Investment in medtech and biotech: Outlook

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:

  1. 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.
  2. Medical devices are becoming increasingly intelligent medical devices, combining “smart” components, human-device interfaces, integration of AI in product development and products.
  3. Medical devices are rarely just “medical devices” anymore, often integrating embedded drugs, bioresorable materials, cell therapy components, etc.
  4. 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:

  • Cell therapies
    • Parkinson’s disease
    • Type I diabetes
    • Arthritis
    • Burn victims
    • Cardiovascular diseases
  • Diabetes
    • Artificial pancreas
    • Non-invasive blood glucose measurement
  • Tissue engineering and regeneration
    • 3D printed organs
  • Brain-computer and other nervous system interfaces
    • Nerve-responsive prosthetics
    • Interfaces for patients with locked-in syndrome to communicate
    • Interfaces to enable (e.g., Stentrode) paralyzed patients to control devices
  • Robotics
    • Robotics in surgery (advancing, despite costs)
    • Robotic nurses
  • Optogenetics: light modulated nerve cells and neural circuits
  • Gene therapy
    • CRISPR
  • Localized drug delivery
  • Immuno-oncology
    • Further accelerated by genomics and computational approaches
    • Immune modulators, vaccines, adoptive cell therapies (e.g., CAR-T)
  • Drug development
    • 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.

Source: Compiled by MedMarket Diligence, LLC.

 

The best medtech investment opportunities

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:

  • Materials technologies
    • graphene
    • bioresorbables
    • biosensors
    • polymers
    • bioadhesives
  • Cell therapy and tissue engineering
    • cell-based treatments (diabetes, spinal cord injury, traumatic brain injury)
    • extracellular matrices in soft tissue repair and regeneration
  • Nanotechnology (subject of forthcoming report)
    • nano coatings
    • nano- and micromedical technologies for localized drug delivery
    • nanoparticles
  • 3D printing
    • prototype development
    • patient-specific implants
  • Minimally- and non-invasive technologies
    • transcatheter alternatives to surgery
    • NOTES (natural orifice transluminal endoscopic surgery)
  • Diabetes non-invasive glucose testing
  • Intraoperative surgical guidance
    • 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
  • point-of-care diagnostics
  • point-of-care imaging
  • AI-enhanced devices

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.

 

Technologies at Medtech Startups, December 2016

Below is a list of technologies under development at startups identified thus far in December 2016 and included in the Medtech Startups Database:

  • Nanoparticle-based imaging for the treatment of epilepsy.
  • Implantable device for continuous relief of congestive heart failure.
  • Nanofiber technology for soft tissue repair.
  • Technology to facilitate intubation.
  • Medical device to manage skin complications suffered by ileostomy patients.
  • An implant for arthritis sufferers that mimics the natural motions of the joint.
  • Embolic protection device used during TAVR procedures.
  • Glucose monitor for diabetes using low-power RF/Microwave detection in fingertips.
  • Novel disinfection and sterilization solutions.
  • Drug delivery.
  • Dental and orthopedic applications of nanomaterials.
  • Catheter and guidewire technologies.

For a comprehensive list of the technologies at medtech startups identified by month, see link.

Technologies Under Development at Medtech Startups, November 2016

Below is a list of the technologies under development at medical startups recently identified by MedMarket Diligence and included in the Medtech Startups Database.

  • Intravenous light therapy.
  • Post-op drainage device.
  • Devices for vascular access during hemodialysis.
  • Implantable, localized drug delivery for cancer.
  • Technology to facilitate ureter placement.
  • Tools to improve safety of surgery.
  • Technologies for improved tendon repair.
  • Needle guidance and analytics to facilitate spinal tap.
  • Closed-loop catheter for localized liver cancer treatment.
  • Cancer detection
  • Improved vascular access for dialysis.
  • Developing an artificial pancreas.
  • Nasogastric feeding system.

For a complete list of technologies in development at medtech startups identified since 2008, see link.

Medtech Fundings for September 2016

Fundings in medical technology stand at $900 million for the month, led by the $345 million private placement by Insulet Corp., followed by the $168 million funding of Intarcia Therapeutics, the $86 million IPO of iRhythm Technologies, and the $75 million IPO of Obalon Therapeutics.

Below are the top fundings for the month thus far. Revisit this post (and refresh your browser) through September to see updates.

For the complete list of September 2016 fundings, see link.

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Source: Compiled by MedMarket Diligence, LLC.

For a historical list of medtech fundings by month since 2009, see link.

Wound management practice patterns, products by wound type

From Report #S251, “Wound Management to 2024”.

Surgical wounds account for the vast majority of skin injuries. We estimate that there are approximately 100 million surgical incisions per year, growing at 3.1% CAGR, that require some wound management treatment. About 16 million operative procedures were performed in acute care hospitals in the USA. Approximately 80% of surgical incisions use some form of closure product: sutures, staples, and tapes. Many employ hemostasis products, and use fabric bandages and surgical dressings.

