Category Archives: Regenerative Medicine

Company on track to submit European marketing application in Q4 2022

No additional studies required

PITTSBURGH, Sept. 21, 2022 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the Company) (NASDAQ: KRYS), the leader in redosable gene therapy, announced today that the European Medicines Agency (EMA) Pediatric Committee (PDCO) has adopted a positive opinion on the Pediatric Investigation Plan (PIP) for beremagene geperpavec (B-VEC) for the treatment of dystrophic epidermolysis bullosa.

As part of the regulatory process for the registration of new medicines inEurope, the EMA requires companies to provide a PIP outlining their strategy for investigation of the new medicinal product in the pediatric population. An approved PIP is a prerequisite for filing a Marketing Authorization Application (MAA). The positive opinion is based on the B-VEC non-clinical safety program as well as data from the clinical studies conducted in the US that will be included in the upcoming MAA.

The approval of the PIP provides a clear path forward, and we look forward to working with the EMA and PDCO to bring this important treatment to the European market as soon as possible, said Suma Krishnan, President, Research & Development.

Based on this positive opinion, the Company would be eligible for up to an additional two years of marketing exclusivity in the EU, on top of the ten-year EU market exclusivity after market approval in the EU.

The U.S. Food and Drug Administration (FDA) and EMA have each granted B-VEC orphan drug designation for the treatment of DEB. The FDA has granted B-VEC fast track designation, Regenerative Medicine Advanced Therapy (RMAT) and rare pediatric disease designation for the treatment of DEB. B-VEC is eligible to receive a Priority Review Voucher (PRV) following approval of B-VEC in the US. The EMA granted PRIority MEdicines (PRIME) eligibility for B-VEC to treat DEB.

About Dystrophic Epidermolysis Bullosa (DEB)DEB is a rare and severe disease that affects the skin and mucosal tissues. It is caused by one or more mutations in a gene calledCOL7A1, which is responsible for the production of the protein type VII collagen (COL7) that forms anchoring fibrils that bind the dermis (inner layer of the skin) to the epidermis (outer layer of the skin). The lack of functional anchoring fibrils in DEB patients leads to extremely fragile skin that blisters and tears from minor friction or trauma. DEB patients suffer from open wounds, which leads to skin infections, fibrosis which can cause fusion of fingers and toes, and ultimately an increased risk of developing an aggressive form of squamous cell carcinoma which, in severe cases, can be fatal.

About B-VECB-VEC is an investigational non-invasive, topical, redosable gene therapy designed to deliver two copies of theCOL7A1gene when applied directly to DEB wounds. B-VEC was designed to treat DEB at the molecular level by providing the patients skin cells the template to make normal COL7 protein, thereby addressing the fundamental disease-causing mechanism.

AboutKrystal Biotech, Inc.Krystal Biotech, Inc.(NASDAQ: KRYS) is a pivotal-stage gene therapy company leveraging its proprietary, redosable gene therapy platform and in-house manufacturing capabilities to develop life-changing medicines for patients with serious diseases, including rare diseases in skin, lung, and other areas. For more information please visithttp://www.krystalbio.com, and follow @KrystalBiotech onLinkedInandTwitter.

Forward-Looking StatementsAny statements in this press release about future expectations, plans and prospects for the Company including statements about the timing of the submission of the Companys EMA marketing authorization application and other statements containing the words anticipate, believe, estimate, expect, intend, may, plan, predict, project, target, potential, likely, will, would, could, should, continue, and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties associated with regulatory review of clinical trials and applications for marketing approvals, the availability or commercial potential of product candidates including B-VEC, the sufficiency of cash resources and need for additional financing and such other important factors as are set forth under the caption Risk Factors in the Companys annual and quarterly reports on file with theU.S. Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Companys views as of the date of this release. The Company anticipates that subsequent events and developments will cause its views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. 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.

CONTACT:Investors and Media:Meg DodgeKrystal Biotechmdodge@krystalbio.comSource: Krystal Biotech, Inc.

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Krystal Biotech Receives Positive Opinion from EMA Pediatric Committee on the Pediatric Investigation Plan for B-VEC for the treatment of Dystrophic...

There are several specific nutrients that are involved in female fertility.

Not only is vitamin D important for maintaining the health of your bones and immune system, it may also be involved in fertility. In fact, a small study in Fertility and Sterility found that women with low levels of vitamin D were less likely to conceive compared to those with normal levels. Additionally, a new 2022 meta-analysis found that vitamin D insufficiency and deficiency are associated with miscarriage.

Because vitamin D is found naturally in few food sources and is usually obtained through sun exposure, supplementation may be recommended for those at risk for deficiency.

Folic acid is a B vitamin frequently found in prenatal supplements and fortified foods. Interestingly, folic acid has also been shown to increase the chances of conception, especially in women with irregular cycles.

Eli Reshef, M.D. a reproductive endocrinologist at the Integris Bennett Fertility Institute in Oklahoma City, recommends folic acid supplementation before and during pregnancy to prevent neural tube defects. Specifically, he recommends taking an over-the-counter prenatal supplement that contains at least 800 milligrams of folic acid to support fertility.

The Centers for Disease Control and Prevention (CDC) notes that women of reproductive age should get at least 400 micrograms of folate per day, which can come from a combination of foods or supplements. Leafy greens, legumes and whole grains are all excellent sources of folate.

Selenium is an essential trace mineral needed for the production of hormones and selenoproteins, a type of protein involved in reproductive health. Not only can a deficiency in selenium impair fertility, but it could also increase the risk of miscarriage and other pregnancy complications.

Most people can get enough of this important micronutrient by following a balanced diet that contains selenium-rich foods like meat, fish and eggs. Its also commonly added to multivitamins and prenatal supplements.

Though most well-known for its positive effects on heart health and inflammation, omega-3 fatty acids may have an impact on fertility as well. In fact, studies show these healthy fats can help balance levels of reproductive hormones, regulate menstruation and improve egg quality and implantation.

Enjoying a few weekly servings of fatty fish, such as salmon, sardines or tuna, is a great way to bump up your intake of omega-3 fatty acids. If you dont regularly eat fish, consider taking a supplement sourced from fish oil or algal oil instead.

Coenzyme Q10 (CoQ10) is a type of antioxidant that is produced naturally by the body and found in many foods, including organ meats and fish. Some studies have found that CoQ10 could improve ovarian response and increase rates of conception in women undergoing fertility treatments.

