New medical technologies at startups, January 2017

Below is a list of the technologies under development at medtech startups identified in January 2017 (thus far) and included in the Medtech Startups Database.

  • Devices and accessories for minimally invasive surgery.
  • Undisclosed surgical technology
  • Technologies for treatment of spinal and orthopedic deformities.
  • 3D visualization and printing for prototyping, surgical planning.
  • Point of care, portable breast cancer screening test.
  • Devices to enable delivery of autologous tissue at point-of-care.
  • Navigation and other technologies to facilitate laparoscopic surgery.
  • Tissue-to-bone reattachment systems
  • Products for bone, joint, and soft tissue conditions of the foot and ankle.
  • Soft tissue marker for ultrasound at surgical sites
  • System to locate breast abnormalities during surgical incision.

For a comprehensive listing of the technologies at medtech startups 2016 and earlier, see link.

Where will medicine be in 2035?

An important determinant of “where medicine will be” in 2035 is the set of dynamics and forces behind healthcare delivery systems, including primarily the payment method, especially regarding reimbursement. It is clear that some form of reform in healthcare will result in a consolidation of the infrastructure paying for and managing patient populations. The infrastructure is bloated and expensive, unnecessarily adding to costs that neither the federal government nor individuals can sustain. This is not to say that I predict movement to a single payer system — that is just one perceived solution to the problem. There are far too many costs in healthcare that offer no benefits in terms of quality; indeed, such costs are a true impediment to quality. Funds that go to infrastructure (insurance companies and other intermediaries) and the demands they put on healthcare delivery work directly against quality of care. So, in the U.S., whether Obamacare persists (most likely) or is replaced with a single payer system, state administered healthcare (exchanges) or some other as-yet-unidentified form, there will be change in how healthcare is delivered from a cost/management perspective. 

From the clinical practice and technology side, there will be enormous changes to healthcare. Here are examples of what I see from tracking trends in clinical practice and medical technology development:

  • Cancer 5 year survival rates will, for many cancers, be well over 90%. Cancer will largely be transformed in most cases to chronic disease that can be effectively managed by surgery, immunology, chemotherapy and other interventions. Cancer and genomics, in particular, has been a lucrative study (see The Cancer Genome Atlas). Immunotherapy developments are also expected to be part of many oncology solutions. Cancer has been a tenacious foe, and remains one we will be fighting for a long time, but the fight will have changed from virtually incapacitating the patient to following protocols that keep cancer in check, if not cure/prevent it. 
  • Diabetes Type 1 (juvenile onset) will be managed in most patients by an “artificial pancreas”, a closed loop glucometer and insulin pump that will self-regulate blood glucose levels. OR, stem cell or other cell therapies may well achieve success in restoring normal insulin production and glucose metabolism in Type 1 patients. The odds are better that a practical, affordable artificial pancreas will developed than stem or other cell therapy, but both technologies are moving aggressively and will gain dramatic successes within 20 years.

Developments in the field of the “artificial pancreas” have recently gathered considerable pace, such that, by 2035, type 1 blood glucose management may be no more onerous than a house thermostat due to the sophistication and ease-of-use made possible with the closed loop, biofeedback capabilities of the integrated glucometer, insulin pump and the algorithms that drive it, but that will not be the end of the development of better options for type 1 diabetics. Cell therapy for type 1 diabetes, which may be readily achieved by one or more of a wide variety of cellular approaches and product forms (including cell/device hybrids) may well have progressed by 2035 to become another viable alternative for type 1 diabetics.

  • Diabetes Type 2 (adult onset) will be a significant problem governed by different dynamics than Type 1. A large body of evidence will exist that shows dramatically reduced incidence of Type 2 associated with obesity management (gastric bypass, satiety drugs, etc.) that will mitigate the growing prevalence of Type 2, but research into pharmacologic or other therapies may at best achieve only modest advances. The problem will reside in the complexity of different Type 2 manifestation, the late onset of the condition in patients who are resistant to the necessary changes in lifestyle and the global epidemic that will challenge dissemination of new technologies and clinical practices to third world populations.

