Stem Cell Clinic

European Medicines Agency Grants Orphan Drug Designation to AlloVirs Viralym-M, an Allogeneic, Off-the-Shelf, Multi-Virus Specific T-Cell Therapy -…

By Stem Cell Medicine

Viralym-M recently received EMA PRIME and U.S. FDA RMAT designations

Phase 3 pivotal and Phase 2 proof-of-concept studies to be initiated for Viralym-M in 2020 targeting six devastating and life-threatening viral pathogens in immunocompromised patients

AlloVir, a late-clinical stage allogeneic T-cell immunotherapy company, today announced it has been granted Orphan Drug Designation from the European Medicines Agency (EMA) for Viralym-M (ALVR105) as a potential treatment of viral diseases and infections in patients undergoing hematopoietic stem cell transplantation (HSCT). Viralym-M is the companys lead allogeneic, off-the-shelf, multi-virus specific T-cell therapy, being developed for the treatment and prevention of serious viral diseases caused by six commonly occurring, devastating viral pathogens in immunocompromised individuals: BK virus, cytomegalovirus, human herpes virus-6, Epstein Barr virus, adenovirus, and JC virus. Viral diseases are a primary reason for poor outcomes in transplant patients, resulting in potentially devastating and life-threatening consequences.

In addition to Orphan Drug Designation, Viralym-M has been granted PRIority MEdicines (PRIME) designation from the EMA and Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA). Viralym-M is one of only seven investigational therapies, to date, to receive both PRIME and RMAT designations from the EMA and FDA, respectively. AlloVir plans to initiate Phase 3 pivotal and Phase 2 proof-of-concept studies with Viralym-M in 2020 targeting six commonly occurring, devastating and life-threatening viral pathogens.

"At AlloVir, we are committed to advancing allogeneic, off-the-shelf novel T-cell therapies with the potential to improve the way we treat and prevent devastating viral diseases," said Agustin Melian, MD, Chief Medical Officer and Head of Global Medical Sciences of AlloVir. "The Orphan Drug Designation by the EMA acknowledges the critical need for new treatment options for patients who have undergone stem cell transplant and are at risk of the serious consequences of viral diseases. Also, leveraging PRIME and RMAT designations, we are working to quickly advance Viralym-M through late-stage clinical development to bring, what we believe to be a transformative new therapy, to patients in the U.S., European Union and eventually around the world."

The EMA grants Orphan Drug Designation status for products intended for the treatment, prevention or diagnosis of life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union, and where the product represents a significant benefit over existing treatments. Orphan Drug Designation provides companies with certain benefits and incentives in the EU, including a 10-year period of market exclusivity after product approval, reduced regulatory fees and protocol assistance.

About Opportunistic Viral Diseases

In healthy individuals, virus-specific T-cells from the bodys natural defense system provide protection against numerous disease-causing viruses. However, in patients with a weakened immune system these viruses may be uncontrolled. Viral diseases are common, with potentially devastating and life-threatening consequences in immunocompromised patients. For example, up to 90% of patients will reactivate at least one virus following an allogeneic HSCT and two-thirds of these patients reactivate more than one virus, resulting in significant and prolonged morbidity, hospitalization and premature death. Typically, when viruses infect immunocompromised patients, standard antiviral treatment does not address the underlying problem of a weakened immune system and therefore, many patients suffer with life-threatening outcomes such as multi-organ damage and failure, and even death.

About Viralym-M (ALVR105)

AlloVirs lead product Viralym-M (ALVR105) is in late-stage clinical development as an allogeneic, off-the-shelf, multi-virus specific T-cell therapy targeting six common viral pathogens in immunocompromised individuals: BK virus, cytomegalovirus, adenovirus, Epstein-Barr virus, human herpesvirus 6, and JC virus. In a positive Phase 2 proof-of-concept study, published in the Journal of Clinical Oncology (Tzannou, JCO, 2017), greater than 90% of patients who failed conventional treatment and received Viralym-M, demonstrated a predefined criteria for a complete or partial clinical response, most with complete elimination of detectable virus in the blood and resolution of major clinical symptoms. The company plans to initiate pivotal and proof-of-concept studies with Viralym-M in 2020 for treatment and prevention of severe and life-threatening viral diseases.

Story continues

Viralym-M has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA) and PRIority MEdicines (PRIME) designation from European Medicines Agency (EMA).

About AlloVir

AlloVir, formerly ViraCyte, is an ElevateBio portfolio company that was founded in 2013 and is the leader in the development of novel cell therapies with a focus on restoring natural immunity against life-threatening viral diseases in patients with severely weakened immune systems. The companys technology platforms deliver commercially scalable solutions by leveraging off-the-shelf, allogeneic, multi-virus specific T cells targeting devastating viral pathogens for immunocompromised patients under viral attack. AlloVirs technology and manufacturing process enables the potential for the treatment and prevention of a spectrum of devastating viruses with each single allogeneic cell therapy. The company is advancing multiple mid- and late-stage clinical trials across its product portfolio.

AlloVirs investors include Fidelity Research and Management Company, Gilead Sciences, F2 Ventures, The Invus Group, Redmile Group, EcoR1, Samsara Biocapital, and Leerink Partners Co-investment Fund, LLC.

AlloVir is an ElevateBio portfolio company. More information can be found at http://www.allovir.com.

About ElevateBio

ElevateBio, LLC, is a Cambridge-based creator and operator of a portfolio of innovative cell and gene therapy companies. It begins with an environment where scientific inventors can transform their visions for cell and gene therapies into reality for patients with devastating diseases. Working with leading academic researchers, medical centers, and corporate partners, ElevateBios team of scientists, drug developers, and company builders are creating a portfolio of therapeutics companies that are changing the face of cell and gene therapy and regenerative medicine. Core to ElevateBios vision is BaseCamp, a centralized state-of-the-art innovation and manufacturing center, providing fully integrated capabilities, including basic and transitional research, process development, clinical development, cGMP manufacturing, and regulatory affairs across multiple cell and gene therapy and regenerative medicine technology platforms. ElevateBio portfolio companies, as well as select strategic partners are supported by ElevateBio BaseCamp in the advancement of novel cell and gene therapies.

ElevateBios investors include F2 Ventures, MPM Capital, EcoR1 Capital, Redmile Group, Samsara BioCapital, Emerson Collective, The Invus Group, Surveyor Capital (A Citadel company), EDBI, and Vertex Ventures.

ElevateBio is headquartered in Cambridge, Mass, with ElevateBio BaseCamp located in Waltham, Mass. For more information, please visit http://www.elevate.bio.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200326005129/en/

Contacts

Courtney HeathScientPRAlloVirPR@scientpr.com +1 617-872-2462

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European Medicines Agency Grants Orphan Drug Designation to AlloVirs Viralym-M, an Allogeneic, Off-the-Shelf, Multi-Virus Specific T-Cell Therapy -...

Vitro Biopharma First Quarter ended January 31, 2020 Financial Results of Operations – Benzinga

By Stem Cell Medicine

GOLDEN, CO / ACCESSWIRE / March 26, 2020 / Vitro Diagnostics, Inc. (OTC:VODG), dba Vitro Biopharma, announced its 1st quarter ended January 31st, 2020 financial results of operations.