As we age, the bodys production of CoQ10 slows down, making it increasingly challenging to protect eggs from oxidative damage and making it harder for women to conceive, notes Rosmy Barrios, M.D., a regenerative medicine specialist at the IM Clinic in Belgrade, Serbia.

Consider asking your doctor if a CoQ10 supplement might be right for you.

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Fertility Supplements And Vitamins For Women: What You Need To Know - Forbes

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DURHAM, N.C., Sept. 23, 2022 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissues, complex tissue systems, and organs at commercial scale, today announced the presentation of a clinical update on the Human Acellular Vessel (HAV) for the treatment of vascular trauma. The update was presented by Ukrainian surgeon collaborators, Oleksandr Sokolov, M.D., Ph.D. and Vasyl Shaprynskyi, M.D., Ph.D., at the 36th European Society for Vascular Surgery (ESVS) Annual Meeting in Rome, Italy taking place from September 20-23, 2022. Humacytes investigational HAV is designed to offer off-the-shelf availability and resistance to infection and to address long-standing limitations in vascular tissue repair and replacement.

Dr. Shaprynskyi attended the conference in-person and presented a live talk entitled, The First Experience of Using the Human Acellular Vessels in Ukraine for the Treatment of Patients with Vascular Trauma, while Dr. Sokolov spoke virtually from Ukraine and presented, Vascular Trauma Due to Blast Injury. Experience of Dnipro in Russian-Ukrainian War 2022. Drs. Shaprynskyi and Sokolov have been instrumental in establishing their hospitals as medical strongholds during the Russian-Ukrainian war and reported that blast trauma, causing massive tissue damage and infected wounds, accounts for approximately 82% of incoming vascular trauma cases to their medical centers. Trauma to the extremities makes up the majority of injuries, primarily vascular injuries to the lower extremities and shoulders.

Access to the HAV, a biologic conduit, has improved our ability to perform vascular reconstructions by eliminating the need to harvest a venous conduit and saving time required to look for useable vein, assisting greatly in limb salvation. While we continue to face this crisis in our country, partnerships with groups like Humacyte allow us to overcome many limitations in wartime medical care that we previously experienced such as lack of readily available conduits that are resistant to infection, particularly important in the contaminated battlefield setting, said Dr. Shaprynskyi.

Drs. Shaprynskyi and Sokolov reported that surgeons in Ukraine have utilized the HAV to treat patients with a multitude of wartime injuries. Dr. Sokolov provided a clinical update on a patient with a blast injury to the shoulder who received a repair using the HAV. The patient is now beyond three-month follow up without complication. Another patient who suffered a blast injury to the lower leg underwent successful HAV implantation and is now one-month past surgery without complication. Dr. Shaprynskyi reported on a patient with a gunshot wound to the right thigh that was initially treated with a synthetic graft, but ultimately the graft failed due to infection, putting the patient at risk of limb loss. The HAV was used to replace the infected graft, and three months later the HAV is supplying blood flow to the limb and is infection free.

Humacyte worked closely with the Office of International Programs of the U.S. Food and Drug Administration (FDA) and the Ukrainian Ministry of Health to provide the HAV as an additional treatment option to those affected with vascular injury in Ukraine. Humacyte is currently evaluating the HAV in a Phase 2/3 clinical trial in vascular trauma for use as a vascular replacement to restore blood flow to a limb, when saphenous veins or synthetic grafts are not feasible. The HAV has received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. The HAV is an investigational product and has not been approved for sale by the FDA or any international regulatory agency.

Laura Niklason, M.D., Ph.D., Chief Executive Officer of Humacyte, added, As we progress in our humanitarian efforts with the HAV, being able to witness these firsthand patient cases from surgeons in Ukraine is a powerful experience. We set out to develop engineered replacement vessels that are durable, infection-resistant and off-the-shelf to address long-standing limitations in vessel repair, both for civilians and for military personnel. Given our existing designation as a Priority Product from the U.S. Department of Defense, it is gratifying to see that the HAV is helping patients suffering from wartime injuries in Ukraine right now.

About HAVHuman Acellular Vessels (HAV) are investigational engineered off-the-shelf replacement vessels initially being developed for vascular repair, reconstruction and replacement. HAV is intended to overcome long-standing limitations in vessel tissue repair and replacement it can be manufactured at commercial scale, it eliminates the need for harvesting a vessel from a patient, and clinical evidence suggests that it is non-immunogenic, infection-resistant, and can become durable living tissue. The HAV is currently being evaluated in two Phase 3 trials in arteriovenous access and a Phase 2/3 trial for vascular trauma, and has been used in more than 500 patients. Humacytes 6mm HAV for AV access for performing hemodialysis was the first product to receive Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA), and has also received FDA Fast Track designation. The HAV has received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense.

About HumacyteHumacyte, Inc. (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues and complex tissue and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries and chronic conditions. Humacytes initial opportunity, a portfolio of human acellular vessels (HAVs), is currently in late-stage clinical trials targeting multiple vascular applications, including vascular trauma repair, arteriovenous access for hemodialysis, and peripheral arterial disease. Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacytes 6mm HAV for arteriovenous (AV) access for performing hemodialysis was the first product candidate to receive the FDAs Regenerative Medicine Advanced Therapy (RMAT) designation, and has also received FDA Fast Track designation. The HAV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit http://www.Humacyte.com.

Forward-Looking Statements This press release contains forward-looking statements that are based on beliefs and assumptions and on information currently available. In some cases, you can identify forward-looking statements by the following words: may, will, could, would, should, expect, intend, plan, anticipate, believe, estimate, predict, project, potential, continue, ongoing or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, statements regarding the initiation, timing, progress, and results of our preclinical and clinical trials; the anticipated characteristics and performance of our HAVs; our ability to successfully complete, preclinical and clinical trials for our HAVs; the anticipated benefits of our HAVs relative to existing alternatives; the benefits and risks related to our humanitarian efforts in the Ukraine; the anticipated commercialization of our HAVs and our ability to manufacture at commercial scale; the implementation of our business model and strategic plans for our business; our rights and obligations under our partnership with Fresenius Medical Care; the scope of protection we are able to establish and maintain for intellectual property rights covering our HAVs and related technology; the timing or likelihood of regulatory filings and approvals; timing, scope, and rate of reimbursement for our HAVs; and our estimated available market opportunity. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among others, the impact of COVID-19 on Humacytes business, changes in applicable laws or regulations, the possibility that Humacyte may be adversely affected by other economic, business, and/or competitive factors, and other risks and uncertainties, including those included under the header Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2021, filed by Humacyte with the SEC and in future SEC filings. Most of these factors are outside of Humacytes control and are difficult to predict. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. The forward-looking statements in this press release represent our views as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.

