Archive for category Biotech – Medical Device – Life Science – Healthcare
Speedy identification of pathogens: saves lives, reduces cost & lowers antibiotic resistance problem
Posted by Darshana V. Nadkarni, Ph.D. in Biotech - Medical Device - Life Science - Healthcare on September 24, 2019
At a recent Bio2DeviceGroup (www.bio2devicegroup.org) event, Kevin Hacker, CEO of BioAffinity Sciences talked about their new technology that when fully developed will identify pathogens more than 100 times faster than the traditional blood culture and related technologies currently in use.
Every year, in the US, 500 thousand people die due to sepsis related complications. Sepsis is a final common pathway for many infections, particularly when an individual’s immunity is low. Body normally releases chemicals into the bloodstream to fight an infection. When the body’s response to these chemicals is out of balance, it results in Sepsis. That is when body’s immune system launches a massive counter attack that harms body’s own tissues and organs. The triggering changes begin to damage body’s vital organ systems that results in dramatic drop in the blood pressure, ultimately leading to death.
Sepsis and septic shock are more common if the individual is very young or very old, have a compromised immune system, have diabetes or cirrhosis, is already sick and frequently in a hospital intensive care unit, have wounds or injuries or severe burns, have invasive devices inserted into the body, and have previously received antibiotics or corticosteroids. Often people can recover from mild sepsis. However, if the body goes into septic shock, the average mortality rate for septic shock is about 40%. Additionally, an episode of severe sepsis may place a person at higher risk of future infections.
Given that widespread infections can progress to Sepsis and Sepsis shock in a matter of few hours, it is imperative that such infections be treated immediately with antibiotics. When given the right antibiotics, there is often a dramatic improvement and speed of cure.
Problem with speedy identification of pathogens
Given that early treatment of sepsis is associated with vastly improved outcomes, rapid diagnosis is essential. However blood culture work is slow and often takes 1-3 days. The diagnosis of sepsis in critically ill patients, housed in hospitals is also challenging because it can be complicated by the presence of inflammation resulting from other underlying diseases and from prior use of antibiotics, making cultures negative. Most testing is done through mass spectrometry that gives mass to charge ratio of ions. Since culture-dependent diagnosis of infection is slow, sometimes patients are given antibiotics, before the results of the culture are available. Patients are given broad spectrum antibiotics and 40% are not effective. In such instances, antibiotics are withdrawn after one cycle of treatment, when the cause of the illness is found to be something else and this can lead to antibiotic resistance.
Bioaffinity Sciences solution will be able to identify pathogens within 10 minutes, 430 fold faster than blood culture. This is cell affinity based, low cost technology. Pathogens are run through microchannels comprising of a surface- grafted scaffold of reactive polymer onto which affinity molecules (sugars, aptamers, vancomycin, and methicillin) have been bio-conjugated. High capacity of the channels allows low numbers of microbes to be quickly identified. The unknown pathogen’s pattern of binding to the channels is recorded, and this pattern is compared to a library of known pathogens. When a match is made, the identity of the pathogen is reported. In addition to speed, this is also more sensitive in terms of the number of different pathogens detected than blood culture.
Disease burden to the healthcare system in the US due to Sepsis
Sepsis management is a major challenge and results in disproportionately high burden in terms of hospital utilization. The average length of stay for sepsis patients in the US is approximately 75% greater than for other conditions. The cost of sepsis management ranks highest among hospital admissions for all disease states. The cost is estimated to be between $25 billion and $27 billion, and represents 13% of total US hospital costs.
Considering that poor sepsis outcomes are directly tied to the delay in diagnosis and treatment, such a dramatic improvement in speed and accuracy of diagnosis leading to speedy and accurate treatment can not only dramatically improve outcome and quality of patient care but also significantly reduce cost of care for hospitals.
The talk was followed by Q&A.
Posted by Darshana V. Nadkarni, Ph.D. in Biotech - Medical Device - Life Science - Healthcare on September 17, 2019
Andre Bessette, CEO & Co-founder at Eclipse Regenesis talked about Short Bowel Syndrome at an event by Bio2DeviceGroup (www.bio2devicegroup.org) held at Wilson Sonsini (WSGR) in Palo Alto. Bessette shared information on prevalence of the disease, it’s impact, and the new technology that offers hope for restoration.
