Valo Health - FDA Collaborative Study in Human Cardiac Tissues Demonstrates Potential to Predict Clinical Efficacy of Cardiac Contractility Modulation Devices to Treat Heart Failure

Valo Health, Inc (“Valo”) shared the ini­tial results of a col­lab­o­ra­tive study with the U.S. Food and Drug Admin­is­tra­tion (FDA), demon­strat­ing the poten­tial of Val­o’s Biowire plat­form to pre­dict clin­i­cal effi­ca­cy of Car­diac Con­trac­til­i­ty Mod­u­la­tion devices to treat heart fail­ure. The study, which is part of a five-year research col­lab­o­ra­tion between Valo and the FDA was pub­lished by the research team in a recent issue of Fron­tiers in Physiology.

The FDA is work­ing to under­stand how Val­o’s Biowire plat­form could be lever­aged to eval­u­ate cur­rent and future Car­diac Con­trac­til­i­ty Mod­u­la­tion (CCM) med­ical devices for the treat­ment of heart fail­ure patients. The Biowire plat­form offers an attrac­tive alter­na­tive par­tic­u­lar­ly to ani­mal test­ing by recre­at­ing func­tion­al adult human heart mus­cle in vit­ro, lever­ag­ing advances in stem cell tech­nol­o­gy and tis­sue engi­neer­ing. At Valo, these in vit­ro human tis­sues are cur­rent­ly being used to accel­er­ate drug dis­cov­ery efforts. 

“Through advances in stem cell tech­nol­o­gy and human tis­sue engi­neer­ing Val­o’s Biowire plat­form is cur­rent­ly used as a trans­la­tion­al tool to accel­er­ate drug dis­cov­ery efforts,” said Michael P. Graziano, Head of Dis­cov­ery and Trans­la­tion­al Biol­o­gy at Valo. “We are thrilled to extend the use of Val­o’s Biowire plat­form through our col­lab­o­ra­tion to poten­tial­ly help the FDA assess the safe­ty and effi­ca­cy of med­ical devices; with the ulti­mate goal of help­ing to save lives,” added Graziano.

While pre­vi­ous stud­ies have pro­vid­ed impor­tant insights into the under­stand­ing of CCM, a major hin­drance to the detailed study has been the lack of appro­pri­ate in vit­ro human car­diac mod­els. Lack of human non­clin­i­cal mod­els to eval­u­ate car­diac med­ical device safe­ty and effec­tive­ness cur­rent­ly hin­ders the reg­u­la­to­ry review process and pro­duces a sig­nif­i­cant bur­den on ani­mal mod­els. Val­o’s Biowire plat­form offers an in vit­ro mod­el that reca­pit­u­lates clin­i­cal CCM response and may pro­vide mech­a­nis­tic insights that make it pos­si­ble to pre­dict which para­me­ters and patient pop­u­la­tions will respond to CCM therapy.

In the research paper, which was fea­tured in Fron­tiers in Phys­i­ol­o­gy, the data show that apply­ing CCM puls­es to 3D Biowire tis­sues results in a robust increase in car­diac con­trac­til­i­ty, mir­ror­ing the effect seen clin­i­cal­ly in heart fail­ure patients. Con­verse­ly, apply­ing the same puls­es to the same car­diac cells cul­tured in 2D on tra­di­tion­al hard sub­strates, no change in con­trac­til­i­ty was observed. Val­o’s func­tion­al­ly mature car­diac tis­sues pro­vide a phys­i­o­log­i­cal­ly rel­e­vant response to the CCM stim­u­la­tion ranges being used in clin­i­cal pro­to­cols. The data con­firm that 3D mod­els are ide­al sur­ro­gates when human test­ing is not pos­si­ble and ani­mal mod­els are insuf­fi­cient. This nov­el in vit­ro human mod­el opens the door to inves­ti­gat­ing the mech­a­nism and pro­vides the abil­i­ty to val­i­date the safe­ty para­me­ters of CCM ther­a­py pre-clinically.

This project pro­vides addi­tion­al data to sup­port the eval­u­a­tion of in vit­ro tools that can poten­tial­ly be used to bring safe and effec­tive new med­ical devices to patients faster. and may be used to inform the devel­op­ment of stan­dards and FDA guidance.

About Valo Health
Valo Health, Inc (“Valo”) is a tech­nol­o­gy com­pa­ny built to trans­form the drug dis­cov­ery and devel­op­ment process using human-cen­tric data and arti­fi­cial intel­li­gence dri­ven com­pu­ta­tion. As a dig­i­tal­ly native com­pa­ny, Valo aims to ful­ly inte­grate human-cen­tric data across the entire drug devel­op­ment life cycle into a sin­gle uni­fied archi­tec­ture, there­by accel­er­at­ing the dis­cov­ery and devel­op­ment of life-chang­ing drugs while simul­ta­ne­ous­ly reduc­ing costs, time, and fail­ure rates. The com­pa­ny’s Opal Com­pu­ta­tion­al Plat­form^™ is an inte­grat­ed set of capa­bil­i­ties designed to trans­form data into valu­able insights that may accel­er­ate dis­cov­er­ies and enable Valo to advance a robust pipeline of pro­grams across car­dio­vas­cu­lar meta­bol­ic renal, oncol­o­gy, and neu­rode­gen­er­a­tive dis­ease. Found­ed by Flag­ship Pio­neer­ing and head­quar­tered in Boston, MA, Valo also has offices in Lex­ing­ton, MA, New York, NY, and San Fran­cis­co, CA.