Category Archives: Regenerative Medicine

As described in Section 3033 of the 21st Century Cures Act, a drug is eligible for regenerative medicine advanced therapy (RMAT) designation if:

Based on FDAs interpretation of Section 506(g) of the Federal Food, Drug, and Cosmetic Act (as added by Section 3033 of the 21st Century Cures Act), certain human gene therapies and xenogeneic cell products may also meet the definition of a regenerative medicine therapy. For more information on FDAs definition of regenerative medicine therapies, refer to the Guidance for Industry, Expedited Programs for Regenerative Medicine Therapies for Serious Conditions.

The request for RMAT designation must be made either concurrently with submission of an Investigational New Drug application (IND) or as an amendment to an existing IND. We will not grant a RMAT designation if an IND is on hold or is placed on hold during the designation review.

You may submit a request for RMAT designation to:

Food and Drug AdministrationCenter for Biologics Evaluation and ResearchOffice of Tissues and Advanced TherapiesDocument Control Center10903 New Hampshire AvenueWO71, G112Silver Spring, MD 20993-0002

If the RMAT designation request is submitted to your IND as an amendment, the cover letter should specify that the submission contains a REQUEST FOR REGENERATIVE MEDICINE ADVANCED THERAPY DESIGNATION in bold, uppercase letters. If the request is submitted with an initial IND, the cover letter should specify that the submission contains both an INITIAL INVESTIGATIONAL NEW DRUG SUBMISSION and REQUEST FOR REGENERATIVE MEDICINE ADVANCED THERAPY DESIGNATION in bold, upper case letters.

No later than 60 calendar days after receipt of the designation request, the Office of Tissues and Advanced Therapies (OTAT) will notify the sponsor as to whether RMAT designation has been granted. If OTAT determines that the RMAT designation request was incomplete or that the drug development program does not meet the criteria for RMAT designation, OTAT will include a written description of the rationale for such determination.

10/06/2021

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Regenerative Medicine Advanced Therapy Designation | FDA

1. Packing More Punch for Regenerative Medicine and Cell and Gene Therapies  Inside Precision Medicine
2. See Whats Next For The Regenerative Medicine Field -- BioRestorative Intends to Lead The Pack In Stem C  Benzinga
3. Regenerative Medicine Market to Observe Strong Development by 2028  Digital Journal
4. Global Regenerative Medicine market Size In 2022 [32.2% CAGR] : latest market plans and business eve  PharmiWeb.com
5. Ausbiotech 2022: Korea looking to accelerate regenerative medicine market  BioWorld Online
6. View Full Coverage on Google News

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Packing More Punch for Regenerative Medicine and Cell and Gene Therapies - Inside Precision Medicine

1. Brush Up: Tissue Engineering and Regenerative Medicine  The Scientist
2. Top 3 grants in regenerative medicine: August 2022  RegMedNet
3. Regenerative Medicine is Predicted to Grow at CAGR of 21.2% During the Forecast Period | Leading Players: 3M,  openPR
4. Regenerative Medicine Market Is Anticipated To Grow At A Near 8.8% CAGR  Taiwan News
5. Global Regenerative Medicine Market Size And Forecast | Organogenesis Inc., Osiris Therapeutics Vericel Corporation, Stryker Corporation and NuVasive, Inc. Sioux City Catholic Globe  Sioux City Catholic Globe
6. View Full Coverage on Google News

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Brush Up: Tissue Engineering and Regenerative Medicine - The Scientist

Carlsbad, CA, Oct. 11, 2022 (GLOBE NEWSWIRE) -- The Alliance for Regenerative Medicine (ARM), the leading international advocacy organization dedicated to realizing the promise of regenerative medicines and advanced therapies, today announced the election of its 2023 Officers, Executive Committee, and Board of Directors.

The announcement comes as ARM kicks off its 2022 Cell & Gene Meeting on the Mesa, a gathering of 1,800 leaders in the cell and gene therapy sector.

The Executive Committee and Board of Directors oversee the formation and execution of ARMs strategic priorities and focus areas. These distinguished leaders are instrumental to ARMs leadership of the sector.

We are delighted to welcome our 2023 Officers, Executive Committee members and Board of Directors, said ARMs Chief Executive Officer Timothy D. Hunt. The pipeline of transformative cell and gene therapies will continue to accelerate in 2023, creating more urgency to ensure that patients have access to life-changing medicines. ARMs Board of Directors and our more than 450 member organizations globally are vital to this mission.

