April 2026
PreciSept enters preclinical testing phase
PreciSept's V1 prototype completed ex-vivo benchtop testing in March 2026. Initial results support the company's mechanical-first crossing approach. Animal studies are planned next.
News
What we're working on, dated and sourced.
Updates on PreciSept's development, regulatory progress, and the broader transseptal access space.
February 2026
Regulatory pre-submission process begins
Astraeus Health Advancement engaged Graematter, Inc. to support FDA pre-submission planning for the PreciSept 510(k) pathway.
December 2025
Operating Agreement amendment formalizes equity structure
Astraeus Health Advancement completed an amendment to its Operating Agreement, formalizing its 10% Equity Incentive Pool and authorizing strategic advisor compensation.