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Clene to Report HEALEY ALS Platform Trial Topline Results on Monday, October 3 – Investing News Network

As announced in February 2022, the trial was stopped prematurely due to COVID-19 pandemic operational challenges, limiting enrollment to 73 out of the 150 planned participants. Due to the limited enrollment, the threshold for significance was pre-specified at p=0.10 prior to database lock. The primary analysis was conducted in a modified intent to treat (mITT) population, which censored invalid data. The mITT population excluded data from a single site (n=9) with LCLA testing execution errors and the timed 25-foot walk data from one subject with a change in mobility assist device. The ITT results were directionally consistent with the mITT results, although the ITT results were not significant.

"These data are very encouraging to us in the MS research and treatment community as we work to address functional improvement in patients," said Benjamin Greenberg, MD, MHS, FANA, FAAN, CRND Professor of Neurology and one of the trial's clinical advisors. "The MS community has been successful at limiting relapses, but we need therapies to address progression independent of relapse activity (PIRA). This study was designed as a proof-of-concept evaluation to establish that treatment of neuronal and glial energetic failure can support remyelination and neuroprotection in people living with MS. I am pleased to see the potential effectiveness of CNM-Au8 demonstrated in this trial."

Primary and secondary results from Baseline to Week 48 were:

Consistent improvements favoring CNM-Au8 were observed across multiple paraclinical biomarkers, including multifocal visual evoked potentials (mfVEP) amplitude and latency, optical coherence tomography (OCT), and MRI endpoints, including magnetization transfer ratio and diffusion tensor imaging metrics. Placebo treated patients, in contrast, generally worsened as expected across these measures during the 48-week period. These data provide independently assessed quantitative physiological evidence that supports the potential neuroprotective and remyelinating effects of CNM-Au8. The full dataset will be reported at an upcoming scientific congress.

CNM-Au8 was well-tolerated, and there were no significant safety findings reported.

Robert Glanzman, MD, FAAN, Clene's Chief Medical Officer, said, "In this study, CNM-Au8 demonstrated neurological improvements in people with stable relapsing MS as adjunctive therapy to immunomodulatory DMTs. I am very impressed by the consistency of structural and functional improvements demonstrated by CNM-Au8 throughout the neuraxis. With these data, Clene looks forward to initiating a Phase 3 clinical program in people with MS who are experiencing progression independent of relapse activity, the most urgent unmet medical need in MS today. We look forward to the next phase of clinical development."

Rob Etherington, Clene's Chief Executive Officer and President, added, "These results further demonstrate the potential of CNM-Au8 to drive neuronal cellular energy production in patients struggling with MS and other neurodegenerative diseases. We also await additional evidence of clinical efficacy from the HEALEY ALS Platform Trial, which is expected to report topline data later in this quarter. Clene will continue to work tirelessly to further CNM-Au8's development to treat neurodegenerative diseases."

Conference Call and Webcast Information Clene will host a conference call and webcast at 7:30 am EDT to discuss the VISIONARY-MS topline results.

Toll free: 1 (888) 770-7152 Conference ID: 5318408 Press *1 to ask or withdraw a question, or *0 for operator assistance .

To access the live webcast, please register online at this link . Participants are requested to register at a minimum 15 minutes before the start of the call. A replay of the call will be available two hours after the call and archived on the same web page for six months. A live audio webcast of the call will be available on the Investors section of the Company's website Presentation page . An archived webcast will be available on the Company's website approximately two hours after the event.

About VISIONARY-MS VISIONARY-MS was a Phase 2 multi-center, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of CNM-Au8 in participants with stable relapsing remitting multiple sclerosis (RRMS) with a history of chronic visual impairment who are allowed disease-modifying therapy (DMT). Enrolled subjects were randomized 1:1:1 to CNM-Au8 15 mg/day, 30 mg/day, or placebo. As announced in February 2022, the trial was stopped prematurely due to COVID-19 pandemic operational challenges, enrolling 73 out of the 150 planned participants. Due to limited enrollment, the threshold for significance was pre-specified at p=0.10 prior to database lock. The primary endpoint was the change in best corrected-low contrast letter acuity (BC-LCLA) from baseline to week 48 in the clinically affected eye. Key secondary efficacy outcomes assessed neurological function by the modified MS Functional Composite (mMSFC) including 25-Foot Timed Walk, Symbol Digit Modalities Test, 9-Hole Peg Test (dominant and non-dominant hands), and LCLA (affected and fellow eye) from baseline through Week 48. For more information, see ClinicalTrials.gov . Identifier: NCT03536559 . The open label extension of VISIONARY-MS is ongoing.

About CNM-Au8 CNM-Au8 is an oral suspension of gold nanocrystals developed to restore neuronal health and function by increasing energy production and utilization. The catalytically active nanocrystals of CNM-Au8 drive critical cellular energy producing reactions that enable neuroprotection and remyelination by increasing neuronal and glial resilience to disease-relevant stressors. CNM-Au8 is a federally registered trademark of Clene Nanomedicine, Inc.