ARM 2023 Officers:

Devyn Smith, Ph.D. Chief Executive Officer, Arbor Biotechnologies (Chair)

Dave Lennon, Ph.D. Chief Executive Officer, Satellite Bio (Vice Chair)

Alison Moore, Ph.D. Chief Technology Officer, Allogene Therapeutics (Secretary)

Chris Vann Senior Vice President, Chief Operations Officer, Autolus (Treasurer)

ARM 2023 Executive Committee:

Devyn Smith, Ph.D. Chief Executive Officer, Arbor Biotechnologies (Chair)

Dave Lennon, Ph.D. Chief Executive Officer, Satellite Bio (Vice Chair)

Alison Moore, Ph.D. Chief Technology Officer, Allogene Therapeutics (Secretary)

Chris Vann Senior Vice President, Chief Operations Officer, Autolus (Treasurer)

Bob Smith, MBA Senior Vice President, Global Gene Therapy Business, Pfizer

Miguel Forte, M.D., Ph.D. Chief Executive Officer, Bone Therapeutics

Laura Sepp-Lorenzino, Ph.D. Executive Vice President and Chief Science Officer, Intellia Therapeutics

Arthur Tzianabos, Ph.D. Chair of the Board, Homology Medicines

ARM 2023 Board of Directors

* New to the Board for 2023

* Faraz Ali, MBA Chief Executive Officer, Tenaya Therapeutics

Robert Ang, MBBS, MBA Chief Executive Officer, Vor Biopharma

* Catherine Bollard, M.B.Ch.B., M.D. Director of the Center for Cancer and Immunology Research, Childrens National Hospital and The George Washington University

Amy Butler, Ph.D. President, Biosciences, Thermo Fisher

Bradley Campbell, MBA President and Chief Executive Officer, Amicus Tx

Miguel Forte, M.D., Ph.D. Chief Executive Officer, Bone Therapeutics

* Christine Fox President, Novartis Gene Therapies

Bobby Gaspar, M.D., PhD. Chief Executive Officer, Orchard Therapeutics

Jerry Keybl, Ph.D. Senior Director, Cell & Gene Therapy, MilliporeSigma

Brett Kopelan Executive Director, Debra of America

* Ann Lee, Ph.D. Chief Technical Officer, Prime Medicine

Dave Lennon, Ph.D. Chief Executive Officer, Satellite Bio

Tim Lu, M.D., Ph.D. Chief Executive Officer and Co-Founder, Senti Biosciences

John Maslowski, M.S. Chief Commercial Officer, Forge Biologics

Chris Mason, M.D., Ph.D. Founder & Director, Ori Biotech

Debra Miller Founder & Chief Executive Officer, CureDuchenne

Alison Moore, Ph.D. Chief Technology Officer, Allogene

Adora Ndu, PharmD, J.D. Chief Regulatory Officer, BridgeBio

Susan Nichols President & Chief Executive Officer, Propel BioSciences

Emile Nuwaysir, Ph.D. Chief Executive Officer, Ensoma

Karah Parschauer, J.D. Chief Legal Officer, Ultragenyx

* Jacob Petersen Corporate Vice President and Head of Stem Cell Research & Development, Novo Nordisk

Louise Rodino-Klapac, Ph.D. Executive Vice President, Head of Research & Development, Chief Scientific Officer, Sarepta Therapeutics

Jeff Ross, Ph.D. Chief Executive Officer, Miromatrix Medical

* Alberto Santagostino Senior Vice President, Head of Cell & Gene Technologies, Lonza

Laura Sepp-Lorenzino, Ph.D. Executive Vice President & Chief Scientific Officer, Intellia Therapeutics

R.A. Session, MBA, MSF President, Founder & Chief Executive Officer, Taysha Tx

Curran Simpson, M.S. Chief Operations and Chief Technical Officer, REGENXBIO

Bob Smith, MBA Senior Vice President, Global Gene Therapy, Pfizer

Devyn Smith, Ph.D. Chief Executive Officer, Arbor Biotechnologies

Arthur Tzianabos, Ph.D. Chair of the Board, Homology Medicines

Christopher Vann Senior Vice President & Chief Operating Officer, Autolus Therapeutics

Kristin Yarema, Ph.D. Chief Commercial Officer, Atara Bio

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The Alliance for Regenerative Medicine Announces Election of 2023 Officers, Executive Committee, and Board of Directors - GlobeNewswire

By: QC Kinetix | 0Shares 159Reads

October 10, 2022 // Franchising.com // JACKSON, Tenn. - QC Kinetix recently opened in Jackson and offers one of the most advanced regenerative medicine protocols in Western Tennessee.

Brian and Andrea Weed are the husband-and-wife business team bringing regenerative medicine to Jackson with their new clinic. The couple used to work in healthcare on the non-clinical side of the industry - Brian as the CEO and Andrea in sales. Now the two are looking to help improve lives through regenerative medicine. They have three sons: one having been in combat in the Afghanistan war and two who played college sports. All have sustained an injury or two.

