Hrishikesh Suresh, CEO As CEO and one of three co-founders of upstart NeuroGate, Hrishikesh Suresh currently is completing his final year as a medical student at McMaster University in Hamilton, Ontario and plans to pursue a six-year residency in neurosurgery. But since the age of 12, he has had a passion for computer coding and, as a result, contributed to the company’s software development, which aims to capture motion data as a method to diagnose neurodegenerative diseases. In this interview with BioTuesdays, Mr. Suresh, who plans to continue with his neurosurgical residency and remain active in developing NeuroGate, discusses his enthusiasm for merging neuroscience and surgery with machine learning and artificial intelligence. Let’s begin with a brief history of the company. I met our co-founders, Declan Goncalves and Zeqi Cui, at a hackathon at Harvard, where we discussed developing an application to incorporate hand motion data with a diagnosis of Huntington’s disease, a progressive degeneration of nerve cells in the brain that usually results in movement, cognitive and psychiatric disorders. The proof-of-concept application was so well received that we began to think about applying the capture of motion data to the diagnosis of other degenerative diseases. That led us to set up NeuroGate in October 2016. Can you give us an overview of the technology? Neurodegenerative diseases damage parts of the brain that control motion and result in characteristic abnormalities that can be observed in the way people walk. And each disease causes a different abnormality. What our technology does is capture motion information from 26 joints in the body. We have our own algorithms that process that motion data, sending it into a neural network, where it is analyzed into a diagnosis of a degenerative disease. What does the system consist of? We have a Kinect sensor, which is used essentially as a camera on a tripod, that’s hooked up to a laptop computer, running our software. The sensor watches a person walk and captures the motion data. All the analysis is done in about 15 seconds, which compares with months of waiting for a referral to a neurologist. The system also has the potential to look for symptoms of several diseases at once, with only a single test. NeuroGate utilizes a single 3D positioning camera to accurately track a patients body profile. What’s your focus currently? We’re trying to differentiate between various neurodegenerative diseases, with our current focus on Parkinson’s disease, Parkinson’s-plus syndrome and Huntington’s disease. In essence, we’re leveraging the power of machine learning to measure the impact of a neurodegenerative disease on gait. We also capture various aspects of posture that give us even more data. Where does the technology go from there? We are also planning to move from a tripod based capture system to something much more mobile. This is on our roadmap already. And there are other neurodegenerative disease we intend to investigate, such as ALS and MS. And then we hope to expand beyond neurodegenerative diseases and pursue diagnosis of any physical problems that lead to abnormality of motion. General motion-capture and analysis is our goal. What are some of the clinical and regulatory hurdles ahead? We have established the proof-of-concept of the NeuroGate system. Since this is a non-invasive procedure, it should require minimal regulatory approval as a medical device. But to be established in a clinical setting, we will need published data that can validate the accuracy of our system. We will be collecting that data over the next few months. At the same time, we’re making some changes that will enhance the system’s accuracy. Have you had any feedback from the medical community? Doctors are very interested in a solution that can more easily clarify the diagnostic process of a neurodegenerative disease. We have a range of doctors that already have expressed an interest in installing this in their practice when we go to market and others that are following our progress. We are also at the point of beginning to look for avenues of funding to accelerate our development and get to market. Do you have the outline of a business model? We expect our business model will involve the sale of hardware and software-as-a-service. We haven’t priced the system as yet but it will not cost doctors thousands of dollars a month. When do you expect to be on the market? Our current timeline is early-to mid-2019, which will allow us to finish development and publish research to validate the technology. Our system is applicable to both the U.S. and Canada because both heath care systems share a general lack of neurologists. More information is available at www.neurogate.ca or at infor@neurogate.ca via Features | BioTuesdays by Kilmer Lucas IR http://ift.tt/2wTeTZy
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A new social enterprise, 123Genetix, has developed a novel systems biology platform capable of evolving complex rare disease specific computer models. These models can be individualized by rare disease researchers to: (1) develop new hypotheses; (2) design and run experimental simulations to test those hypotheses; (3) write better grants; and, (4) discover potential biomarkers. The Unmet Need: A rare disease is generally a disease that affects a small percentage of the population. However, rare diseases are more common than you might think. There are more than 7,000 known rare diseases affecting over 300 million people worldwide. That’s almost the size of the population of the United States. In North America, rare diseases affect 8% to 10% of the population. About 80% of rare diseases have a genetic basis and 50% of rare diseases affect children. Unfortunately, less than 50% of known rare diseases have organizations to advocate on behalf of patients and their families. Compounding this ongoing problem is the ever increasing competition for limited and diminishing resources supporting rare diseases research.
