Category Archives: Regenerative Medicine

| 08 July 2022 | By Michael Mezher 2793 Welcome to another installment of This Week at FDA, your weekly source for updates big and small on FDA, drug and medical device regulation, and what were reading from around the web. This week, we learned that FDA is looking to hire a media-savvy physician to direct its communication strategy. The agency also authorized state-licensed physicians to prescribe Pfizers COVID-19 antiviral drug. Plus, we read that FDA and the US Patent and Trademark Office (USPTO) are planning to work more closely to promote drug competition.After learning of two high-profile hires at FDA last week, we read that FDA is eyeing Vin Gupta, a pulmonologist and Chief Medical Officer at Amazon, who also appears as a medical analyst for NBC and MSNBC, to serve as the agencys principal medical adviser. According to Politico, Gupta would be tasked with steering the agencys communication strategy and acting as a public face on high-profile issues and trying to bolster trust in the agencys health recommendations.Senate Democrats are reportedly working to advance legislation that would enable Medicare to negotiate prescription drug prices, according to Reuters. The news outlet reports that all 50 Senate Democrats are in line on the proposal, and according to Politico, the proposal has been sent to the Senate Parliamentarian for review as part of a larger reconciliation package.To ease access to Pfizers COVID-19 antiviral drug Paxlovid (nirmatrelvir and ritonavir), FDA on Wednesday moved to allow state-licensed pharmacists under certain circumstances. Since Paxlovid must be taken within five days after symptoms begin, authorizing state-licensed pharmacists to prescribe Paxlovid could expand access to timely treatment for some patients who are eligible to receive this drug for the treatment of COVID-19, said Center for Drug Evaluation and Research Director Patrizia Cavazzoni. The same will not be true for Mercks Lagevrio (molnupiravir), Fierce Pharma reports. Were also reading this blog from USPTO Director Kathi Vidal and FDA Commissioner Robert Califf on the two agencies efforts to promote competition and lower drug prices for all Americans. The two agency heads said that more work is needed to ensure that the patent system is not used to unjustifiably delay generic drugs and biosimilar competition beyond that reasonably contemplated by law. The two said their agencies will work more closely with the aim of protecting against the patenting of incremental, obvious changes to existing drugs that do not qualify for patents.Drugs & biologicsThis week, we learned that FDA will reconvene its Peripheral and Central Nervous System Drugs Advisory Committee (PCNSDAC) to review Amylyx Pharmaceuticals amyotrophic lateral sclerosis (ALS) drug known as AMX0035 for a second time in September. The rare move comes after the agency extended its Prescription Drug User Fee Act (PDUFA) goal date for the drug. In March, the PCNSDAC voted 6-4 against approving the drug, Stat reported.The agency also granted Biogen and Eisais Alzheimers disease drug lecanemab priority review under the accelerated approval pathway, with a PDUFA goal date of 6 January 2023. The news follows the agencys controversial decision to grant accelerated approval to the pairs other Alzheimers drug Aduhelm (aducanumab) last June.We also saw FDAs Office of New Drugs (OND) release its 2021 annual report detailing its activities and accomplishments during the calendar year.FDA announced on Friday it is withdrawing Xellia Pharmaceuticals abbreviated new drug application for bacitracin for injection, 50,000 units/vial, at the companys request. The withdrawal comes after the agencys Antimicrobial Drugs Advisory Committee voted almost unanimously that the drugs risks outweigh its benefits for its sole approved indication in April 2019. The agency called for companies to voluntarily withdraw their applications for the drug in early 2020.FDA has released new quarterly data on its regenerative medicine advance therapy (RMAT) designation, which shows that the agency received 21 requests so far in FY2022, compared to a total of 24 requests in all of FY2021. The agency has already granted 9 of those requests, already exceeding the number granted in the previous year.Medical devicesFDA has identified Getinge USAs recall of its Flow-c and Flow-e anesthesia systems as a Class I recall due to the risk of cracked or broken suction system power switches, which could cause delays during procedures or between procedures, and could cause choking, inability of oxygen to get into the blood, pneumonia, brain injury or death. FDA said it has received 21 complaints related to the issue, though none that cited injury or death.Were also looking forward to FDAs upcoming Patient Engagement Advisory Committee meeting next Tuesday and Wednesday. The committee will be tasked with making recommendations related to augmented reality (AR) and virtual reality (VR) medical devices.

2022Regulatory Affairs Professionals Society.

Continued here:
This Week at FDA: USPTO, FDA align on drug competition, Paxlovid from your pharmacist, and more - Regulatory Focus

A new biomanufacturing method for constructing 3D scaffolds composed of narrow fibers with specific alignments has been developed. The method, called focused rotary jet spinning (FRJS), is enabling researchers to fabricate heart structures and to study how the helical alignments of fibers in the musculature of the heart enhance cardiac function.

The findings, which provide proof-of-concept for a streamlined approach to engineering tissues and organs with complex 3D geometries, were reported by Huibin Chang, PhD, a research associate in bioengineering at Harvard University, and colleagues in a Science article entitled Recreating the hearts helical structure-function relationship with focused rotary jet spinning.

The hearts pumping action comes from cardiomyocytesthe muscle cells of the heartwhich are organized as helical fibers that envelop the ventricles. With each beat, this arrangement results in a combined contracting and twisting motion.