We have seen our fair share of sports injuries and we know the toll physically and emotionally it takes on when they are forced to take time off, says Andrea. With regenerative medicine treatments, they can bounce back quicker.

The Weeds set up an exceptional team to treat the community, that includes their clinic manager Danielle Moore. Her background is in kinesiology, where she worked in physical therapy for several years and then in personal training before finding regenerative medicine.

I am always looking for ways to naturally treat ailments. When I found we can use our own body to repair itself through regenerative medicine I knew I needed to bring awareness to it, says Moore. We are already having patients who say they are feeling better compared to the first day they walked through our clinics doors.

QC Kinetix uses all-natural biologic protocols to stimulate the body to repair or heal its own damaged tissues and joints. Its an alternative to surgery, NSAIDs, and pain pills that mask the pain but dont repair the problem. For patients seeking relief from pain due to musculoskeletal injury, chronic joint pain, or hip, knee, back, or shoulder pain, regenerative procedures are the next frontier for treatment.

Former Dallas Cowboys great and NFL MVP Emmitt Smith is the official spokesperson for QC Kinetix. He knows firsthand the need for innovative chronic pain treatments that help people get back to their active lifestyles. It used to be only elite athletes like Smith had access to regenerative medicine treatments, but rapid growth and innovation in the field have made the treatments accessible to everyone.

So many Jackson residents will benefit from these treatments, from those who have retired to anyone enjoying an active lifestyle, as well as athletes and industry workers who cant afford a long surgery recovery, says Weed.

Regenerative medicine can be used to address a wide variety of health conditions. The Weeds and their team are excited to begin providing hair restoration treatment options for men and women in the near future.

Scott Hoots, CEO of Charlotte-based QC Kinetix, is confident that the Weeds and their team will be a tremendous asset to the QC Kinetix franchise.

Brian and Andrea are ideal QC Kinetix franchisees, says Hoots. Their background in business and sports combined with their love of regenerative medicine makes the Weeds a perfect candidate for us. We cant wait to see their business grow, and more Western Tennessee residents see the benefits of these treatments firsthand.

QC Kinetix is a type of concierge medicine, which continues to grow in popularity. There are none of the difficulties of dealing with insurance companies. Patients pay cash and get a very high level of care and service with state-of-the-art treatments. Every patient receives quality time with their medical provider and a customized plan of treatment based on their individual diagnosis and condition.

QC Kinetix Jackson operates at 3014 Greystone Square, Jackson, TN 38305.

SOURCE QC Kinetix

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Husband and Wife Team Bring Regenerative Medicine Clinic to Jackson - Franchising.com

Around 800 BHF runners took to the streets of the British capitalfor the iconic 2022 TCS London Marathon on Sunday 2nd October.

As the 2022 Charity of the Year, our runners have raised nearly 2 million so far, with further donations expected. This will help fund lifesaving science into regenerative medicine, a cutting-edge field of research that has the power to unlock a cure for heart failure.

Among ourmarathon runners was Professor Sanjay Sinha from the University of Cambridge, who completed the event in around four hours fifty minutes.

Professor Sanjay is leading ground-breaking research behind the Heart Healing Patch. Made of stem cells, the patch could be applied to the heart to help repair damage caused by a heart attack and could help save and improve the lives of millions worldwide affected by heart failure.

Nearly a million people in the UK are currently living with heart failure. Poignantly, Sanjays running number for the marathon was 17,000 which is how many people are diagnosed with heart failure in the UK each month.

After crossing the finish line Professor Sanjay Sinha, our Senior Clinical Research Fellow at the University of Cambridge, said: Taking part in the 2022 TCS London Marathon for the British Heart Foundation (BHF), was such a huge challenge. It was my first marathon and an absolutely incredible experience. The atmosphere on the day was electric and I wouldnt have made it round the last few miles without the support from the crowds, who were amazing.

"I am proud to know that by doing this, together with over 800 other BHF runners, weve helped the BHF to continue to fund pioneering research into regenerative medicine including the development of our Heart Healing Patch, which could save and improve the lives of millions of people worldwide affected by heart failure.

The money raised by the BHFs runners and supporters at this years event could be truly transformative and help us carry out the first clinical trials of the patch in patients. I want to thank every single person who has already donated.

Our Chief Executive Dr Charmaine Griffiths said: It was a truly heart-warming and inspirational day cheering on all our Team BHF runners, made even more special with the BHF being the 2022 TCS London Marathons charity of the year.

The hundreds of runners who took part in the iconic TCS London Marathon 2022 have helped us to turbo charge our pioneering research into regenerative medicine, which includes the development of a Heart Healing Patch, which could save and improve the lives of millions of people worldwide affected by heart failure.