Despite increasing levels of attention being raised to the burden of type 2 worldwide, including all its sequellae (vascular, retinal, kidney and other diseases), the pace of growth globally in type 2 is still such that it will represent a problem and target for pharma, biotech, medical device, and other disciplines.

  • Cell therapy and tissue engineering will offer an enormous number of solutions for conditions currently treated inadequately, if at all. Below is an illustration of the range of applications currently available or in development, a list that will expand (along with successes in each) over the next 20 years.

    Cell therapy will have deeply penetrated virtually every medical specialty by 2035. Most advanced will be those that target less complex tissues: bone, muscle, skin, and select internal organ tissues (e.g., bioengineered bladder, others). However, development will have also followed the money. Currently, development and use of conventional technologies in areas like cardiology, vascular, and neurology entails high expenditure that creates enormous investment incentive that will drive steady development of cell therapy and tissue engineering over the next 20 years, with the goal of better, long-term and/or less costly solutions.
  • Gene therapy will be an option for a majority of genetically-based diseases (especially inherited diseases) and will offer clinical options for non-inherited conditions. Advances in the analysis of inheritance and expression of genes will also enable advanced interventions to either ameliorate or actually preempt the onset of genetic disease.

    As the human genome is the engineering plans for the human body, it is a potential mother lode for the future of medicine, but it remains a complex set of plans to elucidate and exploit for the development of therapies. While genetically-based diseases may readily be addressed by gene therapies in 2035, the host of other diseases that do not have obvious genetic components will resist giving up easy gene therapy solutions. Then again, within 20 years a number of reasonable advances in understanding and intervention could open the gate to widespread “gene therapy” (in some sense) for a breadth of diseases and conditions –> Case in point, the recent emergence of the gene-editing technology, CRISPR, has set the stage for practical applications to correct genetically-based conditions.
  • Drug development will be dramatically more sophisticated, reducing the development time and cost while resulting in drugs that are far more clinically effective (and less prone to side effects). This arises from drug candidates being evaluated via distributed processing systems (or quantum computer systems) that can predict efficacy and side effect without need of expensive and exhaustive animal or human testing.The development of effective drugs will have been accelerated by both modeling systems and increases in our understanding of disease and trauma, including pharmacogenomics to predict drug response. It may not as readily follow that the costs will be reduced, something that may only happen as a result of policy decisions.
  • Most surgical procedures will achieve the ability to be virtually non-invasive. Natural orifice transluminal endoscopic surgery (NOTES) will enable highly sophisticated surgery without ever making an abdominal or other (external) incision. Technologies like “gamma knife” and similar will have the ability to destroy tumors or ablate pathological tissue via completely external, energy-based systems.

    By 2035, technologies such as these will measurably reduce inpatient stays, on a per capita basis, since a significant reason for overnight stays is the trauma requiring recovery, and eliminating trauma is a major goal and advantage of minimally invasive technologies (e.g., especially the NOTES technology platform). A wide range of other technologies (e.g., gamma knife, minimally invasive surgery/intervention, etc.) across multiple categories (device, biotech, pharma) will also have emerged and succeeded in the market by producing therapeutic benefit while minimizing or eliminating collateral damage.

Information technology will radically improve patient management. Very sophisticated electronic patient records will dramatically improve patient care via reduction of contraindications, predictive systems to proactively manage disease and disease risk, and greatly improve the decision-making of physicians tasked with diagnosing and treating patients.There are few technical hurdles to the advancement of information technology in medicine, but even in 2035, infotech is very likely to still be facing real hurdles in its use as a result of the reluctance in healthcare to give up legacy systems and the inertia against change, despite the benefits.

