Kevin Chaplin, VP of Business Development

Closely-held Kardium hopes to receive marketing approval in Europe in the fourth quarter of 2018 and launch its breakthrough Globe mapping and ablation system of cardiac tissue for the treatment of atrial fibrillation (AF), the most common heart rhythm disorder where the atrium quivers instead of beating in regular rhythm.

“We are currently going through the CE Mark approval process in Europe,” Kevin Chaplin, VP of business development, says in an interview with BioTuesdays. 

Vancouver-based Kardium also hopes to receive Health Canada approval for the Globe AF mapping and ablation system and to start a pivotal study in the U.S., in 2019 with possible FDA approval in 2022.

“The Globe system uses well established technologies, like radio-frequency (RF) ablation, to treat AF, but in a new and innovative way,” he says, pointing out that the system consists of a proprietary catheter, software console and RF generator.

Globe® mapping and ablation system

Mr. Chaplin says the Globe catheter contains an expanding array of 122 flat electrodes. There is a temperature sensor behind each electrode, which is important for mapping and ablation. “If the system recognizes that an electrode is in blood, it can be moved to tissue in order to ablate,” he adds. When deployed in the atrium, every electrode can map and ablate cardiac tissue.

Globe catheter deployment

In addition, measurements from all the electrodes can be simultaneously and continuously combined into anatomical maps and atrial electrical activity maps, which the doctor can use to select tissue for ablation. 

Specifically, the system generates Flow maps, which show blood flow and tissue contact; Voltage maps, which show tissue voltage amplitude; and WAVE maps, which show real time electrical activation. Mr. Chaplin says doctors can look at all of these maps to see changes in electrical activation during ablations.

The system uses RF energy to heat and ablate cardiac tissue within the left atrium to treat AF. The RF generator contains all the electronics to continuously measure cardiac electrograms and temperature, and control the ablation power of the electrodes, permitting up to 24 simultaneous ablations for a “quick single shot at pulmonary vein isolation,” Mr. Chaplin says.

High resolution mapping

“Based on the high resolution mapping, doctors are able to select the electrodes they want for ablation and the system then performs the ablation automatically,” he adds. “So there is a lower requirement for input from the doctor, who does not have to manage each ablation individually. However, the doctor is in full control and can stop ablations at any time.”

According to Mr. Chaplin, current ablation treatments are designed to burn tissue around the four pulmonary veins, which are the main source of bad electrical signals in the atrium. Burning the tissue around the pulmonary veins isolates them electrically from the rest of the atrium. Current treatments also attempt to map and ablate additional sites inside the atrium that can cause erratic electrical signals.

There are two types of AF: paroxysmal, which comes and goes, and persistent, where a patient is always in AF. Mr. Chaplin suggests that current treatments to isolate the pulmonary vein result in about a 60% to 65% success rate in paroxysmal AF and around 50% in persistent AF.

“By doing better pulmonary vein isolation, we believe we can generate an additional 15% to 20% benefit for patients and with proper mapping and atrial ablation, we hope to improve these outcomes even further.” he contends. “So our goal is better pulmonary vein isolation and targeted atrial ablation.” 

Technologies on the market now include the single tip RF catheter, the Arctic Front Balloon catheter and mapping catheters.

Mr. Chaplin says the J&J’s single tip RF catheter is the market leader and can ablate anywhere in the atrium. However, single tip procedures are long and can take two-to-five hours, with efficacy of 60% to 65%. 

Medtronic’s Arctic Front Balloon catheter features rapid pulmonary vein isolation and ease of use, but result in outcomes similar to the single tip RF catheter, he adds. 

And while mapping catheters like those from Boston Scientific provide high resolution mapping, he says they are unable to ablate tissue and so doctors then have to use a single tip RF catheter, resulting in outcomes that are marginally improved, but with an additional expense.

Mr. Chaplin says Kardium’s Globe system combines rapid pulmonary vein isolation, high resolution 3D mapping of the whole atrium, and the ability to ablate anywhere into a single device that is easy to use.

