CNSDose: Better Depression Prescriptions Through DNA Testing

According to the latest research, one in six Americans takes a psychiatric drug. Of those prescribed, the overwhelming majority belongs to the category of antidepressants. Sadly, when it comes to the standard of care for an antidepressant prescription, finding the right drug and the right dose is largely a trial-and-error process.

CNSDose recognizes that this method is complicated, it leads to unwanted side effects, and at best it’s only accurate in about 50 percent of cases. Due to the reduced cost of genetic testing, CNSDose has been able to personalize the treatment using advanced genetic testing of patient DNA. Now, with just a cheek swab, CNSDose can offer a suggested medication and dose after just five days.

We recently had the opportunity to speak with Harris Eyre, Chief Medical Officer of CNSDose. He gave us some insight into the problem, how the company is dealing with it, and what’s coming next.

Why Did CNSDose Choose Depression?

Eyre tells us that, first and foremost, the company is mission-driven. It’s not the typical medtech entity. “We’ve seen it clinically, know the devastation of the trial-and-error method on our patients, have delved into it scientifically, or we’ve been impacted by it personally.”

The technology was invented by a renowned psychiatrist and geneticist, Ajeet Singh MD Ph.D., who had taken it upon himself to understand why the trial-and-error method is done, and how it can be fixed. Eyre then came on board to support the commercialization through his commercial physician-executive skillset. He had seen the clinical issues that trial and error created, and the opportunities of genomics, so the mission of finding a better method which was highly scalable spoke to him.

Andrew Robb, the company’s Chairman, is a former Trade Minister in the company’s native country of Australia. He has written about his struggles with depression in his memoir, Black Dog Daze (Melbourne University Press). In his book, he tells of the story where he was targeted to become the leader of the opposition party in Australia but ended up having to take six months off from the job while dealing with the effects of the trial-and-error method of antidepressant dosing.

Beyond the personal nature of the mission, Eyre stresses that the field is also one of the fastest-growing diagnostic sectors in the history of medicine. The first-mover in the sector was acquired in 2016 in a $400 million exit, so there’s no question that the area is a hotbed of activity.

Building CNSDose

CNSDose has a significant amount of ammunition at its disposal. The company has a proprietary algorithm and a patent position around the blood-brain barrier genetics. But beyond that, it also has “the strongest support of any technology like this in the world” due to its clinical trial portfolio.

A randomized, controlled trial published in 2015 held the first positive results that the field had seen, and CNSDose was named as the most favorable technology in the market. “Over a twelve-week period, we could double the rate of recovery with CNSDose versus the trial-and-error method,” says Eyre.

Fast forward a year and the Department of Veterans Affairs released its own study showing that CNSDose had the most favorable findings in the field. Then, in 2017, a study was published showing that the CNSDose technology had an 89 percent accuracy at predicting the required dose the first time.

Overcoming the Obstacles

As with any young company, CNSDose has had to wrestle its way to where they are today. They have recently announced a contract with, and begun integration into, Intermountain Healthcare. As one of the largest private healthcare companies in the United States, servicing over four million customers, it’s a “huge deal for us as a seed-funded company.”

The other big part of the CNSDose story was coming to the United States and joining the Texas Medical Center’s digital health accelerator TMCx.

It was pretty amazing to be based at the largest medical center in the world. You have eminent researchers and clinics at your disposal, and this enabled us to get contracts signed or started while at TMCx. It was a great opportunity for us to test our business plan, our pricing model, for finding investors and directors and generally enriching ourselves in the US market.

Coming to America

We spoke at length about the choice to start in the United States. While the company originated out of Melbourne, Australia, the team quickly realized that the US was the best place for them to be. People in the United States, according to Eyre, are more open-minded to the technology. That said, the move did come with some challenges.

We realized that the US system is complex and fragmented, and we had enough sense to understand that we needed to get a US-based CEO.

With that knowledge in hand, the team engaged Mark Heinemeyer. Heinemeyer brings a wealth of experience to the team, having served in high-level positions at startups and growth-stage companies, as well as larger entities such as HCA, Cigna, and Fiserv. According to Eyre, “as a foreign company, we needed to tool ourselves into the US market with a senior healthcare executive like Mark.”

Regulation, The FDA, and the Australian Market

The great news for CNSDose and its customers is that there is not a specifically-required FDA approval for their product. Since it was produced as a lab-developed test, in an FDA- and CLIA-approved facility, CNSDose avoided the level of regulatory burden that we often see in the healthcare market.

