About Bruin Biosciences

Market Analysis for Interventional Radiology Products

Market for DEBs

  • Global market for embolics is expected to grow at 10-15% annually to approximately $4.6B by 2025; DEBs with approved drugs attached is very likely to significantly increase this market
  • US and Europe are the largest markets for embolics, but Asia (especially China) is the fastest growing due to increasing incidence of HCC
  • There are currently NO FDA approved drugs for use with DEB-TACE procedures in the US

Intellectual Property

PCT US1834744 filed May, 2018 details Bruin Bio formulations for:

  • Approved HCC drugs: US Application No. 62/511,895
  • General Platform: US Application No. 62/511,898
  • Priority May 2017
  • National stage filing done Nov 2019

Patent examiner’s rendered opinion stating claims are novel and inventive

Sorafenib became generic in January 12, 2020.

US patent on Regorafenib expires July 2024.

Current Proposed Development Path for Bruin Bio

Year 1

Year 2

Year 3

IND Enabling Studies

Proof-of-concept animal studies with controls; pharmacokinetics studies; safety study

Timeline: 6-9 months

IND Filing

Regulatory affairs related tasks for filing with FDA

Timeline: 6-12 months.

Clinical Studies

Phase 1 clinical study of 10-15 patients

Timeline: 12-18 months