Bioness, a Valencia, California medical device/rehabilitation company, recently received approval from Health Canada for its StimRouter device, an implantable peripheral nerve stimulator designed to reduce chronic pain. We spoke with Mark Geiger, the Global Director of Marketing for Implantables at Bioness to learn more.
Ben Ouyang, Medgadget: Tell me about Bioness and the StimRouter.
Mark Geiger, Bioness: Bioness is a 14-year old medical device company based out of Valencia, California. The founder, Alfred Mann, bought a product called the BION, an implantable to help people with paralysis, and a company called NESS, where a footdrop product came from. The combination is where the name Bioness came from. The BION became the StimRouter. In its current form, it is a product approved for chronic pain from peripheral nerve origin with the exclusion of craniofacial pain. It obtained FDA approval in 2015 and launched in mid-2016. There’s a relationship between this and the rehab side of Bioness because a lot of patients drop out of rehab from pain. We hope to implant the StimRouter and allow the patient to return to rehab. Bioness also has products on the rehabilitation side, like dynamic body weight supports.
Medgadget: Please tell us more about the StimRouter.
Geiger: The StimRouter is a platform technology that has currently treated 22 different peripheral nerves around the body, from the suprascapular nerve all the way down to the tibial nerve.
As an example: if you suffer a stroke on the left side of your brain, it might cause paralysis on the right side of your body. Paralysis on the right arm means you’re not using that arm. That 13 pound arm will start to separate the glenohumeral joint. That subluxation causes traction on the axillary nerve, which causes a lot of pain. When physiotherapists or occupational therapists try to do rehab on the arm, many patients will tell you that touching the arm caused them to scream because it hurt so bad.
StimRouter allows the nerve to be stimulated for the patient to feel paresthesia to prevent the pain. This allows rehab with physiotherapists or occupational therapists on the arm to have the glenohumoral joint reapproximated to reduce traction on the nerve and have less pain. This allows patients to come back to rehab without nerve blocks, which are temporary and have diminishing marginal returns.
Medgadget: How is it implanted?
Geiger: We make a tiny stab incision, then insert the lead either blind, or under fluoro guidance, and ask feedback from the awake patient. “Do you feel the stimulation”, or “where do you feel the stimulation”? The lead is a 15 cm long, 1.5 mm diameter lead that’s placed on the nerve, and the back end is subcutaneous to the skin. Two days after the procedure, the patient comes in to get programmed. The programmer patch is a galvanic cathode to anode energy generator that we call the external pulse transmitter that broadcasts the field through the skin and passes it to the lead and the nerve to create paresthesia.
Medgadget: How long does the implant procedure take?
Geiger: The StimRouter is like a spinal cord stimulator, but moves all the electronics outside the body. Doing so turns a 90 minute procedure while the patient is asleep under general anesthetic for the spinal cord stimulator, into a 15-30 minute procedure under local anesthesia while the patient is awake. By moving the implant outside the body into a wearable, we can reduce the time of implant, use local anesthetic, and integrate the trial lead into the implant.
Medgadget: How is it used?
Geiger: The first time, we program the device and then also teach the patient how to use it. They get a patch and mini remote control that they can use to turn the device on/off, and switch to any of 8 programs provided from the physician’s office. Then they go home in charge of their pain management.
Medgadget: How often do they use it?
Geiger: They’ll wear it a lot, or when the doctor tells them to. But what we’ve seen over time is that some patients get into a routine. They don’t wait for the pain. For example, Felicia is a patient also on our website. She’s a motorcycle cop who got injured chasing a bad guy and crushed her wrist. Surgeries repaired her wrist, but she had nerve damage so her StimRouter is up on her radial nerve. She says “I get up, have coffee, and put on my StimRouter. I work for a few hours, then take it off, do other things, like scuba dive, and then put it on again in the afternoon or before I go to bed.” So, many patients get this “carry over pain relief”. Sometimes it’s minutes, and many times it’s hours. One patient had a spinal cord stimulator taken out, and a StimRouter put in. They stopped having to use it after 5 days. So there’s a potential for long term carry over pain relief. If I had to generalize, I’d say the usage goes down less and less.
Medgadget: Any advice for those considering a career in medical device sales and marketing?
Geiger: First, take what I say with a grain of salt. Now: I’d recommend it to everyone. It’s a pleasure to work with lots of young biomedical engineers. It’s an amazing space because the medical device space is always changing. My advice is: if you’re the type of person that likes change and flourishes in an environment that’s always changing – strategy and tactics and messaging – then the medical device space is for you. We’re all in it to help people at the end of the day. Many of us have been affected by conditions and disease that keeps them interested to do their own research and study and turn it into a career.
I have an implant that’s been keeping me alive since 14 years old. Through my neurosurgeon, I got into the medical device business in 1991 ever since I got out of college. I’ve seen people leave, but it’s like a vortex that sucks them back in because of the energy and enthusiasm of the clinicians, and helping them meet an unmet medical need. As, or more important, are the patients. I know them many of our patients by their first name. You listen to Felicia talk, and it just energizes you because: here’s a person who was a first responder, who in the course of doing her job, couldn’t do her job anymore. Now she’s back to leading a normal life and to see the patient say: “you gave me the part of life back I thought I had lost”. When you hear that over and over again, you can get up in the morning and get into work and work on the next thing.
More people need to do this and help with marketing to spread the word to showcase the other technologies out there that can help patients. It’s a very rewarding space to be in and it’s not affected by waxing and waning of the stock/economy/housing market. It’s a good job to have and I’d recommend it to anybody who fits those criteria.
Medgadget: Who was Alfred Mann?
Geiger: Alfred Mann was a serial entrepreneur who sold companies like MiniMed to Medtronic with the promise of a fully implant pancreas. He founded Advanced Bionics, one of the first cochlear implant companies, SecondSight, which led to a retinal implant to help blind patients see, and this company called Bioness. Alfred Mann died in 2016. At his funeral, he was said to have helped the deaf hear, the blind see, and the lame walk. That’s his legacy, and we’re very proud to be part of the Alfred Mann family of companies.
Link: Bioness homepage…