Project Grant R43CA261381

PATIENT-SPECIFIC NARROW BEAM BREAST CT - EXECUTIVE SUMMARY OPPORTUNITY - BREAST CANCER IS THE MOST COMMON MALIGNANCY AMONG WOMEN. SEVERAL TECHNOLOGIES ARE USED FOR SCREENING AND DIAGNOSIS OF THIS DISEASE: MAMMOGRAPHY, TOMOSYNTHESIS, ULTRASOUND, AND MRI. MAMMOGRAPHY AND TOMOSYNTHESIS NOT ONLY CAUSE DISCOMFORT TO PATIENTS, BUT THEIR OUTCOME IS ALSO DEPENDENT ON THE PATIENT'S BREAST DENSITY: BREAST DENSITY IS ASSOCIATED WITH REDUCED DETECTION SENSITIVITY IN BOTH IMAGING TECHNIQUES. ULTRASOUND HAS A LOW-RESOLUTION, IS HIGHLY USER- DEPENDENT, AND CAN BE TIME-CONSUMING; MRI IS PROHIBITIVELY EXPENSIVE AND TIME-CONSUMING. THERE IS SIGNIFICANT NEED, THEREFORE, FOR AN IMAGING MODALITY THAT ADDRESSES THE LIMITATIONS OF THE CURRENT SCREENING AND DIAGNOSTIC IMAGING TECHNOLOGIES, PRIORITIZES PATIENT EXPERIENCE, AND REDUCES HEALTH CARE COSTS OF DETECTING CANCER. SOLUTION - MALCOVA HAS DESIGNED AND DEVELOPED A MINIMUM VIABLE PRODUCT OF A DEDICATED BREAST CT SYSTEM THAT PROVIDES 3D IMAGES OF BOTH BREASTS, SIMILAR TO BREAST MRI, IN 30 SECONDS OF SCAN TIME, AT MAMMOGRAPHIC DOSE LEVELS, WITHOUT APPLYING BREAST COMPRESSION. THE SCIENTIFIC PREMISE OF OUR PROPRIETARY TECHNOLOGY IS BASED ON NARROW-BEAM CT IMAGE ACQUISITION - MALCOVA'S PROPRIETARY TECHNOLOGY PROTECTED THROUGH TWO UTILITY PATENTS, ALREADY GRANTED AND FULLY OWNED BY MALCOVA. THE SPECIFIC AIMS FOR THE PARENT PROJECT OF THIS I-CORPS APPLICATION ARE: AIM 1: DEVELOPMENT OF FLUENCE MODULATION ASSEMBLY (THIS ASSEMBLY MODULATES THE FLUENCE OF X-RAYS TO GENERATE A NARROW BEAM), AIM 2: DEVELOPMENT OF A LINE DETECTOR ASSEMBLY (WHICH LEADS TO PREVENTING THE ACQUISITION OF SCATTERED PHOTONS), AND AIM 3: DEVELOPMENT OF THE IMAGE ACQUISITION PROTOCOL AND SYNCHRONIZATION OF THE BEAM MODULATION AND LINE DETECTOR ASSEMBLIES. ACHIEVING SYNCHRONY BETWEEN THESE ASSEMBLIES RENDERS PROOF OF CONCEPT OF, AND CLARIFIES THE UNKNOWNS FOR, DECOUPLED GANTRY DEVELOPMENT IN PHASE 2. SO FAR, WE HAVE DEVELOPED THE IMAGE ACQUISITION APPARATUS (SEE THE FOLLOWING FIGURE), AND ARE ON TRACK TO FINISH THE PROJECT ON TIME (BY THE END OF APRIL 2022). MALCOVA'S MVP. THE CONCEPT IS SHOWN IN LEFT, WITH THE PHOTOS OF THE DEVELOPED PROTOTYPE ON RIGHT. UPON COMPLETION OF THIS PHASE 1 PROJECT, OUR DEVELOPED PROTOTYPE WILL BE CAPABLE OF SCANNING A BREAST-LIKE OBJECT WITH A NARROW BEAM DESIGN PARADIGM. IN PHASE 2, WE WILL FOCUS ON OPTIMIZATION OF A PATIENT-TABLE DESIGN TO FACILITATE MAXIMAL CHEST WALL COVERAGE AND BILATERAL BREAST IMAGING. THE FINAL VISION FOR OUR PRODUCT IS A SIMULTANEOUS BILATERAL BREAST CANCER IMAGING PLATFORM READY FOR SUBSEQUENT TECHNOLOGY PLUG-INS SUCH AS INTEGRATED BIOPSY, COMPUTER AIDED DETECTION AND DIAGNOSIS. WITH A PRODUCT COST ESTIMATE AKIN TO THAT OF A TOMOSYNTHESIS UNIT, OUR TECHNOLOGY WILL BE ACCESSIBLE TO RADIOLOGIC FACILITIES, PROVIDING AN EFFECTIVE SCREENING TOOL, IN PARTICULAR, FOR WOMEN WITH DENSE BREASTS. I-CORPS TEAM - CLO (FOUNDER AND CEO AT MALCOVA): THE PROJECT'S PI IS DR. PEYMON GHAZI. HE COMPLETED HIS DOCTORAL DISSERTATION ON BREAST CANCER RADIOLOGY. PRIOR TO LAUNCHING MALCOVA, DR. GHAZI WORKED IN THE MEDICAL DEVICES INDUSTRY AS A SCIENTIST, R & D ENGINEER AND PROJECT MANAGER. TL: (DIRECTOR OF IMAGING AT MALCOVA): DR. LYNDA IKEJIMBA BRINGS IN HER EXPERIENCE IN THE IMAGING REGULATORY SECTOR THROUGH HER SEVERAL YEARS OF WORK AT FDA AS AN IMAGING SCIENTIST AND REVIEWER. IE: (CONSULTANT TO MALCOVA) MR. FRANK CABLE BRING IN OVER 25 YEARS' EXPERIENCE IN BUSINESS DEVELOPMENT, PRODUCT DEVELOPMENT, COMMERCIALIZATION AND QUALITY ASSURANCE ACROSS A VARIETY OF BUSINESSES, INCLUDING BREAST CANCER RADIOLOGY. ALL TEAM MEMBERS ARE ABLE TO MEET THE TIME-INTENSIVE REQUIREMENTS OF THE I-CORPS TRAINING PROGRAM.