The Globe hardware, software and electronics are protected by 76 patents granted and 49 pending.

In Kardium’s pivotal study of 60 patients at two the world’s top heart centers in Zurich and Leipzig, the Globe system achieved 100% pulmonary vein isolation, which is slightly better than data from FDA submissions for single tip RF catheters, cryoballoons and laser balloons.

However, based on patient follow up to determine recurrence of AF, Mr. Chaplin says the Globe system demonstrated 97% efficacy at three months and 82% efficacy at six months.

Clinical results

The treatment phase of the trial finished in October 2017 and so 12-month patient follow up will be available at the end of 2018. However, he suggests that the data is expected to remain near 80%, which is 15% to 20% better in absolute terms than conventional technologies. 

“We also managed to do procedures in a very short time, so based on the data, we believe we have a more effective catheter that is easier to use,” he adds.

Mr. Chaplin says that with CE Mark, Kardium plans to do its own sales and marketing in Europe with a clinical support staff and several sales reps. “We believe our Globe solution is highly differentiated and there is already strong demand from doctors in Europe,” he adds. In addition, the company is in discussions for sales agreements with several European heart centers.

The company also hopes to complete a major financing at the end of 2018 to finance its commercialization plans in Europe and prepare for a U.S. pivotal study in the first quarter of 2019. “We already have several centers in the U.S. interested in recruiting patients for the study,” he adds.

If the company receives FDA regulatory approval in 2022, it forecasts total sales reaching more than $200-million in 2024.

“With outstanding clinical results already in hand and strong IP, we believe we have a disruptive technology addressing a huge market opportunity,” Mr. Chaplin says.

Schedule timeline

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Jim Hutchens, President and CEO

Imagin Medical’s (CSE:IME; OTC:IMEXF) i/Blue Imaging System is expected to improve physicians’ ability to detect bladder cancer with minimally invasive endoscopes and reduce recurrence by dramatically improving the urologist’s ability to visualize, identify and remove cancerous cells.

“We have completed development of our prototype, an advanced optical and light sensor technology that, in conjunction with white light and near-infrared fluorescence, is expected to deliver superior images in less than 15 minutes, instead of the full hour required by conventional systems prior to use in the operating room,” Jim Hutchens, president and CEO, says in an interview with BioTuesdays. 

“We believe the time savings will increase the efficiency of the operating room and reduce healthcare costs by potentially enabling procedures to be performed in the less expensive setting of a physician’s office,” he adds.

And as the i/Blue Imaging System becomes established in the urology market, Mr. Hutchens says Imagin plans to complete development of the i/Vision Imaging System technology, which combines multiple illumination sources into one system.

“The i/Vision will accommodate the most commonly used fluorescing contrast agents, such as indocyanine green (ICG), and would potentially enable Imagin to expand into additional specialties such as, general surgery, gynecology, colorectal and thoracic procedures,” he contends.

The current standard of care using endoscopes with white light has been used for decades and is ripe for innovation, Mr. Hutchens suggests. “White light is highly effective for visualizing cancerous tumors that protrude above the bladder wall, but is not as effective in visualizing their margins or tumors that lie flay on the bladder surface.”

There is a newer endoscopic technique using contrast agents with white light and a blue filter to induce fluorescence. While it improves the ability to visualize cancer, he says it requires surgeons to toggle back and forth between different images in order to detect flat cancers and visualize the margins of the tumors. And that’s in addition to the inconvenience of waiting an hour for the contrast agents to be visible in the bladder before being able to begin surgery.

“Endoscopes with our i/Blue Imaging System have the potential to see bladder cancer in less than 15 minutes, with optics that are 100 times more sensitive,” Mr. Hutchens points out. Premalignant lesions and tumor tissue along the margins would be highlighted and identified for removal, potentially reducing the chances of recurrence, he adds.

Mr. Hutchens explains there is no toggling back and forth with i/Blue, which blends white light and fluorescence images into one image, putting cancerous tissue into context within the bladder, and allowing surgeons to better visualize and resect the cancer. And the i/Blue technology adapts seamlessly to most types of endoscopes on the market, he points out.

