Hemostemix’s robust data at the University of Florida Grand Rounds

Announcement

Hemostemix Inc. has ticked and represented its major key points from its Grand Rounds presentation held on 12^th November at the University of Florida (UF, Gainesville), vascular team. The title of the session was ‘Angiogenic Cell Precursors (ACP-01): Regenerating Microcirculation in CLI, Cardiomyopathy and Angina’. This presentation was presented by Fraser Henderson Sr., MD, a neurosurgeon and President and CEO, Thomas Smeenk showed the policy/operations updates and opening remarks.

The attendees involved UF trainees, external clinicians and vascular faculty, including the MaineHealth, formerly the UF ACP-01 trial coordinator, Kristina Giles and David Alper, DPM (Boston). The discussion revolved around safety, operational preparedness to approve patients, Florida’s treatment pathway (SB 1768) and clinical outcomes.

Session proving the potential of Hemostemix ACP-01 data

The key highlights of the session were the safety profile throughout >498 treated patients in which ACP-01 is shown to be harvested and autologous, patient-centric through a simple blood draw. Under this safety profile the no cell-related complications were registered throughout the 498 treated patients, and 300 are reported in peer-reviewed publications.

Dr Henderson commented, “The endothelial programming and autologous nature of ACP-01 sets it apart from pluripotent or vast multipotent cell types. We observed a favorable and continuous impact on the safety profile, combined with biologic specificity for inflammation modulation and new vessel growth.”

The next highlight was the cardiovascular efficacy signals involving angina and Ischemic and dilated non-ischemic cardiomyopathy, specifying percentage and time frame (per minutes) accuracy led by the presented studies. Thomas Smeenk gave a heartfelt thanks to Dr Shah and his colleagues for greeting cardiology, podiatry and vascular specialists we invited and for hosting our Grand Rounds.

The other key highlights were Florida IRB oversight and access pathway (SB 1768); CLTI (Chronic Limb-Threatening Ischemia) involving limb salvage-wound healing, 7-day production cycle and practical administration. These highlights show the robust insights of the ACP-01 potential.

The next steps after ramping these highlights are treatment scheduling in the Bahamas and Florida, which gives permission to ACP-01. The basket phase 1 program (Bahamas) involves the confirmed four of seven protocols, now preparing for submission to IRBs. The open-label design contributing to the 12-month follow-up will later bolster phase studies. Currently, the Hemostemix is distributing the perfect program brief, trial, and mechanism plan to UF and partnering clinicians to begin the process of site onboarding.