Vitro Diagnostics Inc. ("Vitro Biopharma") is pleased to announce a record 1st comparative quarter in Total Revenues. Vitro Biopharma recorded 1st quarter revenues of $225,921 vs $192,895 an increase of 17% over the same comparative quarter last year. In addition, Stem Cell treatments accounted for 74% of the revenues up from 71% of the revenues in the prior comparative quarter last year. Current quarter stem cell revenues were $167,750 for the 1st quarter ended January 31, 2020 vs $137,123 for the first quarter ended January 31, 2019.

The company's gross profit margins improved to 75% up from 73% in the comparative prior year's quarter. Gross margin improvement is in line with the strategic direction of the company to expand the market of its flagship product AlloRx Stem Cells. The company's clean-room lab expansion last year and expanded Stem Cell manufacturing using its patent-pending cell line, has increased efficiencies and lowered production costs.

Overall operating expenses increased in the quarter to $193,385 from $147,398 in the prior year's comparative quarter. The increase in expenses reflects additional investment as the Company expands its capability to service its strategic direction of offshore Stem Cell treatments while also expanding into US markets. The company expended additional resources on external consultants supporting our regulatory status in maintaining ISO9001 & ISO13485 certifications, expanding our efforts to approach US markets through FDA filings and advancement of existing patent filings.

The company's first quarter is its most seasonal quarter as the period between Thanksgiving and the New Year is slow for all the company's revenue lines of Nutra Vivo/STEMulize, AlloRx Stem Cells, private labeled InfiniVive-MD Stem Cell Serum and our core research products.

During the quarter the company achieved and pursed the following company objectives

During the quarter the company commenced a Series A Convertible Preferred Stock offering to accredited investors under the SEC Regulation D exemption. The preferred Stock is priced at $25 per share which is convertible at $0.25 cents per share for a total of 100 shares. The minimum investment is $50,000 per unit. The company sold $450,000 of the Series A Convertible Preferred Stock during the quarter. The company has additional interest in the offering and subsequent to the quarter has sold an additional $50,000 unit for a total to date of $500,000. The company has additional interested parties for approximately $200,000. The offering is for a total of $1,000,000.

Our partnership with DVC. Stem in the Cayman Islands continued to advance through treatment of new & previous patients. This IRB-approved protocol targets patients with inflammatory conditions including multiple sclerosis, systemic inflammation and new indications including Chrohn's disease, Alzheimer's disease and COPD. To date we have treated 60 patients including repeat treatments. There have been no serious adverse events and we continue to gain evidence of efficacy. One of the initial MS patients has now received a second transplant of our AlloRx Stem Cells and he has reported significant therapeutic benefits of both the initial and subsequent therapy. He had received an earlier transplant of adipose-derived MSCs that was effective, but the improvement lasted 3 months while AlloRx Stem Cell therapy lasted 18 months. We had predicted such a clinical outcome based on significantly higher potency of umbilical cord MSCS compared to those derived from adipose tissue or bone marrow. The Chrohn's disease patient showed significant improvement as did both the AD & COPD patients.

The strategic development of our stem cell therapies involves pursuit of both offshore and domestic markets. The partnership with DVC Stem, our IRB-approved trial in the Bahamas together with other strategic opportunities represent offshore operations & prospects. During Q1 2020, we initiated expansion into US therapeutic markets through development of an Investigational New Drug (IND) application for submission to FDA. Once approved, an IND allows the conduct of clinical trials for specific medical conditions in the US.

Given the current COVID-19 pandemic, our initial IND application is for use of AlloRx Stem Cells in treatment of Coronavirus infections. This is supported by clinical studies showing that 17 critically ill patients responded favorably to IV infusion of umbilical cord-derived MSCs. All patients were receiving assisted ventilation but 3 days following stem cell therapy, were removed from ventilators and subsequently discharged from the hospital. We are pursuing discussions with FDA to establish the appropriate regulatory pathway and expedited review options given the current emergency circumstances. (See Subsequent Events, below, for additional discussion of our COVID-19 response.) Once our initial IND is in place, we have plans for additional INDs for stem cell therapy of musculoskeletal conditions and Alzheimer's disease.

We have received an initial order of AlloRx Stem Cells for testing purposes by PR Medica located in Cabo San Lucas. Given successful test results, we anticipate subsequent new revenue generation from this customer.

Vitro Biopharma's cosmetic topical stem cell serum is being distributed by InfiniVive MD into cosmetic clinics that are providing the topical treatment as a beautification product. To date the company's product is being offered in 10 cosmetic clinics.

Our partner, Dr Jack Zamora, MD was a keynote speaker at a master session at the American Academy of Cosmetic Surgery annual meeting in late February. The topic of his presentation was "Topical Stem Cells, Exosomes and Conditioned Media Serums in Aesthetics." This was the official launch of the InfiniVive-MD platform including: Dailey Serum, Stem Cell Serum 2.0 & Exosomes within the product line. Vitro Biopharma will manufacture & private label these new products for distribution in the US. We anticipate InfiniVive MD growth, development and revenues to mirror the development of Apyx subdermal plasma skin tightening as a cosmetic treatment and technique that has gone global.

http://www.jackzamoramd.com http://www.infinivivemd.com

Our core research product sales continued to expand in Q1 2020. Our facility expansion continued with addition of manufacturing capacity and development of plans to add operational facility to increase outputs further by 100% or more. We were also in discussions with the USPTO regarding our pending patents for our novel stem cell therapy and stem cell activation technology. We continue to work closely with our examiner and have established communication channels to facilitate awards of these patents.

The COVD-19 pandemic is a significant obstacle for all business. However, Vitro Biopharma is uniquely positioned since we have a potential effective therapy. This is based on 3 independent reports showing efficacy of stem cell therapy in 17 COVID-19 patients. All were treated with IV umbilical cord MSCs comparable to AlloRx Stem Cells and all 17 required respiratory assistance but within 3-4 days of treatment, were able to breath without ventilators and were discharged within 14 days. https://www.scmp.com/news/china/society/article/3053080/coronavirus-critically-ill-chinese-patient-saved-stem-cell On the contrary, untreated patients on ventilators have death rates of 50% or more. We have received a formal request to supply AlloRx Stem Cells for compassionate use from a major university medical center and several other potential clinical partners have also expressed interest in using our cells to treat COVID-19 patients. We are presently working with the FDA to gain authority to begin clinical testing in the US. We are currently assessing the overall financial impact of the COVID-19 pandemic on our business, but this depends on overall control of the pandemic. There have been no staff layoffs and our workers are considered essential since we conduct essential research to the COVID-19 response.

Dr. Jim Musick, CEO of Vitro Biopharma, said, "We are very pleased with the increased revenue growth during our first quarter 2020 compared to the prior year However all our resources are currently focused on the emergency response to the COVID-19 pandemic and increasing our inventory of AlloRx to satisfy anticipated emergency demand to treat critically ill COVID-19 patients." The Company is working to get expedited clinical trial approvals to sell our AlloRx Stem Cells to hospitals coping with the pandemic. Vitro is pleased to have recently been recognized by Bioinformant as "a Company Tracking the Coronavirus". https://bioinformant.com/product/coronavirus-covid-19-report/ We anticipate clinical progress in the effectiveness of our stem cell therapies while expecting to see a reduction in our offshore and cosmetic revenues for the next quarter or two. The company is in a good cash position to weather this storm and simultaneously advance its AlloRx stem cell therapies into clinical trials.