From all those who fundraised, donated, volunteered and supported Team BHF on the day, you have played your part in helping to get our ground-breaking research over the finish line even faster and we cannot thank you enough.

Applications for the 2023TCS London Marathon are now open.

Help to make the Heart Healing Patch a reality

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Hundreds run for regenerative medicine research at the 2022 TCS London Marathon - British Heart Foundation

Study of Therapeutic to Restore Hearing Aims to Show Speech Perception Improvements in Individuals with Noise-Induced or Permanent Sudden Sensorineural Hearing Loss

Company Aligned with FDA on Speech Perception Primary Endpoint

Readout Expected in Q1 2023

LEXINGTON, Mass., October 12, 2022--(BUSINESS WIRE)--Frequency Therapeutics, Inc. (Nasdaq: FREQ), a clinical-stage regenerative medicine company focused on developing therapeutics to activate a persons innate potential to restore function, today announced that it has completed enrollment of its placebo-controlled Phase 2b study of FX-322 in adults with acquired sensorineural hearing loss (SNHL). The FX-322-208 study, which enrolled 142 individuals, is designed to show improvement in a pre-specified measure of speech perception. The Company plans to release study data in the first quarter of 2023.

"I am very pleased with our teams execution of this study for the first potential treatment to restore hearing for those with SNHL. The 208 study was rigorously designed to ensure the stability of an individuals hearing prior to entering the trial and to exclusively enroll those with the types hearing loss where we observed the strongest hearing improvement in prior FX-322 studies. FX-322 continues to have a favorable safety profile and we are aligned with FDA on the primary speech perception endpoint. With a successful outcome of this single-dose study, our intent is to advance the program into Phase 3 trials," said David L. Lucchino, Frequencys chief executive officer.

Mr. Lucchino continued: "We are grateful to all the study volunteers, clinicians and site staff for their time and commitment to this trial. We believe the high level of interest from patients and healthcare providers in this study further demonstrates the need for a novel, disease modifying hearing loss treatment to expand the standard of care for the millions of individuals with sensorineural hearing loss."

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FX-322-208 Study Design

FX-322-208 is a prospective, randomized, double-blinded, placebo-controlled, multi-center Phase 2b study designed to evaluate the efficacy of a single administration of FX-322 on speech perception in subjects aged 18-65 with hearing loss associated with either noise-induced or permanent idiopathic sudden SNHL. The study enrolled 142 participants, exceeding the original enrollment target of approximately 124, and is being conducted at 28 clinical sites across the US.

The Company previously aligned with the US Food and Drug Administration (FDA) on the use of the specific speech perception primary endpoint. With improved speech perception, individuals may hear words more clearly, a critical unmet need for individuals with hearing loss. The FX-322-208 study is powered at 80% (significance level of 0.05) to observe a statistically significant and clinically meaningful improvement in speech perception at day 90 following dosing, with study responders defined as individuals exceeding the upper 95% confidence interval in the speech perception test. The Company has not publicly disclosed the specific test used for the primary endpoint to maximize the rigor of the study and mitigate potential bias.

During the study, subjects participate in a range of audiologic exams, including pure-tone audiometry, word recognition in quiet, word recognition in noise, the Tinnitus Functional Index (TFI), as well as multiple patient-reported outcome measures including Frequencys proprietary patient reported outcome instrument (RADIAL) in acquired SNHL. All subjects are required to have a documented audiogram from at least six months prior to screening and most patients are evaluated over a 270-day period following dosing. The studys rigorous design includes a lead-in phase with multiple baseline measures. Subjects with instability of baseline tests are disqualified from participation in the study. Study audiometry testing sessions are recorded and monitored by third party audiologists to ensure consistency and identify any anomalies related to how tests were conducted.

In prior studies, the Company observed the greatest concentration of speech perception improvements in individuals with permanent sudden or noise-induced sensorineural hearing loss in the moderate to lower severe hearing loss range. These learnings informed the design and inclusion criteria for the FX-322-208 study. More than 200 individuals have been dosed with a single injection of FX-322 in prior or ongoing studies, and the drug candidate has continued to exhibit a favorable safety profile with no drug-related serious adverse events.

About Sensorineural Hearing Loss

Sensorineural hearing loss is the most common form of hearing loss, typically resulting from damage to sensory hair cells in the cochlea. These cells convert sound waves to signals sent to the brain which are interpreted as speech and sound. Sensory hair cells are lost due to chronic noise exposure, aging, certain viral infections or exposure to drugs that are toxic to the ear. This type of hearing loss impacts around 40 million individuals in the U.S. alone.