About Clene Clene is a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative disease by targeting energetic failure, an underlying cause of many neurological diseases. The company is based in Salt Lake City, Utah, with R&D and manufacturing operations in Maryland. For more information, please visit http://www.clene.com or follow us on Twitter , LinkedIn and Facebook .

Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended, which are intended to be covered by the "safe harbor" provisions created by those laws. Clene's forward-looking statements include, but are not limited to, statements regarding our or our management team's expectations, hopes, beliefs, intentions or strategies regarding our future operations. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words "anticipate," "believe," "contemplate," "continue," "estimate," "expect," "intends," "may," "might," "plan," "possible," "potential," "predict," "project," "should," "will," "would," and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements represent our views as of the date of this press release and involve a number of judgments, risks and uncertainties. We anticipate that subsequent events and developments will cause our views to change. We undertake no obligation to update forward-looking statements to reflect events or circumstances after the date they were made, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. Accordingly, forward-looking statements should not be relied upon as representing our views as of any subsequent date. As a result of a number of known and unknown risks and uncertainties, our actual results or performance may be materially different from those expressed or implied by these forward-looking statements. Some factors that could cause actual results to differ include our ability to demonstrate the efficacy and safety of our drug candidates; the clinical results for our drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; our ability to achieve commercial success for our drug candidates, if approved; our limited operating history and our ability to obtain additional funding for operations and to complete the development and commercialization of our drug candidates; and other risks and uncertainties set forth in "Risk Factors" in our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q. In addition, statements that "we believe" and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this press release, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and you are cautioned not to rely unduly upon these statements. All information in this press release is as of the date of this press release. The information contained in any website referenced herein is not, and shall not be deemed to be, part of or incorporated into this press release.

Source: Clene Inc.

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Clene to Report HEALEY ALS Platform Trial Topline Results on Monday, October 3 - Investing News Network

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Liquid Biopsy Detects Nano-Sized Signs of Breast Cancer in Early-Stage Patients – Technology Networks

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A USC-led team of scientists has found indications that a special blood test called a liquid biopsy could determine whether a patient has breast cancer at its early stage and if that cancer is unlikely to return.

These high-definition comprehensive liquid biopsies are conducted using a standard blood draw from the arm of a patient in a doctors office. Once in the laboratory, the sample is examined for signs of cancer.

The study demonstrating the liquid biopsy results for early breast cancer detection was published in Natures npj Breast Cancer journal. The work was a collaboration between USC, Billings Clinic, Duke University, Epic Sciences and USC Norris Comprehensive Cancer Center. The results raise hopes that one day doctors could detect breast cancer in patients with a simple blood draw.

The researchers at the USC Michelson Convergent Science Institute in Cancer (CSI-Cancer) are cautiously optimistic about their findings. They are eager to test and see whether the results will be proven in larger clinical trials to demonstrate the benefit of the method for patients everywhere.

Its an amazing opportunity to change how early breast cancer detection is being done with a simple blood draw, but it's only a research outcome at this point and we still need to demonstrate clinical benefit, said Peter Kuhn, a USC cancer physicist who directs CSI-Cancer.

Breast cancer is the most prevalent form of cancer in the world, affecting 1 in 8 women over their lifetime.

Since 1976 when the American Cancer Society endorsed the technique, mammography X-ray, along with a tissue biopsy, has become the standard way for doctors to check patients for breast cancer.

But mammography is not 100% accurate and its detection can be impeded by healthy dense tissue. Mammographys sensitivity to breast cancer is around 87%, according to the Breast Cancer Surveillance Consortium. And for some women, mammograms are not accessible, especially those living in poor isolated communities that have no clinics or hospitals. Others simply do not get a regular mammogram.

But a tissue biopsy also is not a fool-proof method. Although it can reveal information about the tumor, it has limitations. Doctors can sample only a small area and may fail to capture the full extent of the tumor. A tissue biopsy is also invasive and painful.

Combined, the drawbacks for diagnosis with mammograms and tissue biopsies mean some patients are not diagnosed until the cancer has grown and spread. New methodologies such as CSI-Cancers liquid biopsy can bring a complementary toolset into clinical practice.

For the study, Kuhn and his team worked with 100 breast cancer patients some early and late stage and 40 patients without breast cancer from April 2013 through January 2017. The work was conducted at clinical sites including at the Norris Comprehensive Cancer Center at Keck Medicine of USC, the Billings Clinic in Montana, Duke University Cancer Institute in Durham, North Carolina and the City of Hope Comprehensive Cancer Center in Duarte, Calif.

The team tested a theory that the high-definition liquid biopsy could detect multiple cancer biomarkers, including the so-called oncosomes nano-sized, membraned cargo carriers that enrich the bodys environment for cancer growth. These oncosomes are secreted by cancer cells as the group has shown previously.

