Organization (Industry)
Synapse Biomedical (United States)
ClinicalTrials.gov lists Synapse Biomedical (United States) as lead sponsor of 10 trials.
Search trials, drugs, companies and investigators, and follow each one to the others. Individual plan, $249/seat/mo. Card required.
Trials started per year with this organization as sponsor or collaborator, 1990 onward. The series also counts trials where the organization is a collaborator; the lead-sponsor trial count does not.
2026 is partial: 0 registered with a 2026 start date. The dashed outline is the pace from the 0 registered with a start date through September, planned starts included, not adjusted; not a forecast. No forecast is made for this organization: it averages 0.2 trial starts a year over the five years to September, under the 5 a year the method needs.
This page covers Synapse Biomedical (United States): 10 lead-sponsored trials and 1 legal-entity registration.
Disease areas (9)
Shown in this order: most trials first.
| Disease area | Trials |
|---|---|
| Amyotrophic Lateral Sclerosis | 4 |
| Spinal Cord Injuries | 2 |
| Pulmonary Disease, Chronic Obstructive | 1 |
| Quadriplegia | 1 |
| Rare Diseases | 1 |
Showing 5 of 9 disease areas.
Trials by start year as sponsor or collaborator (11)
Shown in this order: most recent first. 2026 is partial: trials registered with a 2026 start date so far, not a full year.
Show the table of trials by start year as sponsor or collaborator
| Year | Trials started |
|---|---|
| 2022 | 1 |
| 2021 | 1 |
| 2020 | 1 |
| 2017 | 1 |
| 2016 | 1 |
| 2015 | 2 |
| 2013 | 1 |
| 2012 | 1 |
| 2011 | 1 |
| 2004 | 1 |
Showing 10 of 11 years.
Recruitment duration, a model prediction: none of the 10 trials evaluated at the 2026-10-09 snapshot is predicted and still running. Source: ClinicalTrials.gov / AACT (CTTI), public domain.
Sponsor delivery record (1)
Enrollment hit target: the share of this sponsor's lead-sponsored trials whose actual enrollment reached the planned enrollment. On time: the share whose actual primary completion date was no later than the planned date. Each share counts only trials where we observed an estimated figure before the actual one, and n is that number of trials. Below 5 trials the count is shown as a fraction, not a percentage.
| Enrollment | Timeline |
|---|---|
| 2 of 3 hit target (n=3) | 3 of 4 on time (n=4) |
Journals published in (4)
Shown in this order: most published in first.
| Journal | Publications |
|---|---|
| Amyotrophic lateral sclerosis : official publication of the World Federation of Neurology Research Group on Motor Neuron Diseases | 1 |
| Clinics (Sao Paulo, Brazil) | 1 |
| European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery | 1 |
| Jornal brasileiro de pneumologia : publicacao oficial da Sociedade Brasileira de Pneumologia e Tisilogia | 1 |
US granted patents (1)
Patents are not classified by disease area in the source, so this is the organization's overall portfolio, not a split by disease.
| US patents granted | Granted in the last 5 years | Most recent grant |
|---|---|---|
| 12 | 1 | 2022-10-18 |
Financing and grant events (1)
| Date | Round type | Amount (USD) | Source |
|---|---|---|---|
| 2022-12-20 | Private placement | 0 | Form d |
FDA inspection record (1)
| Latest classification | Inspections |
|---|---|
| NAI | 5 |
FDA recalls (2)
Shown in this order: most recent first.
| Product | Classification | Initiated |
|---|---|---|
| NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part No. 23-0021. | Class I | 2022-07-11 |
| NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # Part Name 20-0035 NeuRx DPS System Kit 20-0036 NeuRx Diaphragm Pacing System, Patient Kit, SCI 20-0028 NeuRx DPS Surgical Kit, HDE 20-0040 NeuRx Diaphragm Pacing System Spare Sterile Components 21-0001-99 Mapping Probe 21-0004-99 Indifferent Electrode 21-0007-99 Lead Tunneler Set 21-0009-99 Blue Cable Set 21-0010-99 Transducer Tubing 21-0017-99 PermaLoc Electrode 21-0023-99 Green Cable 21-0024-99 Orange Cable 21-0025-99 Yellow Cable 21-0026-99 White Cable 77-0050 Surgeon Instruction Manual 20-0045 NeuRx DPS System Kit, ALS HDE 20-0046 NeuRx Diaphragm Pacing System, Patient Kit, ALS Marketed under HDE H070003 as well as H100006 | Class III | 2022-05-31 |
Manufacturing and distribution sites (1)
| Facility | Location | Regulators | Member organization |
|---|---|---|---|
| SYNAPSE BIOMEDICAL INC. | Oberlin, US | FDA |
Organization relationships (6)
Shown in this order: most evidence first.
| Related organization | Relationship | Evidence |
|---|---|---|
| University Hospitals of Cleveland | Co sponsors trial with | 2 |
| Johns Hopkins University | Co sponsors trial with | 1 |
| Muscular Dystrophy Association | Co sponsors trial with | 1 |
| Universidade de São Paulo | Co sponsors trial with | 1 |
| Dignity Health | Co sponsors trial with | 1 |
Showing 5 of 6 relationships.
Latest dated events (32)
Shown in this order: newest first.
| Date | Event | Source |
|---|---|---|
| 2023-01-18 | FDA inspection | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2022-12-20 | Private placement | Funding rounds and grants (NIH RePORTER + SEC EDGAR) |
| 2022-10-18 | Patent granted | Granted US patents (PatentsView / USPTO) |
| 2022-07-11 | FDA recall | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2022-06-22 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
Showing 5 of 32 events.
Biomarker capability evidence (18)
Shown in this order: tier desc, then gene symbol.
| Gene | Role | Evidence |
|---|---|---|
| MAFIP | Trial collaborator | Named in trial inclusion criteria |
| MAFIP | Trial sponsor | Named in trial inclusion criteria |
| MAFIP | Trial sponsor | Named in trial inclusion criteria |
| MIP | Trial sponsor | Named in trial inclusion criteria |
| MIP | Trial sponsor | Named in trial inclusion criteria |
Showing 5 of 18 evidence rows.
Not on this page
Checked, with nothing recorded for this organization: companies grouped under this page, related companies not grouped here, active development programs, approved assets, sec-reported annual financials, fda warning letters, fda untitled letters, fda import refusals, climate targets, as filed, workforce and board diversity, as filed, clia clinical laboratory certificates, and biomarkers this organization publishes on.