About Frequency Therapeutics

Frequency Therapeutics is leading a new category in regenerative medicine that aims to restore human function first in hearing loss and then in multiple sclerosis by developing therapeutics that activate a persons innate regenerative potential within the body through the activation of progenitor cells. Frequencys hearing research focuses on cochlear restoration and auditory repair, and its lead asset, FX-322, is a small-molecule combination product candidate that is the first to show statistically significant and clinically meaningful hearing improvements in clinical trials for sensorineural hearing loss. Frequency is also following early restorative signals in MS to develop medicines with the same underlying regenerative science being brought to hearing loss.

Headquartered in Lexington, Mass., Frequency has an ex-U.S. license and collaboration agreement with Astellas Pharma Inc. for FX-322, as well as additional collaboration and licensing agreements with academic and nonprofit research organizations including Massachusetts Eye and Ear, Mass General Brigham, the Massachusetts Institute of Technology, and the Scripps Research Institute.

For more information, visit http://www.frequencytx.com and follow Frequency on Twitter @Frequencytx.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the timing and design of the Phase 2b study (FX-322-208), including the timing of results and the ability of design features to reduce bias, the commencement of any future FX-322 trials, the interpretation and implications of the results and learnings of other FX-322 clinical studies, the treatment potential of FX-322, estimates of the size of the hearing loss population, the acceptance by the FDA of particular endpoints in the Companys trials, and the potential application of the progenitor cell activation (PCA) platform to other diseases.

These forward-looking statements are based on managements current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the impact of COVID-19 on the Companys ongoing and planned clinical trials, research and development and manufacturing activities, the Companys business and financial markets; the Company has incurred and will continue to incur significant losses and is not and may never be profitable; the Companys need for additional funding to complete development and commercialization of any product candidate; the Companys dependence on the development of FX-322; the unproven approach of the PCA platform and the inability to identify additional potential product candidates; the lengthy, expensive and uncertain process of clinical drug development and regulatory approval; the Companys limited experience successfully obtaining marketing approval for and commercializing product candidates; the results of earlier clinical trials not being indicative of the results from later clinical trials; differences between preliminary or interim data and final data; adverse events or undesirable side effects; disruptions at the FDA and other regulatory agencies; failure to identify additional product candidates; new or changed legislation; failure to maintain Fast Track designation for FX-322 and such designation failing to result in faster development or regulatory review or approval; ability to seek and receive Breakthrough Therapy designation for FX-322; the Companys ability to enroll and retain patients in clinical trials; costly and damaging litigation, including related to product liability or intellectual property or brought by stockholders; dependence on Astellas Pharma Inc. for the development and commercialization of FX-322 outside of the United States; misconduct by employees or independent contractors; reliance on third parties, including to conduct clinical trials and manufacture product candidates; compliance with changing laws and regulations, including healthcare and environmental, health, data privacy and safety laws and regulations; failure to obtain, maintain and enforce protection of patents and other intellectual property rights covering product candidates; security breaches or failure to protect private personal information; attracting and retaining key personnel; and the Companys ability to manage growth.

These and other important factors discussed under the caption "Risk factors" in the Companys Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 9, 2022 and its other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent managements estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, it disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing the Companys views as of any date subsequent to the date of this press release.

View source version on businesswire.com: https://www.businesswire.com/news/home/20221012005144/en/

Contacts

Investor:Carlo Tanzi, Ph.D.Kendall Investor Relationsctanzi@kendallir.com 617-914-0008

Media:Frequency TherapeuticsEmail: media@frequencytx.com

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Frequency Therapeutics Completes Enrollment of Phase 2b Study of FX-322 for the Treatment of Sensorineural Hearing Loss - Yahoo Finance

EDEN PRAIRIE, MN, Oct. 12, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire SANUWAVE Health, Inc. (OTCPK: SNWV), a leading provider of next-generation wound care products, is excited to announce that three abstracts highlighting the role of the companys dermaPACE system in clinical cases were accepted to the Poster Presentation Hall at the upcoming 2022 Fall Symposium on Advanced Wound Care (SAWC) hosted by HMP Global. The conference is one of wound cares most esteemed events and will take place at Caesars Palace, Las Vegas, Nevada from October 13-16, 2022.

The following clinical cases, which examine the use of dermaPACE in patients with chronic, complex, and challenging wounds, will be presented.

1.) The Use of Non-Invasive Extracorporeal Shockwave Therapy (ESWT) Pulsed Acoustic Cellular Expression (PACE) System In Complex Wounds Related To Erythromelalgia, A Rare Skin Condition.

Dr. Marcelo de Oliveira e Silva, HOSPITAL CAXIAS DOR RIO DE JANEIRO general and plastic surgeon, UNIFESP Medical School Professor, Pontifical Catholic University (PUC) Carlos Chagas Medical Graduate Institute, coordinator, Quinta D'Or Hospital, specialist, evaluator, Brazilian Society of Plastic Surgery (SBCP), preceptor, Ivo Pitanguy Institute.

