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Modeled in part after National Transportation Safety Board, proposed entity would focus on preventing patient injury and harm NEWPORT NEWS, Va., Aug. 2, 2023 /PRNewswire/ -- ivWatch, LLC, the IV safety company, today announced that it has joined the National Patient Safety Board (NPSB) Advocacy Coalition. The proposed NPSB would model the efforts of the National Transportation Safety Board (NTSB) and Commercial Aviation Safety Team (CAST) in the healthcare space and would complement existing agencies in monitoring and anticipating patient safety events. Continue Reading ivWatch patient monitoring system for IV infiltrations and extravasations. ivWatch's goal to promote IV safety across all healthcare environments via its proprietary patient monitoring technology aligns directly with the NPSB's initiative to help protect patients from unpredictable IV complications, among other scenarios, with early IV infiltration and extravasation detection. "The alarming escalation of IV injury in the U.S. is a perfect case study for why a National Patient Safety Board is imperative right now. We are very excited to join the NPSB Advocacy Coalition and further our mission toward standards of practice that will improve patient safety in hospitals – especially reducing the incidence of IV injury to zero," said Christine Hayden, RN, BSN, and Director of Business Development who will serve as ivWatch's representative on the coalition. Prior to the COVID-19 pandemic, medical errors were the third leading cause of death in the United States, with conservative estimates of more than 250,000 patients dying annually from preventable medical harm and costs of more than $17 billion to the U.S. healthcare system. Recent data has shown that patient safety worsened during the pandemic. "We have seen many valiant efforts to reduce the problem of preventable medical error, but most of these have relied on the frontline workforce to do the work or take extraordinary precautions," said Karen Wolk Feinstein, Ph.D., president and CEO of the Pittsburgh Regional Health Initiative and spokesperson for the NPSB Advocacy Coalition. "Innovative technology solutions are crucial to our mission to shift the burden away from frontline healthcare workers while exponentially increasing patient safety across the U.S." ivWatch CEO Gary Warren, whose commentary on the formation of an NPSB is included in this month's issue of industry publication Healthcare Risk Management, notes: "The need for this is highlighted particularly in vascular access, our area of expertise. Over 80% of patients admitted to hospitals have this seemingly simple and common procedure. However, significant complication rates exist that lead to drug dosing errors, skin necrosis, scarring, compartment syndrome, and even amputation in severe instances. Ensuring the same level of safety for patients as we are entitled to in non-medical environments is an important and pressing issue, and we are looking forward to working closely with the National Patient Safety Board Advocacy Coalition in their efforts to do so," Warren says. About ivWatch, LLC ivWatch, LLC is a biosensor technology company focused on improving patient safety and the effectiveness of intravenous therapy. Our dedicated and passionate team is pioneering the use of optical sensors to detect adverse IV events early to minimize the risk of injury caused by infiltrations and extravasations. By using this technology, clinicians can leverage continuous monitoring to help identify infiltrations as early as possible. Our innovative IV monitoring solutions are backed by decades of clinical research and device development. To learn more, follow us on Twitter @ivWatch, Facebook @ivWatchLLC, Instagram @ivWatchLLC and LinkedIn @ivWatch-LLC, or visit . SOURCE ivWatch, LLC

HONG KONG, GERMANTOWN, Md. and SUZHOU, China , June 5, 2023 /PRNewswire/ -- Sirnaomics Ltd. (the "Company", Stock Code: 2257.HK, together with its subsidiaries, the "Group" or "Sirnaomics"), a leading biopharmaceutical company in discovery and development of RNAi therapeutics, today announced the interim results of an ongoing Phase I clinical trial of STP705, an siRNA (small interfering RNA) drug candidate, for fat reduction in adults undergoing abdominoplasty. The initial results of the Phase I trial appear to indicate that the use of STP705 in the treatment of unwanted fat is safe and show clear signs of efficacy. This interim efficacy results examined efficacy data from six participants that were scheduled to undergo abdominoplasty. Each participant was treated with STP705 doses of 120 μg, 240 μg and 320 μg at volume