That same burden was a big part of the reason why CNSDose landed in the US as its first market. While there are similar regulatory hurdles between the United States and Australia, Eyre tells us that things are “a bit more burdensome in Australia” as there is a need to submit a technical dossier for the product. CNSDose is completing the regulatory process in Australia and plans to ‘go live’ in February of 2018.

Costs and Benefits

While there are obvious benefits to both the patient and the provider in finding the right antidepressant dose quickly, there are other positives as well. So far, Eyre tells me, there is reasonable insurer coverage for the procedure, but even cash patients are able to afford the $399 price tag. Beyond that, however, economic models have forecasted savings in excess of $2,400 per patient, per year, in direct healthcare costs over trial-and-error prescription methods.

The Future of CNSDose

Eyre explains that, in three to five years, the company intends to find an exit through a strategic acquisition. In the interim, however, the team refuses to rest. While the team is staying laser-focused on depression right now, they are in the eminent stages of product development that will bring their genetic guidance systems to other areas of psychiatric medication such as ADHD, mood stabilizers, and antipsychotics.

“In three years it would be great to have our depression technology penetrated into the US market, and to have our pipeline of these other genetic guidance systems into the market and being offered.”

The team is also planning a move into a secondary market, with their home of Australia as the target within the next three years.

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Startup Spotlight: Saranas Reduces Bleeding in VAP Surgeries

Recognized for its ability to avoid pain, scarring, and long recovery times, minimally invasive vascular access procedures (VAP) continues to gain popularity year over year. That said, VAP does have inherent risks, with patients in nearly 20 percent of cases seeing at least some negative impact related to bleeding. Saranas is a Texas-based company that is focused on minimizing these risks by providing early detection and monitoring of internal bleeding complications via bioimpedance measurements.

We recently had the chance to speak with Saranas CEO Zaffer Syed. He brought us up to speed with where the company is today, its future plans, and his thoughts on how to build a thriving medical startup.

The History of Saranas

Saranas was incorporated in 2013, with technology licensed out of the Texas Heart Institute. The technology was invented by Dr. Medhi Razavi at Texas Heart, when he identified that he could likely correlate changes in bioimpedence to serve as a proxy for internal bleeding. Dr. Razavi led the early pilot work while serving as an Adjunct Professor at Rice University, eventually finding enough traction to form the company.

Dr. Razavi helped lead the company through its early Seed and A rounds, working toward getting Saranas to its final product development stages. However, challenges in 2016 required a new developer for the product, and Dr. Razavi stepped back to a Director role when Syed took over as CEO.

Saranas Today

Animal lab studies of Saranas’ Early Bird Bleed Monitoring System show that the product works fantastic as it is today. A recent study, completed in August, showed no false positives while still retaining the necessary sensitivity. The next steps, according to Syed, include a completion of the verification and validation stages, then continued testing of the product prior to FDA submission. Saranas is aiming to have these tests completed by the end of 2017.

Building the Team

One recent piece of news from Saranas was the company’s addition of Dr. Philippe Genereux as Chief Medical Officer (CMO). Dr. Genereux has worked as an Interventional Cardiologist since 2009, and is the Co-Director of the Structural Heart Disease Program at Morristown Medical Center.

I asked Syed about the value that Dr. Genereux adds to the team.

Dr. Genereux is very involved, especially from an innovation standpoint. He’s been involved with some of the leading clinical trials in the interventional cardiology (IC) space, and he’s been connected to Saranas as an advisor for a few years.

He holds a keen interest in what we’re doing because he knows first-hand not only the risks related to internal bleeding but also the impact that our product can have. He co-authored a paper published in JAMA that highlights the fact that bleeding occurs in 18-19 percent of IC cases, with significant impacts on mortality, length of stay, and cost to the patient.

Syed tells me that, as CMO, Dr. Genereux has not only been driving awareness, but he’s also made some significant changes in product positioning. He was able to identify ways to use the Saranas technology in the venous position that extends monitoring post procedurally as well as during the procedure.

“His ability to tie together both the business and medical sides is what attracted us to him in this position.”

The Future of Saranas

These are exciting times for the young company. The team continues to grow, while still keeping a focus on efficiency. At present, there are four full-time equivalent members, four consultants, and a team of four leading cardiologist on its Scientific Advisory Board.

