wuhan Asia Heart Hospital performed TAVR on a 78-year-old female, marking the first case of Hubei Province [8]. Although foreign advanced equipment has not been officially introduced to the country, and domestic interventional artificial valve is almost a virgin land, TAVR's application is favored by most doctors.  Domestic company Venus Medtech also actively cooperates with Fuwai Hospital of the Chinese Academy of Medical Sciences and other institutions, and its independently developed product is expected to be launched into the market in 2016 to fill the gap in China. Then it is not difficult to understand Goldman Sachs’ huge investment in Venus Medtech. 
 
References
1、JohnA.Jarcho,Catherine M.Otto.andBernardPrendergastAortic-ValveStenosis-FromPatientsatRisktoSevereValveObstructionThenewenglandjournalofmedicine
2、http://www.edwards.com/zh/Products/TranscatheterValves/Pages/cohort.aspx
3、http://www.corevalve.com/intl/proof/corevalve-us-pivotal-trial-high-risk-study/index.htm
4、OsamaAlsara,AhmadAlsarah,andHeatherLaird-FickAdvancedageandtheclinicaloutcomesoftranscatheteraorticvalveimplantationJGeriatrCardiol.2014Jun;11(2):163-170.
5、ConteJV,etal.Transcatheteraorticvalvereplacementwithaself-expandingvalveandsurgicalaorticvalvereplacementforaorticstenosisinpatientswithpriorcoronaryarterybypassgrafting.Presentedat:AnnualMeetingoftheSocietyofThoracicSurgeons;Jan.24-28,2015 SanDiego.
6、Arie P Kappetein The Lancet, Vol. 387, Issue 10025,p1312–1323
7、Mathew R. Williams; Puja B. Parikh, Cardiology Today’s Intervention, January/February 2015
8、http://hb.sina.com.cn/news/b/2016-03-01/detail-ifxpvzah8461190.shanb
 
 
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