However, it is difficult to specifically assess the extent to which the hearts helical structure contributes to its function, wrote Michael Sefton, ScD, and Craig Simmons, PhD, from the Institute of Biomedical Engineering at the University of Toronto, in a perspective that accompanied the research article. To that end, understanding and replicating the hearts helical structure-function relationship is thought to be an important step.

Designing scaffolds and materials that adequately recapitulate native heart function can be challenging. The newly reported FRJS method offers improvements in fabrication speed and complexity over conventional methods.

In FRJS, long, free-floating polymer fibers are expelled by centrifugal force, and air jet streams align and deposit the fibers on molds. By controlling the shape and rotation of the mold, scaffolds with specific fiber orientations can be constructed. The scaffolds can then be seeded with cellscardiomyocytes, in this caseto recapitulate tissue and organ structures.

Using their method, Chang and colleagues fabricated heart ventricles with similar structural properties to those in natural human hearts. They also fabricated models of diseased hearts with misaligned fiber orientations. Once the scaffolds were seeded with human cardiomyocytes, the authors showed that the helical architecture increased cardiac performance, illustrating that the helical tissue pattern plays a role in the pumping function of the heart.

But the heart is more than a pump. To achieve a fully functional bioengineered heart for use in regenerative medicine, an electrical conduction system, vasculature, and means to avoid immune responses are still needed.

The FRJS method provides an initial pathway toward fabricating more complex tissues and organs. In addition to biofabrication, FRJS may serve an important role in other additive manufacturing processes, wrote Chang and colleagues. It provides production rates comparable to those of current industrial processes while enabling micro/nanoscale feature sizes and controlled 3D alignments.

Original post:
New Biofabrication Process Developed to Engineer Heart Structures - Genetic Engineering & Biotechnology News

WINSTON-SALEM, N.C., July 5, 2022 /PRNewswire/ -- Plakous Therapeutics, Inc. today announced it is has received more than $300,000 in funding from the North Carolina Biotechnology Center (NCBiotech). The funding will support ongoing development and marketing of Protego-PD, the regenerative medicine company's first product.

Plakous received the funding through two NCBiotech programs. Plakous was named the winner of NCBiotech's BIONEER Venture Challenge. Throughout the months-long competition, the company received $60,000. Earlier last month, NCBiotech awarded Plakous a Small Business Research Loan of $250,000 after several months of rigorous due diligence.

"We are grateful to NCBiotech for its mentorship and confidence in our research and development," said Plakous CEO Robert Boyce. "Their loans and grants will complement our currently open $4M seed round to support efforts related to our upcoming Investigational New Drug filing for Protego-PD, our orally delivered acellular biotherapeutic for necrotizing enterocolitis (NEC)."

Plakous' success underscores the strong life sciences community in the state.

"It is exciting and encouraging when research and therapies advance toward commercialization," said Nancy Johnston, NCBiotech executive director for the Piedmont Triad office. "Not only does this attract additional investments, but it also demonstrates the diversity of discovery and solutions underway in the Piedmont Triad."

NEC is a devastating disease with a 30% mortality rate. NEC affects premature infants with very low birthweight (those born weighing less than three pounds) and is caused by inflammation and lack of development of the intestine. Managing NEC consumes 20% of NICU expenditures annually. Plakous seeks to prevent NEC by accelerating intestinal maturation of premature infants with Protego-PD.

About Plakous Therapeutics, Inc.

Plakous Therapeutics is a biotherapeutic company dedicated to researching and developing placenta derived regenerative therapies to improve patient outcomes and reduce health care costs. For more information, please visit the company's website at plakoustherapeutics.com.

SOURCE Plakous Therapeutics, Inc.

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Plakous Therapeutics Announces New Funding to Support Development of Therapies for Necrotizing Enterocolitis - PR Newswire

The Tissue Engineering market research report added by Report Ocean, is an in-depth analysis of the latest developments, market size, status, upcoming technologies, industry drivers, challenges, regulatory policies, with key company profiles and strategies of players. The research study provides market overview, Tissue Engineering market definition, regional market opportunity, sales and revenue by region, manufacturing cost analysis, Industrial Chain, market effect factors analysis, Tissue Engineering market size forecast, market data&Graphs and Statistics, Tables, Bar &Pie Charts, and many more for business intelligence.

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The global tissue engineering market size was US$ 12.1 billion in 2021. The global tissue engineering market is forecast to grow to US$ 39.4 billion by 2030 by registering a compound annual growth rate (CAGR) of 15.6% during the forecast period from 2022 to 2030.

Factors Influencing the Market

The global tissue engineering market is forecast to gain significant traction due to the rising demand for skin replacement surgeries. In addition, the demand for technologically advanced products is also growing at a rapid pace, which is expected to bring lucrative growth opportunities for the market during the study period.

The growing demand for inexpensive and readily available skin-replacement goods will also prompt market growth. In addition, rapidly rising cases of road accidents will also surge the demand for surgeries. Apart from that, growing healthcare expenditure, combined with the rising R&D activities in the region, will prompt the growth of the tissue engineering market.