Syed tells us that Saranas plans to submit its technology to the FDA soon after final testing, which is scheduled to end in December 2017 and expect to have first-in-human clinical experience in early 2018.

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Windpact Brings Science to Sports, Automobiles & Combat Gear

Windpact has big ambitions: to become the most advanced impact protection company in the world.

Before starting Windpact, CEO Shawn Springs had seen countless injuries during his NFL career, where the players were outfitted in what should have been the best gear available. But when Springs totaled his car in an accident, his children walked away with only scratches because of the impact technology in their car seats. What if he could translate that level of protection into helmet technology for use across a variety of sports?

Windpact CEO Shawn Springs

I recently had the chance to speak with Shawn Springs, Windpact’s Founder and Chief Executive Officer. As the company ramps up for its syndicate funding round through angelMD, he had some valuable insight into the genesis of the company, and what it plans to do next.

Windpact is taking a unique approach to building a brand that is solving all types of impacts, from football helmets to race cars. Rather than building its own equipment and end products, the company partners with top brands to integrate its Crash Cloud system into their products. This holds the potential to scale quickly and spread their life-saving technology to more hands, across a variety of fields, with less cost and overhead.

First thing’s first – How does Windpact make money?

We don’t sell ski helmets or shoulder pads or race car seats; we partner with great brands to make their existing ones better. We call this our hybrid go-to-market approach. In some ways, we look just like a component supplier: we get paid on delivery of our padding systems to the host brand. But at the same time, we are a core brand partner to those companies, and work to market the Windpact brand inside other products. Think of us like the Gore-Tex(R) of impact protection.

Partnering with large host brands lets us leverage those companies for sales and distribution of the products, as well as marketing to and reaching end consumers.

What were the early days like?

We started to explore the market, and we quickly understood that this was an area that just lacked innovation. We can look at the automobile sector, and cars change every four years. Even tires change every year. For something to go thirty plus years without some big innovation? You know that there’s an opportunity.

In the early days we spent a lot of time working with very smart people – mostly top engineers in our partner engineering firms to unpack the problem and apply this technology as a solution, but also our IP experts and legal to ensure we had a solid foundation for a business.

I will never forget some of the first feedback we got when we put the technology in a football helmet shell and took it down to the Virginia Tech Helmet Lab to see how it would do on their new 5 Star rating scale – which has now become the gold standard for helmet rating.  Dr. Stefan Duma, who ran the lab, cautioned me to manage expectations: he said that 96 percent of all new helmet concepts tested in the lab never even make it off the rig, much less earn a star score.  At that time, there was only one 5 star helmet. I can still remember the one question he had for me after our prototype helmet received the best score ever tested at the time. He said, “Shawn, how did you do it?”

Talk to me about the Windpact approach.

This is a physics problem. We got a team of engineers together, and we started looking at how the technology worked and how to optimize it for different applications. It wasn’t long before we knew that we had something special. A technology that could improve protection in every sport that required a helmet without losing performance.

Today, when we are solving for a new application, we start with the engineers. They first work to understand the market, what’s being used and what is effective.  We analyze the standards and learn how the industry measures a product: hockey glove testing is completely different than a helmet drop test, which is totally different from a military ballistic shell.  We demonstrate improved performance using prototype testing pods, and once the client understands the gains, we get to work designing a distinct padding system, consistent with our brand.  We want everything we make to be beautiful and effective.

Why not make your own helmets?

We learned a lot about the technology in the early days, but we were also pressure testing the business model and how to bring the tech to market.  I knew I didn’t want to raise 50 or 75 million dollars to build a new helmet brand from the ground up and market it to end consumers.  I just wanted to solve a problem. Focusing this technology on a single Windpact helmet, by definition, would limit how fast and far we can spread the reach of a critical new tool in the conversation about impact protection.

If you look at brands like Intel, Gore-Tex or BASF, that’s the model that we’re using. We found that there are other implications as well. We can apply the Crash Cloud to military, transportation and even healthcare. The companies who make football helmets? All they make are football helmets because that’s where they’ve sunk all of their marketing and R&D dollars.

We’ve already demonstrated improved performance in the automotive setting, where we were approached by a large US automotive maker to put our Crash Cloud system into specific interior areas of their vehicles. That’s a conversation we couldn’t be having right now if we were just a football helmet company.

Talk about your IP and how it works for the business.

