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MAPLE GROVE, Minn., Aug. 5, 2024 /PRNewswire/ -- Upsher-Smith Laboratories, LLC (Upsher-Smith) today announced the recent launch of TORPENZ™ (everolimus) Tablets in 2.5 mg, 5 mg, 7.5 mg and 10 mg strengths. TORPENZ™ is an oral mTOR inhibitor used in patients with Tuberous Sclerosis Complex (TSC). Upsher-Smith's TORPENZ™ (everolimus) Tablets are indicated for the treatment of adult patients with renal angiomyolipoma and TSC, not requiring immediate surgery and is also indicated in adult and pediatric patients aged 1 year and older with TSC for the treatment of subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. Continue Reading TORPENZ™ (everolimus) Tablets, 2.5 mg, 5 mg, 7.5 mg and 10 mg. Upsher-Smith Laboratories, LLC. "As our specialty product portfolio continues to grow, Upsher-Smith remains committed to understanding the unique needs of rare disease communities and providing value-added services that ease access to critical medications," said Jim Maahs, Vice President, Specialty & Rare Disease. "TORPENZ™ is the only everolimus backed our Promise of Support™ Program – a patient-centered initiative designed to offer patients, caregivers, and healthcare providers in the rare disease community comprehensive support throughout the treatment journey." The Upsher-Smith Promise of Support™ Program ensures timely and reliable access to specialty medications through customized services such bridge and starter medication supply. Through its partnership with specialty pharmacy, PANTHERx® Rare, Upsher-Smith commits to providing a best-in-class experience for patients requiring rare disease medications, responding with urgency, and maintaining clear, open communication. It also includes copay assistance for eligible patients to help lessen the financial burden on patients and their families. To learn more about TORPENZ™ and the Upsher-Smith Promise of Support™ Program, visit . Product Information For questions about ordering, please call Upsher-Smith at 1-800-654-2299. Please refer to the full Prescribing Information for TORPENZ™ (everolimus) Tablets, USP here . You can also call 1-888-650-3789 to obtain a copy of the full Prescribing Information. You are encouraged to report suspected adverse reactions to Upsher-Smith Laboratories, LLC at 1-855-899-9180 or to the FDA by visiting . WHAT IMPORTANT SAFETY INFORMATION SHOULD I KNOW ABOUT TORPENZ™ ( everolimus) TABLETS in Tuberous Sclerosis Complex? Do not take TORPENZ if you have had an allergic reaction to everolimus. Talk to your healthcare provider before taking TORPENZ if you are allergic to sirolimus or temsirolimus. Ask your provider if you do not know. TORPENZ can cause serious side effects, including: Lung or breathing problems. In some people, these may be severe and can be life threatening. Tell your healthcare provider right away if you have new or worsening cough, shortness of breath, chest pain, difficulty breathing or wheezing. Higher likelihood of infection such as pneumonia, or a bacterial, fungal, or viral infection. Viral infections may include active hepatitis B in people who have had hepatitis B in the past (reactivation). In some adults and children, these infections may be severe and can be life threatening. You may need to be treated as soon as possible. Tell your healthcare provider right away if you have a temperature of 100.5˚F or above, chills, or do not feel well. Symptoms of infection may include: Severe allergic reactions. Get medical help right away if you have signs of an allergic reaction, including rash, itching, hives, flushing, trouble breathing or swallowing, chest pain or dizziness. Possible increased risk for a type of allergic reaction called angioedema in people who take an Angiotensin-Converting Enzyme (ACE) inhibitor with TORPENZ. Talk with your healthcare provider before taking TORPENZ if you are not sure if you take an ACE inhibitor. Get medical help right away if you have trouble breathing or develop swelling of your tongue, mouth, or throat during treatment with TORPENZ. Mouth ulcers and sores. Mouth ulcers and sores are common during treatment with TORPENZ but can also be severe. When you start TORPENZ, your healthcare provider may tell you to also start a prescription mouthwash to reduce the likelihood of getting mouth ulcers or sores and to reduce their severity. Follow your provider's instructions on how to use this mouthwash. If you develop pain, discomfort, or open sores in your mouth, tell your provider. Kidney failure. In some people, this may be severe and can be life