Heart Valve Diseases

Nuance Communications, part of Microsoft, announced Friday that its Dragon Ambient eXperience Copilot automates clinical documentation during patient appointments in Meditech Expanse electronic health records. WHY IT MATTERS As a partner and a member of the Meditech Alliance Program, Nuance already supports the Expanse EHR with workflow assistance and documentation to help alleviate clinician burnout and improve patient care at the point of care, Nuance said in its announcement. The addition DAX Copilot is an extension of Nuance and Meditech's ongoing collaboration through previous integration with Nuance's cloud-based Dragon Medical One speech recognition software – which earned Best in KLAS four years running. The Dragon Medical platform enables clinicians to use their voices to update patient and clinical information as well as access patient information in EHRs, while DAX Copilot gives healthcare organizations the ability to adopt AI-powered clinical documentation applications at scale. By leveraging unobtrusive generative artificial intelligence and ambient speech recognition technologies during live patient visits, doctors can eliminate manual data entry and immediately review the automated clinical documentation in the Meditech EHR. Generative AI backed by Microsoft resources enhances Meditech's investments in Dragon Medical, said Robert Dahdah, corporate vice president of global health and life sciences and Microsoft, in a statement. THE LARGER TREND Nuance first announced its AI virtual assistance for healthcare technology in 2017 while Meditech, one of the largest EHR developers, has explored an array of AI initiatives and partnerships over the last few years. In 2021, the EHR vendor partnered with Google to adopt advanced natural language processing and large language models. Then in October, Helen Waters, chief operating officer, told Healthcare IT News that the company was using conversational AI in its virtual assistant to automate tasks and augment clinical decision-making , such as for searching patient charts and placing orders. "We carefully evaluate various types of AI," she explained. "We determine which AI can provide the strongest stability to improve the end-user experience and, obviously, more importantly, care outcomes," and "judiciously incorporate those capabilities" into workflows to support health systems in their objectives. Nuance previously announced the integration of DAX Copilot into Epic EHRs in January after a six-month testing phase. According to the company, clinicians surveyed reported a significant reduction in administrative burden with access to the genAI tool. Also, 70% reported that embedded AI in the EHR reduced feelings of burnout and cut time spent on clinical documentation by 50%. "Our clinicians say that DAX Copilot enhances the already vital role of the Epic EHR by making clinical documentation an intuitive and straightforward part of providing high-quality patient care," said Brent Lamm, chief information officer of UNC Health. ON THE RECORD "With DAX Copilot, we will extend our support for conversational and ambient AI to further reduce the documentation burden on today's busy clinicians," Jeff Kimball, Meditech associate vice president, said in a statement. "DAX Copilot is well-aligned with MEDITECH's strategy to accelerate innovation and fundamentally improve physician and patient experiences, clinical efficiency and healthcare costs and outcomes," Dahdah added. Andrea Fox is senior editor of Healthcare IT News. Email: afox@himss.org Healthcare IT News is a HIMSS Media publication.

