Donald W. Black with Leanne Carlson

Ondine Biomedical Inc. wishes to congratulate Donald W. Black, a long time friend and supporter of our company. Don has been awarded the Queen Elizabeth II Diamond Jubilee Medal, recognizing his lifelong contributions to his peers, community and country over the past sixty years. Don is the recipient of other prestigious Canadian honours, including the Order of Canada, the Queen Elizabeth II Silver Jubilee Medal, and the Saskatchewan Order of Merit.

Don was born, raised and educated in Regina, where he has spent the majority of what has been a successful, distinguished, and diverse career. Don is currently the Chair at Greystone Managed Investments and Greystone Capital Management, the investment firm whose success he is largely responsible for.  Throughout his career, Don has been actively involved in the community, leading many charitable organizations including the CNIB “That All May Read” National Capital Campaign, the United Way of Regina Leadership Giving Campaign, the Tomorrow Fund, and the RCMP National Heritage Center.

Don Black is a generous man, quick to smile and never misses the opportunity to make a positive impact on the people and world around him. His friends at Ondine are very proud of this extraordinary man and wish to congratulate him on this well deserved recognition.

In the same way fate seems to keep knocking on Carolyn’s door, she felt the benefits of her determination first-hand. After the crash, Carolyn was taken to Vancouver General Hospital (VGH), the first major institution to roll out Ondine’s technology. Like all patients undergoing surgery, she was zapped clean by Ondine’s laser.

Ondine Biomedical Inc. is a proud supporter of the mission and goals of the PanAmerican Photodynamic Therapy Association. Launched last month, the Association’s purpose is to galvanize the basic science and expertise of photodynamic therapy in the Americas. This will help encourage the study and practice of PDT in the treatment of animal and human diseases.

Many of you may not know that photodynamic therapy has been around for centuries. In fact, the earliest recorded treatment using a photosensitizing agent and a light source occurred in ancient Egypt over 3,000 years ago. Vegetable and plant substances were used as photosensitizers and sunlight was used as the light source. Patients suffering from skin diseases such as vitiligo had the photosensitizers topically applied to the damaged area, and the resulting photochemical reaction restored their tissue to a healthier state. In some cases, it even helped repigment their skin to its normal color.

Today, photodynamic therapy is clinically used worldwide in a number of applications – cancer, macular degeneration, gum disease, infection control, and acne. The antimicrobial application of PDT, commonly known as “Photodisinfection,” is Ondine’s platform technology and is used in all of our products. It is therefore critical that we lend our support to groups such as the PanAmerican PDT Association, which aim to help further the study, education and practice of PDT techniques in disease.

Ondine is a proud supporter of the PanAmerican PDT Association, and is very excited to see how they will move the field of PDT forward. After all, this technology has saved lives. To read these stories, please visit the PanAmerican PDT Association website.

The family then turned to photodynamic therapy (PDT), a treatment proven to be effective in killing cancer. Connah’s treatment consisted of taking a pill containing a photosensitizing agent and then activating this agent with light. A powerful reaction was then initiated, which killed the cancerous cells while preserving the surrounding healthy tissue. Amazingly, after ten months of PDT  treatment, ten of Connah’s eleven tumours have now disappeared. “This is the one miracle in my entire career,” said Connah’s GP, Dr. Eamon Jessop, “He’s doing incredible well, it’s staggering.” To hear Connah’s story, please watch the video below:

Connah from Matt Hunt on Vimeo.

Miracles really do happen. On Thursday October 27^th, Carolyn Cross (our CEO, Chairman, and dear friend) survived a deadly plane crash. On a chartered flight headed to Kelowna, Carolyn knew something wasn’t right when the pilot told passengers there was an oil leak and they were returning to the airport. “I looked at his hands and they were shaking, trembling,” Carolyn said in an interview from her hospital bed, “At that moment I knew we were going to die.” Carolyn then calmly took out her phone and began typing out farewell messages to her three young kids, “Something that they would remember me by, that I could have peace that I had said my goodbyes.”

Seconds later, Carolyn’s plane crashed on a busy road about 900 meters short of the runway. “We crashed and I immediately looked outside because I was at a door window and it was full of flames outside. So I couldn’t go out. It smelled full of gasoline….I went to get up and I could not walk. It was as if I had no legs, as if they were blown off. And I thought of my children, and God and the universe gave me the energy and I got up to the door. I said I don’t know what I am going to do now because I can’t get out of the plane, my legs, I can’t get out of the plane.”

