Entries Published On October, 2017
For this week’s #StartupSpotlight, we take a look at Minimus Spine. Minimus Spine offers a bridge between epidural steroid injections and discectomy. We spoke with CEO David Hooper, to learn about Minimus Spine. To find out more about Minimus Spine, check out their angelMD profile.
Please provide a short overview of your company and the specific need in the market you are currently fulfilling.
A disc herniation can cause intense leg and back pain. While many of these herniations will resolve on their own, the process can take 6-12 months or even longer. Many patients need some help. If you haven’t improved in 4-6 weeks, the treatments are largely epidural steroid injections or surgery. The steroids have limited effectiveness and are often repeated two or three times. They simply buy time.
We estimate that in the U.S., about 1.2 million patients go this route every year. Surgery to remove the herniation is effective 80-90% of the time, but it involves short and long terms risks, a significant recovery period, and is expensive. Still, about 300,000 U.S. patients opt for surgery each year.
Our Triojection product uses ozone gas to reduce the size of the herniation, with the aim of a single injection to the herniated disc giving 70-80% of patients lasting relief.
Why did you start your company?
I had been working in the spinal implant industry, which has become a very crowded space. Everyone wants to develop products that are less invasive and cost less.
In 2006, I started coming across reports of physicians using ozone to reduce the size of a disc herniation through oxidation. A neurosurgeon colleague and I spent a week with physicians that were performing this treatment in Europe. We liked what we saw and more data was coming out in the literature.
While attending these cases, we realized that the equipment used to produce ozone was lacking sophistication, mainly on sterility and control. Doctors were making some ozone in a generator that was not sterile, using a random syringe to collect it directly from the generator, and then taking it to the patient. There was no control on the sterility, little consistency on concentration or volume of ozone injected, no control on the selection of a syringe or consideration of how ozone would react with that syringe. Our feeling was that such systems would never go mainstream. What was lacking was a purpose-designed product that conformed to current expectations of a proper medical device. Triojection is just that.
What have you accomplished so far?
We have already hit many milestones. We successfully developed and validated our product. We have built our own quality system and had it certified to ISO. Triojection has CE Mark, giving us the ability to sell it across the European Union. We have now enrolled 40 patients in a multi-center, randomized study in Europe. I’m particularly proud of the fact that we have done all this on less than $4M.
What are the economics of Triojection?
Our aim is to price Triojection such it is roughly equivalent to a series of steroid injections and less than surgery. The average patient receives 2.5 steroid injections ranging from $500-$3,000 each. Discectomy is about $9,000 if you pay cash- but it can be much higher. These are US costs but even in Europe, we expect to be able to save money for the system.
Many patients will happily pay for an opportunity to avoid surgery. Importantly, the cost to produce the disposable syringe cartridge is sufficiently low that they will be able to pay. These facts mitigate our immediate reimbursement risk. We plan to focus on private clinics initially, but we expect the data from our study against surgery will help us secure wider reimbursement coverage.
How are you trying to differentiate yourself from your competitors?
We designed Triojection to include a sterile, disposable syringe cartridge that is processed by our console. That is unique. This approach to making ozone gives the physician certainty over sterility and the concentration injected into the herniated disc. Our most direct competitors in Europe are the companies selling an ozone generator for general medical use.
We are differentiating ourselves by being the only system that is specifically designed to create ozone for a sterile injection, specifically in the spine. An infection in the disc is a big deal and there are several reports of serious infection after an ozone injection. One cannot simply rely on ozone disinfectant properties to justify the use of a non-sterile product. Particularly, if a sterile product is available.
The console and sterile syringe cartridge work together to produce and measure ozone within the sterile syringe. The syringe is then removed from the protective case and passed into the sterile field.
Triojection is not only sterile but the system is unique in its ability to measure and control the concentration of the ozone while it’s in the syringe. It is supported by volumes of testing, as you would expect of a medical device, including sterilization, biocompatibility, validation of the measurement etc. Now we are sponsoring a post-market clinical study.
We know first-hand that there are physicians who have been following the ozone literature with interest, but never considered using the systems available. In fact, the investigators participating in our randomized study all come from this way of thinking.
Relative to other more traditional options, steroids only address inflammation. Triojection does that, but it also reduces the size of the herniation through oxidation. The gas flows through the herniation, we believe breaking down the herniated disc material and facilitating natural resorption. That should translate to fewer injections. Relative to surgery, Triojection is faster, less expensive, less invasive, and avoids post-operative recovery.
Caption: Intraoperative images showing needle placement and delivery of ozone to the center of the disc. Gas flows through the herniation and into the epidural space, oxidizing the herniated material.
Where do you see the biggest potential for growth in your industry?
I believe that growth in the spine industry will come from less invasive technologies and that spine treatments will move towards interventional radiologists and pain physicians. Injectables, lasers and medications will play an increasing role in the management of these patients. There are a number of these less invasive technologies percolating and big companies will acquire these technologies as they prove their worth.
I’m intrigued by the idea of large private equity players bringing a collection of these less invasive technologies under a single umbrella, creating a company dedicated to building a suite of products for spine interventionalists.
Over the past 10 years what has been the biggest technological innovation that has shaped your industry?
The traditional spine market hasn’t seen much true innovation in that time, it has been more about evolution of existing products. Industry has tried every conceivable spinal implant. In most cases, outcomes haven’t been improved and costs haven’t come down. Artificial discs are having some success, particularly in the neck. Stem cell treatments are gaining some traction as a possible treatment for degenerated discs and back pain, because they are less invasive and low risk, but they remain controversial and protocols are not well standardized. It’s a bit ‘Wild West.’
What about the FDA?
The FDA is the biggest obstacle to innovation in the US. We have had preliminary conversations with FDA. Right now, like many companies with novel therapeutics, we have decided to focus outside the US. It’s a big world and we can build value outside the US, then make decisions about selling the company, raising money to accelerate the US study, or entering a strategic partnership for the US market.
What is your vision and of the strategy for your company for the future?
Minimus is poised to launch in Europe and my immediate vision is to grow Minimus to break-even on the strength of sales outside the US. We expect to demonstrate commercial traction in Europe while we continue to collect rigorous clinical data. I see us launching in Europe, expanding our footprint there, and then getting into other countries expressing interest in Triojection. Clinical data is important to the Triojection brand. We need to complete our current study and be smart about future studies.
Ozone is not a panacea, but it likely has other applications. We are starting with lumbar disc herniation but Triojection could easily be applied to cervical disc herniations. Discogenic back pain may be another application.
I recently came across an interesting study using ozone in osteoarthritic knees. Triojection has the potential to be like Botox. Like ozone, Botox has been around for decades. Over the years, the brand continued to grow as new indications were discovered. ‘Wrinkles’ is the big indication that everyone knows- but it wasn’t the first nor the last. The lumbar disc herniation market alone is large enough to be a great opportunity for Minimus, but Minimus has the potential to be much more than that.