How Parimer Helped Luna Revolutionize Post-Operative Care

Luna Labs. is a technology innovation partner which supports many industry sectors including health sciences in early-stage research and development (R&D) which is primarily funded through government contracts, including the Department of Defense (DoD). The types of work they do include material development, bio-wearable sensors, and diagnostic solutions.
One of their missions is to address complex challenges in civilian and military sectors, Luna focuses on advancing early-stage concepts into viable product development.
Developing a Sprayable Hydrogel for Post-Operative Care
Luna worked on a solid barrier film made from chitosan to prevent surgical adhesions. This barrier was applied during surgeries. However, they identified a critical limitation: the flat sheets were difficult to apply to curved tissues. Surgeons provided feedback and explained the need for a more versatile solution, leading Luna to develop a sprayable hydrogel formulation.
Despite promising results from animal trials, Luna faced significant challenges in scaling the product for FDA approval. Some of these challenges included their lab capabilities, and they needed a partner to help overcome regulatory and production hurdles.
How Parimer and Luna Labs Worked Together
Finding Creative Solutions
Parimer worked closely with Luna to modify their processes and ensure regulatory compliance while maintaining the product’s integrity. Key challenges included:
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Maintaining molecular weight while making the product water-soluble.
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Overcoming sterilization hurdles without degrading the molecular structure.
Challenges in Manufacturing and Scaling
Conduct animal studies, including testing the hydrogel on pigs, to refine dosing and usability.
Gather critical data to support biosafety and efficacy testing for FDA’s Investigational Device Exemption (IDE) and Premarket Approval (PMA) processes.
Promising Partnership
Luna’s partnership with Parimer exemplifies the impact of collaboration in advancing innovative solutions. By combining Luna’s visionary R&D with Parimer’s expertise in scalable manufacturing and regulatory compliance, the sprayable hydrogel project is a success.
Luna views Parimer as a trusted partner for future endeavors, reinforcing their commitment to innovation and excellence in healthcare solutions.

Looking Ahead
Luna plans to manufacture the hydrogel and hopes to modify it by adding new drugs in future development.
They anticipate funding from the NIH through the SBIR program. Parimer will provide production support letters. Luna views Parimer as their first choice in similar future projects after such a positive experience.