Feel free to skip the short tutorial below and jump to SBS and the technology solutions for treatment of SBS
Movement of the food
Typically digestion begins in the mouth where chewing and saliva begin to break down the food. As it passes through the esophagus, the contractions in the esophagus moves the food forward towards the stomach. In the stomach, the food breaks down further into liquid or paste and is mixed with acids and enzymes. The stomach slowly empties the contents, called chyme, into the small intestine.
It is the tube shaped organ and is located between the stomach and large intestine. The small intestine is regarded as the workhorse of the digestive system. It is 20 FEET LONG and includes the duodenum, jejunum, and ileum.
Duodenum is the first part of the small intestine where typically iron and other minerals are absorbed.
Jejunum is the middle section where cabs, proteins, fat and most vitamins are absorbed.
Ileum is the lower end of the small intestine where bile acids and vitamin B12 are absorbed.
From small intestine the food travels to the large intestine which is about 5 feet long in adults and helps in absorption of water and other remaining nutrients. It then changes waste from liquid to a solid matter called stool.
Short Bowel Syndrome (SBS)
Short Bowel Syndrome or SBS is a devastating condition where the small intestine is simply too short. The inadequate length of the small intestine leads to a whole host of problems primarily related to malabsorption of nutrients and depending on the degree of shortness, sometimes it drastically shortens lifespan. Typically SBS is diagnosed when people have at least half of their small intestine removed and sometimes all or part of their large intestine removed due to disease or injury and significant damage of the small intestine. Sometimes it is a congenital abnormality, where a baby is born with very short small intestine. Depending on the length, SBS may be mild, moderate or severe.
People with SBS cannot absorb enough water, vitamins, minerals, protein, fat, calories and other nutrients from food. Difficulty in absorbing nutrients depends upon the area of small intestine that is removed or non-existent. This inability to absorb nutrients and water causes severe and frequent diarrhea, weight loss and other symptoms related to loss of essential vitamins and minerals.
There are about 8 thousand new cases of SBS in the US, each year. About 65% of them are due to congenital or acquired defect. Typically pediatric patients die before they reach 3 years of age. Their short life is marked with TPN (Total Parenteral Nutrition) treatment where by nutrients are given directly into the bloodstream bypassing the gastrointestinal tract. Gattex (teduglutide) is a prescription medicine given through intravenous (IV) feeding or subcutaneous injection. Not only is it a costly treatment, averaging around 200-300K annually without much improvement but a baby would need to continuously be wearing or accompanying a backpack. Surgical treatment costs 150K to 400K and transplants cost over a million dollars and require life long care, possibility of rejection and infections and has about 5 year mortality for 50% of patients. NONE OF THE CURRENT TREATMENT OPTIONS RESTORE FULL BOWEL FUNCTION.
Eclipse Regenesis Solution
The Eclipse XL1 therapy is a restorative solution designed to grow a longer, healthy intestine rapidly in the course of 2-3 weeks. The solution is entirely mechanical and repeatable, without any harmful or toxic effects. Eclipse has devised a nitinol coil that is introduced into the small intestine via a stoma. Plication sutures are then applied outside the intestine to hold it in place. During the course of the therapy of 2-3 weeks, while the device is in place, nutrients continue to flow through the intestine. Over 2-3 weeks period, the coil gradually expands. As it expands, it gently pulls the small intestine, stimulating new tissue growth and lengthening the treated region 2 to 3 times. The solution is striking in its simplicity and beautiful uncomplicated. After expansion, the sutures dissolve, allowing the coil to move forward and finally get passed out naturally.
Besssette shared information on the team of co-founders with impressive credentials and answered various questions from the audience. Yes, the contractile function continues in the newly lengthened intestine, no the length sustains and does not snap back and the process is repeatable to produce clinical significant length of the intestine and all of these is indicated by the animal trials.