In summary, Vitro Biopharma is advancing as a key player in regenerative medicine with 10- years' experience in the development and commercialization of stem cell products for research, recognized by a Best in Practice Technology Innovation Leadership award for Stem Cell Tools and Technology and a growing track record of successful translation to therapy. We are leveraging our proprietary technology platform to the establishment of international Stem Cell Centers of Excellence and regulatory approvals in the US and worldwide.

Sincerely yours,

James R. Musick, PhD.President, CEO & Chairman of the Boardwww.vitrobiopharma.com

Forward-Looking Statements

Statements herein regarding financial performance have not yet been reported to the SEC nor reviewed by the Company's auditors. Certain statements contained herein and subsequent statements made by and on behalf of the Company, whether oral or written may contain "forward-looking statements". Such forward looking statements are identified by words such as "intends," "anticipates," "believes," "expects" and "hopes" and include, without limitation, statements regarding the Company's plan of business operations, product research and development activities, potential contractual arrangements, receipt of working capital, anticipated revenues and related expenditures. Factors that could cause actual results to differ materially include, among others, acceptability of the Company's products in the market place, general economic conditions, receipt of additional working capital, the overall state of the biotechnology industry and other factors set forth in the Company's filings with the Securities and Exchange Commission. Most of these factors are outside the control of the Company. Investors are cautioned not to put undue reliance on forward-looking statements. Except as otherwise required by applicable securities statutes or regulations, the Company disclaims any intent or obligation to update publicly these forward-looking statements, whether as a result of new information, future events or otherwise.

CONTACT:

Dr. James MusickChief Executive OfficerVitro BioPharma(303) 999-2130 Ext. 3E-mail: jim@vitrobiopharma.comwww.vitrobiopharma.com

The company provides its financial information for investor purposes only, the results published are not audited or necessarily SEC or GAAP compliant

The company provides its financial information for investor purposes only, the results published are not audited or necessarily SEC or GAAP compliant

The company provides its financial information for investor purposes only, the results published are not audited or necessarily SEC or GAAP compliant.

The company provides its financial information for investor purposes only, the results published are not audited or necessarily SEC or GAAP compliant.

SOURCE: Vitro Diagnostics, Inc.

View source version on accesswire.com: https://www.accesswire.com/582759/Vitro-Biopharma-First-Quarter-ended-January-31-2020-Financial-Results-of-Operations

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Vitro Biopharma First Quarter ended January 31, 2020 Financial Results of Operations - Benzinga

Over 65s and vulnerable islanders in Jersey to be put in lockdown – ITV News

By Stem Cell Medicine

Jerseys government has issued further measures for people to prevent the spread of Coronavirus.

The advice is targetted at two groups:

Sorry, this content isn't available on your device.

Islanders aged 65 and over, and people with less severe underlying medical conditions

Less severe medical conditions are:

From midnight, Islanders aged 65 and over, and people with less severe underlying medical conditions, should only leave their homes for a total of two hours per day and in the following limited circumstances.

These groups are advised to:

People with medical conditions that put them at severe risk from COVID-19

Severe risk medical conditions are:

Islanders with medical conditions that put them at severe risk from COVID-19 are advised to home isolate.

This includes Islanders with certain cancers, severe respiratory conditions such as severe asthma, those on medications that significantly affect their immune system, and pregnant women with underlying heart disease.

These groups are advised to:

Deputy Richard Renouf, the Health Minister, made the announcement today.

People with certain cancers and respiratory diseases are included in the list of those who should isolate in their homes.

We are introducing this measure to protect our most vulnerable groups of Islanders from the spread of Coronavirus, because the medical advice is that they are more like to suffer from more severe symptoms, be hospitalised and require intensive care.

They are also at greatest risk of death.

By self-isolating, with the support of family, friends and the help of volunteers, we hope to shield over 65s, and those with underlying medical conditions, from the virus. This will help save lives, by significantly reducing hospital demand throughout the infection curve.

Deputy Richard Renouf

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Over 65s and vulnerable islanders in Jersey to be put in lockdown - ITV News

Bone Therapeutics appoints Stefanos Theoharis as Chief Business Officer – OrthoSpineNews

By Stem Cell Medicine

Gosselies, Belgium, 26March 2020, 7am CET BONE THERAPEUTICS(Euronext Brussels and Paris: BOTHE), the bone cell therapy company addressing high unmet medical needs in orthopaedics and bone diseases, today announces that it is further strengthening its management team with the appointment of Stefanos Theoharis, PhD, as Chief Business Officer (CBO).

Stefanos will be responsible for the companys corporate development activities and executing its business strategy. His immediate priorities will be concentrating on partnering Bone Therapeutics products and in-licensing innovations. He will also further develop the commercial strategies for the product portfolio and cell therapy platform.

At this stage of the development of Bone Therapeutics, it is very important to appoint a proven executive with a high level of business experience to achieve our next set of commercial goals,said Miguel Forte, MD, PhD, Chief Executive Officer of Bone Therapeutics. Stefanos has gathered considerable achievements in business development at both rapidly growing biotech and global biopharma companies, coupled with an extensive expertise in cell therapy drug development and manufacturing. His diverse skill set, which includes licensing, M&A transactions and R&D partnerships, will be invaluable to bolster our business initiatives as we continue to advance our mid- to late stage product pipeline through clinical development with a potential commercialization in sight.

Stefanos will contribute more than 15 years of business development experience in the pharma and biotech industry to Bone Therapeutics, specifically in the cell and gene therapy space. This includes his achievements as Senior Vice-President at Cell Medica, a clinical-stage biotech company, where he expanded the companys allogeneic T-cell immunotherapy platform through strategic partnerships with leading research institutions and targeted acquisitions. Prior to Cell Medica, Stefanos was Chief Business Officer at apceth GmbH, a company developing genetically-engineered mesenchymal stromal (MSC) cell products and also acting as a contract manufacturer in the ATMP space. He led all apceths business development activities, including in- and out-licensing and service contracts negotiations. He also held positions as Head of Business Development at the antisense RNA drug specialist Antisense Pharma (now Isarna), and Director Business Development at Roche, focused on partnering activities in emerging science and technologies. Stefanos also worked at Lazard, the global investment bank, advising to a variety of life sciences firms on M&As and financing transactions. Stefanos achieved an MSc. in Molecular Medicine and a PhD in Pathology and Immunology from Imperial College London.

I really wanted to join a cell therapy company where I was able to make a significant difference to the company, the wider field and patients outcomes.With an innovative allogeneic, off the shelf, cell therapy platform and a potentially best-in-class knee osteoarthritic pain treatment, Bone Therapeutics is uniquely positioned to make a meaningful difference in the lives of patients with severe orthopaedic conditions,said Stefanos Theoharis, PhD, Chief Business Officer of Bone Therapeutics. As both products are entering advanced stage clinical trials, Im delighted to join the company at such a critical time and I look forward to working with its talented leadership and scientific teams to take these promising treatments to market.

