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.

Continue reading

Blockchain in Healthcare

If you’ve been keeping up to date on tech over the past few years you’ve probably heard of the complicated system that is blockchain. Blockchain is a new way to structure data that’s been gaining attention everywhere from the technology sector to finance. Nearly every bank is currently undergoing research on blockchain and it is expected that 15% of banks will be using blockchain by the end of 2017.

 

In order to gain an understanding of the blockchain, we should first start by looking at Bitcoin. Bitcoin is the well-publicized cryptocurrency that acted as the first decentralized currency, and it is often heralded as the first public implementation of blockchain. Bitcoin does not operate under a single administrator and instead uses peer-to-peer transactions that process without an intermediary such as a bank.

 

These transactions are verified by network nodes through mining, a process of mathematical verification done by computers that can be done by everyone from individuals to full-fledged Bitcoin mining companies. As a reward for the computing work done in transaction verification, miners are rewarded with newly created bitcoins. In this way, mining is the process in which the supply of bitcoin is controlled.

 

Bitcoin does not have a central authority to distribute currency like traditional currencies do (such as how the dollar is controlled through the federal reserve). Instead, this mining process holds bitcoin steady by fluctuating the payout to match the supply of miners.

 

Blockchain came as a result of the realization that the foundation of bitcoin had application in other realms. Blockchain is powerful in its ability to share ledgers of information without giving any single party the ability to manipulate the information.

How it all works

There are three components of blockchain:

  1. A network of computers
  2. A network of protocol
  3. A consensus mechanism to validate transactions

Together, these pieces allow blockchain to provide a transparent, secure record of transactions. In retail, for example, this can be used to track a product through its lifecycle across different distributors and manufacturers. In the financial world it can be used to track the ownership of assets. The application is widespread and blockchain is positioned to make a major impact on healthcare.

Blockchain in Healthcare

Healthcare record keeping is incredibly outdated. For many hospitals and practices, patient files are still kept as hard copies. Blockchain could open the door for patient records to be transferred between physicians without being managed by a central entity. Blockchain transactions are logged publicly and in chronological order. The database containing these patient records in the form of blocks is secure in that no block can be changed or deleted. Credentialed users will be able to distribute and share information across layers with only the ability to view and add to the transaction log.

 

Blockchain also brings with it a heightened level of security. An estimated of 5-10% of healthcare costs are fraudulent. An estimated $60B worth of Medicare fraud was incurred in the 2015 in the US alone. By creating a system that more efficiently evaluates transactions, these fraudulent costs can be minimized.

 

Costs can also be reduced through the elimination of the administrative middle-man. By cutting down on the costs once incurred to verify transactions and by making that process more effective, blockchain can reduce a significant portion of healthcare’s administrative costs.

 

Healthcare companies will be also be able to create security through creating private chains that will run between specific organizations with binding legal and regulatory agreements. For example, this type of system would allow only the approved users to access sensitive health records.

 

Blockchain has the potential to both normalize and modernize health records and over 35% of health and life science respondents to a Deloitte questionnaire say they plan to implement blockchain within the next year.

Continue reading

Building a Safer Digital Health Landscape

Our lives have been going digital since the invention of computers. But even as we enjoy the conveniences that can come with these advances, we are opening doors to threats that never existed before. While hackers might not be interested in your smart refrigerator, they are absolutely interested in breaching the digital systems that we use in every aspect of our lives.

 

As you’ve no doubt seen, healthcare is especially susceptible to issues related to security. While there are regulations and technology in place to protect this digital infrastructure, hackers are always adapting. It’s therefore critical that the companies in charge of protecting and providing this data stay ahead of their nefarious competition.

Modern Threats

The latest large-scale attack on the healthcare industry occurred when a virus, masked as ransomware, found its way from Eastern Europe all the way to the United States. On the surface, this new virus appeared like the ransomware named “Petya” from 2016 which locked users out of their systems unless they paid a “ransom” to the hacker. Instead, the new virus nicknamed “NotPetya” infiltrated and destroyed files and functionalities.

 

Companies like Nuance Communications, which stores and transmits both patient and insurance data, were deeply affected by the virus. Rather than helping providers via its Dragon Medical Advisor and Radiology Critical Test Results products, Nuance instead found sensitive information destroyed.

The First Step to Safer Data

Although legislation like HIPAA and HITRUST serve to provide standards for data security, it’s clear by the Nuance attack that legislation alone can only go so far. Practitioners, and the companies that serve them, must also do their part.

 

The biggest and easiest step to take right now is cooperation, which involves two parts:
The sharing of threat indicators and sound practices will help ensure that the industry can merge its efforts to keep data secure. The National Health Information Sharing and Analysis Center (NH-ISAC) is an example of a forum that already exists for this exact purpose. The more companies that join the forum, the more information and brain-power there is to prevent or mitigate cyberattacks in the future.