Surgical procedures generate a preponderance of acute wounds with uneventful healing and a lower number of chronic wounds, such as those generated by wound dehiscence or postoperative infection. Surgical wounds are most often closed by primary intention, where the two sides across the incision line are brought close and mechanically held together. Overall the severity and size of surgical wounds will continue to decrease as a result of the continuing trend toward minimally invasive surgery.

Surgical wounds that involve substantial tissue loss or may be infected are allowed to heal by secondary intention where the wound is left open under dressings and allowed to fill by granulation and close by epithelialization. Some surgical wounds may be closed through delayed primary intention where they are left open until such time as it is felt it is safe to suture or glue the wound closed.

Traumatic wounds occur at the rate of 50 million or more every year worldwide. They require cleansing and treatment with low-adherent dressings to cover the wound, prevent infection, and allow healing by primary intention. Lacerations are a specific type of trauma wound that are generally minor in nature and require cleansing and dressing for a shorter period. There are approximately 20 million lacerations a year as a result of cuts and grazes; they can usually be treated in the doctors’ surgery, outpatient medical center or hospital A&E departments.

Burn wounds can be divided into minor burns, medically treated, and hospitalized cases. Outpatient burn wounds are often treated at home, at the doctor’s surgery, or at outpatient clinics. As a result, a large number of these wounds never enter the formal health service system. According to the World Health Organization (WHO), globally about 11 million people are burned each year severely enough to require medical treatment. We estimate that approximately 3.5 million burns in this category do enter the outpatient health service system and receive some level of medical attention. In countries with more developed medical systems, these burns are treated using hydrogels and advanced wound care products, and they may even be treated with consumer-based products for wound healing.

Medically treated burn wounds usually receive more informed care to remove heat from the tissue, maintain hydration, and prevent infection. Advanced wound care products are used for these wounds. There are approximately 6.0 million burns such as this that are treated medically every year.

Hospitalized burn wounds are rarer and require more advanced and expensive care. These victims require significant care, nutrition, debridement, tissue grafting and often tissue engineering where available. They also require significant follow-up care and rehabilitation to mobilize new tissue, and physiotherapy to address changes in physiology. Growth rates within the burns categories are approximately 1.0% per annum.

Chronic wounds generally take longer to heal, and care is enormously variable, as is the time to heal. There are approximately 7.4 million pressure ulcers in the world that require treatment every year. Many chronic wounds around the world are treated sub-optimally with general wound care products designed to cover and absorb some exudates. The optimal treatment for these wounds is to receive advanced wound management products and appropriate care to address the underlying defect that has caused the chronic wound; in the case of pressure ulcers a number of advanced devices exist to reduce pressure for patients. There are approximately 9.7 million venous ulcers, and approximately 10.0 million diabetic ulcers in the world requiring treatment. Chronic wounds are growing in incidence due to the growing age of the population, and the growth is also due to increasing awareness and improved diagnosis. Growth rates for pressure and venous ulcers are 6%–7% in the developed world as a result of these factors.

Diabetic ulcers are growing more rapidly due mainly to increased incidence of both Type I and maturity-onset diabetes in the developed countries around the world. The prevalence of diabetic ulcers is rising at 9% annually. Every year 5% of diabetics develop foot ulcers and 1% require amputation. The recurrence rate of diabetic foot ulcers is 66%; the amputation rate rises to 12% with subsequent ulcerations. At present, this pool of patients is growing faster than the new technologies are reducing the incidence of wounds by healing them.

Wound management products are also used for a number of other conditions including amputations, carcinomas, melanomas, and other complicated skin cancers, all of which are on the increase.

A significant feature of all wounds is the likelihood of pathological infection occurring. Surgical wounds are no exception, and average levels of infection of surgical wounds are in the range of 7%–10%, depending upon the procedure. These infections can be prevented by appropriate cleanliness, surgical discipline and skill, wound care therapy, and antibiotic prophylaxis. Infections usually lead to more extensive wound care time, the use of more expensive products and drugs, significantly increased therapist time, and increased morbidity and rehabilitation time. A large number of wounds will also be sutured to accelerate closure, and a proportion of these will undergo dehiscence and require aftercare for healing to occur.

For the detailed coverage of wounds, wound management products, companies, and markets, see report #S251, “Worldwide Wound Management to 2024”.

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.”

Medtech fundings for July 2016

Medtech fundings for July 2016 stand at $612 million, led by the $183 million IPO of Bioventus, followed by the $49 million Series C funding of VytronUS, the $32 million funding of Endotronix and the $30 million funding of Senseonics.