About Bone Therapeutics

Bone Therapeutics is a leading biotech company focused on the development of innovative products to address high unmet needs in orthopedics and bone diseases. The Company has a broad, diversified portfolio of bone cell therapies and an innovative biological product in later-stage clinical development, which target markets with large unmet medical needs and limited innovation.

Bone Therapeutics is developing an off-the-shelf protein solution, JTA-004, which is entering PhaseIII development for the treatment of pain in knee osteoarthritis. Positive PhaseIIb efficacy results in patients with knee osteoarthritis showed a statistically significant improvement in pain relief compared to a leading viscosupplement. The clinical trial application (CTA) for the pivotal PhaseIII program has been approved by the Danish relevant authorities allowing the start of the study.

Bone Therapeutics other core technology is based on its cutting-edge allogeneic cell therapy platform (ALLOB) which can be stored at the point of use in the hospital, and uses a unique, proprietary approach to bone regeneration, which turns undifferentiated stem cells from healthy donors into bone-forming cells. These cells can be administered via a minimally invasive procedure, avoiding the need for invasive surgery, and are produced via a proprietary, scalable cutting-edge manufacturing process. Following the CTA approval by the Belgian regulatory authority, the Company is ready to start the PhaseIIb clinical trial with ALLOB in patients with difficult tibial fractures, using its optimized production process.

The ALLOB platform technology has multiple applications and will continue to be evaluated in other indications including spinal fusion, osteotomy and maxillofacial and dental applications.

Bone Therapeutics cell therapy products are manufactured to the highest GMP (Good Manufacturing Practices) standards and are protected by a broad IP (Intellectual Property) portfolio covering ten patent families as well as knowhow. The Company is based in the BioPark in Gosselies, Belgium. Further information is available at http://www.bonetherapeutics.com.

Contacts

Bone Therapeutics SAMiguel Forte, MD, PhD, Chief Executive OfficerJean-Luc Vandebroek, Chief Financial OfficerTel: +32 (0) 71 12 10 00investorrelations@bonetherapeutics.com

International Media Enquiries:Image Box CommunicationsNeil Hunter / Michelle BoxallTel: 44 (0)20 8943 4685neil@ibcomms.agency / michelle@ibcomms.agency

For French Media and Investor Enquiries:NewCap Investor Relations & Financial CommunicationsPierre Laurent, Louis-Victor Delouvrier and Arthur RouillTel: + 33 (0)1 44 71 94 94bone@newcap.eu

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors` current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person`s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

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Bone Therapeutics appoints Stefanos Theoharis as Chief Business Officer - OrthoSpineNews

Autologous Stem Cell and Non-Stem Cell Based Therapies Market : Worldwide Business Analysis and Prediction 2020-2025 || Top Players AVRA Medical…

By Stem Cell Medicine

The actions of competitors or major players has a great effect on the market and Healthare industry as a whole with respect to its sales, import, export, revenue and CAGR values hence it is covered thoroughly in Autologous Stem Cell and Non-Stem Cell Based Therapies Market report. It gives professional and in depth overview of the market which focuses on primary and secondary drivers, market share, leading segments and geographical analysis. This business report also makes available the company profiles, product specifications, production value, contact details of manufacturer and market shares for company. Global Autologous Stem Cell and Non-Stem Cell Based Therapies market report comprises of the drivers and restraints for the market that are derived from SWOT analysis.

TheGlobalAutologous Stem Cell and Non-Stem Cell Based Therapies Marketis expected to reach USD113.04 billion by 2025, from USD 87.59 billion in 2017 growing at a CAGR of 3.7% during the forecast period of 2018 to 2025. The upcoming market report contains data for historic years 2015 & 2016, the base year of calculation is 2017 and the forecast period is 2018 to 2025.

For In depth Information Get Sample Copy of this Report @https://www.databridgemarketresearch.com/request-a-sample/?dbmr=global-autologous-stem-cell-and-non-stem-cell-based-therapies-market&raksh

Some of the major players operating in the globalautologous stem cell and non-stem cell based therapies marketareAntria (Cro), Bioheart, Brainstorm Cell Therapeutics, Cytori, Dendreon Corporation, Fibrocell, Genesis Biopharma, Georgia Health Sciences University, Neostem, Opexa Therapeutics, Orgenesis, Regenexx, Regeneus, Tengion, Tigenix, Virxsys and many more.

Market Definition:Global Autologous Stem Cell and Non-Stem Cell Based Therapies Market

In autologous stem-cell transplantation persons own undifferentiated cells or stem cells are collected and transplanted back to the person after intensive therapy. These therapies are performed by means of hematopoietic stem cells, in some of the cases cardiac cells are used to fix the damages caused due to heart attacks. The autologous stem cell and non-stem cell based therapies are used in the treatment of various diseases such as neurodegenerative diseases, cardiovascular diseases, cancer and autoimmune diseases, infectious disease.

According to World Health Organization (WHO), cardiovascular disease (CVD) causes more than half of all deaths across the European Region. The disease leads to death or frequently it is caused by AIDS, tuberculosis and malaria combined in Europe. With the prevalence of cancer and diabetes in all age groups globally the need of steam cell based therapies is increasing, according to article published by the US National Library of Medicine National Institutes of Health, it was reported that around 382 million people had diabetes in 2013 and the number is growing at alarming rate which has increased the need to improve treatment and therapies regarding the diseases.

Browse Detailed TOC Herehttps://www.databridgemarketresearch.com/toc/?dbmr=global-autologous-stem-cell-and-non-stem-cell-based-therapies-market&raksh

Market Segmentation:Global Autologous Stem Cell and Non-Stem Cell Based Therapies Market

Competitive Analysis:Global Autologous Stem Cell and Non-Stem Cell Based Therapies Market

The global autologous stem cell and non-stem cell based therapies market is highly fragmented and the major players have used various strategies such as new product launches, expansions, agreements, joint ventures, partnerships, acquisitions, and others to increase their footprints in this market. The report includes market shares of autologous stem cell and non-stem cell based therapies market for global, Europe, North America, Asia Pacific and South America.

Major Autologous Stem Cell and Non-Stem Cell Based Therapies Market Drivers and Restraints:

Introduction of novel autologous stem cell based therapies in regenerative medicine

Reduction in transplant associated risks

Prevalence of cancer and diabetes in all age groups

High cost of autologous cellular therapies

Lack of skilled professionals

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Autologous Stem Cell and Non-Stem Cell Based Therapies Market : Worldwide Business Analysis and Prediction 2020-2025 || Top Players AVRA Medical...

More Than A Survivor: Stories of Warriors – Curetoday.com

By Stem Cell Doctors

Of late I have heard from many of my patients about the inadequacy and almost condescending nature of the term cancer survivor. While the National Comprehensive Cancer Network defines a cancer survivor as any individual diagnosed with cancer from the point of diagnosis through the balance of his/her life, the laymans term of survival carries connotations that are not accurate to those fighting cancer. To survive literally means to exist after a traumatic or life-threatening event. When someone survives a trauma, something is done to this person and they are still alive. The event is assumed to be over. Passivity is implied.