“There were four people that pulled me out and carried me to safety even though the plane was in flames. It smelled of gas. And then they went back for more. And people were shouting “the plane’s going to blow, it’s full of gas, we smell gas” but they went back in. It was amazing.”

On Friday morning, the day after the plane crash, Carolyn held a conference call with all of us at Ondine. From her hospital bed, she told us about the plane crash, about her cuts, bruises, and broken bones. She told us how thankful she is of the everyday heroes that pulled her out of the plane crash, and she told us about her passion behind this company. “I survived this plane crash for a reason, and one of them is to put our technology on the map. I am more dedicated to PDT than ever.”

Our thoughts and prayers go out to the family of Luc Fortin, the courageous pilot whose gallant efforts saved the lives of passengers onboard that flight. To those everyday heroes that helped pull Carolyn and other passengers out of the burning plane, we can’t thank you enough. “I laid in bed last night understanding how lucky I am,” Carolyn said, “I am alive because of these people. I want them to know how brave they were.” If you are one of these heroes, or know of them, please contact us at cchew@ondinebio.com.

Statistics, indicating that more people die of MRSA infections in the US than from HIV/AIDS⁴, have generated public policy responses in a number of jurisdictions. Due largely to the impact of public outcry, hospitals in the UK and in several US states are now required  to report on, and publicly disclose, their annual HAI numbers. The American states which have mandated that annual HAI occurrences are to be tracked and published as a matter of public record are⁵:  Alabama, California, Colorado, Florida, Illinois,  Minnesota, Missouri, Maine,  New Hampshire , New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Vermont, Virginia, and West Virginia.  More states are expected to follow this lead in the coming years, to see the full list, visit www.hospitalinfection.org/legislation.

In Canada, there is no mandate yet to publicize the extent of the HAI problem or cost, or any incentive to disclose these given that Canada has a provincially-run medical system. Indeed, publicly available healthcare-associated infection data in Canada is sorely lacking and outdated at best, causing, in my view, gross underfunding of appropriate HAI prevention protocols and a lack of economic support for new technologies to combat them.

One of the responses of hospitals in North America has been to increase the use of powerful prophylactic antibiotics to prevent healthcare-associated infections, especially surgical site infections (SSIs). As one can imagine, this behaviour leads to short term HAI reductions at the expense of long term antibiotic resistance setbacks. With few, if any, new antibiotics currently under development, this dependency on greater use of last resort antibiotics to address an antibiotic resistant problem must be seen to be short-sighted and flawed.

Some of the public policies and new HAI protocols that were introduced by the early adopters over the past 5-10 months have begun to demonstrate successes and these results are leading to greater pressures on other jurisdictions to also adopt new HAI control protocols.  Indeed, on October 20, 2011, the CDC  announced data that demonstrated declines in healthcare-associated infection rates.⁶ The public at large, having been sensitized to the risks of superbugs and other healthcare-associated infections, are now alert to HAI prevention progress being made locally. Many people, after all, have heard about patients going in for routine medical operations only to experience loss of life or limb. Each one of us is now aware of a person that has suffered from a serious infection; a phenomenon that is new to our generation. The fact that antibiotic resistant infections have become one of the world’s top ten health issues is well understood.

The first step to fixing any serious problem is to fully understand the extent of the issue and the rate of any changes. Collection of accurate data is critical and key to determining appropriate solutions and resources that may be required.  Once problems and solutions are fully identified, the next challenge is  implementing  the solution plans as well as ongoing systems for monitoring progress against targeted objectives.  Every effort must be made to ensure accuracy and timeliness of data collection throughout this process if we are to optimize results.  Anything to undermine the accuracy of data throughout this process can only compromise infection control successes in the long run.

Successfully introducing new protocols to the healthcare industry often requires both a system of rewards and penalties. Indeed, even the simple necessity of hand washing between patients is well known but still often ignored due to time and convenience considerations.  Additional monitoring and access points are being implemented throughout hospitals globally just to encourage a well-known HAI intervention strategy.

