Potential to boost recovery in stroke patients
The portable magnetic stimulation cap created by Dr. Santosh Helekar of Houston Methodist and Dr. Henning Voss of Weill-Cornell Medical College is a noninvasive, battery-powered device using a novel transcranial stimulation technology that selectively modulates neural activity and modifies brain connections to bring about functional recovery in neurological conditions such as stroke. It could also be used for other therapeutic and diagnostic applications. Dr. Helekar and Dr. David Chiu recently conducted a Phase 1/2a randomized clinical trial in which they tested the cap on 30 ischemic stroke survivors who had chronic motor impairment. The early findings showed that the cap increases activity near stroke-injured areas of the brain, which may induce recovery of motor function. Dr. Chiu notes these results bring hope for stroke survivors with chronic impairment of motor function.
Neurostimulation Therapy for Advanced Stroke Care
This is a neural stimulation-induced molecular (nSIM) protective therapy device that combines an endotracheal tube with nerve stimulation. Stimulating the vagus nerve has a neurological protective effect in acute stroke patients, preventing common debilitations resulting from stroke. Currently, there are prototypes of devices constructed of various materials, coatings and sterilization. The goal is to evaluate the final device design in preclinical Good Laboratory Practice studies and early feasibility clinical studies.
TARGETED LIPOSOMES FOR MANAGING PRETERM LABOR
This is a large drug delivery capsule that carries a drug inside a pregnant woman without crossing the placenta to the baby. This capsule reduces the effects of oxytocin, a hormone that increases contractions during labor, to help treat premature labor. Currently, there are some companies interested in possibly licensing this project’s pending scale-up. The goal is to have controlled, scaled-up manufacturing to complete investigational new drug applications with Good Laboratory Practices.
beta test and obtain fda 510(k) clearance for anatomicaligner system
A comprehensive computer program for craniomaxillofacial surgery planning, the AnatomicAligner allows physicians performing surgery to correct craniomaxillofacial deformities more accurately and efficiently. So far, this project has two potential licensees evaluating the product. Moreover, there is beta testing occurring at several medical centers to refine and improve the software. The ultimate goal is to conduct beta testing at top academic institutions for additional software improvements in preparation for FDA market submission.
A drug precursor for brain cancer treatment
A drug precursor, or pro-drug (PAM-OBG) converted into a DNA repair inhibitor in glioma cells, only becomes active when it interacts with cancerous glioma cells. The pro-drug thereby reduces toxic side effects associated with cancer treatments. Recently, the research team prepared four candidate constructs, and the final candidate has been selected. The goal is to optimize drug chemistry, select the lead construct and test the efficacy in preclinical models of glioma before moving to Good Laboratory Practice studies.
Mitochondrial ‘Smartbomb’ for the Treatment of Glioma
This is a drug that only becomes active when it interacts with cancerous glioblastoma cells, reducing toxic side effects associated with cancer treatments and increasing the effects of other anti-cancer drugs. This project is currently postponed pending a satisfactory progress report for the oncomagnetics project. The goal is to optimize drug synthesis and develop Good Manufacturing Practices protocols, while evaluating the pharmacology and safety profile in preclinical studies.
Less-Invasive Surgical Replacement of the Heart’s Mitral Valve
A prosthetic mitral valve, which is trademarked as MitraMimics, is being developed to mimic the native valve. This prosthetic mitral valve can be placed using a less-invasive surgical procedure. The MitraMimics™ device allows more efficient blood flow from the heart’s left atrium to the heart’s left ventricle. Currently, there is an agreement with a vendor to design and test the surgical mitral valve. Moreover, four prototypes were constructed and are progressing to functional testing. The goal is to manufacture the prototype and perform bench and non-Good Laboratory Practice performance testing.
Imaging Pulmonary Arterial Hypertension
This is a probe that attaches to the heart and lung’s blood vessels, which can be seen through PET scans. This technology will enable early diagnosis for pulmonary arterial hypertension (PAH), a type of high blood pressure that affects the heart and lungs and is typically impossible to detect in its early stages. Right now, there is an agreement in place with a vendor to complete precursor synthesis and the first compound. The goal is to develop a PET imaging protocol for patients with PAH.
Developing Transcranial Magnetic Device For Possible Cancer Treatment With Initial Focus On Glioblastoma
Principal Investigators: Santosh Helekar, MD, PhD & David Baskin, MD
Based on one of Dr. Santosh Helekar’s previous inventions, this transcranial magnetic stimulation device helps generate oscillating magnetic fields (OMF) in a wearable device. Preliminary data show that OMF can induce superoxide and hydrogen peroxide production, reduce mitochondrial volume and increase cell death in cancer cells. This technique has a high potential to treat glioblastoma. Dr. Helekar and Dr. David Baskin recently finalized the device’s design for human use, and they completed compassionate use with one patient. The goal is to confirm OMF’s specific characteristics and frequency variation patterns that are more efficacious for glioblastoma and then develop a custom software package that controls those frequencies and patterns.
Using Imaging to Measure Nerve and Brain Injury
Principal Investigators: Phil Horner, PhD & Tatiana Wolfe, PhD
These are mathematical algorithms for machine learning that allow MR image reconstruction from a standard MRI scanner. The algorithms’ purpose is to measure the MR signal located in the thinly packed layers of myelin — an insulating layer that wraps around nerves and allows nerves to communicate with other nerves and tissues properly — to yield reports that demonstrate myelin integrity. Currently, there is a patent claim review occurring, and Dr. Phil Horner and Dr. Tatiana Wolfe are working with Siemens representatives to coordinate imaging plans. The goal is to develop and test market-compliant software and file a 510(k) FDA application to later conduct a clinical trial.
MAPS: Medication Administration Protection System
These novel, custom algorithms use information from the electronic medical record to cross check multiple repositories of peer-reviewed literature on medication contraindications and interactions to reduce medication errors. Currently, the project is in its startup phase, but the goal is to develop algorithms that trough proof-of-concept phases.