Rapidly surging cases of chronic diseases and trauma injuries will drive the growth of the tissue engineering market during the forecast period. On the flip side, a lack of awareness about tissue engineering may limit the growth of the market during the study period.

COVID-19 Impact Analysis

Healthcare expenditure has significantly grown after the outbreak of the COVID-19 pandemic. The pandemic triggered the need to perform clinical research. However, the unavailability of raw materials hampered innovations in the tissue engineering industry. Apart from that, the focus of pharmaceutical and biotech companies has significantly inclined towards the development of drugs aimed at curing COVID-19 infection. As a result of delays & disruptions in clinical research and reduced demand for surgery, the market witnessed a notable drop in terms of revenue during the forecast period.

Regional Analysis

North America is forecast to dominate the tissue engineering market during the forecast period owing to the early adoption of advanced technology, rising healthcare expenditure, and efficient healthcare infrastructure. In addition to that, growing cases of chronic diseases and high awareness about the effectiveness of tissue engineering will contribute to this regional market growth. The market may also witness several opportunities due to the rising government financing and high healthcare spending.

Due to the escalating demand for advanced healthcare services in emerging nations, the regions increasing R&D industry, and the increased presence of important companies, Asia-Pacific offers attractive prospects for key players operating in the tissue engineering market. Additionally, the industry has developed in the past few years due to expanding healthcare infrastructure and an emphasis on regenerative medicine.

Key Segments Studied in the Global Tissue Engineering Market

Competitors in the Market

Market Segmentation

The global tissue engineering market segmentation focuses on Material, Application, and Region.

By Material Type

By Application

Impact of lockdowns, supply chain disruptions, demand destruction, and change in customer behavior

Optimistic, probable, and pessimistic scenarios for all markets as the impact of pandemic unfolds

Pre- as well as post-COVID-19 market estimates

Quarterly impact analysis and updates on market estimates

What is market research report?

Market research is a defined process to collect information about customers, competitors, and everything that a business needs to understand to sustain and grow. It offers important analysis to distinguish and examine the market needs, size, and trends. Market research is generally divided into, primary research and/or secondary research. The process usually includes collection and interpretation of market data by using statistical and analytical techniques to support the decision making process. The report helps in identifying and tracking emerging players in the market and their portfolios, enhances decision making capabilities and helps to create effective counter strategies to gain competitive advantage. Market research reports provide in-depth analysis about the market conditions and requirements for effective decision making.

The report provides a snapshot of the global market size, segmentation data, marketing growth strategies, market share, export and import information, analysis and forecast of market trends, competition, domestic production, best sales prospects, statistical data, tariffs, regulations, distribution and business practices, end-user analysis, contact points and more. These research reports include information about competitive strategies, solutions, fact-based research, key takeaways, recommendations, market considerations, emerging business models and market opportunities for multiple segments of an industry. Market research reports assist in solving business problems and making better decisions to improve business as per the prevalent market trends.

What our reports offer:

Market share assessments for the regional and country-level segments

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Covers market data for 2020, 2021, till 2025

Market trends (drivers, opportunities, threats, challenges, investment opportunities, and recommendations)

Strategic recommendations in key business segments based on the market estimations

Competitive landscaping mapping the key common trends

Company profiling with detailed strategies, financials, and recent developments

Supply chain trends mapping the latest technological advancements

Browse market information, tables and figures extent in-depth TOC, The latest independent research document on various market development activities and business strategies such as new product/services development, Joint Ventures, partnerships, mergers and acquisitions, etc. In order to provide a more informed view, a market company profiles include Business Overview, Product / Service Offerings, SWOT Analysis, Segment & Total Revenue, Gross Margin and % Market Share. This report explores market definitions, overview, classification, segmentation, inclusive of market type and applications followed by product specifications, manufacturing initiatives, pricing structures, raw material sourcing and supply chain analysis.

Geographical Breakdown: Regional level analysis of the market, currently covering North America, Europe, China & Japan

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Key Points Covered in Tissue Engineering Market Report:

Chapter 1, to describe Definition, Specifications and Classification of Global Tissue Engineering, Applications of, Market Segment by Regions;Chapter 2, to analyze the Manufacturing Cost Structure, Raw Material and Suppliers, Manufacturing Process, Industry Chain Structure;Chapter 3, to display the Technical Data and Manufacturing Plants Analysis of , Capacity and Commercial Production Date, Manufacturing Plants Distribution, Export & Import, R&D Status and Technology Source, Raw Materials Sources Analysis;Chapter 4, to show the Overall Market Analysis, Capacity Analysis (Company Segment), Sales Analysis (Company Segment), Sales Price Analysis (Company Segment);Chapter 5 and 6, to show the Regional Market Analysis that includes United States, EU, Japan, China, India & Southeast Asia, Segment Market Analysis (by Type);Chapter 7 and 8, to explore the Market Analysis by Application Major Manufacturers Analysis;Chapter 9, Market Trend Analysis, Regional Market Trend, Market Trend by Product Type, Market Trend by Application;Chapter 10, Regional Marketing Type Analysis, International Trade Type Analysis, Supply Chain Analysis;Chapter 11, to analyze the Consumers Analysis of Global Tissue Engineering by region, type and application;Chapter 12, to describe Tissue Engineering Research Findings and Conclusion, Appendix, methodology and data source;Chapter 13, 14 and 15, to describe Tissue Engineering sales channel, distributors, traders, dealers, Research Findings and Conclusion, appendix and data source.

