Success Stories
$8.6M in NIH SBIR awards for medical innovation
Our clients are building artificial hearts, implantable pumps for children, smarter airway tools, and new surgical devices. These are their wins, funded through competitive NIH SBIR Phase I and Direct to Phase II awards with support from Blue Haven Grant Consultants.
Real awards. Real patients. Real progress.
Each award below started with a team that had a strong idea and needed a fundable application. Blue Haven helped them shape specific aims, frame clinical need for NIH reviewers, and manage submission. Clients come back for their next award. One cardiovascular client has now won two Direct to Phase II grants worth $6.9M combined. Client names are kept confidential. Click any story to read the full case study.
Funded SBIR projects
Pediatric Cardiology SBIR Direct to Phase II
$4.3M
A returning cardiovascular device client
Pediatric Left Ventricular Assist Device (P-LVAD)
The challenge
About 35,000 U.S. children live with heart failure. The only pediatric support system, Berlin Heart EXCOR, keeps children hospitalized until transplant.
The innovation
A compact blood pump small enough to implant in children and run from a child-sized wearable battery, so kids can wait for a transplant at home.
Second award for a returning client, and the largest on this page
Feasibility proven in a 3-day chronic ovine study
Path to Phase IIB and First-in-Human early feasibility study
Cardiovascular SBIR Direct to Phase II
$2.6M
A cardiovascular device company
Totally-Implanted Left Ventricular Assist Device (TI-LVAD)
The challenge
Up to 44% of LVAD recipients develop infection, largely from the percutaneous driveline and high-power (~8 W) pumps. Only 2–3% of the 100,000+ potential U.S. recipients choose an LVAD each year.
The innovation
A totally implanted LVAD and wireless transcutaneous charging, eliminating the skin-piercing driveline and giving patients up to 12 hours free of external power.
FDA Breakthrough Device Designation
Feasibility shown with 30-day bovine studies
Funding to finalize design and complete all pre-clinical testing
CardiovascularSBIR Phase I
$561K
An artificial heart developer
Mechanically Actuated Total Artificial Heart
The challenge
Total artificial hearts are approved only as a bridge to transplant, leaving patients with severe biventricular failure without a destination-therapy option.
The innovation
The device replaces the pneumatic pump of an existing total artificial heart with a quieter mechanically actuated pump that adapts to blood flow and runs on a wearable, long-lasting battery.
Funds benchtop and porcine feasibility studies
Opens a path to the first TAH for destination therapy
Sets up a Phase II clinical-scale program
Critical Care & Airway SBIR Phase I
$467K
An airway device startup
Optical Sensor-Enabled Endotracheal Tube (OS-ETT)
The challenge
More than 30 million U.S. intubations happen each year. Misplaced or dislodged tubes injure patients and cost about $12B a year.
The innovation
An endotracheal tube with built-in optical sensors that shows a real-time anatomical image for correct placement and continuous, remote position monitoring, with no calibration needed.
Feasibility testing in a live porcine model
Fits standard respiratory workflows
Phase II plan through GLP testing to First-in-Human
Surgical Oncology SBIR Phase I
$374K
A surgical device startup
Biodegradable Anastomotic Leak Barrier
The challenge
Esophageal cancer affects 50,000+ Americans a year, and up to 22% of esophagectomy patients develop anastomotic leakage, which carries high morbidity and mortality.
The innovation
A biodegradable barrier is placed during esophagectomy that protects the anastomosis while it heals, with no second surgery needed.
Mechanical and degradation testing at esophageal pH
Porcine leak-protection studies at 7, 14, and 28 days
A preventive option usable on any patient
Neurology & Pain ManagementSBIR Phase I
$330K
A neurodiagnostics startup
Mechanomyography Diagnostic System (MMG-DS)
The challenge
About 10% of U.S. adults have radiculopathy, and up to 35% of patients still have symptoms after decompression surgery, partly because nerve diagnostics are qualitative.
The innovation
MMG-DS turns routine nerve-block procedures into quantitative diagnostics by measuring the muscle's mechanical response, avoiding EMG's electrical noise, so surgeons can target the right nerves.
Probe works with existing interventional pain needles
Repeatability validated in a porcine model
Phase II plan toward FDA 510(k) clearance