Author: Ken Dropiewski

NewAmsterdam Pharma Announces Issuance of Composition of Matter Patent for Obicetrapib by the United States Patent and Trademark Office

— New patent extends patent term for obicetrapib until July 2043 — NAARDEN, the Netherlands and MIAMI, June 11, 2024 (GLOBE NEWSWIRE) — NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (“CVD”) with elevated low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, today announced that the United States Patent and Trademark Office (“USPTO”) has issued U.S. Patent No. 12,006,305, titled “Salts of Obicetrapib and Processes for their Manufacture and Intermediates Thereof.” The newly issued patent contains claims covering amorphous obicetrapib hemicalcium, the solid form that will be used in the Company’s products and will be listed in the FDA’s “Orange Book” as a drug substance patent, if any such products are approved. The issuance of this composition of matter patent provides intellectual property (“IP”) protection for obicetrapib until July 2043. The USPTO has now issued or allowed a total of nine patents covering obicetrapib and its uses. “We are excited to announce that obicetrapib has been granted our third-generation composition of matter patent by the USPTO, which extends obicetrapib’s IP protection and exclusivity until July 2043, more than 9 years beyond our previous second-generation patent expiration in 2034,” said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam. “There continues to be a need for a safe, efficacious, oral, and potent LDL-lowering therapy. Securing robust patent protection for obicetrapib enables us both to continue the execution of multiple ongoing pivotal Phase 3 trials, as well as reap the potential benefits of obicetrapib’s scientific innovation years beyond potential FDA approval.” About Obicetrapib Obicetrapib is a novel, oral, low-dose CETP inhibitor that NewAmsterdam is developing to overcome the limitations of current LDL-lowering treatments. In each of the Company’s Phase 2 trials, ROSE2, TULIP, ROSE, and OCEAN, evaluating obicetrapib as monotherapy or combination therapy, the Company observed statistically significant LDL-lowering combined with a side effect profile similar to that of placebo. The Company is conducting two Phase 3 pivotal trials, BROADWAY and BROOKLYN, to evaluate obicetrapib as a monotherapy used as an adjunct to maximally tolerated lipid-lowering therapies to provide additional LDL-lowering for CVD patients and TANDEM, to evaluate obicetrapib and ezetimibe as a fixed-dose combination. The Company began enrolling patients in BROADWAY in January 2022, in BROOKLYN in July 2022, and in TANDEM in March 2024; completing enrollment of BROOKLYN in April 2023 and BROADWAY in July 2023. The Company also commenced the Phase 3 PREVAIL cardiovascular outcomes trial in March 2022, which is designed to assess the potential of obicetrapib to reduce occurrences of major adverse cardiovascular events, including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and non-elective coronary revascularization. NewAmsterdam completed enrollment of PREVAIL in April 2024 and randomized over 9,500 patients. About NewAmsterdam NewAmsterdam Pharma (Nasdaq: NAMS) is a late-stage biopharmaceutical company whose mission is to improve patient care in populations with metabolic diseases where currently approved therapies have not been adequate or well tolerated. We seek to fill a significant unmet need for a safe, well-tolerated and convenient LDL-lowering therapy. In multiple phase 3 studies, NewAmsterdam is investigating obicetrapib, an oral, low-dose and once-daily CETP inhibitor, alone or as a fixed-dose combination with ezetimibe, as LDL-C lowering therapies to be used as an adjunct to statin therapy for patients at risk of CVD with elevated LDL-C, for whom existing therapies are not sufficiently effective or well tolerated. Forward-Looking Statements Certain statements included in this document that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding the Company’s intellectual property and its ability to enforce, and sufficiency of, its patents, business and strategic plans, the Company’s commercial opportunity, the therapeutic and curative potential of the Company’s product candidate, the Company’s clinical trials and the timing for enrolling patients, the timing and forums for announcing data, the achievement and timing of regulatory approvals, and plans for commercialization. These statements are based on various assumptions, whether or not identified in this document, and on the current expectations of the Company’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; risks related to the approval of the Company’s product candidate and the timing of expected regulatory and business milestones, including potential commercialization; ability to negotiate definitive contractual arrangements with potential customers; the impact of competitive product candidates; ability to obtain sufficient supply of materials; global economic and political conditions, including the Russia-Ukraine and Israel-Hamas conflict; the effects of competition on the Company’s future business; and those factors described in the Company’s public filings with the Securities Exchange Commission. Additional risks related to the Company’s business include, but are not limited to: uncertainty regarding outcomes of the Company’s ongoing clinical trials, particularly as they relate to regulatory review and potential approval for its product candidate; risks associated with the Company’s efforts to commercialize a product candidate; the Company’s ability to negotiate and enter into definitive agreements on favorable terms, if at all; the impact of competing product candidates on the Company’s business; intellectual property related claims; the Company’s ability to attract and retain qualified personnel; ability to continue to source the raw materials for its product candidate. If any of these risks materialize or the Company’s assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that the Company does not presently know or that the Company currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect the Company’s expectations, plans, or forecasts of future events and views as of the date of this document and are qualified in their entirety by reference to the cautionary statements herein. The Company anticipates that subsequent events and developments may cause the Company’s assessments to change. These forward-looking statements should not be relied upon as representing the Company’s assessment as of any date subsequent to the date of this communication. Accordingly, undue reliance should not be placed upon the forward-looking statements. Neither the Company nor any of its affiliates undertakes any obligation to update these forward-looking statements, except as may be required by law. Company ContactMatthew PhilippeP: 1-917-882-7512matthew.philippe@newamsterdampharma.com Media ContactSpectrum Science on behalf of NewAmsterdamBryan BlatsteinP: 1-917-714-2609bblatstein@spectrumscience.com Investor ContactPrecision AQ on behalf of NewAmsterdamAustin MurtaghP: 1-212-698-8696Austin.Murtagh@precisionaq.com