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Tissue Engineering Market Size Predicted to Increase at a Positive CAGR of 15.6% during the forecast period from 2022 to 2030 - Digital Journal

The global 3D bioprinting market (henceforth referred to as the market studied) was valued at USD 586.13 million in 2019, and it is expected to reach USD 1949.94 million by 2025, registering a CAGR of 21.91%, during the period of 2022-2031. The global 3D bioprinting market is expected to experience growth, owing to its revolutionary breakthrough in healthcare and pharmaceutical industries.

3D bioprinting is an emerging field represented by various biologically applied deposition and assembling systems, which include direct writing, photolithography, microstamping, extrusion, laser writing, stereolithography, electro-printing, microfluidics, and inkjet deposition. Healthcare is one of the major markets where 3D bioprinting has been bringing a seismic change. This is majorly because of the increasing investments in healthcare applications, such as model and organ prototyping and production throughout the globe, and growing innovations in healthcare through 3D printing.

The primarily growing bioprinting applications include 3D bioprinted tissue and hair follicles, as they are very beneficial to cosmetics companies, especially in Europe, where animal testing for cosmetics was banned in 2013. For a cosmetic company, the advantage will be the ability to economically and ethically test products (i.e., not on animals) across varying skin types, for more accurate results.

Several companies have been undergoing extensive R&D expenditures to boost the market growth by making significant product developments and innovations. For instance, Organovo, a medical laboratory and research company, has been at the front of the R&D of 3D bioprinting in the country.

The market studied has been viewing strategic partnerships and collaborations as a lucrative path towards the expansion of the market presence, by leveraging the various skills and expertise of the other players in the market. For instance, in December 2019, CELLINK, a Swedish 3D bioprinter manufacturer collaborated with microgravity manufacturer, Made In Space., with the aim to identify 3D bioprinting development opportunities for the International Space Station (ISS).

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Key Market Trends

Drug Testing to Hold Major Share

3D bioprinters are of the highest importance for drug testing and clinical trial applications expected to drastically reduce the need for animal trials (therefore not only being ethically beneficial but also being cost-effective).

Traditionally, clinical trials for new drug development involved testing on animals with artificially induced affected tissues. With the advent of 3D bioprinting, drug developers may be able to address the complications associated with human clinical trials of new drugs, by identifying them in a short period (since these can be tested with human-like 3D printed tissues). Thus, they are expected to reduce the losses incurred during late-stage failures.

The regulatory agency of the United States Food and Drug Administration has already started to consider integrating alternatives for drug safety and efficacy assessment, providing scope for the market. Companies, like Organovo (US-based) were instrumental in the development of 3D bioprinter able to develop liver and kidney tissue for drug discovery applications.

In April 2019, NIBIB-funded researchers at the University of Minnesota (UMN) created a new, dynamic 3D Bioprinted tumor model in a laboratory dish to screen anticancer drugs and study the spread of cancer and primary site tumor growth.

Asia-Pacific Anticipated to Witness Fastest Growth

Asia-Pacific is the fastest-growing market for 3D bioprinting, mainly due to a strong existing consumer base that will drive demand for 3D bioprinting, huge scope of 3D printing in medical services, increasing R&D for 3D printing, and government support and tax incentives.

The Chinese researchers have made rapid advancements in 3D-bioprinting technology, such as Liquid-in-liquid printing method. This method involves liquid polymers that create a stable membrane where they meet. The resulting liquid structures, as they claim, can hold their shape for as long as 10 days, before they begin to merge. Using this new technique, they were able to print an assortment of complex shapes. This has further been leading the path to print complex 3D-printed tissues made, by including living cells.

The Japanese government estimates that the regenerative medicine industry is presumed to grow to JPY 1 trillion by 2030, the New Energy and Industrial Technology Development Organization (NEDO) expects that emerging and innovative technologies, such as 3D bioprinting, may lead the market in near future.

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In July 2019, the Government of India (GoI) also agreed to collaborate with the United States in the research and development of 3D bioprinting regenerative medicine. This co-operation involves the exchange of faculty members and students for the exchange of scientific ideas/information and technologies, as well as the joint use of scientific infrastructure for research, especially in the areas of 3D bioprinting.

The Government of South Korea announced plans to invest about USD 37 million to boost the development of 3D printing across the country. The countrys Ministry of Science announced plans to spend a considerable portion of its budget on a plethora of 3D applications, in order to strengthen its competitiveness and ability to meet the demand.

Competitive Landscape

The 3D bioprinting market is highly competitive and consists of several major players. In terms of market share, few of the major players currently dominate the market. These major players with a prominent share in the market have been focusing on expanding their customer base across foreign countries. These companies are leveraging strategic collaborative initiatives to increase their market share and increase their profitability.

In January 2020, 3D Systems and CollPlant Biotechnologies announced a joint development agreement to play a pivotal role in advancing and accelerating innovations in the biomedical industry. This alliance may be focusing on the development of regenerative medicines with the help of 3D bioprinting.