Initial Data from Ongoing MyPeak™-1 Phase 1b of TN-201 for MYBPC3-associated HCM Expected in Second Half of 2024 On Track to Dose First Patient in RIDGE™-1Phase 1b Clinical Trial of TN-401 for PKP2-associated ARVC in Second Half 2024 $47 Million Net Proceeds from Recent Financing Extends Cash Runway into Second Half of 2025 SOUTH SAN FRANCISCO, Calif., March 18, 2024 (GLOBE NEWSWIRE) -- Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a corporate update. “Tenaya had a successful year of sustained execution in 2023 that meaningfully advanced our portfolio of genetic medicines for heart disease. We announced IND clearance for the TN-201 and TN-401 gene therapy programs; activated clinical trial sites in the USA, Canada, and Europe; dosed the first patient with TN-201; manufactured sufficient clinical trial material for both gene therapy programs at our own cGMP facility; and presented compelling preclinical data from our gene editing and capsid engineering efforts,” said Faraz Ali, Chief Executive Officer of Tenaya. “We look forward to focusing efforts in 2024 on generating early clinical data with TN-201 from the MyPeak-1 study and on initiating patient dosing with TN-401 in the RIDGE-1 study.” Business and Program UpdatesTN-201 – Gene Therapy for MYBPC3-Associated Hypertrophic Cardiomyopathy (HCM) In October 2023, the first patient was dosed in the MyPEAK-1 Phase 1b clinical trial of TN-201 for the treatment of Myosin Binding Protein C3 (MYBPC3)-associated HCM. MyPEAK-1 is a multi-center, open-label, dose-escalation trial designed to assess safety, tolerability and clinical efficacy of a one-time intravenous infusion of TN-201. Tenaya anticipates sharing initial safety, biopsy and biomarker data from the first cohort of patients in MyPEAK-1 trial in the second half of 2024. Tenaya is conducting two non-interventional studies to support the development of TN-201: MyClimb, a natural history study of pediatric patients with MYBPC3-associated HCM and a study evaluating seroprevalence to adeno-associated virus serotype 9 (AAV9) antibodies among adults with MYBPC3-associated HCM. In October 2023, Tenaya shared interim results indicating that a majority of MYBPC3-associated HCM patients could be eligible for TN-201 treatment due to low levels of preexisting neutralizing antibodies to AAV9. TN-401 – Gene Therapy for PKP2-Associated Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC) Tenaya is on track to begin dosing in the RIDGE-1 Phase 1b clinical trial of TN-401 in the second half of 2024. RIDGE-1 is a multicenter, open-label, dose-escalation trial designed to assess safety, tolerability and clinical efficacy of a one-time intravenous infusion of TN-401 for the treatment of ARVC caused by mutations to the Plakophilin-2 (PKP2) gene.In November, TN-401 received Fast Track Designation from the FDA.Tenaya is currently conducting a global, non-interventional seroprevalence and natural history study (RIDGE™) enrolling adult PKP2-associated ARV patients. TN-301 – Small Molecule HDAC6 Inhibitor for Heart Failure with Preserved Ejection Fraction (HFpEF) At the 2023 Heart Failure Society of America Annual Scientific Meeting in October 2023, Tenaya shared positive clinical and preclinical data for its small molecule HDAC6 inhibitor program, TN-301. Results from a Phase 1 dose-escalation study demonstrated that TN-301 was generally well tolerated across the broad range of doses studied. Pharmacokinetic (PK) results showed overall dose proportionality in the single- and multiple-ascending dose stages of the study with a half-life supportive of once-daily dosing. Robust HDAC6 inhibition was observed and increasing doses and exposures with TN-301 correlated with increased pharmacodynamic effects.New preclinical results demonstrated that the combination of Tenaya’s HDAC6 inhibitor with empagliflozin (a sodium-glucose cotransporter-2 inhibitor) achieved additive benefits in validated HFpEF mouse models compared to either compound alone. Follow-on FinancingIn February 2024, Tenaya completed a follow-on offering with net proceeds of $46.5 million after discounts, commissions, and other offering expenses. The offering consisted of approximately 8.89 million shares of common stock priced at $4.50 per share and, in lieu of common stock for one investor, pre-funded warrants to purchase up to an aggregate of approximately 2.2 million shares at a price of $4.499 per pre-funded warrant. The offering included participation from new and existing investors, The Column Group, RA Capital Management, Venrock Healthcare Capital Partners, Octagon Capital, funds and accounts managed by BlackRock, Armistice Capital, Integral Health Asset Management, PFM Health Sciences, LP and Soleus Capital. Fourth Quarter and Full Year 2023 Financial Highlights Cash