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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Syndicate Announcement: ECOM Medical

ECOM Medical, Inc. (EMI) is a leader in the development and commercialization of Internal Impedance Cardiography for hemodynamic monitoring, which is a key component in administering Goal Directed Therapy consistent with ERAS practice guidelines.

EMI has developed, market tested, refined, and 510(k) cleared for market the Endotracheal Cardiac Output Monitoring System (ECOM), the first version of EMI’s approach to the development of what it calls “Smarter Anesthesia Devices.” Smarter Anesthesia Devices are capable of monitoring beat-to-beat changes in cardiovascular flow, electrocardiogram, blood oxygen saturation, body temperature and respiration.   

The ECOM is a standard endotracheal tube that has seven sensors printed on the cuff and shaft. Using information obtained from an arterial line placed in the patient’s radial artery, along with Internal Impedance Cardiography, it continuously monitors Cardiac Output (CO), Stroke Volume Variation (SVV) and Systemic Vascular Resistance (SVR).

angelMD had a chance to talk to ECOM Medical CEO Guy Lowery, and learn more about their important work. We hope you enjoy this conversation. If you’d like to know more about this exciting angelMD company, please CLICK HERE to be included in exclusive communications.


Can you tell us more about ECOM?

ECOM, the Endotracheal Cardiac Output Monitor system, was originally developed as an alternative to invasive cardiac output monitoring technologies such as the pulmonary artery catheter (PAC), as well as non-continuous technologies such as transesophageal echocardiography.

The premise behind the development of the product was to create a family of tools designed around standard devices that are used every day in the operating room and intensive care unit. The thinking was to reduce – or eliminate outright – any change in existing clinical practice. We have found this to be one of the greatest obstacles to adoption of new technology.

The existing ECOM product is based on a standard endotracheal tube, which is modified to incorporate a series of sensors that monitor the heart from the body core. The ECOM tube is inserted exactly like a regular tube but provides real-time, beat-to-beat hemodynamic readings within seconds of plugging in the ECOM cable.

The next generation of products being released in the near future will be based on the same premise of turning standard devices into smarter ones that give needed information without changing existing clinical practice.


What is Internal Impedance Cardiography and how accurate is it?

Internal Impedance Cardiography is a way to utilize Ohm’s Law, which relates current, voltage and resistance to extract useful information from the body. A very low-energy electrical field is established inside the patient, and changes in the property of this field caused by blood moving through the aorta are used as the basis of calculating cardiac output and other hemodynamic parameters.

The ECOM Internal Impedance Cardiography approach is in contrast to EXTERNAL bioimpedance platforms that have been around for decades. These early systems were non-invasive (electrodes placed on the chest and neck), but suffered from large signal-to-noise issues, as the aortic flow represents a very small signal within the entire thoracic cavity.

ECOM changes the paradigm by placing the field immediately adjacent to the ascending aorta. Upon intubation using standard techniques, the electrode array sits within millimeters of the heart, and as such is reading from core vasculature. In terms of accuracy, ECOM is statistically equivalent to the invasive gold standard (the PAC).


For those less familiar with ERAS (Enhanced Recovery after Surgery), can you describe the guidelines and explain how your technology improves outcomes?

One of the most significant advancements in anesthesiology in the past decade is the adoption of Enhanced Recovery after Surgery (ERAS) practice guidelines that are designed to improve patient outcomes, reduce patient morbidity and reduce the overall cost of treatment.

These ERAS guidelines are comprised of over 20 perioperative protocols that have been proven to reduce hospital Length Of Stay (LOS), reduce complications, improve patient cardiovascular function, and speed return to normal Active Daily Life (ADL). Key among these ERAS guidelines is the protocol known as “Goal-Directed Therapy” (GDT).

GDT uses key hemodynamic parameters to optimize tissue perfusion by perioperatively managing a patient’s fluid status. This real-time monitoring can reduce surgical complications by up to 50 percent. Clinical studies clearly demonstrate that optimal delivery of oxygen – in other words, tissue perfusion – to vital organs during surgery dramatically decreases complications and mortality while at the same time reducing recovery time and overall hospital costs.

While the concept of using a patient’s fluid status as an indicator of tissue perfusion dates back to the early 1990s, the challenge has been to provide the anesthesiologist with the tools necessary to obtain beat-to-beat hemodynamic information that can be used to actively manage the patient, and then intervene (and monitor the intervention) in real time.

