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Sanovas Takes on Lung Cancer with a Suite of New Technologies - Part 1 of 2

Published: May 3, 2012, on mddionline.com by Brian Buntz
 
Among the technologies the firm has developed what it hails the world’s smallest endoscopic steerable camera.

Sanovas (Sausalito, CA) is a company founded on bold ambition. “Only so often in life does the opportunity to leave a footprint on the legacy of mankind come along,” reads a quote in the company’s shareholder’s report from the first quarter of 2012. And the firm takes those words seriously, having collaborated for years with interventional pulmonologists, to give hope to patients suffering from chronic lung diseases such as lung cancer and chronic obstructive pulmonary disorder (COPD). Lung cancer is the deadliest all cancers. In the United States, it claims the lives of nearly 400,000 people annually, according to the American Lung Association. COPD is the third leading cause of death in the country.

Larry Gerrans, CEO of Sanovas
Larry Gerrans, CEO of Sanovas holds a prototype of one of the firm's products with a model of an artery.

Treating pulmonary diseases in general and lung cancer in particular, however, has remained daunting for surgeons, partly because the spaces within the lung are difficult to access. Complicating matters further is the fact that, unlike the heart, the lungs must continue to function during surgery. Managing the airways has also remained difficult, which makes interventional pulmonary procedures inherently risky.

The company realized that to significantly advance patient care in this field, they would need to develop a suite of technologies. “Interventional pulmonologists need not just a new tool, but a new tool belt,” explains Larry Gerrans, the company’s president and CEO, who cofounded the company with CTO Erhan Gunday. “Over the last couple of years, we have reached out to some of the best minds across the interventional pulmonary science to assess their skills, their capabilities, their comforts, and their concerns,” Gerrans says. The two men used the resulting input to develop a comprehensive portfolio of technologies. The firm, which has more than 25 international patents pending, plans to begin commercializing the first of its product portfolio this year.

One of the things the two men recognized was that interventional pulmonologists lacked sufficient access to the pulmonary anatomy, Gerrans says. “The technology had not been miniaturized enough to get to the places in the lungs to access, image, diagnose, to remove obstructions, and treat cancer and pulmonary diseases locally.”

“We can achieve hemostasis without the use of thermal ablative technologies... It is kind of an organic approach and we have found that it is a very efficacious and safe way to remove obstructions.”

To fill that need, the company developed what it calls the world’s smallest endoscopic steerable camera. It also developed a novel transbronchial needle aspiration technology for detecting disease in the lymph nodes and to diagnose the pathology that is found in the lungs. Once a pathology is found, it inevitably creates some type of obstruction. “We have created some very novel technologies to remove those obstructions,” Gerrans says.

Traditionally, removing such obstructions has been a challenge. Endobronchial neoplasms and fibrotic lesions are difficult to access and manage. The anatomy in the lungs is highly vascular. Consequently, removing tissue is dangerous because of the risk of excessive bleeding.

There are other risks, as well. “A lot of doctors venture in with electrosurgical-type tools, like laser and Argon-beam devices and whatnot. The smoke plume that gets created from electrocautery and thermal ablative technologies creates a vaporous discharge that could result in embolism and a stroke and even death,” Gerrans says. “And so we created a nonthermal re-cannulization technology that manages the airway.”

One of the main focal points of the firm’s technology is its ability to manage the airway and control bleeding. “We can achieve hemostasis without the use of thermal ablative technologies to mitigate the risk of embolism and stroke,” Gerrans says. “It is kind of an organic approach and we have found that it is a very efficacious and safe way to remove obstructions.”

lung cancer
The lungs are the last frontier of innovation in the interventional sciences as a result of their inability to be turned off during surgery and the lack of safe, efficacious technologies to manage the airways, which creates a high procedural risk.

A 'One and Done' Approach to Diagnostics

Sanovas developed a proprietary biopsy system to obtain tissue samples for diagnostics, which differs from other similar products on the market in that it uses a pressure vacuum actuated system. The device allows a surgeon to go into the pathology and suck the target tissue into a biopsy forcep. “The reason that is important is because a lot of times with current transbronchial needle aspiration procedures, they use a 21-gauge needle and make multiple passes into the tissue, to acquire a large cell sample, causing trauma ,” Gerrans says. “When you insert it, it effectively goes through the mucosa, into the bronchus, and then into the lymph node.” Consequently, the amount of target tissue in the sample is limited.