Humacyte Investor Contact:Joyce AllaireLifeSci Advisors LLC+1-617-435-6602[emailprotected][emailprotected]

Humacyte Media Contact:Elizabeth Miller, M.D.LifeSci Communications LLC+1-646-791-9705[emailprotected]

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Humacyte Announces Presentations by Ukrainian Surgeons on Use of the Human Acellular Vessel to Treat Wartime Vascular Trauma at the European Society...

Editors note: Each week WRAL TechWire focuses itsInnovation Thursdayreport on companies, people and technology that could make a big difference in our collective future.

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RESEARCH TRIANGLE PARK A Georgia company that specializes in placental biologics is the latest company to establish a presence in Winston-Salems Regenerative Medicine Hub, a growing ecosystem for regenerative medicine research, development and manufacturing.

MIMEDXwill have a laboratory in the RegeneratOR Innovation Accelerator in Winston-Salems Innovation Quarter. There the company will draw on the RegenMed Hubs resources to advance the use of placental technologies in wound care and regenerative medicine.

MIMEDX

As a growth company within the Innovation Accelerator, MIMEDXs research, development and manufacturing teams can collaboratively advance the process efficiencies, biomanufacturing techniques and cutting-edge technologies required to drive innovation in regenerative medicine, specifically in the field of placental biologics, said Robert B. Stein, M.D., Ph.D., president of regenerative medicine and biologics innovation at MIMEDX. This opportunity furthers our ability to create and engineer products that address the unmet clinical needs of patients and providers and advance the next generation of therapies for a broad range of disease states.

The company declined to say how many employees would be based in Winston-Salem or what its future staffing might be.

MIMEDXs presence in the Innovation Accelerator will give it access to strategic partners, biomanufacturing equipment, technologies, industry expertise, talent, a training program and other resources. The Innovation Accelerator supports innovation from research to commercialization for startups, growth companies and established companies developing emerging technologies in regenerative medicine.

We are looking forward to supporting MIMEDX through access to our Test Bed, which really offers up manufacturing-in-a-box solutions to optimize any manufacturing process with state-of-the-art equipment, technologies and resources, said Anthony Atala, M.D., director of theWake Forest Institute for Regenerative Medicine(WFIRM).

WFIRM, a part of Wake Forest School of Medicine,is in theInnovation Quarter, and is the worlds largest institute of its kind. It employs more than 400 scientists and staff who translate scientific discoveries into clinical therapies involving more than 40 different tissues and organs.

Atala, an internationally recognized scientist in regenerative medicine, was recently appointed to MIMEDXs new Regenerative Medicine Scientific Advisory Board, created to guide the companys clinical product pipeline and support its focus on placental biologics innovation.

The Regen Med Hub is a unique distinction and important opportunity for this region, said Nancy Johnston, executive director of the North Carolina Biotechnology Centers Piedmont Triad Office. It is exciting to welcome new companies and see continued growth of this cluster in North Carolina.

MIMEDX joins an expanding roster of about 30 bioscience companies that have established a presence in the Innovation Accelerator to gain access to the regions resources in regenerative medicine.

We believe this region has a lot to offer in terms of helping these companies be successful, and, at the same time, we can advance the regenerative medicine field nationally, said Joshua Hunsberger, Ph.D., chief technology officer of theRegenMed Development Organization(ReMDO), the non-profit organization that runs the Innovation Accelerator.

Gary Green, Ed.D., chief operating officer of ReMDO, added, Addressing manufacturing process optimization for companies in this space is the most critical need to enable these technologies to become widespread, affordable and the next standard of care.

MIMEDX is a placental biologics company and a pioneer in placental tissue engineering. The company has distributed more than two million tissue allografts thus far, primarily to address the needs of patients with acute and chronic non-healing wounds, and is also advancing a late-stage biologics pipeline targeted at decreasing pain and improving function for patients with degenerative musculoskeletal conditions including knee osteoarthritis.

The company, headquartered in Marietta, Ga., was founded in 2008 and has about 800 employees. Its shares are publicly traded on the Nasdaq stock market under the ticker symbol MDXG.

(C) N.C. Biotech Center

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Regenerative Medicine Hub at W-S Innovation Quarter keeps growing with new addition - WRAL TechWire

Brian Cummings, UCI professor of physical medicine & rehabilitation and founding member of the Sue & Bill Gross Stem Cell Research Center, has received a five-year, $2.7 million grant from the California Institute for Regenerative Medicine to establish a training program that supports first-generation and underserved students pursuing careers in public health and regenerative medicine. The Creating Opportunities Through Mentorship and Partnership Across Stem Cell Science program will pair student scholars with faculty mentors. With their tuition covered and a stipend provided during their two years as scholars, the students will learn hands-on lab skills and human cell culture; be introduced to good manufacturing procedures in UCIs new GMP facility; and earn a certificate in clinical research coordination. COMPASS provides the opportunity for students to explore a variety of ways in which their education and research skills can be applied toward improving human health through career paths in the public and private sectors. UCIs COMPASS scholars program will produce a cadre of well-trained individuals who are ready to contribute to the workforce, said Cummings, who is also the School of Medicines associate dean for faculty development. A parallel objective is to foster greater awareness and appreciation of diversity, equity and inclusion in trainees, mentors and other program participants. Administered via the Sue & Bill Gross Stem Cell Research Center, the program will train 25 undergraduate and two-year college transfer students.

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CIRM awards UCI $2.7 million to create regenerative medicine training program - UCI News

Chandler, AZ The focus on healthy living has increased the uptake of sports and other physical activities. However, this comes with an increased incidence of injuries. Traditional methods of managing these pains often involve drugs that may have adverse effects. However, there are safer and more effective alternatives, such as regenerative medicine. Regenerative medicine is a branch of medicine that focuses on the repair and regeneration of tissues. This treatment has shown great promise in treating various conditions, including joint pain, knee pain, back pain, and muscle pain. QC Kinetix (Chandler) is a leading provider of regenerative medicine in Arizona. The pain control clinic has seasoned treatment providers passionate about helping their patients live their best lives.