In September 2020, CELLINK launched its newly developed BIO X6, which is a six-printhead bioprinting system that allows the combination of various materials, tools, and cells. It also offers an intelligent exchangeable printhead system backed by CELLINKs patented Clean Chamber Technology. This product may help to enhance advanced research and clinical applications.

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3D Bioprinting Market Size In 2022 with CAGR of 21.91% : Industry Size Estimation, Revenue Analysis, Worldwide Research by Fastest Growing Companies -...

Individuals with hard-to-control type 1 diabetes can stabilise their blood sugars by following a long-term cell transplant programme, a new study shows.

Academics have praised the islet transplant treatment after outlining how it benefits people with severely low or high blood sugar levels.

Islets are groups of cells which produce insulin, a hormone that helps to control the flow of energy from food.

In people with type 1 diabetes, the immune system destroys the cells within islets, so those with the condition must inject themselves with insulin.

New data from Canada has disclosed how this cell-based therapy impacts survival rates, insulin independence and defences against dangerously low blood sugars.

Over the duration of the 20-year programme, more than 250 individuals underwent 700 islet transplants at the University of Alberta Hospital.

According to the researchers, the programme is extremely effective and transforms the lives of many people living with type 1 diabetes.

Lead academic Dr James Shapiro, professor of surgery at the University of Alberta and Canada Research Chair in regenerative medicine and transplant surgery, said: Weve shown very clearly that islet transplantation is an effective therapy for patients with difficult-to-control type 1 diabetes. This long-term safety data gives us confidence that we are doing the right thing.

Dr Peter Senior, Charles A. Allard Chair in Diabetes Research and director of the Alberta Diabetes Institute at the university, added: This data shows really strong proof that cell-based therapies can deliver a meaningful and transformative impact for people with diabetes.

We are delivering something which all other treatments for diabetes dont deliver theres a comfort, a predictability, a stability to blood sugar levels that dont exist with anything else.

More than 60 per cent of islet infusion recipients were still on insulin a year after following the programme, the study has revealed.

After five years, this reduced to 32 per cent, while after 20 years this dropped down to eight per cent, the results have reported.

Dr Shapiro added: Being completely free of insulin is not the main goal. Its a big bonus, obviously, but the biggest goal for the patient when their life has been incapacitated by wild, inadequate control of blood sugar and dangerous lows and highs is being able to stabilise. It is transformational.

Islet transplant as it exists today isnt suitable for everybody, but it shows very clear proof of concept that if we can fix the supply problem and minimise or eliminate the anti-rejection drugs, we will be able to move this treatment forward and make it far more available for children and adults with type 1 and type 2 diabetes in the future.

Click here to access this study.

Link:
'Life-changing' cell-based therapy beneficial for those with hard-to-control type 1 diabetes - The Diabetes Times

The key players in the global Bone Cement market in terms of value include DePuy DJO Global, Inc., Arthrex, Inc., Tecres S.p.A., Heraeus Holding GmbH, Teknimed, Synthes (The Orthopedics Company of Johnson & Johnson), Zimmer Biomet, Stryker Corporation, Smith & Nephew, and Cardinal Health Inc.

The latest market report published by Credence Research, Inc. Global Bone Cement Market: Growth, Future Prospects, and Competitive Analysis, 2016 2028. The Global Bone Cement Market generated revenue of around USD 982.5 million in 2021 and is anticipated to grow a CAGR of over 5.50% during the forecast period from 2022 to 2028 to reach around USD 1354.71 million in 2028. While, cumulative growth opportunity presented by the global Bone Cement is around USD 372.21 million during 2022 to 2028.

Bone cement, also referred to as Plexiglas or polymethylmethacrylate (PMMA), is frequently used in orthopaedic, dental, and trauma surgeries for implant fixation. Usually, artificial joints are attached with bone cement. By bridging the gap between the bone and the artificial body part, it fills the function of an elastic zone. Bone cement is used to anchor artificial joints. The tight mechanical interlock between the prosthesis and the uneven bone surface is what makes bone cement work; it lacks intrinsic adhesive properties. Commercially, bone cement is offered as calcium phosphate cement and glass polyalkenoate (ionomer) cement (GPC) (CPC). Due to its low mechanical strength, calcium phosphate cementwhich is biocompatible and absorbableis primarily used in cranial and maxillofacial surgeries.

Increased occurrences of periodontics among young people, rising need for orthopedic bone cement and casting materials, particularly among the geriatric population, and a growing geriatric population are some of the primary drivers driving the worldwide bone cement markets growth. The increased prevalence of osteoporosis, rising need for arthroplasty, and a considerably growing older population are the factors driving market expansion. The rising number of sports injuries and road traffic accidents is also driving the expansion of the bone cement industry. Furthermore, advancements in the field of regenerative medicine are fueling market expansion. The growing incidence of hip, knee, and other bone replacement procedures around the world is predicted to propel the bone cement industry. On the other hand, rising unfavorable compensation scenarios, growing costs, and wide clinical data requirements for the introduction of new bone cements are among the major factors impeding market growth over the forecast period.

