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Metcela Inc | Kenichi Nogami & Takahiro Iwamiya

To live a meaningful life, one’s health must be the top priority. “Health is wealth” and a healthy heart is central to overall good health and long life. The human heart works 24 hours a day, every beat, every second. Therefore, it needs the most care.

However, heart diseases are the leading cause of death globally than any other illness. And delay in heart care may lead to serious health problems and disability.

According to the summary of vital statistics 2005, in Japan, approximately 1 to 2 million patients are suffering from chronic heart failure and nearly 170,000 patients die due to heart diseases each year.

To deal with this severe problem there is a strong demand for a promising health care solution that can bring about drastic changes and benefits in human life and society.

Fortunately, we have a solution to this as Metcela, with excellence being at the crux of their mission. Metcela, founded in 2016, exhibits true potential and brings a paradigm shift in the heart care solution.

Metcela is a clinical-stage biotech startup in Japan that provides patients with an innovative and alternative treatment option for heart disease.

In an exclusive interview with Insights Success, Kenichi NogamiCo-founder and Co-CEO, and Takahiro IwamiyaCo-founder and Co-CEO, shed light on the company’s journey, the current industry scenario, and their vision for the company’s future.

Please brief our audience about your company, its USPs, and how it is are currently positioned as one of the most reliable companies in the healthcare sector.

Metcela is a biotech startup, founded in 2016, for developing regenerative medicine products for chronic fibrotic diseases, including heart failure. Its lead pipeline, MTC001, targeting chronic heart failure, is in Phase I clinical trial in Japan.

The technology clearly stands out in the market for two distinctive elements: minimally invasive precision delivery method, and use of autologous and homologous cells. MTC001 enables minimally invasive administration of the therapeutic cells to the highly immunoresponsive heart without the use of immunosuppressive drugs, while other stem-cell-based technologies utilize donor-derived allogeneic cells that require open-chest invasive delivery and use of immunosuppressive drugs.

A high level of basic research and manufacturing process development capabilities give Metcela an edge in the global cell therapy field.

Tell us more about Metcela, its offerings, and its stronghold in the healthcare space.

Metcela is working on the development of regenerative medicine using highly proliferative autologous cardiac fibroblasts. Recent research has highlighted the key roles that cardiac fibroblasts play in heart failure and cardiomyocyte culturing. The biopsied fibroblasts are processed using Metcela’s proprietary culture technology of transforming ordinary cardiac fibroblasts to a particular sub-population of fibroblasts that unleashes fundamental regenerative capability and then returned to the patient’s heart. The fibroblasts are returned to the patient’s heart using an administration catheter developed in collaboration with a leading Japanese catheter company and cardiologists, enabling accurate and precise administration to the diseased areas.

From a business leadership perspective, what is your opinion on the impact of the COVID-19 pandemic on the health space in general?

The spread of COVID-19 has made the management of biotech startups very challenging. Particularly for products that are in the clinical stage, much of the resources of medical institutions and supporting industries are devoted to dealing with COVID-19, which have affected the progress of clinical trials.

On the other hand, with more understanding of COVID-19 and highlighting the power of biotech’s roles in the development of vaccines and therapeutics, funding for biotech startups has continued, and Metcela has successfully raised the necessary funds to continue accelerating the development of the lead pipeline. We also believe that the industry’s rapid response in developing vaccines and therapeutics has provided an opportunity for pharmaceutical companies to show their superior R&D capabilities to the world.

Being an experienced leader, share your opinion on how the adoption of modern technologies has impacted the healthcare industry and how is your company adapting to the change?

Over the past few years, the collaboration of different technological fields has dramatically increased, making it increasingly challenging to create disruptive innovations through research and development in a single area alone. We are actively working to create innovations by collaborating with academia and companies in different fields.

For example, when Metcela started developing a new cell therapy, efficient cell delivery to the diseased area remained underdeveloped in the cardiac field. There were efforts to process cells into sheets to surgically attach to the heart or encapsulate the cells with hydrogel to improve the cell retention rate. However, considering the physical and financial burden on patients, it was apparent that catheter administration was the most desirable delivery method.

Therefore, Metcela collaborated with Japan Lifeline, a leading electrode catheter manufacturer in Japan, and the University of Tsukuba Hospital to develop a catheter that can efficiently and precisely deliver our fibroblast (VCF; VCAM1-positive cardiac fibroblast). Since fibroblasts secrete a rich ECM (extracellular matrix), which improves cell adhesion, retention of the cells after administration is readily enhanced, which also led to the success of this approach.

What efforts did you take during the pandemic to sustain operations and ensure the safety of your team at the same time?

During the pandemic period, as a biotech startup with a cell manufacturing facility, a major concern was the well-being of manufacturing staffs that were essential to commute to work. Not only do we encourage members not involved in research or manufacturing of cells to work from home, but we are also investing proactively in improving the IT environment to maintain operational efficiency outside the office.

As an established industry leader, what would be your advice to the budding entrepreneurs and enthusiasts aspiring to venture into the healthcare sector?

Although Japan is still a country with a small entrepreneurial base, I feel that the environment surrounding entrepreneurs is improving by leaps and bounds, with an increase in talents willing to work in startups and an improved funding environment. Metcela is a startup founded by two co-founders in the 20s, leveraging our respective strengths in basic research and business expertise. Eight years have passed since we teamed up, and with a team size of more than 30 people, we feel that we are getting much closer to realizing our dream.

The healthcare sector can bring about drastic changes and benefits in human life and society. It is a tough job and a competitive field, but you also get an incredible feeling of accomplishment when you reach every milestone. We hope to work together to open the future of healthcare.

How do you envision scaling your company’s services in 2022 and beyond?

The year 2021 was marked by many milestones, including the completion of significant fundraising and initiation of the clinical trial for our lead pipeline, MTC001.

On the other hand, due to the pandemic, the activities of our U.S. subsidiary were restricted, and our actions for global expansion were also constrained.

In 2022 and beyond, we will begin to examine the partnership for the commercialization of the product in Japan as the clinical trials progress. At the same time, we will prepare for the global supply of our cells to initiate clinical trials, making it a year of business development on a worldwide scale.

With this unique approach of using fibroblasts to treat chronic fibrotic ailments, we will continue to devote all our efforts to bringing new hope and cure to the many patients with these debilitating diseases.

Exhibiting Excellence

Metcela was selected for J-Sartup in 2019, a public-private joint initiative for supporting selective startups. J-Startup was inaugurated in 2018 and is organized by The Ministry of Economy, Trade, and Industry (METI), the Japan External Trade Organization (JETRO), and the New Energy and Industrial Technology Development Organization (NEDO). The selected companies are entitled to make use of joint support from the public and private sectors to become leaders in overseas markets.

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