SpeedBird 38 & SpeedBird Universal Soft Tissue Biopsy Device Platform

TransMed7’s first Project is SpeedBird, LLC, created to immediately and effectively address well-defined gaps in women’s health care around the world.

The SpeedBird product platform of hand-held soft tissue biopsy devices has been generated to fulfill the needs of surgeons, radiologists, and other clinicians utilizing minimally invasive procedures by providing next-generation, minimally invasive, cost-effective, single insertion, multiple sample (SIMS) biopsy devices in a choice of sizes that are designed to safely, reliably, and consistently obtain high-quality biopsy samples from all tissues encountered in the breast and other areas of the body (e.g. prostate, liver, lung, etc.) that have been discovered to be abnormal by physical exam, x-rays, ultrasound, or 3D imaging.

Design Features:

  • Choice of fully automated or manually operated hand-held devices, guided most often by ultrasound.
  • Simple design; cost-effective in relation to coding/reimbursement, and enabling worldwide availability and rapid adoption; single-use or re-useable handle (driver).
  • Designed for maximum ease of use: forward coring action and full function commonality across all device model iterations is designed to facilitate a flattened learning curve.
  • Single insertion, multiple sample (SIMS) biopsy devices designed to obtain full thickness, uniform diameter tissue samples of any length with preserved architecture from a wide range of tissue densities.
  • Meaningful scalability: smaller size devices retain full efficacy in obtaining high quality tissue samples.

 

Health Care Advancements:

  • The SpeedBird product platform utilizes TransMed7’s patented Zero5 technology, designed to eliminate “dead space” beyond the tips of the working element. This means that a core biopsy sample can be collected all the way through (and beyond, if desired) the tissue abnormality, while minimizing the potential for damage to important nearby structures (e.g. nerves, blood vessels, neighboring organs).  SpeedBird biopsy devices are thus designed to be as safe as possible, while maximizing efficacy and maintaining a high degree of cost-effectiveness and ease of use.
  • SpeedBird devices are truly minimally invasive, as they are designed for “minimally disruptive access”, enabling multiple biopsy samples to be taken of the suspect tissue via a single, small incision made in the skin.
  • All sizes/gauges of device models are designed to obtain high-quality biopsy samples from a wide range of tissue densities that may be encountered in the breast and other areas of the body. While availability of final biopsy results may depend on the pathology laboratory schedule, an accurate diagnosis can only be available quickly when reliable biopsy procedures provide high-quality tissue samples.  High-quality tissue samples are not only critically important to the diagnosis, such samples best enable the many options available in the diagnostic arena for optimization of treatment planning, including enabling precision medicine using the latest genomic technologies.
  • SpeedBird devices are designed to facilitate single insertion/multiple sample (SIMS) procedures being performed in the convenience of an office, clinic, or ambulatory center in addition to the hospital setting.

Development Status:

The SpeedBird product platform includes three device models:  SB38 (fully automated), SBU (manually operated), and SBU99 (manually operated, reusable handle).  These devices have been developed under a TransMed7 subsidiary Project LLC – SpeedBird, LLC.  Regulatory documents for market release in the U.S. as well as internationally have been prepared for submission pending final validation testing.  Commercial manufacturing and sales/distribution will follow market release.

Technology Details:

The SpeedBird product platform is described further below.

SpeedBird 38 and SpeedBird Universal

  • Stainless steel one-piece coring, parting-off, and transport mechanism;
  • Internal DC motor;
  • Nearly effortless penetration and coring.

sb and sbu 1st collage

  • Single insertion, multiple sample (SIMS) capable devices which are hand held and do not require a console;
  • Radiolucent tissue magazine which may contain fixative;
  • Multiple options for delivery of a variety of materials (i.e. therapeutic agents, markers, metallic pellets, etc.) to the procedure site.

sb & sbu collage extra

SpeedBird 38 – Fully Automated, Single Use

  • Built in battery power;
  • Automatic cycling (tissue coring, part-off, and transport) with unrestricted core length;
  • 12 cm working element.sb & sbu collage 3

SpeedBird Universal – Manually Operated, Single Use

SBu2 with text and images

SpeedBird Universal – Manually Operated, Single Use

SBU 1 text and images together