Michael Zilbershlag, Co-Founder and CEO Closely-held Leviticus Cardio of Israel is developing a wireless system capable of providing day-to-day power needs for implanted ventricular assist devices (VADs), eliminating the complications that congestive heart failure (CHF) patients face with existing VADs. “Our solution uses a unique proprietary technology called, coplanar energy transfer (CET), that has the potential to work with all available commercial VADs,” Michael Zilbershlag, co-founder and CEO, says in an interview with BioTuesdays. “VADs are increasingly in use to support patients with severe heart failure as an alternative for thousands of patients who are candidates for heart transplantation each year,” he adds. CHF is a common disease in the developed world, affecting some 23 million people worldwide. Of the six million people who suffer from CHF in the U.S., 250,000 have severe CHF, which has a low chance of survival and results in a very poor quality of life. The gold standard treatment for these patients is a heart transplant or treatment with a VAD. According to recent estimates from the National Institutes of Health, 50,000-to-100,000 patients in the U.S. are currently eligible for a VAD implant. Mechanical pumps now on the market are charged by a driveline power cord that protrudes from a patient’s abdomen and is connected to batteries or plugged into an electrical outlet. Patients must always have backup batteries on hand. “Driveline maintenance is a major quality of life issue for current VAD users,” Mr. Zilbershlag says. To prevent infection, patients undergo complex cleaning and dressing procedures to anchor the driveline. Mr. Zilbershlag explains that Leviticus Cardio’s technology uses a receiver inductive coil implanted in the body alongside a VAD, coupled with a battery and an internal controller. “An external coil, which is in a belt surroundings the chest for easy carrying, charges the inner coil electromagnetically,” he adds. In existing technology, to be successful, the transmitter and receiver must be aligned, so the energy is transferred through the small area of skin that separates them. In Leviticus’ technology, the transmitting is more robust, and the alignment isn’t an issue. The Leviticus battery lasts for around eight hours, after which the user needs to wear a vest for charging. A wrist monitor is used to keep track of the VAD, coupled with an internal vibration alarm that is triggered by a major hazard such as low battery power. The technology also includes a wire-based backup charging system that uses an internal power cable connected to the VAD. The cable passes under the neck skin and provides a skull-mounted "socket" behind the ear, Mr. Zilbershlag says, adding that the backup wire system will become a barrier for competition. System Components “Our wireless technology would allow patients to walk around without any physical impediments for up to eight hours a day, which represents a major leap in the quality of life for these severely ill patients,” he adds. “Our CET system also is an economically superior choice to external driveline systems, whose annual maintenance costs approach $20,000 per patient-year.” The company has 10 approved and four pending U.S. patents, covering wireless energy transfer into the human body and its related VAD implementations. There are an estimated 1.1 million people in the U.S. hospitalized annually with CHF, with hospitalizations growing 50% every five years, according to the American Heart Association. The available VAD market is some $14-billion a year. In February, Leviticus announced the first successful human implant on a compassionate basis of a fully implanted Jarvik Heart VAD with its CET powering system at the National Research Center for Cardiac Surgery in Astana, Kazakhstan. The procedure was published in the peer-reviewed Journal of Heart and Lung Transplantation. Mr. Zilbershlag says Leviticus plans to conduct an initial clinical trial with approximately 10 patients with the Jarvik pump before the end of 2019 and then seek an investigational device exemption (IDE) from the FDA. It plans to apply to the FDA to conduct an IDE study in the U.S. to collect data on the technology’s safety and efficacy in the second half of 2020. “In parallel, we will start development to incorporate our CET technology with any fully implanted VAD product,” Mr. Zilbershlag says, adding that the company plans to begin clinical studies with this second VAD at the start of 2022. “Our goal is to show that patients can expect an improved quality of life with Leviticus’ fully implanted VAD because they will be free from external equipment for many hours a day,” he contends. • • • • •To connect with Leviticus Cardio, or any of the other companies featured on BioTuesdays, send us an email at editor@biotuesdays.com. via Features | BioTuesdays by Kilmer Lucas http://bit.ly/2ZK89N7