  • Personalized medicine. Perfect matches between a condition and its treatment are the goal of personalized medicine, since patient-to-patient variation can reduce the efficacy of off-the-shelf treatment. The thinking behind gender-specific joint replacement has led to custom-printed 3D implants. The use of personalized medicine will also be manifested by testing to reveal potential emerging diseases or conditions, whose symptoms may be ameliorated or prevented by intervention before onset.
  • Systems biology will underlie the biology of most future medical advances in the next 20 years. Systems biology is a discipline focused on an integrated understanding of cell biology, physiology, genetics, chemistry, and a wide range of other individual medical and scientific disciplines. It represents an implicit recognition of an organism as an embodiment of multiple, interdependent organ systems and its processes, such that both pathology and wellness are understood from the perspective of the sum total of both the problem and the impact of possible solutions.This orientation will be intrinsic to the development of medical technologies, and will increasingly be represented by clinical trials that throw a much wider and longer-term net around relevant data, staff expertise encompassing more medical/scientific disciplines, and unforeseen solutions that present themselves as a result of this approach.Other technologies being developed aggressively now will have an impact over the next twenty years, including medical/surgical robots (or even biobots), neurotechnologies to diagnose, monitor, and treat a wide range of conditions (e.g., spinal cord injury, Alzheimer’s, Parkinson’s etc.).

The breadth and depth of advances in medicine over the next 20 years will be extraordinary, since many doors have been recently opened as a result of advances in genetics, cell biology, materials science, systems biology and others — with the collective advances further stimulating both learning and new product development. 


See the 2016 report #290, “Worldwide Markets for Medical and Surgical Sealants, Glues, and Hemostats, 2015-2022.”

New medical technologies at startups in December 2015

Listed below are the technologies under development at medical technology startups identified in December 2015 and added to the Medtech Startups Database.

  • 3D-printed, patient-specific implants
  • Therapeutic temperature management.
  • Vessel preparation angioplasty balloon.
  • Control system for minimally invasive surgical tools.
  • Surgical solutions focused on robotic and other technology.
  • Undisclosed products, but based on brain-gut pathway; principals with background in diabetes, endocrinology.
  • Robotically-assisted minimal access surgery.
  • Novel catheter device as a treatment for heart failure with preserved ejection fraction.

For a historical listing of medtech startups identified by month, see link.

The Five Biggest Medical Technology Forces

There are five fundamental forces driving change in virtually every medical technology market. (There are many other forces, of course, that impact these markets, such as regulation, reimbursement, etc., but here I speak of forces driven by technology and the innovators employing them.) They represent challenges and opportunities — depending merely upon how companies perceive and respond to them.

Devices are no longer devices (only).

An inert medical or plastic device is likely to present little competitive threat. The device that succeeds stretches the boundaries of what a device is. Devices can be:

  • Biocompatible
  • Bioresorbable
  • Bioactive
  • Shape-shifting (e.g., nitinol)
  • Hybridized with drugs, cells, other biologics
  • Integrated with RFIDs and sensors
  • Combinations of the above

Competition comes from all directions. And so does opportunity.

Competition in medical technology has long since been defined by the device, having been replaced by the definition of the specific problem solved. And that problem is the disease state and the costs of managing and/or eliminating it. (An angioplasty catheter’s competition is not just angioplasty catheters, but also drug-eluting and/or bioresorbable coronary stents, drug-coated balloons, atherectomy, minimally invasive coronary artery bypass graft, atherosclerotic plaque-reducing drugs, etc.) Successful innovators consider all possible alternatives to solving the disease state need and define themselves by the solution, not the product. The only limitation a manufacturer has is its willingness to pursue all avenues to solving the problem.

Zero invasiveness.

Any technology that is not focused on the ideal of zero collateral damage, zero complications, and zero adverse side-effects will be threatened by those that do. The advances in materials technologies, medical/surgical techniques and understanding of pathology, among other advances, are sufficient to challenge manufacturers to pursue the goal of zero invasiveness. Just as open surgery has evolved to incisionless surgery, medical technologies increasingly take on the potential to be more like drugs, or better — treating the disease on a one-time basis with no complications whatsoever.

Decentralized, point-of-care technology.

