Lung Cancer Authority Dr. Gordon H. Downie Warns that Existing Resources to Treat Peripheral Tumors are "Grossly Inadequate" as Medicare Coverage of Lung Cancer Screening for At-Risk Beneficiaries Goes into Effect

SAN RAFAEL, Calif., Feb. 10, 2015 /PRNewswire/ -- Sanovas Inc., a Life Science company accelerating the development and commercialization of next-generation micro invasive diagnostics, devices and drug delivery technologies, announced today that one of its clinical advisers is warning that the US healthcare system faces a shortage of therapeutic resources as Medicare coverage of lung cancer screening for at-risk beneficiaries goes into effect. Lung cancer is the leading cause of cancer death and the second-leading cause of all deaths in the U.S.

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"The U.S. healthcare system is about to be deluged with diagnoses of early-stage lung cancers, and therefore we need to develop appropriate therapies for peripheral tumors, where the majority of lung cancers begin," said Gordon H. Downie, MD, PhD, FCCP whose clinical research has been published in peer-reviewed medical journals such as American Journal of Respiratory Critical Care Medicine, CHEST, and Journal of Bronchology. Dr. Downie is a Pulmonologist at Northeast Texas Interventional Medicine, and a clinical adviser to Sanovas.

"Medicare coverage has a 'good news/bad news' scenario to it. On the one hand, screening at-risk Medicare beneficiaries with CT scans will absolutely reduce the number of deaths from lung cancer. On the other hand, our country's healthcare system is going to be inundated with patients who have been diagnosed with early-stage lung cancer, a potential order-of-magnitude spike in the diagnosis of peripheral nodules," explained Downie. "This expected significant increase in the diagnosis of early stage lung cancers will stress the resources now available for treating early stage lung cancers."

Results of the National Lung Screening Trial (NLST), funded by the National Cancer Institute (NCI) and published in the August 2011 edition of the New England Journal of Medicine, concluded that "screening with the use of low-dose CT (computed tomography) reduces mortality from lung cancer." Subsequently, in November 2014, the U.S. Centers for Medicare & Medicaid Services (CMS) announced that, beginning in 2015, Medicare coverage of low-dose CT lung cancer screening for at-risk beneficiaries will be required by law. Approximately four million (4,000,000) Medicare beneficiaries fit the eligibility criteria for screening, according to the Lung Cancer Alliance (LCA).

"What are we going to find? A boat-load more cancers, but in the peripheral airways of the lungs, not in the central airways. How do we want to deal with them? That's the question," said Dr. Downie. "Surgery and radiation for treatment of peripheral early stage lung cancer are current standards but there are excellent alternative treatments and these certainly need to be explored.  But how do you get these alternative treatments to these hard to reach peripheral locations in the lung?  Of course, you need small-diameter technologies to get to the periphery of the lung and then, once you get out there, you've got to be able to deliver something locally and focally.  What is that solution? PhotoDynamic Therapy, or P-D-T. PDT can be delivered locally and focally without having to systemically toxify the patient for a small centimeter nodule that's out in the periphery of the lungs and is starting to metastasize. 

"PDT is the only evidence-based intervention that makes sense for carcinoma in situ for early stage lung cancer. There has been a core of people advocating PDT for peripheral lung cancer for almost 15 years. The Sanovas PDT approach offers a really attractive alternative to stereotactic radiation, surgery, you name it," added Dr. Downie, who is also widely recognized as one of the foremost authorities on the use of PhotoDynamic Therapy in the lungs.

"No doubt, the diagnosis of peripheral tumors is going to proliferate as lung cancer screening becomes mainstream," said Dr. Downie. "Challenges facing the clinician include protecting lung function in patients with already compromised abilities, optimal targeting of therapy to avoid serious injury to normal structures, real-time confirmation of clinical effectiveness, non-mutanegenic or carcinogenic tumorcidal agents, and the ability to assess for tissue hypoxia. Locally/regionally delivered and activated PDT can address all these challenges," he added.

"First, a directly observed delivery system ensures a concentration gradient favoring tumor kill over normal structure side effects. Second, the biochemical PDT reaction allows direct correlation of drug consumption with clinical real-time response. Because oxygen is also required for the PDT reaction, drug consumption can act as a surrogate marker for tissue oxygenation. Third, in my experience, I have never seen a primary lung tumor or any metastatic tumor to the lung be resistant to the PDT tumorcidal effect, and the reaction is neither mutagenic nor carcinogenic," Dr. Downie said.

"One of the most common problems encountered during radiation therapy of malignant tumors is that the tumor cells become deficient in oxygen - a condition referred to as hypoxia," explained Dr. Downie. "It looks promising that the Sanovas PDT technology addresses the hypoxia dilemma. As a long-time proponent of using PDT technology to address peripheral lung tumors, I am truly excited by the potential this approach could lead to, and I look forward to seeing clinical research to confirm the promise this patent suggests."

"There is a significant unmet clinical need for a method of treating hypoxic malignant tumors that is capable of delivering an oxygenating agent directly to target tumor tissue within a bodily cavity in order to achieve more precise and efficient oxygenation of the target tumor site, as well as to avoid exposing the surrounding healthy tissue to potentially damaging chemical agents," said Larry Gerrans, the Inventor, Founder, President and CEO of Sanovas. "This is especially promising for Lung Cancer, which is among the most recalcitrant cancers in the world and, by far, the deadliest of all. Our recently issued PDT patent represents a milestone event toward a more targeted and less-invasive treatment for cancer and one that promises to mitigate the deleterious side effects of cancer treatment that we have become all too familiar with. Sanovas PDT solution is arriving just in time to meet this expected inundation of early stage Lung Cancer patients."

About Sanovas
At the heart of the Sanovas companies' scientific advances is the miniaturization of tools for minimally invasive surgery, or "M-I-S." Its products extend access beyond current limits, enabling physicians to diagnose and perform therapeutic interventions in spaces as small as one millimeter in diameter that have previously been unreachable. Sanovas expects to commercialize the technology in coordination with its various partners to address unmet clinical needs in Oncology, Pulmonology, Cardiology, Neurosurgery, ENT, GI, General Surgery, Urology and Gynecology.

NOTE:  US Census, persons 55—74, total Medicare patient demographic is 42,665,670; at only a 25% penetration rate, the estimated impact is 10,666,417 persons who would seek a reimbursable lung cancer-screening test.

Contacts:
Steve Goldsmith, Sanovas, 415-729-9391 x1023, Email
Ronald Trahan, APR, Ronald Trahan Associates, 508-359-4005 x108, Email

SOURCE Sanovas, Inc.

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