per injection of either 0.5 ml or 1.0 ml per injection site as well as placebo consisting of normal saline. The test article administration area was the central to lower abdomen region designated for abdominoplasty and participants received a single injection per site up to three injections of test article approximately 28 days apart. Participants in the safety review were examined for the presence of and severity of Local Skin Reactions (LSR) including erythema, edema, and bruising over a time frame as well as the incidence (severity and causality) of any adverse events for a time frame of approximately 98 days. Secondary analysis looked at histological evidence of fat changes that would be seen in fat tissue remodeling such as fat inflammation, panniculitis, fibrosis and fat necrosis. Statistical analysis was performed with non-parametric one-way ANOVA using Kruskal-Wallis test and Dunn's multiple comparison test. The interim analysis results include data from six participants with 42 tissue samples in total. There were no significant adverse events and all tissue samples examined in this review using variables doses of STP705 showed histological evidence suggestive of fat remodeling. Based on the histological scoring and panniculitis + fat necrosis ranking, a dose-dependent effect was observed for all treatment groups comparing to the placebo group with statistical significance (P < 0.05). The 240 μg at the volume of 1.0 ml treatment group has demonstrated the most potent activity. Professor Mark Nestor, M.D., Ph.D., Director of the Center for Clinical and Cosmetic Research and the Center for Cosmetic Enhancement, Aventura, Florida, a Voluntary Professor in the Division of Plastic Surgery at the University of Miami, Miller School of Medicine and the principal investigator (PI) of the Phase I clinical study commented, "the initial data from the Phase I trial appears to indicate that the use of STP705 in the treatment of unwanted fat is safe and shows clear signs of efficacy. Safety has been examined in the first of three subjects and histology of the injected areas post abdominoplasty has been evaluated. Regarding histology, there is a clear difference in many of the specimens between the placebo, and the subjects injected with STP705. We look forward to completing this first study and analyzing all the results in the near future." "Interim data from our clinical study of STP705 for fat reduction indicate that subjects that have received various doses of STP705 show clear histologic evidence of fat changes that would be observed in fat remodeling," said Dr. Michael Molyneaux, M.D., Executive Director and Chief Medical Officer of Sirnaomics. "The safety results were very encouraging with no systemic adverse events and no significant local skin or tissue changes. This finding is very important when selecting a product that will be used for non-surgical fat remodeling and the fact that there was clear histological evidence of fat remodeling in a dose dependent manner is very encouraging as we move into Phase II of the program. We anticipate final study report sometime in Q3 2023 after which time, we will request a meeting with the FDA to determine the path to approval for the program." This study is the Group's first exploration to apply an RNAi therapeutic candidate for localized fat remodeling and Sirnaomics plans to use the information from this study to expand into the treatment of submental fat and other areas of noninvasive fat remodeling. The positive interim results have better informed the Group about the later stage development of STP705 in the medical aesthetics category. Together with the positive results from STP705 for treatment of squamous cell carcinoma in situ (isSCC) and basal cell carcinoma (BCC), the Group has successfully leveraged the proof-of-concept human data from STP705. This advancement in fat remodeling is expected to open up a new therapeutic area of medical aesthetics for Sirnaomics' pipeline and has received very positive responses from the market. "The interim results of this Phase I clinical study have brought a strong enthusiasm using RNAi drug for medical aesthetic treatment. This novel non-invasive fat-reduction option potentially offers millions of people with unwanted fat on their bodies, which are resistant to diet and exercise and influenced by aging and genetics, a unique way to address those all-too-common conditions," said Dr. Patrick Lu, Founder, Chairman of the Board, Executive Director, President and Chief Executive Officer of Sirnaomics. "During our preclinical studies with a well-defined animal model, we found that STP705 demonstrated superior efficacy and