VALENCIA, Calif., MELBOURNE, Australia & AURORA, Colo.--(BUSINESS WIRE)--AVITA Medical (ASX: AVH, NASDAQ: RCEL), a regenerative medicine company with a technology platform positioned to address unmet medical needs in therapeutic skin restoration, and scientists at the Gates Center for Regenerative Medicine at the University of Colorado School of Medicine announced today a preclinical research collaboration to establish proof-of-concept and explore further development of a spray-on treatment of genetically modified cells for patients with epidermolysis bullosa (EB), with potential applicability to other genetic skin disorders.
The partnership will pair AVITA Medicals patented and proprietary Spray-On Skin Cells technology and expertise with the Gates Centers innovative, patent-pending combined reprogramming and gene-editing technology to allow cells to function properly. Under the terms of the Sponsored Research Agreement (SRA), AVITA Medical retains the option to exclusively license technologies emerging from the partnership for further development and commercialization. The Gates Center team is further supported by the EB Research Partnership in New York, the Los Angeles-based EB Medical Research Foundation, the London-based Cure EB Charity, and government grants in a collaborative effort to rapidly develop and translate this technology to the clinic for meaningful impact on patient lives.
The Gates Center is a leader in developing therapeutic approaches for genetic skin diseases. Researchers at the Gates Center have developed a powerful new approach for treating genetic skin disorders and improving the lives of patients with epidermolysis bullosa, said Dr. Mike Perry, Chief Executive Officer of AVITA Medical and adjunct professor at the Gates Center for Regenerative Medicine. We look forward to collaborating with the team at the Gates Center on the expanded use of our technology. This agreement marks an important milestone in AVITAs mission to harness the potential of regenerative medicine to address unmet medical needs across a broad range of dermatological indications, including genetic disorders of the skin.
Epidermolysis bullosa is a group of rare and incurable skin disorders caused by mutations in genes encoding structural proteins resulting in skin fragility and blistering, leading to chronic wounds and, in some sub-types, an increased risk of squamous cell carcinoma or death. There are no approved curative therapies, and current treatment is palliativefocused primarily on pain and nutritional management, itching relief, wound care, and bandaging.
Its very exciting to partner with AVITA Medical to help advance our epidermolysis bullosa program, said Director of the Gates Center for Regenerative Medicine Dr. Dennis Roop. Were looking forward to exploring a novel approach to delivering gene-edited skin cells to patients that addresses current treatment challenges.
We believe that Spray-On Skin Cells technology combined with our genetically corrected cells has the potential to be game changing in the treatment of this disease. This combination could reduce time to treatment, lower manufacturing complexity, reduce costs, and improve patient outcomes, said Dr. Ganna Bilousova, assistant professor of dermatology, who is a co-principal investigator on this research program.
ABOUT THE CHARLES C. GATES CENTER FOR REGENERATIVE MEDICINE
The Charles C. Gates Center for Regenerative Medicine was established in 2006 with a gift in memory of Denver industrialist and philanthropist Charles C. Gates, who was captivated by the hope and benefit stem cell research promised for so many people in the world. The Gates Center aspires to honor what he envisionedby doing everything possible to support the collaboration between basic scientific researchers and clinical faculty to transition scientific breakthroughs into clinical practice as quickly as possible.
Led by Founding Director Dennis Roop, Ph.D., the Gates Center is located at the University of Colorados Anschutz Medical Campus, the largest new biomedical and clinical campus in the United States. Operating as the only comprehensive Stem Cell Center within a 500-mile radius, the Gates Center shares its services and resources with an ever-enlarging membership of researchers and clinicians at the Anschutz Medical Campus, which includes University of Colorado Hospital, Childrens Hospital Colorado, and the Veterans Administration Medical Center, as well as the Boulder campus, Colorado State University, the Colorado School of Mines, and business startups. This collaboration is designed to draw on the widest possible array of scientific exploration relevant to stem cell technology focused on the delivery of innovative therapies in Colorado and beyond.
ABOUT THE UNIVERSITY OF COLORADO SCHOOL OF MEDICINE
Faculty at the University of Colorado School of Medicine work to advance science and improve care. These faculty members include physicians, educators, and scientists at University of Colorado Hospital, Childrens Hospital Colorado, Denver Health, National Jewish Health, and the Denver Veterans Affairs Medical Center. The school is located on the Anschutz Medical Campus, one of four campuses in the University of Colorado system. To learn more about the medical schools care, education, research, and community engagement, visit its web site.