The news here is that we found the vast majority of early-stage breast cancer patients have these oncosomes at very robust levels, said Kuhn, a Deans Professor at USC Dornsife College of Letters, Arts and Sciences and cancer physicist. Theyre about 5-10 microns in diameter. About the size of a cell. We first identified these large vesicles in prostate cancer about a year-and-a-half ago and showed that they are related to the cancer. They are hiding in plain sight.

If further studies produce similar results, this could mean that the next generation high-definition liquid biopsy may become a diagnostic tool for early breast cancer detection and other cancers, he said. The test also could inform patients who have been treated for cancer that they will most likely remain cancer-free.

Typically, Im the bearer of bad news. I say, You have cancer in your blood, Kuhn said. But a test like this could give hope that if there is a sign of cancer, we can find it very early and improve treatment and survival.

Reference: Setayesh SM, Hart O, Naghdloo A, et al. Multianalyte liquid biopsy to aid the diagnostic workup of breast cancer. npj Breast Cancer. 2022;8(1):1-11. doi: 10.1038/s41523-022-00480-4

This article has been republished from the following materials. Note: material may have been edited for length and content. For further information, please contact the cited source.

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Pulse Biosciences Announces FDA 510(k) Clearance for the Treatment of Sebaceous Hyperplasia – Business Wire

HAYWARD, Calif.--(BUSINESS WIRE)--Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company developing the CellFX System powered by Nano-Pulse Stimulation (NPS) technology, today announced receipt of U.S. Food and Drug Administration (FDA) 510(k) clearance for its CellFX System, expanding the indication for use to include the treatment of sebaceous hyperplasia in patients with Fitzpatrick skin types I-III. This specific indication clearance enhances the CellFX Systems general indication FDA clearance and enables the Company to support clinics in marketing and promoting CellFX treatments specifically for patients with sebaceous hyperplasia. The clearance was based on clinical data from the Companys IDE approved study for the treatment of sebaceous hyperplasia.

The Company also recently received FDA 510(k) clearance of two additional treatment tips with larger spot sizes, specifically 7.5mm and 10mm tip sizes, for treating larger benign lesions. These treatment tips broaden the portfolio of previously available 1.5mm, 2.5mm and 5.0mm treatment tip sizes.

We are pleased with the continued advancement of the CellFX System and its capabilities to enhance its value proposition for patients, clinicians and any potential commercial partner. These clearances provide further validation of the systems strong safety and effectiveness profile, said Kevin Danahy, President and Chief Executive Officer of Pulse Biosciences. We would like to thank all of the investigators, the staff at their clinics and the patients who participated in these trials, as well as the FDA for their ongoing collaboration as we endeavor to offer the benefits of NPS technology to more patients.

About Pulse Biosciences

Pulse Biosciences is a novel bioelectric medicine company committed to health innovation that has the potential to improve the quality of life for patients. The Companys proprietary Nano-Pulse Stimulation technology delivers nano-second pulses of electrical energy to non-thermally clear cells while sparing adjacent non-cellular tissue. The CellFX System is the first commercial product to harness the distinctive advantages of NPS technology to treat a variety of conditions for which an optimal solution remains unfulfilled. The Company is actively pursuing application development in cardiology, oncology, gastroenterology, and other medical specialties. Designed as a multi-application platform, the CellFX System offers customer value with a utilization-based revenue model. Visit http://www.pulsebiosciences.com to learn more.

Pulse Biosciences, CellFX, Nano-Pulse Stimulation, NPS, and the stylized logos are among the trademarks and/or registered trademarks of Pulse Biosciences, Inc. in the United States and other countries.

Forward-Looking Statements

All statements in this press release that are not historical are forward-looking statements, including, among other things, statements relating to Pulse Biosciences expectations concerning customer adoption and future use of the CellFX System to address a range of dermatologic conditions, statements relating to the Companys future product development in healthcare outside of dermatology and the Companys other activities to develop and commercialize NPS technology to drive growth, statements about the Companys ability to pursue and complete strategic transactions and its prospects to partner any of its programs, whether in dermatology or otherwise, statements relating to the effectiveness of the Companys NPS technology and the CellFX System to improve the quality of life for patients, and Pulse Biosciences expectations, whether stated or implied, regarding whether any regulatory clearances will enhance the value proposition of the CellFX System for patients, clinicians or others, and other future events. These statements are not historical facts but rather are based on Pulse Biosciences current expectations, estimates, and projections regarding Pulse Biosciences business, operations and other similar or related factors. Words such as may, will, could, would, should, anticipate, predict, potential, continue, expects, intends, plans, projects, believes, estimates, and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond Pulse Biosciences control. Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including those described in Pulse Biosciences filings with the Securities and Exchange Commission. Pulse Biosciences undertakes no obligation to revise or update information in this release to reflect events or circumstances in the future, even if new information becomes available.