Capital equipment is expensive, big and lethargic. A handheld imaging — ultrasound, even MRI — performed at the patient’s bedside or doctor’s office, offers enormous potential to reduce cost and increase clinical utility. But decentralization is not limited to diagnosis, since treatment is the ultimate goal and its incentives are the same. Of course, the trend moving diagnostics and therapeutics from the centralized to the point-of-care is not a new idea, but the reality is that a whole range of therapeutic devices (e.g., numerous ablation modalities) have been developed that no longer require OR suites, general anesthesia and their associated costs, and imaging systems have been shrinking to the point that words like “handheld” and “MRI” can be used in the same sentence (see Butterfly Network).

Research and development tools eliminate excuses.

R&D is inevitably challenged to evaluate ideas thoroughly, considering difficult-to-anticipate obstacles and rapidly evaluating ideas to reveal the best prospects and bring them to manufacturing, then to market. But multiple technologies have been developed and put into use that can accelerate the iterative cycles of development and yield prime product candidates to bring to market — biotech, pharma, biopharm, device, drug/device and others.  Computer modeling of hemodynamic blood flow, computer simulation of drug candidates (hybridized with devices or not), 3D printing (prototypes, custom implants) and many other advances are rapidly accelerating development of products that more perfectly fit the need.

 

Medical technologies at startups, July 2014

Below is a list of technologies under development at medical technology startups identified in July 2014 and included in the Medtech Startups Database.

  • thrombectomyInstrumentation for electrophysiology diagnosis and treatment.
  • Products for the treatment of hypertension and other chronic disease by interventional cardiologists
  • Surgical stapling device for use during natural orifice transluminal endoscopic surgery.
  • Low cost medical technologies to improve patient management in emerging markets.
  • Heart valve for the treatment of mitral valve regurgitation
  • Thrombectomy catheter
  • Microstaple bandage for wound closure.
  • Whole-body cryotherapy chambers as well as devices for local cryotherapy and cryosurgery.
  • Minimally invasive surgical device for the treatment of glaucoma
  • Electrical muscle stimulation.

For a historical listing of medical technologies at startups, see link.

Harsh questions for complex medtech

robotic_or_scalpelOn the one hand, as I track medical device technology development, I see the increasing trend toward a reduction in the complexity of approaches to accomplish therapeutic ends. The underlying force seems to be, “healthcare technology is expensive, so let’s minimize the technological complexity, minimize the invasiveness, reduce collateral damage, make treatments more specific to the resolution of symptoms and/or disease…” The result is that, for example, endoscopic surgery leads to laparoscopic surgery, which leads to single port laparoscopic surgery, which leads to natural orifice transluminal endoscopic surgery, potentially competing in its minimally invasiveness against alternatives like transcatheter interventional procedures — even for procedures like cardiac valve repair or replacement or coronary artery bypass grafting.

Then, on the other hand, I see technological development moving in the entirely opposite direction of increasing complexity with developments like robotic surgical systems, intraoperative imaging and others, all of which raise the question as to whether we are simply developing technologies for technology’s sake. Do these increasingly complex technologies provide a clinical endpoint not achievable with alternative technologies, or more importantly, procedural approaches? Certainly, I think that technologies that enable a surgeon to perform a procedure that he otherwise simply could not perform, such as those involving the use of intraoperative imaging technologies that enable the surgeon to see healthy versus pathological tissues and differentiate his actions accordingly can arguably result in a better clinical outcome. And as part of this process, one must consider the cost of the accompanying technology such as imaging systems.

Accordingly, when one considers the range of different complex robotic surgical technologies on the market or under development, one has to ask whether these systems truly allow the performance of procedures that the average, well-trained surgeon could not perform without that technology. Certainly, there are complex surgical procedures, such as delicate neuro procedures that, if not performed with extremely precise accuracy, might result in serious collateral damage. But hernia repair? Appendectomy? Colon resection? Hysterectomy? Some of these fairly high-volume procedures have indeed been presented as justification for the enormous expenditure needed to acquire robotic surgical systems.