There is nothing passive about the struggle with cancer. Nor is the fight ever completely over. Fighting cancer is, in no uncertain terms, a war. Cancer and its subsequent treatments attack the body, psyche and spirit. As a nurse on the front lines I am in awe of the grit, determination, resiliency, creativity, endurance and sheer will I have seen my patients enact amid this conflict.

Miss A (a patient I have met who will remain anonymous) is a patient with Acute Lymphoblastic Leukemia. Her treatment has caused a baseline of persistent nausea and altered her sense of taste to the point that food is no longer appetizing. Furthermore, Miss A is constantly fatigued. Miss A, however, forces herself to drink an Ensure with each meal to maintain adequate protein intake as her body repairs after each cycle of chemotherapy. She also forces herself to take daily walks to stimulate energy and prevent muscle wasting. These are conscious acts of willpower. This is not passive. The fight is not over.

Miss B has been battling colon cancer with liver metastases for three years. After disease progression, while on her third-line treatment, Miss B took two weeks off treatments and doctor appointments to perform a one-woman show she had been working on for four years. The main premise of this inspiring production was about a woman regaining her life again after years of domesticity nearly broke her spirit. This act of creativity helped Miss A, and others, recall the joys of life and the reason to continue fighting. This is not passive. The fight is not over.

Miss C had Hodgkins Lymphoma. After years of failed chemotherapy related to toxicity and a subsequent Stem Cell Transplant, Miss C is now cancer free. The years of harsh treatment, however, have left Miss C with chronic pain, peripheral and motor neuropathy, leading to frequent falls and difficulty with fine motor skills. Miss C now works with physical therapists daily to maintain her ability to walk and to relearn how to manipulate objects that she cannot always feel. Furthermore, each routine PET scan leads to paralyzing fear, anxiety and other PTSD-like symptoms. Learning to live with chronic conditions and the stigma of mental health issues are acts of resiliency and determination. This is not passive. And although the cancer may be gone, the fight is not over.

It is understandable that people would want a term to describe their plight with cancer, but care must be taken in the naming of things. Names are potent. Names carry meaning even when not intended. And while anyone unlucky enough to be diagnosed with cancer may look to the term cancer survivor as something to strive for, it is far from adequate to describe what this person goes through. Miss A, Miss B and Miss C are far more than simply survivors. We do not call soldiers returning from, or currently fighting, a war survivor. We call them warriors. Therefore, I propose changing the term cancer survivor to cancer warrior.

Finally, it seems more than unfair for those who lost the battle to cancer to then also lose the term they fought so hard to obtain. Miss D had Acute Lymphoblastic Leukemia. She went through a stem cell transplant and was in remission for six months before relapsing. Even as her body wasted to a wisp of the young woman she was, she continued to come to the outpatient clinic for salvage chemotherapy and blood transfusions with an upbeat and hopeful spirit. And while Miss D succumbed to Leukemia, her struggle was anything but passive. Her fight may be over, and she is no longer considered a survivor, but she will always be a warrior.

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More Than A Survivor: Stories of Warriors - Curetoday.com

Lost Smell and Taste Hint COVID-19 Can Target the Nervous System – The Scientist

By Stem Cell Doctors

Nearly two weeks ago, Alessandro Laurenzi, a biologist working as a consultant in Bologna, Italy, was mowing the grass in his garden when a friend stopped him and said the mower reeked of fuel. I couldnt smell anything at all, he tells The Scientist. That was in the morning. A few hours later, he went to have lunch and realized he couldnt smell the food he was about to eat and when he took a bite, he couldnt taste it either. Within a few days, he developed symptoms of COVID-19 and called his doctor to ask if he could get tested. Because his symptoms were mild, Laurenzi says, his doctor said no.

Laurenzi had heard anecdotally that many COVID-19 patients in Italy suffered from a loss of smell, so he started reading all the scientific papers he could find to see if his anosmia and ageusia would ever abate. One of the papers, a review published March 13, mentioned that SARS-CoV-2, like other coronaviruses such as SARS-CoV and MERS-CoV, could target the central nervous system, possibly infecting neurons in the nasal passage and disrupting the senses of smell and taste.

Some of the purely respiratory symptoms that you might attribute to the disease, the inability to get air into the lungs, might actually be defects in respiration controlled by the nervous system.

Matthew Anderson, Beth Israel Deaconess Medical Center

Reading this, Laurenzi immediately reached out to the corresponding author, Abdul Mannan Baig, a researcher at Aga Khan University in Pakistan, and asked if his symptoms were reversible. The evidence, Mannan told Laurenzi and reiterated to The Scientist, indicates they will abate, possibly because the loss of sense is caused by inflammation in the area as the body fights the virus, so those symptoms could disappear in seven to 14 days. Lets hope so, Laurenzi tells The Scientist.

Documenting such peculiar symptoms is important, Mannan tells The Scientist, because the loss of smell and taste could be an early warning sign of SARS-CoV-2 infection. Based on the literature, British ear, nose, and throat doctors have now called for adults who lost those senses to quarantine themselves in an attempt to tamp down the spread of the disease, The New York Times reports. The symptoms, Mannan adds, also suggest that the virus has the ability to invade the central nervous system, which could cause neurological damage and possibly play a role in patients dying from COVID-19.

This is something to keep a careful eye on, says Matthew Anderson, a neuropathologist at Beth Israel Deaconess Medical Center in Boston. Theres been some intriguing observations in previous studies on viruses, including coronaviruses, to show that they have the capacity to enter the nervous system. Its important that this be considered for SARS-CoV-2 and for people to do the experiments, including autopsies, to look for signs of this damage.

Because COVID-19 has symptoms similar to the flu, much of the attention could get diverted towards the pulmonary aspect of SARS-CoV-2, while neural involvement may remain covert, Mannan says. When a patient begins to exhibit severe neurological symptoms, such as a loss of involuntary breathing, it may be too late to prevent fatalities.

In a review article first published February 27, Yan-Chao Li of Jilin University in China and colleagues argue that if SARS-CoV-2 infects nerve cells, particularly neurons in the medulla oblongata, which is part of the brain stem that serves as the control center for the heart and the lungs, the damage could contribute to acute respiratory failure of patients with COVID-19.

The epidemiological evidence supports the hypothesis that neurons in the medulla can become infected with SARS-CoV-2 and contribute to a patients breathing problems and potential death. Li and colleagues explain that the time it takes for COVID-19 to progress from first symptoms to difficulty breathing is typically five days; patients are then admitted to the hospital roughly two days later, and a day after that put into intensive care. The latency period is enough for the virus to enter and destroy the medullary neurons, they write.

SARS-CoV-2 enters human cells using a receptor called ACE2. Researchers have reported that ACE2 regulates cardiovascular function, and according to a search of protein databases, many human cell types express ACE2, including lung, heart, kidney, intestine, and brain tissue, Mannan says. There are also multiple ways that the virus could invade the central nervous system, he explains. It might circulate through the blood and then attack ACE2 receptors in the endothelia that lines blood capillaries in the brain, breaching the blood-brain barrier and invading neurons through that route. A breached blood-brain barrier could also cause brain swelling, compressing the brain stem and affecting respiration, Mannan says. The cells innervating the lungs could also become infected, making involuntary respiration more difficult.