safety, compared to a commercially available injection drug for the same indication. This observation encourages us not only to explore the utility of STP705 for medical aesthetics but also to advance it to become a best-in-class drug candidate for fat-remodeling." Additional information about this clinical trial is available at clinicaltrials.gov using the identifier: NCT05422378. About STP705 Sirnaomics' leading product candidate, STP705, is a siRNA (small interfering RNA) therapeutic that takes advantage of a dual-targeted inhibitory property and polypeptide nanoparticle (PNP)-enhanced delivery to directly knock down both TGF-β1 and COX-2 gene expression. The product candidate has received multiple IND approvals from both the U.S. Food and Drug Administration (FDA) and the Chinese National Medical Products Administration (NMPA), including treatments of cholangiocarcinoma, non-melanoma skin cancer and hypertrophic scar. There are currently three product pipeline advancing programs prioritized by STP705: a Phase IIb for squamous cell carcinoma in situ (isSCC), a Phase II for basal cell carcinoma (BCC) and a Phase I for the fat remodeling. In addition, in the treatment of other indications, STP705 has received Orphan Drug Designation for the treatment of cholangiocarcinoma (CCA) and primary sclerosing cholangitis (PSC). About Sirnaomics Ltd. (Stock Code: 2257) Sirnaomics is an RNA therapeutics biopharmaceutical company with product candidates in preclinical and clinical stages that focuses on the discovery and development of innovative drugs for indications with medical needs and large market opportunities. Sirnaomics is the first clinical-stage RNA therapeutics company to have a strong presence in both Asia and the United States. Based on its proprietary delivery technologies: Polypeptide Nanoparticle Formulation and the 2nd generation of GalNAc conjugation, the Group has established an enriched drug candidate pipeline. Sirnaomics is currently holding a leadership position on advancing RNAi therapeutics for oncology application with multiple successes of its clinical programs for STP705 and STP707. STP122G represents the first drug candidate of GalAhead™ technology entering clinical development. With the establishment of the Group's manufacturing facility, Sirnaomics currently is undergoing a transition from a biotech company to a biopharma corporation. Learn more at: . SOURCE Sirnaomics

For the first time at SCOPE Miami Beach, Galderma, a leader in advancing the future of aesthetics, will invite attendees to explore its portfolio of injectable treatments DALLAS, Nov. 28, 2022 /PRNewswire/ -- Galderma announced today its upcoming collaboration with SCOPE Miami Beach 2022, the premier showcase for emerging contemporary art. As the exclusive aesthetic injectables sponsor of the 21st annual art show, Galderma will be highlighting its aesthetics portfolio – Restylane®, Dysport®* (abobotulinumtoxinA) and Sculptra® – and hosting a variety of activations for visitors beginning November 29th through December 4th, 2022. "We are thrilled to be among the artists and innovators at SCOPE Miami Beach this year," said Carrie Caulkins, Vice President, U.S. Aesthetics Marketing, Galderma. "Every skin story begins with a beautiful canvas and this partnership serves as a great reminder that expression can come in many forms." During the showcase, Galderma will create an interactive space for guests, celebrating the beauty of art and aesthetics via a custom art installation from renowned street artist, HOTTEA. Brand representatives onsite will provide information about Restylane, Dysport and Sculptra and the booth will offer personalized consultations and real-time treatments with Miami-based aesthetic injectors, custom beauty tips and touchups from a celebrity makeup artist. Guests will be able to enjoy a coffee bar featuring latte art and participate in giveaways and meet and greets with A-list influencers throughout the week. Guests can also receive up to $200 off Galderma Aesthetics treatments through a special ASPIRE Galderma Rewards offer.