Medtech fundings for April 2017 stand at $524 million, led by the $120 million credit facility secured by Endologix, followed by $40 million raised by Cardiovascular Systems, $36 million by ALung Technologies, $32 million by Frequency Therapeutics, and $30 million by ProTom International.
Below are the top listings of medtech fundings for the month to date. For a complete listing of fundings to date, see link.
Source: Compiled by MedMarket Diligence, LLC
For a complete list of medtech fundings recorded since 2009, see link.
Medtech fundings for March 2017 totaled over $2 billion, led by the $1.2 billion raise by ConvaTec, the $59 million IPO of Symetics, the $50 million Series C funding of Moximed, the $45 million funding of Corindus, and the $40 million funding round of VertiFlex.
The complete list of fundings in medtech for March 2017 are shown at link. Below are the top fundings for the month.
Source: Compiled by MedMarket Diligence, LLC
For a historical list of fundings by month since 2009, see link.
The nature of graphene’s structure and its resulting traits are responsible for a tremendous burst of research focused on applications.
Find cancer cells. Research at the University of Illinois at Chicago showed that interfacing brain cells on the surface of a graphene sheet allows the ability to differentiate a single hyperactive cancerous cell from a normal cell. This represents a noninvasive technique for the early detection of cancer.
Graphene sheets capture cells efficiently. In research similar to that U. Illinois, modification of the graphene sheet by mild heating enables annealing of specific targets/analytes on the sheet which then can be tested. This, too, offers noninvasive diagnostics.
Contact lens coated with graphene. While the value of the development is yet to be seen, researchers in Korea have learned that contact lenses coated with graphene are able to shield wearers’ eyes from electromagnetic radiation and dehydration.
Cheaply mass-producing graphene using soybeans. A real hurdle to graphene’s widespread use in a variety of applications is the cost to mass produce it, but Australia’s CSIRO has shown that an ambient air process to produce graphene from soybean oil, which is likely to accelerate graphenes’ development for commercial use.
Advanced materials development teams globally are spinning out new materials that have highly specialized features, with the ability to be manufactured under tight control.
3D manufacturing leads to highly complex, bio-like materials. With applications across many industries using “any material that can be crushed into nanoparticles”, University of Washington research has demonstrated the ability to 3D engineer complex structures, including for use as biological scaffolds.
Hydrogels and woven fiber fabric. Hokkaido University researchers have produced woven polyampholyte (PA) gels reinforced with glass fiber. Materials made this way have the structural and dynamic features to make them amenable for use in artificial ligaments and tendons.
Sound-shaping metamaterial. Research teams at the Universities of Sussex and Bristol have developed acoustic metamaterials capable of creating shaped sound waves, a development that will have a potentially big impact on medical imaging.
In vitro testing models that more accurately reflect biological systems for drug testing and development will facilitate clinical diagnostics and clinical research.
Stem cells derived neuronal networks grown on a chip. Scientists at the University of Bern have developed an in vitro stem cell-based bioassay grown on multi-electrode arrays capable of detecting the biological activity of Clostridium botulinum neurotoxins.
Used for mimicking heart’s biomechanical properties. At Vanderbilt University, scientists have developed an organ-on-a-chip configuration that mimics the heart’s biomechanical properties. This will enable drug testing to gauge impact on heart function.
Used for offering insights on premature aging, vascular disease. Brigham and Women’s Hospital has developed organ-on-a-chip model designed to study progeria (Hutchinson-Gilford progeria syndrome), which primarily affects vascular cells, making this an affective method for the first time to simultaneously study vascular diseases and aging.
Medtech fundings for February 2017 stand at $500.4 million, led by the $75 million credit facility secured by BioDelivery Sciences, the $45 million private placement by Corindus Vascular Robotics, the $41 million funding of Rhythm, Inc., the $37.2 million funding of Entellus Medical, and the $33 million funding of startup Surrozen.
Below are the top fundings for the month. For a complete list of fundings, see link.
Source: Compiled by MedMarket Diligence, LLC
For a historical listing of fundings in medtech, see link.
Medtech and biotech investment is driven by an expectation of returns, but rapid advances in technology simultaneously drive excitement for their application while increasing the uncertainty in what is needed to bring those applications in the market.
