Implantica (IMP) investor relations material

Strategic milestones and U.S. market entry

• Achieved FDA PMA approval for RefluxStop, enabling access to the world's largest medical device market and accelerating the U.S. launch.

• Over 100 leading U.S. surgeons express interest, with 13,000 devices ready for launch and initial rollout targeting five Centers of Excellence, expanding to 100+ accounts.

• Five-year clinical data and extensive European experience position the product for rapid U.S. adoption.

• Reimbursement strategy includes CMS pass-through payment, commercial payer engagement, and device-specific applications to support broad coverage within two years.

• Manufacturing capacity is secured, with plans to move production to the U.S. for scalable supply.

Product differentiation and clinical outcomes

• RefluxStop addresses the root anatomical cause of GERD, restoring normal function without tightening the esophagus, and is applicable to a broader patient population.

• Demonstrated superior outcomes: less than 2% reoperation rate, minimal dysphagia, and lower recurrence compared to fundoplication and LINX.

• Five-year data show 98% of patients remain free from daily PPI therapy, with stable, reproducible results in both clinical trials and real-world settings.

• Largest real-world safety study (602 patients, 22 centers) confirms high safety and reproducibility.

• Surgeons and patients report significant improvements in quality of life, with high satisfaction and minimal side effects.

Commercialization, marketing, and global expansion

• U.S. launch leverages direct-to-consumer marketing, digital platforms, and patient empowerment tools to drive demand.

• Regional and national campaigns, surgeon and GI referral networks, and a robust online presence are central to patient acquisition.

• Structured surgeon training ensures consistent outcomes and supports rapid scaling across centers.

• European market growth is steady, with NHS approval in the U.K., increasing reimbursement, and expanding hospital adoption in Germany, Italy, and Spain.

• Global interest is high, with future expansion planned for Canada, Japan, Latin America, and the Middle East.