SS Innovations’ SSi Mantra Surgical Robotic System Approved for Use in Indonesia

FORT LAUDERDALE, Fla., June 11, 2024 (GLOBE NEWSWIRE) — SS Innovations International, Inc. (the “Company” or “SS Innovations”) (OTC: SSII), a developer of innovative surgical robotic technologies dedicated to making world-class robotic surgery affordable and accessible to a global population, today announced that its SSi Mantra Surgical Robotic System has received regulatory approval from the Indonesian Ministry of Health for clinical use in the Republic of Indonesia. With more than 279 million people, Indonesia is the world’s fourth-most-populous country. However, robotic surgery has been slow to reach the island nation. Indonesia’s Bunda Hospital in Jakarta acquired its first robotic surgical system in 2012 and has only completed about 700 surgeries in the past 12 years. “With the entry of the SSi Mantra to the Indonesian market, we believe that we can be instrumental in increasing access to and decreasing costs of robotic surgery options,” said Dr. Sudhir Srivastava, SS Innovation’s Chairman and CEO. “We look forward to broadening surgical horizons for Indonesians and continuing to expand our innovative surgical services and options across the globe.” “I have been in the healthcare business for the past 30 years, and this is the first time I have seen such an impressive technology,” said Mohammad Ridwan, CEO of Neuro Medika Sejahtera, the distributor of the SSi Mantra in Indonesia. “I was very satisfied to see the quality of the SSi Mantra and the advancement offered by the SSi Maya, the Company’s mixed-reality software application. I believe that SS Innovations offers a practical and cost-effective solution to help expand robotic surgery access in Indonesia.” Last month, SS Innovations announced that it had completed 100 robotic cardiac surgery cases in just over a year, utilizing the SSi Mantra Surgical Robotic System. It is the first surgical robotic system made in India, and one of the only systems in the world designed to be cost-effective with broad-spectrum surgical applications. The SSi Mantra is clinically validated in more than 70 different types of surgical procedures. SS Innovations has commenced the regulatory approval process in the United States and the European Union and anticipates receiving FDA approval to market and CE Mark approval in 2025. About SS Innovations International, Inc. SS Innovations International, Inc. (OTC: SSII) is a developer of innovative surgical robotic technologies with a vision to make the benefits of robotic surgery affordable and accessible to a larger part of the global population. SSII’s product range includes its proprietary “SSi Mantra” surgical robotic system, and “SSi Mudra” its wide range of surgical instruments capable of supporting a variety of surgical procedures including robotic cardiac surgery. SSII’s business operations are headquartered in India and SSII has plans to expand the presence of its technologically advanced, user-friendly, and cost-effective surgical robotic solutions, globally. For more information, visit SSII’s website at ssinnovations.com or LinkedIn for updates. About SSi Mantra Supporting advanced, affordable, and accessible robotic surgery, the SSi Mantra Surgical Robotic System provides the capabilities for multi-specialty usage including cardiothoracic, head and neck, gynecology, urology, general surgery and more. With its modular arm configuration, 3D 4K vision open-console design and superior ergonomics, the system engages with the surgeon and surgical teams to improve safety and efficiency during procedures. SS Innovations has partnered with Johns Hopkins University, installing the SSi Mantra at the University’s Minimally Invasive Surgical Training and Innovation Center (MISTIC) in Baltimore, MD. This installation is actively training new surgeons and promoting the global dissemination of advancements in medical robotics. The SSi Mantra system has received Indian Medical Device regulatory approval (CDSCO) and is clinically validated in India in more than 70 different types of surgical procedures. SS Innovations has commenced the regulatory approval process in the United States and the European Union and anticipates receiving FDA approval to market and CE Mark approval in 2025. Forward-Looking StatementsThis press release may contain statements that are not historical facts and are considered forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. The words “anticipate,” “assume,” “believe,” “estimate,” “expect,” “will,” “intend,” “may,” “plan,” “project,” “should,” “could,” “seek,” “designed,” “potential,” “forecast,” “target,” “objective,” “goal,” or the negatives of such terms or other similar expressions to identify such forward-looking statements. These statements relate to future events or SS Innovations International’s future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. For more information:PCG AdvisoryJeff Ramson
jramson@pcgadvisory.com

