Managing Critical Risks in Early-Stage Medtech

Key Learnings From Amar’s Experience

• Understanding and mitigating risks early on is essential. Don't take on too many risk factors simultaneously, especially those outside your expertise. Choose ideas with immediate, clear value propositions over those with long-term, cloudy outcomes. Creating a "wow moment" with demonstrable results will likely result in market pull vs. market push.

• When designing clinical trials, ensure your primary endpoints align clearly with the core function of your technology. You can have cascading secondary endpoints, but you must start simple and layer in sophistication only after your key goals are established.

• Pick your initial indication wisely. A strong start can set the stage for future success, while a misstep can hinder your platform's potential. Identify areas where there's a real, pressing need and a hungry market. Aim for something that has the potential to be disruptive, instead of implementing minor tweaks to existing solutions.

Amar Sawhney is a chemical engineer with deep experience in absorbable and biocompatible materials, from sealing leaks in organs to delivering targeted drugs. “These materials are used in various surgical areas, and we form companies around them to execute upon each of those business plans,” says Amar. Today, he’s the CEO of Instylla, Rejoni, Sealonix, and Pramand. 

One of Amar's most significant innovations is the process of in-situ polymerization, which changes materials from liquid to solids, setting off chemical reactions in contact with living tissue inside the body and creating flexible seals on organs that may be leaking air, blood, or cerebrospinal fluid. This breakthrough enables a variety of biosurgery applications. Additionally, his work with hydrogels, which absorb liquids at different rates, is equally noteworthy, setting the foundation for many biosurgery applications and drug delivery systems. 

Currently, at Instylla, Amar is developing liquid embolics with initial clinical applications in interventional oncology and peripheral hemostasis. Prevailing embolization technologies include beads, particles, solvent-based liquid glues, coils, and plugs. However, Amar highlights that none of these are based on aqueous, self-polymerizing, and absorbable materials. Instylla’s aqueous and absorbable liquid embolic, Embrace, mixes with blood and self-polymerizes without the need for blood clotting. Unlike other embolics that use permanent metal particles or plastic resins, “over six months of duration, the materials are designed to absorb and leave nothing behind,” explains Amar. 

Embrace’s regulatory pathway has been as demanding as its development. Subject to a PMA process, it must meet rigorous safety and efficacy standards compared to a 510(k). Having undertaken a trial on its efficacy in hypervascular tumors on 150 patients—the largest trial of its kind—the team is in the home stretch. If they can show that these tumors can be safely killed by shutting down the blood supply through embolization, Embrace will be off the races soon.