A healthy back is vital to a persons quality of life. It allows us to do the things we love without pain or worry. When our backs are injured, it can be difficult to return to normal activities. Our team at QC Kinetix (Chandler) is dedicated to helping patients find relief from back pain and regain their quality of life. To learn more about their Chandler office, please visit their website.

Any physical exertion strains the joints, which can result in pain and inflammation. In some cases, the damage to the joints may be too extensive for them to heal independently. Regenerative medicine can help to repair this damage and promote healing. This minimally invasive treatment option is a great alternative to traditional methods, such as surgery, and the Chandler joint pain treatment clinic has set the pace in providing this treatment to patients in Arizona. Their customized approach to each patients condition ensures they get the best possible results.

The knees are some of the most vulnerable joints in the body that are susceptible to injury and pain, and for athletes, knee pain can be a career-ending injury. However, biologic therapies have shown great promise in treating knee injuries. These therapies use the bodys own healing mechanisms to repair the damage. QC Kinetix (Chandler) offers customized biologic therapy treatments designed to enhance the healing process.

The ability to move the arms freely is often taken for granted. However, this movement may be restricted by shoulder pain. The shoulder is a complex joint that is made up of bones, muscles, and tendons, and any injury to these structures can result in pain. For instance, rotator cuff tears commonly cause shoulder pain among athletes. However, this condition can be effectively treated with biologic therapies. The benefit of these therapies is their short recovery time, as biologic therapies help promote the bodys natural healing process. QC Kinetix (Chandler) is one of the clinics steering the way in providing these restorative therapies to patients.

QC Kinetix (Chandler) is located at 1100 S Dobson Rd, Suite 210, Chandler, AZ, 85286, US. Clients can also contact the pain control clinic at (602) 837-7246. They can also learn more by browsing the companys website.

Media Contact

Company NameQC Kinetix (Chandler)Contact NameScott HootsPhone(602) 837-7246Address1100 S Dobson Rd, Suite 210CityChandlerStateAZPostal Code85286CountryUnited StatesWebsitehttps://qckinetix.com/phoenix/chandler/

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QC Kinetix (Chandler): The Future of Regenerative Medicine in Arizona - Digital Journal

Platelet-rich plasma (PRP) could be understood as a special preparation of plasma in which the concentration of platelet is immensely high. This rationale for plasma use hasbeen in the medical sciencefor many years with plenty of success in various fields where it was inculcated, bringing dramatically favorable and better outcomes in terms of disease management and prognosis. PRP has been widely used in orthopedics from the very beginning, but in the past few years its use has been extended to other fields too, such as obstetrics and gynecology. From the very onset of the introduction of platelet-rich plasma in gynecology, there had been constant researchbeing carried out all around the globe in order to scientifically prove and confirm its exact role in the management of gynecologicalproblems. Regenerative medicine in gynecologywas among the first areas where the platelet-rich plasma was implemented and has substantially given great results, which encouraged further extensiveresearchto be carried out in other spectrums of gynecology.The implications of such great struggles ultimately gave way to evidencesuggesting the importance of platelet-rich plasma in managing gynecological disorders like Ashermans syndrome, urinary incontinence, genital fistulas, thin endometrium, etc. This review article collectively summarizes the various use of platelet-rich plasma in gynecology.

Platelet-rich plasma (PRP) may be understood as an autologous plasma preparation that is enriched with an increased concentration of platelet when compared to those present in whole blood [1]. The immense potential of platelet-rich plasma is often not made use of, as this particular entity is seldom understood in depth as it should be. Researchis being conducted all around the globe to understand the true potential of platelet-rich plasma, and undoubtedly a deeper knowledge of the same could be a solution to many problems in medical science, as this would pave the way for advanced and affordable therapeutic management strategies. Platelet-rich plasma (PRP) is obtained by the centrifugation of whole blood [2]. PRP contains growth factors and bioactive proteins that positively aid in the healing of ligament, bone, tendon and muscle [3]. It has been used in sports medicine to a good extent because of its effects on the musculoskeletal system. PRP has been helpful in tackling medical conditions in sports like muscle strains, Achilles tendon, lateral epicondylitis, ligament strains, rotator cuff tears, etc. [4].The incorporation of PRP into the hydrogel, which on biomineralization, could significantly accelerate the generation of bone [5]. In patients with androgenic alopecia, the use of PRP has the potential for hair restoration [6]. Apart from the increment in hair growth, the quality and density of the hair are also increased with its use [7]. It is also used in plastic facial surgeries because of its potential in the healing of wounds [8]. PRP, when combined with autologous fat grafting, laser therapies, dermal fillers, and microneedling, have been found to have synergistic effects that lead to better aesthetic outcomes apart from their widespread applications in dermatology like the areas of acne scars, striae distensae, skin rejuvenation, dermal augmentation, hair restoration, etc. [9]. PRP is a potential candidate for the regeneration of damaged tissues, including the liver and the dental pulp [10]. Autologous PRP could be developed easily and is an effective surgical adjunct, which is proven to be helpful in accelerating postsurgical healing in oral surgeries and periodontics [11]. The extensive use of the platelet-rich plasma in gynecology is hopefully expected to give good positive results, as was seen in musculoskeletal system and skin regeneration.