When trying to implement change, however, it is never useful to simultaneously implement a system of data collection and a system of penalties because it can encourage underreporting and therefore the generation of compromised data. When asking hospital facilities to report and publicize HAI incidence rates across various wards, there is a natural system-wide incentive to underreport due to the negative publicity which could potentially impact reputational capital, revenues and margins as well as provide ammunition for undesirable and costly lawsuits. After all, which of us would willingly choose a hospital that is known for higher-than-average superbug infection rates? Reputational damage, once done, is very difficult to fix.  Public admission of significantly higher than average HAI occurrences will likely lead to patient flow to other facilities for high margin elective and major surgeries. Any loss of patient flow, of course, will have the effect of reducing both revenues and overall profit margins.

Complicating, and potentially undermining the emerging HAI data collection process, the US and UK Government have recently begun to simultaneously adopt tough penalties to discourage HAI.

Two year MRSA trends in UK after implementation of universal screening and decolonization.

In the UK, the Government is adopting a system of withholding budgetary funds for hospitals which exceed infection quotas.  In an effort to curb rising costs of the Medicare and Medicaid programs, the US Government is attempting to adopt a stance that it will no longer reimburse hospitals and other healthcare facilities for the costs of treating the HAIs incurred within their facilities. The premise is that if the costs of patient care related to HAIs are borne entirely by the hospital facility instead of by the Government, the hospital facility will quickly adopt the necessary measures to ensure that infection control procedures are implemented and properly executed.  Without such penalties, it is argued that the hospital facilities in the US have little economic incentive to reduce HAI rates as they are currently being reimbursed (generating additional revenues) for HAI related costs by the Government.

This growing disclosure requirement combined with reduced HAI cost reimbursements and other economic penalties related to HAIs (including lawsuits and budget cuts), has created a growing temptation to disguise the number and scope of healthcare-associated infections.  This potential conspiracy is made more likely because healthcare personnel have a tendency to protect their personal interests and patient results.

When combining the simultaneous phenomena of publicizing HAI data with the transference of HAI cost burdens to hospitals in a weak economy, there are enough incentives and opportunities to ‘reclassify’ and underreport HAI occurrences.   Any deliberate misclassification, of course, would represent a tremendous step backwards in the global fight to reduce healthcare-associated infections, as it would obscure the magnitude of the problem and funds relating to HAI prevention.

My first exposure to this concept of underreporting came about during discussions with an experienced Venture Capitalist when pursuing their financial support. This VC lost interest in our HAI technology during due diligence, when he learned from his contacts that the medical community was not ready to embrace, at its own cost, new HAI prevention technology. Instead, the VC advised me that the medical community would simply resort to reclassifying and underreporting the number and scope of infections to minimize their financial consequences in the short term.  With millions of dollars at stake, I was told, that this kind of initial response in the marketplace was to be expected.

If this temptation to underreport HAIs is indeed to be expected as suggested by this VC, we should therefore also then expect compromised outcomes, fewer real successes, and reduced patient benefits from the public policy initiatives that are being introduced.  With widespread underreporting, there is reduced economic justification to invest in the future HAI solutions and worse, little justification for the people within the medical, insurance and policy communities to embrace the changes needed. Without their support, small innovative companies cannot raise the funds required to commercialize the innovations needed to treat and prevent HAIs. Under this scenario, the whole world suffers.

My goal is to shed light on this temptation and ability to manipulate the HAI data to prevent the critical global health issue from being marginalized. My hope is that we can alert policy makers to the importance of accurate data and encourage them not to introduce policies which will inhibit the collection and communication of the very data needed by all constituents.

We need to encourage accurate HAI readings to understand the real trends as they arise. Accurate data collection is critical to ensure the appropriate policy decisions are being made, appropriate HAI control protocols are being supported universally, adequate resources are being allocated and properly implemented, and most importantly, that HAI reductions continue to be made until they are eliminated. Any concurrent policy changes/requirements that will stand in the way of accurate HAI data reporting as is currently being considered, in my view, must take a backseat. With antibiotic resistance reaching new heights, the HAI crisis is too important to allow for underreporting temptations to stand in the way of real solutions and real commitment. Above all, we must be made aware of the current temptation to underreport HAIs and understand that any underreporting of HAIs is an impediment to global long term HAI reduction.