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Susan Linna, Managing Director Life Sciences As managing director, life sciences specialty services at BDO, the global professional services firm, Susan Linna has more than 25 years of drug, vaccine and biologic development experience, 13 of which were at a Fortune 100 pharmaceutical company, and 13 years in biotechnology. Ms. Linna started her career as a biostatistician and later took a leadership position building project management departments for biotechnology companies. She has led the creation of integrated product development plans, created joint plans for complex collaborations, and successfully managed these partnerships. She has also led teams to shepherd several product candidates successfully through development and obtain licensure through the FDA and other regulatory agencies. In this interview with BioTuesdays, Ms. Linna discusses the origin and expansion of BDO’s technical and operational life sciences services. When did you join BDO and what was the motivation? My route to BDO began with a strong relationship between Eric Sobota, national leader of BDO’s industry specialty services and life sciences practice, and his team at BDO. I was in the industry, and we worked with Eric’s team on multiple projects to assist with government proposals and financial compliance support for our government contracts funding research and development. Eric and his team helped my company secure more than $200-million in funding from the government and our relationship grew from there. I joined BDO in 2012, and Eric and I developed a plan to expand our team and technical consulting services. What are some of the life sciences services BDO provides? Our life sciences practice provides guidance to pharmaceutical, biotech, and medical device companies at every stage of a company’s lifecycle. If you are familiar with the standard metrics for this industry’s success rate, which can be around $2-billion in upfront costs before a product is approved, you recognize it is an extremely high-risk endeavor. Our main objective is to help our clients overcome technical or operational hurdles as quickly as possible to save time, reduce costs and successfully obtain product approval. Our services include product development support such as chemistry, manufacturing and controls (CMC), regulatory, project management, clinical operations, commercial strategy, product pricing and more. I believe BDO’s deep industry experience - now bolstered by the addition of BioProcess Technology Consultants (BPTC) - and commitment to client services set us apart from competitors. Can you describe project management services in life sciences? Project management is a skillset that integrates activities across all technical functional lines in the industry. It takes significant resources and support to discover, develop, license and commercialize a biopharmaceutical. The process from discovery to approval is typically an average of 10 years or more. The project manager’s job is to work with a team of technical specialists, scientists and MDs to formulate and execute on a project plan and timeline. Of course, product development is rarely predictable, so project management is also responsible for working with the team to develop and execute a risk management plan to minimize the impact of technical hurdles that result in timeline delays and added costs. Who is a typical BDO client? Our typical clients tend to be small-to medium-sized biotech companies that are developing large molecule products, such as monoclonal antibodies and vaccines. Some of the reasons they seek our support include limited in-house experience, financial resource constraints and a desire to pursue government funding to offset the high costs of late-stage development. Of course, not all clients fit this mold. Let’s talk about the expansion of BDO’s technical and operational life sciences services. On April 1, we acquired BPTC, a provider of CMC consulting and related services to the global biopharmaceutical industry. Joining forces with BPTC strengthens our ability to offer a broader range of services and to continue to assist life sciences companies in managing risk, maximizing profitability and fostering continued innovation to unlock new value and deliver improved outcomes. A total of 26 professionals from BPTC joined BDO, including 13 PhD’s, and Howard Levine, PhD founder, president and CEO. We’re so pleased to expand with a team of true industry leaders. How will the acquisition impact BDO? This acquisition will be extremely beneficial for our life sciences clients and for all internal BDO folks who work within the industry. The acquisition of BPTC allows us to provide a more comprehensive suite of services for clients to find the support they need to overcome challenges or to make necessary improvements to product development. BPTC has an experienced team adept at resolving technical challenges, assisting clients navigate regulations