Evidence from experiments in mice also suggest that the virus might target the nervous system through the olfactory bulb. In a 2008 study, immunologist Stanley Perlman of the University of Iowa and colleagues showed that SARS-CoVthe virus that caused the SARS outbreak that killed more than 770 people in 2003entered the brains of transgenic mice expressing human ACE2 through neurons in the nose. The virus then rapidly spread to connecting nerve cells. The extensive nerve damage was the major cause of death, the team reported, even though low levels of the virus were detected in the animals lungs.

Although this has not been demonstrated, SARS-CoV-2 could potentially enter the nervous system through the olfactory bulb, as SARS-CoV does in mice.

Death of the animal likely results from dysfunction and/or death of infected neurons, especially those located in cardiorespiratory centers in the medulla, the team wrote. A study with the MERS virus in mice expressing ACE2 showed a similar result, Perlman tells The Scientist. The brain certainly can be readily infected in mice, he notes. Whether this occurs in humans to any great extent is really unknown, but not very likely at this point, given how much larger rodents olfactory bulbs are relative to the overall size of their brains compared with humans and the paucity of evidence in humans.

Still, he says, the fact that COVID-19 patients have lost their sense of smell or taste is interesting because, if the virus infects the nose, it would use the exact same neurons as in the mouse studies to enter the brain. If taking this path, SARS-CoV-2 could work its way up to the olfactory mucosa, which consists of epithelium cells, blood vessels, and the axons from olfactory neurons. This area is connected to the olfactory bulb, via small, sieve-like, tiny openings called the cribriform plate that is located at the base of the frontal lobes of the brain, Mannan explains. Because the brains frontal lobes are close to the olfactory bulb where neurons may be infected, the tissue deeper in the brain could be endangered too.

Infection of the brainstem could cause changes that would affect involuntary respiration, which suggests some of the purely respiratory symptoms that you might attribute to the disease, the inability to get air into the lungs, might actually be defects in respiration controlled by the nervous system, Anderson says.

Mannan emphasizes that the neurological data on SARS-CoV-2, though preliminary, could be important for doctors deciding how to treat patients. Asking about neurological symptomsloss of taste or smell, twitching, seizurescould factor into who might go into acute respiratory failure, or at least who might suffer from it soonest, and allow for more efficient triaging of patients, with a close eye kept on those with neurological symptoms. It is important to screen the patients for neurological signs early and late in the course of COVID-19, he says, as this could be life-saving in our fight against COVID-19 pandemic.

Anderson and Perlman add that postmortem examinations of the brains of patients who died from COVID-19 are essential to understanding the role nerve damage might play in the progression of the disease. Few, if any, autopsies of these patients are being done because of fear of contracting the disease, and if the autopsies are being done, its not likely that examiners are looking at the brain, only the lungs. Theyre just not thinking that the brain could be the site of the problem, Anderson says, and so thats the really important aspect of these reviews, getting that idea out there.

Ashley Yeager is an associate editor atThe Scientist. Email her atayeager@the-scientist.com. Follow her on Twitter@AshleyJYeager.

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Lost Smell and Taste Hint COVID-19 Can Target the Nervous System - The Scientist

While we were stockpiling, here’s what astronauts were up to in space last week – CNN

By Stem Cell Doctors

While many of us are practicing social distancing, working from home or living in quarantine-like and isolated situations, life goes on as normal for the space station-dwelling astronauts.

They're aware of the pandemic and have been sharing their support for people across the globe through their Twitter accounts. NASA astronaut Jessica Meir shared her perspective: "From up here, it is easy to see that we are truly all in this together. #EarthStrong."

But the astronauts aren't just floating around and taking cool pictures of Earth. Each week, hundreds of science experiments are in progress on the station. In addition to working on these experiments, the astronauts study themselves to better understand the human body in space.

Here's a look at the cool science they've been doing 254 miles from Earth.

Space pants

Living in space is an adjustment for the human body as it adapts to the lack of gravity.

Over the years, astronauts have noticed changes in their vision as a response to the headward fluid shift they experience. This also increases pressure in the head.

Last week, NASA astronauts Jessica Meir and Andrew Morgan, as well as Russian cosmonaut Oleg Skripochka, tested out the Russian Chibis hardware, also known as the Russian Space Agency's Lower Body Negative Pressure experiment.

It's basically a pair of pants housed in the Russian Orbital Segment of the space station.

The rubber pants use suction to draw fluids back down towards the legs and feet, just like we experience walking on Earth.

Researchers hope that hardware to reverse the fluid shift astronauts experience in space could also help with their vision changes.

While Morgan was wearing the Chibis pants, Meir used a tonometer to measure his eye pressure, with doctors on Earth watching in real time. Morgan's head and chest were also scanned to monitor blood flow.

The astronauts also tested their hearing as part of the European Space Agency's Acoustic Diagnostics experiment to monitor if the astronauts' hearing changes in response to noise and lack of gravity on the station.

Heart, muscle and bone

Multiple experiments are currently occurring on the station that could not only benefit the health of astronauts, but human life on Earth as well.

These cells could treat astronauts who experience heart abnormalities and be used to treat people and children with cardiac diseases and disorders on Earth. The cells can also be used to investigate the development of new pharmaceuticals.

One experiment, called Engineered Heart Tissues, allows the astronauts to watch heart cell muscle contractions in real time.

Meir and Morgan have been taking care of the heart cells, watching how they react to the lack of gravity. When the heart cells return to Earth, the results of the space experiment will be compared with a similar control experiment on Earth.

The astronauts have also been studying bone samples to understand and develop bone treatments for astronauts who suffer bone loss in space, as well as people diagnosed with osteoporosis on Earth. The goal is to determine new treatments for both.

Mice are also sharing space on the station with the astronauts in a mouse habitat so they can study how the mice and their gene expression reacts to zero gravity.

Understanding how their gene expression is altered can help NASA better prepare for long-term human spaceflight. The study also serves a secondary purpose of allowing them to determine countermeasures for muscle atrophy, which can occur in space or for patients on bed rest.

It's all in your gut

Astronauts don't get much of a chance to vary their diets in space. That means they could also be missing out on vital nutrients and other added benefits of the fresh food we consume on Earth.

The Japanese space agency's Probiotics investigation is studying how good gut bacteria could improve the human microbiome on long-term missions.

Meanwhile, the astronauts are also participating in an experiment called Food Acceptability, looking at the "menu fatigue" that happens when they eat based on limited options over months on the station. This usually causes them to lose weight by the time they return to Earth.

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While we were stockpiling, here's what astronauts were up to in space last week - CNN

Scientists Have ‘Reset’ The Cellular Age Of Cells Taken From A 114-Year-Old Woman – IFLScience

By Adult Stem Cells

For the first time, scientists have reprogrammed cells from a 114-year-old woman into induced pluripotent stem cells (iPS cells), a move which they describe as a significant step toward understanding"the underlying mechanisms of extreme longevity and disease resistance."

iPS cells are adult cells that have been genetically reprogrammed into an embryonic stem cell-like state and are able to give rise to any of the specialized cell types of the body, whether its neurons, blood cells, or heart cells.