MedMarket Diligence has tracked technology developments and trends in advanced medical technologies, inclusive of medical devices and the range of other technologies — in biotech, pharma, others — that impact, drive, limit, or otherwise affect markets for the management of disease and trauma. This broader perspective on new developments and a deeper understanding of their limitations is important for a couple of reasons:
Healthcare systems and payers are demanding competitive cost and outcomes for specific patient populations, irrespective of technology type — it’s the endpoint that matters. This forces medical devices into de facto competition with biotech, pharma, and others.
Medical devices are becoming increasingly intelligent medical devices, combining “smart” components, human-device interfaces, integration of AI in product development and products.
Medical devices are rarely just “medical devices” anymore, often integrating embedded drugs, bioresorable materials, cell therapy components, etc.
Many new technologies have dramatically pushed the boundaries on what medicine can potentially accomplish, from the personalized medicine enabled by genomics, these advances have served to create bigger gaps between scientific advance and commercial reality, demanding deeper understanding of the science.
The rapid pace of technology development across all these sectors and the increasing complexity of the underlying science are factors complicating the development, regulatory approval, and market introduction of advanced technologies. The unexpected size and number of the hurdles to bring these complex technologies to the market have been responsible for investment failures, such as:
Theranos. Investors were too ready to believe the disruptive ideas of its founder, Elizabeth Holmes. When it became clear that data did not support the technology, the value of the company plummeted.
Juno Therapeutics. The Seattle-based gene therapy company lost substantial share value after three patients died on a clinical trial for the company’s cell therapy treatments that were just months away from receiving regulatory approval in the US.
A ZS Associates study in 2016 showed that 81% of medtech companies struggle to receive an adequate return on investment
As a result, investment in biotech took a correctional hit in 2016 to deflate overblown expectations. Medtech, for its part, has seen declining investment, especially at early stages, reflecting an aversion to uncertainty in commercialization.
Below are clinical and technology areas that we see demonstrating growth and investment opportunity, but still represent challenges for executives to navigate their remaining development and commercialization obstacles:
Type I diabetes
Non-invasive blood glucose measurement
Tissue engineering and regeneration
3D printed organs
Brain-computer and other nervous system interfaces
Interfaces for patients with locked-in syndrome to communicate
Interfaces to enable (e.g., Stentrode) paralyzed patients to control devices
Robotics in surgery (advancing, despite costs)
Optogenetics: light modulated nerve cells and neural circuits
Localized drug delivery
Further accelerated by genomics and computational approaches
Computational approaches to accelerate the evaluation of drug candidates
Organ-on-a-chip technologies to decrease the cost of drug testing
Impact on investment
Seed stage and Series A investment in med tech is down, reflecting an aversion to early stage uncertainty.
Acquisitions of early stage companies, by contrast, are up, reflecting acquiring companies to gain more control over the uncertainty
Need for critical insight and data to ensure patient outcomes at best costs
Costs of development, combined with uncertainty, demand that if the idea’s upside potential is only $10 million, then it’s time to find another idea
While better analysis of the hurdles to commercialization of advanced innovations will support investment, many medtech and biotech companies may opt instead for growth of established technologies into emerging markets, where the uncertainty is not science-based
Below is illustrated the fundings by category in 2015 and 2016, which showed a consistent drop from 2015 to 2016, driven by a widely acknowledged correction in biotech investment in 2016.
*For the sake of comparing other segments, the wound fundings above exclude the $1.8 billion IPO of Convatec in 2016.
Hemostats are normally used in surgical procedures only when conventional bleeding control methods are ineffective or impractical. The hemostat market offers opportunities as customers seek products that better meet their needs. Above and beyond having hemostats that are effective and reliable, additional improvements that clinicians wish to see in hemostat products include:
work regardless of whether the patient is on anticoagulants or not
easy to prepare and store, with a long shelf life
transparent so that the surgeon continues to have a clear field of view
preferably not made from human or animal materials.
Source: “Worldwide Markets for Medical and Surgical Sealants, Glues, and Hemostats, 2015-2022”; MedMarket Diligence, LLC (Report #S290).
