BOLD TYPE LLC - Florida Company Profile

617-320-7998

jose@boldtype.com

JOSE BOHORQUEZ

Hispanic American, Other Minority Owned, Self-Certified Small Disadvantaged Business

P2885808

813967063

2024

16

4079844937

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2023

20

4079844937

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2022

21

6173207998

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2021

19

6173207998

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2020

13

6173207998

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2024-08-28

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Department of Health and Human Services

AN INTRAVAGINAL, WEARABLE DEVICE FOR TREATING WOMEN WITH PELVIC FLOOR MYOFASCIAL PAIN - ABSTRACT HIGH TONE PELVIC FLOOR DYSFUNCTION (HTPFD) IS A MAJOR CONTRIBUTOR TO CHRONIC PELVIC PAIN, AFFECTING UP TO 15% OF WOMEN IN THE UNITED STATES. INTRAVAGINAL ELECTRICAL STIMULATION (IES) AND FOCAL MUSCLE VIBRATION (FMV) CAN PLAY PIVOTAL ROLES IN MANAGING MUSCLE PAIN THROUGH DISTINCT MECHANISMS. IES INVOLVES APPLYING LOW-LEVEL ELECTRICAL CURRENTS TO STIMULATE NERVES, WHICH CAN REDUCE PAIN PERCEPTION BY DISRUPTING PAIN SIGNALS' TRANSMISSION TO THE BRAIN AND PROMOTES THE RELEASE OF ENDORPHINS, PROVIDING SHORT-TERM RELIEF FOR MUSCLE DISCOMFORT. FMV EMPLOYS MECHANICAL OSCILLATIONS TO TARGET MUSCLE FIBERS, ENHANCING BLOOD FLOW AND RELAXING MUSCLE TENSION. THIS PROCESS CAN ALLEVIATE MUSCLE SORENESS AND AID IN RECOVERY AFTER EXERCISE, MAKING IT EFFECTIVE IN BOTH PAIN MANAGEMENT AND PERFORMANCE ENHANCEMENT. BY COMBINING THE BENEFITS OF IES AND VIBRATION IN A WEARABLE, INTRAVAGINAL DEVICE FOR WOMEN WITH HTPFD, INDIVIDUALS WITH MUSCLE PAIN CAN DISCREETLY ACCESS A MULTIFACETED APPROACH THAT ADDRESSES PAIN PERCEPTION, CIRCULATION, AND MUSCLE RELAXATION FOR PAIN RELIEF. BOLD TYPE PROPOSES DEVELOPMENT OF AN INTRAVAGINAL, WEARABLE DEVICE CALLED “VIOLET” TO PROVIDE PELVIC FLOOR MUSCLE VIBRATION AND ELECTRICAL NERVE STIMULATION THERAPY FOR PATIENTS WITH HTPFD ON AN “AS NEEDED” BASIS THROUGHOUT THE DAY. BOLD TYPE SPECIALIZES IN DEVELOPING CONNECTED, WIRELESS MEDICAL DEVICES. OUR TEAM HAS DECADES OF PRODUCT DEVELOPMENT EXPERIENCE WITH EXPERTISE IN MEDICAL DEVICES, QUALITY, AND REGULATORY AFFAIRS. WE HAVE DEVELOPED PROPRIETARY HARDWARE AND SOFTWARE DEVELOPMENT KITS THAT ALLOW US TO DESIGN AND IMPLEMENT MEDICAL DEVICES EFFICIENTLY BY LEVERAGING REUSABLE SUBSYSTEMS THAT ARE DESIGNED AND DOCUMENTED TO COMPLY WITH FDA REGULATIONS. BUILDING OFF THESE RESOURCES WE PROPOSE THE FOLLOWING SPECIFIC AIMS: 1) DEVELOP THE VIOLET DEVICE TO: (1) PROVIDE ON-DEMAND INTRAVAGINAL ELECTRICAL STIMULATION (IES) AND VIBRATION THERAPY TO PROVIDE PAIN RELIEF, AND (2) MEASURE AND TRACK INTRAVAGINAL TEMPERATURE, MOTION, AND POSITION; 2) DEVELOP THE VIOLET SOFTWARE (MOBILE APP AND EMBEDDED SOFTWARE) TO TRACK SYMPTOMS, WIRELESSLY CONTROL THE DEVICE, AND EXTRACT DATA; AND 3) PERFORM FORMATIVE USABILITY AND PRELIMINARY VALIDATION TESTING ON A GROUP OF 15 HEALTHY WOMEN. COMPLETION OF THESE THREE AIMS WILL PRELIMINARILY CONFIRM THE FOLLOWING: (1) THAT PATIENTS CAN INSERT, RETAIN, AND REMOVE THE VIOLET DEVICE WITHOUT UNACCEPTABLE DISCOMFORT; (2) THAT PATIENTS CAN FEEL THE IES AND VIBRATION STIMULATION AND ADJUST THEIR SETTINGS; AND (3) THAT THE SYSTEM CAN ACCURATELY MEASURE TEMPERATURE, MOTION, AND BODY POSITION AND TRANSFER DATA TO A MOBILE DEVICE. SUCCESSFUL COMPLETION OF THESE AIMS WILL PREPARE THE WAY FOR A PHASE 2 PROJECT WHERE A COMMERCIAL GRADE SYSTEM WILL BE DEVELOPED UNDER FDA DESIGN CONTROLS AND VALIDATED IN A LONGITUDINAL STUDY TO EVALUATE EFFICACY AND ACHIEVE FDA CLEARANCE.

