Ten Years of Innovation: Huamai Tech's Three R&D Platforms Delivering Comprehensive Vascular Solutions

“Entrepreneurship is truly challenging; you reap exactly what you sow.”

From a senior executive at a multinational corporation to an entrepreneur, Zhou Jian has traversed a decade-long entrepreneurial journey. Reflecting on the past ten years, her greatest takeaway is that it has been far from easy. What conviction and perseverance, then, enabled her to overcome the "hardships" along this path and lead Percutek Therapeutics to celebrate its tenth anniversary?

“They are truly pitiful.”

During his tenure at a foreign enterprise, Zhou Jian witnessed too many Chinese patients selling their homes and borrowing money extensively just to afford life-saving implants of foreign-branded aortic stent grafts. However, the long-term outcomes of such emergency interventions proved unsatisfactory, with some patients developing complications or even dying within two to three years. In Europe and North America, aortic pathologies are predominantly aortic aneurysms, whereas in China, aortic dissections account for the majority of cases. Driven by global market considerations, several leading international corporations have primarily focused their efforts on developing stents tailored for aortic aneurysms.

"Why don't we do it ourselves?"

During discussions and exchanges with experts in China, Zhou Jian conceived this idea. At that time, the market for aortic interventional devices had not yet matured. Zhou Jian aimed to lead his team in developing more suitable and highly effective aortic stent graft products for patients in China, to address the clinical challenges in aortic disease treatment in China.

Such a vision never emerged out of thin air; while passion provided the initial spark, capability is the true foundation for sustained progress.Previously serving as Head of Medtronic's Cardiovascular Business for Greater China and General Manager of Edwards Lifesciences China, Zhou Jian frequently engages with business operations across the aortic, peripheral vascular, coronary, and structural heart disease segments, granting him a comprehensive understanding of the overall cardiovascular interventional device market.During her tenure in a leadership role at Medtronic, she introduced and launched multiple new products and therapies in China, notably pioneering the introduction of transcatheter aortic valve technology to the country and accumulating successful experience in the clinical application of these novel treatments. Furthermore, she has maintained close ties with aortic experts both domestically and internationally, ensuring a solid foundation in professional expertise.

“Staying true to the original aspiration and never giving up is truly important.”

While this straightforward principle has long been a commonplace, truly practicing it when confronted with real-world difficulties and obstacles is what makes it remarkable. True to its founding mission, the Percutek Therapeutics team remains clinically driven, dedicated to developing innovative products that address unmet clinical needs. Simultaneously, they strive to minimize surgical complexity as much as possible, employing simplified approaches to manage complex cases.

"Imitating a product is quite easy, but true innovation is genuinely difficult; it requires overcoming numerous technical challenges and having the courage to take risks." At the time, Percutek Therapeutics faced two paths: one was to develop a technologically straightforward product based on existing models, obtain the product registration certificate as quickly as possible, and have a marketable product; the other was to pursue technological innovation and remain committed to developing an aortic stent graft specifically tailored for Chinese patients.

Faced with investors' skepticism and an uncharted path ahead, they chose the latter, embarking on an arduous journey of research and development. At that time, no controlled clinical trials had been conducted in China's aortic field, yet Percutek Therapeutics broke new ground. After more than six years of R&D and testing, Percutek Therapeutics developed two flagship products—the "Huamai·Tianyi Thoracic Aortic Stent Graft System" and the "Huamai·Tianzhuo Abdominal Aortic Stent Graft System".“Percutek·TianZhuo” received its product registration certificate in 2017, becoming the first domestically manufactured abdominal aortic stent-graft system approved for market launch to feature a barbed bare stent design. In 2019, “Percutek·TianYi”, the world’s first device specifically engineered for aortic dissection, was also approved by the National Medical Products Administration (NMPA). These two stent products cover a broad range of indications and require only a 10 mm proximal landing zone.The abdominal aortic stent graft system can treat complex abdominal aortic aneurysms with a 75° infrarenal angulation when the proximal landing zone is 10 mm.