Imagin’s i/Blue Imaging System

“We believe this is a disruptive imaging technology for a significant unmet medical need,” he adds.

The company’s IP is protected by three U.S. patents licensed from Lawrence Livermore National Laboratory, a federal research lab, and as “our product is redesigned for commercialization, we’re looking to add three-to-five new pieces of IP,” Mr. Hutchens notes.

Bladder cancer is the sixth most common cancer in the U.S., yet is the most expensive to treat. There is a more than 50% recurrence rate in the more common non-muscle type of bladder cancer, along with 81,000 new cases a year in the U.S. and 17,000 deaths, according to the American Cancer Society.

“Bladder cancer is a hot-button urology issue looking for innovation,” Mr. Hutchens suggests. “Our prototype product has been completed, so our R&D risk has been mitigated. This is in large part an execution play, addressing a $750-million-plus global market.”

Dr. Edward Messing, chair of Urology at the University of Rochester Medical Center and a member of Imagin’s SAB, is currently conducting a first-in-human research study with the i/Blue Imaging System. The 10-patient project, which is designed to show that the system can detect bladder cancer within 15 minutes, is expected to conclude within the next few months.

“The study will help us prepare our submission to meet with the FDA late in the summer to discuss the clinical and regulatory pathway for an i/Blue product redesigned for commercialization,” Mr. Hutchens says. The company will likely seek premarket approval of i/Blue through a clinical study that compares its performance to other devices currently on the market.

Imagin expects to conduct its clinical programs at the University of Rochester and University of California at Davis, as well as with private physician groups, where patients can be enrolled quickly, he adds.

“If all goes according to plan, we hope to launch our product or at least demonstrate its effectiveness at the American Urology Association meeting in Chicago in May 2019,” Mr. Hutchens says. The company’s 2019 program also includes continued development of the next generation i/Vision Imaging System.

Mr. Hutchens says Imagin’s growth strategy begins with installing i/Blue in the operating room and then expanding into physician’s offices where diagnosis of bladder cancer is performed. “Establishing up to four Centers of Excellence would immediately create credibility in the market.”

Milestones - Multiple Potential Value Inflection Points

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Thomas Waddell, CEO

Closely-held XOR Labs hopes to dramatically increase the number of lungs suitable for transplantation with its Ex-Vivo Lung Perfusion (EVLP) technology.

“Only about 20 out of every 100 donated lungs are currently suitable for transplant worldwide, but our aim is to boost this to 60% with our EVLP platform,” Dr. Thomas Waddell, CEO, says in an interview with BioTuesdays.

Dr. Waddell contends that XOR’s EVLP technology has the potential to help hundreds of thousands of people who are in critical need for lung transplantation due to diseases such as pulmonary fibrosis, cystic fibrosis, pulmonary hypertension and chronic obstructive pulmonary disease.
 
“Our ultimate goal is to reduce waiting list deaths to zero and to become the worldwide leader in advanced multi-organ transplantation technology,” he adds.

According to industry estimates, more than 100,000 people would benefit from a lung transplant, but only 6,000 are performed annually. And some 20% to 30% of patients die while waiting from a transplant. “The key limiting factor is insufficient quality donor lungs available for transplantation,” he suggests.

“Only about 20 out of every 100 donated lungs are currently suitable for transplant worldwide, but our aim is to boost this to 60% with our EVLP platform”

Dr. Waddell participated in the scientific and clinical development of the world renowned “Toronto EVLP protocol,” led by Dr. Shaf Keshavjee, used at University Health Network (UHN), which allows for re-evaluation, repair and eventually regeneration of donated lungs. He and his team also have led the effort to translate the Toronto protocol into a XOR EVLP platform.

Toronto EVLP System

“The Toronto EVLP is the gold standard of care for lung transplantation and has been used about 400 times over the past nine years, resulting in some 300 transplants,” he points out, In addition, the Toronto protocol has increased utilization of donated lungs to 40%. “Our aim is to move the utilization needle higher still.”