Positive Six-Month Results from CroíValve’s TANDEM I Study to Treat Tricuspid Regurgitation Presented at New York Valves 2024

DUBLIN–(BUSINESS WIRE)–Favorable patient outcomes from the TANDEM I first-in-human clinical trial of the CroíValve DUO™ System for the percutaneous treatment of tricuspid regurgitation (TR) were presented today by Professor Wojciech Wojakowski at the New York Valves 2024 scientific conference. The […]

Cardio Diagnostics Holdings, Inc. Achieves SOC 2 Type I Compliance Certification for Security and Confidentiality

CHICAGO–(BUSINESS WIRE)–Cardio Diagnostics Holdings, Inc. (NASDAQ: CDIO), a leader in AI-driven precision cardiovascular medicine, today announced the successful completion of its System and Organization Controls (SOC) 2 Type I audit, achieving compliance with the leading industry standards for customer data security. […]

MedsEngine and NI Medical Announce Improved Cardiovascular Outcomes Utilizing NICaS Hemodynamic Measurements with MedsEngine Clinical Decision Support Software for Hypertension

DAYTON, Ohio–(BUSINESS WIRE)–MedsEngine and NI Medical are pleased to announce they will be presenting a comprehensive analysis on their management of hypertension at the European Society of Cardiology 2024 meeting in London. The impact of combining NICaS hemodynamic data with […]

Morton Plant Hospital Offers Robotic-Assisted Coronary Artery Bypass Surgery

CLEARWATER, Fla., June 7, 2024 /PRNewswire/ — Morton Plant Hospital recently completed its first robotic-assisted, minimally invasive coronary artery bypass surgery (CABG), making it one of only two hospitals in the Tampa Bay area to offer robotic-assisted CABG. Morton Plant Hospital was ranked #1 in Florida for Cardiac Surgery in 2023 by Healthgrades.  Cardiothoracic Surgeon Michael Kayatta, MD, and his partner, Cardiovascular Surgeon John Ofenloch, MD, performed the procedure earlier this week, with the assistance of their highly skilled surgical team.  

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Cardiothoracic Surgeon Michael Kayatta, MD (center) works with his surgical team to prepare for Morton Plant Hospital’s first robotic-assisted coronary artery bypass surgery.