Dr. Paulo Roberto Castelleti Liborio Da Costa Brazilian Society of Plastic Surgery and Ivo Pitanguy Institute. Practices at Salgado Filho Municipal Hospital (Trauma Surgery,General Surgery) and Duque de Caxias DOr Hospital as Plastic Surgeon

2.) Extracorporeal Shockwave Therapy (ESWT) PACE-Technology: Pilot Trial to Treat Mixed Etiologies Lower Leg Ulcer in a Mobile Setting; When All Else Failed

John David Thomas, MD, FAPWCA Medical Director Solutions Medical Group, PLLC, Houston, TX. DIRECTOR OF WOUND CARE: Signature Home Health Baytown, TX; The Heights of North Houston Spring, TX; Park Manor, The Woodlands The Woodlands, TX; IPR Healthcare Systems Houston, TX; Crimson Heights Humble, TX. SPEAKER: Kerecis Omega3 Fish Skin technology. FORMER-SPEAKER: Acelity / KCI San Antonio, TX; Tissue Regenix Woundcare Inc. San Antonio, TX

3.) Extracorporeal Shockwave Therapy (ESWT) Pace-Technology: A New Approach to an Old Nemesis-Pyoderma Gangrenosum

Dr Perry Mayer; Medical Director of The Mayer Institute (TMI), Center of Excellence Hamilton Ontario Canada

Representatives from SANUWAVE will be available at SAWC booth #619 in the exhibit hall for inquiries on their ENERGY FIRST product portfolio which includes both dermaPACE and UltraMIST. The companys CEO, Kevin Richardson, and CRO, Jack Schlechtweg, will also be in attendance.

If you are attending the event and would like to schedule some time to meet with a team member, please email the companys Marketing contact Sabrina Ruelle at Sabrina.Ruelle@Sanuwave.com so she can help facilitate a meet time.

Additional information regarding SANWUAVEs product portfolio is available through their website at https://sanuwave.com/

About SANUWAVE

SANUWAVE Health is focused on the research, development, and commercialization of its patented, non-invasive and biological response-activating medical systems for the repair and regeneration of skin, musculoskeletal tissue, and vascular structures.

SANUWAVEs end-to-end wound care portfolio of regenerative medicine products and product candidates help restore the bodys normal healing processes. SANUWAVE applies and researches its patented energy transfer technologies in wound healing, orthopedic/spine, aesthetic/cosmetic, and cardiac/endovascular conditions.

Forward-Looking Statements

This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements relating to financial results and plans for future business development activities and are thus prospective. Forward-looking statements include all statements that are not statements of historical fact regarding intent, belief or current expectations of the Company, its directors or its officers. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond the Companys ability to control. Actual results may differ materially from those projected in the forward-looking statements. Among the key risks, assumptions and factors that may affect operating results, performance and financial condition are risks associated with the regulatory approval and marketing of the Companys product candidates and products, unproven pre-clinical and clinical development activities, regulatory oversight, the Companys ability to manage its capital resource issues, competition, and the other factors discussed in detail in the Companys periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statement.

INVESTOR RELATIONS CONTACT:Investorrelations@Sanuwave.com

2022 GlobeNewswire, Inc., source Press Releases

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SANUWAVE's Energy First Technology to be Featured in 3 Clinical Posters at Upcoming 2022 Fall Symposium on Advanced Wound Care (SAWC) -...

WASHINGTON, Oct. 09, 2022 (GLOBE NEWSWIRE) -- Global 3D bioprinting market was valued at USD 1.5 Billion in 2021 and is projected to attain a value of USD 3.7 Billion by 2028 during the forecast period, 20222028.

Get Sample Copy of This Report: https://www.vantagemarketresearch.com/3d-bioprinting-market-1235/request-sample

As the demand for bioprinting continues to increase, so too does the need for 3D bioprinting. 3D bioprinting market uses small droplets of cell-containing material to create 3D objects in vitro It is useful for creating organs, tissues, and other structures from stem cells or other cells. It is also useful for creating customized implants and drugs.

The growing demand for 3D bioprinting has led to the development of new technologies and processes that make it easier and faster to create 3D objects. As the technology opens up new opportunities for the development of novel medical treatments, 3D bioprinting market growth is being driven by the increasing demand for personalized medicine, as well as the increasing need for customized structures and therapies. With each passing year, the technology is also becoming more affordable and accessible, making it an attractive option for clinical applications. This growth in demand will likely continue to accelerate in the future, as further advances in technology are made.