The abundant use of PRP in regenerative medicine has provoked researchers all around the world to apply its potential in other fields of medical science too. These efforts were carried out in obstetrics and gynecology as well, and the outcome was a wide range of applications in the domain of reproductive medicine, particularly in Ashermans syndrome, cases of thin endometrium, urinary incontinence, recurrent genitourinary fistula auxiliary treatment, etc.[12]. Although this requires more research, with the little information that is available now from the few research conducted, there is a good hope that in the near future, platelet-rich plasma could resolve various challenges that are currently being faced in obstetrics and gynecology. Some of its achievements in gynecologyand obstetrics are a decrease in the FSH levels, increasedendometrial thickness, increasedanti-Mullerian hormone (AMH), etc. [13]. If the potential of PRP is utilized, then women who suffer from premature ovarian insufficiencies, poor ovarian reserve, and even early menopause cases where they are trying to conceive using their own oocytes may find this helpful [14]. The benefits of the use of PRP over conventional management strategies in obstetrics and gynecology include minimally invasive procedures, low cost, easy availability, lesser adverse effects, etc., but the issue that is quite prominent is that there is as such, no standardized concentration of PRP that could effectively resolve gynecological problems in one go. PRP is concerned that they shouldnt be used in coagulation disorder patients [15]. The use of platelet-rich plasma in patients with coagulation disorders would worsen their general condition at a very rapid pace, thus, should neverbe used in these patients. There are other conditions too, where it is prudent to avoid its use as a management modality, such as cases of active infectionsor patients under NSAIDs; particularly with respect to gynecology, it should never be prescribed to pregnant women and lactating mothers [16]. Stress urinary incontinence and overactive bladder are two gynecological entities that affecta vast majority of women, and the good part is that treatment with PRP had a profound impact on these disorders [12].

Although platelet-rich plasma (PRP) therapies have a huge potential to revolutionize the management of various gynecological conditions at this point in time, only a very less fraction of the same is made a reality. The continuing research in the field of gynecologyhas hope for the involvement of more of this gracious and effective management strategyand, for the time being, more research is to be conducted to deepen the understanding of the effects of PRPon thediseases it is being tried out. Here, in this review article, some of the widely promising and practically applicable aspects of the gynecological manifestations would be dealt with.

An intact endometrium is one of the main prerequisites for the implantation to take place. Much of the implantation-related pregnancy issues do take place as a result of the disparities in the endometrial layer. A proper endometrium is a must for safe implantation. Platelet-rich plasma interventions have been shown to successfully figure out several issues of the endometrium and thus haveproved beneficial to many women suffering from endometrial problems. Platelet-rich plasma increased the receptivity of the endometrium and thereby ledto a rise in the rate of implantation. In patients with thin endometrium, platelet-rich plasma is effective in the growth of endometrium as it restores the structure of the endometrium and decreases fibrosis. Their role in the management of Ashermans syndrome is also phenomenal. It aids in the management of patients with endometrial difficulties that are a result of associated chronic systemic diseases and thus has emerged as a golden ray of hope even in these low prognosis patients. Various studies have proved its effectiveness in endometrial abnormalities [17-20] (Table 1).

Platelet-rich plasma (PRP) has promising positive impacts on the growth of follicles alongside endometriumand thus has become a good alternative for older womenwho possess low follicular reserve and unresponsive endometriumseeking motherhood [21]. The improvement in the microenvironment of ovaries, along with the provision of growth factors for germline stem cells of the ovaries makes platelet-rich plasma a potential management strategy for low reserves of the ovaries [22]. The injection (intra-ovarian) of calcium gluconate-activated autologous platelet-rich plasma is likely to improve the functions of the ovaries after a span of two months in 38 to 46 years age group women [23]. The advantage of the ovaries being amassively angiogenic organ is that it could be expected that neoangiogenesis in ovarian tissues could be brought about by angiogenic factors that are derived from the platelet-rich plasma, which, in turn, makes room for the reactivation and regeneration of tissue [24].

In the autologous transplantation of ovaries, the angiogenicpotential of platelet-rich plasma is made handy [25]. Damages to the ovaries that occuras a result of torsion-related ischemia would be reduced to a good extent by the administration of platelet-rich plasma intraperitoneally [26]. Oxidative stress-induced injuries are prevented with the help of platelet-rich plasma as it increases vascular endothelial growth factor (VEGF) and a few nuclear factors that aid in angiogenesis [27]. Even though platelet-rich plasma is made useful in various ovary-related problems but more researchwould help add more gynecological problems to the list that PRP could resolve. Platelet-rich plasma is serving as a good management strategy in tackling many of the urinary problems of patients attending gynecology clinics. It has a profound effect as a supportive treatment modality in case of recurrent vesicovaginal fistulas. Disorders of the urinary tract and difficulty in urination were seldom complained by patients in whom platelet-rich plasma was used asadjuvant therapy for the treatment of recurrent vesicovaginal fistula [28]. PRP is also found to be of use in the management of cystoceles. Considering the complications of cystoceles like mesh complications, platelet-rich plasma may serve as a good option to prevent the recurrence of cystoceles [29].

Platelet-rich plasma is useful in cases of stress urinary incontinence (SUI) as PRP contains several growth factors that helpin the reconstruction of the damaged ligament in, i.e., pubourethral ligament [30]. Urethral sphincter injection of platelet-rich plasma is a minimally invasive, safe, and effective treatment modality in cases of postprostatectomy urinary incontinence with considerable urodynamic and clinical evidence[31]. Platelet-rich plasma helps not only in the management of urogynaecological problems but is handy in the diagnosis of certain conditions like painful bladder syndrome/interstitial cystitis. It has the potential to act as a modulatorof urothelial repair,and this could be made useful in painful bladder syndromes [32]. Various researchin the past couple of years is clearly suggestive of the fact that intravesical platelet-rich plasma reduces chronic inflammation in bladder pain syndrome/interstitial cystitis (BPS/IC) as they could improve regeneration of the urothelium [33].

There is clinical evidencethat the injections of platelet-rich plasma could substantially decrease the urinary inflammatory proteins in interstitial cystitis/bladder pain syndrome (IC/BPS) and thus aids in the improvement of symptoms [34]. A study demonstrated that autologous platelet-rich plasma intravesical injections helped to improve interstitial cystitis as it safely decreases MMP-13, urinary NGF, and levels of VEGF [35]. The instillation of intravesical PRP has been found to increase the mitotic index in cyclophosphamide and saline groups, along with aiding in the decrement of bleeding macroscopically [36]. Considering the outcomes of multiple types of research, we could come to an inference that the intravesical injection of platelet-rich plasma could potentially act as an effective and safe treatment option in cases of bladder pain syndrome by its multiple actions that aidin tissue regeneration, wound healing and modulation of the immunity [37].