CABG surgery is needed when plaque has built up in arteries carrying blood to the heart causing the arteries to be severely narrowed. The surgeon creates a new path for blood to flow by using a healthy artery or vein from another part of the body and connects it past the blockage on the heart. 
In a traditional CABG, the surgeon cuts open the chest by dividing the breastbone and spreads the ribs to expose the heart. The heart is stilled, requiring the patient to be on a heart-lung machine during the surgery. Full recovery often takes about two months. The robotic-assisted CABG only requires four small incisions between the ribs. A small camera and surgical tools are attached to the robotic arms and guided through the incisions. The heart continues to beat through the procedure, with special tools stabilizing a part of the heart.Cardiothoracic Surgeon Michael Kayatta, MD (center) works with his surgical team to prepare for Morton Plant Hospital’s first robotic-assisted coronary artery bypass surgery.The computer console, which shows images of the heart magnified up to 10 times normal vision, gives the surgeon the ability to guide the surgical instruments, attached to the robotic arms, with his fingers while watching the screen. The robotic arms that are controlled by the surgeon have greater range of motion and are more precise than human arms. A major potential benefit of a robotic-assisted CABG is a quicker recovery for the patient. The smaller incisions should also result in less scarring. “We are excited to bring this new technology to patients at Morton Plant Hospital,” said Dr. Kayatta. “Many people hear robot and think a machine will be doing the surgery. We have a highly skilled, experienced team performing each surgery. The robot is simply a tool that helps us to treat more patients and get them back to their life in weeks rather than months.” Drs. Kayatta and Ofenloch are both with BayCare Medical Group’s Cardiovascular and Thoracic Surgery clinic in Clearwater.  For more information on heart and vascular services at BayCare: Heart and Vascular Services.About BayCareBayCare is a leading not-for-profit health care system that connects individuals and families to a wide range of services at 16 hospitals and hundreds of other convenient locations throughout the Tampa Bay and central Florida regions. The system is West Central Florida’s largest provider of behavioral health and pediatric services and its provider group, BayCare Medical Group, is one of the largest in the region. BayCare’s diverse network of ambulatory services includes laboratories, imaging, surgical centers, BayCare Urgent Care locations, wellness centers and one of Florida’s largest home care agencies, BayCare HomeCare. BayCare’s mission is to improve the health of all it serves through community-owned, health care services that set the standard for high-quality, compassionate care. For more information visit BayCare.org.SOURCE Morton Plant Hospital

BioMarin Presents New Phase 3, Four-Year Data Underscoring Long-Term Safety and Efficacy of ROCTAVIAN® (valoctocogene roxaparvovec-rvox) at International Society on Thrombosis and Haemostasis 2024 Congress

Data from Longest and Largest Hemophilia Gene Therapy Study Show Durable and Sustained Bleed Control and Factor VIII Expression Maintained Four Years Post-ROCTAVIAN Infusion
Additional Data Show Meaningful Impact of ROCTAVIAN on Health-Related Quality of Life (HRQoL) 
SAN RAFAEL, Calif., June 7, 2024 /PRNewswire/ — BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) today announced that new data supporting the long-term safety and efficacy of ROCTAVIAN® (valoctocogene roxaparvovec-rvox) will be presented at the 32nd Congress of the International Society on Thrombosis and Haemostasis (ISTH) in Bangkok, Thailand, June 22-26, 2024.
“We are pleased to share data at ISTH demonstrating that ROCTAVIAN continues to offer durable and sustained bleed control and endogenous factor VIII expression four years after the infusion, representing the longest and largest Phase 3 follow-up results of a gene therapy in hemophilia,” said Hank Fuchs, M.D., president of Worldwide Research and Development at BioMarin. “Importantly, these Phase 3 data also indicate a plateauing of factor VIII levels after year three with the majority of patients remaining off prophylaxis, which shows ROCTAVIAN can offer long-term bleed protection for adults with severe hemophilia A and may provide relief from the burden of chronic infusions and injections.”  
Four-Year Data from Largest Phase 3 Hemophilia Gene Therapy Study Demonstrate Long-Term Safety and Efficacy of ROCTAVIANThe Phase 3 GENEr8-1 trial demonstrated that durable bleed control and sustained factor VIII (FVIII) expression were maintained four years after treatment with ROCTAVIAN, with FVIII activity near stable compared with results reported previously and no new safety signals observed. Of the 134 patients who received ROCTAVIAN in the study, the rollover population of 112 patients had baseline annualized bleeding rate (ABR) data prospectively collected during a period of at least six months while on routine FVIII prophylaxis prior to receiving ROCTAVIAN, and two of the 112 patients discontinued the study prior to year four. During year four, 73.6% of the remaining participants (81/110) had zero treated bleeds. Over the entire study period to the time of the data cut, 24 of the 134 total participants resumed prophylaxis with either FVIII or emicizumab without any complications. Mean FVIII activity at the end of year four (n=130) was 27.1 and 16.1 IU/dL as assessed by one-stage assay (OSA) and chromogenic assay (CSA), respectively. These levels are near stable from the previously reported three-year data. Over four years, the mean ABR for treated bleeds for the rollover population was 0.8 bleeds/year, and the mean ABR for all bleeds was 1.3 bleeds/year.
Table 1. Rates of bleeding and FVIII use over four years post-ROCTAVIAN treatment in the rollover population (N=112)

Baseline
Year four
All post-prophylaxis cessation (week 5 to data cutoff)

(n=112)
(n=110)
(n=112)

