Capstan Medical Advances Minimally Invasive Robotic Platform for Heart Valve Replacement Following $31.4M Series B Funding

As the leading cause of death among patients with diseases in the United States, heart disease claims nearly 7 million American lives each year.

Orient Securities Research Institute disclosed that the United States conducted a total of 175,300 heart valve replacements in 2018, including 99,800 surgical bioprosthetic valves and 60,300 interventional bioprosthetic valves.

Valvular heart disease falls under structural heart disease, with clinical manifestations of abnormal morphology and structure in one or multiple valves. Valves control the flow of arterial and venous blood in the body through normal opening and closing functions, acting as "one-way valves." If valve stenosis or insufficiency occurs, it can impede normal blood flow, leading to functional damage to the heart. For patients with moderate to severe valvular disease who do not receive treatment, the 5-year survival rate is only 20%.

According to data from the Xintong prospectus, in 2019, China already had 36.3 million patients with valvular heart disease, and it is predicted that this number will increase to 40.2 million by 2025, indicating a significant unmet demand in the treatment of valvular heart disease. Capstan Medical is dedicated to addressing this challenge and has pioneered a new paradigm for the treatment of valvular heart disease.

Capstan Medical is a company focused on developing minimally invasive technologies for treating heart valve diseases. The company was founded in 2020 in Santa Cruz, California, USA. It is developing a new generation of heart valve implants and a first-of-its-kind transcatheter robotic delivery platform. By combining surgical robotics, catheter technology, and next-generation heart valve implants, Capstan Medical has created a solution capable of treating mitral and tricuspid valve diseases through a catheter while the heart is beating. This solution provides a less invasive alternative to open-heart surgery, improving patient outcomes and reducing recovery time.

Due to the high technical difficulty and long learning curve, transcatheter mitral valve replacement (TMVR) and transcatheter tricuspid valve replacement (TTVR) have seen almost no products gain FDA approval after more than a decade of development.

To reduce the learning curve, improve operational efficiency, and increase the popularity of surgeries, it is necessary to "standardize" surgical procedures, minimizing the influence of a surgeon’s individual experience and technical skills. An important way to achieve this is through the robotization of surgeries. Although robotic systems have made progress in many types of surgeries, such as joint replacement, spinal implant placement, and laparoscopic keyhole procedures, heart valve replacement largely remains manual. Recognizing this, Capstan Medical has begun developing surgical robots specifically for cardiac valve disease.

Capstan Medical's technical confidence stems from founder Dan Wallace's extensive experience and background in the surgical robotics field. He has worked at renowned surgical robotics and valve companies such as Intuitive Surgical, Hansen Medical, Auris Health (acquired by Johnson & Johnson), and Cephea Valve Technologies (acquired by Abbott). Its CEO, Maggie Nixon, previously worked at the Da Vinci Surgical Robotics company and has over 20 years of work experience.

The platform developed by the company can deliver a catheter into the patient's heart through minimally invasive methods. Then, the robotic delivery platform is operated to precisely position the heart valve implant at the site of the original valve that needs replacement or repair. The platform can also monitor and adjust the position and angle of the catheter in real time to accommodate different anatomical structures, lesion types, and pathological conditions. Subsequently, the doctor releases the heart valve implant via the robotic delivery platform, allowing it to expand and secure itself in the position of the original valve.

In this process, Capstan Medical applied the precision of robot-assisted techniques to minimally invasive surgeries for heart valve diseases, achieving the initial goal set during product design.

Currently, most mitral and tricuspid valve-related diseases are treated through open-heart surgery.

What is known as open-heart surgery refers to surgical procedures performed on the heart muscle, valves, or arteries through an incision in the chest for visual access. Open-heart surgery is a traditional form of surgery, distinct from minimally invasive surgeries that involve smaller incisions and quicker recovery. Moreover, open-heart surgery typically takes 3 to 6 hours, during which the patient is placed under general anesthesia to ensure they remain pain-free throughout the procedure. During the surgery, the patient's chest is opened with an incision measuring 8 to 10 inches.