After having a careful review of the various research works on the use of platelet-rich plasma in gynecology, published on internationally recognized scientific platforms, various valuableinsights were obtained, which havethe potential to bring about a great revolution in obstetrics and gynecology. Starting from very minor ailments and spanning to some of the most chronic forms of gynecological issues, platelet-rich plasma is undoubtedly a worthy candidate for the management of these problems. The wide spectrum of its usage has made various gynecological issues such as thin endometrium, recurrent genital fistulas, ovarian abnormalities, Ashermans syndrome, urinary stress incontinence, etc., effectively managed. Platelet-rich plasma has been scientifically proven to increase the thickness of the endometrium. Therebyaiding implantation in women as implantation wouldnt have been otherwise possible in these females because of their thin endometrium. Those women who were suffering from ovary-related issues benefited when platelet-rich plasma was administered to them. The role of platelet-rich plasma in the management of urinary complaints is phenomenal, and thus the implementation of PRP substantially improves the symptoms in these women. From the analysis of the effects of platelet-rich plasma in gynecology which is currently available, there is no doubt that more research would aid in discovering the hidden potentials of platelet-rich plasma in the management of many more of the issues encountered in gynecology.

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Platelet-Rich Plasma: A Promising Regenerative Therapy in Gynecological Disorders - Cureus

Today, the White House will host a Summit on Biotechnology and Biomanufacturing. The Summit is led by National Security Advisor Jake Sullivan, Director of the National Economic Council Brian Deese, and Director of the Office of Science and Technology Dr. Alondra Nelson who will be joined by Secretary of Health and Human Services Xavier Becerra, Secretary of Energy Jennifer Granholm, Deputy Secretary of Defense Kathleen Hicks, Deputy Secretary of Agriculture Jewel Bronaugh, Under Secretary of Commerce for Standards and Technology and Director of the National Institute for Standards and Technology Laurie Locascio, and Director of the National Science Foundation Sethuraman Panchanathan, as well as Senator Mark Warner and Representative Deborah Ross. Together, they will lift up the following key stepswith funding of more than $2 billionto advance President Bidens Executive Order to launch a National Biotechnology and Biomanufacturing Initiative to lower prices, create good jobs, strengthen supply chains, improve health outcomes, and reduce carbon emissions. U.S.departments and agencies will:Leverage biotechnology for strengthened supply chains. The Department of Health and Human Services will invest $40 million to expand the role of biomanufacturing for active pharmaceutical ingredients (APIs), antibiotics, and the key starting materials needed to produce essential medications and respond to pandemics. DoD is launching the Tri-Service Biotechnology for a Resilient Supply Chain program with more than $270 million investment over five years to turn research into products more quickly and to support the advanced development of bio-based materials for defense supply chains, such as fuels, fire-resistant composites, polymers and resins, and protective materials. Through the Sustainable Aviation Fuel Grand Challenge, the Department of Energy (DOE) will work with the Department of Transportation and USDA to leverage the estimated 1 billion tons of sustainable biomass and waste resources in the United States to provide domestic supply chains for fuels, chemicals, and materials. These efforts will collectively lower prices for American families, especially in times of global supply chain turbulence.Expand domestic biomanufacturing. The Department of Defense (DoD) will invest $1 billion in bioindustrial domestic manufacturing infrastructure over 5 years to catalyze the establishment of the domestic bioindustrial manufacturing base that is accessible to U.S. innovators. This support will provide incentives for private- and public-sector partners to expand manufacturing capacity for products important to both commercial and defense supply chains, such as critical chemicals. DoD will invest an additional $200 million to support enhancements to biosecurity and cybersecurity posture for these facilities. The U.S. Department of Agriculture (USDA) will make $500 million available through a new grant program in the summer of 2022 to support independent, innovative, and sustainable American fertilizer production to supply American farmers, which can make use of advances in biotechnology and biomanufacturing.Foster innovation across the United States. The National Science Foundation (NSF) recently announced a competition to fund Regional Innovation Engines throughout the United States. These Engines will support key areas of national interest and economic promise, including biotechnology and biomanufacturing topics such as manufacturing life-saving medicines, reducing waste, and mitigating climate change. In May 2022, USDA announced $32 million for wood innovation and community wood grants, leveraging an additional $93 million in partner funds to develop new wood products and enable effective use of U.S. forest resources. DOE also plans to announce new awards of approximately $178 million to advance innovative research efforts in biotechnology, bioproducts, and biomaterials. In addition, the U.S. Economic Development Administrations $1 billion Build Back Better Regional Challenge will invest more than $200 million to strengthen Americas bioeconomy. Investments in New Hampshire, Virginia, North Carolina, Oregon, and Alaska will help expand the bioeconomy by advancing regional biotechnology and biomanufacturing programs. These regional investments will rebuild pharmaceutical supply chains to lower drug costs, catalyze a sustainable mariculture industry, better utilize mass timber to accelerate affordable housing production and restore forest health, enhance the production and distribution of regenerative tissues and organs, and develop a robust pipeline of biotech talent, expanding opportunities to underserved and historically excluded communities.