ABR (treated), bleeds/year

Mean ± standard deviation (SD)
4.8 ± 6.5
0.9 ± 2.3
0.8 ± 2.0

Median (Q1, Q3)
2.8 (0.0, 7.6)
0.0 (0.0, 1.0)
0.0 (0.0, 0.5)

  Annualized FVIII infusion rate, number/year

Mean ± SD
135.9 ± 52.0
10.6 ± 29.5
6.1 ± 15.6

Median (Q1, Q3)
128.6 (104.1, 159.9)
0.0 (0.0, 3.0)
0.6 (0.0, 3.0)

  ABR (all), bleeds/year

Mean ± SD
5.4 ± 6.9
1.2 ± 2.5
1.3 ± 2.2

Median (Q1, Q3)
3.3 (0.0, 7.9)
0.0 (0.0, 1.0)
0.5 (0.0, 1.3)

  Participants with 0 bleeds (treated), n (%)
36 (32.1)
81 (73.6)
61 (54.5)

  Participants with 0 bleeds (all), n (%)
34 (30.4)
68 (61.8)
29 (25.9)

Results Suggest Positive Impact of ROCTAVIAN on Health-Related Quality of LifeIn an additional analysis from the Phase 3 GENEr8-1 study, ROCTAVIAN provided important improvements in health-related quality of life (HRQoL) over four years in people with severe hemophilia A, even for those with FVIII levels below 5%. These improvements were measured using the Haemo-QOL-A assessment, a questionnaire designed to measure HRQoL in people with hemophilia A and B. Four years after treatment, the average Haemo-QOL-A Total Score increased by 6.2 points from baseline, with improvements observed in Physical Functioning (4.8 points), Role Functioning (5.9 points), and Consequences of Bleeding (9.2 points). Based on FVIII activity at year four, average Haemo-QOL-A Total Score increased by 6.3, 5.8, and 6.9 points for participants with FVIII activity in ranges ≥40%, ≥5% to ULN. Patients also experienced adverse reactions from corticosteroid use.
Isotretinoin, Efavirenz, and HIV Positive Patients: Isotretinoin is not recommended in patients who are benefiting from ROCTAVIAN. Efavirenz is not recommended in patients treated with ROCTAVIAN. Clinical studies of ROCTAVIAN did not include sufficient numbers of patients with HIV to determine whether the efficacy and safety differs compared to patients without HIV infection.
Females and Males of Reproductive Potential: ROCTAVIAN is not intended for administration in women. There are no data on the use of ROCTAVIAN in pregnant women or regarding lactation. For 6 months after administration of ROCTAVIAN, men of reproductive potential and their female partners must prevent or postpone pregnancy using an effective form of contraception, and men must not donate semen.
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to BioMarin at 1-866-906-6100.
Please see the ROCTAVIAN full Prescribing Information for additional Important Safety Information.
About BioMarin
Founded in 1997, BioMarin is a global biotechnology company dedicated to transforming lives through genetic discovery. The company develops and commercializes targeted therapies that address the root cause of genetic conditions. BioMarin’s unparalleled research and development capabilities have resulted in eight transformational commercial therapies for patients with rare genetic disorders. The company’s distinctive approach to drug discovery has produced a diverse pipeline of commercial, clinical, and pre-clinical candidates that address a significant unmet medical need, have well-understood biology, and provide an opportunity to be first-to-market or offer a substantial benefit over existing treatment options. For additional information, please visit www.biomarin.com.
Forward-Looking Statements
This press release contains forward-looking statements about the business prospects of BioMarin Pharmaceutical Inc. (BioMarin), including without limitation, statements about: data to be presented at the 32nd Congress of the International Society on Thrombosis and Haemostasis, including the oral and poster presentations; the development of BioMarin’s ROCTAVIAN program generally; the safety profile, efficacy and potential positive impact of ROCTAVIAN for adults with severe hemophilia A; and the potential benefits of ROCTAVIAN for adults with severe hemophilia A, including offering long-term bleed protection, providing relief from the burden of chronic infusions and injections, helping treated patients move more freely and reducing the burden of caring for bleeding episodes. These forward-looking statements are predictions and involve risks and uncertainties such that actual results may differ materially from these statements. These risks and uncertainties include, among others: results and timing of current and planned preclinical studies and clinical trials of ROCTAVIAN; any potential adverse events observed in the continuing monitoring of the patients in the clinical trials; the content and timing of decisions by the Food and Drug Administration, the European Commission and other regulatory authorities; BioMarin’s success in the commercialization of ROCTAVIAN, including achieving adequate market share and reimbursement levels; whether ROCTAVIAN will have the impacts and benefits as anticipated; and those factors detailed in BioMarin’s filings with the Securities and Exchange Commission, including, without limitation, the factors contained under the caption “Risk Factors” in BioMarin’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, as such factors may be updated by any subsequent reports. Stockholders are urged not to place undue reliance on forward-looking statements, which speak only as of the date hereof. BioMarin is under no obligation, and expressly disclaims any obligation to update or alter any forward-looking statement, whether as a result of new information, future events or otherwise.
BioMarin® and ROCTAVIAN® are registered trademarks of BioMarin Pharmaceutical Inc.