An AI-Based Solution: 123Genetix has developed DeepNEU --- a highly novel deep learning computational platform that combines (1) extensive and publicly available rare diseases gene network data with (2) modified Neutrosophic Logic, and (3) features of deep artificial neural netwroks and Support Vector Machines. The current version (v2.1) of DeepNEU continues to undergo testing and has been used to generate beta versions of several rare disease models for which the underlying genetics and clinical features are reasonably well characterized. A few examples of such well characterized diseases are Cystic Fibrosis, Duchenne Muscular Dystrophy and Sickle Cell Disease. These system biology models are easily customized and in the coming weeks we will be reaching out to key opinion leaders and rare disease researchers. The purpose of these advanced models is to empower rare disease researchers to: (1) develop new disease hypotheses; (2) design and run experimental simulations to test those hypotheses; (3) write better grants and (4) identify potential disease specific biomarkers. While DeepNEU itself is not a drug discovery engine, the identification of novel biomarkers should drive future research towards new and effective therapies where none exist now. For more information on 123Genetix and DeepNEU, visit the organization's website at www.123Genetix.com and follow @123Genetix on Twitter. John Arnone, chairman and CEO American CryoStem (OTC:CRYO) has developed platform technologies dedicated to the collection, processing, bio-banking, culturing and differentiation of adipose tissue and adipose derived stem cells (ADSCs) for current or future use in regenerative medicine. “Fat tissue contains 100-to-1,000 times more mesenchymal stem cells than bone marrow, is far less invasive to collect and can be collected in greater amounts,” John Arnone, chairman and CEO, says in an interview with BioTuesdays. For many years, the medical industry has been working with bone marrow stem cells, umbilical cord blood stem cells and peripheral blood cells in order to develop regenerative therapies. “We are a new player in the field using fat tissue,” he contends, adding that the company can generate multiple products from a single tissue source. American CryoStem provides end-to-end commercial adipose solutions beginning with CELLECT, a validated tissue collection and transportation system for a fat tissue sample collected by a physician. The tissue is sent to the company’s lab, where it is processed to an ATGRAFT sample that can be processed, stored and retrieved for use as natural fillers for cosmetic procedures. According to Mr. Arnone, a growing number of people in the U.S. and Asia are visiting their physician to extract a few ounces of their own fat tissue and cryo-preserving the pure tissue or the stem cells for future use in the event they are diagnosed with a disease so they could have a personalized treatment available to them. Stem cells also are being used to create personalized skin care products that are used by cosmetic and plastic surgeons to topically regenerate skin, he adds. Mr. Arnone says the company has expanded its FDA-registered tissue lab in New Jersey to meet demand, and has licensed its technology to labs in Hong Kong, China and Japan. American CryoStem’s core platform serves multiple markets in the regenerative medicine industry, including cosmetic and reconstructive procedures, cell therapy and cell culture and media. Cellular Platform Products “Over the past eight years, we have strategically transitioned from a developmental-stage company in an early market environment to a fully operational, commercial stem cell processing and cryo-banking facility, supporting the rapidly expanding regenerative medicine Industry,” Mr. Arnone points out. The company’s cellular processing platform was developed to allow the company, partners and other cellular therapy developers to quickly develop products without having to recreate the necessary underlying technology of collecting, processing and storing each new product. American CryoStem provides end-to-end commercial adipose solutions beginning with CELLECT, a validated tissue collection and transportation system for a fat tissue sample collected by a physician. The tissue is sent to the company’s lab, where it is processed to an ATGRAFT sample that can be processed, stored and retrieved for use as natural fillers for cosmetic procedures. Mr. Arnone explains that patients have the ability to use their stored adipose tissue for multiple cosmetic augmentations of the breast and buttocks or volume corrections in the hands, face and neck. “When you and your physician decide on a follow up cosmetic procedure,we deliver your cryopreserved tissue to your treating physician for immediate use,” he adds. The stored tissue can be further processed into additional ATGRAFT products for regenerative and personalized medical applications, including the company’s Autokine-CM topical skin care products, which are unique to each individual, and mesenchymal stem cells, using stromal vascular fraction of adipose tissue. Mr. Arnone explains that the cytokines, growth factors and matrix proteins that comprise each Autokine-CM sample provide user specific anti-aging and preventative benefits that appear to rejuvenate damaged skin. The company’s ATCELL adipose derived adult stem cell products are isolated from stored ATGRAFT samples and can be further expanded or differentiated using American CryoStem’s line of patented ACSelerate animal-free media products in order to be bio-banked for a patient’s future therapeutic use or sold for research. “Our near-term