ABOUT AVITA MEDICAL LIMITED
AVITA Medical is a regenerative medicine company with a technology platform positioned to address unmet medical needs in burns, chronic wounds, and aesthetics indications. AVITA Medicals patented and proprietary collection and application technology provides innovative treatment solutions derived from the regenerative properties of a patients own skin. The medical devices work by preparing a REGENERATIVE EPIDERMAL SUSPENSION (RES), an autologous suspension comprised of the patients skin cells necessary to regenerate natural healthy epidermis. This autologous suspension is then sprayed onto the areas of the patient requiring treatment.
AVITA Medicals first U.S. product, the RECELL System, was approved by the U.S. Food and Drug Administration (FDA) in September 2018. The RECELL System is indicated for use in the treatment of acute thermal burns in patients 18 years and older. The RECELL System is used to prepare Spray-On Skin Cells using a small amount of a patients own skin, providing a new way to treat severe burns, while significantly reducing the amount of donor skin required. The RECELL System is designed to be used at the point of care alone or in combination with autografts depending on the depth of the burn injury. Compelling data from randomized, controlled clinical trials conducted at major U.S. Burn Centers and real-world use in more than 8,000 patients globally, reinforce that the RECELL System is a significant advancement over the current standard of care for burn patients and offers benefits in clinical outcomes and cost savings. Healthcare professionals should read the INSTRUCTIONS FOR USE - RECELL Autologous Cell Harvesting Device (https://recellsystem.com/) for a full description of indications for use and important safety information, including contraindications, warnings, and precautions.
In international markets, our products are marketed under the RECELL System brand to promote skin healing in a wide range of applications, including burns, chronic wounds, and aesthetics. The RECELL System is TGA-registered in Australia and received CE-mark approval in Europe.
To learn more, visit http://www.avitamedical.com.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This letter includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as anticipate, expect, intend, could, may, will, believe, estimate, look forward, forecast, goal, target, project, continue, outlook, guidance, future, other words of similar meaning and the use of future dates. Forward-looking statements in this letter include, but are not limited to, statements concerning, among other things, our ongoing clinical trials and product development activities, regulatory approval of our products, the potential for future growth in our business, and our ability to achieve our key strategic, operational and financial goal. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Each forward- looking statement contained in this letter is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, the timing of regulatory approvals of our products; physician acceptance, endorsement, and use of our products; failure to achieve the anticipated benefits from approval of our products; the effect of regulatory actions; product liability claims; risks associated with international operations and expansion; and other business effects, including the effects of industry, economic or political conditions outside of the companys control. Investors should not place considerable reliance on the forward-looking statements contained in this letter. Investors are encouraged to read our publicly available filings for a discussion of these and other risks and uncertainties. The forward-looking statements in this letter speak only as of the date of this release, and we undertake no obligation to update or revise any of these statements.
- FDA touts advanced manufacturing to address Covid-19 shortfalls - Endpoints News - August 5th, 2020
- Cancer Research Institute Awards $30.2 Million in Grants and Fellowships to Support Basic and Clinical Research in Immunology and Cancer Immunotherapy... - August 5th, 2020
- RenovaCare Appoints Dr. Lydia M. Evans to Its Board of Directors and Increases Board Membership - GlobeNewswire - August 4th, 2020
- MediVet Biologics Rebrands as Ardent Animal Health - Benzinga - August 3rd, 2020
- Church Point Police Captain dies from COVID-19 complications: 'Go and protect the heavens, my dearest friend' - The Advocate - August 1st, 2020
- BMT survivor study finds significant breast cancer risk in young women who received total body irradiation - The Mix - July 31st, 2020
