SBIR-STTR Award

Actuated Low-Force Biopsy Tool for Versatile Bone Lesion Access with Less Trauma
Award last edited on: 5/2/20

Sponsored Program
SBIR
Awarding Agency
NIH : NCI
Total Award Amount
$1,895,171
Award Phase
2
Solicitation Topic Code
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Principal Investigator
Maureen L Mulvihill

Company Information

Actuated Medical Inc (AKA: PRII~Piezo Resonance Innovations Inc)

310 Rolling Ridge Drive
Bellefonte, PA 16823
   (814) 355-0003
   info@actuatedmedical.com
   www.actuatedmedical.com
Location: Single
Congr. District: 15
County: Centre

Phase I

Contract Number: 1R43CA139774-01A1
Start Date: 9/23/09    Completed: 10/30/10
Phase I year
2009
Phase I Amount
$180,356
In this Phase I NIH SBIR program, PRII will develop the Biopsy Force Reduction (BIFOR) Tool for adult patient Bone Marrow Biopsy. The BIFOR will reduce insertion force, improve biopsy sample quality and sampling rate success, and decrease patient discomfort and healing time. The Phase I feasibility study will determine if the BIFOR can reduce insertion force, improve biopsy sample quality, and is clinically desirable. Over 500,000 bone biopsies are performed every year in the United States. Inspection of the bone marrow is considered one of the most valuable diagnostic tools to evaluate hematologic disorders. Bone marrow biopsies are used to diagnose a variety of conditions including, leukemia, anemia, renal osteodystropy (ROD), tumors, osteoporosis, osteogenesis imperfect, Paget's disease, and other metabolic bone diseases The most commonly used site for the bone marrow biopsy is the anterior iliac crest. The major disadvantage is the force required to penetrate the cortical bone which is tiring to the clinician, often results in poor or crushed samples, and increases patient discomfort and healing time. Bone density and hardness can also vary significantly among patients, making it difficult for the clinician to obtain a suitable core. The Phase I Hypothesis is that an active motion technology device can be developed that reduces the force for penetrating cortical bone and improves bone marrow biopsy sample quality and reduces patient discomfort. The long-term objective of this work is to commercialize BIFOR in partnership with a major OEM. A tool that can reduce insertion force, decrease patient discomfort, and also improve biopsy core quality would generate significant commercial revenue.

Public Health Relevance:
This Phase I NIH SBIR will develop and test the Biopsy Force Reduction (BIFOR) Device for adult patient bone marrow biopsy. The BIFOR will reduce insertion force, reduce clinician fatigue, decrease patient discomfort and healing time, improve biopsy sample quality and sampling rate success.

Public Health Relevance Statement:


Project narrative:
Relevance -This Phase I NIH SBIR will develop and test the Biopsy Force Reduction (BIFOR) Device for adult patient bone marrow biopsy. The BIFOR will reduce insertion force, reduce clinician fatigue, decrease patient discomfort and healing time, improve biopsy sample quality and sampling rate success.

NIH Spending Category:
Bioengineering; Cancer

Project Terms:
21+ years old; Adult; Anemia; Animal Model; Animal Models and Related Studies; Animal Testing; Anterior; Anxiety; Area; Be element; Be++ element; Beryllium; Biopsy; Biopsy Sample; Biopsy Specimen; Biopsy, Core Needle; Biopsy, Needle; Blood (Leukemia); Body Tissues; Bone; Bone Density; Bone Diseases, Metabolic; Bone Formation; Bone Marrow; Bone Mineral Density; Bone and Bones; Bone marrow biopsy; Bones and Bone Tissue; Cadaver; Cannulas; Cell Communication and Signaling; Cell Signaling; Clinical; Core Biopsy; Data Banks; Data Bases; Databank, Electronic; Databanks; Database, Electronic; Databases; Devices; Diabetes Mellitus; Diagnosis; Diagnostic; Diaphyses; Diaphysis of the Bone; Disadvantaged; Disease; Disorder; Distal; Effectiveness; Electronics; Elements; Family suidae; Fatigue; Feasibility Studies; Feedback; Femur; Foot Ulcer; Frequencies (time pattern); Frequency; Goals; Grant; Hardness; Healed; Heating; Human; Human, Adult; Human, General; Intellectual Property; Intracellular Communication and Signaling; Kidney; Knowledge; Lack of Energy; Legal patent; Length; Leukemias, General; Licensing; Man (Taxonomy); Man, Modern; Manuals; Marketing; Medical; Medical center; Metabolic Bone Diseases; Metabolic disorder of bone; Method LOINC Axis 6; Methodology; Modeling; Monitor; Motion; NIH; National Institutes of Health; National Institutes of Health (U.S.); Needle biopsy procedure; Needles; Orthopedic; Orthopedic Surgical Profession; Orthopedics; Osteogenesis; Osteoporosis; Paget Disease; Paget's Cell Neoplasm; Paget's Disease; Patents; Pathology; Patients; Penetration; Perception; Phase; Pigs; Procedures; Production; Programs (PT); Programs [Publication Type]; Publications; Radiology; Radiology Specialty; Radiology, General; Reticuloendothelial System, Bone Marrow; SBIR; SBIRS (R43/44); Safety; Sales; Sampling; Scientific Publication; Shapes; Signal Transduction; Signal Transduction Systems; Signaling; Site; Small Business Innovation Research; Small Business Innovation Research Grant; Sterilization; Sterilization for infection control; Suidae; Swine; System; System, LOINC Axis 4; Tactile; Technology; Temperature; Testing; Time; Tissues; Transducers; Ultrasonic; Ultrasonics; United States; United States National Institutes of Health; Urinary System, Kidney; Weight; Work; adult human (21+); base; biological signal transduction; bone; bone metabolism disorder; clinical data repository; clinical data warehouse; commercialization; data repository; diabetes; disease/disorder; healing; improved; innovate; innovation; innovative; interest; leukemia; metabolic bone disease; model organism; next generation; porcine; programs; prototype; public health relevance; relational database; renal; sample collection; soft tissue; specimen collection; success; suid; technological innovation; tool; tumor; web site