These tools represent a significant departure from the traditional practice of using static parameters of a patient’s fluid responsiveness, such as central venous pressure, pulmonary wedge pressure and urine volume. Utilizing GDT represents a substantive change in the practice of anesthesia over the past 10 years, and the momentum of the past decade is only expected to increase as the clinical benefits dovetail with the concomitant reductions in healthcare costs.

Both the American Society of Anesthesiology and the European Society of Anesthesiology have recently endorsed GDT as part of their Enhanced Recovery After Surgery protocols. While this approach to perioperative care has been widely practiced in Europe since 2002, hospitals throughout the US are only now rapidly adopting ERAS protocols that include GDT because of economic pressures put in motion by changes in Medicare reimbursement (2007) and the Affordable Care Act (2010). These changes are only expected to accelerate as cost-containment pressures increase.


What advantages does the ECOM endotracheal tube offer over its competitors?

ECOM offers several advantages over competitive systems in terms of ease-of-use, robustness of signal and point of measurement.  As pointed out above, we started out with the premise that we wanted a system that was based on existing everyday technology so that we could eliminate the need for special (and repeated) training.

Using ECOM, if a clinician can intubate, they can get beat-to-beat hemodynamic monitoring. All other systems on the market require the setup and operation of specialized equipment and associated training.

These competitive systems also rely on a single input for their data – in some cases it’s arterial waveform analysis, in other cases it’s doppler ultrasound. This renders the system susceptible to changes in vascular tone (the relative “stiffness” of the arterial wall), or positionality of the doppler sensor.

ECOM’s algorithm incorporates input not only from internal impedance, but also from arterial waveform analysis as well as an internal ECG. This fusion algorithm allows ECOM to provide data display regardless of the position of the tube or patient, and makes the ECOM system not susceptible to changes in vascular tone – changes that take place every single time the anesthesiologist administers a vasoactive medication.

This latter point is reinforced by the position of the ECOM electrode array being very close to  the ascending aorta. Our thinking was that if you’re going to be measuring hemodynamic parameters, why would you want to measure from anywhere but right next to the heart?


What other devices are in production and how soon will they be market ready?

We have a number of truly revolutionary products coming down the line later this year, all of which are based on the idea of making “Smarter Anesthesia Devices” from everyday anesthesia products.

These products will be targeted not only into the operating room, but to other areas in the healthcare delivery matrix. We will be glad to discuss these on a confidential basis. In the immediate term, however, we can say that one of the products that is closest to market will be a double-lumen endobronchial tube that will used in thoracic cases such as pneumonectomies, wedge resections and the like. We anticipate having this in 2017 (depending on FDA review).  

This is a product that has been specifically requested by our customer base, and we’re really excited to be making plans for its market release.


What interest in EMI have you had from physicians and industry?

Sales are over twice what they were a year ago, and the trend is continuing upward. That can be attributed to two elements.

First, ERAS has made a lot of difference, because GDT works. It is documented, it is accepted, and it saves hospitals money – and hospitals have to watch every dime. Hospitals are genuinely interested in implementing ERAS protocols, so we’re in the right place at the right time.

Second, we find that we are performing very well against the competition once we enter into head-to-head evaluations. In fact, our strength really comes in the toughest surgical cases in which the patient is being subjected to the most aggressive protocols (vasoactive medications, repositioning, long duration, etc.).

Because internal impedance cardiography is measuring from the immediate vicinity of the ascending aorta, ECOM’s response time is very fast, which allows anesthesiologists to intervene more rapidly in critical situations. As a related side note, we believe that the double-lumen tube will help cement our strength in the toughest cases; thoracic patients are among the most clinically fragile patients in the surgical environment, and there are no good alternatives (in fact, none at all) in the minimally-invasive hemodynamic monitoring space.


How do you think syndicating an investment with angelMD will benefit EMI?

ECOM is entering into a very exciting period in its corporate history. The base technology has been developed, market tested, clinically validated and FDA-cleared. We are now at the stage where a slate of new products is on the immediate horizon.

Partnering with angelMD will allow EMI to release multiple ground-breaking innovations simultaneously. In other words, EMI has the potential to be more than innovative – funding that will be used in final product development and message enhancement will make EMI disruptive.


Tell us about your team and their unique capability in this specific field.