- Hyperbaric Oxygen Therapy Can Enhance Cognition in Healthy Older Adults - PsychCentral.com - July 29th, 2020
- The surprising recovery with stem cells of 26 COVID-19 patient in Hidalgo - Explica - July 29th, 2020
- Johnny Tabaie is proud to announce the most powerful Stem Cell Therapy - Press Release - Digital Journal - July 29th, 2020
- COVID-19 Fibroblast Based Cell Therapy Candidate Shown to Reduce Lung Scarring in Aggressive Animal Model - El Paso Inc. - July 25th, 2020
- 'Self-eating' process of stem cells may be the key to new regenerative therapies - 7thSpace Interactive - July 23rd, 2020
- R3 International Now Including Exosomes with Stem Cell Therapy Program for Autism in Mexico - PR Web - July 23rd, 2020
- CAR T-Cell Therapy Offers Potential Solution for Relapse in MCL, But With Toxicity Risk - Targeted Oncology - July 22nd, 2020
- Fine-tuning adoptive cell therapy for advanced cancers - Newswise - July 22nd, 2020
- Global Cart Cell Therapy Market To Grow At A CAGR of 29.4% With The Emergence Of Immunotherapies In Medical Treatment - GlobeNewswire - July 22nd, 2020
- In Remission for 10 Years: Long-term Data on CAR-T Therapy - Medscape - July 21st, 2020
- MRFR predicts an Upsurge in the Leukemia Therapeutics Market valuation to USD 10.7 billion by 2023 - Jewish Life News - July 21st, 2020
- Cannabis Found Effective to Treat Sickle Cell Disease Pain - The Weed Blog - July 20th, 2020
- End of Palestinian Authority coordination with Israel in response to annexation threat: decision already impacting medical referrals - occupied... - July 20th, 2020
- Addiction Treatment Market Survey Report 2020 Stats and Forecasts to 2026 - Cole of Duty - July 18th, 2020
- 13 Promising Covid Treatments Emerging from Israel - The Jewish Voice - July 15th, 2020
- New Clues from Fruit Flies about the Critical Role of Sex Hormones in Stem Cell Control - Newswise - July 15th, 2020
- Impact of Covid-19 on Preimplantation Genetic Testing Market is Projected to Grow Massively in Near Future - Cole of Duty - July 13th, 2020
- Covid-19 Update : Cord Stem Cell Banking Market 2020 Outlook and Deep Study of Top Key Players Cryo-Save AG, Lifecell, StemCyte India Therapeutics... - July 13th, 2020
- Coronavirus updates: California to release 8,000 inmates; masks 'only way' to prevent another shutdown, Texas Gov. says - USA TODAY - July 10th, 2020
- BCLI: KOL Event Gives Overview of the use of NurOwn in Alzheimer's Disease; Raising Valuation to $25/Share - Zacks Small Cap Research - July 10th, 2020
- Hammond police officer jumps at chance to donate stem cells - The Times of Northwest Indiana - July 8th, 2020
- Joint Study by Sunway University and Harvard Medical School Shows Gene Therapy Can Advance Cancer Treatment - QS WOW News - July 8th, 2020
- Astex Pharmaceuticals, Taiho Oncology, and Otsuka Pharmaceutical Announce FDA and Health Canada Approval of INQOVI (Decitabine and Cedazuridine)... - July 8th, 2020
- HRMC to open hematology and oncology clinic - The Ottawa Herald - June 29th, 2020
- Gift of Life, Root and Rutgers Researchers Launch COVID-19 Study - Patch.com - June 29th, 2020
- Obituaries in the Sunday and Monday Courier, June 28-29 - Waterloo Cedar Falls Courier - June 29th, 2020
- Efforts at coronavirus vaccines and treatments abound in the Bay Area - San Francisco Chronicle - June 23rd, 2020
- New Preclinical Data Demonstrates Immune-Enhancing Effects of Triple I/O Combination Therapy with BeyondSpring's Plinabulin - GlobeNewswire - June 23rd, 2020
- [Herald Interview] Spinning cord blood into stem cell therapies - The Korea Herald - June 22nd, 2020
- Children's Hospital Los Angeles Ranked No. 1 Children's Hospital in the Western U.S., No. 5 Nationally for Second Straight Year - Business Wire - June 22nd, 2020
- The BCG a Tuberculosis Vaccine Boosts Immune Cells and Reduces Risk of Other Infections - Gilmore Health News - June 18th, 2020
- FDA Approves Second Biomarker-Based Indication for Merck's KEYTRUDA (pembrolizumab), Regardless of Tumor Type - The Baytown Sun - June 17th, 2020
- UCLA receives nearly $14 million from NIH to investigate gene therapy to combat HIV - Mirage News - June 17th, 2020
- Orca Bio Emerges With Nearly $300 Million to Transform Allogeneic Cell Therapy - Stockhouse - June 17th, 2020
- UChicago working on COVID-19 saliva test Pandemic energizes health care unions Rehab hospital to be built in Libertyville - Crain's Chicago Business - June 17th, 2020
- UofL researchers to study health impacts of vaping, nicotine on youth - The Lane Report - June 14th, 2020
- Houston coronavirus updates: What you need to know about June 14 - msnNOW - June 14th, 2020