** "Self-expression is a cornerstone of art," Caulkins said. "A recent study*** found that the majority of consumers find it important to be able to visually express themselves, which is why, at Galderma, we embrace and encourage self-expression through the art of aesthetics. We strive to innovate and deliver products that allow patients to fully express a range of emotions, while looking their best." Galderma's presence at SCOPE Miami Beach 2022 builds on the momentum of Restylane's "XpresYourself" communications campaign, aimed at destigmatizing aesthetics and promoting natural-looking results. The brand's proprietary XpresHAn Technology™, a unique manufacturing process used to formulate four Restylane products****, allows for natural movement and expression.1-3 Dysport and Sculptra are also designed to provide natural-looking results, giving consumers a portfolio of products to choose from. SCOPE Art Show's mission to provide a platform for experiential innovation and discovery complements Galderma's commitment to design innovative and effective aesthetic treatments with natural-looking results for every laugh, smile and expression. For those unable to join Galderma at SCOPE Miami Beach 2022, check out RestylaneUSA, DysportUSA and SculptraUSA on Instagram to follow the conversation. To learn more about Galderma's portfolio, visit . *Please see full Important Safety Information for Dysport, including Distant Spread of Toxin Effect Boxed Warning, below. **Terms and conditions apply. For details, visit ASPIRE Galderma Rewards. ***Results based on a nationwide online survey conducted by Real Chemistry of 1,000 directionally representative aesthetically conscious consumers in the U.S. ****Products formulated with XpresHAn Technology™ include Restylane® Contour, Restylane® Kysse, Restylane® Defyne and Restylane® Refyne. About Galderma Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermo-cosmetics and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we're in shapes our lives, we are advancing dermatology for every skin story. For more information: . About Galderma's RESTYLANE® Product Portfolio With over 50 million treatments worldwide4 and counting, the Restylane® family of HA dermal fillers is a diverse and broad portfolio of dermal fillers in the U.S. These products help smooth facial wrinkles and folds, such as smile lines (Restylane® L, Restylane® Refyne, Restylane® Defyne and Restylane® Lyft with Lidocaine), augment and correct mild to moderate chin retrusion (Restylane® Defyne), create fuller and more accentuated lips (Restylane® Silk, Restylane®-L and Restylane® Kysse), add lift and volume to the cheeks and back of the hands (Restylane® Lyft with Lidocaine), and augment cheeks and correct midface contour deficiencies (Restylane® Contour). To learn more about the Restylane® family of HA dermal fillers, visit . About Galderma's collaboration with Ipsen Dysport® (abobotulinumtoxinA) is a prescription injection for temporary improvement in the appearance of moderate to severe frown lines between the eyebrows (glabellar lines) in adults less than 65 years of age. Dysport is also marketed as Azzalure in the EU for the treatment of glabellar lines and lateral canthal lines. Dysport has more than 30 years of clinical experience globally for therapeutic indications and 13 years for aesthetics indications, with extensive clinical evidence of safety and efficacy. It is li-censed for aesthetic indications in 85 markets5 worldwide, Dysport is one of the world's leading brands of aesthetic neuromodulators with over 100 million treatments delivered in the aesthetics indications to date. To learn more about Dysport products, visit . Dysport is manufactured by Ipsen, a global specialty-driven pharmaceutical company. Since 2009, Galderma and Ipsen have had a strategic partnership under which Galderma has promoted and distributed Ipsen's botulinum toxin type A products in aesthetic indications. The Ipsen-Galderma strategic partnership now covers China, the United States, the European Union, Australia, South Korea, Canada, Brazil, Argentina and certain other countries. Ipsen continues to promote Dysport within certain therapeutic indications in countries around the world. For more information on Ipsen, visit . About SCULPTRA® Sculptra® works to help stimulate the skin's own collagen production and is indicated for use in people with healthy immune systems for the correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles.6,7 Sculptra is an injectable biostimulator containing microparticles of poly-l-lactic acid (PLLA) which helps gradually revitalize the skin's structural foundation, providing natural-looking, long-term results for up to 2 years.6† Sculptra was first approved for aesthetic use in 2009 in the United States and is currently available in more than 40 countries globally. To learn more about Sculptra products, visit . † Clinical study ended at 96 weeks (2 years) To earn exclusive rewards, bonuses and discounts on Galderma's aesthetic treatments, join the ASPIRE Galderma Rewards program. To learn more, visit . Media Zach Randles-Friedman Head of U.S. Communications [email protected] +1 (305) 299-5700 DYSPORT IMPORTANT SAFETY INFORMATION Dysport® (abobotulinumtoxinA) is a prescription injection