We have assembled a team of veterans, all of whom have spent several years of their career not just developing and launching medical devices, but ECOM itself. We are not spending time bringing each other up to speed, because we’ve spent a long time getting the product to its current state.

There is a real excitement on the team, because we know we’re on the edge of releasing the innovations that our customers have been demanding. Frankly, this is going to be a lot of fun.


What are your current status and goals for the next 12 months?

As I’ve mentioned above, ECOM Medical is in a very dynamic phase of its corporate history, particularly regarding the release of new products. In addition to the double lumen tube, we’re well underway on the development of a new ECOM monitor, along with several products that we can discuss in a different forum.

In addition to the significant focus on R&D, however, EMI is in the midst of transitioning its sales model from one of independent representation to one of regional and national dealers. We are also planning for an international rollout pending regulatory clearance of several of the new products that are nearing launch.

We have the right team in place, and the right products in the pipeline to make some serious progress in the next 12 months.


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9 Questions with Clario, the Smart Worklist for Radiology

Clario is a Seattle-based company that has produced a smart Radiology worklist management, in use daily by more than 1400 Radiologists around the country.  angelMD sat down with Clario CEO, Chris Wood, to discuss his company’s successes and challenges.

angelMD is opening investment for Clario syndicate. If you’re an angelMD member interested in learning more about Clario, please follow them on angelMD and visit this link to request more information.

What is the typical workflow for the average radiologist who is not using an enterprise worklist solution?

This is a highly inefficient and distracting process. Many radiologists log in and out of several systems (called PACS) all day, checking for exams. Each PACS has several worklists that a radiologist may be responsible for. Within each list, there may be dozens of exams that need to be read. The radiologist will look through the lists and manually find the exams they should be reading next, oftentimes having to pick through subspecialty exams outside their area of expertise.

What makes your worklist “smart” and how does that improve efficiency and quality of radiology interpretations?

Our system knows about all the exams in the enterprise, so we completely eliminate the need to look through multiple systems. Then, we automatically create a prioritized stack of exams for the radiologist to read. To determine the priority, we incorporate each radiologist’s subspecialty, their shift, how quickly they read certain exams, and the practice Service Level Agreements.

When radiologists are not distracted by bouncing between systems and modalities (CT, MR, Ultrasound, etc.) they are more efficient, and the quality of their work product improves. We also optimize subspecialty reading percentages. Subspecialty exams read by a radiologist fellowship trained in the area are not only read more quickly but at a higher level of quality.

How do you plan on incorporating AI and machine learning into the product?

Our system currently uses a manually configured rule set to determine what is in each radiologist’s queue and the order of the exams to be read. Over the years, our rule sets have become extremely complex because we have continued to uncover things that can optimize efficiency.

For example, we have found that some radiologists will read an MRI up to 20% faster if the exam they just finished reading was also an MRI. With AI, we will be able to optimize each radiologist’s queue individually, and can consider many more variables. The system will “learn” how to tailor the queue to optimize their efficiency. Because we have peer review data (a surrogate for quality) we can also drive up the quality of reports each radiologist creates.

Through partnerships with other companies we will also use AI to escalate exam priority based upon the computer’s “first look” at the actual images. If AI uncovers a potential critical result, we will escalate this exam to the top of the list. The radiologist will not know that anything has changed, but they will be producing more work at a higher quality. They will feel less stress, and will make more money by reading more exams while providing a higher level of patient care.

Can you elaborate on your subscription-based revenue model, and retention numbers?

Calculating the amount of revenue generated by customers in 2016 and comparing it to the revenue generated by those same customers in 2015 our revenue retention is 116%. This is because our customers are growing and purchasing more licenses each year.

What is your market share and who are your major competitors? 

We process about 1.3 million exams per month through our system. That gives us about 3% of all the exams in the USA. Our biggest competitor was Medicalis which was just purchased by Siemens. Primordial is also a competitor, but they tend to focus on custom solutions.

To grow, we will continue to sell directly to private practices (50% of the total market), and anticipate hiring sales representatives toward the end of 2017. Lexmark and Mach7 are our distributors to health systems. They can couple our products with theirs and present a complete solution to a health system (which is how they like to buy).

Tell us about yourself and what led you to start Clario.

I am a medical physicist who did imaging research in a cancer center in grad school in the late 1980’s. We were funded by NASA and I applied satellite image processing technology (including AI) to MRI images. This got me into software and medical imaging at a time when radiology was still almost entirely film based.

