Lumoptik, Inc is a medical device company that has developed the BrightPointTM needle guidance system to assist physicians with needle placement during epidural procedures for childbirth, spine/back pain and surgical procedures such as knee and hip replacements. Over 11 million epidural procedures are performed in the US each year. The large majority of these procedures are performed free hand by physicians with no mechanical or electronic needle guidance. Complications are common.
The BrightPointTM Needle Guidance System is designed to be a low cost, easy to use device composed of a reusable handheld controller plus a single use, disposable fiber optic light channel designed to fit in the lumen of existing epidural needles. This is a razor (reusable handheld controller) and razor blade (disposable fiber optic) commercial design.
BrightPointTM operates based on the changes in light reflection from different tissue types at the tip of the needle. The color of the tissue at the tip of the needle is shown on the controller screen along with a scrolling line graph of the relative reflectance of the tissue at the tip of the needle—the line moves to the bottom of the chart for darker tissue and top of the chart for lighter tissue.
As the tip of the needle penetrates in to different tissue (skin, fat, muscle, connective, ligamentum flavum and epidural space) the reflection changes providing the physician with real-time information on the location of the tip of the needle. Upon penetrating the ligamentum flavum and entering in to the epidural space, the reflection makes a distinct change from the whitish ligament color to the blackish reflection of the epidural space. On the controller screen, the tissue color will show the change from white ligament to the dark epidural space and the scrolling line chart will show a significant drop from the high reflectance of the white ligament to the low reflectance of the dark epidural space.
The lumoptik device is an addition to, not a replacement for, the manual (unguided) Loss of Resistance (LOR) method currently used by anesthesiologists. It does not require any changes to the LOR method and works with the current needles and syringes.
The BrightPointTM Epidural system is designed to provide real-time visual guidance for training procedures with the aim to reduce the number of training procedures, reduce complications and increase successful procedures.
Platform Technology
The company believes that the Lumoptik technology has multiple high-value medical uses beyond epidural procedures. These uses include:
- Urology catheter placement
- Orthopedic access for pedicle screws and other procedures
- Vascular access
- Cardiac catheter introduction
- Ophthalmic treatments
- Veterinary use
Management plans to develop the next generation product after launching the epidural needle guidance product. A pipeline of products is intended to increase the value of the company and help attract large acquirers. The epidural needle guidance product was chosen as the company’s first due to the market size, need, access and regulatory timing.