The global Bone Cement market is segmented into type, application, and Geography. Based on type the market is categorized Polymethyl Methacrylate (PMMA) Cement, Calcium Phosphate Cement (CPC), Glass Polyalkenoate Cement (GPC) and Others. On the basis of application, the market is segmented into Arthroplasty, Kyphoplasty and Vertebroplasty. On the basis of geography, the market is segmented as North America, Europe, Asia Pacific, Latin America and the Middle East, and Africa.

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Table Of Content:

1. Preface

1.1. Report Description

1.1.1. Purpose of the Report

1.1.2. Target Audience

1.1.3. USP and Key Offerings

1.2. Research Scope

1.3. Research Methodology

1.3.1. Phase I Secondary Research

1.3.2. Phase II Primary Research

1.3.3. Phase III Expert Panel Review

1.3.4. Approach Adopted

1.3.4.1. Top-Down Approach

1.3.4.2. Bottom-Up Approach

1.3.5. Assumptions

1.4. Market Segmentation

2. Executive Summary

2.1. Market Snapshot: Global Bone Cement Market

3. Market Dynamics & Factors Analysis

3.1. Introduction

3.1.1. Global Bone Cement Market Value, 2016-2028, (US$ Bn)

3.2. Market Dynamics

3.2.1. Key Growth Trends

3.2.2. Major Industry Challenges

3.2.3. Key Growth Pockets

3.3. Attractive Investment Proposition,2021

3.3.1. Type

3.3.2. Application

3.3.3. Geography

3.4. Porters Five Forces Analysis

3.4.1. Threat of New Entrants

3.4.2. Bargaining Power of Buyers/Consumers

3.4.3. Bargaining Power of Suppliers

3.4.4. Threat of Substitute Types

3.4.5. Intensity of Competitive Rivalry

3.5. Value Chain Analysis

4. Market Positioning of Key Players, 2021

4.1. Company market share of key players, 2021

4.2. Top 6 Players

4.3. Top 3 Players

4.4. Major Strategies Adopted by Key Players

5. COVID 19 Impact Analysis

5.1. Global Bone Cement Market Pre Vs Post COVID 19, 2019 2028

5.2. Impact on Import & Export

5.3. Impact on Demand & Supply

6. North America

6.1. North America Bone Cement Market, by Country, 2016-2028(US$ Bn)

6.1.1. U.S.

6.1.2. Canada

6.1.3. Mexico

6.2. North America Bone Cement Market, by Type, 2016-2028(US$ Bn)

6.2.1. Overview

6.2.2. Polymethyl Methacrylate (PMMA) Cement

6.2.3. Calcium Phosphate Cement (CPC)

6.2.4. Glass Polyalkenoate Cement (GPC)

6.2.5. Others

6.3. North America Bone Cement Market, by Application, 2016-2028(US$ Bn)

6.3.1. Overview

6.3.2. Arthroplasty

6.3.3. Kyphoplasty

6.3.4. Vertebroplasty

6.3.5. Others

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Related Reports:

Bone Fixation Plate Market

Bone Marrow Transplantation Market

About Us

Credence Research is a worldwide market research and counseling firm that serves driving organizations, governments, nonlegislative associations, and not-for-benefits. We offer our customers some assistance with making enduring enhancements to their execution and understand their most imperative objectives. Over almost a century, weve manufactured a firm extraordinarily prepared to this task.

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Bone Cement Market Size Estimated to Reach USD 1354.71 MN By 2028, With 5.5 % CAGR: Credence Research - Digital Journal

Press release 1 July 2022

Research Collaboration with Kyoto University in Biomaterial-assisted

Regenerative Medicine using HGF

Kringle Pharma, Inc. (Head office located in Osaka, Japan; President & CEO, Kiichi Adachi; "KRINGLE"), a late clinical-stage biopharmaceutical company, today announces signing of collaborative research agreement with Kyoto University (Located in Kyoto, Japan) focused on applied research combining HGF with biomaterials to create novel regenerative medicine products.

Professor Yasuhiko Tabata, Laboratory of Biomaterials, Institute for Life and Medical Sciences, Kyoto University, is a renowned leading scientist in the field of regenerative medicine utilizing biomaterials. Professor Tabata and KRINGLE jointly initiate applied research on regenerative medicine based on the biomaterial technologies and KRINGLE's recombinant human HGF (development code: KP-100). The goal of this collaboration is to develop biomaterial-assisted regenerative medicine using HGF for the treatment of incurable diseases.

Regenerative medicine is a treatment method that promotes the functional regeneration of tissues and organs by administering cells and other materials prepared outside the body to the damaged tissues or organs. In recent years, research on stem cell transplantation therapy using iPS cells and other stem cells has been attracting attention. The importance of biomaterials in regenerative medicine has been recognized, and intensive research is being conducted not only on their function as a scaffold for transplanted cells, but also on the combined use of drug delivery systems (DDS) technology and drugs to efficiently reach target cells, improve stability in vivo, and control drug release.

HGF is an endogenous biological protein responsible for the regeneration and repair of tissues and organs. Previous studies revealed that HGF administration resulted in functional recovery in animal models for various diseases. KRINGLE has been developing KP-100 for incurable diseases such as acute spinal cord injury, ALS, vocal fold scar and acute kidney injury. Through this collaboration, KRINGLE aims to maximize the therapeutic potential of HGF, expanding target indications over the existing pipelines, eventually providing novel therapies for patients suffering from incurable diseases.

