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Customer discovery for minimally invasive nerve block device to treat severe pain and reduce usage of opiates

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41NS115460-01
Agency Tracking Number: R41NS115460
Amount: $554,325.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: 106
Solicitation Number: PA19-029
Timeline
Solicitation Year: 2019
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-09-30
Award End Date (Contract End Date): 2020-09-30
Small Business Information
3711 MARKET ST STE 800 STOP 105
Philadelphia, PA 19104-5504
United States
DUNS: 080980990
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: Yes
Principal Investigator
 STEPHEN MELONI
 (484) 679-6274
 meloni@sas.upenn.edu
Business Contact
 STEPHEN POPIELARSKI
Phone: (484) 679-6274
Email: thermaquil@gmail.com
Research Institution
 UNIVERSITY OF PITTSBURGH
 
4200 5TH AVE
PITTSBURGH, PA 15260-0001
United States

 Nonprofit College or University
Abstract

Abstract:
Thoracotomy is one of the most painful surgical procedures and patients are at high risk of developing
opioid addiction. Recent studies have shown 1 in 7 patients became new persistent opioid users after
physical recovery from the surgery was complete. The largest risk factor for opioid addiction is being
prescribed opioids in the first place, and Thermaquil wants to reduce this incidence by developing
patient-controlled, drug-free, reversible nerve block devices. Our approach involves gently warming and
cooling a short segment of any nerve, and we believe that all mammalian and amphibian nerves are
susceptible to thermal nerve blocks. In the parent STTR to this I-Corps proposal, we are specifically
blocking intercostal nerves that transmit severe thoracic-region pain. The system includes a minimally
invasive thermal tip and an externally worn controller/power unit. The thermal tip will be primarily
inserted by thoracic surgeons, regional (peripheral) anesthesiologists and interventional pain specialists
– so people in these roles will likely be the initial targets of our I-Corps Customer Discovery work.
Thermaquil has a highly engaged team of world renowned thought-leaders in neurosurgery,
neuropathology, anesthesiology, pain, computational fluid dynamics and thermal modeling, and
regulatory affairs. We have designed and built four generations of thermal device prototypes and
validated their thermal performance matches expectations to attain thermal nerve block efficacy.
Thermal nerve block is potentially applicable to a wide range of human pain conditions. In this I-Corps
project we want to confirm that we are selecting most ideal initial target market and that we are
developing the right product to fully meet the critical needs of the market and all key stakeholders in the
ecosystem. This proposed Customer Discovery will refine Thermaquil’s go to market strategy including
our value proposition while also starting to explore reimbursement and revenue considerations to make
sure that our selected market is viable financially. If new market needs are identified, alternate nerve
block devices or approaches could be adapted to best meet the better understood need. Specifically we
seek to understand current surgical and patient / care team workflows and opportunities/challenges
with current approaches. We’d like to clarify what ‘job’ we can help each stakeholder accomplish and
the outcomes that they are trying to achieve. This will help us define an ideal product-market-fit to
confirm that we are approaching the right foothold market with the right technical solution. We’d also
like to identify other constraints and concerns that decision-makers will have when considering new
pain block solutions. Thermaquil commits to interview over 100 key stakeholders to clarify these points
and plans to attend 1-2 national conferences for pain specialists and thoracic anesthesiologists.Narrative:
Patients with severe thoracic pain have no safe and effective long-term options to block pain associated
with thoracotomy, rib fractures, or chest tubes. Thermaquil has discovered a novel thermal mechanism
to block pain signal transmission and is developing a patient-controlled intercostal nerve block device. In
this I-CORPS project Thermaquil will refine our go-to market strategy by engaging with thoracic
surgeons, anesthesiologists and pain specialists to better understand the needs of patients and care
teams.

* Information listed above is at the time of submission. *

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