384973.00

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0.00

2023-09-28

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Department of Health and Human Services

DEVELOPMENT OF AN ELECTRICAL IMPEDANCE MYOGRAPHY (EIM) VAGINAL DEVICE FOR THE EVALUATION OF PELVIC SKELETAL MUSCLES - 1 ABSTRACT 2 BOLD TYPE IS DEVELOPING THE “SENSEWAND”, A WIRELESS PELVIC FLOOR DIAGNOSTIC SYSTEM (DEVICE AND APP) 3 TO EVALUATE PELVIC FLOOR MUSCLE HEALTH USING ELECTRICAL IMPEDANCE MYOGRAPHY (EIM). PFDS ARE COMPLEX 4 CONDITIONS (E.G. PELVIC ORGAN PROLAPSE, STRESS URINARY INCONTINENCE, HIGH TONE PELVIC FLOOR DYSFUNCTION) THAT IMPACT 5 MILLIONS OF WOMEN WORLDWIDE. IT IS ESTIMATED THAT PFDS WILL AFFECT UP TO 50% OF WOMEN OLDER THAN 50 YEARS. RISK 6 FACTORS INCLUDE PREGNANCY, CHILDBIRTH, OBESITY, AGING, AND GENETIC PREDISPOSITION, THOUGH THE PATHOGENESIS 7 CONTINUES TO BE POORLY UNDERSTOOD. CONSEQUENTLY, PFDS ARE ASSOCIATED WITH SIGNIFICANT HEALTH CARE EXPENDITURE 8 DUE TO LACK OF PREVENTIVE MEASURES, HIGH FAILURE RATE OF CURRENT INTERVENTIONS, AND THE NEED FOR RETREATMENTS. THE 9 SKELETAL PELVIC FLOOR MUSCLES (PFMS) SUPPORT THE PELVIC AND ABDOMINAL VISCERA AND INJURY AND DYSFUNCTION PLAY A 10 ROLE IN PFDS. THESE DISORDERS REQUIRE CONSIDERABLE ONGOING EVALUATION TO BE MANAGED EFFECTIVELY IN SYMPTOMATIC 11 PATIENTS. CURRENT DIAGNOSTIC METHODS ARE LIMITED, AND NO NONINVASIVE DIAGNOSTIC METHODS ARE AVAILABLE TO 12 EVALUATE PFM QUALITY. SPECIFICALLY, WE CURRENTLY LACK DIAGNOSTIC TOOLS TO HELP CLINICIANS BETTER DIAGNOSE 13 AND TREAT PATIENTS WITH PFDS. 14 WE PROPOSE DEVELOPMENT AND EVALUATION OF THE “SENSEWAND”, A WIRELESS PELVIC FLOOR DIAGNOSTIC SYSTEM 15 (DEVICE AND APP) TO