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Pulse Biosciences Announces FDA 510(k) Clearance for the Treatment of Sebaceous Hyperplasia - Business Wire

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Nano Products Online Store | Nanoproducts, Nanoparticles, Nanopowders …

Nanotechnology today is growing very rapidly and has infinite applications in almost everything we do. The medicine we take, food we eat, chemicals we use, car we drive and much much more.mknano offers large variety of nano products in various forms as mentioned below. We offer many nano powders at very affordable prices.

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Carbon Nanotubes Single wall (SWNT), Double wall (DWNT), Multiwall (MWNT), (alligned/tangled/dispersable), OH, COOH Functionalized SWNT/MWNT, Industrial Grade SWCNTs, MWCNTs, Conducting (Metallic) and Semiconducting SWCNTs, MWCNT Nonwoven Papers, CNT Foam, Special application CNTs.

Other Nanotubes (Metals, Compounds, and Oxides/Hyroxides)

Quantum Dots Cadmium Mercury Telluride (CdHgTe), Cadmium Selenide (CdSe), Cadmium Selenide/Zinc Sulfide (CdSe/ZnS), Cadmium Sulfide (CdS), Cadmium Telluride (CdTe), Cadmium Telluride/Cadmium Sulfide (CdTe/CdS), Lead Selenide (PbSe), Lead Sulfide (PbS)

Nano Dry Lubricant Powders Tungsten Disulfide (WS2), Molybdenum Disulfide (MoS2), Hex-Boron Nitride (hBN), Graphite

Specially formulated Nano Lubricant Additive Powders to improve lubricity and save energy.

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Nanocarriers in Drug Delivery; Where are We Now? – AZoNano

Nanoparticles, nanocarriers and nanomaterials are now more commonly known in the science world and by nanotechnology enthusiasts. These words have gained significant backing and have driven this technology to be utilized for applications within other fields, such as drug delivery for advancement and optimization.

Image Credit:Kateryna Kon/Shutterstock.com

Richard Feynman, who is referred to as the father of nanotechnology, is one of the leading theoretical physicists in the world due to his innovative vision of physics and the future. Although the term nanotechnology had not yet been used, the concept of this novel field had been planted and has grown exponentially in recent years. This has included the growth of nanotechnology within drug delivery, such as through nanocarriers.

Nanocarriers can be described as colloidal nanoparticles that are used for transporting therapeutic substances to a target site. These carrier molecules usually include 1-100 nanometers in diameter, which is useful for applications such as drug delivery due to the natural interaction between nanocarriers and biological systems.

These nanoscale carriers have a sustained circulatory presence and drug release, enabling them to overcome many challenges in conventional drug delivery systems. These challenges can include overcoming the endosome-lysosomal mechanism, crossing the blood-brain barrier, and passing barriers that would be difficult for larger drug molecules. Additionally, targeting the areas of concern is also an advantage for using nanocarriers in drug delivery, as the surface of these particles can be functionalized with ligands, enabling these particles to be directed effectively.

This is significant for drug delivery as it can ensure that drugs are being targeted to the areas of concern as opposed to systemic delivery of the drug, which causes all cells to experience side effects of the drug. Directing drugs to target sites is beneficial to minimize toxicity to healthy cells and tissue, which would be especially significant for cancer drugs as these drugs can cause significant damage to healthy tissues and even result in organ failure.

Nanomedicine, including nanocarriers that hold active substances or drugs, require Food and Drug Administration (FDA) approval before it can be made available to patients.

This can be challenging due to the FDA approval process being estimated to take approximately 10-15 years, as well as costing $1 billion for every new drug being developed. The reason behind this is to be comprehensive in ensuring new drugs are both effective and safe for use, with pre-clinical stages involving animal studies as well as stages that investigate the most appropriate dose.

Nanomedicines have been scrutinized more than most conventional drugs due to being relatively new, which is demonstrated by trends in FDA-approved nanomedicines. Since the mid-1990s, the average number of nanomedicines that have received FDA approval for specific clinical indications per 5-year period has been approximately 13 drugs.

The highest peak of FDA approvals for nanomedicine has been between 2001 and 2005, and most FDA approvals for nanomedicine as a whole has included liposomal and polymeric nanoparticles, predominantly.

The growth of nanotechnology-based medicine has been estimated to grow exponentially for drug delivery, with a predicted CAGR of 11.6% between 2022 and 2027. The projection for this market has also been estimated to reach 391.5 billion USD by the year 2026.

With a healthy FDA pipeline for nanomedicine products under development, the progression of this field may be remarkably optimistic.

An example of a nanomedicine product under development includes Clenes ALS drug, which utilizes a gold nanocrystal suspension. This drug aims to potentially re-myelinate and has neuroprotective effects to aid the rare neurodegenerative disease, ALS. This disease is characterized by motor neuron death and can rapidly progress, with an average life expectancy of four years after diagnosis.