Below are the top fundings for the month thus far. Check back before month end to see updates.

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For a complete list of fundings in July 2016, see link.

Medtech midterm; Cardiovascular procedures; Wound shifts; Fundings

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advanced medical technologies

A weekly(ish) newsletter to our blog subscribers.
From MedMarket Diligence, LLC
(Make note of this code: “Optinthirtyoff”)

From “Medtech is Dead. Long Live Medtech“, here is some of what we can expect in the next 5-10 years in medtech:

  • Type 1 diabetes gradually becomes less burdensome, with fewer complications, and improved quality of life for patients.
  • Type 2 diabetes continues to plague Western markets in particular, despite advances in diagnosis, treatment, and monitoring due to challenges in patient compliance.
  • Cancer five year survival rates will dramatically increase for many cancers. The number of hits on Google searches for “cure AND cancer” will reflect this.
  • Multifaceted approaches available for treatment of traumatic brain injury and spinal cord injury – encompassing exoskeletons to help retrain/rehabilitate and increase functional mobility, nerve grafting, cell/tissue therapy, and others.
  • Organ/device hybrids will proliferate and become viable alternatives to transplant, or bridge-to-transplant, for pulmonary assist, kidney, liver, heart, pancreas and other organ.
  • Stem cells have had dramatic success, and the science will have improved, but challenges remain, especially since the excitement around stem and other pluripotent cells has created a climate not far removed from the wild west – the potential of such open territory being up for grabs has drawn hordes of activity, not all in the best interests of patients or shareholders. But in this time frame, specific treatments will likely have become standards of care for some diseases, while the challenge and opportunity remain for many others.
From “Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022”.

Cardiovascular Surgical and Interventional Procedures

  • Coronary Artery Bypass Graft Surgery
  • Coronary Mechanical and Laser Atherectomy
  • Coronary Angioplasty and Stenting
  • Mechanical Thrombectomy
  • Ventricular Assist Device Placement
  • Total Artificial Heart
  • Donor Heart Transplantation
  • Lower Extremity Arterial Bypass Surgery
  • Percutaneous Transluminal Angioplasty (PTA) and Bare Metal Stenting
  • PTA and Drug-Eluting Stenting
  • PTA with Drug-Eluting Balloons
  • Mechanical and Laser Atherectomy
  • Catheter-Directed Thrombolysis and Thrombectomy
  • Surgical and Endovascular Thoracic Aortic Aneurysm Repair
  • Surgical and Endovascular Abdominal Aortic Aneurysm Repair
  • Vena Cava Filter Placement
  • Endovenous Ablation
  • Venous Revascularization
  • Carotid Endarterectomy
  • Carotid Artery Stenting
  • Cerebral Thrombectomy
  • Cerebral Aneurysm and Arteriovenous Malformation (AVM) repair
  • Congenital Heart Defect Repair
  • Heart Valve Repair and Replacement Surgery
  • Transcatheter Valve Repair and Replacement
  • Pacemaker Implantation
  • Implantable Cardioverter Defibrillator Placement
  • Cardiac Resynchronization Therapy Device Placement
  • Standard SVT Ablation
  • Surgical AFIb Ablation
  • Transcatheter AFib Ablation

See Report #C500, published August 2016.

From “Worldwide Wound Management, Forecast to 2024”, Report #S251, published December 2015

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Source: Report #S251.

 

Selected Medtech Fundings, May 2016

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Source: Compiled by MedMarket Diligence, LLC

Pending Reports from MedMarket Diligence:

  • Global Nanomedical Technologies, Markets and Opportunities, 2016-2021. Details.
  • Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022. Details.
  • Worldwide Markets for Medical and Surgical Sealants, Glues, and Hemostats, 2015-2022. Details.

Patrick Driscoll
(patrick)
MedMarket Diligence

Wound healing factors; Growth in peripheral stenting; Nanomed applications

From our weekly email to blog subscribers…

Extrinsic Factors Affecting Wound Healing

From Report #S251, “Worldwide Wound Management, Forecast to 2024: Established and Emerging Products, Technologies and Markets in the Americas, Europe, Asia/Pacific and Rest of World.”

Extrinsic factors affecting wound healing include:

Mechanical stress
Debris
Temperature
Desiccation and maceration
Infection
Chemical stress
Medications
Other factors

Mechanical stress factors include pressure, shear, and friction. Pressure can result from immobility, such as experienced by a bed- or chair-bound patient, or local pressures generated by a cast or poorly fitting shoe on a diabetic foot. When pressure is applied to an area for sufficient time and duration, blood flow to the area is compromised and healing cannot take place. Shear forces may occlude blood vessels, and disrupt or damage granulation tissue. Friction wears away newly formed epithelium or granulation tissue and may return the wound to the inflammatory phase.