for temporary improvement in the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults less than 65 years of age. Important Safety Information What is the most important information you should know about Dysport? Spread of Toxin Effects: In some cases, the effects of Dysport and all botulinum toxin products may affect areas of the body away from the injection site. Symptoms can happen hours to weeks after injection and may include swallowing and breathing problems, loss of strength and muscle weakness all over the body, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, or loss of bladder control. Swallowing and breathing problems can be life threatening and there have been reports of death. You are at the highest risk if these problems are pre ‐ existing before injection. These effects could make it unsafe for you to drive a car, operate machinery, or do other dangerous activities. Do not have Dysport treatment if you: are allergic to Dysport or any of its ingredients (see the end of the Medication Guide for a list of ingredients), are allergic to cow's milk protein, had an allergic reaction to any other botulinum toxin product, such as Myobloc®, Botox®, or Xeomin®, have a skin infection at the planned injection site, under 18 years of age, or are pregnant or breastfeeding. The dose of Dysport is not the same as the dose of any other botulinum toxin product and cannot be compared to the dose of any other product you may have used. Tell your doctor about any swallowing or breathing difficulties and all your muscle or nerve conditions such as amyotrophic lateral sclerosis [ALS or Lou Gehrig's disease], myasthenia gravis, or Lambert‐Eaton syndrome, which may increase the risk of serious side effects including difficulty swallowing and difficulty breathing. Serious allergic reactions have occurred with the use of Dysport. Dry eye has also been reported. Tell your doctor about all of your medical conditions, including if you have surgical changes to your face, very weak muscles in the treatment area, any abnormal facial change, injection site inflammation, droopy eyelids or sagging eyelid folds, deep facial scars, thick oily skin, wrinkles that can't be smoothed by spreading them apart, or if you are pregnant or breastfeeding or planning to become pregnant or breastfeed. Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal and other natural products. Using Dysport with certain other medicines may cause serious side effects. Do not start any new medicines while taking Dysport without talking to your doctor first. Especially tell your doctor if you: have received any other botulinum toxin product, such as Myobloc® (rimabotulinumtoxinB), Botox® (onabotulinumtoxinA), or Xeomin® (incobotulinumtoxinA), in the last four months or any in the past (be sure your doctor knows exactly which product you received, have recently received an antibiotic by injection, take muscle relaxants, take an allergy or cold medicine, or take a sleep medicine. Common Side Effects The most common side effects are nose and throat irritation, headache, injection site pain, injection site skin reaction, upper respiratory tract infection, eyelid swelling, eyelid drooping, sinus inflammation, and nausea. Ask your doctor if Dysport is right for you. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. Please see Dysport Full Prescribing Information including Medication Guide at DysportUSA.com. RESTYLANE IMPORTANT SAFETY INFORMATION The Restylane family of products are indicated for patients over the age of 21, and includes Restylane®, Restylane-L®, Restylane® Lyft with Lidocaine, Restylane® Silk, Restylane® Kysse, Restylane® Refyne, Restylane® Defyne, and Restylane® Contour. APPROVED USES Restylane® and Restylane-L® are for mid-to-deep injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. Restylane® and Restylane-L® are also indicated for injection into the lips. Restylane® Lyft with Lidocaine is for deep implantation into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds and for cheek augmentation and for the correction of age-related midface contour deficiencies. Restylane® Lyft with Lidocaine is also indicated for injection into the dorsal hand to correct volume loss. Restylane® Silk is for lip augmentation and for correction of perioral wrinkles. Restylane® Kysse is for lip augmentation and for correction of upper perioral wrinkles. Restylane® Refyne is for mid-to-deep injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. Restylane® Defyne is for mid-to-deep injection into the facial tissue for the correction of moderate to severe deep facial wrinkles and folds, such as nasolabial folds. Restylane® Defyne is also indicated