Position and Guidance: As of December 31, 2023, cash, cash equivalents and investments in marketable securities were $104.6 million. Tenaya expects these funds, combined with net proceeds of $46.5 million from the recent financing, will be sufficient to fund the company into the second half of 2025.Research & Development (R&D) Expenses: R&D expenses were $22.9 million for the fourth quarter and $98.0 million for the full year ended December 31, 2023. Non-cash stock-based compensation included in R&D expense was $1.8 million for the fourth quarter and $7.0 million for the full year ended December 31, 2023.General & Administrative (G&A) Expenses: G&A expenses were $8.6 million for the fourth quarter and $33.2 million for the full year ended December 31, 2023. Non-cash stock-based compensation included in G&A expense was $2.1 million for the fourth quarter and $8.3 million for the full year ended December 31, 2023.Net Loss: Net loss was $29.9 million, or $0.40 per share for the fourth quarter ended December 31, 2023. For the full year 2023, net loss was $124.1 million, or $1.68 per share. About Tenaya TherapeuticsTenaya Therapeutics is a clinical-stage biotechnology company committed to a bold mission: to discover, develop and deliver potentially curative therapies that address the underlying drivers of heart disease. Leveraging integrated proprietary core capabilities enabling target identification and validation, design of AAV-based genetic medicines and in-house manufacturing the company is advancing a pipeline of novel therapies with diverse treatment modalities for rare genetic cardiovascular disorders and more prevalent heart conditions. Tenaya’s most advanced candidates include TN-201, a gene therapy for MYBPC3-associated hypertrophic cardiomyopathy (HCM), TN-401, a gene therapy for PKP2-associated arrhythmogenic right ventricular cardiomyopathy (ARVC), and TN-301, a small molecule HDAC6 inhibitor being initially developed for heart failure with preserved ejection fraction (HFpEF). Tenaya also has multiple early-stage programs progressing through preclinical development. For more information, visit www.tenayatherapeutics.com. Forward Looking StatementsThis press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Words such as “expected,” “on track,” “look forward,” “anticipates,” “expects,” and similar expressions are intended to identify forward-looking statements. Such forward-looking statements include, among other things, Tenaya’s plans and expectations regarding its clinical development efforts and activities, including the planned timing of sharing initial data from MyPeak-1 and planned initiation of patient dosing in RIDGE-1; the clinical, therapeutic and commercial potential of, and expectations regarding, Tenaya’s product candidates; the sufficiency of Tenaya’s cash resources to fund the company into the second half 2025; and statements made by Tenaya’s chief executive officer. The forward-looking statements contained herein are based upon Tenaya’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. These forward-looking statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, including but not limited to: the timing and progress of Tenaya’s clinical trials; availability of data at the referenced times; unexpected concerns that may arise as a result of the occurrence of adverse safety events in Tenaya’s clinical trials; the potential failure of Tenaya’s product candidates to demonstrate safety and/or efficacy in clinical testing; the potential for any clinical trial results to differ from preclinical, interim, preliminary, topline or expected results; risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and operating as an early stage company; Tenaya’s ability to develop, initiate or complete preclinical studies and clinical trials, and obtain approvals, for any of its product candidates; Tenaya’s continuing compliance with applicable legal and regulatory requirements; Tenaya’s ability to raise any additional funding it will need to continue to pursue its business and product development plans; Tenaya’s reliance on third parties; Tenaya’s manufacturing, commercialization and marketing capabilities and strategy; the loss of key scientific or management personnel; competition in the industry in which Tenaya operates; Tenaya’s ability to obtain and maintain intellectual property protection for its product candidates; general economic and market conditions; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in documents that Tenaya files from time to time with the Securities and Exchange Commission. These forward-looking statements are made as of the date of this press release, and Tenaya assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. ContactMichelle CorralVP, Corporate Communications and