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Creating a Device Around Headache Benjamin Pless, CEO Autonomic Technologies, Inc. North America Neuromodulation Society I 3 Session Las Vegas, December 2012. 2007(March): The beginning. Cleveland Clinic presentation to KPCB of autonomic patents to control a wide range of disorders
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Creating a Device Around Headache Benjamin Pless, CEO Autonomic Technologies, Inc. North America Neuromodulation Society I3 Session Las Vegas, December 2012 Autonomic Technologies Not For Distribution
2007(March): The beginning • Cleveland Clinic presentation to KPCB of autonomic patents to control a wide range of disorders • Headache • Vascular • Cardiac • Pulmonary • Renal Autonomic Technologies Not For Distribution
SPG is a known therapeutictarget to treat headache • SPG interventions have a long history in the treatment of Migraine and Cluster Headache • Anesthetic trans-nasal topical blocks • Drug injection blocks • Pulsed RF and ablative blocks • Surgical procedures including gamma knife • Acute interventions have been reported sometimes to provide weeks of sustained pain relief Autonomic Technologies Not For Distribution
Acute SPG Stimulation Early Proof of Concept research at the Cleveland Clinic by physician inventors demonstrating ability of stimulation to stop cluster headaches Autonomic Technologies Not For Distribution
Sphenopalatine Ganglion (aka Pterygopalatine Ganglion) – a closer look R.L. Drake, Grays Anatomy for Students, 2005 Autonomic Technologies Not For Distribution
ATI Product Considerations • Good cosmesis • majority of patients are women • Minimally invasive implant • Difficult surgery would reduce acceptability • Simple and easy explant • “no harm, no foul” lowers barriers to acceptance Autonomic Technologies Not For Distribution
Prior Neurostimulator Paradigm Autonomic Technologies Not For Distribution
Early ATI Product Concept Autonomic Technologies Not For Distribution
Patient Experiences of Tunneling Autonomic Technologies Not For Distribution
Surgical Retreat August 2008 • ATI dissatisfaction with invasiveness of approach • Included variety of • Neurosurgeons • ENTs • Plastic surgeons • CMF Autonomic Technologies Not For Distribution
Gingival Buccal Approach to the SPG Adopted by ATI Developed by: Dr. Frank Papay, Cleveland Clinic, Cleveland Ohio Autonomic Technologies Not For Distribution
New ATI Neurostimulator Concept • No battery • Patient activated Stimulating probe neurostimulator Fixation bracket Autonomic Technologies Not For Distribution
Upper Lip Mucosa Incision The procedure begins by doing a submucosal injection of a vasoconstrictor and local anesthesic. An 1-2 cm incision is made approximately 3 to 5 mm superior to the mucogingival junction. Autonomic Technologies Not For Distribution
Mucosa Periosteal elevators are used to elevate the tissue in the subperiosteal plane. Dissect the tissue until the inferior aspect of the zygomaticomaxillary buttress area is exposed, also called the zygomatic process of the maxilla. Autonomic Technologies Not For Distribution
ATI introducer The proprietary ATI introducer is then inserted subperiosteally behind the zygomaticomaxillary buttress, and advanced on the posterior side of the maxillary sinus to the pterygopalatine fossa. Autonomic Technologies Not For Distribution
ATI neurostimulator The neurostimulator is then placed in the PPF either by using the introducer as a guide, and sliding the neurostimulator probe between the bone and introducer, or by removing the introducer and placing the neurostimulator probe into the dissection path created by the introducer. Autonomic Technologies Not For Distribution
ATI neurostimulator Implantation Neurostimulator lead in the pterygopalatine fossa stimulates the sphenopalatine ganglion (SPG) Neurostimulator lead within the pterygopalatine fossa Autonomic Technologies Not For Distribution
Autonomic TechnologiesSPG Stimulator for Headache • Simple therapy controls:on/off and up/down • Wirelessly powers and controls Neurostimulator • Implantable Neurostimulator • Miniaturized • Minimally invasive • CE Marked • Investigational use only in the US On-demand, patient-controlled therapy Autonomic Technologies Not For Distribution
Acute Response to SPG Stimulation Autonomic Technologies Not For Distribution
Special Thanks to Physician Collaborators • Frank Papay • Stew Tepper • Ali Rezai • Samer Narouz • Mehdi Ansarinia • Joseph Roberson • Michael Stanton-Hicks • Peter Goadsby • Richard Lipton • Jean Schoenen • Rigmor Jensen • Arne May • Soren Hillerup • Stephen Silberstein • Miguel Lainez • …and many more!!! Autonomic Technologies Not For Distribution
Thank You! Autonomic Technologies Not For Distribution