After graduating, I worked in large radiology companies (Picker and Siemens) writing 3D visualization software and managing software teams. I then co-founded a Computer Aided Detection company (Confirma) which received the first FDA clearance for Breast MR cancer detection. This company was sold to Merge Healthcare.

In 2008 I started Clario because I realized how inefficient workflow became when we switched from film to PACS. In the days of film, the workflow was optimized by people who handed out films. With radiologists reading from lists, and trying to figure out what to read, they were wasting a great deal of time. I ran the idea by some radiologist friends and their response was universal. Now was the time to fix this!

What makes your team unique?

All of the senior managers (as well as many of the employees) worked with me at Confirma, each having over 10 years experience in radiology software solutions.. I also had 75 engineers reporting to me at Siemens in Seattle so I have a fairly deep bench of talent I can draw from. It also does not hurt to be in Seattle and across the street from Amazon. There is a lot of technical talent in Seattle, and we have more than enough domain expertise.

Are there any specific pitfalls that concern you?

We fight health care inertia every day. Radiology departments are currently getting the job done, but they are inefficient, so they do not have much time to look at new technology. It is our job to educate them about how we can make them function better.

We have learned that the best way to combat this inertia is showing them what other practices have done. This is of great interest to a radiology group. Luckily for us, our customers love to tell the story of how they made their business more efficient with Clario. All of our customers are reference sites for us, and several will host visits by potential Clario customers.

Where do you see Clario in 12-18 months? 

We have over $2M in recurring revenue currently, and will add at least $1.5M in recurring revenue in the next 18 months. Our investment in AI will help us generate excitement around our product and build our sales pipline to over $12M in recurring revenue.

We will sell the company when we have several million in free cash flow. At that time, we will talk to all the strategics (such as GE, Nuance and our distributors) but we do not want to rely on them. Company valuations in Health IT are quite high, so we will have the option of selling to private equity to return capital to our investors.

angelMD is pleased to announce a new syndicate for investment in Clario. If you are considering joining this exciting angelMD syndicate, please follow Clario on angelMD and visit this link to request more information.

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Announcing a New Open Syndicate for Otomagnetics

angelMD is pleased to announce that we are opening a syndicate for investment in Otomagnetics, a startup developing an innovative, non-invasive magnetic delivery system for drugs and other therapeutic payloads. If you’re interested in learning more about Otomagnetics, please visit our info form to request more information.

Otomagnetics is a spin-out startup from the University of Maryland at College Park. Their team has developed a magnetic field-generating small device that works with proprietary nano-particle formulation to carry drugs, proteins, or genes. The effect of the localized magnetic field on the nano-particles allows therapeutics to be carried across tissue barriers, and allows delivery to hard-to-reach targets in the body that would otherwise require needles or surgery.

angelMD had a chance to talk to Otomagnetics’ CEO, Dr. Benjamin Shapiro, and learn more about their important work. We hope you enjoy this conversation. If you would like to know more about this innovative angelMD company, please click on this link to be included in exclusive communications.

1. How did you develop the idea to use magnets and magnetized particles as a drug delivery platform?

We got a phone call from an otolaryngology group that was interested in effective but non-invasive drug delivery to the cochlea. This group had found us based on our work in magnetic drug delivery. They were envisioning a large and complex magnetic instrument that would pull particles into the cochlea from the opposite side of the head. Instead, we were able to design a device that pushed (injected) instead of pulled, which allowed the device to be small, simple, and effective. The device was patented, built, and tested first in the lab, and then in animals (and now also in human cadavers). Hence we started as an ear company to fill an unmet drug delivery need.

The same novel magnetic push concept (till then, all other magnetic delivery systems could only pull) has also shown it can deliver therapy into the eye and through the skin, without needles. The system is therefore now also being developed for vision and dermatology.

2. Do you consider Otomagnetics a device or pharma company?

We consider Otomagnetics a biotech company. We have a platform technology. Our delivery system acts like a syringe, but the needle has been replaced by magnetic forces acting on bio-compatible nano-particles that can carry drugs, proteins, or gene therapy. We can reach targets that cannot be reached by current standards-of-care, or that would otherwise require an invasive surgery to reach.

3. Your first target customer is prevention and treatment of sudden hearing loss. How does your approach improve on current therapies?

