SpiraMed: A Stereotactic Helix-based Therapy Delivery system for the Human Brain

Kavli Affiliate: David Rowitch

| Authors: Harry JCJ Bulstrode, Adam Young, Ifenya Huysman, Dushanth Seevaratnam, King Ki Man, Ho Lim Pak, Grace Wilson, AthenaStamper, Xinyi Wang, Yujun Wang, Xin Tang, An Truong, Saeed Kayhanian, Francisca Ferreira, Mark Plummer, Adam O’Connell, Dominika Bogusiewicz, Daniel Brown, Danny Godfrey, Ronan Daly, George G Malliaras, David H Rowitch, Peter JAHutchinson, William P Gray and Roger A Barker

| Summary:

Stereotactic needle-based delivery remains the standard for local administration of Advanced Therapy Medicinal Products (ATMPs) to the human brain. ATMP administration typically involves multiple trajectories, presenting cumulative risks and prolonging surgery. Reflux-prone, patchy therapy coverage compromises clinical results. We demonstrate a novel approach, deploying a helical delivery catheter via a single access trajectory per target, referred to as ‘SpiraMed’. Helix retraction is synchronised with therapy delivery, enabling comprehensive target coverage in seconds. Helix pitch and diameter can be precisely tailored to patient-specific target volume and vascular anatomy, as part of the preoperative stereotactic surgical planning process. Testing in agarose phantoms, live sheep and cadaveric human brain confirms enhanced therapy delivery volume, delivery speed and target coverage, with reductions in reflux and predicted risk of bleeding complication. SpiraMed represents a new paradigm, promising to help deliver on the transformative potential of cell and gene therapies across the spectrum of human CNS disease.

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