This was a topic that really grabbed my attention when I first learned about photodynamic therapy.   How is it possible that with the creation of highly reactive molecules are we only limiting cellular destruction to bacterial cells? Although there may be a few different answers to this question, the primary solution is that we are not. Don’t be afraid and swear off photodynamic therapy right away, here me out first. Photodynamic therapy is primarily used as a treatment option for cancers. This treatment is used on cancerous tumours formed in esophageal cancer, lung cancer, skin cancer, as well as many different types. The photosensitizer is accumulated in the tumour either by direct injection or utilizing mutations of the cancerous cells that concentrate the photosensitizer inside the cell. After light is applied, the tumour cells are damaged, but the healthy cells are not greatly harmed. Why? One trait of a cancerous growth is the mutation of certain DNA repair enzymes. (Have a look at this Wikipedia article to give you a small background on DNA repair enzymes) These repair enzymes are responsible for fixing oxidative damage problems caused by free radicals. Scientific researchers, knowing this small fact about most cancerous tumour cells, use PDT and reactive oxygen species to their advantage. A healthy human cell can take some free radical “abuse”, but a tumour cell can only take so much until the cell dies. This fact, coupled with selective photosensitizer accumulation within tumour cells, makes PDT an excellent treatment option in some forms of cancer.

But what about antimicrobial PDT, commonly known as Photodisinfection? Firstly, an interesting finding is how terrible cancer photosensitizers work on bacteria. (Photodynamic therapy: a new antimicrobial approach to infectious disease? by Micheal R. Hamblin and Tayyaba Hasan is a great paper on antimicrobial photosensitizers) This means that we are not using photosensitizers that are known to cause the most oxidative damage against eukaryotic cells. Secondly, we are using a cell that is more attracted to bacterial cells. By this I mean that the photosensitizer molecule itself is positively charged, whereas the bacterial outer membrane is negatively charged, on average more so than a human cell membrane. It doesn’t take a photochemist to tell you that a big negative and positive attract more than a little negative and a positive.

The third, but not necessarily the final reason, is in the application strategy of photosensitizer. Periowave and MRSAid, two of Ondine’s main products, utilize local application of a photosensitizing solution to areas known to posses bacterial infection/colonization. This cuts down on any toxic effects that could occur by means of global injection of the photosensitizing solution in the body. Another application strategy utilized is the small amount of solution that is applied to the treatment site. Ondine uses small amounts of 0.6-2 ml of solution per treatment. Ten times that amount by ingestion would have very little effect on you with or without your body being illuminated!!

To wrap it up, antimicrobial PDT (or Photodisinfection) employs targeting to bacterial cells, application strategies, and your body’s general “super enzymatic” abilities to reduce, repair, and eliminate the negative side effects of PDT on human cells. To learn more about Photodisinfection, click here.

The World Health Organization has called antibiotic resistance one of the greatest global health concerns to date.

Before answering that question it is important to understand how bacterial cells work. Bacterial cells look and work differently than say a cell from our body. They have a genetic code (within DNA) but some of that code floats freely within the cell in circular structures called plasmids. One of the particularities of bacterial cells is their ability to pass plasmids amongst each other (plasmid transfer), allowing them to share traits on an extremely rapid scale. Furthermore, one bacterium can divide into two cells without the need for sexual reproduction between two parent cells.

Like us, bacteria survive on chemical based processes, which allow them to grow and replicate. Protein molecules are essential to these processes. They allow for three things:

• Destroy/change other molecules
• Form physical structures and barriers
• Help build new molecules

Interference with any one protein can mean death for the bacteria. In fact, that is the principle that antibiotics are based upon. For example, penicillin works by creating a strong cell wall that interferes with a specific protein.

During cell replication, mistakes can cause the formation of abnormal proteins or mutations. These mutations can be the cause of cancers or other diseases but are also the basis for evolution over time. As mentioned above, bacterial cells can replicate and divide very quickly (in hours rather than years). Therefore, mutations occurring within bacterial cells can also develop and spread more rapidly. In some cases, mutations result in a protein that is altered just enough to keep its functions but no longer recognizable to an antibiotic molecule. Many have speculated that this is why a regular Staph infection can be treated with a course of antibiotics while MRSA can be life threatening.