With other companies such as Amylyx Pharmaceuticals also developing an ALS drug and currently undergoing FDA review, Clene Nanomedicine hopes to learn and fine-tune outcome measures for their clinical trial, RESTORE-ALS, which has recently reported a significant decrease in mortality within this trial.

Nanomedicine drugs such as Clene may find it challenging to gain FDA approval due to testing heterogeneous populations. It can be difficult to measure survival in late-stage clinical trials, which is the case for ALS, because of fast disease progression. These challenges can subsequently affect FDA review; however, with further trialing and time, there is hope that the efficacy of significant drugs can be observed and therefore gain FDA approval.

Nanomedicine holds a significant role in many fields and the advancement of society as a whole, and the natural progression of nanocarriers in drug delivery may be revolutionary for medicine. This is especially true for diseases that may not have a treatment yet, such as neurodegenerative diseases, including ALS.

With this market being predicted to grow exponentially in the foreseeable future, as well as with the development of many nanomedicines within the FDA pipeline, the future of nanomedicine and nanocarriers is very promising.

(2022) ALS: Clene plans 300-patient Phase III trial of CNM-Au8. Clinical Trials Arena. Available at:https://www.clinicaltrialsarena.com/news/als-clene-plans-300-patient-phase-iii-trial-of-cnm-au8/.

Bobo, D., et al.(2016) Nanoparticle-Based Medicines: A Review of FDA-Approved Materials and Clinical Trials to Date.Pharmaceutical Research,33, pp. 23732387. doi.org/10.1007/s11095-016-1958-5

Chamundeeswari, M., et al. (2019) Nanocarriers for drug delivery applications.Environmental Chemistry Letters,17, pp. 849865. doi.org/10.1007/s10311-018-00841-1

(2022) Clene Reports Significantly Decreased Mortality in RESCUE-ALS Long-Term Open Label Extension Trial. Invest.clene.com.Available at:https://invest.clene.com/PressReleases/news-details/2022/Clene-Reports-Significantly-Decreased-Mortality-in-RESCUE-ALS-Long-Term-Open-Label-Extension-Trial/default.aspx.

ZKAN S, DEDEOLU A, KARADA BAKIRHAN N, ZKAN Y. (2019) Nanocarriers Used Most in Drug Delivery and Drug Release: Nanohydrogel, Chitosan, Graphene, and Solid Lipid.Turkish Journal Of Pharmaceutical Sciences,16(4), pp. 481-492. doi.org/10.4274/tjps.galenos.2019.48751

'Plenty of room' revisited.(2009)Nature Nanotech,4, p. 781. doi.org/10.1038/nnano.2009.356

Sabit H., et al. (2022) Nanocarriers: A Reliable Tool for the Delivery of Anticancer Drugs.Pharmaceutics. 14(8), p. 1566. doi.org/10.3390/pharmaceutics14081566

Disclaimer: The views expressed here are those of the author expressed in their private capacity and do not necessarily represent the views of AZoM.com Limited T/A AZoNetwork the owner and operator of this website. This disclaimer forms part of the Terms and conditions of use of this website.

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The Use of Nanorobotics in the Treatment Therapy of Cancer and Its Future Aspects: A Review – Cureus

Researchers have emphasised nanotechnology as an outstanding technological trend in the last few decades, and it is characterized by the fast proliferation of electronics for applications in communication, known as nanomedicine, and environmental monitoring. Studies are now being conducted on the scientific bottlenecks that affect the lifespan of the living, particularly humans. Among these constraints are illnesses with few or no alternatives for treatment and healing. A drug delivery system (DDS) refers to an alternative diagnosis and/or therapy that has been shown in the medical fraternity [1,2]. Nanorobots are nanoelectromechanical systems (NEMS), a recently developed chapter in miniaturisation, similar to microelectromechanical systems (MEMS), which is already a multibillion-dollar business. Designing, architecting, producing, programming, and implementing such biomedical nanotechnology are all part of nanorobotics and NEMS research. Any scale of robotics includes calculations, commands, actuation and propulsion, power, data-sharing, interface, programming, and coordination. There is heavy stress on actuation, which is a key prerequisite for robotics [1]. The similarity in size of nanorobots to that of organic human cells and organelles brings up a huge variety of its possible uses in the field of health care and environmental monitoring of microorganisms. Other potential uses, such as cell healing, may be possible if nanorobots are tiny enough to reach the cells. Furthermore, it is still to be realised that the tiny sensors and actuators' square measures are necessary for the growing concept of a strongly connected ascending information technology infrastructure; the envision of artificial cells (nanorobots) that patrol the cardiovascular system, thus, detecting and destroying infections in minute quantities. This might be a programmable system with approachable ramifications in medicine, creating a revolutionary replacement from therapy to bar [1]. Chemotherapeutic substances employed in cancer treatment measure disseminates non-specifically throughout the body, where they exert an influence on both malignant and normal cells, restricting the drug quantity feasible within the growth and also resulting in unsatisfactory medication due to excessive toxic hazards of the chemotherapy drugs on normal cells of the body. It is safe to say that molecularly focused medical care has evolved as a collaborative method to overcome the lack of specificity of traditional cancer therapy drugs [3]. With the help of nanotechnology, intercellular aggregation of the drugs in cancer cells can be increased while minimising the risk of unwanted drug toxicity in normal cells by utilising various drug targeting mechanisms [4].