threatening. Your healthcare provider should check your kidney function before and during treatment. Wound healing problems. Wounds may not heal properly during TORPENZ treatment. Tell your healthcare provider if you plan to have any surgery before starting or during treatment. You should stop TORPENZ at least 1 week before planned surgery. Your provider should tell you when to start taking TORPENZ again after surgery. Increased blood sugar and fat (cholesterol and triglyceride) levels in the blood. Your healthcare provider should check your fasting blood sugar, cholesterol, and triglyceride levels in the blood before you start and during treatment. Decreased blood cell counts. TORPENZ can cause you to have decreased red blood cells, white blood cells and platelets. Your healthcare provider should check your blood cell counts before you start and during treatment. Worsening side effects from radiation treatment that can sometimes be severe. Tell your healthcare provider if you have had or are planning to receive radiation therapy. Before taking TORPENZ, tell your healthcare provider about all of your medical conditions, including if you: Have or have had kidney or liver problems, have diabetes or high blood sugar, have high blood cholesterol, have any infections, or previously had hepatitis B. Are scheduled to receive any vaccinations. You should not receive a "live vaccine" or be around people who have recently received a "live vaccine" during your treatment with TORPENZ. If you are not sure about the type of immunization or vaccine, ask your provider. For children, work with your provider to complete the recommended childhood series of vaccines before your child starts TORPENZ. Are pregnant, can become pregnant, or have a partner who can become pregnant. TORPENZ can cause harm to your unborn baby. For females who are able to become pregnant, your provider will give you a pregnancy test before you start TORPENZ. Use effective birth control during treatment and for 8 weeks after your last dose of TORPENZ. Males with a female partner should use effective birth control during treatment and for 4 weeks after your last dose of TORPENZ. Are breastfeeding or plan to breastfeed. Do not breastfeed during treatment and for 2 weeks after your last dose of TORPENZ. Are planning to have or have had a recent surgery. You should stop taking TORPENZ at least 1 week before planned surgery. Have received or are planning to receive radiation therapy. Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking TORPENZ with some medicines can cause serious side effects. Keep a list of medications you take, and show it to your healthcare provider and pharmacist when you get a new medicine. Especially tell your provider if you take: St. John's Wort (Hypericum perforatum) Medicine for fungal or bacterial infections, tuberculosis, seizures, HIV-AIDS, heart conditions or high blood pressure, including ACE inhibitors Medicines that weaken your immune system (your body's ability to fight infections and other problems) Ask your provider or pharmacist if you are not sure if your medicine is one of those taken for the conditions listed above. If you are taking any medicines for the conditions listed above, your provider might need to prescribe a different medicine or your dose of TORPENZ may need to be changed. Tell your provider before you start any new medicine. You should not drink grapefruit juice or eat grapefruit during your treatment with TORPENZ. It may make the amount of TORPENZ in your blood increase to a harmful level. The most common side effect of TORPENZ in people who have SEGA or renal angiomyolipoma include respiratory tract infection. Other side effects that may occur with TORPENZ: Absence of menstrual periods (menstruation). Tell your healthcare provider if this happens. TORPENZ may affect fertility and may affect your ability to become pregnant if you are female or your ability to father a child if you are male. Talk to your provider if this is a concern. Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of TORPENZ. