Lumoptik
Lumoptik

Marketing Opportunity

Market Size

Epidural procedures are one of the fastest growing procedures in the US and worldwide. It is estimated that over 11 million epidural procedures are performed each year in the US and over 30 million worldwide. Over $5 billion is spent annually on epidural injections in the US alone. The approximate break down of epidural procedures in the US is:

  • 11+ million epidurals in the US per year and growing according to Medicare data
    • 2.4 million labor procedures~9 million pain intervention steroid injections
    • Nerve blocks for hip and knee surgeries
      • ~900,000 total and growing
    • Medicare patients account for about 20% of the total epidural procedures

There are approximately 52 thousand anesthesiologists currently practicing in the US. The epidural procedure is mainly performed by anesthesiologists, but also by nurse anesthetists and physicians in other specialties, such as orthopedic surgeons.

Market Need

The standard of care to perform epidural injections uses the technique called Loss of Resistance (LOR) which was first described in 1921. Tactile feedback from the needle, and surface landmarks on the patient’s back are traditionally used to guide the epidural needle tip in to the epidural space. This technique is used to perform over 12 million epidural injections in the US annually.

The LOR technique relies on advancing a Tuohy needle through the ligamentum flavum, to the epidural space, with constant pressure applied to the piston of a syringe, loss of resistance on the piston occurs once the needle enters the epidural space due to the change in pressure. The identification of this space, allows subsequent administration of epidural anesthesia, a technique used primarily for analgesia during childbirth and for pain management with steroids and other pharmaceuticals.

The LOR technique has remained largely unchanged since 1921, and is commonly referred to as the loss of resistance to saline technique (LORS) or its variation, the loss of resistance to air technique (LORA). The LORS technique is used more often due to the increased complication risk with the LORA technique such as pneumocephalus or air embolism.

Epidural injections using the LOR technique are associated with a significant failure rate and a long learning curve to train new physicians. Because the LOR technique is based entirely on tactile touch and feel, the training physician cannot tell if the trainee has entered the epidural space. This has been the subject of review articles in the anesthesiology community. As an example, we can provide a recent review article “Localization of Epidural Space: A review of available technologies” published in March 2017 in the Journal of Anesthesiology and Clinical Pharmacology. This is a comprehensive review article of the current technologies for epidural needle guidance and issues associated with the Loss of Resistance technique.

Because epidural procedures are one of the fastest growing medical procedures in the US reimbursement has been affected and cost is an issue. The amount of reimbursement for epidurals has declined as the number of procedures has increased. In order for any new product to be successful, it will have to add benefit at a low cost.

Clinician Training Tool

The BrightPoint™ Epidural system will be introduced as a useful training tool for new clinicians. Most new clinicians (anesthesiology residents and nurse anesthetists) are initially trained on rubber models and then on living patients. It typically takes a junior clinician about 50 to 100 “practice” patient procedures under the supervision of a senior clinician before they are ready to perform epidural procedures on their own.

Since epidural procedures are performed 100% by hand tactile touch and feel, it is difficult for the senior clinician to know how the junior clinician is progressing beyond watching the depth marks on the needle. Since the training procedure is being performed on a live patient, in most cases they must keep conversation to a minimum so as not to disturb the patient. Use of the BrightPoint™ Epidural device provides the senior clinician with a real-time visual aid on the location of the tip of the needle and allows the trainer to provide better guidance to the trainee. This can help provide better outcomes during training procedures and reduce the overall number of required training procedures. This benefit was pointed out to us by clinicians at our physician focus group meetings.

In addition to a range of statistical bench performance testing, Lumoptik is conducting a live animal study (porcine) and a live human trial to support the benefit as a training tool and secondary confirmation to LOR in our FDA 510(k) submission. These studies are focused on use of the BrightPoint™ device as a training tool for new clinicians.

The go-to-market strategy is to focus initially on teaching hospitals. Teaching hospitals comprise roughly 20% of all hospitals in the US. Once clinicians are trained using a tool, they have a strong preference to continue using that tool in their practice.

Market Research Focus Group Results

Before developing the current product, Lumoptik conducted 3 physician focus groups with 21 anesthesiologists and nurse anesthetists. The key points they stated to us regarding an epidural needle guidance product were:

  • It must be effective in assisting the physician with performing the epidural procedure, especially for training new clinicians
  • Must not interfere with the Loss of Resistance technique. This is the standard of practice which they depend on. Do not try to replace the Loss of Resistance technique.
  • It must work with the existing needles and syringes. Do not try to replace the existing needles and syringes which are an integral part of the Loss of Resistance technique.
  • It must be simple to use. Similar to fluoroscopy with a foot pedal for simple operation and screen viewing. The physician’s attention must remain focused on the needle in the patient’s back, not operating complex equipment.
  • It must be cost effective—the anesthesiologists do not feel the need for high cost capital equipment for epidural procedures.

Product Design to Meet Market Needs

Based on the feedback from clinicians in the market research focus groups the Lumoptik BrightPoint™ system has been designed with the following features and benefits:

  • Operates by sending light signals through a fiber optic in the epidural needle and on to the tissue at the tip of the needle—Different tissues return different reflected light patterns allowing the anesthesiologist to see when they have passed from one tissue type to another. Designed to provide a visual secondary confirmation of LOR.
  • It works with the Loss of Resistance method—it actually requires Loss of Resistance with sterile saline for the light to travel to and from the tip of the needle
  • It works with the current epidural needles and plastic or glass syringes that the anesthesiologist is comfortable using. There is no need to change to a different needle or syringe.
  • The controller will work for a full day without a recharge and will be useable over a minimum two-year period with thousands of uses
  • The controller can connect via Bluetooth to display the results on any other device such as a laptop or tablet.
  • Both the controller and the disposable are purposely low price for a medical device
    • The controller looks similar to and is priced similar to a high-end smart phone.
  • The system is easy to use and has a short learning curve.