Top Players in Global 3D Bioprinting Market

Bioprinting is booming as a technology for creating tissue and organ replacement parts. The following are three factors driving demand for this innovative technology:

1. Growing aging population: The worlds population is growing older, which means there will be an increasing need for tissue and organ replacements. Bioprinting can help to fill this need by creating replacement tissues and organs from patient-specific cells. Over 1 billion people are above 60 years old and the number is projected to expand to 1.4 billion by 2050.

2. Declining supplies of natural organs and tissues: The availability of natural organs and tissues for transplantation is dwindling in worldwide 3D bioprinting market due to the increasing incidence of diseases such as Alzheimers, heart failure, and cancer. By using bioprinting, hospitals can create replacement tissues or organs specifically tailored to the needs of individual patients.

3. Progress in regenerative medicine: Regenerative medicine utilizes techniques such as cell therapy and 3D printing to restore function to damaged or diseased tissue. By printing tissue components in a controlled environment, regenerative medicine providers are able to engineers complex tissue constructs that would otherwise be extremely difficult or impossible to achieve.

Immediate Delivery Available | Buy this Premium Research Report@ https://www.vantagemarketresearch.com/buy-now/3d-bioprinting-market-1235/0

Key Findings:

Scope of the Report:

Increasing Adoption of 3D Bioprinting for Engineering Organs

3D bioprinting market is becoming an increasingly important as it enables the rapid, low-cost fabrication of complex components and structures from a variety of biocompatible materials. Vantage Market Research estimates that global spending on 3D printing services will top $2.3 billion by 2025, with growth rates well above the average for all software categories over the same period.

3D bioprinting market currently has niche applications in large-scale industrial production, but its potential to create low-cost human tissues and organs has drawn considerable interest. This is due in part to the high degree of customization that is possible with 3D bioprinting, which can enable precise control over tissue properties, including shape, size, and composition.

Every year, more than 10,000 Americans are put on waiting list for organ transplantation and over 6,000 of them die due to shortage or inability to get the suitable donor. This represents a huge opportunity for the players active in the global 3D bioprinting market to incentivize this revenue opportunity by engineering organ at scale to meet the demand and supply gap.

In fact, bioprinting is an emerging technology that enables the printing of nearly any type of biological tissue and organ. This technology has already been used to create structures such as heart valves, skin patches, and bone implants. However, there are still many applications for bioprinting that have yet to be explored.

3D printing is revolutionizing the way products are designed, and it is now being used to create organs at scale. By printing organs in a customized manner, we can improve the accuracy, predictability, and efficiency of organ printing.

There are many different types of organs that could benefit from bioprinting. Examples of organs that could be printed using this technology include lungs, liver, kidneys, and hearts. With bioprinting, surgeons could potentially print new organs onsite if they become damaged or diseased.

The applications for 3D bioprinting market are endless, and we are just starting to scratch the surface of what this technology can do. We believe that bioprinting will play a major role in engineering organ at scale in the future.

Download Full Report (176 Pages PDF with Insights, Charts, Tables, Figures) at@ https://www.vantagemarketresearch.com/industry-report/3d-bioprinting-market-1235

As per Vantage Market Research, end-users and scientist have started paying attention to making use of 3D bioprinting on large scale thanks to numerous benefits of using 3D bioprinting for organ engineering. Some of the most important benefits include:

Browse market data Tables and Figures spread through 176 Pages and in-depth TOC on "3d Bioprinting Market by Technology (Inkjet-based, Magnetic Levitation, Syringe-based, Laser-based), by Application (Medical, Dental, Biosensors, Consumer/Personal Product Testing), by Region (North America, Latin America, Europe, Asia Pacific) - Global Industry Assessment (2016 - 2021) & Forecast (2022 - 2028)".

Inkjet Technology Generates More than 38% Revenue of Bioprinting Market

3D bioprinting market is becoming popular due to its versatility and ability to create complex tissue structures. However, one disadvantage of 3D bioprinting is the need for magnetic levitation technology in order to print large objects. Inkjet technology is becoming more popular for 3D bioprinting due to its lower printing costs and the ability to print larger objects. Inject technology uses a syringe filled with liquid bioprinters to create realistic tissue constructs.

Some of the biggest advantages of inkjet technology in the global 3D bioprinting market include its low cost and the ability to print complex tissue constructs. Inkjet printers can also produce large quantities of tissue at once, which makes them ideal for medical applications. Deploying inject printers in hospitals could improve the quality of patient care by allowing for faster production of customized tissue constructs. In addition, inject printers could help to reduce the cost of healthcare by reducing the need for magnetic levitation technology.

As per Vantage Market Research, most of the users in the global 3D bioprinting market prefer inkjet bioprinting technology because the printing can be faster and more accurate than magnetic levitation printing. Second, inkjet printing does not require the use of a cold bed or vacuum chamber both of which can be time-consuming and expensive to set up. Third, inkjet printing is less likely to produce errors due to materials incompatibility than magnetic levitation printing. Inkjet printing is also better at reproducing delicate features and patterns than magnetic levitation printing.