For patients with an insufficient proximal landing zone, fenestration and chimney techniques are commonly employed in clinical practice. However, these techniques are relatively complex and technically demanding, typically requiring senior clinical experts to successfully perform the procedures. Through product innovation, Percutek Therapeutics has expanded the indications for its devices, enabling physicians to treat patients with complex pathologies such as short aneurysm necks using conventional endovascular techniques. This advancement allows a broader range of physicians to perform the procedure, thereby saving more patients.

In addition,Percutek Therapeutics' aortic stent graft system features a unique waveform design that ensures optimal wall apposition, minimizing the incidence of Type I endoleaks. The stent's distinctive radial force design minimizes the occurrence of secondary entry tears, thereby achieving favorable long-term outcomes.

To develop products best suited for Chinese patients, Percutek Therapeutics has paid meticulous attention to numerous details, such as the company'sOffers over 400 models of thoracic aortic stent graft products., enabling physicians to select the stent that best fits the patient's vasculature, thereby achieving optimal therapeutic outcomes.

"Clinical trial results demonstrate that our abdominal aortic product is on par with the internationally top-ranked product and outperforms it in several key metrics. In the field of aortic dissection treatment, our product significantly outperforms the control group. This outcome has greatly boosted team morale, validating our initial decision to stay true to our original mission and adhere to high standards. It has also further reinforced our confidence in continuing on the path of innovation."

Percutek Therapeutics has not limited itself to the aortic field.

To provide comprehensive vascular solutions, the company has established three major R&D platforms, focusing on innovations in therapies, surgical procedures, and products to improve clinical standards, reduce procedural complexity, and enhance the safety, efficacy, and accessibility of interventions.

One of the platforms focuses primarily on the aorta, achieving comprehensive coverage in the aortic field. In addition to two aortic stent-graft products, Percutek Therapeutics is actively developing a hybrid stent for the treatment of Type A aortic dissection to fill the gap in clinical therapy.This stent graft features a globally pioneering integrated suture-free design, which can replace the complex total arch replacement combined with the stented elephant trunk procedure, significantly reducing the surgical difficulty for Type A aortic dissection.，enabling physicians at prefecture-level hospitals to perform Type A aortic dissection surgeries, thereby improving the treatment rate of the disease. Currently, the relevant products are undergoing clinical trials.

Another platform develops coronary and peripheral vascular products, with its Head of R&D being a renowned scientist in the field of ultrasound applications in the United States, dedicated to providing innovative solutions for patients with arterial ischemic diseases.For patients with arterial ischemic diseases, the platform utilizes chip- and software-controlled ultrasonic energy to fragment intraluminal and subintimal calcified plaques, thereby restoring vascular patency. When necessary, it can be combined with an atherectomy and aspiration system to achieve effective vessel patency without the need for stent implantation.For patients with CTO (chronic total occlusion), an ultrasonic catheter can penetrate hard calcified plaques by emitting forward-directed ultrasonic vibration waves, recanalizing the occluded vessel and enabling endovascular interventional therapy.

The ultrasound technology platform holds extensive application prospects in the treatment of arterial and venous diseases. Percutek Therapeutics has a comprehensive product R&D plan dedicated to achieving the clinical outcome of completely resolving arterial ischemic diseases without stent implantation, pioneering a new era of "implant-free, residue-free" interventional therapy for arterial ischemic diseases.

The third is the R&D platform for neurointerventional and access devices. The company positions access devices as volume-driving products, leveraging its accumulated industry resources to increase market share. In the neurointerventional sector, the company offers a comprehensive product portfolio. Notably, it features the intracranial covered microstent. Currently, the mainstream trend for treating intracranial aneurysms is flow-diverting stents, but...This stent developed by Percutek Therapeutics features a novel covering technology and a unique braiding process., marking another product innovation. Based on animal and human trial data, the therapeutic efficacy of the intracranial covered microstent is superior to that of flow-diverting stents.

