Pulse Therapeutics, Inc. — Department of Health and Human Services SBIR Phase I: NIMHD

Description

DESCRIPTION provided by applicant Coronary heart disease CHD accounts for every of deaths in the United States US with acute incidences estimated at M annually Of these up to are classified as ST elevation myocardial infarction STEMI in which a clot blocks a coronary artery leading to a change in the ECG ST wave Because the heart muscle rapidly dies time to reperfusion is critical While current CHD annual indirect costs are high they are projected to further increase from $ B in to $ B by Early percutaneous coronary intervention PCI remains the standard of care in the US However PCI has not shown to be of benefit to STEMI patients living in rural communities due to increased transportation times Efforts to expand PCI to rural communities have largely failed due to new PCI centers only being established in urban regions As a result andgt of transferred STEMI patients do not receive PCI therapy within the recommended min from first medical contact resulting in significantly higher mortality and greater patient costs Given that over M people live in geographically remote or rural communities andgt miles from a PCI center it is estimated that andgt k STEMI victims will remain without timely access to PCI each year While clot dissolving drugs are effective most physicians remain uncomfortable with their elevated bleeding risk and sub PCI recanalization rates Fundamentally thrombolytic drugs are limited in their effectiveness due to their inability to rapidly diffuse to clot in the occluded vessel due to poor fluid dynamics Pulse Therapeutics Inc andapos s PTIandapos s patented and clinically tested technology has overcome this limitation in a way that dramatically accelerates drug delivery to a clot by using non drug attached magnetite particles controlled by a magnetic cart in the emergency department However by attaching the FDA approved drug tenecteplase TNK to PTIandapos s magnetite particles the technology promises substantially faster clot lysis while eliminating associated bleeding risks with therapy deliverable in both the community hospital and ambulance settings Unfortunately this strategy likely faces an expensive FDA combination product regulatory pathway PTIandapos s objective is to demonstrate dramatic improvements in fibrinolysis by attaching TNK to magnetite particles In Phase I PTI will attempt to develop a optimally sized magnetite particle with the best performing TNK coating conjugated to the magnetite surface collect data on candidate particleandapos s clot lysis rates in vitro optimize a software algorithm for automated particle collection develop an ECG signal filtering system to enable the use of the technology without affecting electrocardiographic waveforms and conduct investigations evaluating lysis efficacy and hemorrhage risks in preclinical animal models The proposed technology has dramatic implications for rural STEMI treatment and will address the American Heart Associationandapos s concern that andquot Where you live should not determine whether you live andquot PUBLIC HEALTH RELEVANCE Pulse Therapeutics Inc intends to substantially improve accelerate and expand care to remote underserved populations for ST elevation myocardial infarction STEMI by attaching tenecteplase TNK to its magnetically controlled particles Of the andgt k STEMI events seen in the US each year of the victims are in rural communities andgt min away from an urban area which results in substantially inferior care due to persistent transfer times for percutaneous coronary intervention By extending its patented proven and clinically evaluated technology Pulse Therapeutics hopes to destroy blood clots faster and more reliably while substantially reducing TNK associated hemorrhage risks thereby greatly accelerating therapy for those victims without timely access to qualified medical facilitie