The EVLP process keeps lungs nourished and alive outside the body for up to 12 hours by circulating blood-free fluid through the lungs at body temperature, while the lungs are gently ventilated.

This gives lungs, which would have been discarded, time to be assessed, and transplanted, if they perform well, Dr. Waddell says. In addition, injured lungs can be rehabilitated instead of discarded, and if sufficiently recovered, can be transplanted. 

Dr. Waddell explains that Dr. Keshavjee and a team of leading thoracic surgeons and researchers from UHN, who helped develop the original Toronto system, founded XOR Labs with the goal of commercializing a standardized and mobile version of the Toronto system for transplant patients around the world. The company hopes to unlock the pool of potential donors and expand lung transplants to 15,000 to 20,000 a year, from 6,000 currently.

XOR’s EVLP System

“Our system simplifies the EVLP process and drastically cuts hospital costs for lung transplants,” he contends. In addition, its “mobility makes it uniquely suited for out-of-hospital use, opening up opportunities to use the EVLP process during the transportation of donated organs.”

The XOR EVLP System is comprised of a re-usable cart, which includes perfusion pumps, sensors and a ventilator; a single-use Lung Tower where the lung is placed; and several per-procedure sterile single-use cannulas to connect the donor lungs to the Lung Tower.

“In animal models, Dr. Keshavjee’s research team has kept lungs going for 24 hours, which allows us to contemplate some interesting therapy options,” Dr. Waddell says.

XOR hopes to begin a three-month first-in-man validation trial of its EVLP device as early as January 2019 in order to seek Health Canada approval. The trial will be conducted at Toronto General Hospital with 25 EVLP patients and will require 20 transplants. “We hope the Canadian data would allow us to submit an application for CE Mark approval in Europe,” he adds.

The company is seeking an additional investment of up to $7-million to complete Health Canada and CE Mark approvals and begin its entry into the U.S. market.

In Europe, XOR has partnered with Xenios, a member of the Fresenius Healthcare Group, for manufacturing, regulatory, infrastructure, and sales and marketing support. Xenios also owns a minority interest in XOR, which has already had discussions with key clinical leaders in China, Europe, and the U.S.

Dr. Waddell says discussions also have begun with the FDA to establish an “early feasibility evaluation pathway” for its technology that would lead to a humanitarian device exemption or premarket approval application.

Dr. Keshavjee and Dr. Waddell have also established a close relationship with United Therapeutics, which is leading the introduction of EVLP into the U.S., using the “Toronto protocol” and hopes to sell XOR devices into their “service centers” as well.

“Our five-year plan includes installing 36 XOR ELVP carts in 25 transplant or perfusion centers around the world,” he adds.

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David Sutton, President and COO

NanoSphere Health Sciences (CSE:NSHS; OTC:NSHSF) has developed a newly-patented delivery technology that increases the bioavailability and bioactivity of its Evolve line of gel-like cannabinoids for the treatment of pain, inflammation and anxiety.

The NanoSphere Delivery System (NDS) also reduces adverse side effects by delivering precise doses of smart nanoparticles to target sites.

“Following more than 20 years of research and development of our NDS, we are the first and only company to nano-size and encapsulate cannabinoids from pharmaceutical grade cannabis,” David Sutton, president and COO, says in an interview with BioTuesdays.

“And we are one of the few companies with human pharmacokinetic blood study data on THC absorption, which favors our products,” he adds.

Mr. Sutton explains that smoking cannabis has no reliable dosages as a medicine and oral absorption of THC is slow, unpredictable and has very low bioavailability. “Cannabis requires a scientifically-proven delivery and carrier system to reach systemic circulation and be effective.”

He contends that the company’s nano-sized spheres supply a high concentration of cannabinoids to the bloodstream and target sites in a short period of time, avoiding first-pass metabolism in the liver and bloodstream. “Our precision-metered, microliter dose packaging system allows for standardization and consistent usage, and is convenient and easy-to-use anywhere.”