EVALUATE PELVIC FLOOR MUSCLE HEALTH USING EIM. EIM APPLIES WEAK, NON-DETECTABLE, 16 MULTIFREQUENCY ELECTRICAL CURRENTS TO A MUSCLE (OR MUSCLE GROUP) THROUGH TWO EXCITATION ELECTRODES, AND RESULTING 17 VOLTAGES ARE MEASURED VIA TWO SENSE ELECTRODES. MEASUREMENTS ARE FAST (<2 S/MUSCLE), SIMPLE TO PERFORM, 18 QUANTITATIVE, AND HIGHLY REPEATABLE. PARAMETERS EXTRACTED FROM THESE MEASUREMENTS CORRELATE STRONGLY WITH 19 DIFFERENT NEUROMUSCULAR CONDITIONS AND SENSITIVELY TRACK MUSCLE HEALTH AND DISEASE PROGRESSION. MULTIPLE STUDIES 20 HAVE DEMONSTRATED WIDE APPLICATION POTENTIAL FOR EIM IN A VARIETY OF FIELDS IN WHICH MUSCLE INJURY OR DYSFUNCTION 21 OCCURS. EIM COULD HAVE A PARTICULAR IMPACT IN THE ASSESSMENT OF PELVIC FLOOR MUSCLES, WHERE ITS RAPID, 22 QUANTITATIVE AND PAINLESS NATURE IS ESPECIALLY IMPORTANT. 23 BOLD TYPE IS A PRODUCT DEVELOPMENT FIRM SPECIALIZING IN CONNECTED, WIRELESS MEDICAL DEVICES. OUR TEAM HAS 24 DECADES OF PRODUCT DEVELOPMENT EXPERIENCE WITH EXPERTISE IN MEDICAL DEVICES, QUALITY, AND REGULATORY AFFAIRS. 25 WE HAVE DEVELOPED PROPRIETARY HARDWARE AND SOFTWARE DEVELOPMENT KITS THAT ALLOW US TO DESIGN AND IMPLEMENT 26 MEDICAL DEVICES EFFICIENTLY BY LEVERAGING REUSABLE SUBSYSTEMS THAT ARE DESIGNED AND DOCUMENTED TO COMPLY WITH 27 FDA REGULATIONS. BUILDING OFF THESE RESOURCES WE PROPOSE THE FOLLOWING SPECIFIC AIMS: 1) DEVELOP A PROTOTYPE OF 28 THE “SENSEWAND”: A WIRELESS, INTRAVAGINAL EIM DEVICE. 2) VALIDATE THE SENSEWAND IN 10 POSTMENOPAUSAL WOMEN 29 WITH SYMPTOMATIC ANTERIOR COMPARTMENT PROLAPSE AND 10 PREMENOPAUSAL NULLIPAROUS CONTROLS. 3) EVALUATE 30 SENSEWAND AGAINST AN FDA CLEARED, NON-VAGINAL BIOIMPEDANCE SYSTEM (SFB7) TO VALIDATE ITS ACCURACY.