We have an issued patent for our technology in helmets, and have a second application pending that expands that coverage.  The key is that our IP is on the Crash Cloud system, not the specific materials. The better foam gets, the deeper our ocean becomes. Contrast that to companies whose core IP is around a certain formulation of a certain material, to build a certain product. That is very limited.

We use off the shelf materials, then we can optimize the system by using different foams or adjusting airflow to build particular products. That’s where things get interesting.

Give me an example of what that looks like.

With a baseball helmet, for example, there is a layer of impact attenuating foam and a layer of comfort foam.  We tune our system by adjusting foams, skin thickness and airflow, to provide a pad that is softer than the hard impact foam, but outperforms it at high and low impact.

What about the challenges?

The biggest challenge is getting this tech out as fast as we want to in order to take advantage of the opportunities that exist today.  We were surprised, for instance, to hear baseball equipment companies talking about the pressure they feel over the concussion concern.  Everyone knows it’s an issue in football and hockey, but we are amazed to see how pervasive the need is for innovation in this area. At times it can be frustrating to balance staying lean and smart, with aggressive fundraising and team building when the opportunities are stacking up.

And how about milestones?

We won the NFL First and Future Startup Challenge at the Texas Medical Center during the Super Bowl, we won the NFL HeadHealth TECH Challenge II, we won the NFLPA-sponsored Leaders Sports Summit in London, we already have a product on the market for women’s lacrosse, and we are working on a number of new products with major brands we hope to be able to announce in the coming weeks and months.

There are challenges, but it’s fun. Now we are turning a corner and are ready to scale to meet the opportunity. That will bring a new mix of fun and challenge.

What about the NFL HeadHealthTECH Challenge?

[Read the story from the NFL here.]

That’s big. It definitely helps when you have a former Pro Bowl athlete because you can get that level of visibility. But the fact that we are being validated in the scientific community is extremely humbling, and not just because of having your CEO be an athlete.

It’s great because the NFL is not just throwing money around; they’re looking for real products and not just research at this point.

What’s the future look like for Windpact?

Our focus today is on building a great company with superior products to help protect people, and we are well on our way. We have a terrific technology and are turning the corner from R&D to putting products on the market.  We are excited to see what tomorrow holds for us.

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Startup Spotlight: Minimus Spine

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.

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Startup Spotlight: Aqueduct Critical Care

For this week’s startup spotlight we spoke to Tom Clement, CEO of Aqueduct Critical Care, Inc. The Aqueduct Critical Care team is developing devices to manage acute and chronic Cerebral Spinal Fluid (CSF) problems.

 

Clement is a seasoned medical device veteran and has brought eight medical devices to market and started a number of medical device companies including Pathway Medical Technologies and Cardiac Insight. He recently helped launch the medical device incubator Mercury, an initiative of the Biomedical Innovation Partnership Zone in Bothell, Washington.

Challenging the Status Quo

Aqueduct’s technology is an innovation on traditional gravity fed temporary CSF drains. The technology currently used for drains is passive and largely unchanged for decades. Adjustments have to be made manually resulting in the need for constant monitoring from a skilled nurse. Aqueduct aims to change this industry standard.

“If a patient sits up as little as two inches and their CSF drain isn’t adjusted, it can make them sick, and from there they can go downhill pretty quickly,” explained Tom Clement.

Aqueduct’s technology, consisting of a single use Smart External Drain (SED) cartridge, and the SED console, eliminates the need for constant monitoring. The SED automatically adjusts for patient movement while maintaining the physician-prescribed settings. The technology is designed to both increase the ease of use and safety when managing patients with external CSF drains.

The IP behind Aqueduct was spun out of the University of Washington in 2013. Aqueduct has since received FDA clearance, with two 510(k)s completed and a third in progress.

 

“In my 35 years of experience this is the fastest I’ve seen a product get into the clinic,” said Clement.

 

Due to the nature of the product, the FDA didn’t require clinical testing. However, Aqueduct is conducting its own post market study and is currently enrolling patients at multiple sites under a protocol that compares current technology to Aqueduct’s SED in a clinical setting.

A market changer

The CSF drain market is dominated by two companies with virtually the same technology. Aqueduct represents the first major change in gravity based CSF drains in 60 years.

“We expect [our SED] to become the standard of care for all patients being managed on temporary CSF drains. If someone gets sick on the current technology, and the hospital gets sued, they will be asked “why wasn’t the patient on Aqueduct technology?” claimed Clement.

Aqueduct is currently focusing on expanding its reach and confirming its value proposition for hospitals across the country.

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