Open-chest surgery often leads to various complications, such as respiratory system complications, anemia, nervous system complications, wound and respiratory tract infections, restricted upper limb movement, and incisional hernias. Therefore, many patients, after considering the risks associated with open-heart surgery, choose to delay treatment. This inadvertently increases their health risks and may lead to physical weakness, potentially resulting in the loss of the opportunity to undergo open-heart surgery.

"Open-heart surgery is invasive and an impractical treatment option for many people," said Maggie Nixon, CEO of Capstan Medical.

Therefore, Capstan Medical introduces minimally invasive options for patients. Its innovative technology provides a less invasive alternative to traditional open-heart surgery while ensuring precise placement of heart valve implants, significantly reducing patient recovery time and minimizing the risk of complications.

Transcatheter treatment can address heart valve disease through a small incision in the groin, without the need to stop the heart or open the chest as required in open-heart surgery. This technology can reduce patient recovery time from months to weeks, and even the most critically ill patients can undergo such procedures.

On August 9, 2023, Capstan Medical announced the completion of a $31.4 million Series B financing round, led by Eclipse Ventures, which manages over $4 billion in assets and has a portfolio of more than 70 companies, with participation from Puma Venture Capital and Intuitive Ventures.

With the completion of Series B financing, Capstan Medical also announced the appointment of Justin Butler, a partner at Eclipse, as a member of its board of directors. In the coming months, Capstan Medical will expand its engineering, clinical development, and operations teams to advance the technology through the next phase of development and into its first-in-human clinical trials.

In terms of surgical methods, cardiac valve treatment in China is still dominated by open-heart surgeries. According to the Orient Securities Research Institute, in 2017, the number of open-heart surgeries for cardiac valves in China reached 65,700 cases, while only about 3,000 patients were treated through interventional methods. Open-heart surgery remains the mainstream approach. To address this challenge, many companies in China are continuously innovating in related medical devices and technologies.

Ningbo Jens Technology Co., Ltd. is a medical device company that develops innovative solutions for structural heart disease, with its innovative products covering tricuspid valve, mitral valve, aortic valve, and heart failure treatment. The company’s self-developed transcatheter mitral valve replacement system, JensRelive, is designed to treat patients with severe mitral regurgitation without the need for conventional open-heart surgery, replacing the dysfunctional native mitral valve. Its transcatheter tricuspid valve replacement system, LuX-Valve, is designed to treat patients with severe tricuspid regurgitation and high surgical risk through minimally invasive intervention, substituting the dysfunctional native tricuspid valve with an artificial valve stent. It has been designated as a Breakthrough Device by the FDA, marking it as the first self-developed medical device in China's valve field to receive such recognition.

Hangzhou Qiming Medical Device Co., Ltd. is a leading company in China's minimally invasive interventional treatment for heart valves, focusing on the development and commercialization of innovative medical devices in the field of structural heart disease. On December 7, 2021, Qiming Medical announced the acquisition of Cardiovalve, a company that independently developed the Cardiovalve, a transcatheter replacement product capable of treating both mitral regurgitation and tricuspid regurgitation. Compared to similar products, the femoral vein access method of Cardiovalve significantly enhances treatment safety. Currently, for the indication of treating mitral regurgitation, Cardiovalve has entered the clinical research stage in Europe and the early feasibility study (EFS) stage in the United States. For the indication of treating tricuspid regurgitation, Cardiovalve received the "Breakthrough Device Designation" from the U.S. FDA in January 2020 and has entered the EFS stage.

Currently, the treatment demand in China's heart valve industry is far from being fully met, with a still low treatment penetration rate. However, with the continuous emergence of innovative enterprises in related fields, heart valve implants as well as associated implantation and replacement technologies are also constantly being updated and iterated, which will help address this challenge and bring patients safer and more effective treatment options.