Small Bowel Syndrome is an orphan disease and as such the Eclipse XL1 has received a HUD designation (which requires incidence rate of less than 8000 new cases a year, in the US). Eclipse is anticipating using the HDE regulatory pathway which requires safety and probable benefit data. Eclipse plans to commercialize in pediatric market, in the near future.
Posted by Darshana V. Nadkarni, Ph.D. in Big Data -Cloud -IoT-Software -Mobile -Entrepreneurship, Biotech - Medical Device - Life Science - Healthcare on January 12, 2018
JPM 2018 and concurrent events just ended with what may be one of its biggest draws. As many as 10,000 people from life science industry and its related sectors are likely to have descended upon the city, during last four days. In addition to JPM event itself, everything health was under review and up for discussion at various conferences including at EBD Group & Demy Colten’s #BiotechShowcase #DigitalMedicine #BTS18 and #WuXiGlobalForum2018 . Networking and deal making continued late in the nights at various receptions held across the city. Receptions by legal firms like #WilsonSonsini #MoFoLLP #ReedSmithLLP attracted some of the biggest crowds.
Overall the tone for 2018, seemed highly optimistic. BiotechShowcase held a media roundup and echoes of optimism were heard from almost all panelists @barbara_ryan12 @TriangleInsight @CarolineYLChen @adamfeuerstein @statnews @SFBIZronleuty @BrittanyMeiling @endpts @juliet_preston @medcitynews @ldtimmerman .
There is a general agreement that the pace of #innovation in biotech greatly accelerated in 2017 and is likely to continue. According to Luke Timmeerman, “sheer velocity of news in healthtech innovation is fascinating”. Transformative therapies across huge and diverse range of diseases are increasingly focusing on cures and going beyond the short term treatment focus. The surge of innovation has been led by focus on oncology although concern was also raised in one of the panels that we still continue to get stymied and realize how friggin smart the disease of cancer is and if we will truly crack the code on cancer in the immediate upcoming years. All signs are however, that next year we may see critical data from some clinical trials in immuno-oncology space that can cause market spikes.
Here are some areas of concern raised in some of the panels. In 2017, a slight dip was observed in the areas of orphan and rare diseases. Also there seemed to be a general consensus that we need smart policies that incentivize new anti microbial drugs and other treatments for infectious diseases. Due to increasing resistance of antibiotics, there is an ongoing and real fear for some of the infectious diseases to turn into pandemics. These are areas that bold entrepreneurs may focus on. Also medical devices continues to remain somewhat underfunded. Discussions around accelerating healthcare costs and drug pricing issues creeped over into many panels. Entrepreneurs with disruptive pricing innovation in product development as well as healthcare can easily have a tremendous leverage. It can’t be overstressed that finding effective pricing solutions holds key to continued and sustainable growth in healthcare sector.
Discussion in one of the panels focused for a few minutes around large investments in life sciences and if that indicated a healthtech bubble that may be due for a crash. Indeed, some experts observed that pace of 2017 is unlikely to continue and there may well be a slight dip in 2018. But overall the consensus seemed to be, that a steep and deep pipeline of innovation in R&D is likely to prevent a crash, and the venture funding blizzard is likely to continue. Overall, the feeling among investors and healthcare experts was that among the industry, there is a strong focus on science and people are pursuing innovation with discipline that will ensure unprecedented mechanisms and novel medicines. All this activity is taking healthcare to a new level of cures and sustainability and stability from temporary treatment focus. Exciting indeed to be living in this era of amazing healthcare innovation.
Posted by Darshana V. Nadkarni, Ph.D. in Big Data -Cloud -IoT-Software -Mobile -Entrepreneurship, Biotech - Medical Device - Life Science - Healthcare on December 26, 2017
Biotech Showcase taking place concurrently with the J P Morgan event in San Francisco in January 2018, is an investor and networking conference. Many partnerships and collaborations will be forged with over over 7000 one on one meetings, with opportunities for eager innovators to seek out enthusiastic investors. Besides one on one meetings, general sessions will focus on a number of disease areas that are significantly expected to impact the healthcare arena. More blogs to follow and will highlight focus on new treatment modalities.