- Be The Match Appoints Amy Ronneberg as Chief Executive Officer - Southernminn.com - June 11th, 2020
- A&B could become premier stem cell producer - Antigua ... - June 11th, 2020
- Nick Cordero Had a 'Rocky Night' After He 'Spiked a Fever' During His Hospitalization, Wife Says - PopCulture.com - June 11th, 2020
- R3 International Now Offering New Stem Cell Therapy Program for Lyme Disease in Mexico - Yahoo Finance - June 10th, 2020
- Nick Cordero's Wife Says His COVID-19 Recovery Is 'Going in the Right Direction' - countryliving.com - June 10th, 2020
- Memorial Sloan Kettering - Hackensack Meridian Health Partnership Announces Funding for Inaugural Immunology Research Collaboration Projects - The... - June 10th, 2020
- Longeveron Announces Japanese Approval of Clinical Trial for Treatment of Aging Frailty With Longeveron's Stem Cells - Yahoo Finance - June 3rd, 2020
- Human Mesenchymal Stem Cells (hMSC) Market investigated in the latest research - WhaTech Technology and Markets News - June 3rd, 2020
- Longeveron Announces Japanese Approval of Clinical Trial for Treatment of Aging Frailty With Longeveron's Stem Cells | DNA RNA and Cells | News... - June 2nd, 2020
- CSL Behring and Seattle Children's Research Institute to Advance Gene Therapy Treatments for Primary Immunodeficiency Diseases - P&T Community - June 2nd, 2020
- New Leaders at ASTCT and CIBMTR Provide Guidelines and Measures for Combating COVID-19 and Protecting Transplant Patients - Business Wire - June 2nd, 2020
- Exceptional stem cell science on tap for ISSCR 2020 Virtual June 23-27, 2020 - 7thSpace Interactive - June 2nd, 2020
- In situ repair abilities of human umbilical cordderived mesenchymal stem cells and autocrosslinked hyaluronic acid gel complex in rhesus monkeys with... - May 23rd, 2020
- UH studying use of convalescent plasma to improve health of COVID-19 patients - Crain's Cleveland Business - May 23rd, 2020
- COVID-19: Recommendations for Treating MS and Related... : Neurology Today - LWW Journals - May 21st, 2020
- New hybrid embryos are the most thorough mixing of humans and mice yet - Science News - May 20th, 2020
- Hotel in Spain requires two negative Covid-19 tests to check in with a free antibody test during your stay - CNBC - May 20th, 2020
- Sumit Dewanjee, MD, is being recognized by Continental Who's Who - PRNewswire - May 7th, 2020
- Results From Pivotal Phase 2/3 Study of Emapalumab in Patients With Primary HLH Published in New England Journal of Medicine - BioSpace - May 7th, 2020
- COVID-19 Impact and Recovery Analysis | Global Cell Isolation Market 2020-2024 | Evolving Opportunities with Agilent Technologies Inc. and Becton,... - May 7th, 2020
- Stem Cell Alopecia Treatment Market Detailed Analysis of Current Industry Figures With Forecasts Growth by 2026 - 3rd Watch News - May 7th, 2020
- AMC to use stem cell therapy in treating graft-versus-host disease - Korea Biomedical Review - May 7th, 2020
- Drumming class finds a new rhythm with creative connections - Yes! Weekly - May 7th, 2020
- Drumming class finds a new rhythm with creative connections - Wake Forest University News Center - May 5th, 2020
- Insights on the Worldwide Cell Expansion Industry to 2027 - Analysis and Forecasts - Yahoo Finance UK - May 5th, 2020
- These 5 Houston-area research institutions have bright minds at work to battle COVID-19 - InnovationMap - May 5th, 2020
- GCC Condemns Israeli Plans to Annex Parts of the West Bank - Asharq Al-awsat English - May 2nd, 2020
- Jerusalem residents concerned Israel is changing their residency rights - Arabnews - May 2nd, 2020
- Four UTSW Researchers Named to The National Academy of Sciences - D Magazine - May 1st, 2020
- CHMP Grants Positive Opinion for DARZALEX (daratumumab) Subcutaneous Formulation for the Treatment of Patients with Multiple Myeloma - Yahoo Finance - May 1st, 2020
- Verify the URL - InnovationMap - May 1st, 2020
- Houston banking exec shares tips for keeping online information secure amid COVID-19 threats - InnovationMap - May 1st, 2020
- Trials and Tribulations: Neurology Research During COVID-19 - Medscape - April 30th, 2020
- Into the Lungs and Beyond - Harvard Medical School - April 30th, 2020
- Five UC San Diego Professors Elected to National Academy of Sciences - UC San Diego Health - April 29th, 2020
- Suffering from ED? Discover how our combined treatments of Hormone Balancing and FDA Approved Acoustic Wave Pulse Therapy Ends Your ED - Magazine of... - April 29th, 2020
- BrainStorm-Cell Therapeutics to Announce First Quarter Financial Results and Provide a Corporate UpdateThursday, May 7, 2020, 8:30 am EDT - BioSpace - April 29th, 2020