As time flies, Zhou Jian divides the past decade into two five-year periods.

During the first five years, the company was established and began operations, with this stage primarily focused on the research and development of new products. The "12th Five-Year Plan" National Ministry of Science and Technology Major Support Program provided financial and technical support to Percutek Therapeutics. In the second five-year period, the company entered a development phase, and its product line expanded,With over thirty commercialized and pipeline products, the business scope has expanded from the aortic domain to coronary, peripheral, and neurointerventional fields, and a comprehensive vascular solution has largely taken shape.

Class III medical devices represent the highest classification level within the national medical device regulatory framework. There are no shortcuts in the R&D process; it requires a solid, step-by-step approach. Different market positioning has given rise to distinct strategic orientations. To achieve low risk and high returns, some companies closely follow international industry leaders, imitating their more mature products to rapidly enter the market. Although the core technologies of these products may not be industry-leading, this approach reduces time investment and allows for early market entry to accumulate resources. Percutek Therapeutics’ development strategy is driven by clinical needs, focusing on the creation of innovative products. Through advancements in therapies, interventional procedures, and medical devices, the company aims to address clinical challenges, elevate treatment standards, and maximize therapeutic benefits for patients.

“Positioning must be precise. Enterprises must clearly understand their strengths and market potential to identify the right direction; otherwise, changing course midway will render past investments futile. Team members must stay true to their original mission, never retreat or evade when facing difficulties, but instead strive to overcome them and never give up.”

Driven by precise positioning and a strategic development plan, Percutek Therapeutics has achieved multiple industry firsts. Possessing several globally pioneering products, the company was the first to design clinical trials in accordance with the highest national standards, the first to conduct fatigue testing in China, and the first to perform comparative studies against the internationally top-ranked product. Percutek Therapeutics has consistently remained at the forefront of pioneering innovation.

Currently, Percutek Therapeutics' products have entered over 400 hospitals, and the company is conducting its final pre-IPO financing round.As the 10th anniversary arrives and the company enters a fast track of development, Zhou Jian hopes it will take Edwards as a role model and continue to develop innovative products.

People are the foundation of a company, and positioning and strategy determine its future.

Throughout a decade-long entrepreneurial journey, including an R&D phase spanning more than six years, the team has been sustained by its original passion. Many colleagues at Percutek Therapeutics previously worked at multinational companies but chose to forgo high salaries to return to China and launch this venture, hoping to contribute to China's healthcare sector and achieve a greater sense of personal fulfillment.

“I am deeply grateful to every member of the team, who gave up high-paying jobs to endure hardships alongside me.”

Over the past decade, the Percutek Therapeutics team has expanded to over 230 members, many of whom have previously worked at multinational corporations and possess a broad international perspective. With a deep understanding of both domestic and global medical markets, they are adept at discerning industry trends and executing forward-looking strategic planning. The sales and marketing teams demonstrate formidable capabilities, maintaining industry-leading standards across the entire supply chain, from technical support to channel management.

“Patient benefit is the greatest driving force behind our company.”Percutek Therapeutics has consistently upheld the mission of “saving lives and benefiting millions of families,” and through collective efforts, cultivates a corporate culture characterized by customer-centricity, innovation-driven growth, agility and efficiency, accountability, and the relentless pursuit of excellence.

The company is advancing toward the goal of becoming a top-tier domestic medical device enterprise, striving to develop its own flagship products in every sector, aiming to achieve market leadership, and gradually expanding into the international market. Zhou Jian remarked with a smile, "After all, Medtronic is also a major enterprise that was founded in a garage."

“Only through belief can we see.” With dedication as its cornerstone and product technology and resources as its armor, the Percutek Therapeutics team forges ahead on the medical device battlefield. After five years of silent self-refinement, the team entered the market to compete with industry peers. Driven by a shared resolve, every member is committed to building a world-class Chinese enterprise.

So, over the next decade, how will Percutek Therapeutics intensify its efforts, expand its market footprint, and develop breakthrough new technologies and products?