Current administration methods do not effectively reach the cochlea, and therefore do not treat sudden hearing loss effectively. For oral administration, less than 1 out of 10,000,000 drug molecules reach the cochlea; for trans-tympanic administration, the number is less than 1 out of 40,000 [Juhn, 2001; Inamura & Salt, 1992; Bird, 2007].

We deliver therapy 1,000x more efficiently to the cochlea and have shown we can restore hearing, suppress tinnitus, and prevent hearing loss due to chemotherapy regimens in recognized animal models.

4. What other applications are there for your therapeutic delivery system and what advantages will you offer in those markets?

In addition to treating the cochlea, we can magnetically deliver into the middle ear without needles or surgery. In animal studies, we have shown we can clear middle ear infections. (Chronic and recurrent middle ear infections/inflammations are currently treated by surgical insertion of tubes through the ear drum, the most common pediatric surgery in the US.) For macular degeneration and other eye conditions, we can delivery therapy without needle insertions into the eye.

Animal studies have also shown magnetic forces can deliver therapy through the skin, which enables improved drug delivery to burns, wounds, or diabetic ulcers.

Otomagnetics Magnetic Injection Technology

Learn about Otomagnetics' innovative magnetic injection technology.

5. What third-party validation have you received from the scientific community?

The technology was developed in response to a clinical need articulated by otolaryngologists, a need that is well recognized in the field. Clinicians at Johns Hopkins, Children’s National Medical Center, Sunnybrook Health Sciences Center, and the University of Nottingham have reached out to us, and have initiated projects with our group. In England, the Action of Hearing Loss supports and has helped fund our research and efforts.

6. What interest in Otomagnetics have you had from industry?

Angel investors at Keiretsu envision Otomagnetics as a Star Trek technology, a technology of the future. They are currently in the due-diligence phase and we expect them to conclude their process in next few months. Two pharmaceutical companies are already interested in our magnetic delivery because they recognize it could enable them to deliver their therapeutic compounds safely and effectively to new targets, and we are in discussions with additional companies.

7. How do you think syndicating an investment with AngelMD will benefit Otomagnetics?

Our interest in AngelMD is the access to clinical expertise that it will provide. We started as a company that was motivated by a clinical need in otolaryngology (we were not a technological hammer looking for nails, instead we developed the magnetic injection technology to address a pressing and unmet need). Now that the system has also shown utility for delivering therapy magnetically into eyes and through the skin, without needles or surgery, we would welcome the opportunity to collaborate with clinicians to expand our technology to additional applications and clinical needs.

8. Tell us about your team and their unique capability in this specific field?

Dr. Benjamin Shapiro, PhD, CEO is an expert in magnetic drug targeting, nano-therapy, lab-on-chip/microfluidics. He is a Fulbright scholar, the inventor of the magnetic injection technology, and is currently responsible for the operations for Otomagnetics. He has helped raise over $6M in non-dilutive grant funding for the effort thus far.

Mr. Ting Pau Oei, MBA, Chairman of the Board, has extensive operating and investing experience in the healthcare industry. He has been a venture capital partner in both a corporate strategic venture capital firm and in an independent venture capital partnership. He was a Vice President of Johnson & Johnson Development Corporation, J&J’s venture capital arm. He has invested in over 50 life sciences, medical device and healthcare information technology companies and served on the board of over 25 of these portfolio companies.

Ms. Abhita Batra, MS, MBA, Chief Business Officer, is the Founder and Managing Director of Advanced Biopharma Consulting (ABC), a strategic advisory firm that offers business development and commercialization services to life science companies. She is co-owner of Admac Group of Companies, wherein she managed a product portfolio encompassing 150 generics. She is a co-founder and former COO of Navya, a biotechnology company developing and commercializing PHF for destruction of solid tumors. Abhita completed her Global MBA at UCLA Anderson and NUS, and has a Masters in Biotechnology with specialization in Pharmaceutical Sciences from University of Pennsylvania.

We have expert regulatory advisors, including a former FDA Branch Chief and a former Vice President of R&D at AMAG Pharmaceuticals who previously took two iron-oxide (magnetic) nano-particles through FDA regulatory approval and to market for millions of patients.

9. What are your key company goals for the next 12 months?

Complete FDA-mandated large and small animal safety studies to enable entry into human clinical trials.

angelMD is pleased to announce a new syndicate for investment in Otomagnetics. If you are considering joining this exciting angelMD syndicate, please visit this link to request more information.

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