Overall, inkjet technology is becoming more popular for 3D bioprinting due to its speed, accuracy, and versatility.

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3D Bioprinting Market Size to Touch Valuation of $1.5 Billion by 2028 | Inkjet Technology Generates More than 38% Revenue of Bioprinting Market -...

COLUMBIA, MO - (NewMediaWire) - October 3, 2022 - via QC Kinetix - QC Kinetix (Columbia) therapies work by stimulating the body's natural healing abilities to heal damaged tissues much faster than normal.

Although unpleasant, pain is many times useful to our bodies as it signals us about body parts that need more attention and care. However, some pain can persist for several weeks, months, or even years and negatively affect the quality of life. In many cases, physicians recommend surgery or prescription medication when other interventions have failed. These recommendations often come unwelcome by patients. Fortunately, technology and innovation have led to the discovery of new, effective ways of treating pain naturally, such as through regenerative medicine.

QC Kinetix (Columbia) treats different types of mild and severe pain naturally using regenerative medicine. The clinic has a wide spectrum of treatments that do not involve surgery or prescription of addictive medications. The therapies work by stimulating the body's natural healing abilities to heal damaged tissues much faster than normal, resulting in pain relief and reduced inflammation. They treat many conditions, including pain in the knee, back, wrist, shoulder, ankle, hip, and other body parts. They also treat pain in the large joints like the legs and small joints like fingers and toes caused by degenerative conditions like arthritis.

The pain control clinic offers customized treatment plans that are tailor-made to meet patients' unique health needs. They begin each treatment with a free consultation that diagnoses patients' conditions and informs on patients' eligibility for regenerative medicine. The consultation involves a thorough analysis of the patient's medical history and may require additional tests to improve accuracy in diagnosis. This is followed by a recommendation of the most useful therapies based on the diagnosis. The physician takes time to explain to patients what regenerative medicine entails and how it can help them to improve their condition.

QC Kinetix (Columbia)'s treatments help relieve many symptoms, including limited joint mobility, swelling, redness, stiffness, bone-on-bone grinding, knee cracking, popping, and many more. The procedures allow patients to get back to their normal lives fast, as they barely have any downtime once the healing process begins. They are minimally invasive, have long-lasting results, and improve function and quality of life. The clinic offers a personalized concierge-level service that provides logistical support to patients receiving treatment at the facility. The physicians keep patients informed every step of the process.

The pain control clinic has an entire division dedicated to providing regenerative medicine for sports and accident injuries. The therapies are ideal for when patients have tried the common advice of rest, ice, compression, and elevation but have failed in rehabilitating the injuries. The clinic steps in to offer a full recovery regime that combines traditional sports injury treatments, rest, and bracing with regenerative medicine for the best possible results. The therapies do not only heal the injured areas but also strengthen the tendons, ligaments, and cartilage to avoid re-injury. Some of the sports injuries they treat include golfer's elbow, torn Meniscus, torn rotator cuff, torn ACL/MCL, and joint and musculoskeletal pain from a thrown-out joint or muscle.

QC Kinetix (Columbia) has invested in advanced technologies and modern equipment that improves paint outcomes. Regenerative medicine remains one of the fastest growing industries, which has led them to adopt a continuous learning culture that allows easy adoption of new, well-researched techniques that match industry trends. Treatments are administered by a team of board-certified physicians with extensive experience in the industry. They use a patient-centered approach that focuses on meeting patient needs and encouraging patient engagement.

The clinic representative had this to say about their services,

"When you visit our facility in Columbia, MO, an orthopedic specialist from our Team Will evaluate you and review your symptoms and previous treatments. QC Kinetix (Columbia) has several regenerative protocols that we use to create customized treatment plans for every patient. Our natural pain treatments can address joint pain and produce long-lasting results."

QC Kinetix (Columbia) is located at 3700 I-70 Dr. SE, Suite 106, Columbia, MO, 65201, US. For consultation and booking, contact their staff by calling (573) 545-5588. Visit the company website to learn more about their Columbia office and their non-surgical regenerative medicine treatments for mild and severe pains and injuries.

Media Contact:

Company Name: QC Kinetix (Columbia)

Contact Person: Scott Hoots

Phone: (573) 545-5588

Address: 3700 I-70 Dr SE, Suite 106

City: Columbia

State: MO

Postal Code: 65201

Country: US

Website: https://qckinetix.com/mid-missouri/

Original post:
QC Kinetix (Columbia) Offers Regenerative Medicine Treatments to Treat Different Types of Physical Pain and Injuries - Yahoo Finance