“When you look at personalized medicine companies, their capacity to deliver immunologically morphed genes and drugs is limited by the physician's ability to obtain a quantitative analysis of immunology.” At present, obtaining sufficient immunologic cell samples from the target tissue is a difficult and imprecise process can cause trauma to the patient. “So our focus is to create something of a one and done approach to the diagnostic. Our device is almost like a liposuction type thing. It sucks the tissue in and seals the chamber. The physician then pulls it out, breaks of the hermetically sealed capsule, puts it in a specimen jar and then sends it off to pathology hermetically sealed,” Gerrans says. “In the end, you have got a very robust, large volume cell sample for diagnosis.”

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Sanovas Takes on Lung Cancer with a Suite of New Technologies - Part 2 of 2

Published: May 4, 2012 on mddionline.com

Enabling the Patient to Breathe

To make the process of intervention in the airway easier for surgeons, Sanovas identified the importance of ‘shaping the operative space’ in the airway. The company’s Vas Zeppelin clear vessel technology prevents the inhalation of blood and cellular debris, allowing the patient to breathe throughout the procedure.

The technology works to manage the airway by, firstly, providing a distal blockade when necessary that prevents the translocation of cells and fluid to prevent diaphragmatic spasm. Secondly, its technology can be used to put a cannulation through the middle that allows the aspiration and inspiration of the patient so that any debris or fluids that had been stuck can be removed. Doing this helps maximize the inhalation expiration volume, permit the aspiration of the distal airway and restore the vitality to the organ while surgeons are operating on it.

“This effectively takes the surgeons off of the clock, so to speak, allowing them to work in a very calm and controlled environment,” Gerrans says. “We have patented this and as far as the airway management approach goes, we have a very sophisticated approach that helps the doctor manage the airway. We often overlook that, but it has been brought to my attention by a number of clinicians who we speak to.”

Traditionally, the fact that patients must continue to breathe throughout interventional procedures can pose challenges for surgeons. Tumors in the lungs are highly vascular and bleed when violated. When this happens, as a patient breathes in, blood floods into the distal airway. During expiration, blood can hit the camera, which requires it to be removed, wiped off, and repositioned within the lungs. “Under these conditions, the patient can go into a diaphragmatic spasm in a very short period of time, which is the body’s primal response to the recognition that it is suffocating under the duress of the inhalation of this debris and fluid,” Gerrans says. “Then they go into an involuntary bronchial contraction, tracheal stricture, and they start to come off the table, expectorating their fluid and blood. It is traumatic—for the patient and the doctor and staff.”

The Vas Zeppelin catheter-based microsurgery system was designed to meet unmet needs within interventional pulmonary science.

Taking Interventional Technology to the Next Level

Sanovas has observed that there have been a number of companies that have tried but failed to introduce interventional technologies. Among the reasons why is that their products did not provide surgeons with a real-time understanding of the physiology or the affect their tools had on it.

The company's PhysioSense physiologic metric acquisition system and biofeedback technology seek to fill that need. “This is a huge part of some of the advances we are trying to make on behalf of interventional technology in general,” Gerrans says. In order for interventional technologies to be useful, they need to be developed with a sufficient understanding of the environment in which they are meant to be deployed. This has historically been difficult within the lungs because many doctors lacked basic information about the environment that they are operating in.”

“If you don’t have an intuitive command of the operating environment, you are inevitably going to do harm to it and it is going to lead to a poor outcome.”

The PhysioSense technology enables surgeons to understand the physiologic characteristics of the environment they are working in and the dimensional characteristics within it: the diameter, the dimensional shape, the modulus of elasticity of the vessel of the wall, and so forth.

For interventional pulmonologists, this has been especially challenging. “What their expectation of a vessel’s integrity is, in any given case, could be different because diseased anatomy is different in every patient,” Gerrans says. “If you don’t have an intuitive command of the operating environment, you are inevitably going to do harm to it and it is going to lead to a poor outcome.”

So, Sanovas sought to create new tools that will give doctors a fundamental understanding of the anatomy and afford them an intuitive command of the operative site. This technology lets the surgeon know whether the tumor has the consistency of a marshmallow or a marble. Determining the modulus of elasticity of the vessel walls and pathology enables physicians to understand the integrity of the environment he or she is working in. “That can provide these doctors with real-time feedback—physiological analytics and biofeedback to help them make better intraoperative decisions and helps them use greater levels of care with respect to the mechanical or translational force that they use,” Gerrans says. The PhysioSense takes these measurements and renders the anatomy in a 3-D image on a monitor. “It accurately recreates the anatomy, recreates the pathology, and gives surgeons a real-time image that changes in milliseconds,” he adds.