Bring bio-products to market. DOE will provide up to $100 million for research and development (R&D) for conversion of biomass to fuels and chemicals, including R&D for improved production and recycling of biobased plastics. DOE will also double efforts, adding an additional $60 million, to de-risk the scale up of biotechnology and biomanufacturing that will lead to commercialization of biorefineries that produce renewable chemicals and fuels that significantly reduce greenhouse gas emissions from transportation, industry, and agriculture. USDAs BioPreferred Program advances the development and expansion of markets for biobased products with a catalog of over 16,000 registered products. The new $10 million Bioproduct Pilot Program will support scale-up activities and studies on the benefits of biobased products. Manufacturing USA institutes BioFabUSA and BioMADE (launched by the DoD) and NIIMBL (launched by the Department of Commerce (DOC)) will expand their industry partnerships to enable commercialization across regenerative medicine, industrial biomanufacturing, and biopharmaceuticals. For example, NIIMBL will launch a biomanufacturing initiative that will engage the institutes 200 partners across industry, academic, non-profit, and Federal agencies to mature biomanufacturing technology needed to improve patient access to gene therapies. BioMADE will launch hubs supporting equitable regional development, create jobs nationwide, and enhance American economic competitiveness. BioFabUSA is standing up the BioFab Foundries, a first-of-its-kind U.S. facility that integrates engineering, automation, and computation with biology. BioFab Foundries will be accessible to U.S. innovators to enable manufacturing of preclinical and early-stage clinical products.Train the next-generation of biotechnologists. The National Institutes of Health (NIH) is expanding the I-Corps program, a biotech entrepreneurship bootcamp. NIIMBL will continue to offer a summer immersion program, the NIIMBL eXperience, in partnership with the National Society for Black Engineers, that connects underrepresented students with biopharmaceutical companies, and support pathways to careers in biotechnology. In March 2022, USDA announced $68 million through the Agriculture and Food Research Initiative to train the next generation of research and education, professionals.Drive regulatory innovation to increase access to products of biotechnology. The Food and Drug Administration is spearheading efforts to support advanced manufacturing through regulatory science, technical guidance and increased engagement with industry seeking to leverage these emerging technologies These efforts will increase medical supply chain resilience and improve patient access to new medical products. NIHs Accelerating Medicines Partnership Bespoke Gene Therapy Consortium will support up to six new clinical trials, each focused on a different rare disease, to streamline manufacturing and regulatory frameworks. For agricultural biotechnologies, USDA is building new regulatory processes to promote safe innovation in agriculture and alternative foods, allowing USDA to review more diverse products.Advance measurements and standards for the bioeconomy. DOC plans to invest an additional $14 million next year at the National Institute of Standards and Technology for biotechnology research programs to develop measurement technologies, standards, and data for the U.S. bioeconomy. This support will catalyze development of capabilities for engineering biology, advance biomanufacturing processes and technologies, and help utilize artificial intelligence to analyze biological data.Reduce risk through investing in biosecurity innovations. DOEs National Nuclear Security Administration plans to initiate a new $20 million bioassurance program that will advance U.S. capabilities to anticipate, assess, detect, and mitigate biotechnology and biomanufacturing risks, and will integrate biosecurity into biotechnology development.Facilitate data sharing to advance the bioeconomy. Through the Cancer Moonshot, NIH is expanding the Cancer Research Data Ecosystem, a national data infrastructure that encourages data sharing to support cancer care for individual patients and enables discovery of new treatments. USDA is working with NIH to ensure that data on persistent poverty can be integrated with cancer surveillance. NSF recently announced a competition for a new $20 million biosciences data center to increase our understanding of living systems at small scales, which will produce new biotechnology designs to make products in agriculture, medicine and health, and materials.

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FACT SHEET: The United States Announces New Investments and Resources to Advance President Bidens National Biotechnology and Biomanufacturing...

LEXINGTON, Ky. (WTVQ) Four will be inducted into the Equine Research Hall of Fame, the University of Kentucky Gluck Equine Research Center announced Wednesday.

The induction honors achievements in equine research and those who have made a lasting tribute to equine health. The induction will be held on Wednesday, Oct. 26 at Kroger Field for Lisa Fortier, Katrin Hinrichs, Jennifer Anne Mumford and Stephen M. Reed.

The following achievements were provided via a press release:

Lisa Fortier

Over the past 30 years, Fortier has garnered an international reputation for significant contributions in equine joint disease, cartilage biology and regenerative medicine. She has focused her research on early diagnosis and treatment of equine orthopedic injuries to prevent permanent damage to joints and tendons. She is perhaps best known for her work in regenerative medicine, pioneering the use of biologics such as platelet-rich plasma, bone marrow concentrate and stem cells for use in horses and humans. Fortiers lab has also been instrumental in breakthroughs related to cartilage damage diagnosis and clinical orthopedic work. A testament to her impact is that 87% of U.S. equine veterinarians now use biologics for regenerative medicine in their equine patients.

Fortier earned her bachelors degree and doctor of veterinary medicine degree from Colorado State University. She completed her residency at Cornell, where she also earned a Ph.D. and was a postdoctoral fellow in pharmacology. She now holds the James Law Professor of Surgery position at Cornells College of Veterinary Medicine. She is the editor-in-chief of the Journal of the American Veterinary Medical Association and serves on the Horseracing Integrity and Safety Authority Racetrack Safety Standing Committee.

Katrin Hinrichs

Hinrichs devotes her career to research primarily in equine reproductive physiology and assisted reproduction techniques. Specifically, her focus has included equine endocrinology, oocyte maturation, fertilization, sperm capacitation and their application to assisted reproduction techniques.

Hinrichs 40 years of research have led to several significant basic and applied research achievements. The applied accomplishments include producing the first cloned horse in North America and developing the medical standard for effective intracytoplasmic sperm injection and in vitro culture for embryo production in horses. She has mentored more than 85 veterinary students, residents, graduate students and postdoctoral fellows in basic and applied veterinary research. Her laboratories have hosted approximately 50 visiting scholars from throughout the world.

Hinrichs earned her bachelors degree and doctor of veterinary medicine degree from the University of California, Davis. She completed residency training in large animal reproduction at the University of Pennsylvanias New Bolton Center and earned a Ph.D. at the University of Pennsylvania.

Jennifer Anne Mumford

A posthumous inductee, Mumford earned international respect as one of the most prominent researchers of equine infectious diseases, in particular equine viral diseases. Her distinguished career at the Animal Health Trust, Newmarket, United Kingdom, began when she became the first head of the newly established equine virology unit. Her work focused on the leading causes of acute infectious respiratory disease in the horse, primarily equine herpesvirus and equine influenza virus, and to a lesser extent,Streptococcus equi, the causative agent of equine strangles.

Mumford made numerous significant contributions in these areas, including developing improved vaccines, diagnostics and international surveillance. She also helped establish research groups in the related fields of equine genetics and immunology.

During Mumfords more than 30 year-career, she established the Animal Health Trust as one of the worlds leading centers for the study of the biology, epidemiology, immunology and pathology of diseases, including equine herpes rhinopneumonitis and equine influenza, as well as bacterial diseases, including Streptococcus and Clostridium.

Stephen M. Reed

Reeds nominators credited him as the last word in equine neurology. Reed is widely recognized as one of the most prominent equine neurologists worldwide. His list of 180 peer-reviewed publications includes significant contributions to equine medicine, neurology, physiology and pathophysiology, and has earned him worldwide recognition throughout the equine community. He has shared in his achievements as a mentor and role-model for hundreds of aspiring equine practitioners.

One of the most unique and refreshing things about Dr. Reed is he absolutely embodies the need and overlap of discovery science with clinical assessments to further our understanding of equine neurologic disease, wrote Jennifer Janes, associate professor of veterinary pathology at the UK Veterinary Diagnostic Laboratory, in her letter of support for the nomination. This mission has served as the foundation and pillars of his long career in equine veterinary medicine.