Forgive me for stating the obvious, but it seems incumbent upon healthcare systems to critically evaluate the cost/benefit of new technology, given the limited resources in healthcare.

For this reason, it does not surprise me in the least that recent reports of complications or, in the least, device problems associated with the use of Intuitive Surgical’s robotic systems have promptly led to a precipitous decline in that company’s stock value. If a technology can’t enable the performance of a procedure that otherwise could not be performed, then its value is in question. Further, if the technology cannot perform a procedure flawlessly, and without complication or error that can arguably be performed without that technology, then its value is seriously in question.

The drug and device trends in the treatment of obesity

Several events have set the stage for change in the markets for treatment of obesity. Key among them are the 2012 FDA approvals of (link) of Vivus’ Qsymia (combination of phentermine and topiramate) and Arena Pharmaceuticals’ Belviq (lorcaserin).  In a market that has been dominated by surgical procedures and medical devices, the introduction of two significant pharmaceutical options has served notice that pharma is finally seizing hold of this large and growing opportunity.  The potential addition of yet another obesity drug, Orexigen’s Contrave (combination of naltrexone and bupropion), will only hasten this change.

Combine the advent of obesity drugs (whether or not reimbursement is at optimum levels) with the demand-pinching force of a still somewhat hobbled economy and its impact on the significantly out-of-pocket payment for obesity surgery and device procedures and it becomes clear that the market is shifting away from device and toward pharma. Gastric bypass (e.g., Roux en-Y) will hold stronger than device treatments due to lower cost. As a result, the adjustable gastric band, such as Allergan’s Lap-Band, will see a decline in the total share of obesity surgeries.  See the trend in Europe as an example:

Trend in Metabolic/Bariatric Surgery, Europe, 2003-2013

RYGB= Roux-en-Y gastric bypass
AGB=Adjustable gastric band
BPD/DS= Biliopancreatic diversion with duodenal switch
SG=Sleeve gastrectomy

Source: MedMarket Diligence, LLC; Report #S835.

Established obesity devices such as restrictive devices (e.g., Lap-Band and transoral gastropexy) and artificial fullness devices (e.g., gastric balloon) will represent slower growth than malabsorption devices, gastric emptying devices and appetite suppression devices, but which have thus far gained little presence in the market.  By comparison, appetite suppression drugs are already on the market and, with combination drugs taking off quickly, the share of the future market will be increasingly dominated by appetite suppression and combination drugs.

Source: MedMarket Diligence, LLC; Report #S835.

 

The report, “Products, Technologies and Markets Worldwide for the Clinical Management of Obesity, 2011-2019”, may be purchased online at link.

 

 

Allergan Looking to Slim Down

In a move that could be considered ironic, Allergan is looking to shed some excess weight as it looks to sell its Lap-Band business. While Lap-Band initially demonstrated extraordinary growth as the incidence and prevalence of obesity began to skyrocket (along with attention in the press), the product was also tarnished by the aggressive marketing of 1-800-GET-THIN. Lap-Band has also been a victim of the economy because many patients elect to pay for the surgery out of pocket. This is due to the fact that, while third party payers may ultimately be more inclined toward the product’s reimbursement since it may prevent or ameliorate obesity’s co-morbidities (e.g., Type 2 diabetes), current reimbursement levels do not yet reflect this. Allergan now believes that Lap-Band (which only represents only 3% of the company’s revenue) no longer exhibits attractive enough growth.

The future of obesity treatment is forecast in any case to be increasingly divided between devices and drugs.

——————
MedMarket Diligence has completed a global report on the clinical management of obesity. See link.

Pharmaceutical research in obesity

The challenges in the treatment of obesity are in providing practical, long-term solutions to a condition that is growing rapidly and is associated with numerous co-morbidities that include diabetes, hypertension (and other cardiovascular diseases), gastroesophageal reflux disease (GERD), osteoarthritis, fatty liver disease, obstructive sleep apnea, and cancer, among others.