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You can also visit TORPENZ.com, upsher-smith.com or call 1-888-650-3789. You are encouraged to report negative side effects of prescription drugs to FDA. Visit or call 1-800-332-1088. WHAT ARE TORPENZ (everolimus) TABLETS? TORPENZ is a prescription medicine used to treat the following types of benign (non-cancerous) tumors that are seen with a genetic condition called tuberous sclerosis complex (TSC): Brain tumors called subependymal giant cell astrocytoma (SEGA), when the tumor cannot be removed completely by surgery, in adults and children 1 year and older. Kidney tumors called angiomyolipoma, when the tumor does not require surgery right away, in adults. For additional information, including safety information, for non-TSC indications, see the full Prescribing Information, including Patient Information. About Tuberous Sclerosis Complex Tuberous Sclerosis Complex (TSC) is a rare genetic disease that causes non-cancerous (benign) tumors to grow in the brain and several areas of the body, including the spinal cord, nerves, eyes, lung, heart, kidneys, and skin. Nearly one million people worldwide are estimated to be living with TSC, with approximately 50,000 in the United States. About Upsher-Smith Upsher-Smith Laboratories, LLC, now a member of Bora Group, is a trusted U.S. pharmaceutical company that strives to improve the health and lives of patients through an unwavering commitment to high-quality products and sustainable growth. We bring generics and brands to a wide array of customers, always backed by our attentive level of service, strong industry relationships, and dedication to uninterrupted supply. For more information, visit . About Bora Founded in 2007, Bora Pharmaceutical Co., Ltd. ("Bora" or "the Company", 6472.TW) now is the largest pharmaceutical manufacturer in Taiwan with well-connected global distribution to supply more than 100 countries around the world. Headquartered in Taiwan, Bora has dedicated itself to becoming a global leader in pharmaceutical manufacturing by offering its clients the best quality, efficiency and reliability. TORPENZ and PROMISE OF SUPPORT are trademarks of Upsher-Smith Laboratories, LLC. SOURCE Upsher-Smith Laboratories

91% of Venous Ulcer Patients Evaluated at One Year Have Either Fully Healed Ulcers or Ulcers That Have Improved 100% of Venous Ulcers with a Duration of One Year or Less Prior to VenoValve Surgery Have Fully Healed 89% of Venous Ulcers with a Duration of More Than One Year Prior to VenoValve Surgery Have Fully Healed or Improved No Ulcer Recurrences Company on Track to File Application Seeking VenoValve FDA Approval in Q4 2024 IRVINE, CA / ACCESSWIRE / June 21, 2024 / enVVeno Medical Corporation (NASFAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, today announced that positive interim venous ulcer healing data showing significant clinical improvement from the SAVVE U.S. pivotal trial for the VenoValve will be presented today at the Society for Vascular Surgery 2024 Vascular Annual Meeting in Chicago. The data being presented includes twenty-one venous ulcer patients who have now reached the one-year milestone, representing thirty venous ulcers. Overall, 91% of venous ulcer patients evaluated at one year have either fully healed ulcers or ulcers that have improved. Of that group, 100% of venous ulcers with a duration of one year or less prior to VenoValve surgery have fully healed, with the majority (67%) fully healed 90 days after VenoValve surgery. For venous ulcers with a duration of more than one year prior to VenoValve surgery, 89% have either fully healed or improved at one year, representing a decrease in average of total ulcer of 85%. In addition, none of the patients with a fully healed venous ulcer have experienced an ulcer recurrence. "We are very pleased with the interim VenoValve ulcer healing data, especially when you consider this very difficult to treat population of patients who all failed conventional treatments such as wound care and compression therapy, and many of which did not respond to more invasive treatments for CVI such as ablation therapy for superficial disease and/or stenting for iliofemoral obstruction," said Robert Berman, enVVeno Medical's CEO. "Our data shows the importance of the deep venous system to ulcer healing, supports the VenoValve as a part of a new treatment paradigm for the large population of patients with venous ulcers who have deep venous disease, and provides evidence that it is better to treat venous ulcer patients with the VenoValve sooner after ulcer occurrence (within one year, if possible), for faster and complete ulcer healing." Venous ulcers in the SAVVE study were evaluated with the help of an U.S. Food and Drug Administration (FDA) registered scientific calibrant applied to each venous ulcer image to track wound healing over time. The technology relies on artificial intelligence to accurately measure wound circumference and progress. Severe Chronic Venous insufficiency (CVI) is a debilitating disease that is most often caused by blood clots (deep vein thromboses or DVTs) in