Due to the uncertainty in the development, clinical testing, and regulatory approval of both biotech and medical technologies, which increasingly have to be viewed with the same competitive lens, investors have over the past few years shied away from seed stage or Series A stage company investment in favor of those nearer to market introduction. However, with the advent of a great number of new technologies and advances in the underlying science, there is enormous opportunity to identify companies and emerging sectors arising from these advances. The problem in identifying realistically promising companies is that it must be done so without falling prey to the bad investment practices in the past that ensued from a poor understanding of the technologies and their remaining commercial hurdles. Without careful consideration of remaining scientific development needed, the product’s target market, its competitors, and the sum total of the company’s capabilities to commercialize these technologies, investment in these areas will fall short of investment objectives or fail them outright.
While any of these considerations have the capacity to preempt a successful market introduction, a failure to understand the science behind the product and its remaining development hurdles to commercialization is likely to be the biggest cause of failure.
“We’ve already had one glaring example of a company, and its investors, learning the hard way that health and science advisors are important: Theranos.” (link)
Venture Capital has backed away from early stage investment
Earlier stage investment, with its higher risk, has higher potential reward, so there is a big need for more effective evaluation of potential early stage investments in order to (1) seize these opportunities that will otherwise potentially be lost with the shift to later stage fundings, (2) sort out those companies/technologies with overwhelming commercialization hurdles from those that will profitably tap an opportunity, and (3) gain the value of these opportunities before the innovation appreciates in value, driving up the price of the investment.
The Biotech Bubble
Biotech in the 1980s was enamored with companies pursuing “magic bullets” — technologies that had the potential to cure cancer or heart disease or other conditions with large, untapped or under-treated populations. With few exceptions, these all-in-one-basket efforts were only able achieve a measure of humility in the VCs who had poured volumes of money into them.
Here was evidenced a fundamental problem with biotech at a time when true scientific milestones were being reached, including successes in mapping the human genome: Landmark scientific milestones do not equate with commercial success.
As a result, money fled from biotech as few products could make it to market due to persistent development and FDA hurdles. By the late 1980s, many biotechs saw three quarters of their value disappear.
A Renewed Bubble?
The status of biomedical science and technology, with multiple synergistic developments, will lead to wild speculation and investment, potentially leading to yet another investment bubble. However, there will be advances that can point to real timelines for market introduction that will support investment.
Recent advances, developments and trends supporting emerging therapeutics
Stem cells. A double-edged sword in that these do represent some the biggest therapeutics that will emerge, yet caution is advised since the mechanisms to control stem cells are not always sufficient to prevent their nasty tendency to become carcinogenic.
Drug discovery models, such as using human “organoids” and other cell-based models to test or screen new drugs.
Systems to accelerate the rapid evaluation of hundreds, perhaps, thousands of potential drugs before moving to animal models or preclinicals.
Meta-analysis, the practice of analyzing multiple, independently produced clinical data to draw conclusions from the broader dataset.
cell biologists, immunologists, molecular biologists and others have a better understanding of pathology and therapeutics as a result of information sharing; plus BIG DATA (e.g., as part of the “Cancer Moonshot”). Thought leaders have called for collection and harnessing of patient data on a large scale and centralized for use in evaluating treatments for specific patients and cancer types.
Artificial intelligence applied to diagnosis and prescribed therapeutics (e.g., IBM Watson).
Examples of resulting therapies, at a minimum, include multimodal treatment – e.g., radiotherapy and immunotherapy – but more often may be represented in considerably more backend research and testing to identify and develop products with greater specificity, greater efficacy, and lowered risk of complications.
High strength medical and surgical glues currently command a $1.2 billion market that will grow to $1.7 billion by 2022, representing a 6.4% compound annual growth rate. More importantly, however, is that during this time frame the market will undergo steady shifts, including the regional representation, with growth slowing in western markets relative to Asia-Pacific and the rest of the world.
Below is illustrated the size versus growth of high strength glues in the U.S., Western Europe, Asia-Pacific and Rest of World.
In reviewing patents, fundings, technology development trends, market development, and other hard data sources, we feel these are some of the strongest areas for investment in not only the medical device side of medtech, but also the broader biomedical technology arena:
Cancer probes (e.g., fluorescent or optical coherence tomography, frozen section, cytologic imprint analysis, ultrasound, micro-computed tomography, near-infrared imaging, and spectroscopy)
neurostimulation and neuromodulation
In addition, there are many areas in healthcare in which there is much untapped demand with problems that, so far, seem to have eluded medtech solutions. These include infection control (Zika, MRSA, TB, nosocomial infections, etc.), chronic wound treatment (including decubitus/stasis/diabetic ulcers), type 2 diabetes and obesity.