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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Startup Spotlight: Windpact Brings Science to Football Helmets

Windpact began because of a car seat.

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 their car seats. What if he could translate that level of protection into helmet technology?

Chronic traumatic encephalopathy (CTE) is a neurodegenerative disease most commonly found in people who have had repeated head trauma — such as those in the NFL or professional boxing. The rise of post-mortem CTE findings has caused the alarm bells to sound in every level of sports. From players to owners, everyone involved knows that we are at a crossroads when it comes to balancing sports with potential dangers.

Windpact CEO Shawn Springs

I recently had the chance to speak with Maurice Kelly, Windpact’s Chief Innovation 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 solving the problem. Rather than building its own equipment, the company partners with top host brands to integrate its Crash Cloud system in their products. This holds the potential to get lifesaving equipment into more hands, with less red tape and overhead.

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

We take a hybrid approach to the business. We don’t sell helmets, we make the existing ones better. Let’s say that a brand manufacturer comes to us with 500 helmets because they knew that if they could pass the high-velocity test then they could pass the low-velocity ones as well. We’re first going to put them through an extensive series of our own tests. With those results, we can then integrate the Crash Cloud system. Our customers pay us for the system when it’s integrated into the helmet.

There’s a point here that doesn’t get enough credit — You never want to try to change user behavior. We’re not changing the buying behavior of anyone who is in the market for a helmet. They can still buy the same helmet that they have been using, and we’ll make it exponentially more protective.

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.

As we were researching, the Virginia Tech reports started to come out, and their data showed that all impacts are very different. The majority of impacts in football happen at low or medium velocity. These helmets, that manufacturers and players thought were so great, were not providing the protection that they claimed.

If you look at today’s helmets, they were built to address high-velocity impacts because that’s what is required to pass the standard, but they are not optimized to protect against a range of impacts.

Talk to me about the Windpact approach.

This is a physics problem. We got a team of engineers together, and we started looking at this sort of visco-elastic system — meaning that it would adjust based upon the level of impact. We knew then that we could offer protection at every level, from pee-wee leagues to the NFL, without losing performance.

Then we had to decide what this looked like, in terms of a business. Every data point that we looked at pointed to the idea that government regulation was coming. Football, baseball, lacrosse, and hockey were not under government regulation. Lo and behold, thirty days into our effort, the Senate calls top football helmet manufacturers to The Hill. They want to know what these companies knew about concussions.

Between Shawn and I, we had thirty plus years of experience in wearing helmets. So we could either build a helmet company, and put our time and effort into bringing it to market, or we could do the research and license the technology to the sporting industry.

How surprising was it to take the licensing approach?

What we learned through this process of deciding what the business would look like is that the ecosystem was not at all like what we anticipated that it would be. We didn’t want to go out and raise 50 or 100 million dollars to build a manufacturing infrastructure. We just wanted to solve a problem. We knew that the problem was so critical that it shouldn’t just be our product.

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 Crash Cloud to the military, to healthcare, or even the automotive industry. The companies who make football helmets? All they make are football helmets because that’s where they’ve sunk all of their R&D dollars.

We’ve already been able to do some piloting with the automotive community. We’ve been approached by a large automotive manufacturer to put our Crash Cloud system into specific interior areas of their performance automobiles.

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

The real difference for us is that we don’t make the materials. Our IP is on the system. The more foam makers that are out there, 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 products, then we can customize the foam to build particular products. That’s where things get interesting.

Give me an example of what that looks like.

Let’s look at headrests in cars. Go inside your car and you can cut open the headrest and give us that material. We can then take that material, tune it in our system without changing its characteristics of its structure. We then encapsulate it into our Crash Cloud, adjust the hole sizes, and we’ve just made that same headrest perform better across a variety of different impact scenarios.

What about the challenges?

The biggest challenge is a space constraint. When you think about a car seat, and how it keeps a child safe, it’s a matter of multiple layers. You have the metal of the car, then the crumple zones. Inside the doors and the body, you have steel. Once you’re through those layers, then there are airbags and the car’s own seat. After that, you finally reach the car seat.