the deep veins of the leg. When valves inside of the veins of the leg fail, blood flows in the wrong direction and pools in the lower leg, causing pressure within the veins of the leg to increase (venous hypertension). Symptoms of severe CVI include leg swelling, pain, edema, and in the most severe cases, recurrent open sores known as venous ulcers. The disease can severely impact everyday functions such as sleeping, bathing, and walking, and is known to result in high rates of depression and anxiety. There are currently no effective treatments for severe CVI of the deep vein system caused by valvular incompetence and the Company estimates that there are approximately 2.5 million new patients each year in the U.S. that could be candidates for the VenoValve. The Surgical Anti-reflux Venous Valve Endoprosthesis (SAVVE) U.S. pivotal study for the VenoValve is a prospective, non-blinded, single arm, multi-center study of seventy-five (75) CVI patients enrolled at 21 U.S. sites. The FDA has asked the Company to collect a minimum of one year of data on all SAVVE patients prior to filing its PMA application seeking FDA approval, which the Company expects to Q4 of this year. As of March 31, 2024, the Company had cash and investments of $42.9 million on hand, which the Company expects to be sufficient capital to fund operations through an FDA decision on the VenoValve and the end of 2025. Today's presentation, entitled The Impact of VenoValve Implantation on Venous Ulcer Healing in Patients with Deep Venous Reflux,which will be made by primary investigator Dr. Cassius Iyad Ochoa Chaar, Associate Professor Surgery, Yale School of Medicine, Division of Vascular and Endovascular Surgery. Excerpts will be made available after the presentation on the Company's website. About enVVeno Medical Corporation enVVeno Medical (NASDAQ:NVNO) is an Irvine, California-based, late clinical-stage medical device Company focused on the advancement of innovative bioprosthetic (tissue-based) solutions to improve the standard of care for the treatment of venous disease. The Company's lead product, the VenoValve®, is a first-in-class surgical replacement venous valve being developed for the treatment of deep venous Chronic Venous Insufficiency (CVI). The Company is also developing a non-surgical, transcatheter based replacement venous valve for the treatment of deep venous CVI called enVVe®. CVI occurs when valves inside of the veins of the leg become damaged, resulting in the backwards flow of blood (reflux), blood pooling in the lower leg, increased pressure in the veins of the leg (venous hypertension) and in severe cases, venous ulcers that are difficult to heal and become chronic. Both the VenoValve and enVVe are designed to act as one-way valves, to help assist in propelling blood up the leg, and back to the heart and lungs. The VenoValve is currently being evaluated in the SAVVE U.S. pivotal trial and the company is currently performing the final testing necessary to seek approval for the enVVe pivotal trial. Cautionary Note on Forward-Looking Statements This press release and any statements of stockholders, directors, employees, representatives and partners of enVVeno Medical Corporation (the "Company") related thereto contain, or may contain, among other things, certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential" or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission. Actual results and timing may differ significantly from those set forth or implied in the forward-looking statements. Forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future presentations or otherwise, except as required by applicable law. ### INVESTOR CONTACT: Jenene Thomas, JTC Team, LLC NVNO@jtcir.com (833) 475-8247 SOURCE: enVVeno Medical Corporation View the original press release on accesswire.com

IRVINE, CA / ACCESSWIRE / June 17, 2024 / enVVeno Medical Corporation (Nasdaq:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, today announced that new interim venous ulcer healing data from the VenoValve U.S. pivotal trial will be presented at the Society for Vascular Surgery 2024 Vascular Annual Meeting (VAM2024) being held June 18-22, 2024 in Chicago, IL. The presentation, entitled "The Impact of VenoValve Implantation on Venous Ulcer Healing in Patients with Deep Venous Reflux," will be made on Friday, June 21, 2024 by primary investigator Dr. Cassius Iyad Ochoa Chaar MD, MS, RPVI, Associate Professor of Surgery, Division of Vascular Surgery, Yale School of Medicine, the top enrolling site for the trial. The data to be presented will include venous