Advancing Hemora10: Balancing Performance and Regulatory Compliance
Technical Objectives and Challenges:
The primary objective of our Phase I project is to advance the technical aspects of Hemora10, a critical step toward its commercial viability in the medical device market. Specifically, we are focused on optimizing its functional properties to achieve a delicate balance between high-performance capabilities and adherence to stringent regulatory standards.
Regulatory Compliance:
Hemora10, categorized as a medical device, must undergo FDA approval before it can be brought to market. This necessitates not only meeting customer needs but also adhering to rigorous safety and effectiveness standards for medical devices. Hence, the core technical challenge is to enhance Hemora10's performance without compromising its biocompatibility or regulatory compliance.
Functional Improvements
Our R&D efforts in Phase I revolve around improving Hemora10's functionality in two pivotal areas: combating common bacterial strains responsible for wound infections and promoting efficient hemostasis to control bleeding. Two primary methods of functionalization are at our disposal, each with its trade-offs. Increasing positive charge density and hydrophobic segments enhances bactericidal lethality but may jeopardize biocompatibility. Conversely, a zwitterionic approach, incorporating both positive and negative charged groups, enhances hemostatic function and biocompatibility but may reduce bactericidal lethality.
Optimization Process
In Phase I, we aim to strike the optimal balance by fine-tuning the material's charge and hydrophobic segments. This optimization process is crucial as it mitigates several key risks in our commercialization pathway. Through comprehensive laboratory testing, we can demonstrate the material's utility in a cost-effective pre-clinical setting, confirming its ability to meet customer specifications. This data guides our selection of the most promising material configuration for a minimum viable product, streamlining the validation process in animal (in-vivo) settings and enhancing the prospects for biocompatibility, safety, and efficacy testing required for regulatory approval.
Addressing Regulatory Concerns:
One of our primary risks as a medical technology company lies in addressing regulatory concerns. Demonstrating the technology's effectiveness is only part of the equation; we must provide objective evidence of its safety for the intended conditions of use. Our proactive approach, including pre-clinical laboratory evaluation and early consideration of biocompatibility, reduces the risk of encountering adverse issues during the later stages of Good Laboratory Practice (GLP) validated studies. This rigorous methodology not only ensures a smoother path toward regulatory approval but also positions us for success in the commercialization phase.