In a football helmet? We have 30 millimeters of space. So that becomes the major challenge. How do we innovate and develop the approach to manage impact energy in only 30 millimeters of space? That was probably the biggest challenge and the biggest lesson that we had to learn, but we didn’t realize how hard the problem was until after we’d already solved it.

The beauty of the Crash Cloud system is that there is simplicity in manufacturing now that we’ve solved the hard problem. It’s just multiple layers of foam in a bag, and then we poke holes in the bag. Now the engineers don’t like to hear the science, the data, and all of the formulas simplified like that. We still know that it’s a complex business problem, but we had to look at the simplicity of it.

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 already have a product on the market for women’s lacrosse, and we are working to a number of new products with major brands we hope to be announce in the coming weeks and months.

It’s been fun, and it’s been hard. Now we have to scale it.

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.

You have our CEO who played on Sunday nights, and now he’s doing TED Talks as a thought leader in the space. He said that, given all of that, his greatest achievement in life now is having his name on the Windpact patent.

What’s the future look like for Windpact?

Our focus today is on building a great company with superior products to help protect people. We have a terrific technology and can be nimble and agile in ways that large entities can’t, which will open opportunities 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 will 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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Startup Spotlight: Concure Oncology

For this week’s #startupspotlight, I had the chance to visit Concure Oncology’s Mercer Island offices to learn about their exciting technology and expert team.

 

One in eight women in the U.S. will be diagnosed with breast cancer, triggering a long and painful treatment process. But what if there was a better way?

Enter Concure Oncology

The technology behind Concure Oncology was discovered in 2013 by CEO Sandra Rorem during a consulting engagement for a company that owned the rights to technology for breast stabilization for precision during surgery. Rorem immediately recognized the value of the technology to breast cancer patients.

 

While the technology was not commercialized at the time, much of the initial work had been completed. Patents had been filed and the results of the clinical studies would soon be published.

 

In 2014, after working to help separate the IP from the broader holdings of its owner, Rorem and two co-founders purchased the Breast Microseed Treatment equipment and IP. Concure Oncology was born. The team moved the technology to their new offices on Mercer Island, WA.

 

Over the next several years, the Concure team built their quality system, became ISO certified, and created the regulatory and marketing infrastructure to make the Breast Microseed Treatment available to women throughout the U.S.

How Breast Microseed Treatment can change the patient experience

The technology enables placement of tiny radioactive “seeds” in the breast following a lumpectomy. The company’s template grid and the fiducial needle are both part of a patented medical device called the Breast Microseed System. The system enables exact placement of the seeds to achieve the best possible results.

 

The treatment offers women an alternative to enduring weeks of high dose rate radiation therapy following lumpectomy. The Breast Microseed Treatment is delivered in a single procedure that usually takes less than an hour. The treatment boasts an observed local recurrence rate of just 1.2%, and fewer side effects than other treatments.

“Breast Microseed Treatment has the potential to be the treatment of choice for most early stage breast cancer patients.”

– President and CMO Mike Ribaudo.

Watch to see Byron Stuck, Director of Operations, demonstrate the technology.

 

The Market for Microseed

Early stage breast cancer is a huge market. Over 255,000 new cases of breast cancer are expected to be diagnosed in 2017 in America alone. Nearly one-third of these women will initially be candidates for Breast Microseed Treatment.

 

“We don’t have to get a third of the market, that’s just an indication of how big the market is. We can get five percent of the market and be wildly successful for our investors,” CFO Kevin Kelley claims.

 

With a 98 percent patient satisfaction rate, the technology promises to be an exciting option. And with reimbursement comparable to established treatments, microseed is an attractive option for hospitals as well.

 

Concure first commercialized the technology in late 2015, and signed their first contract with Seattle’s Swedish Cancer Institute as their proof of concept site. Since the start of 2017, the company has built a robust pipeline of interested partners. With over 200 procedures to date, the technology is well proven.

 

The Concure Oncology team

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