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Women Deserve an Improved Cervical Cancer Test: Hera Diagnostics

Teófilo Tijerina - Hera Diagnostics
CEO

STORY INLINE POST

Sofía Garduño By Sofía Garduño | Journalist & Industry Analyst - Mon, 11/14/2022 - 14:00

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Q: Why did Hera Diagnostics choose to address cervical cancer?

A: Cervical cancer is the first of a series of cancers we aim to target. Cervical cancer is the most treatable form of cancer if it is detected early; there is no reason a woman should die from cervical cancer. The inventor of our diagnostic device witnessed this disease in his family. He participated in several government programs to address this disease and identified some opportunities to improve diagnosis, including accuracy, comfort and the option to provide immediate results. Furthermore, we estimate that the global cervical cancer market is about US$6 billion per year.

Q: What progress have you made on the product to detect cervical cancer s?

A: We are a bit behind from where we want to be, as we faced some challenges attracting capital that have now been resolved. But we lost a few months. We have built our manufacturing facility and our clean room in Monterrey, Nuevo Leon, and we are getting a certificate from COFEPRIS. We expect to start building inventory between February and March 2023 and to start selling in Mexico by the end of Q1 23.

Q: How will this solution revolutionize the industry?

A: HeraFem will disrupt the Pap smear industry. It will not be an easy task because that pap smear has been around for a long time and changing behaviors in the medical industry is difficult. However,our competitive advantages in terms of accuracy, cost and patient experience will lead to significant market capture over the long term We also plan to work with the medical community to receive their  endorsement. Adoption will first take place with early adopters, but transitioning from penetration to disruption will be more challenging task that will take some time. 

Our technology is now better and will exceed the accuracy of the Pap smear in 2/3 of the world, and as we collect more data to improve our detection algorithm, it will match the accuracy of the pap smear in developed economies.  In middle to low income countries, the availability of a superior test with a lower cost will allow us to increase our penetration globally. As we match the pap smear accuracy in developed economies, our ability to substantially lower costs and improve patient experience we believe will also result in significant adoption.  Ultimately, we believe that women deserve a better test. Surveys indicate that the existing procedure causes tremendous anxiety as women wait for results. We have also heard from patients that they experience spotting and bleeding.

Q: What strategies has Hera Diagnostics implemented to educate the market on cervical cancer prevention?

A: We are limited in what we can do until we obtain COFEPRIS’s approval to start marketing the technology but we plan to attend trade shows and conferences to educate the medical community on the merits of our HeraFem. . We also plan to raise more capital and conduct further independent clinical studies with prestigious institutions across Latin America, the US, the EU and Asia to validate our accuracy within the medical community. Finally, we will work plan to work closely with the American College of Obstetricians and Gynecologists and we aim to get FDA approval to build more confidence among the global medical community. We also plan to use social media to educate women about the existence of a new cervical cancer screen that is more accessible and pleasant..

Q: What have been the main challenges of introducing Hera Diagnostics’ solutions to the Mexican public health sector?

A: We have faced many challenges. The first has been attracting capital, Introducing a new medical device is an expensive endeavor. For example, the average US medical device company, during its lifetime, will end up raising between US$50 to US$100 million.  That type of investment requires investors not only from Mexico but also from the US, the EU and other regions.  While there have been some success stories, Mexico is not yet known as a country that produces innovative technologies  in the biotech and medical space.  Consequently, we have experienced doubts about the validity of the technology and the clinical data we have generated out of Mexican institutions.  In some cases, even the medical community in Mexico demand to see clinical data from the United States.

The venture capital space in Latin America is better than it was 10 years ago but it is still quite small, and their check sizes are small as compared to USA venture capital firms Venture capital firms in Mexico and Latin America often focus on fintech, software as a service and consumer products, and deep tech Mexican technologies struggle to obtain those investment dollars from Latam VC’s  In their own words, , many of them have told us they love what we are doing, but that they simply don’t have the expertise to properly evaluate a medical device company. We have also experienced xenocentrism. Some Mexican  hospitals have told us that they will not adopt our technology unless it is FDA-approved, which is baffling and sad at the same time. Evidently, some leaders in the Mexican healthcare industry mistrust their own institutions. A home grown (Mexican) technology needs both private and public support from its own country so that it can than build a base of revenue and solid clinical data.  It will then be easier to receive broad acceptance internationally.   If your own family won’t help you, then what can you expect from the rest of the world?

Q: How are you promoting your solutions in the private market?

A: The public sector can be a powerful catalyst to further Mexican technologies that other countries are not ready to adopt. We are still reaching out to the public sector, hoping that it will lead to building trust in the market and help us strengthen our revenue base and then export to other countries. Governmental support for new homegrown technologies has often been used effectively as an Economic Development strategy to help build domestic companies that can eventually have a global footprint.  For example, it is my understanding that Korean government support played a key role in the success of companies like Samsung or LG. For this reason, we hope that we can build strategic partnerships with federal and state institutions in Mexico

In terms of the private sector, this is a big priority for our company.  The private sector is large and segmented across many different demographic segments. . We will mainly do direct sales to the private sector by attending trade shows and having our own salesforce.   We also plan to work with some distributors and we are going to hold events in various cities to educate the medical community.

Q: What will be your priorities for 2023?

A: We are hoping to get COFEPRIS’ approval to start sales in 1Q23. We will also raise a second round of financing in 2023 for between US$15 million to US$20 million, which will allow us to scale up in Mexico, pursue FDA and CE regulatory approvals, and enter at least six to eight countries in South and Central America.

With sufficient funding, we also want to start working on an algorithm to detect skin cancer in 2023, which might take between 12 and 18 months to get to market. Skin cancer screening is very different market from screening for cervical cancer. There is no screening for skin cancer. If a doctor believes that a mole or spot  in the skin may be cancerous, the only option is to request a biopsy and some of the data we have seen suggest that greater than 90 percent of skin biopsies come out negative. With our technology, we can substantially reduce unnecessary biopsies in the skin cancer space, representing cost reductions for both the government and the patient.

 

Hera Diagnostics is a US company that is commercializing a Mexican technology, aiming to improve cancer diagnosis through the use of AI and optoelectrical spectroscopy. Hera aims to be the go-to option for cervical cancer screening.

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