Skull Substitute Manufacture Is Not Afraid of Tough Market

Cost plays an important role in any surgery, but the need to delay a necessary operation because of an inability to pay can have severe consequences. This is particularly true for those waiting to have part of their skull repaired. Epóxicos para la Salud (EPSalud), a Mexican startup that manufactures Masi-Epoxi, an affordable bone substitute for cranial and vertebral protheses, hopes this product will bring relief to these patients. “There are many individuals in Mexico who have required a cranioplasty for many years but have been unable to afford it. Furthermore, there are approximately 22,000 new cases ever year,” says Karina Ramírez, EPSalud’s Administrative Director.

Cranioplasty refers to the surgical repair of a defect on the skull. If the missing part of the cranium is unavailable, a substitute made of metal, synthetic bone or acrylic can be used. Masi-Epoxi, a patented product that is awaiting COFEPRIS approval for commercialization, is meant to be an affordable option for these patients. “The cost of Masi-Epoxi is similar to that of other metal prostheses. On average, both the metal plate and Masi-Epoxi cost MX$15,000, but with a metal plate it is necessary to also acquire four screws or more, the appropriate tools to cut the prothesis depending on the type of lesion, imaging studies and all necessary accessories to place the prothesis. Altogether, the cost of these add-ons runs the price of the surgery with a metal plate up to MX$150,000. Masi-Epoxi does not need any other accessories to fix the prothesis to the bone.”

Masi-Epoxi, expected to launch in late 2018, is the formulation of an epoxy resin, several minerals and accelerators that allow EPSalud to modulate the hardening process. “MasiEpoxi’s main advantage lays in its adhesive properties, which eliminate the need to use screws, adhesives or cements. Unlike other substitutes, Masi-Epoxi strengthens over time while other materials become loose or gradually crack,” says Ramírez.

EPSalud has positive expectations for Masi-Epoxi and the benefits for patients but bringing it to market has been an arduous process. “The Mexican market for medical devices is extremely complex. COFEPRIS guidelines are long and complicated. This leads many startups to give up or sell their technology to another company, sometimes in another country,” explains Ramírez. In her opinion, a large challenge for all startups in the sector is their inability to sell a product without COFEPRIS approval, which takes up to a year to acquire. “To finance ourselves through the approval process, EPSalud developed a parallel line for the import and sale of urology catheters.”

According to Ramírez, innovation for healthcare in Mexico faces two major obstacles. The first is regulatory. “COFEPRIS is still a young organization so it does not yet have the appropriate measures to tackle innovative projects developed in the country. That leads to a smaller number of startups willing to develop these products, which in turn eliminates COFEPRIS’ need and opportunity to update its processes.” The second hurdle is the lack of investment funds. “Most local funds work with Big Data solutions and other technologies, but they are reluctant to fund projects in healthcare because they are fully aware that the recipient will not produce sales for an entire year.”

The company’s long-term plan is to acquire FDA approval to export to the US, while also entering the basic lists of Mexico's public institutions, including the General Health Council, IMSS, ISSSTE and every hospital the company hopes to sell to. “Since this process can take up to six years, we are planning to work with the government through a different strategy that involves the generation of small clinics that perform this surgery with the support of public institutions. This strategy will also allow us to bring the surgery closer to patients who have been left waiting on the surgery backlog.”

EPSalud’s ambitious plans will start with the commercial launch of Masi-Epoxi. “We are now 90 percent ready to launch the product,” Ramírez says.