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First-of-its-Kind Bio-Artificial Pancreas on Track for Type-I Diabetes Cure

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First-of-its-Kind Bio-Artificial Pancreas on Track for Type-I Diabetes Cure

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Imagine a world where those living with Type 1 Diabetes, a chronic illness affecting more than 60 million adults globally, no longer had to deal with regular blood glucose monitoring, daily insulin injections or life-threatening nighttime hypoglycemic events, but instead could eat, exercise and sleep worry-free. That’s the kind of future an up-and-coming breakthrough technology is on track to creating.

Beta-O2 Technologies, a privately held biomedical company headquartered in Israel with research and industry affiliates across the U.S., is working to deliver a first-of-its-kind bio-artificial pancreas as a safe, effective and long-term cure for the disease. With preliminary animal trials showing promising results for its second generation breakthrough device, called Bio-artificial Pancreas (ßAir), the company is planning to begin human clinical trials within the year.

“We have strong pre-clinical evidence to prove the safe operation of our device on animals,” said Beta-O2 CEO Amir Lichter, noting that the second generation ßAir is performing well in ongoing animal studies. “It’s an enormous achievement that is paving the road for human trials.”

Measuring approximately 2.5 by 2.5 inches, ßAir is made of titanium. It has two components: a macrocapsule that contains pancreatic cells and an oxygen tank equipped with an external port, so patients can easily refresh oxygen levels weekly. Once implanted under a patient’s skin, it becomes a natural source of insulin, sensing blood glucose levels and delivering insulin as required.

While there are a couple of other artificial pancreatic solutions being explored by different industry players, Beta-O2’s disruptive technology is the only bio-artificial pancreas to incorporate an active oxygen supply, necessary to keep the pancreas cells in the implanted device functional and viable over the long term. Other solutions are demonstrating limited success because they rely on a patient’s bloodstream to deliver enough oxygen to keep the transplanted cells viable, which is problematic, Lichter explained.

“Pancreas cells (islets) are extremely delicate,” he said. “We solve the problem by proactively supplying oxygen through an external source, providing a superior solution.”

Lichter said the beauty of the Beta-O2 solution — which holds 10 global patents for its exclusive immune protection capabilities and oxygen supply mechanisms — is that it’s very generic, meaning “it can contain cells from a human donor, cells from the pancreas of a pig, or cells derived in a lab from stem cells.” Other advantages are that Beta-O2’s bio-artificial pancreas does not require a patient to take intensive immunosuppression therapies after implant due to its protective encapsulation capabilities, and the device can quickly be retrieved from a patient if necessary due to malfunction or other health concerns, he explained.

U.S. affiliates helping to bring product to market

Beta-O2 is currently collaborating with several U.S.-based pharmaceutical companies and academics, including researchers from Harvard University, MIT, University of Virginia and Cornell University, to further enhance the ßAir oxygen supply and its ability to measure glucose levels and secrete insulin once implanted. The company is also in negotiations to solidify its collaboration with several stem cell providers as it looks to secure an additional $15 million in investment funds to support its aggressive go-to-market strategy.

“The active oxygen supply used by Beta-O2 is currently the best and most advanced technique for maintaining viability and function of large numbers of pancreatic islets (or stem cell-derived islets) in an encapsulation transplantation device,” said Clark K. Colton of the Department of Chemical Engineering at MIT and Beta-O2 Scientific Advisory Board member.

Calling the Beta-O2 device a “next-gen treatment option,” Dr. José Oberholzer, Professor of Surgery, Biomedical Engineering and Experimental Pathology at the University of Virginia and Beta-O2 Scientific Advisory Board member, explained that “after years of insulin injections and ‘closed-loop’ insulin pumps and glucose sensors, patients will finally have access to a biological device solution to treat the most brittle forms of diabetes. The Beta-O2 device is the only implant that has shown reproducible results in humans with diabetes, with measurable insulin production originating from human islet cells within the device without the need for recipients to take any immunosuppressive drugs.”

An earlier safety trial involving four patients in Sweden, supported by New York-based JDRF (Juvenile Diabetes Research Foundation), successfully demonstrated that Beta-O2’s device is fully safe for use. No side effects were observed in patients who carried the device for up to 10 months, and the cells remained viable and functional.