There are four ways in which this new resistant bacterium will deal with antibiotic treatments:

1. Can produce enzymes (a type of protein molecule) that destroy the antibiotic molecule before it can have an effect.
2. The protein might be so changed that the antibiotic molecule can no longer associate with it.
3. Bacterium can use different metabolic pathways and abandon the one targeted by the antibiotic.
4. Can produce protein channels and pumps that help rid the molecule of antibiotic molecules.

If it were only a question of one mutated bacterium giving resistance to a specific antibiotic, there would be no problem. However, if this bacterium has all the room and nutrients it needs to grow and divide, a whole new population of bacteria can grow from this one parent cell in a matter of hours. As the genetic code is passed on as the cell divides, the new population of cells will have the same antibiotic resistance. Furthermore, as plasmids can be transferred from bacterium to bacterium, mutation can be transferred to non-descendant bacteria, creating totally different resistant strains. It is therefore easy to see why a single small genetic mutation can cause a global health concern.

Antimicrobial photodynamic therapy (aPDT), commonly known as Photodisinfection, is a non-invasive technique that used to study the reduction of biofilm in the lumen of an endotracheal tube. When patients undergo mechanical ventilation, an endotracheal tube is inserted into their throat to assist with breathing. This tube has long been recognized as a major factor in a patient’s risk for developing biofilm infections. For patients that require mechanical ventilation, such as those in ICUs, the biofilm can dislodge from the endotracheal tube and enter the lungs directly, often resulting in difficult-to-treat pneumonia.

In order to more closely simulate an actual human clinical study environment, a simulated clinical model was developed for testing. In this study, MRSA and multidrug-resistant Pseudomonas aeruginosa were grown in a bacterium broth and circulated through an endotracheal tube for 48 hours, coating the lumen.  Following this, a small amount of photosentizing solution was sprayed inside the tube and activated with a laser light, initiating the photodisinfection process. The results of this study showed that after a single treatment using Photodisinfection, a significant reduction of endotracheal tube biofilm was observed (more than 3 log reduction (P<0.005) from the baseline).

Photodisinfection is a non-invasive and non-antibiotic approach in eradicating biofilm from the endotracheal tube without removing it from the body.  Ventilator-associated pneumonia is the #1 most common healthcare-associated infection in intensive care units and is one of the largest contributors of prolonged hospital stays, increased costs, and increased patient morbidity in hospitals.

The Photosidisinfection system developed in this study was designed to prevent and control the growth of biofilm within the endotracheal tube, and would therefore be planned for use 24 hrs after a patient is mechanically ventilated, and every 8 hrs thereafter. To read the full study, please go to  http://onlinelibrary.wiley.com/doi/10.1002/lsm.21103/abstract

1. Davis et al. Ventilator-Associated Pneumonia: A Review. Journal of Intensive Care Medicine July 2006. Vol 21 (4): 211-226

The use of Photodisinfection to disinfect the birth canal is a novel approach that can bypass the stigma associated with HIV treatment and any reliance on patient compliance.

Ondine is pleased to congratulate Dr. Bryon Bhagwandin of Vitalwave™ on the publication of his abstract at the International AIDS Society (IAS) Conference. This is an important accomplishment as it highlights the need to develop new approaches in preventing mother-to-child HIV transmission.

A higher vaginal HIV viral load has been independently associated with a higher risk of transmission. Dr. Bhagwandin’s study evaluated the use of antimicrobial Photodynamic Therapy (aPDT), also known as Photodisinfection, as a means to reduce the vaginal viral load of pregnant women infected with HIV/AIDS. In 2008, more than 1.4 million pregnant women were living with this disease. An additional 430,000 children had been infected through mother-to-child transmission.

More than 90% of children living with HIV in developing countries were infected through their mothers, and many are left without regular access to effective prophylaxis such as antiretroviral medication. Innovative approaches are therefore needed to address this problem. Vitalwave™ is the application of antimicrobial Photodynamic Therapy to the birth canal and is designed to destroy a variety of pathogens, including HIV. Currently under development, Vitalwave will be an in-clinic, low cost, and easy to administer procedure for use in the third world.

“The Use of Antimicrobial Photodynamic Therapy for Prevention of HIV Transmission from Mother–to-Child: A Novel Approach” was presented at the International Aids Society (IAS) 6th Conference on HIV Pathogenesis, Treatment & Prevention which will took place in Rome, Italy from July 17th-20th.