such as current good manufacturing practices, conducting cost of goods analyses and due diligence efforts, quality and regulatory compliance as well as many related aspects of producing biopharmaceuticals. BPTC has been rebranded at BDO as the BioProcess Technical Group (BPTG), and BDO will continue to offer specialized life sciences services through our life sciences consulting and government contracting groups. We believe BPTG will be an extraordinary practice and will open other doors for growth outside the U.S., as well. BPTG has clients around the world, including China, India and other countries where biopharmaceutical and drug manufacturing is done. Biotechnology is on the rise internationally, and we anticipate growth in several countries around the world that play a significant role in product development and manufacturing. When does a CMC group get involved with product development? Surprisingly, very early. Early process development activities initiate as soon as a company identifies a viable molecule that passes muster to enter preclinical development. The CMC group’s primary responsibility is to develop a process, analytical testing methods and all the associated activities to produce preclinical and clinical trial materials for investigative studies. As the product candidate advances in development, the CMC activities ramp up in parallel to develop more sophisticated and commercial scale processes and methods. In short, CMC is one of the most critical functions in the industry and they are engaged throughout the lifecycle of product development. Are there aspects of CMC that BDO might expand? We are always exploring new opportunities for growth. One of the more critical sub-specialties of CMC is regulatory compliance, which large pharmaceutical companies often have in-house. However, many small-and mid-sized biotech companies may not have the specific experience in-house that complements their product portfolio in development. Additionally, there is demand for regulatory experience in the industry, as navigating the regulatory pathway to FDA licensure can be complex. Another challenge for small-to mid-sized firms is that they typically rely on contract manufacturing organizations because they lack resources to build their own pilot plants and manufacturing facilities. This challenge applies to both biopharmaceutical products but also small molecule drugs and we view this as another opportunity for growth. Can you discuss BDO’s expansion planning in life sciences generally? There are several avenues for growth that are under discussion, but at this time, our focus is building strong relationships with our BPTG team and continuing stellar support for our current clients. We are very pleased to welcome a new team that has such critical experience and look forward to discovering creative ways to expand our services in the direction the market demands. • • • • •Connect with Susan Linna, or any of the other companies featured on BioTuesdays, send us an email at editor@biotuesdays.com. via Features | BioTuesdays by Kilmer Lucas http://bit.ly/2IAqy9Z Yesterday afternoon, Centric Health Corporation (TSX: CHH), a company focused on providing pharmacy and other healthcare services to Canadian seniors, issued an update on its recent medical cannabis initiatives.
During the first quarter of 2019, Centric Health continued the implementation of its medical cannabis strategy with Canopy Growth Corporation ("Canopy Growth"), its strategic partner. To date, Centric Health's clinical pharmacists have led several prescriber information evenings, as well as staff, resident and family education sessions, at long-term care and retirement homes. The Company's implementation plan remains on track and revenue generation has commenced through deliveries to the first 50 patients. Centric Health expects the adoption of medical cannabis to quickly accelerate as seniors, home care operators and medical practitioners continue to be educated on the benefits and uses of medical cannabis. As part of its commitment to offering seniors full clinical oversight of their medical cannabis needs, Centric Health announced that it has collaborated with Apollo Cannabis Clinics ("Apollo"), one of Canada's leading medical cannabis research organizations, to assist with virtual assessments of potential medical cannabis candidates. Apollo's clinical team of physicians, healthcare practitioners and support staff will assist seniors in Centric Health serviced homes in determining if medical cannabis is suitable for them, as well as prescribing products and providing ongoing monitoring for eligible candidates. Centric Health will also be participating in the upcoming Ontario Long-Term Care Association ("OLTCA") medical cannabis pilot study, which is being led by Canopy Growth. The OLTCA study aims to measure how medical cannabis use can potentially displace other, less-desirable treatments and therapies in long-term