Biologically-based medical glues, cyanoacrylate, or other synthetic. The bulk of global sales of medical glues are biologically-based, (includes fibrin, thrombogen, and others), rather than cyanoacrylate-based or other synthetic glues.
Cyanoacrylate-based glues, include those from Ethicon, Adhezion Biomedical, B. Braun, Meyer-Haake, and others. Cyanoacrylate-based glues for medical use are said to be stronger, less irritating to the skin when used externally, and more flexible than the household ‘super glue.’
Topical skin adhesives (TSAs) are used quite commonly for closing small wounds and incisions. There are two basic TSAs: 2-octyl cyanoacrylate (intended to close wounds and surgical incisions, and useful as an antibacterial barrier), and n-butyl cyanoacrylate, which is more flexible than the former, but also not as strong. Dermabond® and SurgiSeal™ are 2-octyl cyanoacrylates (OCA); Histoacryl®, Indermil®, and LiquiBand™ are n-butyl cyanoacrylates (BCA). These glues are intended for topical use only due primarily to toxicity and safety issues.
Other Synthetic Glues
Innovators are developing “other” glues from a variety of synthetic types; these glues have yet to gain more than 4% share globally. Synthetic glues may be derived from polyurethane or other polymers and may be light-activated. As yet, these synthetics have not been able to create anything more than a minor dent in bio-glue sales.
Biologically-based Medical Glues
Manufacturers of biologically-based medical glues have made these glues the most popular, accounting for almost two-thirds of medical glue revenues. However, ongoing developments mean that products are being improved and new products are being invented. These new glues may start to cannibalize from the biologically-based products.
Below is illustrated the growth of biologically-based glues by region, showing that most growth in this segment will be from Asia/Pacific markets, which are consistently demonstrating higher growth than in western markets.
Global Markets for Biologically-Based Medical Glues, 2015-2022, USD MillionsSource: MedMarket Diligence, LLC; Report #S290. (Order online)
Market shares for sales of sealants, glues, and hemostats vary considerably from region to region globally due to the significant variations in the local market demand, rate of adoption of specific manufacturers’ products, the regulatory climate, local economies, and other factors. Consequently, manufacturers with significant share of sales in the U.S. or Europe or Asia/Pacific may have considerably lower or higher shares in other regions.
In the U.S., Ethicon and Baxter have dominant positions in sales of surgical sealants. However, in Europe and Asia/Pacific, Baxter has substantially smaller position, particularly relative to competitors like Takeda Pharmaceuticals and The Medicines Company.
In the market for hemostats, similarly, Ethicon and Baxter have dominant position in the U.S. market, but in Asia/Pacific and Europe, Baxter is subordinate to Takeda Pharmaceuticals, CryoLife, and others.
Body-Machine: The interface between us and technology.
We are learning to listen to and interact with our body’s systems to ameliorate disease and trauma.
At the Wyss Center, a Swiss research institute, researchers applied functional near-infrared spectroscopy to create a brain-computer interface that enables patients with locked-in syndrome to communicate. The system is based on metabolic changes and was piloted on four patients with amyotrophic lateral sclerosis (ALS).
Engineers at the University of California San Diego and La Jolla-based startup Nanovision Biosciences Inc. have developed a retinal prosthesis using nanotechnology and wireless electronics that is intended to enable neurons in the retina to respond to light. The research has been tested on rat retina with a prototype of the device in vitro.
In an unrelated study in a rat model, Italian researchers reporting in Nature Materials developed an organic photovoltaic material annealed to the retina on a substrate of silk to convert light into current that is directly adapted by the brain to accept the signal.
Researchers at Stanford University have developed stretchable conductive electrodes to enable a flexible interface with brain implants and muscle stimulators. The technology has not yet been tested in animal models.
Diabetes: Wide-ranging advances in the study and treatment of diabetes are driven by huge clinical and economic need.
The body-machine of diabetes is the ‘artificial pancreas’, already FDA approved and available, which mechanically compensates for T1 diabetic symptoms, while the future nears for cellular and non-device interventions aspiring to reverse or cure.