A panel led by Jennifer Goldstein from Silicon Valley Bank will focus on body’s largest organ that is often misunderstood and frequently underrated, the skin. Panelists Alan Dunton from Purdue Pharma, David Giljohann from Exicure, Jennifer Good from Trevi Therapeutics, Shelley Harman from Aegle and Mark Wilson from MatriSys will discuss early signs and symptoms on the skin that often signal infectious and internal diseases.
Antimicrobial resistance or (AMR) is increasingly a prominent public health concern and has been highlighted by both WHO and CDC. Since the discovery of first antibiotic penicillin in 1928, more than 100 compounds have been created but no new class has been found. In panel moderated by Bibhash Mukhopadhyay at New Enterprise Associates, leading anti-microbial drug development experts, Alan Carr of Needham, Julia Gregory from Contrafect, Kenneth Hillan from Achaogen, Gregory Mario from Taxis Pharma, John Rex from F2G, and Chris Stevens from Arsanis will discuss the tailwinds and headwinds in this space that is getting a fresh second look from both experts and investors.
Current epidemic of metabolic syndrome will be the focus in a panel moderated by Philip Kenner from ClearView with panelists Deborah Dunsire from DTuit, Tomas Landh from Novo Nordisk, Harith Rajagopalan from Fractyl Labs, and Wendye Robbins from Blade Therapeutics. Having any one of the risk factors like high blood pressure, high blood sugar, obesity, high cholesterol, or high triglycerides can greatly increase health risk. However having a cluster of these conditions together indicate metabolic syndrome and vastly increase health risk. Metabolic syndrome is on the rise, reaching epidemic proportions according to some health experts.
While JPM conference is by invitation only event, registration is open for Biotech Showcase at email@example.com or at https://ebdgroup.knect365.com/biotech-showcase/agenda/1
With shrinking pool of serious early stage life science investors and stringent capital requirements, the path for medtech companies has become greatly challenging. As is the case every year, Wilson Sonsini Goodrich & Rosati 2017 Medical Device Conference provided a forum for addressing challenges faced by new medtech companies as well as opportunities presented by current trends.
Various speakers and panels addressed these issues from diverse angles and perspectives. Following a welcome address by Casey McGlynn, an early morning panel moderated by Donna Petkanics addressed new models for medtech investing. Panelists Andrew ElBardissi (Deerfield Capital), Eric Milledge (Endeavor Vision SA), Leighton Read (Brandon Capital Partners), and Valeska Schroeder (KCK Group) discussed how the investors are adapting their financing strategies and business models in response to the newer challenges that medical device companies face. Milledge opined that it is now crucial for medtech companies to get some regulatory approval before seeking to raise money. Even CE mark could help, said Milledge. ElBardissi offered that if the company is US based and focused on US commercialization strategy then EU approval does not help. He advised that medtech companies “keep the head down and focus on US approval UNLESS there is capital efficient advantage of focusing on EU”. Schroeder said their fund was “geographically agnostic” but they believed that for an early stage medtech company it is important that they not “simply throw capital without a plan”. but there are values you can get out which may not be revenue based but you can get close to your customer base etc… not go in every country but choosing a small no. of country to go through. Read observed that a company seeking to create larger returns must go after larger markets.
With the current challenges medtech world has become more global as companies and investors are finding win-win solutions through newer models of partnering by going across continents and countries. Geographically, Pacific Rim has emerged as hot collaboration frontier. A panel moderated by Elton Satusky with CEOs Yue-Teh Jang (Medeon Biodesign), Kewen Jin (Serica Partners, Trevor Moody (M. H. Carnegie & Company), and Norman Weldon (Partisan Management Group), who completed such collaborations, financings and mergers with companies and investors in Asia discussed how these transactions may be structured. Another panel moderated by Jack Moorman (US-Japan MedTech Frontiers – USJMF), with panelists Kenichi Hata (Terumo Corporation), Masazumi Ishii (AZCA Inc.), Yuichiro Morimoto (Enplas Corporation), and Richard Packer (Asahi Kasei Corporation) discussed collaborations between Japan and Silicon Valley. Japan has emerged as a major partner in medtech OUS financing and growth strategy.