care residents. In addition to participating in the study some of its serviced homes, Centric Health will be providing insight to the OLTCA's Cannabis Advisory Committee on the role of pharmacies in supporting medical cannabis use in long-term care homes. "Centric Health's participation in the OLTCA study demonstrates our commitment to the clinical validation and pharmacy oversight of medical cannabis in seniors housing," said David Murphy, Centric Health's President and Chief Executive Officer. "We always strive to deliver the highest quality of care to seniors, and our strategic partnerships with Canopy Growth and Apollo will help increase medical oversight and reduce barriers to access for seniors who may be eligible candidates for medical cannabis." ABOUT CENTRIC HEALTH Centric Health's vision is to be the leading provider of pharmacy and other healthcare services to Canadian seniors. The Company is one of Canada's leading, and most trusted providers of comprehensive Specialty Pharmacy services and solutions to seniors. We operate a large national network of pharmacy fulfilment centres that deliver high-volume solutions for the cost-effective supply of chronic medication and other specialty clinical pharmacy services, serving more than 30,000 residents in over 450 seniors communities (long-term care, retirement homes, and assisted living facilities) nationally. With services that address the growing demand within the Canadian healthcare system, Centric Health's unparalleled national care delivery platform provides significant potential for future expansion and growth. FORWARD-LOOKING STATEMENTS This press release contains statements that may constitute "forward-looking statements" within the meaning of applicable Canadian securities legislation. These forward-looking statements include, among others, statements regarding the Company's business strategy, plans and other expectations, beliefs, goals, objectives, information and statements about possible future events. Forward-looking statements generally can be identified by the use of forward-looking terminology such as "may", "will", "expect", "intend", "estimate", "anticipate" or similar expressions suggesting future outcomes or events. Such forward-looking statements reflect management's current beliefs and are based on information currently available to management. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those contemplated by such statements. Factors that could cause such differences include the Company's liquidity and capital requirements, government regulation and funding, the highly competitive nature of the Company's industry, reliance on contracts with key customers and other risk factors described from time to time in the reports and disclosure documents filed by the Company with Canadian securities regulatory agencies and commissions. These and other factors should be considered carefully and readers should not place undue reliance on the Company's forward-looking statements. As a result of the foregoing and other factors, no assurance can be given as to any such future results, levels of activity or achievements and neither the Company nor any other person assumes responsibility for the accuracy and completeness of these forward-looking statements. The factors underlying current expectations are dynamic and subject to change. SOURCE: Centric Health Corporation Padma Sundar, VP of Strategy and Market Access Closely-held CellMax Life has developed FirstSightCRC, the first blood test to identify precancerous adenomas, with accuracy similar to colonoscopies, when prevention of colorectal cancer (CRC) is possible. “Our CMx platform is optimized to selectively capture and identify precancerous adenomas and cancer cells that are shed into the blood in the lower gastrointestinal tract,” Padma Sundar, VP of strategy and market access, says in an interview with BioTuesdays. “The only real cure for cancer is finding it early,” Ms. Sundar says, noting that while colonoscopies are the gold standard for colon cancer detection, “compliance in the U.S. is only 38% because it is an invasive test.” While FirstSight could replace colonoscopy for screening, “we expect the highest adoption [will be] among the 53 million Americans 45 years and older who have never been screened,” Ms. Sundar suggests. This includes 20 million younger individuals who are between the ages of 45 and 50. New guidelines from the American Cancer Society (ACS) now recommend screening for this age group, compared with its previous guidelines to start screening at 50 years of age. “Colonoscopy will be the confirmatory diagnostic for our test just like it is for other stool and blood-based screening tests,” she adds. Ms. Sundar explains that the FirstSight liquid biopsy utilizes a patented technology consisting of a microfluidic chip with a proprietary nano layer for cell capture; high-affinity antibodies; a unique biomimetic process to effectively