In work published in Frontiers in Immunology, City of Hope researchers using autologous hematopoietic stem cell transplantation demonstrated increased C-peptide levels and induced insulin independence in patients with Type I diabetes.
In a study of Type 2 diabetes, Joslin Diabetes Center have identified the mechanism that prevents successful proliferation of beta cells in response to insulin resistance. The mechanism blocks the body’s own attempt to correct insulin resistance.
Researchers at Sweden’s Umeå Centre for Molecular Medicine have used optical projection tomography to produce 3D visualization of the pancreas that maps the three-dimensional distribution and volume of the insulin-producing cells in the pancreas. The data generated will enhance diabetes research, as in “planning of stereological analyses, in the development of non-invasive imaging techniques or various types of computational modelling and statistical analyses”.
We highlight recent developments pushing medical markets toward the future.
Type 1 Diabetes Mellitus and Artificial Pancreas Development
This month, the NIH announced that it is funding four projects to test fully automated artificial pancreas devices in Type 1 diabetics.
This important because, aside from Medtronic’s MiniMed 670G device (FDA approved in 2016), there are no other artificial pancreases on the market, and patients are begging for these to test successfully and be made available. I have a family member with Type 1 and can confirm that a “closed system” — one that tests glucose and adjusts insulin (and/or glucagon) in response — would dramatically ease the burden of managing this disease. No endless finger pricks, bouts of hypoglycemia or hyperglycemia, no elevated HbA1C — no bad sequellae from poorly managed diabetes, like peripheral neuropathy, retinopathy, vascular disease.
Three of the four trials, slated to begin in 2017 and 2018, are focused on testing devices in predominantly under 18 patients, while one trial will be for those 18 and over. These studies will refine the algorithms so that they more closely approximate normal glucoregulation.
The real future for diabetes management is likely to be determined by a biotech development — stem cells that regenerate pancreatic cells combined with mechanism to prevent the autoimmune response of type 1 that destroys functional insulin-producing pancreatic cells. The perfect solution to this disease is a cure, and maybe a form of cell therapy will ultimately be developed to provide that. Advances in cell biology and immunology suggest this may still be 5-10 years away.
In the interim, the liberation provided by safe, effective glucose control in an “artificial pancreas” (pump/glucometer) is likely to be dramatic for those type 1 patients fortunate enough to get one.
This month, a number of developments occurred in the area of body-machine interface, the connection of implants or other devices/systems to the body tissues:
Stentrode electrode implanted minimally invasively in brain to record signals from the motor cortex and transmit them wirelessly through the skin to a device outside the body.
Harvard study to place implant on visual cortex in brain to reverse blindness, potentially paralysis as well.
Living diode: Using cardiac muscle cells and cardiac fibroblasts — cells found in connective heart tissue — researchers at the University of Notre Dame have created a “living diode,” which can be used for cell-based information processing, according to a recent study in Advanced Biosystems. Bioengineers created the muscle-based circuitry through a novel, self-forming, micro patterning approach.
Advanced information systems are creating new possibilities in the development and application of therapeutics. Computer modeling of prospective drugs is accelerating the process toward manufacture of new safe and effective drugs, predicting complications based on better data integration of chemistry, biology, genetics, and other factors impacting drug efficacy.
As evidence of the force for innovation coming in these areas, the number of AI-related companies is surging. CB Insights reported that, in Q1-2011, there were 10 deals in artificial intelligence, but by Q2-2016, that number had hit 120 deals.
ALSO: CRISPR gene-editing patent dispute between MIT Broad Institute and University of California, Berkeley, resulted in a win for MIT Broad Institute, which will garner multitudes of money from licensing in “eukaryotes”(cells with nucleii) while UC Berkeley is left with open loopholes for patenting prokaryotic cells — Or, as Berkeley’s Jennifer Doudna (patent applied for) described it, “They have a patent on green tennis balls. We [likely] will have a patent on all tennis balls,” says Doudna. Meanwhile, CRISPR developments continue to emerge (e.g., gene-edited virus resistant pigs).
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