Increasingly there is a pressure on medtech industry that is unlike most other industries, to show value. Many organizations have now come up with ways to define and measure value creation. Among them, AdvaMed has developed a new framework to assess the value of medical technologies and diagnostics in a broad, patient-centric approach. A panel moderated by Donald May (AdvaMed) with panelists Maneesh Arora (Exact Sciences Corp), Jeff Farkas (Medtronic), and Jo Carol Hiatt (Kaiser Permanente) addressed how companies may leverage value creation to make internal business decisions to allow for more efficient use of capital and to drive discussions with potential investors as well as to keep track of milestones during the commercialization process.
AdvaMed model focuses on following drivers of value creation, 1) clinical outcomes, effectiveness and utility measures 2) non clinical patient impact including impact on caregivers, families, ease of product use, ease of care, financial impact etc. 3) new drivers around value based purchasing, care delivery costs, reduction in readmissions etc. from provider perspectives, and 4) broader public impact on population and communities in terms of whether or not the technology reduces overall cost to the system, helps identify diseases, helps employers reduce absenteeism and so on. May said the model begins with the patient and goes on to incorporate multiple stakeholders and values for all may not always be aligned or the time frames may differ. As an industry, “we need to think of appropriate levels and types of evidence as we think of new value based models of integrated care”, said May. Speakers discussed the need to move away from one number and focus on broad picture with many factors that include clinical as well as economic value, in order to get better outcomes while reducing costs.
As is the case, WSGR medtech conference provides an excellent forum for investors, startups, and professionals in the industry to come together in a spirit of learning and collaboration. And compared to previous years, it seemed to be even more well attended with hallways abuzz with discussions on partnering. As always, the conference ended with short presentations from select few startups and the announcement of the $25,000 grand prize and Medtech Innovator Award. But the best was reserved for the last. More networking happened and deals were done as attendees mingled with good food at the reception and as the best wines were uncorked and venture capitalists served as sommeliers and poured wine for the attendees.
Posted by Darshana V. Nadkarni, Ph.D. in Big Data -Cloud -IoT-Software -Mobile -Entrepreneurship, Biotech - Medical Device - Life Science - Healthcare on April 15, 2017
Current discussions on repeal of Obamacare has brought much focus on issues of health and wellness in America and has energized the underserved communities. The 6th Annual Health Technology Forum Innovation Conference taking place at Stanford University on May 1 and 2, 2017 will explore health and wellness through panels and speakers, with a central focus on technology and on implementation of key health policies.
What kind of technology innovations may effectively address the unmet needs of the underserved and underrepresented markets? Can next generation technology solutions provide better access and improve care outcomes? These and other issues will be discussed in outstanding panels. The Innovation Showcase will offer an exclusive networking opportunity to startups and investment community to develop strategic partnerships. The high visibility demo space in the expo corridor will allow startups an opportunity to highlight their offerings.
Every year, health technology forum conference offers phenomenal opportunity to bay area health strategists, providers, venture capitalists, startups, and professionals to come together with a mission to do “common good” through better health. Please register for the conference at www.healthtechnologyforum.com .
Posted by Darshana V. Nadkarni, Ph.D. in Big Data -Cloud -IoT-Software -Mobile -Entrepreneurship, Biotech - Medical Device - Life Science - Healthcare on March 20, 2017
One of the latest most talked about buzzwords in cancer treatment is “immunotherapy” where body’s immune system is used to wage a war against the cancer cells. Cancer cells divide rapidly than ordinary cells and manage to evade the immune system. The focus of a range of immunotherapies is to put body’s immune system on high alert so it can easily locate and destroy cancer cells.
This year, EPPICon (annual flagship conference at eppicglobal at www.eppicon.org) will focus on Immunotherapy, Bioinformatics, and Devices. Another recent buzzword, “bioinformatics” focuses on harnessing technological advances for management and analysis of data, for cancer immunology and immunotherapy. The hope is that more reliable and comprehensive picture can emerge of tumor genomics landscape and that can point a way towards more effective personalized medicine.