wash away unwanted cells, while retaining circulating tumor cells; and a special air-foam release technology to gently release the captured cells, enabling high intact cell preservation and high detection rates of precancerous cells. The process also includes algorithms for high throughput image analysis and reproducibility, she adds. While CRC is the second-leading cause of cancer deaths in the U.S., it is largely preventable with regular screening and treatable with early detection. Screening helps find precancerous polyps, or abnormal growths, so they can be removed before they have a chance to turn into cancer. According to estimates from the ACS, more than 100,000 new cases of colon cancer and almost 45,000 new cases of rectal cancer will be diagnosed in 2019, with some $14-billion spent on treatment. Finding and removing precancerous polyps can save lives. According to Ms. Sundar, precancerous adenomas account for more than 90% of actionable colonoscopy findings. A study published in the New England Journal of Medicine in 2012 found that adenoma removal reduced CRC mortality by 53% after a 16-year follow-up of subjects in the study. At the ASCO Gastrointestinal Cancer Symposium in January, CellMax presented results of a study in Taiwan with 737 adults 50 years of age or older, of which 301 were found to be healthy, 111 had precancerous adenomas and 325 were confirmed to have cancer by colonoscopy or tumor biopsy. “The test results presented a high accuracy for detecting colorectal cancer, with a close to 90% accuracy for pre-cancer and 95% accuracy for cancer,” Ms. Sundar points out. In addition to the 53 million people in the U.S. who have never been screened, estimates point to more than 15 million people who use at-home stool tests and 40 million who have colonoscopies. “It is our belief that people would overwhelmingly prefer to take a blood test for CRC screening over a stool test, especially if the blood test offered a high sensitivity to a precancerous condition,” she adds. The process also includes algorithms for high throughput image analysis and reproducibility, she adds. While CRC is the second-leading cause of cancer deaths in the U.S., it is largely preventable with regular screening and treatable with early detection. Screening helps find precancerous polyps, or abnormal growths, so they can be removed before they have a chance to turn into cancer. According to estimates from the ACS, more than 100,000 new cases of colon cancer and almost 45,000 new cases of rectal cancer will be diagnosed in 2019, with some $14-billion spent on treatment. Finding and removing precancerous polyps can save lives. According to Ms. Sundar, precancerous adenomas account for more than 90% of actionable colonoscopy findings. A study published in the New England Journal of Medicine in 2012 found that adenoma removal reduced CRC mortality by 53% after a 16-year follow-up of subjects in the study. At the ASCO Gastrointestinal Cancer Symposium in January, CellMax presented results of a study in Taiwan with 737 adults 50 years of age or older, of which 301 were found to be healthy, 111 had precancerous adenomas and 325 were confirmed to have cancer by colonoscopy or tumor biopsy. “The test results presented a high accuracy for detecting colorectal cancer, with a close to 90% accuracy for pre-cancer and 95% accuracy for cancer,” Ms. Sundar points out. In addition to the 53 million people in the U.S. who have never been screened, estimates point to more than 15 million people who use at-home stool tests and 40 million who have colonoscopies. “It is our belief that people would overwhelmingly prefer to take a blood test for CRC screening over a stool test, especially if the blood test offered a high sensitivity to a precancerous condition,” she adds. The process also includes algorithms for high throughput image analysis and reproducibility, she adds. While CRC is the second-leading cause of cancer deaths in the U.S., it is largely preventable with regular screening and treatable with early detection. Screening helps find precancerous polyps, or abnormal growths, so they can be removed before they have a chance to turn into cancer. According to estimates from the ACS, more than 100,000 new cases of colon cancer and almost 45,000 new cases of rectal cancer will be diagnosed in 2019, with some $14-billion spent on treatment. Finding and removing precancerous polyps can save lives. According to Ms. Sundar, precancerous adenomas account for more than 90% of actionable colonoscopy findings. A study published in the New England Journal of Medicine in 2012 found that adenoma removal reduced CRC mortality by 53% after a 16-year follow-up of subjects in the study. At the ASCO Gastrointestinal Cancer Symposium in January, CellMax presented results of a study in Taiwan with 737 adults 50 years of age or older, of which 301 were found to be healthy, 111 had precancerous adenomas and 325 were confirmed