Entries Written By Ki Lee
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.
According to the American Diabetes Association, 9.3% of the population has diabetes, and it is the 7th leading cause of death in the United States. As the population ages and rates of obesity rise, diabetes and often co-morbid chronic conditions like hypertension and cardiovascular disease will increasingly drive health care cost increases. Saturn Care is trying to help primary care providers who manage diabetic patients achieve significant health improvements using its Chronic Disease Management Program (CDMP), a data-driven service. We spoke with CEO Phil Heifetz, to learn about Saturn Care’s approach to this significant problem.
What motivates your company?
Saturn Care exists to to help primary care physicians leverage data and technology so they can be more efficient and effective. This is especially important for optimizing the management of patients with diabetes and related chronic diseases. We are motivated by seeing our technology put into action and how it can really change the lives of some amazing patients and their health care providers.
We believe that by simplifying and combining clinical and behavioral information, CDMP helps create more impactful primary care encounters. We know that the complexity of managing a disease like diabetes and co-morbidities contributes to provider burnout and poor patient engagement. Deploying a program like CDMP that address both the clinical and behavioral aspects of disease can help prevent that. This was demonstrated in one of our published clinical studies where we saw 100% provider acceptance of CDMP and 97% patient engagement over a 3-month period.
What has been the biggest achievement you have accomplished?
The biggest achievement so far might be the outcomes data from an NIH-funded randomized, controlled in Diabetes Care, the scientific journal of the American Diabetes Association. That study showed how use of CDMP by a care team helped diabetes patients achieve significant improvements in both clinical and behavioral endpoints through a truly comprehensive approach.
The NIH study was just one piece of research behind CDMP that spans over 12 years and $50 million of grant-based funding, and included participation from Joslin Diabetes Center, Baystate Health, McKesson, the US Department of Defense, Walter Reed Medical Center and other institutions.
Is there anything people need to know regarding internal medicine? What do you want to tell them?
Internists in primary care should have a look at CDMP and our data. They already know how complex diabetes can be. CDMP is integrated as a single-screen dashboard into the electronic health record so we can save them time and give them patient insights no EHR we know of provides.
We also offer access to a team of certified diabetes nurse educators and nutritionists who can work remotely with diabetes patients to offer a program of education, self-management and behavioral assessments that complements the regular office visits, and the results of those encounters are visible to primary care providers as part of the EHR.
Furthermore, our pricing is on a per-month basis, and designed to fit with payments providers are receiving under value-based contracts.
How do you anticipate the field of primary care changing in the future?
The role of the internist in primary care is changing very rapidly. Once the under-resourced gatekeepers of the health system who were rewarded for seeing as many patients as possible under fee for service (and referring to other health system specialists), they are now put in the role of starting quarterback of the medical home model. Although this comes with potentially lucrative financial incentives for quality and outcomes, it also comes with heightened expectations for providing a more comprehensive level of care.
The new CPC+ program is a good example of this, and many providers in that program are finding it overwhelming at times. This is particularly true for the diabetes population, where practices are incentivized to provide things like education, self-management and care coordination that in the past were handled by specialties and other arms of the health care system.
Internists in primary care will increasingly look to rely on other skilled members of the care team (eg, nurses, medical assistants) to work at the top of their credentials. They may also want to outsource functions to third parties who can interact directly with patients outside of office visits using modalities like telehealth to extend the capacity and capability of the primary care practice. If done properly, this approach can be both highly effective and highly scalable, and could be one way we achieve improvements at the population level.
Tell us about upcoming projects or events your company has.
Saturn Care has had a busy summer. Primarily, we are onboarding our newest customer and hoping to announce another one shortly. Our new practice group is partnering with Saturn Care to use CDMP as a technology platform, integrated with their EHR, to facilitate delivering Chronic Care Management under Medicare billing codes.
In their case, the chronic disease education team was already providing a tremendous amount of patient services, but they did not have any technology beyond paper and Excel that would allow them to collect and analyze data, nor could they feasibly complete the documentation required to bill for the care management piece of their services.
We also just held a follow-on webinar to an earlier highly successful one with William Polonsky, PhD, CDE this spring. Dr. Polonsky is one of the world’s leading authorities on the behavioral aspects of diabetes care and is the Founder and President of the Behavioral Diabetes Institute in San Diego. We are very proud to have him as a Saturn Care advisor, and his talks provided a great deal of useful information for primary care providers trying to help their patients tackle the daily challenges of diabetes.
Finally, we are expecting some more data later this year from a pilot study of the telehealth program taking place now in Hawaii.
What is your company’s ultimate goal?
We believe we are well positioned to work with practices as they advance in the medical home model and outcomes-based payments, and we think CDMP could emerge as the go-to solution for primary care systems to manage their chronic disease populations. We think that goal is achievable either as a stand-alone entity, or more likely, as part of a larger organization.
What can be done to encourage innovation in primary care?
Overall, I think when it comes to primary care, a major challenge will be to find ways to provide a higher level of care for a broader range of chronic care patients. Innovation will come from changing incentives and processes so that prevention of acute care episodes becomes the primary goal of medicine. Leveraging data and technology (eg, remote monitoring, machine learning) to improve medical decision-making and engage patients in their own care goals can then follow.
Diavacs is a preclinical biotechnology company developing first-in-class therapies to prevent and reverse the onset of autoimmune disease. Their initial focus is reversing new-onset type 1 diabetes (an orphan indication).
