Vanish

Highlights

• Vanish is a novel bioresorbable, non-surgical nerve stimulator for acute post-surgical pain and chronic pain relief.
• Our minimally-invasive implantable stimulator represents a clear improvement over the current steel and titanium stimulators, which require surgery to implant and remove, with 30%-40% leading to painful complications.
• The Vanish bioresorbable nerve stimulator also includes a unique degradation on command function, eliminating any need for repeated surgeries.
• The PInCh award would help us complete animal model testing and further prototyping of our stimulator lead and pulse generator for the central nervous system.
• Recipient of $100,000 PInCh Award + $15,000 Bonus Award for Engineering Good Health.

Problem

Nearly 50 million Americans suffer with chronic pain, and with nearly 1 million yearly joint replacement surgeries in the U.S., there is a significant portion of the population without viable options for their acute or chronic pain.

For example, patients with acute postoperative pain after joint replacement often struggle with pain after surgery which delays discharge from the hospital and enrollment in physical therapy. Other patients with chronic nerve pain have failed many conservative options such as physical therapy, medications, and injections.

As a pain management physician, I often offer these patients to the only commercially available option for their pain – surgically-placed steel nerve stimulators, which many patients won’t consider because it involves surgery/anesthesia and a surgically-implanted battery pack via a large incision for these stimulators.

These nearly 100,000 yearly implanted steel nerve stimulators include a 30-40% complication rate, from the stimulator wire moving, breaking, not working, or the implantable battery pack or permanent wire causing worsening pain.

These complications require yet another surgery to correct the problem. Unfortunately, given the lack of available options, these patients and their providers often turn to opioids to fill the void which carries significant risks.

Solution

Our device is a bioresorbable nerve stimulator to treat acute and chronic pain. The temporary bioresorbable nature of this device, and the fact that no battery pack is surgically installed, greatly reduces the risk of worsening pain from the device itself. Any wire migration, device failure, infection, or wire breakage will not lead to additional surgery because the wire is ultimately reabsorbed by the body.

The Vanish bioresorbable wire is placed under the skin near the nerve using ultrasound, without requiring an incision or surgery to be implanted. The implanted wire would be secured through the skin and attach to a small external battery pack sticker on the skin surface. The external battery pack and soft, flexible protruding wire would be safe under a waterproof, changeable adhesive layer.

The electrical stimulation would produce a soothing vibration in the area of pain. Even though the device stops stimulating the nerve after a set time, ample evidence exists that shows that temporary nerve stimulation can lead to long-term pain relief due to nervous system changes and re-wiring as it adapts.

Team

• Trent Emerick, MD, MBA: Associate Professor, Department of Anesthesiology and Perioperative Medicine, University of Pittsburgh Medical Center.
• Tracy Cui, PhD, Professor, Department of Bioengineering, Univ. of Pittsburgh.
• Raj Kubendran, PhD, Assistant Professor, Electrical and Computer Engineering, Univ. of Pittsburgh.

Path to Impact Plan

We have incorporated as Vanish Therapeutics, Inc., in April 2021. The funding for this project will help with the testing necessary to move towards an FDA submission for our bioresorbable stimulator. These animal model studies are essential for the FDA approval process via the Class II/Denovo pathways. After FDA approval, our team will then begin testing our stimulator in humans with a goal of eventual marketing of this technology to physicians and providers nationwide.

Frequently Asked Questions

• Are the degradation products safe? The degradation products and their potential toxicity have been found to be very safe in humans and have been well-studied in the literature.
• What is the value of nerve stimulation? Nerve stimulation is an extremely beneficial offering for patients with chronic pain.  Its benefits have been well-studied and documented in decades of research and provide vast improvements to patients in terms of pain relief and physical function.
• Can you potentially receive a second stimulator after the first dissolves? In theory, yes, although research shows that even temporary stimulation provides years of relief.  In fact, multiple temporary Vanish stimulators would still be more cost effective than a permanent steel stimulator (including surgery and anesthesia).