Contacts:

Investors                               
Media

Traci McCarty                   
Andrew Villani

BioMarin Pharmaceutical Inc.        
BioMarin Pharmaceutical Inc.

(415) 455-7558                  
(628) 269-7393

SOURCE BioMarin Pharmaceutical Inc.

BioCardia Announces United States Patent Issuance on Intramyocardial Delivery of Cell Aggregates to the Heart Including Minimally Invasive Radial Artery Approach

SUNNYVALE, Calif., June 07, 2024 (GLOBE NEWSWIRE) — BioCardia®, Inc. [Nasdaq: BCDA], a company focused on cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announces that the Unites States Patent Office has granted Patent No: 11,986,611 titled “Radial and Transendocardial Delivery Catheter,” with a patent term that will expire in 2036.   The present invention relates to medical methods and systems suitable for substance delivery to the heart via a radial artery and for the intracardiac delivery of cellular aggregates and other agglomerated materials. Radial artery delivery is a means by which cardiac catheters are advanced through a blood vessel in a patient’s wrist to treat the heart. This approach has significant advantages for patients, enabling them to leave the hospital soon after the procedure with a band aid on their wrist and their arm in a simple sling, allowing them to immediately return to their active lives. In addition, a radial approach permits hospitals and other care centers to greatly reduce costs by eliminating the need for an overnight stay by the patient. For these reasons, trans-radial access is becoming the default approach in many cardiac centers worldwide. Enabling radial access has enormous potential advantages for biotherapeutic delivery to the heart.   BioCardia’s Helix system, used in our ongoing clinical trials, is the only known system with patented designs that can enable radial transendocardial biotherapeutic delivery. The issued patent claims further protect this approach and add value to both BioCardia’s therapeutic programs and those of our biotherapeutic delivery partners. Therapeutic cell aggregates have the potential advantage over single cell suspensions by enhancing retention in the heart to maximize therapeutic benefit. However, the delivery of cell aggregates carries greater risks of potentially life-threatening strokes should they leak into the ventricular chamber. As 20% of the blood in the heart chamber goes to the brain, 20% of any cell or cell aggregates released in the heart are expected to obstruct the first cerebral artery that is too small to allow the cell or cell aggregate to pass. The larger the cell aggregate, the larger the vessel they are capable of obstructing, with greater risk of a significant life-threatening stroke. BioCardia’s delivery systems are designed to prevent leakage of therapeutic agents into the ventricular chamber by providing stable and safe engagement to the heart tissue during the delivery process. The issued patent claims further protect this design and add value to both BioCardia’s therapeutic programs and those of our biotherapeutic delivery partners. “Our minimally invasive biotherapeutic delivery platforms enable the successful development of cell and gene-based therapies for the heart,” said Dr. Peter Altman, BioCardia CEO. “The Helix platform underlies BioCardia’s cell therapy clinical programs and this recent patent issuance provides additional protection to our technology and product offerings in the United States for at least another dozen years. This is just one of many patent applications we are advancing to protect our value creation for the benefit of shareholders, which in turn enables these advances to be supported for expected benefit to millions of patients.” About BioCardia® BioCardia, Inc., headquartered in Sunnyvale, California, is developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases. CardiAMP™ autologous and CardiALLO allogeneic cell therapies are the Company’s biotherapeutic platforms in three clinical stage product candidates in development. BioCardia also partners with other biotherapeutic companies to provide its delivery systems and development support to their programs. For more information visit: www.BioCardia.com. Forward Looking Statements: This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, references to the Company’s investigational product candidates, the benefits and risks of cell aggregates, the benefits of radial artery access, the level and duration of patent protection that the Company’s patents provide to its product candidates, and the expected safety of BioCardia’s delivery device designs. These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements. We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 27, 2024, under the caption titled “Risk Factors” And in its subsequently filed Quarterly Reports on Form 10-Q. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.