to have cancer by colonoscopy or tumor biopsy. “The test results presented a high accuracy for detecting colorectal cancer, with a close to 90% accuracy for pre-cancer and 95% accuracy for cancer,” Ms. Sundar points out. In addition to the 53 million people in the U.S. who have never been screened, estimates point to more than 15 million people who use at-home stool tests and 40 million who have colonoscopies. “It is our belief that people would overwhelmingly prefer to take a blood test for CRC screening over a stool test, especially if the blood test offered a high sensitivity to a precancerous condition,” she adds. The process also includes algorithms for high throughput image analysis and reproducibility, she adds. While CRC is the second-leading cause of cancer deaths in the U.S., it is largely preventable with regular screening and treatable with early detection. Screening helps find precancerous polyps, or abnormal growths, so they can be removed before they have a chance to turn into cancer. According to estimates from the ACS, more than 100,000 new cases of colon cancer and almost 45,000 new cases of rectal cancer will be diagnosed in 2019, with some $14-billion spent on treatment. Finding and removing precancerous polyps can save lives. According to Ms. Sundar, precancerous adenomas account for more than 90% of actionable colonoscopy findings. A study published in the New England Journal of Medicine in 2012 found that adenoma removal reduced CRC mortality by 53% after a 16-year follow-up of subjects in the study. At the ASCO Gastrointestinal Cancer Symposium in January, CellMax presented results of a study in Taiwan with 737 adults 50 years of age or older, of which 301 were found to be healthy, 111 had precancerous adenomas and 325 were confirmed to have cancer by colonoscopy or tumor biopsy. “The test results presented a high accuracy for detecting colorectal cancer, with a close to 90% accuracy for pre-cancer and 95% accuracy for cancer,” Ms. Sundar points out. In addition to the 53 million people in the U.S. who have never been screened, estimates point to more than 15 million people who use at-home stool tests and 40 million who have colonoscopies. “It is our belief that people would overwhelmingly prefer to take a blood test for CRC screening over a stool test, especially if the blood test offered a high sensitivity to a precancerous condition,” she adds. Earlier this year, CellMax initiated its Zenith study in the U.S., with the goal of enrolling several hundred patients who are 45 years and older. The study is being done under Institutional Review Board approval to ensure patient safety and privacy. Prior to undergoing a colonoscopy, subjects will provide a blood sample for a FirstSight test so that results can be compared. The study protocol will group subjects into two categories: negative or healthy; or positive, meaning they are likely to have adenomas or colorectal cancer. Ms. Sundar says the sample sizes will be sufficient to demonstrate sensitivity within each group and specificity for healthy populations. The primary objective of the Zenith study is detection of precancerous adenomas and CRC, with initial data expected in the second half of 2019. A positive outcome would enable CellMax to commercialize the FirstSight test at its CLIA-accredited lab in Sunnyvale, Calif. However, Ms. Sundar says that longer term, CellMax may also consider a separate study to seek FDA approval for FirstSight. “The advantage of FDA approval is that it would allow us to transfer the technology to reference labs around the country to expand usage of FirstSight,” she says. “We’ve had a lot of interest from national reference labs in adding this test to their offering since there is no other blood test for preventative colon cancer screening.” • • • • •To connect with CellMax Life, or any of the other companies featured on BioTuesdays, send us an email at editor@biotuesdays.com. via Features | BioTuesdays by Kilmer Lucas http://bit.ly/2IzQuBJ Kenneth Londoner, Founder, Chairman and CEO With the FDA’s 510(k) clearance of its PURE EP System in August 2018 and first successful patient cases, BioSig (NASDAQ:BSGM) is advancing its vision to improve medicine through biomedical signal processing. “Our larger focus is on bioelectronic medicine, a new field of healthcare, which uses biomedical signals to develop new tools to help treat challenging diseases, such as heart conditions, hypertension, diabetes and chronic pain,” Kenneth Londoner, founder, chairman and CEO, says in an interview with BioTuesdays. BioSig’s first product, PURE EP System, has been designed to provide enhanced cardiac signals during the procedures used to treat abnormal heart rates and rhythms. “PURE EP aims to minimize the effect noise and other electrical interference in the electrophysiology (EP) lab has on cardiac procedures. The system creates high-fidelity cardiac signals, which may provide better data