Until this new project, researchers werent even certain whether they could create viable iPS cellsfrom someone so elderly, let alone a supercentenarian. Now they have shown it's possible to effectively make these aged cells resemble young pluripotent cells, the researchers believe they might have made a step towards the reversal of cellular aging.

"We set out to answer a big question: Can you reprogram cells this old?" Evan Snyder, stem cell researcher at Sanford Burnham Prebys Medical Discovery Institute in California, said in a statement.

"Now we have shown it can be done, and we have a valuable tool for finding the genes and other factors that slow down the aging process."

Reporting in the journal Biochemical and Biophysical Research Communications, researchers harnessed iPS cells from the blood cells of a 114-year-old woman, a healthy 43-year-old person, and an 8-year-old child with a rare genetic condition characterized by the rapid aging in childhood. These iPS cells were then turned into mesenchymal stem cells, cells that help maintain and repair the body's structural tissues differentiating into bone, cartilage, muscle, or fat cells.

Remarkably, the cells produced from the supercentenarian transformed just as easily as the others. They also noted the supercentenarian-derived stem cells appeared to have reset their telomeres.

Telomeresarethe protective caps on the end of a chromosome. Since they shorten each time a cell copies itself, they also get shorter as we age and eventually stop functioning properly. Thispersistent shortening allows researchers to use telomeres as a kind of aging clock in every cell.Interestingly, the stem cells from the supercentenarian showed no indication of this aging. They had effectively reset the clock on the cells from114 years to zero.

To dive deeper into this discovery, the researchers hope to compare body cells derived from the healthy iPSCs and supercentenarian iPSCs. The researchers could also start to use the supercentenarian cells to understand why certain people have such long lives compared to others.

Why do supercentenarians age so slowly? We are now set to answer that question in a way no one has been able to before, said Snyder.

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Scientists Have 'Reset' The Cellular Age Of Cells Taken From A 114-Year-Old Woman - IFLScience

iCAD Launches New Initiatives Leveraging Unique Capabilities of its Robust Product Portfolio to Reduce Health Care System Pressures During the…

By Gene Therapy Clinics

ProFound AI can assist radiologists in prioritizing patients for breast cancer screening and address the growing mammography backlog

Xoft breast IORT offers single-fraction therapy alternative to weeks of daily radiation, reducing resources needed and minimizing patients risk of COVID-19 exposure

NASHUA, N.H., March 23, 2020 (GLOBE NEWSWIRE) -- iCAD, Inc. (ICAD), a global medical technology leader providing innovative cancer detection and therapy solutions, today announced the launch of new initiatives to address emerging challenges hospitals are facing due to the pandemic of the coronavirus disease, or COVID-19. The Company and its portfolio of technologies supporting cancer detection and therapy continue to offer a strong value proposition and multiple benefits to clinicians and patients, which may be particularly relevant in light of the coronavirus outbreak:

ProFound AI, the first artificial intelligence (AI) software for digital breast tomosynthesis (DBT) to be FDA-cleared, provides crucial data, such as Case Scores, which can help radiologists prioritize which patients should not delay screening and presents a solution to the growing mammography backlog that will need to be cleared once COVID-19 passes. It is also clinically proven to decrease the rate of false positives and unnecessary recalls,1 which reduces resources needed and minimizes patient risk of COVID-19 exposure.

The Xoft Axxent Electronic Brachytherapy (eBx) System offers a single-fraction therapy option that allows patients who are candidates to replace weeks of daily radiation with one treatment, delivered at the time of surgery. This could also significantly reduce the healthcare system resources needed and reduce patients risk of COVID-19 exposure.

iCAD is mobilized to support critical facility and physician needs related to both its Detection and Therapy businesses.

A ProFound Impact on ScreeningIn recent weeks the number of people diagnosed with COVID-19 has rapidly increased, placing a growing burden upon hospitals and clinicians worldwide, and this issue may continue to proliferate in the near-term. According to recent guidance from the American College of Radiology and the American Cancer Society, some women should consider rescheduling routine mammograms to allow hospitals to address critical COVID-19 cases. Due to this emerging issue, some patients with more urgent and higher risk factors may be deferred, which could have negative consequences in the long run, according to Michael Klein, Chairman and CEO of iCAD.

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Studies from published academic research show that on average, a mammography provider can expect to detect up to 6 cancers per 1,000 screening mammograms,2 which indicates that even in the face of this pandemic, cancer is not going away, according to Stacey Stevens, President of iCAD. Now more than ever, it is increasingly critical to empower radiologists with the technology to quickly and effectively prioritize mammography screening.

Where breast cancer screening is concerned, our initiative involving ProFound AI could be exceptionally helpful for radiologists, as the technology can be used on patients prior year mammograms to prioritize which women may be at higher risk of developing breast cancer, and thereby should work with their healthcare provider to determine the availability of expedient follow up screening. Further, when the threat of COVID-19 passes, physicians and the healthcare system as a whole will be faced with an enormous backlog of mammograms. ProFound AI is uniquely positioned to address these emerging challenges, added Klein.

In the face of COVID-19, improving accuracy and efficiency for breast cancer screening is now more essential than ever. Using this leading-edge technology, radiologists have the ability to review prior year mammograms and prioritize which patients should not delay breast cancer screening based on the technologys unique Case Score, which represents a relative level of suspicion for the case containing potentially cancerous findings that may require further workup, according to Mark Traill, MD, radiologist at University of Michigan Health, Metro Health. It is clinically proven to help radiologists significantly increase their productivity. ProFound AI can also reduce the rate of false positives,1 which are not only stressful for patients, but also place a significant additional burden on providers. Clinicians using ProFound AI will be very happy they have such a sophisticated tool helping them better position their screening programs recovery from this unprecedented global disruption.

Trained with one of the largest available DBT datasets, ProFound AI rapidly and accurately analyzes each DBT image, or slice, and provides radiologists with key information, such as Certainty of Finding lesion and Case Scores, which assists radiologists in clinical decision-making and improving reading efficiency. Featuring the latest in deep-learning artificial intelligence, the algorithm also allows for continuously improved performance via ongoing updates.

Single-Fraction Therapy Shaves Treatment Time to One DayThe burden COVID-19 is placing on hospitals is resulting in some healthcare facilities needing to reschedule surgeries and other procedures, including cancer treatments, noted Klein. As COVID-19 is forcing hospital systems to begin to reframe protocols relating to the treatment of cancer, our initiative for the Xoft System may help to address this emerging burden placed on the system and patient concerns related to potential COVID-19 exposure, as it offers significant time savings benefits to clinicians and patients.

The Xoft System offers the ability to deliver an entire course of treatment to an early-stage breast cancer patient in just one day, at the time of lumpectomy, which not only frees up space in hospitals and allows clinicians to focus on more critical needs, it reduces immunocompromised patients time in hospitals and therefore minimizes their potential exposure to the virus, Stevens added.

