Omeq Medical received FDA regulatory clearance ("FDA") for its EPiFINDER.
Updated: Jul 27
MISGAV, Israel, May 9, 2023 /PRNewswire/ -- Omeq Medical Ltd. a portfolio company of The Trendlines Group Ltd. (SGX: 42T) (OTCQX: TRNLY), announced today that it has received regulatory clearance from the United States Food and Drug Administration ("FDA") for its EpiFinder, which assists physicians to accurately position an epidural needle while performing the standard Loss of Resistance ("LOR") technique.
Since the 1920's, epidurals have been performed utilizing the LOR technique, dependent upon the clinician's experience, dexterity, and tactile feedback to identify a narrow 4-5 mm space. In up to 30%  of cases the procedure initially fails. Furthermore, in up to 5+% of cases, the needle tip inadvertently tears the protective sac surrounding the spinal fluid (a wet tap) leading to severe headache and possible neurological complications. EpiFinder is the first real improvement of this technique since its inception. It provides physicians with an additional signal identifying the epidural space.
Dr. David Gichtin M.D., senior anesthesiologist at the Johns Hopkins Hospital and Omeq's medical director, said, "Clinical literature shows that a significant percentage of all epidural insertions are initially misplaced. While most of these are corrected procedurally without adverse events, a meaningful number of complications such as post-procedure headaches from dural puncture, nerve injury, inadequate pain relief, result in patient suffering and substantial institutional costs. The EpiFinder smart device offers to improve the performance of epidural technique for potentially better outcomes, with the intent to make epidural procedures safer and easier for doctors and patients."
Omeq Medical CEO, Lior Margalit remarked, "We are grateful to the anesthesia community that has supported our development. We now turn our focus to bring EpiFinder to US patients receiving epidural injections. EpiFinder offers the potential to become the new standard of care while performing LOR. The procedure today is performed by advancing the epidural needle forward until the clinician senses a loss of resistance indicative that the epidural space in the spine has been reached. Using the same procedure, EpiFinder adds a second independent objective signal that the epidural space has been reached. Our initial clinical experience indicates that clinicians' targeting, and placement is accurate with the EpiFinder."
EpiFinder is a sensor-based, battery-operated single-use epidural placement device for safe, accurate epidural injections. The simple, easy-to-use device fits between a standard needle and syringe, requires no capital equipment, and is compatible with standard epidural syringes on the market. The device integrates seamlessly with the standard LOR technique and monitors tissue resistance at the needle tip to accurately detect needle penetration into the epidural space, protecting the patient from complications associated with misplacement.
Omeq conducted a first-in-human clinical study to demonstrate the safety and effectiveness of EpiFinder. The study results confirmed that Omeq's solution is safe and reliable to use to accurately place an epidural needle. During the study the participating physicians were able to safely provide successful epidural block in 100% of the thirty-one (31) patients while using the device, commenting positively on the ease of use and the benefits that the device offers.
Omeq Medical's Chairman, Mr. Carl Rickenbaugh, former VP M&A at Bard Peripheral Vascular & Biopsy, added: "With the FDA's US marketing clearance achieved, we are excited to accelerate our discussions with the anesthesia community to bring this exciting development to market for the benefit of US patients. Our current discussions include major US anesthesia product distributors, strategic partners, and investors. We encourage interested parties to contact us directly."