Now, current animal trials underway at Beta-O2 are focused on extending the life of functional cells even further, with promising early results showing that rats implanted with ßAir are maintaining normal glucose levels.

“With tangible evidence that we can maintain the viability and functionality of our cells for a long duration in rats, which have an immune system very similar to humans, we are looking forward to moving ahead with our second round of human clinical trials,” Lichter said, noting that the company aims to be first to show that implanted biological pancreatic cells can successfully achieve normal blood sugar levels in diabetic patients without the need for immunosuppression therapy.

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About Beta-O2 Technologies Ltd. (www.beta-o2.com)

Beta-O2 Technologies Ltd. is a biomedical company developing a proprietary implantable bioreactor, the ßAir, for the treatment of Type 1 Diabetes. ßAir is designed to address the main problems of the otherwise successful procedures in which islets of Langerhans (i.e. pancreatic endocrine cells) are transplanted in diabetic patients, such as the need for life-long immunosuppressive pharmacological treatment and limited functionality of the transplanted islets over time due to an insufficient oxygen supply. Beta-O2 investors include SCP Vitalife Partners, Sherpa Ventures, Aurum Ventures, Pitango Venture Capital, Saints Capital, Japanese and Chinese private investors.

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Report: Medical Bed Market

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The global geriatric population is on the rise with the population aged over 65 years set to outnumber children under the age of 5 years over the coming years. Older people are generally more susceptible to infectious or chronic ailments, mostly due to age-related deterioration of the immune system. This vulnerability to various health risks including contagious and chronic diseases, as well as injuries associated with falls and physical disabilities is likely to add impetus to the global medical bed market.

The surge in the occurrence of chronic ailments is also causing a rise in hospitalizations for accurate and effective patient care. This upsurge in tandem with rising disposable incomes and rapid healthcare infrastructure advancements are promoting the widespread acceptance of medical beds on a global scale.

Several favorable healthcare policies and mandates have been enacted to ensure the availability of proper and effective medical care to those in need. For instance, in March 2017, the Indian government released a healthcare reform that requires healthcare facilities to have a minimum of 2 beds per 1000. This means there will be nearly 2,623 beds over the coming decade, including new as well as replacement beds.

Elderly population growing at a rapid pace

The older generation, or the “baby boomers”, account for a large chunk of the global population, and rising. In 2019, the number of individuals over the age of 65 years was recorded at nearly 703 million. This number is set to double by 2050 to reach 1.5 billion.

Most frequent users of the Emergency Department or ED services are elderly people suffering from one or more chronic ailments. Common maladies associated with old age include cataracts and vision deterioration, hearing loss, back, neck pains and osteoarthritis, diabetes, cardiovascular conditions, dementia, and depression, among others. As a result of this, the demand for effective and adequate emergency services has been growing extensively of the past year, proliferating the requirement for efficient healthcare equipment, including medical beds.

The growing elderly population has also brought about the establishment of dedicated geriatric healthcare facilities like Athulya Assisted Living, the brainchild of Karthik Ramakrishnan. The facility, located in Chennai, is considered a premium assisted living center and features myriad advanced healthcare provisions including sophisticated ECH machines, assisted medical beds as well as trained healthcare staff.

Rising occurrences of chronic ailments and subsequent rise in hospitalizations

The rapid expansion of the elderly population is also leading to a higher prevalence of chronic health conditions such as diabetes, cancers, cardiovascular ailments, stroke, and respiratory ailments. This increase is likely to assert pressure on healthcare systems to be able to provide adequate care and treatment to these patients.

In 2017, emergency department visits from patients suffering from at least one chronic condition accounted for nearly 60% of the cumulative annual visits, incurring an expenditure of nearly $8.3 billion.

Furthermore, over 90 million U.S residents suffer from at least one chronic condition, with seven out of 10 individuals succumbing to a chronic ailment. These numbers indicate a strong need for effective medical equipment including sophisticated medical beds.

While there are several healthcare systems put in place for the treatment of acute medical issues, many facilities are not equipped to deal with chronic ailments and long-term care. Given the prolific rise of chronic disease cases, medical bed industry players are taking consistent efforts towards developing revolutionary healthcare solutions geared towards long-term treatment.

The emergence of new healthcare technologies

For hospitalized patients, hospital bed security is characterized by sporadic visits from nurses and doctors. Due to this, any potential decline in the patient’s clinical condition may go unnoticed for a period of time, causing a delay in treatment administration and increasing the risk of mortality or morbidity.