This review article focuses on the recent advancements, technological growth, and expansion in the field of nanorobotics and nanotechnology and its application in the discipline of bio-healthcare systems, principally for the DDS in the medication of cancer. Existing research literature and relevant studies regarding the topic of concern were read and a detailed analysis was undertaken in the indexes of PubMed, Science Direct, MEDLINE, Scopus, and Google Scholar. Hardly any language or time constraints were applied. To obtain a detailed search, more articles, synonyms, and derivatives of the phrases were employed; the following evaluation phrases were used: "drug delivery", "cancer", "neoplasms", and "cancer therapy".

Nanorobots are miniaturised machines that have the ability to perform work at par with that of current existing machines, having applications in the aspects of medicine, industry, and other areas like the development of nanomotors employed for the conservation of energy; nanorobots havealso proved to be serviceable inreducing infertility problems by acting as an engine and giving a boost to the sperm motility when attached to them [2]. Organic and inorganic nanorobots are by far the most commonly studied. Organic nanorobots, also known as bio-nanorobots, are created by combining virus and bacterium DNA cells. This type of nanorobot is less harmful to the organism. Diamond structures, synthetic proteins, and other materials are used to make inorganic nanobots, which are more hazardous than organic nanobots. To overcome this hurdle of toxicity, researchers have devised a way involving encapsulating the robot, thusdecreasing its chances of being destructed by the body's self-defence mechanism[5,6]. Scientists can gain an understanding of how to energise micro and nano-sized devices using reactionary processes if they understand the biological motors of live cells [7]. The Chemistry Institute of the Federal Fluminense University created a nano valve, which is made up of a tank covered with a shutter in which dye molecules are housed and may leave in auniform fashion whenever the cover is opened. This gadget is also natural, made of silica (SiO2), beta-cyclodextrins, and organo-metallic molecules, and shall be used in therapeutic applications [1]. Proteins are employed in certain studies to feed nanomotors that can move huge objects, as well as the use of DNA hybridisation and antibody protein in the development of nanorobots. DNA hybridisation is defined as a process by which two complementary single-stranded DNA and/or RNA molecules bond together to form a double-stranded molecule.A nanorobot can be functionalized using a variety of chemical compounds [8]. It has been investigated in nanomedicine in DDS, which operates directly on targeted cells of the human body. Researchers create devices that can administer medications to precise places while simultaneously adjusting the dose and amount of release. This DDS using nanorobots can be used to treat joint disorders, dental problems, diabetes, cancer, hepatitis and other conditions [2,9-12]. One of the benefits of this technology is the potential to diagnose and treat illnesses with minimal impact on normal tissues, minimizing the likelihood of negative effects and guiding healing and remodelling therapy at the cellular and sub-cellular levels [13,14].