to a physician, potentially improving the accuracy and efficacy of catheter ablation procedures used to treat arrhythmia, atrial fibrillation and ventricular tachycardia,” he adds. Mr. Londoner explains that PURE EP consists of both hardware and software platforms. BioSig’s hardware amplifies and converts a patient’s electrocardiogram (ECG) data into a digital signal for further processing by the company’s software, which “displays signals that can be undetectable in existing systems,” he contends. PURE EP™ System Comprises Two Proprietary Technologies These high fidelity, real time recordings might provide physicians performing cardiac ablations with higher clarity graphic displays of the electrical functioning of the heart. “This is not a trivial task,” Mr. Londoner says, adding that BioSig engineers spent more than seven years developing the technology. The medical literature for years has documented suboptimal outcomes of current cardiac ablation procedures that could be enhanced with increased ECG clarity. Mr. Londoner says the FDA head for EP in 2017 called for “technical innovations in catheter ablation to improve the safety, effectiveness and procedural efficiency” when physicians remodel the heart’s electrical conduction system. BioSig’s current Class 2 approval as a medical device allows the company to make only technical claims about PURE EP. “We make no clinical claims at this point because we are essentially a computer system that does not enter the body and we are in the process of generating clinical data,” he adds. “However, our system was designed by doctors, for doctors.” The PURE EP System is indicated as a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing EP procedures in an EP laboratory. The system is used by licensed healthcare practitioners who are responsible for interpreting the data. In February 2019, BioSig successfully conducted first patient cases at the Texas Cardiac Arrhythmia Institute (TCAI) in Austin, where the PURE EP concept was developed in 2011. TCAI is widely recognized as one of the leading research, training and treatment facilities in the country, which is dedicated to heart rhythm disorders. “With the use of the PURE EP System, I was able to identify cardiac signals that were previously undetectable to me,” Dr. Andrea Natale, Executive Medical Director of TCAI, said in a statement. “I believe that the PURE EP System could change diagnostic and treatment strategies of arrhythmias, leading to more successful outcomes.” Arrhythmia: A Challenging, Costly Disease Some five million people in the U.S. have atrial fibrillation, which leads to 750,000 hospitalizations each year and can greatly increase the risk of stroke. The estimated annual health care costs per atrial fibrillation patient are $15,000-to-$25,000. Ventricular tachycardia is more rare, but is responsible for some 300,000 sudden cardiac deaths a year in the U.S. Individuals with ventricular tachycardia almost always have symptoms of heart failure. “One of the reasons we started BioSig was to make a difference in atrial fibrillation,” Mr. Londoner says. Additional clinical cases are scheduled to take place at Mayo Clinic, which has conducted around 15 preclinical studies of PURE EP since 2014. In 2017, BioSig and Mayo Clinic began collaborating under a 10-year accord that, among other things, could lead to developing advanced clinical features of PURE EP and explore additional applications of BioSig’s technology outside of electrophysiology. A Mayo Clinic peer-reviewed article in the Journal of Innovation and Cardiac Rhythm Management in 2017 suggested that with BioSig’s expanded capabilities, Mayo could potentially map neuron signaling throughout the body and potentially diagnose and develop new therapies for a range of diseases in neurology and ophthalmology. Earlier this year, BioSig hired John Kowalski as VP of sales to lead market launch efforts of PURE EP. “We are planning to introduce our system into several centers of excellence, and continue our commercial expansion in 2020,” Mr. Londoner says. The company also plans to build a commercial team of educators, system trainers and clinical support staff in 2019 and expects to record initial revenues by the end of 2019. BioSig also expects to submit a European CE Mark application later in 2019 and plans to establish its own European sales and marketing teams for PURE EP, he adds. According to Mr. Londoner, a key objective for 2020 is publishing clinical study results to drive further adoption of PURE EP in the U.S. and internationally. “PURE EP works in parallel with other lab systems and does not compete head-to-head with big medical device makers,” he points out. “Heart rhythm disturbances are debilitating conditions, which significantly increase risks of many other serious diseases, and we are hoping to play our part in improving an overall clinical experience in the lab, which will hopefully lead to better outcomes