ulcer healing and improvement rates for venous ulcer patients who have now reached the one-year milestone in the Company's Surgical Anti-reflux Venous Valve Endoprosthesis (SAVVE) U.S. pivotal study for the VenoValve. Overall healing or improvement rate data for thirty-one ulcers among twenty-one patients will be presented, and the presentation will also include sub-categories for ulcers that existed for more than one year and less than one year prior to the VenoValve surgery. Recurrence rate data for any venous ulcers that fully healed, and then recurred, will also be presented. Excerpts from the presentation will be made available on the Company's website. In assessing the benefit and risk of a novel technology such as the VenoValve, which addresses an unmet medical need, the U.S. Food and Drug Administration (FDA) considers whether a medical device provides a clinically meaningful benefit compared to existing technologies. Subjects with venous ulcers who were enrolled in the SAVVE study all received at least three (3) months of conventional treatment with existing technologies (compression therapy, leg elevation, and wound care) and many also received vein ablations for superficial venous disease, and venous stenting for obstruction, if indicated. As a result, the venous ulcer patients in the SAVVE study are the most difficult to treat, having venous ulcers that remained after at least three and as many as five types of existing treatments. Severe Chronic Venous Insufficiency (CVI) is a debilitating disease that most often occurs when valves inside of the veins of the leg fail, causing blood to flow in the wrong direction (reflux) and increased pressure within the veins of the leg (venous hypertension). Symptoms of severe CVI include leg swelling, pain, edema, and recurrent open sores known as venous ulcers. The disease can severely impact everyday functions such as sleeping, bathing, and walking, and is known to result in high rates of depression and anxiety. There are currently no effective treatments for severe CVI of the deep vein system caused by valvular incompetence and the Company estimates that there are approximately 2.5 million new patients each year in the U.S. that could be candidates for the VenoValve. The FDA has asked the Company to collect one year data on all SAVVE patients to support its PMA application seeking FDA approval to market and sell the VenoValve, which the Company expects to Q4 of this year. For more information about the 2024 Vascular Annual Meeting, please visit vascular.org/vam-2024. About enVVeno Medical Corporation enVVeno Medical (NASDAQ:NVNO) is an Irvine, California-based, late clinical-stage medical device Company focused on the advancement of innovative bioprosthetic (tissue-based) solutions to improve the standard of care for the treatment of venous disease. The Company's lead product, the VenoValve®, is a potential first-in-class surgical replacement venous valve being developed for the treatment of deep venous Chronic Venous Insufficiency (CVI). The Company is also developing a non-surgical, transcatheter based replacement venous valve for the treatment of deep venous CVI called enVVe®. CVI occurs when valves inside of the veins of the leg become damaged, resulting in the backwards flow of blood (reflux), blood pooling in the lower leg, increased pressure in the veins of the leg (venous hypertension) and in severe cases, venous ulcers that are difficult to heal and become chronic. Both the VenoValve and enVVe are designed to act as one-way valves, to help assist in propelling blood up the leg, and back to the heart and lungs. The VenoValve is currently being evaluated in the SAVVE U.S. pivotal trial and the Company is currently performing the final testing necessary to seek approval for the enVVe pivotal trial. Cautionary Note on Forward-Looking Statements This press release and any statements of stockholders, directors, employees, representatives and partners of enVVeno Medical Corporation (the "Company") related thereto contain, or may contain, among other things, certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential" or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission. Actual results and timing may differ significantly from those set forth or implied in the forward-looking statements. Forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future presentations or otherwise, except as required by applicable law. INVESTOR CONTACT: Jenene Thomas, JTC Team, LLC NVNO@jtcir.com (833) 475-8247 SOURCE: enVVeno Medical View the original press release on accesswire.com