Phase II

Contract Number: 2R44CA139774-02A1
Start Date: 3/2/09    Completed: 5/31/15
Phase II year
2013
(last award dollars: 2014)
Phase II Amount
$1,714,815

In this Phase II SBIR, Actuated Medical, Inc. will complete the development of the "Actuated Low-Force Biopsy Tool for Versatile Bone Lesion Access with Less Trauma." Public Health Problem: Percutaneous bone biopsy is performed to obtain tissue for specific diagnosis of bone lesions identified through imaging or clinical evaluation. A major disadvantage of the biopsy process is the force required to penetrate the cortical bone. Penetrating dense, thick cortical bone to interrogate sclerotic lesions or sample lesions contained within the intramedullary canal of long bones is particularly difficult. Another major limitation of current biopsy devices is the challenge of penetrating through cortical bone using low inclination angles (< 30 degrees) relative to the cortical surface, limiting the path choices available to reach the lesion. Re-seeding of tumor cells along the biopsy needle track leading to cancer recurrence is a recognized risk with primary sarcomas. In order to ensure the best prognosis and preserve the option of limb-sparing resection, the clinical team must carefully plan out the approach to the lesion to ensure the needle track avoids vital structures and tissue compartments. A device is needed that allows greater flexibility in planning the path to the lesion by enabling oblique angle penetration and easier purchase onto bone surfaces with high curvature, while simultaneously allowing greater control by reducing penetration force. Phase I successfully met the Specific Aims. Phase I demonstrated that a vibrated sharp can reduce insertion force by 60% and substantially improve bone biopsy procedures in animal and human tissue models. Reviews by practicing clinicians were extremely positive and have guided the Phase II Beta prototype design requirements. Phase II Hypothesis: The BIFOR system will enable core needle bone lesion biopsy using low inclination angles (<30 degrees) relative to the cortical surface with 60% reduced insertion force. In addition, core needle bone biopsy performed with the BIFOR system will reduce lesion biopsy procedure time by 50% while increasing diagnostic sample yield over the standard commercial needle system. Phase II Specific Aims: 1. Final Optimization and Verification - Finalize handset, electronics, and user interface. 2. Design Validation through Cadaver Testing - Evaluate rib and femur sampling. 3. Safety and Efficacy in Animal Model - Performance data with assessment of biopsy sites for healing, and safety. 4. Pilot Human Clinical Evaluation - Clinical evaluation in image-guided lesion biopsy.

Public Health Relevance Statement:


Public Health Relevance:
Bone biopsies are used to analyze suspected tumors in bones throughout the body. A major disadvantage is the force required to insert the needle through the cortical bone to reach the target tissue, which often results in poor, crushed, or otherwise inadequate samples, clinician fatigue, and increased patient discomfort, anxiety, and healing time. Penetrating dense, thick cortical bone to interrogate sclerotic lesions in long or thn bones is particularly difficult. Sampling bone in locations with delicate tissue nearby, such as th spine or ribs, is risky. A device that reduces insertion force would lower risk for sampling near delicate tissue structures, allow more flexibility in sampling approach for the clinician, and provide the ability to sample in some locations without having to resort to an open surgery.

Project Terms:
Adult; Agreement; Anatomic Sites; Animal Model; animal tissue; Animals; Anxiety; Area; Biopsy; Biopsy Specimen; bone; Bone Surface; Cadaver; cancer recurrence; Charge; Clinical; commercial application; commercialization; cost; Country; Custom; Data; design; Development; Device Designs; Devices; Diagnosis; Diagnostic; Disadvantaged; efficacy testing; Electronics; Ensure; Evaluation; Excision; Fatigue; Femur; flexibility; Funding; Goals; Healed; healing; Hospitals; Human; human tissue; Image; Image Analysis; improved; Lesion; Life; Limb structure; Location; long bone; Malignant Bone Neoplasm; Marketing; Medical; Medical Device; meetings; Motion; Needle biopsy procedure; Needles; neoplastic cell; Operative Surgical Procedures; Outcome; outcome forecast; Patients; Penetration; Performance; Phase; Pilot Projects; Procedures; Process; programs; prototype; public health medicine (field); public health relevance; radiologist; Relative (related person); research clinical testing; Resort; rib bone structure; Risk; Safety; safety testing; Sales; Sampling; sarcoma; Site; Small Business Innovation Research Grant; Structure; Surface; System; Technology; Testing; Thick; Time; Tissue Model; Tissues; tool; Trauma; Tube; tumor; Validation; Vertebral column; vibration