objectives are to accelerate marketing of our collect-process-store platform to physicians, clinics, and customers in the U.S.; continue to expand our international footprint of licensed laboratories that purchase our processing consumables; and to affiliate with off-shore treatment facilities while developing safe and effective cellular medicine applications for indications that represent a large unmet need globally,” Mr. Arnone says. In addition to its Asian ventures, the company is in discussions to license its core lab processing modules, cell banking technology and synergistic products in Australia, the Middle East, Brazil and the Caribbean islands, where stem cell medical tourism is a thriving industry. via Features | BioTuesdays by Kilmer Lucas IR http://ift.tt/2w5EgYi Ron Babecoff, founder, president & CEO BiondVax Pharmaceuticals (NASDAQ, TASE:BVXV) expects to be Phase 3 ready in 2018 to begin pivotal testing in Europe of a universal flu vaccine with the potential to provide multi-season and multi-strain protection against all human influenza virus strains, both seasonal and pandemic. “We have financing and successful Phase 2 trial results in hand to assess the safety and clinical efficacy of our M-001 vaccine in a pivotal Phase 3 trial,” Ron Babecoff, founder, president and CEO, says in an interview with BioTuesdays. The company plans to meet with the European Medicines Agency (EMA) and FDA to discuss the protocol for the pivotal trials, which would continue in the 2019 flu season and possibly in 2020, depending on whether seasons one and two have low “attack rates” of influenza. “Our go-to-market strategy for M-001 is to initially obtain regulatory approval as a standalone influenza vaccine in older adults and the elderly, and then extend the indication to other groups,” he adds. “We are also in the planning stages of a mid-size commercial manufacturing facility designed to supply some of the Phase 3 vaccines and tens of millions of commercial doses.” Seasonal flu in the U.S. results in 23,000 deaths, of which 90% are in the elderly, and 200,000 hospitalizations a year. According to a study in the International Journal of Epidemiology, the vaccination rate in the U.S. between 1989 and 1997 for people over the age of 65 rose to 67% from 30%, yet morality and hospitalization rates continued to increase. Dr. Babecoff cites a “mismatch phenomenon” for those trends because the previous season’s vaccine will not necessarily protect against next season’s flu strains. And while the average flu vaccine effectiveness in the general population stands at about 40%, it is as low as 9% in the elderly. Dr. Babecoff explains that nine common regions, or epitopes, of flu strains are connected to produce M-001. “This epitope-based approach induces cell-medicated immunity (CMI) and enhances a humoral immune response to flu,” he adds. M-001 has broad universal coverage, Dr. Babecoff contends, with a single formulation enabling year-round vaccination and quick, robust year-round production in six-to-eight weeks. Existing vaccines, on the other hand, are strain specific, requiring a new vaccine every year, with a long four-to-six month production cycle. Dr. Babecoff points out that the human immune system includes two arms: B-cells that produce antibodies and T-cells that produce cytokines known specifically for their anti-viral activities. He contends that existing flu vaccines mainly induce antibodies against specific flu virus strains. “Viruses are intracellular parasites, thus are mostly out of reach of our immune system’s antibodies. However, CMI targets viruses within the cells,” he adds. One for all: The Universal Flu Vaccine M-001 was designed to induce T-cells that target common and conserved regions of flu viruses, he suggests, and to produce anti-viral cytokines as well as a T-cell priming effect for enhanced B-cell responses. “As a result, M-001’s dual modes of action potentially can offer multi-season and multi-strain protection.” M-001 has been tested in six clinical trials with 698 young adults and the elderly, inducing T-cell and enhancing humoral immunity, with no treatment-related adverse events. BiondVax also has an ongoing collaboration with the NIH, which may test M-001 in the 2017 flu season with 180 adults in the U.S. aged 18-to-45. In July, BiondVax reported statistically significant positive safety and elevated T-cell immune responses from a Phase 2b clinical trial of M-001 that was conducted in collaboration with Europe’s UNISEC consortium. UNISEC consists of three university partners, five National Health Institutes and three small-and medium-sized enterprises, all with leading expertise in influenza vaccine research and development. In 2018, BiondVax plans to obtain “scientific advise” from the EMA for its Phase 3 program and have an end-of-Phase 2 meeting with the FDA to discuss a protocol that would be acceptable for registration of M-001. “There are no specific regulations for approval of a universal flu vaccine so we are all learning a procedure together,” Dr. Babecoff points out. BiondVax hopes to enroll some 7,500 older adults and the elderly in its pivotal study in European countries where there is no specific recommendation to receive a flu shot. The study’s endpoints would be clinical efficacy determined by a reduction in the illness rate and severity. Dr. Babecoff says a contract manufacturing organization in the U.S. will supply the first batch of M-001 for the pivotal program. BiondVax is currently in the planning stages to build a manufacturing plant in Jerusalem, which would supply vaccine for the second season of the Phase 3 trial. The