NanoSphere’s Evolve Formulas products are available in more than 120 dispensaries in Colorado. Earlier this month, the company inked a strategic partnership with Vertical Companies to launch the Evolve brand in Arizona and California.

Currently, nine states have adult-use cannabis laws and 39 states have medical cannabis-use laws. Some 59% of the U.S. population lives in states with legal cannabis.

In March, NanoSphere received a U.S. patent that covers the core technology behind the production of its NDS for the delivery of cannabinoids, pharmaceuticals, neutraceuticals, cosmeceuticals and other biological agents. 

“This is one of the most important advancements for the non-invasive delivery of biological agents in over 25 years,” Mr. Sutton contends.

Last month, NanoSphere received the 2018 Technology Innovation Award by Frost & Sullivan in recognition of its superior delivery of pharmaceutical, cosmetic, and nutraceutical agents, which outperforms competing solutions by providing significant biocompatibility, safety, efficacy and versatility. 

The award also recognized that NanoSphere has effectively solved a complex problem in drug delivery with its unique ability to control the efficacy of drug formulations once inside the body.

The company’s Evolve NanoSerum transdermal enables cannabis to be rapidly absorbed into the systemic circulation for direct relief of pain and inflammation. The pharmacodynamic effects occur in 10-to-15 minutes and last three-to-five hours.

“Our viscoelastic nanoparticle gel delivers precision dosages of THC, CBD, and terpenes through the skin to peripheral CB1 and CB2 receptors of localized injury and into the bloodstream to the CNS CB1 receptors in the spine, and brain for analgesic effects,” he adds.

The transdermal NanoSerum is beneficial for peripheral, acute and chronic, pain as well as neurogenic or inflammatory pain, cramps, headaches, inflammation and muscle soreness, anti-anxiety and chronic stress, and clinical endocannabinoid deficiency of hyperalgesic states, such as migraine, fibromyalgia and irritable bowel syndrome.

Mr. Sutton says NanoSphere later this year will offer two more product delivery applications under the Evolve brand: an intra-nasal and an intra-oral in varying strengths and strains.

“We have developed a custom intra-nasal application device to target dispersion of a precision dosage of NanoGel cannabinoids to the olfactory zone of the sinus cavity for direct nose-to-brain delivery in minutes,” he adds. The mucoadhesive gel increases mucosal retention time and absorption.

Citing a preferred method of administration because of its rapid onset of action, he contends that intra-nasal product has potential for the treatment of central pain, neurodegenerative diseases, brain trauma, and neurological and psychiatric pain.

NanoSphere’s precision intra-oral delivery of cannabinoids through the buccal mucosa into the circulatory system for distribution to the central nervous system and peripheral receptors takes advantage of a rich vasculature and large surface for absorption, resulting in an onset of action within 15 minutes, Mr. Sutton contends.

In April 2016, the company completed a pharmacokinetics blood study on its 5mg nano-encapsulated THC product to study the bioavailability and bioactivity of intra-oral products, as well as measuring pharmacodynamic effects.

Mr. Sutton says the study found that, among other things, the time of highest concentration of THC in the bloodstream occurred 3.5 times faster with Nano THC than ingested THC and GW Pharma’s Sativex.

“Buccal mucosa delivery has the potential of a new platform of cannabis therapeutics,” he adds.

The company’s future pipeline includes development of neutraceuticals, non-steroidal anti-inflammatory drugs (NSAIDS) and animal health applications. “There is a huge opportunity to improve the performance of NSAIDS and reduce bleeding and ulcers by avoiding the gastrointestinal tract,” he adds.

NanoSphere has completed R&D on a NSAID product and hopes to actively engage in preclinical studies during the next year. “At that point, we would like to partner with a small-to medium-sized pharma company to take us through the FDA process,” he suggests. “Imagine an intra-nasal NSAID with the potential of getting rid of a migraine in a few minutes instead of an hour.”

There is also a huge potential in helping pets and industrial animals take their medication. “We have the potential to develop sprays that absorb quickly in this sector,” Mr. Sutton adds.

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