About Hepatocyte Growth Factor (HGF)

HGF was originally discovered as an endogenous mitogen for mature hepatocytes. Subsequent studies demonstrated that HGF exerts multiple biological functions based on its mitogenic, motogenic, anti-apoptotic, morphogenic, anti-fibrotic and angiogenic activities, and facilitates regeneration and protection of a wide variety of organs including not only liver, but also kidneys, heart, lungs, nerve tissues and skin.

About Biomaterials

Biomaterials are materials that are used in the body by itself or in combination with biological components including cells, proteins, nucleic acids or bacteria. Biomaterial technologies (e.g., scaffold to promote the formation of biological tissues, DDS technology to enhance the biological activity of proteins and genes that have cell differentiation and proliferation effects, etc.) can be utilized to enhance the regenerative and repair

capabilities of biological tissues.

Source: Yasuhiko Tabata, "Regenerative medicine in terms of DDS technology - Regenerative therapy and regenerative research," (2015)

About Kringle Pharma, Inc. https://www.kringle-pharma.com/en/

Kringle Pharma is a late clinical-stage biopharmaceutical company established in December 2001 to develop novel biologics based on HGF. Currently, Kringle's clinical programs with recombinant human HGF are: 1) Phase 3 ongoing in acute spinal cord injury, 2) investigator-initiated Phase 2 ongoing in ALS, 3) Phase 2/3 in preparation in vocal fold scar, and 4) Phase 1a and 1b completed in acute kidney injury. Kringle's mission is to contribute to societal and global healthcare through the continued research, development and commercialization of HGF drug for patients suffering from incurable diseases.

For more information, please contact

Daichika Hayata

Director, Pharmaceutical Development

Kringle Pharma, Inc.

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Kringle Pharma : Research Collaboration with Kyoto University in Biomaterial-assisted Regenerative Medicine using HGF - Marketscreener.com

St. Paul, M.N.

--News Direct--

Vascudyne, Inc., a biotechnology trailblazer in regenerative medicine, announced today that it was awarded a grant from Regenerative Medicine Minnesota for a project titled "Development of a Peripheral Nerve Wrap Using Regenerative Engineering Tissue Tube".

The one-year, $100,000 grant will commence in June 2022 and utilize Vascudyne's TRUE Tissue technology that is unique and 100% natural. The TRUE Tissue allogeneic biomaterial is completely biological, non-immunogenic and regenerates by the host. Nothing synthetic or artificial is ever used in the manufacturing process, in contrast to other regenerative medicine soft tissue biomaterials made from synthetic polymer-based scaffolds that slowly degrade in the body and may lead to adverse immune response.

Chronic nerve compression is one of the most common peripheral nerve injuries with carpal tunnel syndrome being the most common type of nerve compression affecting 3-6% of the general population. Tissues isolated from the patient are used in surgery but have shortcomings such as donor site morbidity, limited availability, and risk of surgical complications.

"We are excited to expand our TRUE Tissue platform technology to other soft tissue applications such as nerve repair," said Rick Murphy, Vascudyne's Chief Operating Officer. "The exquisite regenerative properties of our 100% biological biomaterial combined with its non-immunogenic properties and off-the-shelf availability are a perfect fit for addressing the challenging nerve injury applications. Demonstrating these benefits in a preclinical nerve injury model will greatly advance the field of peripheral nerve injury and offer a promising alternative to current treatments that often lack complete and functional nerve repair."

Vascudyne has prioritized commercialization of its cardiovascular products and recently announced the first clinical results of its regenerative vascular conduit for hemodialysis access. "While we are initially focusing on cardiovascular applications for our TRUE Tissue technology, we continue research and development efforts in other soft tissue applications such as nerve injury repair," stated Dr. Zeeshan Syedain, Vascudyne's Chief Scientific Officer. "This grant from the Regenerative Medicine Minnesota will help accelerate our preclinical animal study timeline and demonstrate safety and efficacy of the TRUE Tissue technology as a peripheral nerve wrap."

Vascudyne licensed its proprietary TRUE Tissue technology developed by world renowned tissue engineering leader Robert Tranquillo, PhD, Distinguished McKnight University Professor, and his colleagues from the University of Minnesota in 2017.

TRUE Tissue products are not available for commercial sale.

About Vascudyne

Headquartered in the heart of Medical Alley in Minnesota, Vascudyne is on a mission to improve patient care with regenerative biomaterials that are inspired by nature. Vascudyne, a privately held company founded in 2014, uses the TRUE Tissue technology to develop TRUE to Nature biomaterials for soft tissue repair and replacement. For more information, please visit https://www.vascudyne.com/.

About TRUE Tissue Technology

TRUE Tissue is developed from cells isolated from donor tissue and is 100% biological. There are no synthetic materials or chemical fixation used, and implanted tissues are completely cell-derived and acellular. The TRUE Tissue technology can be readily shaped into tubes, sheets, and other geometries making it suitable for many soft tissue applications, is mechanically comparable to native tissues, and is a ready to use, off-the-shelf allograft.