Debris, such as necrotic tissue or foreign material, must be removed from the wound site in order to allow the wound to progress from the inflammatory stage to the proliferative stage of healing. Necrotic debris includes eschar and slough. The removal of necrotic tissue is called debridement and may be accomplished by mechanical, chemical, autolytic, or surgical means. Foreign material may include sutures, dressing residues, fibers shed by dressings, and foreign material which were introduced during the wounding process, such as dirt or glass.

Temperature controls the rate of chemical and enzymatic processes occurring within the wound and the metabolism of cells and tissue engaged in the repair process. Frequent dressing changes or wound cleansing with room temperature solutions may reduce wound temperature, often requiring several hours for recovery to physiological levels. Thus, wound dressings that promote a “cooling” effect, while they may help to decrease pain, may not support wound repair.

Desiccation of the wound surface removes the physiological fluids that support wound healing activity. Dry wounds are more painful, itchy, and produce scab material in an attempt to reduce fluid loss. Cell proliferation, leukocyte activity, wound contraction, and revascularization are all reduced in a dry environment. Epithelialization is drastically slowed in the presence of scab tissue that forces epithelial cells to burrow rather than freely migrate over granulation tissue. Advanced wound dressings provide protection against desiccation.

Maceration resulting from prolonged exposure to moisture may occur from incontinence, sweat accumulation, or excess exudates. Maceration can lead to enlargement of the wound, increased susceptibility to mechanical forces, and infection. Advanced wound products are designed to remove sources of moisture, manage wound exudates, and protect skin at the edges of the wound from exposure to exudates, incontinence, or perspiration.

Infection at the wound site will ensure that the healing process remains in the inflammatory phase. Pathogenic microbes in the wound compete with macrophages and fibroblasts for limited resources and may cause further necrosis in the wound bed. Serious wound infection can lead to sepsis and death. While all ulcers are considered contaminated, the diagnosis of infection is made when the wound culture demonstrates bacterial counts in excess of 105 microorganisms per gram of tissue. The clinical signs of wound infection are erythema, heat, local swelling, and pain.

Chemical stress is often applied to the wound through the use of antiseptics and cleansing agents. Routine, prolonged use of iodine, peroxide, chlorhexidine, alcohol, and acetic acid has been shown to damage cells and tissue involved in wound repair. Their use is now primarily limited to those wounds and circumstances when infection risk is high. The use of such products is rapidly discontinued in favor of using less cytotoxic agents, such as saline and nonionic surfactants.

Medication may have significant effects on the phases of wound healing. Anti-inflammatory drugs such as steroids and non-steroidal anti-inflammatory drugs may reduce the inflammatory response necessary to prepare the wound bed for granulation. Chemotherapeutic agents affect the function of normal cells as well as their target tumor tissue; their effects include reduction in the inflammatory response, suppression of protein synthesis, and inhibition of cell reproduction. Immunosuppressive drugs reduce WBC counts, reducing inflammatory activities and increasing the risk of wound infection.

Other extrinsic factors that may affect wound healing include alcohol abuse, smoking, and radiation therapy. Alcohol abuse and smoking interfere with body’s defense system, and side effects from radiation treatments include specific disruptions to the immune system, including suppression of leukocyte production that increases the risk of infection in ulcers. Radiation for treatment of cancer causes secondary complications to the skin and underlying tissue. Early signs of radiation side effects include acute inflammation, exudation, and scabbing. Later signs, which may appear four to six months after radiation, include woody, fibrous, and edematous skin. Advanced radiated skin appearances can include avascular tissue and ulcerations in the circumscribed area of the original radiation. The radiated wound may not become evident until as long as 10-20 years after the end of therapy.

Source: “Wound Management to 2024”, Report #S251.


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Source: “Global Market Opportunities in Peripheral Arterial and Venous Stents, Forecast to 2020”, Report #V201.


Selected Therapeutic and Diagnostic Applications of Nanotechnology in Medicine

Below are selected applications for neuromedical technologies in development or on the market currently.

Drug Delivery
Chemotherapy drug delivery
Magnetic nanoparticles attached to cancer cells
Nanoparticles carrying drugs to arterial wall plaques
Therapeutic magnetic carriers (TMMC) [guided using magnetic resonance navigation, or MRN]

Drugs and Therapies
Diabetes
Combatting antimicrobial resistance
Alzheimer’s Disease
Infectious Disease
Arthritis

Tissue, cell and genetic engineering involving nanomedical tools
Nanomedical tools in gene therapy for inherited diseases
Artificial kidney
ACL replacements
Ophthalmology
Implanted nanodevices for alleviation of pain

Biomaterials 

Nanomedicine and Personalized Treatments

Source: Report #T650, “Global Nanomedical Technologies, Markets and Opportunities, 2016-2021”. Report #T650.