New advances in medication delivery have resulted in greater quality in targeted drug delivery that uses nanosensors to detect particular cells and regulate discharges through the use of smart medicines [1]. Traditional chemotherapeutic drugs act by eliminating swiftly replicating cells, which is a primary feature of malignant cells. Most anticancer medications have a limited therapeutic boundary, often resulting in cytotoxicity to normal stem cells that proliferate quickly, such as bone marrow, macrophages, gastrointestinal tract (GIT), and hair follicles, causing adverse effects like myelosuppression (lower synthesis of WBCs, producing immunosuppression), mucositis (inflammation of the GIT lining), alopecia (hair loss), organ malfunction, thrombocytopenia/anaemia, and haematological side effects, among other things. Doxorubicin is used to treat numerous forms of cancer, including Hodgkin's disease, when it is combined with other antineoplastic medicines to minimize its toxicity [15,16]. Paclitaxel is a drug that is injected intravenously and is used to treat breast cancer. Some of the significant side effects include bone marrow suppression and progressive neurotoxicity. Cisplatin is an alkylating drug that results in the intra-DNA binding filament. Its negative effects include giddiness and severe vomiting, and it can be nephrotoxic [1]. Camptothecin is applied to treat neoplasiaby inhibiting type 1 topoisomerases, an enzyme required for cellular duplication of genetic information. Numerous initiatives have been launched with the goal of employing nanotechnology to build DDS that can reduce the negative impacts of traditional therapy. On the surface of single-walled carbon nanotubes (SWNTs), doxorubicin was layered [17]. Doxorubicin was used in metastatic tumour cells as a polymer prodrug/collagen hybrid. The use of polymeric pro-drug nanotechnology in the therapy of rapidly dividing abnormal cells is a novel advance in the field [18]. Nanotechnology is continually looking for biocompatible materials that may be used as a DDS. The nanoparticle hydroxyapatite (HA), a significant component of bone and teeth, was employed to deliver paclitaxel, an anti-neoplastic medication, and the out-turn implies that therapy should begin with hydrophobic medicines [19]. Various initiatives have been launched with the goal of employing nanotechnology to build DDS, which can reduce the negative influence of traditional chemotherapy. The limitation of conservative chemotherapeutics is that it is unable to target malignant cells exclusively. These above-listed adverse effects often result in a delay in treatment, reduced drug dose or intermittent stopping of the therapy [20]. Given the ability of nanorobots to travel as blood-borne devices, they can aid in crucial therapy procedures such as early diagnostics and smart medication administration [21]. A nanorobot can aid with smart chemotherapy for medication administration and give an efficient early dissolution of cancer by targeting only the neoplastic-specific cells and tissues and preventing the surrounding healthy cells from the toxicity of the chemotherapy drugs so being used. Nanorobots as drug transporter for timely dose administration allow chemical compounds to be kept in the bloodstream for as long as essential, giving expected pharmacokinetic characteristics for chemotherapy in the therapies for anti-cancer as shown in Figure 1 [22-25]. The clinical use of nanorobots for diagnostic, therapy, and surgery can be accomplished by injecting them via an intravenous route. The nanorobots may be getting intravenously injected into the body of the recipient. The chemotherapy pharmacokinetics comprises uptake, metabolism, and excretion, as well as a rest period to allow the body to re-establish itself ahead of the succeeding chemotherapy session. For tiny tumours, patients are often treated in two-week cycles [26]. As a primary time threshold for medical purposes, nanorobots can be used to assess and diagnose the tumour within a short span of time using proteomic-based sensors. The magnetic resonance contrast-agent uptake kinetics of a very small molecular weight can forecast the transport of protein medicines to solid tumours [27]. Testing and diagnostics are critical components of nanorobotics study. It provides speedy testing diagnosis at the initial visit, eliminating the need for a follow-up appointment following the lab result, and illness identification at an earlier stage. The demand for energy for propulsion is a restriction in the usage of nanorobots in vivo. Because small inertia and strong viscous forces are associated with less productivity and less convective motion, higher quantities of energy are required [28]. Drug retention in the tumour will decide the medication's effectiveness after nanorobots pass cellular membranes for targeted administration. Depending on its structure, medication transport pathways from plasma to tissue impact chemotherapy to achieve more effective tumour chemotherapy [27]. According to the latest research, nanotechnology, DNA production of molecular-scale devices with superior control over shape, and site-specific functionalisation assures interesting benefits in the advancement of nanomedicine. However, biological milieu uncertainty and innate immune activation continue to be barriers to in vivo deployment. Thus, the primary benefit of nanorobots for cancer medicine administration is that they reduce chemotherapeutic side effects. The nanorobot design integrates carbon nanotubes and DNA, which are current contenders for the latest types of nanoelectronics, as the optimum method [29]. As a compound bio-sensor with sole-chain antigen-binding proteins, a complementary metal oxide semiconductor (CMOS) is used for building circuits with characteristic sizes in tens of nanometres [30]. For medicament release, this approach employs stimulation elicited upon proteomics and bioelectronics signals. As a result, nanoactuators are engaged to adjust medication delivery whenever the nanorobot detects predetermined modifications in protein gradients [1,31]. Thermal and chemical signal changes are relevant circumstances directly connected to significant medical target identification. Nitric oxide synthase (NOS), E-cadherin, and B cell lymphoma-2 (Bcl-2) are some instances of fluctuating protein aggregation within the body near a medical target under diseased conditions. Furthermore, temperature changes are common in tissues with inflammation [32]. The framework integrates chemical and thermal characteristics as the most essential clinical and therapeutic recommendations for nanorobot template analysis. It also integrates chemical and thermal characteristics as the most essential diagnostic and therapeutic recommendations for nanorobot framework evaluation. The simulation in a three-dimensional real-time setting attempts to provide a viable model for nanorobot foraging within the body. One of the breakthroughs describes a hardware structure rooted in nano-bioelectronics for the use of nanorobots in neoplasia therapy [33,34]. The continuous venture in building medical micro-robots has led to the initial conceptual framework research of a full medical nanorobot until now issued in a peer-reviewed publication, "Respirocytes", detailed a theoretical unnatural mechanical red blood cell, or "Respiro-cytes", consisting of 18 billion perfectly ordered architectural atoms proficient in delivering 236 times extra oxygen to the tissues and cells of the body per unit volume than normal red blood cells [35]. Microbivores, or unnatural phagocytes, might monitor the circulation, searching for and eliminating pathogens such as bacteria, viruses, or fungi. These nanobots may use up to 200 pW continuously. This capability is employed to break down germs that have been entrapped. Microbivores have biological phagocytic defences that are either organic or antibiotic-assisted, and they can operate up to 1,000 times quicker. Even the most serious septicaemic diseases will be eliminated by microbivores within a short span of time. Because virulent microorganisms are entirely digested into harmless sugars and amino acids, which are the nanorobots sole discharge, the nanorobots reject the advanced possibility of sepsis or septic shock [36,37].