plant is being designed to make 20 million single syringe doses a year, with year-round production and stockpiling to meet market demand. BiondVax earlier this year signed €20 million royalty-based, non-dilutive loan agreement with the European Investment Bank to finance the plant’s construction and the Phase 3 trial. “This was the bank’s first loan outside of Europe and the first for a biopharmaceutical venture,” Mr. Babecoff says. Israel’s Ministry of Economy and Industry also has approved a grant representing 20% of the budget to construct the plant. “These significant milestones signify the evolution of BiondVax from a biotech start-up to a pharmaceutical company positioned for significant growth and contributions to society,” he adds. Meeting Milestones & Catalyst via Features | BioTuesdays by Kilmer Lucas IR http://ift.tt/2xt3pR2 Arun Menawat, CEO With its recent acquisition of Royal Philips’ (NYSE:PHG; AEX:PHIA) Sonalleve business, Profound Medical (OTCQX:PRFMF; TSXV:PRN) is making the leap from a medical device company focused on prostate cancer ablation to a platform company, offering real-time magnetic resonance (MR)-guidance as the imaging platform and ultrasound as the energy source for the delivery of non-invasive ablative technology to clinicians. “This was a truly transformative transaction and points to how dramatically different we have just become,” Profound CEO, Arun Menawat, says in an interview with BioTuesdays. Dr. Menawat says Profound is now positioned as the only company to provide a single therapeutics platform that provides the precision of real time MR imaging, combined with the safety and ablation power of ultrasound technology for the incision-free ablation of diseased tissue. For example, Dr. Menawat explains that Philips, Siemens and GE, which make and sell diagnostic imaging devices such as MRI machines in hospitals, can be considered to be iPhone and Android cell phone companies, while Profound is like a developer of applications for those cell phones. “Our applications are about extending the usability of the Imaging devices into surgical applications that extend the value of the imaging device and just as cell phone applications, Profound applications are available on multiple types of manufacturers of MR devices,” he adds. Profound’s TULSA-PRO combines real-time MR imaging with transurethral, robotically-driven therapeutic ultrasound and closed-loop thermal feedback control. It is designed to provide precise ablation of the prostate while simultaneously protecting critical surrounding anatomy from potential side effects. TULSA-PRO is CE marked and Profound is currently conducting a pilot commercial launch of the technology in key European and other CE mark jurisdictions. The computer and robotic systems are sold with MRI partners, Siemens and Philips, while the disposable applicators are sold directly by Profound. For the second quarter of 2017, Profound posted revenue of $919,845, a 62% increase sequentially from $591,517 in the first quarter of the year. Mr. Menawat says Sonalleve historically has generated annual revenue of about $6-million, which “we expect will continue for the near term.” Philips’ Sonalleve MR-HIFU is approved in Europe for the treatment of uterine fibroids and palliative pain treatment of bone metastases. The system uses non-invasive, high-intensity focused ultrasound (HIFU) guided by MR for tumor therapy through intact skin. “Over the long term, we see expanding the potential treatment markets for Sonalleve, such as incision-free ablation of abdominal cancers and hyperthermia for cancer therapy, where the technology has been shown to have clinical application,” Dr. Menawat suggests. “We can make a compelling argument to hospital administrators to apply our technology to their MRI machines so that with one platform, the MRI suite can do many more things cheaper, faster and with reduced side effects,” he adds. Precise & Personalized Ablation of Prostate Dr. Menawat points out that this is especially significant in the U.S., where reimbursements are impacted as a result of poor outcomes that require hospital readmissions. In exchange for selling Sonalleve, Philips received an upfront consideration of 7.4 million shares of Profound, equal to about a 12% stake, plus an earn-out provision tied to future revenue levels through to the end of 2020. “The integration of Sonalleve, including the transfer of staff and know how, began almost immediately after we reached a definitive agreement with Philips, and the transition has been very smooth so far,” Dr. Menawat points out. He says Profound is preparing a package of Sonalleve’s existing clinical and safety data in order to meet with the FDA to discuss the protocol for a registration trial in the U.S. Profound is currently sponsoring a multicenter, prospective FDA-registered clinical trial, known as TACT, which, if successful, is expected to support its application to the FDA for approval to market TULSA-PRO in the U.S. “The recruitment process continues to proceed quite well as sites come on board and investigators move up the learning curve,” Dr. Menawat offers. TACT has moved from being about 25% enrolled at the end of the first quarter to about 50% enrolled at the end of the second quarter. The company hopes to publish interim TACT results in early 2018 and full results in late 2018. “We are getting outstanding feedback from the patients who are being treated by our technology,” he contends, adding, “Building this business is an exciting ride.” via Features | BioTuesdays by Kilmer Lucas IR http://ift.tt/2w1YLV9 |
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