Reed earned his bachelors degree and doctor of veterinary medicine degree from The Ohio State University. He completed internship and residency training in large animal medicine at Michigan State University.

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4 to be inducted into UK Equine Research Hall of Fame - WTVQ

AVITA Medical

VALENCIA, Calif. and MELBOURNE, Australia, Sept. 12, 2022 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH) (Company), a regenerative medicine company leading the development and commercialization of first-in-class devices and autologous cellular therapies for skin restoration, today announced positive topline results from a pivotal randomized, controlled trial evaluating the safety and effectiveness of the RECELL System for repigmentation of stable vitiligo lesions.

The study compared repigmentation success rates, in a design where each patient randomly received RECELL treatment in one portion of depigmented area and treatment with the study control in another portion of depigmented area. The study control treatment was the standard of care narrowband ultraviolet-B phototherapy, which is typical first-line treatment for vitiligo. Repigmentation was evaluated 6 months after treatment by an expert central review committee (CRC).

The CRC reported the following:

Fifty-six percent (56%) of RECELL treatments (versus 12% of control treatments) resulted in repigmentation of more than 50% of the treated area

Thirty-six percent (36%) of RECELL treatments (versus 0% of control treatments) resulted in repigmentation of at least 80% of the treated area, establishing super-superiority for the primary endpoint (p<0.025)

RECELLs compelling safety profile to date is reflected in preliminary review of adverse events in this study.

These are the first results from a U.S. randomized, controlled trial of the RECELL System in treating patients with segmental and nonsegmental stable vitiligo and provide a foundation for communicating favorable clinical benefit in pursuit of FDA approval via submission of a PMA supplement for this indication later this year.

Vitiligo often has a severe impact on quality of life and is a therapeutic area within which there have been very limited treatment options. We are excited by our topline data, as we are now closer to our goal of providing patients with a durable, clinically meaningful, one-time treatment for repigmentation, said Dr. Mike Perry, Chief Executive Officer of AVITA Medical. RECELL has the potential to address the unmet medical need for an estimated 1.3 million people in the U.S. who suffer from stable vitiligo, and further, we envision a potential opportunity for RECELL as part of a multi-modal treatment plan for patients achieving stability with JAK inhibitor treatment.

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Repigmentation is challenging to manage and burdensome for patients with vitiligo, said Iltefat Hamzavi, MD, of Henry Ford Hospital (Detroit, MI), lead investigator of the trial. These are encouraging results that underscore the potential for RECELL to address repigmentation in patients with stable vitiligo in a rapid and sustained fashion which is distinct from existing therapies.

Vitiligo is a disease that attacks pigment-producing cells, called melanocytes, resulting in their destruction or malfunction. The result is a loss of pigmentation in patches of skin. Vitiligo affects up to 2% of the population worldwide,i including up to 6.5 million Americans,ii with an estimated 1.3 million suffering from stable vitiligo. Vitiligo has a comparable psychosocial impact to other major dermatology diseases including psoriasis (thick, scaly skin) and atopic dermatitis (red, cracked skin).iii, iv, v Like these diseases, those living with vitiligo may suffer from poor body image along with low self-esteem, leading to an impaired quality of life.vi

ABOUT AVITA MEDICAL, INC.AVITAMedical is a regenerative medicine company leading the development and commercialization of devices and autologous cellular therapies for skin restoration. The RECELL System technology platform, approved by the FDA for the treatment of acute thermal burns in both adults and children, harnessesthe regenerative properties of a patients own skin to create Spray-On Skin cells. Delivered at the point-of-care, RECELL enables improved clinical outcomes and validated cost savings. RECELL is the catalyst of a new treatment paradigm and AVITA Medical is leveraging its proven and differentiated capabilities to develop first-in-class cellular therapies for multiple indications, including acute traumatic wounds and repigmentation of stable vitiligo lesions.

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 approved for acute partial-thickness thermal burn wounds in patients 18 years of age and older or application in combination with meshed autografting for acute full-thickness thermal burn wounds in pediatric and adult patients. In February 2022, the FDA reviewed and approved the PMA supplement for RECELL Autologous Cell Harvesting Device, an enhanced RECELL System aimed at providing clinicians a more efficient user experience and simplified workflow.

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 15,000 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 approved under the RECELL System brand to promote skin healing in a wide range of applications including burns, acute traumatic wounds, vitiligo, and aesthetics. The RECELL System is TGA-registered in Australia, received CE-mark approval in Europe and has PMDA approval in Japan. To learn more, visitwww.avitamedical.com.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTSThis press release 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 press release 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 press release 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 press release. 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 press release speak only as of the date of this release, and we undertake no obligation to update or revise any of these statements.

This press release was authorized by the review committee of AVITA Medical, Inc.

FOR FURTHER INFORMATION:

U.S. MediaSam Brown, Inc.Christy CurranPhone +1-615-414-8668christycurran@sambrown.com

O.U.S. MediaRudi Michelson Phone +61 (0)3 9620 3333 Mobile +61 (0)411 402 737 rudim@monsoon.com.au

InvestorsWestwicke PartnersCaroline CornerPhone +1-415-202-5678 caroline.corner@westwicke.com

i Picardo et al. Vitiligo. Nature Reviews Disease Primers. 2015.ii John Harris, MD, PhD Presentation as part of Incyte Corporate presentation. (Harris, UMass, is a global leader in Vitiligo; AVITA collaborator). https://investor.incyte.com/static-files/01f77a1c-6351-4348-adc2-597e2bc1f42eSERTiii National Psoriasis Foundation Statistics, https://www.psoriasis.org/psoriasis-statistics/ Accessed 10/5/2020iv The burden of vitiligo: Patient characteristics associated with quality of life. Homan, et al. JAAD. 2009v Comparison of the Psychological Impacts of Asymptomatic and Symptomatic Cutaneous Diseases: Vitiligo and Atopic Dermatitis.Noh, et al. Annals of Derm. 2013vi Willingness-to-pay and quality of life in patients with vitiligo. Radtke, et al. BJD. 2009

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AVITA Medical Achieves Positive Topline Pivotal Trial Results for Treatment of Stable Vitiligo Using the RECELL System - Yahoo Finance