for patients.” • • • • •To connect with BioSig, or any of the other companies featured on BioTuesdays, send us an email at editor@biotuesdays.com. via Features | BioTuesdays by Kilmer Lucas http://bit.ly/2D6dBAf Sonna Patel-Raman, President Closely-held NuPulseCV is enrolling patients with advanced heart failure in a feasibility study with its intravascular ventricular assist system (iVAS), a minimally invasive heart pump designed to allow patients to be discharged from hospital and resume their daily activities. “The focus of iVAS therapy is to support a heart that is weakened by advanced heart failure in order to improve blood flow, carrying nutrients and oxygen throughout the body,” Sonna Patel-Raman, president, says in an interview with BioTuesdays. Dr. Patel-Raman explains that the iVAS system is a balloon-like device placed in the descending aorta. The device is inserted through the left or right subclavian artery, just below the collarbone, through a two-inch incision, and fed into the descending aorta, where it inflates and deflates. This counterpulsation reduces pressure that the heart must work against, making it easier for the heart to pump blood to the body. The pump is controlled by a small drive unit contained in a satchel that can be worn over the shoulder. The placement of electrodes under the skin and a skin interface device enables communication between the implanted components and the external drive unit. iVAS - Intravascular Ventricular Assist System “The iVAS is the first minimally invasive, long-term, ambulatory counterpulsation device that is designed to work in sync with the heart,” says Rebecca Cogswell, assistant professor of medicine and co-investigator of the study at the University of Minnesota. “It is a potential option for someone who has advanced heart failure and is no longer benefiting from medications and cardiac resynchronization therapy (CRT),” a type of electrical therapy,” she adds. Dr. Cogswell reports that in this patient population, individuals with New York Heart Association (NYHA) Class 3 and 4 heart failure, have advanced disease. She points out that patients with resting shortness of breath, despite optimal medical therapy (NYHA Class 4), have a mortality of 70% at one year, without advanced therapies such as a heart transplant or a left ventricular assist device. Heart Failure Progression - Available Therapies and Gaps The iVAS is a minimally invasive, intermediate support device that fills an important gap in the field of mechanical support, with many potential roles, Dr. Cogswell says. “This device can be used as a bridge to recovery, bridge to transplant, and as a bridge-to-decision regarding candidacy for transplant or left ventricular assist device.” Citing the minimally invasive design of the iVAS system, Dr. Cogswell says that her patients have been up and walking on the day of the surgery, have transitioned out of the ICU quickly, and have been able to be discharged home. In January 2018, the results of the company’s first-in-human trial of iVAS were published in the peer-reviewed Journal for Heart and Lung Transplantation. Fourteen bridge-to-transplant patients were enrolled in the trial and 13 were implanted with an iVAS device. The primary endpoint was survival of patients to transplant or stroke-free survival at 30 days. At the conclusion of the trial, 12 of the 13 iVAS-implanted patients successfully met the primary endpoint. NuPulseCV has implanted over 50 patients with plans to enroll up to 100 with advanced heart failure in its feasibility study in the U.S. and Canada, with results to be published later in 2019. The study is designed to demonstrate whether iVAS can support patients longer-term and improve quality of life. Dr. Patel-Raman says the company plans to initiate a pivotal study with NYHA Class 3 and 4 patients in the second half of 2019 and obtain FDA approval for commercialization in 2021. To fund the pivotal trial, NuPulseCV is seeking $40-million from current and new investors to cover patient recruitment and enrollment, and site start-up and ongoing expenses for the trial. * “We don’t see ourselves competing with VADs and CRT but would like to offer patients another option before requiring open-heart surgery to implant a VAD,” she adds. “As a bridge-to-decision device for a patient who could recover, is waiting to be transplanted, or needs longer-term support, we are the ultimate ‘why not’ device.” • • • • •*This article does not constitute an offer to sell or the solicitation of an offer to buy any securities of NuPulseCV, and shall not constitute an offer, solicitation or sale of any security in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. • • • • •To connect with NuPulseCV, or any of the other companies featured on BioTuesdays, send us an email at editor@biotuesdays.com. via Features | BioTuesdays by Kilmer Lucas https://ift.tt/2FR1tVE |
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