Investor RelationsIR@tenayathera.com InvestorsAnne-Marie FieldsStern Investor RelationsAnnemarie.fields@sternir.com MediaWendy RyanTen Bridge Communicationswendy@tenbridgecommunications.com TENAYA THERAPEUTICS, INC. Condensed Statements of Operations (In thousands, except share and per share data) (Unaudited) Three Months EndedDecember 31, Year EndedDecember 31, 2023 2022 2023 2022 Operating expenses: Research and development $22,865 $25,748 $98,038 $94,537 General and administrative 8,581 8,802 33,155 31,084 Total operating expenses 31,446 34,550 131,193 125,621 Loss from operations (31,446) (34,550) (131,193) (125,621)Other income, net: Interest income 1,470 1,037 7,056 1,954 Other income (expense), net 41 (3) 53 2 Total other income, net 1,511 1,034 7,109 1,956 Net loss before income tax expense (29,935) (33,516) (124,084) (123,665)Income tax expense — — — — Net loss $(29,935) $(33,516) $(124,084) $(123,665)Net loss per share, basic and diluted $(0.40) $(0.61) $(1.68) $(2.76)Weighted-average shares used in computing net loss per share, basic and diluted 74,097,642 55,250,372 73,786,126 44,823,597 Condensed Balance Sheet Data (In thousands)(Unaudited) December 31, 2023 2022 Cash, cash equivalents and marketable securities $104,642 $204,230 Total assets $170,515 $278,945 Total liabilities $31,091 $35,569 Total liabilities and stockholders’ equity $170,515 $278,945

DALLAS--( BUSINESS WIRE )--AIC, a division of AIS Healthcare, now offers GLASSIA and ARALAST NP, manufactured by Takeda, for the treatment of adult patients with clinically evident emphysema due to severe hereditary deficiency of Alpha 1 -PI (alpha 1 -antitrypsin deficiency). The nationally accredited home infusion teams at AIC collaborate closely with physicians to provide specialized infusion services to patients in their home or at an infusion suite setting. The addition of these therapy options expands AIC’s ability to better serve patients with alpha 1 -antitrypsin deficiency. “We’re excited and proud to be able to add Takeda’s Alpha 1 therapies to our growing portfolio of infusion therapies,” said Jud Hall, President at AIC. “The addition of GLASSIA and ARALAST NP can help us provide patients with more options to meet individual treatment needs.” Approved by the U.S. Food and Drug Administration (FDA) in 2010 and 2002, respectively, GLASSIA and ARALAST NP are Alpha 1 -Proteinase Inhibitors (Human) (Alpha 1 -PI) indicated for chronic augmentation therapy in adults with clinically evident emphysema due to severe hereditary deficiency of Alpha 1 -PI. ARALAST NP increases antigenic and functional (anti-neutrophil elastase capacity, ANEC) serum levels and antigenic lung epithelial lining fluid levels of Alpha 1 -PI. The effect of augmentation therapy with GLASSIA, ARALAST NP, or any Alpha 1 -PI product on pulmonary exacerbations and on the progression of emphysema in Alpha 1 -PI deficiency has not been conclusively demonstrated in randomized, controlled clinical trials. Clinical data demonstrating the long-term effects of chronic augmentation and maintenance therapy of individuals with GLASSIA or ARALAST NP are not available. GLASSIA and ARALAST NP are not indicated as therapies for lung disease in patients in whom severe Alpha 1 -PI deficiency has not been established. Both GLASSIA and ARALAST NP are now available at all AIC locations (Valdosta, Georgia; Birmingham, Alabama; Panama City, Florida; Dallas, Texas). Like all AIC patients, those with alpha 1 -antitrypsin deficiency will receive a high level of care from AIC, including 24/7 access to clinical and support staff. Every patient is assigned a dedicated team of professionals, including clinical pharmacists, home infusion nurses, RN clinical review specialists and patient onboarding specialists to provide support throughout the treatment process. For providers, AIC is a full-service care delivery partner. We also work directly with patients, insurance companies, and provider offices to secure all needed insurance authorizations and approvals. AIC is dually accredited by URAC and the Accreditation Commission for Health Care (ACHC), further setting it apart from other infusion services providers. Physicians interested in AIC care services should contact their AIC representatives to get started or visit us at www.aiscaregroup.com/our-divisions/infusion-care/ About AIS Healthcare Advancing quality. Improving lives. As the leading provider of targeted drug delivery and infusion care solutions, AIS Healthcare is committed to doing more of what matters. From pharmacies that put patient safety first to comprehensive services that enhance the entire care experience, we go beyond the expected in everything we do. Learn more at aiscaregroup.com . About Takeda Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com .