To bring in combination the required collaborative skills to produce these unique technologies, numerous conventional streams of science, such as medicine, chemistry, physics, materials science, and biology, have come together to form the expanding field of nanotechnology. Nanotechnology has a vast span of possible applications (Figure 2) [39],from improvements to current practices to the creation of entirely new tools and skills. The last few years have observed an exponential increase of interest in the topic of nanotechnology and research, which has led to the identification of novel applications for nanotechnology in medicine and the emergence of an advanced branch called nanomedicine. It includes the science and technology of diagnosing, treating, andpreventing illness, traumatic injury, and alleviating pain; conserving and enhancing human health using nanoscale architectured materials, biotechnology, and genetic engineering; eventually, complex machine systems and nanorobots, known as "nanomedicine" (Figure 3) [40,41].

In vivo diagnostics, nanomedicine might create technologies that can act within the human body to diagnose ailments earlier and identify and measure toxic chemicalsand tumour cells. In the surgical aspect,when launched into the body through the intravenous route or cavities, a surgical nanorobot controlled or led by a human surgeon might work as a semi-autonomous on-site surgeon. An inbuilt computer might manage the device's operations, such as looking for disease and identifying and fixing injury by nanomanipulation while maintaining communication with the supervising surgeon via coded ultrasonic signals [37]. By transforming mechanical energy from bodily movement, muscle stretching, or water flow into electricity, scientists were able to design a new generation of self-sustained implanted medical devices, sensors, and portable gadgets [39]. Nanogenerators generate electricity by bending and then releasing piezoelectric and semiconducting zinc oxide nanowires. Nanowires may be produced on polymer-based films, and the utilization of flexible polymer substrates may one day allow portable gadgets to be powered by their users' movement [39]. Fluorescent biological labelling, medication and gene delivery, pathogen identification, protein sensing, DNAstructure probing, tissue engineering, tumour identification, separation and purification of biological molecules and cells, MRI contrast enhancement, and phagokinetic research are among the uses. The extended duration effect of nanomedicine study is to describe quantitative molecular-scale components called nanomachinery. Accurate command and manipulation of nanomachinery in cells can lead to a more diverse and advanced gain in the interpretation of cellular processes in organic cells, as well as the creation of new technologies for disease detection and medication. The advantage of this research is the formation of a platform technology that will affect nanoscale imaging methodologies aimed to investigate molecular pathways in organic cells [40,42].

The main target of writing this review was to provide an outline of the technological development of nanotechnology in medicine by making a nanorobot and introducing it in the medication of cancer as a new mode of drug delivery. Cancer is described as a collection of diseases characterised by the unregulated development and spread of malignant cells in the body, and the number of people diagnosed every year keeps adding up. Cancer treatment is most likely the driving force behind the creation of nanorobotics; it can be auspiciously treated using existing medical technology and therapeutic instruments, with the major help of nanorobotics. To decide the prognosis and chances of survival in a cancer patient, consider the following factors: better prognosis can be achieved if the evolution of the disease is time-dependent and a timely diagnosis is made. Another important aspect is to reduce the side effects of chemotherapy on the patients by forming efficient targeted drug delivery systems. Programmable nanorobotic devices working at the cellular and molecular level would help doctors to carry out precise treatment. In addition to resolving gross cellular insults caused by non-reversible mechanisms or to the biological tissues stored cryogenically, mechanically reversing the process of atherosclerosis, enhancing the immune system, replacing or re-writing the DNA sequences in cells at will, improving total respiratory capacity, and achieving near-instant homeostasis, medically these nanorobots have been put forward for use in various branches of dentistry, research in pharmaceuticals, and aid and abet clinical diagnosis. When nanomechanics becomes obtainable, the ideal goal of physicians, medical personnel, and every healer throughout known records would be realized. Microscale robots with programmable and controllable nanoscale components produced with nanometre accuracy would enable medical physicians to perform at the cellular and molecular levels to heal and carry out rehabilitating surgeries. Nanomedical doctors of the 21st century will continue to make effective use of the body's inherent therapeutic capacities and homeostatic systems, since, all else being equal, treatments that intervene the least are the best.

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The Use of Nanorobotics in the Treatment Therapy of Cancer and Its Future Aspects: A Review - Cureus

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