384558.00

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0.00

2023-06-01

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Department of Health and Human Services

A MULTI-SENSOR CATHETER FOR DIAGNOSING OBSTRUCTIVE SLEEP APNEA - PROJECT SUMMARY FEW MEDICAL DISORDERS HAVE A LARGER PUBLIC HEALTH IMPACT THAN OBSTRUCTIVE SLEEP APNEA (OSA). OSA AFFECTS MORE THAN 20 MILLION PEOPLE IN THE US ALONE, AND WHEN UNTREATED, IT IS ASSOCIATED WITH SIGNIFICANT COMORBIDITIES AND MORTALITY. CURRENT DIAGNOSTIC TESTS FOR OSA, HOWEVER, ARE EXPENSIVE, INCONVENIENT, AND LARGELY INEFFECTIVE. OVERNIGHT IN-FACILITY SLEEP STUDIES, ALSO KNOWN AS POLYSOMNOGRAPHY (PSG), SHOW LOW PATIENT COMPLIANCE AND LIMITED SENSITIVITY AND SPECIFICITY, LARGELY DUE TO THE ANATOMICAL COMPLEXITY OF OSA. DRUG-INDUCED SLEEP ENDOSCOPY (DISE) CAN PROVIDE ADDITIONAL INFORMATION ON THE TYPE AND LOCATION OF OBSTRUCTION, BUT IT REQUIRES DIRECT INVOLVEMENT OF A TRAINED OTOLARYNGOLOGIST AND ANESTHESIA PROFESSIONAL. FURTHERMORE, ITS RELIABILITY IS LIMITED DUE TO THE SUBJECTIVE NATURE OF THE FINDINGS. IN SHORT, A SAFE, PORTABLE, AND EFFICIENT INSTRUMENT FOR RAPID CHARACTERIZATION OF OBSTRUCTIVE AIRWAY PHYSIOLOGY WOULD FIND WIDE USE IN THE ASSESSMENT OF PATIENTS WITH SUSPECTED OBSTRUCTIVE SLEEP APNEA. THIS SYSTEM WOULD BENEFIT MILLIONS OF PATIENTS BY PROVIDING CRITICAL INFORMATION TO AID IN THE DETERMINATION OF THE BEST THERAPY FOR OSA IN A PARTICULAR PATIENT. WE BELIEVE THAT THE MULTI-SENSOR CATHETER SYSTEM WE ARE PROPOSING CAN SERVE THIS ROLE. BOLD TYPE IS DEVELOPING THE “SMARTCATHETER” SYSTEM, A WIRELESS, CLOUD-CONNECTED, MULTI-SENSOR CATHETER AND TABLET APP DESIGNED TO PROVIDE RAPID EVALUATION OF UPPER AIRWAY OBSTRUCTION TO DIAGNOSE OBSTRUCTIVE SLEEP APNEA (OSA). WE HYPOTHESIZE THAT: (1) AN INNOVATIVE SYSTEM FOR MEASURING AND ANALYZING ACOUSTIC AND PRESSURE ALONG THE UPPER AIRWAY CAN BE DEVELOPED; (2) THAT COMBINED DATA FROM ACOUSTIC AND PRESSURE SENSORS WILL BE SENSITIVE TO OBSTRUCTION PRESENCE, LOCATION, TYPE, AND DEGREE; AND (3) THAT ALGORITHMS CAN BE DEVELOPED TO CONVERT RAW ACOUSTIC AND PRESSURE DATA INTO SUMMARY METRICS THAT FACILITATE THE DIAGNOSIS OF OBSTRUCTIVE SLEEP APNEA. WE PROPOSE THE FOLLOWING SPECIFIC AIMS: IN AIM 1, WE WILL DEVELOP A SMARTCATHETER SYSTEM COMPOSED OF A WIRELESS, NASO-ESOPHAGEAL MULTI-SENSOR CATHETER TO RECORD DYNAMIC ACOUSTIC PRESSURE AND STATIC PRESSURE ALONG THE UPPER AIRWAY, AND A TABLET APP TO COMMUNICATES WIRELESSLY WITH THE CATHETER, PERFORM ALGORITHMS ON ACOUSTIC AND PRESSURE WAVEFORMS, PROVIDE VISUAL FEEDBACK TO THE USER, AND TRANSFER DATA TO A DATABASE FOR STORAGE AND ANALYSIS. IN AIM 2, WE WILL DEVELOP PRELIMINARY DIAGNOSTIC ALGORITHMS CAPABLE OF DETECTING THE PRESENCE, LOCATION, TYPE, AND DEGREE OF OBSTRUCTION IN AN AIRWAY SIMULATOR. AND IN AIM 3, WE WILL CONDUCT A LIMITED PROOF-OF-CONCEPT HUMAN STUDY USING THE SYSTEM DEVELOPED IN AIM 1 WITH 5 HEALTHY CONTROLS AND 5 OSA PATIENTS TO GATHER PRELIMINARY HUMAN DATA AND EVALUATE ACOUSTIC AND PRESSURE DIFFERENCES BETWEEN THE TWO GROUPS. UPON SUCCESSFUL COMPLETION OF THESE THREE AIMS, WE WILL BE WELL POISED TO PURSUE A PHASE 2 SBIR PROJECT GEARED TOWARD DEVELOPING A COMMERCIALIZATION READY SMARTCATHETER SYSTEM AND VALIDATING IT IN A MULTI-SITE STUDY COMPARING PERFORMANCE AGAINST PSG AND DISE.

299721.00

0.00

0.00

2023-05-29

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Department of Health and Human Services