We got in touch with Head of Operations Mr. Richard Murphey to discuss Diavacs’s approach.
What motivates your company?
Our CEO, Alan Lewis, was previously the CEO of the Juvenile Diabetes Research Foundation, the leading non-profit funder of type 1 diabetes research in the country. In that role, he has met hundreds of people and families living with type 1. For these people, insulin therapy keeps their life-threatening disease at bay, but managing the disease requires constant vigilance: one off day can mean a hospital visit (or worse).
A lot of people don’t realize how big the unmet need is in type 1, but even with great self-management, insulin does not necessarily prevent the serious complications of type 1, including blindness, leg amputations, and kidney failure. We think that giving patients a chance to avoid these complications is a goal worth working towards.
What has been the biggest achievement you accomplished?
Our biggest achievement has been pushing our technology to its limits and uncovering the broad potential of our platform beyond type 1. When we licensed our product from Baxter and the University of Pittsburgh, it was able to prevent and reverse type 1 diabetes in animal models by inhibiting the expression of three proteins by 40-50 percent.
We have since optimized the product to consistently achieve 95%+ inhibition of these same proteins. This could mean longer-lasting effectiveness, less dependence on insulin, and a better chance at preventing downstream complications like foot amputations or kidney transplants. It could also mean our platform can be used to treat other autoimmune diseases like rheumatoid arthritis or Crohn’s disease, or even cancer.
How does your therapy treat type 1 diabetes?
At the heart of the vicious cycle of autoimmunity are dendritic cells. Dendritic cells collect antigens from destroyed beta cells and present these antigens to T cells, programming these T cells to destroy beta cells. Diavacs’ technology re-engineers dendritic cells by using antisense-DNA to inhibit the expression of three key molecules (CD40, CD80 and CD86) involved in programming cytotoxic T cells to attack beta cells. These re-engineered dendritic cells protect healthy tissue by stimulating a type of tolerogenic T cell called a “T regulatory” cell and also by destroying cytotoxic T cells.
If patients are treated with this approach within a few months of being diagnosed, we believe we can stop the autoimmune attack in its tracks while the body is still able to produce sufficient insulin, effectively reversing the onset of Type 1 Diabetes. Further, recent evidence suggests that beta cells regenerate throughout a patient’s life, and by protecting these new beta cells, we hope that Diavacs’ products can restore full function to patients.
Our approach has successfully reversed the onset of Type 1 Diabetes in animal models of disease. While Diavacs will not initiate its first study in humans until 2018, other therapies designed to create more T regulatory cells have been successful in treating autoimmune diseases in humans. We believe our approach may have a better safety profile, be more convenient for patients, and be potentially more effective than other approaches
Tell us about upcoming projects or events your company will have.
The most exciting near-term milestone is initiation of our first animal study of Type 1 Diabetes with our optimized formulation. We are kicking this off as we speak and expect this study to read out in late 2017. Completion of this study will enable us to meet with the FDA to discuss when we are able to initiate our first human study. Our partners did a ton of great work on the product before we licensed it, and FDA is familiar with a lot of this work, so we hope this will mean a quick path into clinical trials. A positive proof of concept study in humans will be a tremendous accomplishment for the company, a meaningful value inflection point for investors, and an incredibly promising development for patients.
In addition to the Type 1 work, we are looking to use our platform to develop additional candidates to treat other autoimmune diseases and cancer. One project we are particularly excited about is using our product to program dendritic cells to activate T cells against neoantigens in cancer. We are in discussions with some academic researchers about applying for grants to fund this work, but if we get some additional equity funding we can get started sooner.
What is your company’s ultimate goal?
Our ultimate goal is to help people with autoimmune disease to live happier and healthier lives. There are a lot of great products out there that relieve symptoms for some of these people, but most of these products come with their own baggage, and very few medicines exist to alter the course of these diseases in a sustainable way. Hopefully we can offer a product to patients that significantly reduces the burden of their illness.
How does your company stand out from the competition?
Most drugs for autoimmune disease are broad-acting anti-inflammatory products that treat autoimmunity but also weaken the immune system’s ability to fight other infections. Our product is designed to induce local, rather than systemic, immune tolerance: we reduce immunogenic activity in the parts of the body where the immune system is malfunctioning, but we do not broadly reduce the immune system’s ability to fight infections.
To our knowledge, we are the only company developing therapies that act locally versus systemically. However, there are several companies that are trying to limit systemic side effects through other means, often through antigen-specific approaches. Some of the most promising products for not just type 1 but autoimmunity in general act by expanding populations of T regulatory cells that stop autoimmunity — analogous to the most promising new cancer therapies that act by expanding populations of T cells that fight tumors. Notable examples of this approach include Delinia (acquired by Celgene in January), Parvus (recently partnered with Novartis) and Caladrius (public).
Our product also expands populations of T regulatory cells, but we believe our product has two other mechanisms of action that competitors do not: reduction in populations of T effector cells and expansion of B regulatory cell populations. In type 1 diabetes, there is a big difference between, say, reducing required insulin injections by 25 percent and reducing dependence on insulin entirely. We hope that our product’s additional mechanisms of treating the autoimmune pathology will put us closer to the latter goal.
All that said, the field of autoimmunity is vast and there is room for several next-generation products. As one of the largest therapeutic areas, we believe pharmaceutical companies will look to bolster their pipelines with several promising candidates, and we have spoken with several large biopharma companies that are excited about our approach.