Obesity is most commonly addressed, from a clinical solution, in device- and non-device-related bariatric surgery and a very limited number of drugs. Roux-en-Y and other gastric bypass procedure volumes have seen steady increases over the past few years as these procedures have been aggressively marketed and third party reimbursement has become more common.  Obesity device sales (lap-band and others) have grown, and will continue to grow, steadily.

As with most surgeries, however, there are morbidities associated with the procedures, whether or not devices are employed and long-term success has not been high enough to displace demand for pharmaceutical solutions.  Development of pharmaceuticals for obesity has been aggressive, but fraught with uncertainty in the regulatory process that, until only in mid-2011, seemed to make approval to be a moving target, if not unreachable.

Beyond the revived approval process now in play for drugs by Vivus, Orexigen, and Arena, pharmaceutical development in the field of obesity is focusing on several major areas:

  • Melanocortin receptor system
  • Cannabinoid receptor agonists
  • GLP-1 analogs
  • Methionine aminopeptidase 2 (MetAP2) inhibitor
  • Appetite suppression drugs (Arena’s lorcaserin, NeuroSearch’s Tesofensine, Shionogi’s Velneperit)
  • Malabsorption drugs
  • Satiety drugs
  • Combination drugs

We track the market for all obesity drugs and devices on the market and in development in our Report #S835, “Products, Technologies and Markets Worldwide for the Clinical Management of Obesity, 2011-2019.”

Posted via email from medmarket’s posterous

The Obesity Drug Opportunity Remains

Memory is as fleeting in the marketplace as are the FDA's policies. So, when it comes to considering the potential for developing drugs in the treatment of obesity, it should not be a surprise that the obesity market rises and falls in synchrony with the whims of the FDA.

In mid 2010, the thrust was on for obesity drug manufacturers.  Rising prevalence, a heightened sensitivity that obesity is a lynchpin for a litany of healthcare costs and an implicit recognition that a drug will always be less invasive than a gastric bypass were the forces collectively responsible for obesity drug development.  Then, from that black box that drives FDA policy came a conclusion a la fen-phen that obesity drugs are inherently dangerous.  Hence, by early 2011, Motley Fool reports:

Obesity drugs with safety issues are as common as celebrities getting fired for saying (or tweeting) something stupid. The Food and Drug Administration wants a cardiovascular safety trial before it'll approve Orexigen's (Nasdaq: OREX  ) Contrave. Arena Pharmaceuticals' (Nasdaq: ARNA  ) lorcaserin has potential cancer issues. And VIVUS (Nasdaq: VVUS  ) is dealing with the potential for its combination drug, Qnexa, to cause cleft lip in babies whose mothers take the drug.

They, without so much as a mea culpa, in September 2011, the FDA turns around and relaxes its demands for safety data.  Obesity drugs now have a seemingly shorter path to approval than it seemed a scant month ago. Stocks of Arena Pharmaceuticals, Orexigen and Vivus are back on the rise (not where they were, mid-2010) but headed back in that direction.

Below is the global market opportunity for obesity drugs that remains unchanged as a result of the FDA turnaround.

Source: "Products, Technologies and Markets Worldwide for the Clinical Management of Obesity, 2011-2019". MedMarket Diligence, LLC; Report #S835.

One cannot say that an opportunity exists irrespective of the stance of the FDA, at least not anyone who witnessed, as Motlely Fool called FDA bullying.  In the U.S., regardless of the latent demand or the amount of efficacy sans safety data, the FDA is a gatekeeper.  Even without the obesity drug barricade that the FDA erected, then has seemingly started tearing down, the capricious, unpredictable and, most of all, drawn-out regulatory approval process has been driving manufacturers elsewhere — the EU, even though it is far more Europe than it is Union, is still a well developed western market, and even South America, with its proximity to U.S. distribution systems, has become very attractive.

Demand for drug treatments for obesity remains high — in some ways it may be even higher than had the FDA not become such a barrier. In a free market economy, even as flawed as that model may seem in today's debt-riddled, recessionary world, demand remains a driver that seems to have much more staying power than anyone previously considered.

 

 

Posted via email from medmarket's posterous