A DEVICE TO TREAT HIGH-TONE PELVIC FLOOR DYSFUNCTION IN WOMEN - ABSTRACT BOLD TYPE IS DEVELOPING THE “SMARTWAND”, AN INTERACTIVE, CONNECTED PELVIC FLOOR SYSTEM (DEVICE AND MOBILE APP) TO GUIDE PATIENTS THROUGH PELVIC FLOOR PHYSICAL THERAPY (PT) IN THE PRIVACY OF THEIR HOME. PT IS A HIGHLY EFFECTIVE AND FIRST-LINE TREATMENT FOR HIGH TONE PELVIC FLOOR DYSFUNCTION (HTPFD), A MAJOR CONTRIBUTOR TO CHRONIC PELVIC PAIN (CPP), AFFECTING UP TO 15% OF WOMEN IN THE UNITED STATES. DESPITE PROVEN EFFECTIVENESS, ONLY 20% OF WOMEN COMPLETE THE PT TREATMENT COURSE, WHICH INCLUDES A HOME EXERCISE COMPONENT WITH AN EXTERNAL AND INTERNAL EXERCISE REGIMEN. WOMEN REPORT LIMITATIONS IN CONTINUING PT AS TIME, COST, ACCESS TO THERAPY, THE LACK OF DIRECT FEEDBACK FROM THE HOME PROGRAM AND THE INABILITY TO MEASURE PROGRESS AT HOME. BOLD TYPE’S TEAM HAS DECADES OF PRODUCT DEVELOPMENT EXPERIENCE WITH MEDICAL DEVICES, QUALITY, AND REGULATORY AFFAIRS. WE HAVE DEVELOPED PROPRIETARY HARDWARE AND SOFTWARE DEVELOPMENT KITS THAT ALLOW US TO DESIGN AND IMPLEMENT MEDICAL DEVICES EFFICIENTLY BY LEVERAGING REUSABLE SUBSYSTEMS THAT ARE DESIGNED AND DOCUMENTED TO COMPLY WITH FDA REGULATIONS. TO MEET THE CRITICAL NEED FOR ACCESSIBLE AND IMPROVED PT, WE HYPOTHESIZE THAT: (1) AN ERGONOMIC WAND DESIGN WILL IMPROVE USABILITY, (2) AN INNOVATIVE SYSTEM FOR PERFORMING PT CAN BE DEVELOPED THAT PROVIDES GUIDANCE AND BIOFEEDBACK TO PHYSICAL THERAPISTS AND PATIENTS; AND (3) PATIENTS WILL BE ABLE TO EFFECTIVELY PERFORM PT USING THE GUIDANCE AND BIOFEEDBACK PROVIDED BY THE PLATFORM. WE PROPOSE THE FOLLOWING SPECIFIC AIMS FOR THIS PROJECT: 1) FINALIZE THE WAND DESIGN FROM THREE PRELIMINARY DESIGN PROTOTYPES USING HUMAN FACTORS VALIDATION TESTING. A FORMATIVE USABILITY EVALUATION OF THREE PRELIMINARY WAND PROTOTYPES WILL BE CONDUCTED IN 15 MECHANICAL WAND EXPERIENCED HTPFD PATIENTS TO IDENTIFY PREFERRED DESIGN FEATURES. WE WILL USE SIMULATED-USE TESTING UNDER THE SUPERVISION OF A PELVIC FLOOR PHYSICAL THERAPIST AND SYSTEMATICALLY COLLECT DATA FROM TEST PARTICIPANTS USING THE UNPOWERED DEVICE PROTOTYPE; 2) DEVELOP A WIRELESS, HANDHELD “SMARTWAND” AND MOBILE APP THAT (1) RECORDS PRESSURE AND LOCATION (DEPTH AND ORIENTATION) IN THE FEMALE PELVIS IN RELATION TO THE PELVIC FLOOR MUSCLES, (2) PROVIDES THE USER AUDIO AND VISUAL FEEDBACK ON WAND PRESSURE, POSITION, AND ORIENTATION, AND (3) TRANSFERS DATA TO A DATABASE FOR STORAGE AND ANALYSIS; AND 3) VALIDATE THE SYSTEM DEVELOPED IN SPECIFIC AIM 2 ON A GROUP OF 10 HEALTHY WOMEN AND 10 WOMEN WITH HTPFD. WOMEN >18 YEARS WILL BE RECRUITED BY GRACE PHYSICAL THERAPY AND THERAPISTS ASSIGNED TO PERFORM PRESSURE PAIN THRESHOLDS AND INSTRUCT ON WAND USE. THE SUCCESS METRIC FOR AIM 3 IS THAT WITH GUIDANCE FROM THE APP, THE PARTICIPANTS WILL BE ABLE TO PERFORM WAND EXERCISES WITH MINIMAL VARIANCE AS COMPARED TO MEASUREMENTS MADE BY THE PT (WITHIN 15% OF APPLIED PRESSURE, 5 DEGREES OF ANGLE/ORIENTATION AND WITHIN 8 MM OF INSERTION DEPTH).

384959.00

0.00

0.00

2020-05-02

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Small Business Administration

TO AID SMALL BUSINESSES IN MAINTAINING WORK FORCE DURING COVID-19 PANDEMIC.

0.00

306702.00

306702.00

17

$306,702

2020-05-01

Paid in Full

100

$306,702

White

Hispanic or Latino

Unanswered

Unanswered

$309,474.92

Bank of America, National Association

Payroll: $306,702