Creating a Device Around Headache Benjamin Pless, CEO Autonomic Technologies, Inc. North America Neuromodulation Society I 3 Session Las Vegas, December

Creating a Device Around Headache

Benjamin Pless, CEOAutonomic Technologies, Inc.

North America Neuromodulation Society I3 SessionLas Vegas, December 2012

Dec 6, 2012Autonomic Technologies

Not For Distribution1

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

Dec 6, 2012 2

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

3Dec 6, 2012

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



Sphenopalatine Ganglion (aka Pterygopalatine Ganglion) – a closer look



R.L. Drake, Grays Anatomy for Students, 2005



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



Prior Neurostimulator Paradigm



Early ATI Product Concept



Patient Experiences of Tunneling



Surgical Retreat August 2008

• ATI dissatisfaction with invasiveness of approach

• Included variety of – Neurosurgeons– ENTs– Plastic surgeons– CMF





Gingival Buccal Approach to the SPG

Adopted by ATI

Developed by: Dr. Frank Papay,Cleveland Clinic, Cleveland Ohio



New ATI Neurostimulator Concept



Stimulating probe neurostimulator Fixation bracket

• No battery• Patient activated

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.



Upper Lip

Mucosa Incision

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.



Mucosa

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.



ATI introducer

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.



ATI neurostimulator

ATI neurostimulator Implantation

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Neurostimulator lead within the pterygopalatine fossa

Neurostimulator lead in the pterygopalatine fossa stimulates the sphenopalatine

ganglion (SPG)


Not For Distribution

Autonomic TechnologiesSPG Stimulator for Headache

• Simple therapy controls:on/off and up/down

• Wirelessly powers and controls Neurostimulator

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On-demand,

patient-controlled therapy

• Implantable Neurostimulator

• Miniaturized• Minimally invasive

• CE Marked• Investigational use

only in the US


Not For Distribution

Acute Response to SPG Stimulation



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!!!



Thank You!



Documents

Creating a Device Around Headache Benjamin Pless, CEO Autonomic Technologies, Inc. North America Neuromodulation Society I 3 Session Las Vegas, December