for injection into the mid-to deep dermis (subcutaneous and/or supraperiosteal) for augmentation of the chin region to improve the chin profile in patients with mild to moderate chin retrusion. Restylane® Contour is for cheek augmentation and for the correction of midface contour deficiencies. Do not use if you have severe allergies with a history of severe reactions (anaphylaxis), are allergic to lidocaine or gram-positive bacterial proteins used to make hyaluronic acid, prone to bleeding, or have a bleeding disorder. The safety of use while pregnant or breastfeeding has not been studied. Tell your doctor if you have a history of scarring or pigmentation disorders as these side effects can occur with hyaluronic acid fillers. Tell your doctor if you are planning other cosmetic treatments (i.e., lasers and chemical peels) as there is a possible risk of inflammation at the injection site. Tell your doctor if you're taking medications that lower your body's immune response or affect bleeding, such as aspirin or warfarin, as these medications may increase the risk of bruising or bleeding at the gel injection site. Using these products on gel injection sites with skin sores, pimples, rashes, hives, cysts, or infections should be postponed until healing is complete. The most common side effects are swelling, redness, pain, bruising, headache, tenderness, lump formation, itching at the injection site, and impaired hand function. Serious but rare side effects include delayed onset infections, recurrence of herpetic eruptions, and superficial necrosis at the injection site. The risk of unintentional injection into a blood vessel is small but can occur and could result in serious complications, which may be permanent including, vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring of the skin. As with all skin injection procedures, there is a risk of infection. To report a side effect with any Restylane® product, please call Galderma Laboratories, L.P. at 1-855-425-8722. To learn more about serious but rare side effects and full Important Safety Information, visit . SCULPTRA IMPORTANT SAFETY INFORMATION Indication: Sculptra® (injectable poly-L-lactic acid) is indicated for use in people with healthy immune systems for the correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles. Sculptra should not be used by people that are allergic to any ingredient of the product or have a history of keloid formation or hypertrophic scarring. Safety has not been established in patients who are pregnant, lactating, breastfeeding, or under 18 years of age. Sculptra has unique injection requirements and should only be used by a trained healthcare practitioner. Contour deficiencies should not be overcorrected because they are expected to gradually improve after treatment. Sculptra should not be injected into the blood vessels as it may cause vascular occlusion, infarction or embolic phenomena. Use at the site of skin sores, cysts, pimples, rashes, hives or infection should be postponed until healing is complete. Sculptra should not be injected into the red area (vermillion) of the lip or in the peri-orbital area. The most common side effects after initial treatment include injection site swelling, tenderness, redness, pain, bruising, bleeding, itching and lumps. Other side effects may include small lumps under the skin that are sometimes noticeable when pressing on the treated area. Larger lumps, some with delayed onset with or without inflammation or skin discoloration, have also been reported. Sculptra is available only through a licensed practitioner. Complete Instructions for Use are available at . References: Philipp-Dormston WG, Schuster B, Podda M. Perceived naturalness of facial expression after hyaluronic acid filler injection in nasolabial folds and lower face. J Cosmet Dermatol. 2020;19:1600-16064. Öhrlund Å. Evaluation of rheometry amplitude sweep cross-over point as an index of flexibility for HA fillers. JCDSA.2018;8:47-54. Data on file. MA-34483 Study Report. Fort Worth, TX: Galderma Laboratories, L.P., 2021. Data on file. MA-39680. Fort Worth, TX: Galderma Laboratories, L.P., 2019. Data on file. Ipsen World-Wide Marketing Authorisation Status. Fort Worth, TX: Galderma Laboratories, L.P., February 2017. Sculptra. Instructions for Use. Galderma Laboratories, L.P., 2021. Goldberg D, Guana A, Volk A, Daro-Kaftan E. Single-arm study for the characterization of human tissue response to injectable poly-L-lactic acid. Dermatol Surg. 2013;39(6):915-922. © 2022 Galderma Laboratories, L.P. The Dysport® trademark is used under license. All trademarks are the property of their respective owners. US-DYS-2200244 SOURCE Galderma