Immunotherapy often involves delivery of a cocktail of immune drugs to awaken the body’s immune system and put it in a “ready” mode to get rid of the cancer cells. Implantable devices can be used to provide regular dosages of medication for several days or everyday for a few weeks and can be used to make localized delivery. This convergence of technologies makes it an interesting time for treatment of cancer and other diseases.
EPPICon, EPPIC’s all day conference will be held on Saturday, March, 25th at Crowne Plaza, Burlingame, CA and has a fabulous lineup of keynotes, speakers, and panels.
Morning keynote, Ira Mellman is VP of Cancer Immunology at Genentech and has an illustrious career in solving most profound health problems with strong research, grounded in science. He spent 20 years at Yale University School of Medicine, prior to joining Genentech in 2007. After the keynote, the conference program will continue with excellent speakers and panels with a special speed pitch session thrown in, where startups looking for funding will have an opportunity to pitch to a panel of investors and receive critical feedback, in real time. At the end of the day, 2017 “EPPIC Eleven” awards will be given out to chosen startups, from around the globe.
To register for the conference, please go to www.eppicon.org .
A panel moderated by Jim Hesling, at Wilson Sonsini Medical Device Conference, with Eric Bell from Spring Rock Ventures, Mir Imran from Incube Ventures, and Gwen Watanabe from Teleflex, discussed the role of IP due diligence in corporate finance. The panel offered great advice and insights for medtech startups.
From the buy side perspective, InCube Ventures invests in mid to late stage companies and focuses specifically on disruptive innovations that change patients outcomes, said Imran. While their focus area may be in white space of IP, depending on the technology, Incube does thorough investigation of IP, said Imran. Also early on they assess if it is incremental innovation of existing solution or a truly disruptive concept.
Also from buy perspective, Watanabe said, during the acquisition process, they like to see entire application, talk with the team and then do complete due diligence on the patent portfolio. Watanabe said when buying “we also deconstruct claims for validity”. She added, “we don’t stop at patents, IP also includes grants, know hows, and any other secrets”. Teleflex also uses software tools to map out the IP area and it operates in 160 countries. They have an external counsel going through the FTO and they pay specific attention to any potential for patent infringement. Eric Bell from Springrock Ventures, said, they use external counsel to do thorough assessment and clearly consider issued patents versus filed patents, because when issued it provides contextual validity.
Speaking from the sell side perspective, Imran offered lot of great advice to the entrepreneurs. Imran is a serial entrepreneur with several successful companies, and advised that entrepreneur hire a litigator to review their patent portfolio to point out holes and weaknesses as well as areas of strength. A litigator can have a vastly different perspective than a prosecutor, said Imran. Both Bell and Imran also suggested that entrepreneurs continue to focus on the IP as the technology moves forward. Many founders focus strongly on IP earlier and specially when fundraising but then put it on the back burner. However, as direction changes occur, they become lax on IP and it may not allow for product to be fully covered and it can impact subsequent fundraising. Also the patent landscape is too crowded and freedom to operate is very important, said Imran.
Panelists asserted that while ongoing IP commitment is extremely important, they agreed that IP alone does not create value. Real value is created from total context including patient outcomes, regulatory approvals, reimbursement etc. Some young CEOs do a press release when a patent is filed or approved and Imran advised, they not do it and Watanabe chimed in that they do it when they get FDA approval. “One thing I do is to step back and think about how I would get around my own patents and then file more patents, so I think like a competitor”, said Imran, himself a holder of hundreds of patents. Imran said, while patent filings are very expensive and companies can’t do it frivolously, he also suggested that companies file patents in other countries with substantial markets like India and China. Founder should formalize the process internally in the company so that employees are keeping good lab notebooks and everything is documented to be able to defend obviousness claim, said Imran.
PS – Please check out exciting jobs offering opportunities to work with disruptive technologies in JOBS category on this blog & please send leads or resume at wd_darshana at hot mail dot com.