However, in recent times, many up and coming technologies are coming into existence, designed to combat this issue and mitigate risks associated with hospitalization.

In fact, the digital healthcare sector is expected to hit $536.6 billion by 2025.

One of the most prominent advancements in the medical bed industry is brought forth by Hill-Rom, a multinational medical technologies provider and the foremost hospital bed producer in the world. Hill-Rom has unveiled a new technology called EarlySense, designed to integrate with Hill-Rom’s Centrella Smart+ bed platform and provide continuous, contact-free monitoring solutions including heart and respiratory rate sensing and analytics system.

Additionally, a new study published in an American Society for Microbiology journal has revealed that using copper as a component in ICU medical beds would harbor an average of 95% less bacteria than conventional beds, ensuring low-risk levels among hospitalized patients.

Source: https://www.gminsights.com/industry-analysis/medical-bed-market

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How Technology Can Make Health Care Cheaper and More Efficient

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As the rising costs of health care remain a major concern for consumers, industry experts say new technology could help reduce costs and increase efficiency — a potential win-win for patients and providers.

The way advancements in technology could work for both involves the accumulation and distribution of patient data, says Alex Zlatin, CEO of Maxim Software Systems (alexzlatin.com).

“Whether it’s related to doctors’ offices, specialists, hospitals or oral care, data is the foundation to curb costs,” says Zlatin, the author of Responsible Dental Ownership. “Data is the key to delivering accountable, affordable and informed care.

“While many have struggled to use data effectively, the time is ripe for the industry to become data-driven and, with that, align costs, procedures, and outcomes. Researchers and innovators are bringing medical care and the dental industry into a new era of trying to improve effectiveness and curb the cost of care. But it’s the responsibility of providers and their offices to stay current with data management practices to help make this all work.”

Zlatin offers the following points about technology’s impact on data accessibility, and the associated benefits, in health care:

Telehealth and consumer technology. These are playing larger roles in supporting new health care delivery models, with companies like Apple and Uber getting involved. Apple has developed mobile apps and Uber is launching a medical-transit program. “Both examples speak to another shift pushing the industry toward value-based care: consumerization,” Zlatin says. “Patients are bearing a larger portion of costs, and with more options for where to get care, they are becoming more discerning and demanding.”

Exchange of patient data. This is one technology evolution that’s already helping health care reduce costs and increase efficiency. “It allows doctors to better understand the context of a patient’s overall health,” Zlatin says. “Improving the integration of the electronic health record means labs, care plans, and medical histories from different sources are available quickly. Thus the provider can make a clear diagnosis and develop the most effective care plan in less time.”

Full digital office management systems. Having a digital system streamlines record-keeping. In dental offices, digital processes keep the provider and patient informed regarding hygiene appointments, future treatments and account balances.”Having a scheduling system, billing and personal information, charts and integrated X-rays all by digital means makes for a more efficient practice and enhances the patient experience,” Zlatin says.

Wearable devices and patient lifestyle. Information from wearable health devices incorporate valuable data about patient health behaviors, including heart rate, sleep patterns, physical activity and calorie burn. “Those different factors will integrate into decision-making for your health,” Zlatin says. “Expanded access to data also can help manage patients’ costs. Providers will have access to information such as current benefits offered by insurance providers, based on a patient’s health profile.”

-More importance on data protection. Patient privacy must remain a priority for technologists and providers. “Advancements in technology and data integration heighten the importance of patient record protection,” Zlatin says. “Large volumes of data bring ethical concerns about proper use of patient information. There needs to be a regulatory component to ensure tools are used properly and to protect the patients. And choosing the right partner to manage data will become even more critical.”

“The future of health care includes technology that could seamlessly combine data on a patient’s medical history, real-time health, insurance coverage, and financial information,” Zlatin says. “All of that can support provider decision-making, improve patient health, and reduce costs.”

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Alex Zlatin, author of the book Responsible Dental Ownership (alexzlatin.com), had more than 10 years of management experience before he accepted the position of CEO of dental practice management company Maxim Software Systems. He earned his MBA at Edinburgh Business School and a B.Sc. in Technology Management at HIT in Israel.

His company helps struggling dental professionals take control of their practices and reach the next level of success with responsible leadership strategies.