Targeting the Pathology

After the PhysioSense technology has provided the modulus of elasticity of the native geometric lumen area, the surgeon can target the region where the pathology resides. “We then start to put these algorithms together that manage the concentric force and pulsation of that dilatation balloon so that we can apply the appropriate amount of dilatation force without creating too much concentric force that would lead to a perforation or any other deleterious effect.” This iteratively breaks down the tumor and sequentially dilates the obstruction and then removes it. “By creating this chamber, we then can localize therapy enabling technologies and the delivery of drug and immune therapies,” Gerrans says, “We can put them in there, we can manage the bleeding, the environment is contained, we’ve shaped the operative space so that the physicians can operate with relative comfort and assuredness.”

The PhysioSense provides feedback to surgeons so that they can get a feel of the anatomy, enabling them to, for instance, determine the modulus of elasticity of the vessel wall.

The fact that the chamber enables the focal delivery of therapeutic agents is key in that it represents the shift from a palliative approach to care to a curative approach. “In the past, the basic approach to care was just palliation,” Gerrans says. “The tools and techniques to really help these patients haven’t existed up until now. So that is the fundamental reason why 85% of the patients that get diagnosed with lung cancer are dead in five years.”

Sanovas worked with interventional pulmonologists to develop a curative approach to care, which involves removing the submucosal tumors that reside outside of the airway. To develop this technology, the company did a deep dive on evaluating a number of drug-delivery methods to bring local delivery of high-dose, high-concentration drugs to the submucosal, submural tumors that reside outside of the tubular anatomy. The drugs can then kill the tumor locally before it goes metastatic.

The company is exploring the use of a number of drugs cleared by FDA through the 60s, 70s, 80s, and 90s. “These are drugs that were extracted from the chemical and biological warfare assets of our military and others,” Gerrans says. “They were harnessed by the pharmaceutical industry for their oncological promise.” As it turns out, however, these drugs were found to be overly cytotoxic or too cardiotoxic to deliver systemically. “They work so effectively that you might have killed the cancer but you have killed the patient in the process,” Gerrans says. Even though they were FDA cleared, they had fallen out of favor and subsequently fell off patent. “As part of our drug delivery patents, we’ve taken a number of these drugs and put them back on patent and are endeavored in taking them off of the shelf and are evaluating new purposes for them in the forms of high-dosage local delivery in vivo using our proprietary drug-delivery methods.”

The company’s Vas Zeppelin can be used to deploy drugs as well as immune therapies within a controlled environment. The drug or therapeutic agents are energized into the tumor as the chamber is pressurized to create an osmotic effect that impregnates the tumor. These agents can destroy the tumor independently or they can be used in conjunction with radiation treatment.

Dealing with Tumor Hypoxia

Another consideration that makes lung tumors difficult to treat is that they are sometimes hypoxic, lacking oxygen at the molecular level. This fact makes radiation therapy difficult because oxygen facilitates the transfer of radiation to the nucleus of the cell to destroy DNA to ultimately kill the cell. “If you don’t have oxygen within the tumor, there is nothing to facilitate the transfer of the electron beam, so it passes through the tumor and inevitably, blows up the immunosuppressor cells which are suppressing the tumor around the periphery,” Gerrans says. “So it kills off all of the cells around the tumor, which are the suppressor cells containing it, effectively increasing the available margin around the tumor enabling it to grow and advance.”

“We believe the timing is right for our technology to make a difference.”

To address this issue, Sanovas has developed proprietary delivery methods to boost the delivery of oxygen and hemoglobin-based oxygen carriers, among other therapies, to the cell, thus potentially improving the efficacy of radiation treatment.

Looking to the Future with Optimism

Sanovas is optimistic that its products can make a real difference in addressing an urgent humanitarian need. Gerrans points to a The New England Journal of Medicine's publication of the National Lung Screening Trial as a sign that its technology will provide hope to the thousands upon thousands of people diagnosed with pulmonary diseases each year. That study effectively declared chest CT as the new standard of care in pulmonary disease detection and its study showed a 300% increase in diagnostic capability of chest CT compared with chest x-ray, Gerrans says. "This makes it critical that technologies such as Sanovas' are there to provide the early intervention treatments required as a result of early detection," he says. "We believe the timing is right for our technology to make a difference."

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FDA REGULATORY DISCLOSURE: Sanovas Inc. is an emerging technology company.
These products are investigational medical devices that have not been approved or cleared for use in the United States.