 

The second part of cooperation involves outsourcing. It can be hard for CEOs to let a third party control part of their operation, but when it comes to things as complex as cybersecurity, often times someone else can do it better. There are numerous companies that specialize in cloud-based healthcare data management and security. Their commitment to security allows them to focus their efforts on protecting against threats.

Outsourcing: Galen Data

Many companies have joined in on the movement toward a secure medical world including angelMD startup Galen Data. Galen provides custom, compliant, and affordable cloud storage for small to medium sized companies. Galen is able to make storage systems faster than competitors while upholding safety compliance because the infrastructure is existing and tested. After customizing the system, Galen can focus efforts on maintaining, monitoring, and updating it for the customer.

 

According to Galen Data’s CEO Alex Condon, the healthcare data security field has two major issues that can lead to breaches. The first issue is that smaller companies simply don’t know the best practices, which is why it is beneficial to outsource. The other issue is that data is shared a lot in healthcare, which makes it subject to phishing or ransomware attacks on the individual level. Alex claims that, to minimize this potential threat, companies have to limit the amount of people who have access to certain data.

The Future of Data Security

While many companies like Galen Data are taking the right steps, the industry must always be looking for new ways to stay ahead of the curve. Right now, we can do what Abbott’s Executive VP of Medical Devices Robert Ford calls for: create an industry standard that protects data while still leaving room for innovation. Ford acknowledges the fact that this will not get done by government, so it will fall on the healthcare industry to make and follow its own standards. Abbott released what they are doing in this report to help guide the conversation.

 

In the long term, there are more complex solutions for data security that need to be kept in mind. Healthcare IT News ran an interview with Robert LaMagna-Reiter, Senior Director of Information Security at First National Technology Solutions, where he discusses the possible use of AI and machine learning in data security. AI systems could self-monitor, self-heal, and with the ability to predict threats, could prevent attacks from ever happening.

 

It is important to understand that cyber threats are real today, and working together is the best way to create a safer digital health field. This includes forums like the NH-ISAC and in bringing innovations to the field like AI, machine learning, and quantum computing. The more minds that we have working together, the safer healthcare data will be in the years to come.

Continue reading

Science behind the Startup: Pro-Arc Diagnostics

As Michelle Faits discussed earlier in an angelMD #StartupSpotlight, Pro-Arc Diagnostics makes a blood test to detect mutated forms of the JC virus (JCV) which may increase one’s risk of developing Progressive Multifocal Leukoencephalopathy (PML), an often fatal disease.

What is PML?

Approximately 75-80% of humans are infected by the JC virus, a polyomavirus which is asymptomatic following primary infection and often occurs during early childhood. [1],[2] Although a definitive route of transmission is not known, it is likely that JCV spreads via a respiratory route or a urine or fecal to oral route as 20-40% of the population can periodically excrete JCV in their urine and JCV can be found in untreated wastewater. [1,2,3,4]

 

In healthy individuals, JCV infects kidney epithelial cells and bone marrow-derived cells where it likely establishes either low-level persistent infections or latent infections due to inefficient viral replication in those cell types. [2],[3]

 

In immunosuppressed individuals, certain strains of JCV can migrate to the central nervous system (CNS) and infect oligodendrocytes and astrocytes where the virus can robustly replicate. [2],[3] Changes to the noncoding control region (NCCR) and to the sequence encoding capsid protein VP1 of the JCV genome can allow JCV to become neurovirulent. [5] However, these mutations’ exact roles in developing PML is not completely understood, [3] and while DNA mutations in JCV may be a necessary feature of PML, they may not be sufficient to induce PML. [5]

 

In the CNS, JCV targets oligodendrocytes, the glial cells primarily responsible for myelinating axons in the white matter, for lytic infection leading to the progressive, often fatal demyelinating disease PML.[1] In addition to demyelination in the white matter, PML can also comprise demyelination of other CNS regions including the brainstem and cerebellum. Between 35-45% of PML patients will exhibit a visual deficit, approximately 33% of patients will exhibit a mental deficit, and 25-33% of patients will experience motor weakness.[1]

PML Incidence

The incidence of PML was considered low (0.07%) prior to the AIDS epidemic, but affected 7-10% of HIV-1+ patients before the introduction of highly active antiretroviral therapies (HAART). After HAART was introduced, the incidence decreased to between 3-5%, and combined antiretroviral therapy (cART) decreased the incidence even further to approximately 0.13-0.33% in HIV-1+ patients. [1],[4]

 

Patients with autoimmune diseases such as multiple sclerosis and Crohn’s disease who were treated with certain monoclonal antibodies have also developed PML. In known cases in which PML was caused by immunosuppressive therapies, the incidence of the diseases is less than 0.13%, [5] although reported incidence rates can reach 1.0% depending on the length of immunosuppressive treatment. [2]

 

As Michelle Faits shared in the Pro-Arc Startup Spotlight, “patients with diseases like MS kept telling us they would take better medications if only there was a way to know if they’d be safe from the PML side effect.” For this reason, Pro-Arc is developing blood tests to identify not simply whether or not a patient is infected with JCV, but whether they are infected with a mutated form of JCV that is associated with PML.