Forward Looking Statements

This announcement contains forward-looking statements. Such statements may include, without limitation, statements identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential" or similar expressions. These statements relate to future events or Vascudyne's clinical development programs, reflect management's current beliefs and expectations and involve known and unknown risks, uncertainties and other factors that may cause Vascudyne's actual results, performance or achievements to be materially different. Vascudyne undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future presentations or otherwise, except as required by applicable law.

Vascudyne, Inc.

Sandy Williams, Marketing Director

+1 952-412-5975

swilliams@vascudyne.com

Vascudyne, Inc.

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Vascudyne Receives BioBusiness Award from Regenerative Medicine Minnesota for Treatment of Nerve Injury - - Benzinga

ByDanny Jacobs

Two faculty teams with members affiliated with the Johns Hopkins Whiting School of Engineering have received grants for their research through the Cohen Translational Engineering Fund.

The fund, made possible by a generous commitment from Sherry and Neil Cohen '83, serves as a catalyst for translating cutting-edge research into practice by providing faculty with critical early funding. The grant is designed to help researchers move their work out of the laboratory and toward commercializationthe process includes developing patents, obtaining materials and supplies, and building prototypes.

"We are pleased to continue helping Whiting School of Engineering faculty advance their cutting-edge research," says Neil Cohen, who is also the founder of venture capital firm Emerald Development Managers. "Previous grantees are already realizing promising developments in their work, and we look forward to seeing this year's grantees further strengthen the pipeline of innovation and entrepreneurship coming out of the Whiting School of Engineering and Johns Hopkins."

Grantees receive a maximum of $100,000 for a nine-month project. Since its inception eight years ago, the Cohen Fund has awarded more than $1.3 million for 28 projects. Among the past recipients are LifeSprout, a regenerative medicine company; Ready Robotics, creator of operating software for industrial automation; Galen Robotics, which is developing steady-hand surgical robots; and Vectech, which is developing a surveillance system of cloud-connected smart mosquito traps.

A panel of experienced researchers, engineers, startup entrepreneurs, and business executives reviewed presentations from the five faculty finalists for this year's award in March.

"This year's recipients reflect the wide breadth of research done at the Whiting School and the key role that many Whiting faculty members play in cross-school collaborations," says Brian Stansky, senior director of FastForward. "Once again, the generous funding provided by Sherry and Neil Cohen will help multiple faculty members meaningfully move their academic research toward commercialization. We look forward to working with both recipient teams over the course of these projects and beyond."

The grantees are detailed below.

Principal investigator: Mark Foster, associate professor, Department of Electrical and Computer Engineering

The pitch: Monitoring 3D laser printing in real time to save manufacturers time and money

Laser powder bed fusion, or LPBF, is a 3D-printing process that uses high-powered lasers to rapidly melt and solidify metal powder into 3D objects such as heat sinks (which move heat away from a hot device) and jet fuel nozzles. The process, known as additive manufacturing, often leads to microscopic, random defects in the object, costing manufacturers time and money to replace parts.

Image caption: Mark Foster

Foster, working with Milad Alemohammad, a postdoctoral fellow, and Steven Storck, a senior materials scientist at the Johns Hopkins University Applied Physics Laboratory, has created novel, high-speed spectroscopic sensors that can be integrated into LPBF printing machines and provide real-time data so operators can correct defective layers as the object is being made.

The team developed the sensor at the request of collaborators at JHU APL's additive manufacturing center. They have received $250,000 in seed funding sponsored by the Army Research Laboratory and enabled by the MEDE+ AI-M program at the Hopkins Extreme Materials Institute, and they have taken part in the National Science Foundation's I-Corps program through Johns Hopkins Technology Ventures.

The team plans to use the funding to continue to refine its sensors as well as develop a user dashboard.

Principal investigators: Danielle Gottlieb Sen, director of pediatric cardiac surgery at Johns Hopkins Medicine and Youseph Yazdi, assistant professor of biomedical engineering and executive director of the Center for Bioengineering Innovation and Design

The pitch: Detecting a potentially deadly disease in infants and premature babies before symptoms appear

Image caption: Danielle Gottlieb Sen

Necrotizing enterocolitis, or NEC, is an often-fatal intestinal disease that disproportionately affects infants with congenital heart disease as well as premature babies. Treatment of NEC is most effective when started early, but currently, a diagnosis is confirmed only after symptoms appear, at which point substantial damage may already have occurred. Treatment can involve extended hospital stays or surgeries, and NEC can cause lifelong complications.

Image caption: Youseph Yazdi

Gottlieb Sen and Yazdi, working with Ellen Roche, on faculty at the Institute for Medical Engineering & Science at the Massachusetts Institute of Technology, are developing a noninvasive device that goes on a baby's belly to monitor intestinal ischemia, inadequate blood flow that is a known biomarker of the onset of NEC. The device, which will connect to bedside monitors, uses near-infrared spectroscopy, or NIRS, sensors to continuously record, store, and transmit data.

The team is building NIRS sensors that account for differences in pediatric patient size, and they are mapping pediatric intestine and vascular beds to ensure monitoring specificity. Their work could serve as a platform to develop accurate NIRS sensors for others tissues and diseases.

The team plans to use the funding to build the device as well as obtain results to start the process of receiving device approval from the U.S. Food and Drug Administration.

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Meet the newest grantees of the Cohen Translational Engineering Fund - The Hub at Johns Hopkins