Clinical guidelines from several national medical societies support an abbreviated course of radiation for appropriate breast cancer candidates, and a growing body of clinical evidence suggests Xoft breast IORT is a viable alternative to traditional radiation therapy, 3,4,5 according to Barbara Schwartzberg, MD, Western Surgical Care. IORT with the Xoft System offers significant cost savings and quality of life benefits to patients, while enabling them to get the cancer care they need in just one day, versus weeks of daily radiation treatments. As healthcare systems adjust to the emergent needs relating to the coronavirus, IORT offers a valuable solution for early-stage breast cancer patients, and physicians delivering their care.

The American Society for Radiation Oncology (ASTRO) recently recommended shorter courses of radiation therapy, such as intraoperative radiation therapy (IORT) and hypofractionated radiation therapy, for appropriate patients in its recent recommendations on COVID-19.6 Recognizing the potential for staff reductions, ASTRO advised radiation oncologists to follow evidence-based guidelines while striving for the shortest possible course of radiotherapy, where appropriate. The overall goal is to reduce the risk of transmission of COVID-19 and to allow cancer care to continue for those most likely to benefit.

For the treatment of early-stage breast cancer, IORT with the Xoft System offers a single-fraction therapy option that allows patients who are candidates to be treated for breast cancer in just one day. This targeted treatment option enables some women to potentially replace four to six weeks of daily fractions of post-operative external beam radiation therapy (EBRT) with a single-fraction of radiation that can last as little as eight minutes, thereby reducing the amount of time women need to be in the hospital and allowing doctors to treat more women in less time.

In addition to early-stage breast cancer, Xoft IORT technology is also being explored in the treatment of other types of tumors. iCAD recently announced the first metastatic brain tumor was treated in the U.S. with IORT using the Xoft System at the James Graham Brown Cancer Center at the University of Louisville. The Xoft System is also currently being studied for the treatment of other types of brain tumors in leading institutions worldwide, including the European Medical Center, one of the largest private medical clinics in Russia and an international leader in comprehensive care and oncology. The Company continues to work with key neurosurgeons to enroll patients in a multi-institutional study on Xoft IORT for the treatment of recurrent glioblastoma (GBM).

Homegrown Technology Positioned to Sustain in the Face of PandemiciCAD has quickly mobilized to support critical facility and physician needs related to both sides of our business, said Scott Areglado, Chief Financial Officer of iCAD.

Health systems are increasingly seeking alternative ways to accomplish daily clinical challenges, drive operational efficiency, and streamline patient management, and our technologies are well-positioned to address this demand, particularly as facilities fight against COVID-19, added Klein. Our world-class core technology is homegrown and entirely manufactured in the United States. We have minimal reliance upon outside vendors or external suppliers, and therefore we will continue to be able to offer our cutting-edge solutions to more hospitals and imaging centers as demand continues to grow. We are partnering and collaborating with virtually all of our OEM and PACS partners, particularly those aligned with our risk and remote access support initiatives, and we are also partnering with healthcare systems and large imaging chains to get these proven technologies into peoples hands as fast as possible.

References:

Conant, E et al. (2019). Improving Accuracy and Efficiency with Concurrent Use of Artificial Intelligence for Digital Breast Tomosynthesis. Radiology: Artificial Intelligence. 1 (4). Accessed via https://pubs.rsna.org/doi/10.1148/ryai.2019180096

Conant, E. et al. (2020). Five Consecutive Years of Screening with Digital Breast Tomosynthesis: Outcomes by Screening Year and Round. Radiology. Accessed via https://doi.org/10.1148/radiol.2020191751.

Correa, Candace et al. (2017) Accelerated Partial Breast Irradiation: Executive summary for the update of an ASTRO Evidence-Based Consensus Statement. Practical Radiation Oncology, Volume 7, Issue 2, 73 79. Accessed via https://www.practicalradonc.org/article/S1879-8500(16)30184-9/fulltext.

Schwartzberg, BS. et al. (2018). Application of 21-gene recurrence score results and ASTRO suitability criteria in breast cancer patients treated with intraoperative radiation therapy (IORT). American Journal of Surgery. 216(4): 689-693. Accessed via https://www.americanjournalofsurgery.com/article/S0002-9610(18)30097-7/fulltext

Silverstein, M.J., Epstein, M., Kim, B. et al. Intraoperative Radiation Therapy (IORT): A Series of 1000 Tumors. Ann Surg Oncol 25, 29872993 (2018). https://doi.org/10.1245/s10434-018-6614-3

American Society for Radiation Oncology (ASTRO) COVID-19 Recommendations to Radiation Oncology Practices. (2020). Accessed via https://www.astro.org/Daily-Practice/COVID-19-Recommendations-and-Information

About iCAD, Inc.

Headquartered in Nashua, NH, iCAD is a global medical technology leader providing innovative cancer detection and therapy solutions.

ProFound AI is a high-performing workflow solution for 2D and 3D mammography, or digital breast tomosynthesis (DBT), featuring the latest in deep-learning artificial intelligence. In 2018, ProFound AI for Digital Breast Tomosynthesis (DBT) became the first artificial intelligence (AI) software for DBT to be FDA-cleared; it was also CE marked and Health Canada licensed that same year. It offers clinically proven time-savings benefits to radiologists, including a reduction of reading time by 52.7 percent, thereby halving the amount of time it takes radiologists to read 3D mammography datasets. Additionally, ProFound AI for DBT improved radiologist sensitivity by 8 percent and reduced unnecessary patient recall rates by 7.2 percent.1

The Xoft System is FDA-cleared, CE marked and licensed in a growing number of countries for the treatment of cancer anywhere in the body. It uses a proprietary miniaturized x-ray source to deliver a precise, concentrated dose of radiation directly to the tumor site, while minimizing risk of damage to healthy tissue in nearby areas of the body.

For more information, visitwww.icadmed.com and http://www.xoftinc.com.

Forward-Looking Statements

Certain statements contained in this News Release constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements about the future prospects for the Companys technology platforms and products. Such forward-looking statements involve a number of known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Such factors include, but are not limited, to the Companys ability to achieve business and strategic objectives, the risks of uncertainty of patent protection, the impact of supply and manufacturing constraints or difficulties, uncertainty of future sales levels, to defend itself in litigation matters, protection of patents and other proprietary rights, the impact of supply and manufacturing constraints or difficulties, product market acceptance, possible technological obsolescence of products, increased competition, litigation and/or government regulation, changes in Medicare or other reimbursement policies, risks relating to our existing and future debt obligations, competitive factors, the effects of a decline in the economy or markets served by the Company; and other risks detailed in the Companys filings with the Securities and Exchange Commission. The words believe, demonstrate, intend, expect, estimate, will, continue, anticipate, likely, seek, and similar expressions identify forward-looking statements. Readers are cautioned not to place undue reliance on those forward-looking statements, which speak only as of the date the statement was made. The Company is under no obligation to provide any updates to any information contained in this release. For additional disclosure regarding these and other risks faced by iCAD, please see the disclosure contained in our public filings with the Securities and Exchange Commission, available on the Investors section of our website athttp://www.icadmed.comand on the SECs website athttp://www.sec.gov.

Contacts:Media inquiries:Jessica Burns, iCAD +1-201-423-4492jburns@icadmed.com

Investor relations:Jonathan Wexler+1-203-247-8767jonathan@scopeir.com

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