 

Sources:

 

  1. Saribas, A. S., Ozdemir, A., Lam, C. & Safak, M. JC virus-induced Progressive Multifocal Leukoencephalopathy. Future Virol. (2010).
  2. Ferenczy, M. W. et al. Molecular biology, epidemiology, and pathogenesis of progressive multifocal leukoencephalopathy, the JC virus-induced demyelinating disease of the human brain. Clin. Microbiol. Rev. (2012).
  3. Maginnis, M. S. et al. Progressive multifocal leukoencephalopathy-associated mutations in the JC polyomavirus capsid disrupt lactoseries tetrasaccharide c binding. MBio (2013).
  4. Beltrami, S. & Gordon, J. Immune surveillance and response to JC virus infection and PML. J. Neurovirol. (2014).
  5. Johnson, E. M., Wortman, M. J., Dagdanova, A. V, Lundberg, P. S. & Daniel, D. C. Polyomavirus JC in the context of immunosuppression: a series of adaptive, DNA replication-driven recombination events in the development of progressive multifocal leukoencephalopathy. Clin. Dev. Immunol. (2013).
Continue reading

The Orthopedic Surgeon’s Hammer

“The internist has the stethoscope, but the orthopedist has the hammer.” This is a medical mantra heard throughout many medical training institutions.

As funny as it may sound, it is true, within an orthopedic surgeon’s DNA lies the ability to build things or put things back together. It should come as no surprise that when something is broken, we want to fix it. This may be why we see a large number of orthopedic surgeon entrepreneurs and developers in the innovation space.

A Decade of Orthopedic Innovation

There have been many reasons for orthopedic innovation over the past 10 years, but none has driven the orthopedic surgeon more than the desire to be less invasive with a quicker return to function. This has led to dramatic improvements in technique and pain control allowing same day partial and total joint arthroplasty which is likely to become the norm within the next five years.

 

The incorporation of adductor nerve blocks combined with pericapsular anesthetic infiltration has allowed faster mobility and better pain control after total knee arthroplasty, permitting many patients to go home that same day. This particular advancement has saved hospitals and payers countless dollars and produces better patient outcomes, decreasing a 7 to 10-day hospital stay to a same-day discharge or at most a 23-hour stay.

 

The drive towards minimally invasive procedures has also heralded the movement towards minimally invasive diagnostics. In-office ultrasound for diagnostic and interventional purposes has increased dramatically over the past 10 years.

 

During that period of time, ultrasound technology has improved so much that a cordless office device that connects to an iPad now costs half of what a larger fixed unit would cost and provides a clearer picture that can actually show blood flow or a healing response at a tissue repair site or a broken bone.

 

These portable devices can be used in the office, on the sidelines, or in the emergency room making it very convenient for orthopedic surgeons to make a quick diagnosis without an MRI (essentially saving the patient and the payers money and time). Many surgeons now implement the use of ultrasound in addition to the use of biologics for tissue healing and regeneration.

 

Another big advancement came in the field of biologics. In 2012, Drs. Grudon and Yamanaka won the Nobel Prize in Physiology/Medicine for demonstrating that mature adult cells can be reprogrammed into immature pluripotent stem cells.

 

It is only a matter of time before these cells can be manipulated into progenitor cells of the central nervous system or articular cartilage possibly reversing or improving the effects of spinal cord injury and osteoarthritis. These progenitor cells could be used to augment tissue repair sites in ACL and rotator cuff surgery or used to create a biologic scaffold for tissue ingrowth in meniscus repair or cartilage growth.

 

The Future of Orthopedics

3D printing is another technology that is being tested in orthopedic surgery for its potential in custom joint replacement surgery, custom patient specific fracture fixation, or cartilage and bone transplant. 3D printing in conjunction with biologic scaffolding will eventually lead to a revolutionary biologic joint replacement option in the near future.

 

There has also been a great interest in the use of robotics in orthopedic surgery, creating more accurate implant placement by customizing the configured bone cuts that are made during surgery. Like many of these other technologies, we are still in the data-collection phase regarding this specific technology regarding the economics. However, early results have shown favorable outcomes and more accurate implant placement.

 

The flurry of new technologies are exciting and very promising, however the biggest challenge we currently face is the adoption of many of these technologies by the payers. Innovation and insurance coverage almost have an inverse relationship so even though there may be a cost savings and better outcomes in the long run, many payers will not likely cover these treatment options for another 10-15 years.

 

The future of orthopedic surgery and innovation is promising but patient demand and physician involvement/entrepreneurship will be needed to drive many of these products to market therefore it is key that physicians get involved and continue to advance innovation on behalf of their patients.


Find out about companies making exciting innovations at angelMD.

Continue reading